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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

(Mark one)

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2015

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

COMMISSION FILE NUMBER 1-35144

Sagent Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   98-0536317

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1901 N. Roselle Road, Suite 700, Schaumburg, Illinois   60195
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: 847-908-1600

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered

Common Stock, $0.01 par value per share   NASDAQ Global Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ¨    No  x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer   ¨        Accelerated filer   x
Non-accelerated filer   ¨   (Do not check if a smaller reporting company)   Smaller reporting company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ¨    No  x

The aggregate market value of the shares of Common Stock held by non-affiliates of the registrant, computed by reference to the closing price of such stock on June 30, 2015, was $605 million. At February 29, 2016, there were 32,837,857 shares of the registrant’s Common Stock outstanding.

Documents Incorporated by Reference

Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission within 120 days after the end of its 2015 fiscal year in connection with its 2016 annual meeting of shareholders are incorporated by reference into Part III hereof.

 


Table of Contents

Sagent Pharmaceuticals, Inc.

Table of Contents

 

          Page No.  

Part I -

  

Item 1.

   Business      4   

Item 1A.

   Risk Factors      14   

Item 1B.

   Unresolved Staff Comments      26   

Item 2.

   Properties      26   

Item 3.

   Legal Proceedings      27   

Item 4.

   Mine Safety Disclosures      28   

Part II -

  

Item 5.

   Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
     29   

Item 6.

   Selected Financial Data      31   

Item 7.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations      32   

Item 7A.

   Quantitative and Qualitative Disclosures about Market Risk      54   

Item 8.

   Financial Statements and Supplementary Data      56   

Item 9.

   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure      98   

Item 9A.

   Controls and Procedures      98   

Item 9B.

   Other Information      102   

Part III -

  

Item 10.

   Directors, Executive Officers and Corporate Governance      102   

Item 11.

   Executive Compensation      102   

Item 12.

   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters      102   

Item 13.

   Certain Relationships and Related Transactions, and Director Independence      102   

Item 14.

   Principal Accountant Fees and Services      102   

Part IV -

  

Item 15.

   Exhibits and Financial Statement Schedules      103   
   Signatures      107   
   Valuation and Qualifying Accounts      108   


Table of Contents

Disclosure Regarding Forward-Looking Statements

This Annual Report on Form 10-K contains forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact included in this report are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “could have,” “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. For example, all statements we make relating to our estimated and projected costs, expenditures, cash flows, growth rates and financial results, our plans and objectives for future operations, growth or initiatives, strategies, our product pipeline and anticipated product approvals or the expected outcome or impact of pending or threatened litigation are forward-looking statements. In addition, this report contains forward-looking statements regarding the adequacy of our current cash balances to fund our ongoing operations; our utilization of our net operating loss carryforwards; our ability to realize the expected benefits from our acquisition of Omega; and our expectation that the sale of our China subsidiary will close during 2016.

The forward-looking statements contained in this Annual Report on Form 10-K are subject to a number of risks and uncertainties. The cautionary statements set forth below and those contained in Item 1A under the heading “Risk Factors,” in Item 7 under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in this Annual Report on Form 10-K identify important factors that could cause actual results to differ materially from those indicated by our forward-looking statements. Such factors include, but are not limited to:

 

   

we rely on our business partners for the manufacture of a significant portion of our products, and if our business partners fail to supply us with high-quality active pharmaceutical ingredient (“API”) or finished products in the quantities we require on a timely basis, sales of our products could be delayed or prevented, and our revenues and margins could decline, which could have a material adverse effect on our business, financial condition and results of operations;

 

   

if we or any of our business partners are unable to comply with the quality and regulatory standards applicable to pharmaceutical drug manufacturers, or if approvals of pending applications are not granted or are delayed, we may be unable to meet the demand for our products, may lose potential revenues, may incur penalties, and our business, financial position and results of operations could be materially adversely effected;

 

   

changes in the regulations, enforcement procedures or regulatory policies established by the Food and Drug Administration (“FDA”) and other regulatory agencies could increase the costs or time of development of our products and could delay or prevent sales of our products and our revenues could decline and, as a result, our business, financial condition and results of operations could be materially adversely affected;

 

   

one of our products, heparin, represents a significant portion of our net revenues. Heparin is manufactured by and supplied to us by a single vendor, and, if the volume or pricing of this product declines, or we are unable to satisfy market demand, such event could have a material adverse effect on our business, financial position and results of operations;

 

   

we participate in highly competitive markets, dominated by a few large competitors, and if we are unable to compete successfully, our revenues could decline and our business, financial condition and results of operations could be materially adversely affected;

 

   

if we are unable to continue to develop and commercialize new products in a timely and cost-effective manner, we may not achieve our expected revenue growth and profitability, or our business, results of operations and financial position could be adversely affected;

 

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if we are unable to maintain our group purchasing organization (“GPO”) and distributor relationships, our revenues could decline and our results of operations could be adversely affected;

 

   

we rely on a limited number of pharmaceutical wholesalers to distribute our products;

 

   

we depend to a significant degree upon our key personnel, the loss of whom could adversely affect our operations;

 

   

if we fail to attract and retain the talent required for our business, our business could be materially harmed;

 

   

our inability to manage our planned growth or successfully integrate newly acquired businesses or product rights could harm our business;

 

   

we may be exposed to product liability claims that could cause us to incur significant costs or cease selling some of our products;

 

   

our products may infringe the intellectual property rights of third parties, and in such cases we may incur substantial liabilities and may be unable to commercialize products in a profitable manner or at all;

 

   

healthcare reform legislation or other regulatory changes may adversely affect our business;

 

   

our business could suffer if reimbursement by government-sponsored or private sector insurance programs for our current or future products is reduced or modified;

 

   

we may need to raise additional capital in the event we change our business plan or encounter unexpected developments, which may cause dilution to our existing stockholders or restrict or limit our operations;

 

   

we are subject to risks associated with managing our international network of business relationships, which include business partners and other suppliers of components, API and finished products located throughout the world;

 

   

we may not receive approval from the Chinese government to complete the sale of our Chinese subsidiary;

 

   

we may never realize the expected benefits from our acquisition of Omega and it will require substantial capital resources to maintain its manufacturing capabilities and overall profitability;

 

   

we rely on a single vendor to manage our order to cash cycle and our distribution activities in the U.S. and the loss or disruption of service from this vendor could adversely affect our operations and financial condition;

 

   

we are likely to incur substantial costs associated with both implementation and maintenance of our new enterprise resource planning software and other related applications, and unforeseen problems may arise with the implementation. If the new systems do not perform as originally planned, our business, financial position and results of operations could be adversely affected;

 

   

currency fluctuations may have an adverse effect on our business;

 

   

we may seek to engage in strategic transactions, including the acquisition of products or businesses, that could have a variety of negative consequences, and we may not realize the intended benefits of such transactions;

 

   

we are likely to incur substantial costs associated with the expansion of the Omega facility, and unforeseen problems may arise in the construction of the facility or equipment. If the new facility and equipment are delayed or do not operate as planned, we may never realize the expected benefits from our expansion and it will require substantial capital resources to improve;

 

   

Our competitors and customers are consolidating which may affect our ability to compete effectively.

 

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We derive many of our forward-looking statements from our work in preparing, reviewing and evaluating our long-term growth strategy and our operating budgets and forecasts, which are based upon many detailed assumptions. While we believe that our assumptions are reasonable, we caution that it is very difficult to predict the impact of known factors, and, it is impossible for us to anticipate or accurately calculate the impact of all factors that could affect our actual results. Important factors that could cause actual results to differ materially from our expectations, or cautionary statements, include, but are not limited to, those disclosed under the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. You should evaluate all forward-looking statements made in this report in the context of these risks and uncertainties.

We cannot assure you that we will realize the results or developments we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our operations in the way we expect. The forward-looking statements included in this report are made only as of the date hereof. We undertake no obligation and do not intend to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

In this report, “Sagent,” “we,” “us” and “our” refers to Sagent Pharmaceuticals, Inc. and its consolidated subsidiaries, and “Common Stock” refers to Sagent Pharmaceuticals, Inc.’s Common Stock, $0.01 par value per share.

 

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PART I

 

Item 1. Business.

General

We are a leading provider of affordable pharmaceuticals to the hospital market, which we sell primarily throughout North America. Initially founded in 2006 as Sagent Holding Co., a Cayman Islands company, we reincorporated as Sagent Pharmaceuticals, Inc., a Delaware corporation, in connection with our initial public offering, on April 26, 2011.

With a primary focus on generic injectable pharmaceuticals, which provide customers a lower-cost alternative to branded products when applicable patents have expired or been declared invalid, or when the products are determined not to infringe the patents of others, we offer our customers a broad range of products across anti-infective, oncology and critical care indications in a variety of presentations, including single- and multi-dose vials and ready-to-use pre-filled syringes and premix bags. We generally seek to develop injectable products where the form or packaging of the product can be enhanced to improve delivery, product safety or end-user convenience. Our management team includes industry veterans who have served critical functions at other pharmaceutical companies or key customer groups and have long-standing relationships with customers, regulatory agencies, and suppliers. We have rapidly established a growing and diverse product portfolio and product pipeline as a result of our innovative business model. Our model combines an extensive network of international development, sourcing and manufacturing collaborations with our proven and experienced regulatory, quality assurance, business development, project management, and sales and marketing teams.

On June 4, 2013, we acquired the remaining 50% equity interest in Kanghong Sagent (Chengdu) Pharmaceutical Co. Ltd. (“KSCP”) from our former joint venture partner (the “SCP Acquisition”). In August 2013, we formally changed the name of this entity to Sagent (China) Pharmaceuticals Co., Ltd. (“SCP”). The SCP facility, received its Establishment Inspection Report from the FDA in April 2013, and first product approval in June 2013. On December 29, 2015, our Board of Directors authorized the Company to proceed with a sale of all of the Company’s interests in SCP. On February 3, 2016, the Company entered into a Share Purchase Agreement with Hong Kong King-Friend Pharmaceutical Co., Ltd., a subsidiary of Nanjing King-Friend Pharmaceutical Co., Ltd., (“NKF”) whereby NKF will acquire 100% of the outstanding shares of SCP in exchange for $0.5 million. We expect this transaction to close in the second quarter of 2016, at which time SCP will cease to be a subsidiary of the Company.

On October 1, 2014, we, through our wholly-owned subsidiary, Sagent Acquisition Corp., a Canadian company, acquired all of the issued and outstanding shares of the capital stock of 7685947 Canada Inc., and its subsidiary, Omega Laboratories Limited (collectively, “Omega”), a privately held Canadian pharmaceutical and specialty healthcare products company. Omega represents our first international market expansion, and the facility currently provides us with the ability to manufacture products for the Canadian and other international markets. In conjunction with the acquisition, we committed to a capital expansion project which would significantly increase Omega’s manufacturing capacity and enhance its quality systems to enable Omega to pursue FDA approval to manufacture injectable products for the US market.

Operating Segments

We conduct our operations across North America and are currently managed in two reportable segments:

 

Segment    Percentage of 2015 net sales
Sagent US    90%
Omega    10%

 

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For financial information relating to our reportable segments, principal product lines, and other geographic information, see Note 20 to the consolidated financial statements included in “Item 8. Financial Statements and Supplementary Data” of this report. Unless the context otherwise requires, the disclosures in “Item 1. Business” and “Item 1A. Risk Factors” relate to both reportable segments.

Products

Since our inception, we have focused on developing a broad product portfolio of injectable pharmaceuticals. As of December 31, 2015, our product portfolio has grown to a total of 55 products in our Sagent U.S. segment and 48 products in our Omega segment, which can be classified into the following three product categories: anti-infective, oncology and critical care. Our anti-infective products assist in the treatment of various infections and related symptoms, our oncology products are used in the treatment of cancer and cancer-related medical problems, and our critical care products are used in a variety of critical care applications and include anesthetics, cardiac medications, steroidal products and sedatives. Critical care products in our Omega segment also include certain allergy and phlebology medications. The table below presents the percentage of our consolidated net revenue attributed to each product category for the years ended December 31, 2015, 2014 and 2013.

 

     Percentage of Net Revenue  
Product category    For the year ended December 31,  
   2015     2014     2013  

Anti-infective products

     40     35     37

Oncology products

     22     35     36

Critical care products

     38     30     27
  

 

 

   

 

 

   

 

 

 

Total

     100     100     100
  

 

 

   

 

 

   

 

 

 

Within our anti-infective product category, levofloxacin accounted for approximately 13% and 13% of our consolidated net revenue for the years ended December 31, 2014 and 2013, respectively. Within our critical care product category, our heparin products accounted for approximately 13%, 15% and 18% of our consolidated net revenue for the years ended December 31, 2015, 2014 and 2013, respectively. Within our oncology category, our zoledronic acid products accounted for approximately 15% of our consolidated net revenue for the year ended December 31, 2013. No other products accounted for more than 10% of our consolidated net revenue in any of the periods presented in the preceding table. We expect that heparin will continue to represent a significant portion of our consolidated net revenue for the foreseeable future, however, we expect its percentage contribution to our consolidated net revenue to decline going forward with the launch of new products.

Anti-Infective Products

Our key anti-infective products include:

Cefepime. Cefepime is a fourth-generation cephalosporin, an antibiotic used to treat a variety of infections, including infections of the urinary tract, skin and skin structure, as well as moderate to severe pneumonia, complicated intra-abdominal infections, and as empiric therapy for febrile neutropenic patients. Cefepime is the generic equivalent of Elan Corporation, plc’s MAXIPIME®. We launched cefepime for injection in April 2008 upon the expiration of the innovator patents. We are currently one of six competitors in the US market.

Levofloxacin. Levofloxacin is a fluoroquinolone antibacterial indicated in adults 18 years of age or older with infections caused by designated, susceptible bacteria including: nosocomial and community acquired pneumonia, sinusitis, chronic bronchitis, skin and skin structure infections, prostatitis, urinary tract infection and pyelonephritis. Levofloxacin is the generic equivalent of Johnson & Johnson’s Levaquin ®. In July 2011, we were the first company to launch the generic form of levofloxacin in three ready-to-use premix bag strengths following patent expiry in June 2011. We launched the generic form of levofloxacin in two vial presentations in

 

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March 2012. We are currently one of five competitors offering a premix bag in the US market. Our levofloxacin products accounted for approximately 13% and 13% of our consolidated net revenue for the years ended December 31, 2014 and 2013, respectively.

Oncology Products

Our key oncology products include:

Leucovorin Calcium. Leucovorin Calcium is a folic acid derivative used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer. Leucovorin Calcium is also used to treat people who have accidentally received an overdose of methotrexate or similar medications. We launched Leucovorin Calcium in October 2012 and are currently one of three competitors in the US market.

Zoledronic Acid. Zoledronic Acid is a bisphosphonate given intravenously to prevent skeletal fractures in patients with cancers such as multiple myeloma and prostate cancer, as well as for treating osteoporosis. Zoledronic Acid 4mg is the generic equivalent of Novartis’ Zometa ® , and Zoledronic Acid 5mg is the generic equivalent of Novartis’ Reclast ® . We launched zoledronic acid at market formation in a 4mg vial presentation in March 2013. We subsequently launched a 4mg per 100mL premix bag presentation in August 2013, and a 5mg per 100mL premix bag presentation in October 2013. We are currently one of six generic competitors offering a 4mg presentation, and one of four generic competitors offering a 5mg presentation in the US market. Our zoledronic acid products accounted for approximately 15% of our consolidated net revenue for the year ended December 31, 2013.

Critical Care Products

Our key critical care products include:

Heparin. Heparin is an anticoagulant used to prevent and treat blood clotting, especially during and after surgery and dialysis. In July 2010, we launched nine different presentations of heparin sodium injection in latex-free vials, including 1,000 USP units per mL, 10,000 USP units per 10 mL, 30,000 USP units per 30 mL, 10,000 USP units per mL, 40,000 USP units per 4 mL, 5,000 USP units per mL, 50,000 USP units per 10 mL, 2,000 USP units per 2 mL and 20,000 USP units per mL. We are currently one of six suppliers of heparin finished product in the U.S. market. Our heparin products accounted for approximately 13%, 15% and 18% of our consolidated net revenue for the years ended December 31, 2015, 2014 and 2013, respectively.

Propofol. Propofol is a sedative used to induce and maintain general anesthesia during surgical procedures. Propofol is the generic equivalent of Fresenius Kabi’s Diprivan ®. We launched Propofol in November 2013 through a supply and distribution agreement with Teva Pharmaceutical Industries Ltd. (“Teva”) and are currently one of three competitors in the US market.

Sales and Marketing

Our sales, marketing and national accounts team was comprised of 55 members as of December 31, 2015, including 10 in Omega. Collectively our sales force has an average of over 20 years of experience. We believe that our target markets are highly concentrated and can be penetrated effectively by our dedicated and experienced sales and national accounts teams with respect to both our existing and new products.

Our marketing efforts include a focus on enhanced delivery systems. We provide our products in a variety of convenient presentations, including ready-to-use pre-filled syringes and premix bags, eliminating unnecessary steps in the administration of our products to patients. All of our U.S. products are packaged and labeled using PreventIV Measures, our comprehensive, user-driven and patient-centered approach designed to improve patient safety by helping to prevent errors in the administration and delivery of medication to patients through the use of distinctive color coding and easy-to-read labels.

 

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We market our products in both the U.S. and Canada to group purchasing organizations (“GPOs”), wholesalers, specialty distributors and a diverse group of end-user customers. We have extensive experience contracting with, marketing to and servicing members of the major GPOs in the U.S. and Canada. We currently derive, and expect to continue to derive, a large percentage of our revenue from end-user customers that are members of a small number of U.S. GPOs. For example, the five largest U.S. GPOs, HealthTrust Purchasing Group (“HPG”), Intalere, Inc. (“Intalere”), MedAssets Inc. (“MedAssets”), Novation, LLC (“Novation”), and Premier, Inc. (“Premier”) represented end-user customers that collectively accounted for approximately 35%, 44% and 39% of our Sagent US segment net contract revenue for the years ended December 31, 2015, 2014 and 2013, respectively. Med- Assets was acquired by Novation in November 2015 and the combined company will operate as Vizient. We have pricing agreements for specified products with the major GPOs in both the U.S. and Canada. The scope of products included in these agreements varies by GPO and segment. Our strategy is to have substantially all of our products covered under these agreements as we launch new products and these agreements come up for renewal. These agreements are typically multi-year in duration, but most of them may be terminated by either party with 60 or 90 day notice.

Customers

As is typical in the pharmaceutical industry, we distribute our products primarily through pharmaceutical wholesalers and, to a lesser extent, specialty distributors that focus on particular therapeutic product categories, for use by a wide variety of end-users, including hospitals, integrated delivery networks and alternative site facilities. For the year ended December 31, 2015, the products we sold through our three largest wholesalers, AmerisourceBergen Corp. (“Amerisource”), Cardinal Health Inc. (“Cardinal Health”) and McKesson Corp. (“McKesson”), accounted for approximately 28%, 23% and 27%, respectively, of our consolidated net revenue.

As end-users have multiple channels to access our products, we believe that we are not dependent on any single GPO, wholesaler or distributor for the distribution or sale of our products, although sales made to customers that contract through Premier accounted for approximately 18%, 21% and 19% of our consolidated net revenue for the years ended December 31, 2015, 2014, and 2013 respectively, and MedAssets accounted for approximately 9% and 11% of our consolidated net revenue for the year ended December 31, 2015 and 2014, respectively. Med- Assets was acquired by Novation in November 2015 and the combined company will operate as Vizient. No other single end-user customer or group of affiliated end-user customers accounted for more than 10% of our consolidated net revenue for the year ended December 31, 2015.

Product Distribution

We utilize an outside third-party logistics contractor to distribute our U.S. products. Since May 2007, our third-party logistics provider has handled all aspects of our product logistics efforts and related order to cash processes. Our products are distributed through a 450,000 square foot facility located in Memphis, Tennessee. Under our agreement with our third-party logistics provider, we maintain ownership of our finished products until sale to our customers. In 2015 we renewed our contract with our third-party logistics provider with a term that extends through December 2018, subject to automatic annual extensions unless either party elects not to extend the agreement by notifying the other party at least 90 days prior to expiration of the initial term or the applicable renewal term. Our Canadian products are distributed through three owned and two leased facilities in Montreal, Quebec, where we perform the manufacturing and distribution of products for our Omega segment. The three owned facilities occupy approximately 62,000 square feet, and the leased facilities occupy approximately 45,000 square feet.

Seasonality

There are no significant seasonal aspects to our consolidated net sales.

 

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Competition

Our industry is highly competitive and our principal competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies and generic drug companies. Our principal competitors include Fresenius Kabi (“Fresenius”), a division of Fresenius SE, Hospira, Inc., a division of Pfizer Inc. (“Pfizer”), Sandoz International GmbH (“Sandoz”), a division of Novartis AG, Actavis, a division of Allergan plc, Mylan N.V., Valent Pharmaceuicals International, Inc., Dr. Reddy’s Laboratories Ltd. and West-Ward Pharmaceutical Corp (“West-Ward”), a subsidiary of Hikma PLC. In most cases, these competitors have access to greater financial, marketing, technical and other resources than we do. As a result, they may be able to devote more resources to the development, manufacture, marketing and sale of products, receive a greater share of the capacity from API suppliers and finished product manufacturers, obtain more support from independent distributors, initiate or withstand substantial price competition or more readily take advantage of acquisition or other growth opportunities. We believe that the key competitive factors that will affect the development and commercial success of our current products and any future products that we may develop are price, reliability of supply, quality and enhanced product features.

Revenue and gross profit derived from sales of generic pharmaceutical products tend to follow a pattern based in large part on regulatory and competitive factors. As patents for branded products and related exclusivity periods expire or are ruled invalid, the first generic pharmaceutical manufacturer to receive regulatory approval for a generic version of the reference product is generally able to achieve significant market penetration and higher margins on that product. As competing generic manufacturers receive regulatory approval and begin to market this product, market share, revenue and gross profit typically decline for the original generic entrant. As more competitors enter a specific generic market, the average selling price per unit dose of the particular product typically declines for all competitors. The level of market share, revenue and gross profit attributable to a particular generic pharmaceutical product is significantly influenced by the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch in relation to competing approvals and launches. We intend to continue to develop and introduce new products in a timely and cost-effective manner, identify niche products with significant barriers to entry and develop products with enhanced features or other competitive advantages in order to maintain and grow our revenue and gross margins. In addition, we may challenge proprietary product patents to seek first-to-market rights.

Intellectual Property

As a specialty and generic pharmaceutical company, we have limited intellectual property surrounding our generic injectable products. However, in the normal course of business, we develop specialized devices, systems and branding strategies that we aggressively seek to protect through trade secrets, unpatented proprietary know-how, continuing technological innovation and traditional intellectual property protection through trademarks, copyrights and patents to preserve our competitive position. We also preserve our competitive position through traditional intellectual property protection, including trademarks, copyrights and patents. Our current trademarks include “Sagent,” “Sagent Pharmaceuticals” (in English and Chinese), “Omega,” “SSS” design, “Advance Injectables Excellence,” “Create Injectables Excellence,” “Discover Injectables Excellence,” and “Invest in Injectables Excellence.”

Product Development

We maintain an active product development program. Our Sagent U.S. segment new product pipeline can generally be classified into two categories: (i) products we developed or acquired and for which regulatory submissions (Abbreviated New Drug Applications (“ANDAs”) or NDA 505(b)(2)s) have been filed with the FDA and are currently under review; and (ii) products which are considered in development, meaning work is currently at a stage between initial development activities, such as sourcing of API, and compilation of the ANDA or NDA 505(b)(2) documentation prior to submission to the FDA. As of December 31, 2015, our U.S. new product pipeline included: (i) 67 ANDAs that we had filed, or licensed rights to, and were under review by the FDA, and six ANDAs that the FDA recently approved and are pending commercial launch; and (ii) 31 additional products under initial development.

 

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Our 67 ANDAs under review by the FDA as of December 31, 2015 have been on file for an average of approximately 38 months, with two of them being on file for less than 12 months, 24 of them being on file for between 12 and 24 months and 41 of them being on file for longer than 24 months.

As of December 31, 2015, we had an additional 14 products either under review by the relevant regulatory authority or under development in our Omega segment.

Our product development activities also include expanding our product portfolio by adding new products through in-licensing and similar arrangements with manufacturers, virtual pharmaceutical development companies, and others that seek to utilize our sales and marketing expertise. We believe we provide our business partners with significant value under these arrangements by eliminating their need to develop and maintain a separate North American based sales and marketing organizations. As of December 31, 2015, we marketed 31 of our 55 products in our Sagent US segment under these types of in-licensing arrangements, and we intend to continue to expand our global product portfolio across both of our segments in a cost-effective manner through these types of arrangements.

We generally own or license the rights to ANDAs for the products that we market and sell, which is determined based on the scope of services provided to us by a particular business partner. For example, we typically license the rights to ANDAs under arrangements in which the supplier only provides us with manufacturing services and typically own the ANDAs under arrangements in which the supplier also provides us with development services. When possible, we manage the regulatory submission of ANDAs for products developed in conjunction with our partners. We also assist our partners in developing ANDAs and will often lead FDA interactions post submission.

The goal of our product development activities is to select opportunities, develop finished products, complete and submit regulatory submissions and obtain regulatory approvals allowing product commercialization. Our product development efforts are customer focused and use our strong understanding of market needs from our long-term customer relationships to drive product selection. In addition, we currently have the capability to develop and manufacture products for sale in Canada and the European Union through our Omega segment, and expect to have the ability to develop and manufacture products for sale in the U.S. market through our Omega facility following the completion of its new manufacturing line. Once we identify a new product for development, we determine whether to perform the development and manufacturing internally or through one of our existing or new business relationships and secure API sourcing. We also select new products for development based on our ability to expand our existing collaborations to cover additional products that are currently manufactured or being developed by our business partners. We have made, and will continue to make, substantial investment in product development costs for the year ended December 31, 2015 totaled $29.1 million, including $3.2 million incurred by our Omega segment.

We utilize an in-house project management team of 35 employees, including 14 in our Omega segment, to manage and execute our internal product development activities and coordinate our product development activities with our business partners. Our experienced project management team has expertise in areas such as pharmaceutical formulation, analytical chemistry and drug delivery and experience working with our business partners. Actual development activities occur in the laboratories and other facilities of our business partners, at our manufacturing facility in Canada.

Our U.S. Business Partner Network

Overview

We have developed an international network of arrangements that provides us with extensive and diverse capabilities in the areas of new product development, API sourcing, and finished product manufacturing. As of December 31, 2015, we had 47 business partners worldwide, including 16 in the Americas, 12 in China and Taiwan, 11 in Europe, seven in India and one in the Middle East.

 

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In general, our business partners provide us with product development services, API or finished product manufacturing or a combination of the three with respect to one or more of our products. We typically enter into long-term agreements with our business partners. The specific terms of these agreements vary in a number of respects, including the scope of services being provided to us by the partner and the nature of the pricing structure. In general, we believe our agreements contain a degree of flexibility to ensure that both we and our partners can achieve attractive financial returns depending on changes in market conditions and the competitive landscape for specific products. Our most common types of agreements are manufacture and supply, development, licensing or marketing agreements. The general terms of these types of agreements are summarized below.

Manufacture and Supply Agreements Our manufacture and supply agreements typically consist of the following elements:

 

   

the supplier agrees to manufacture and supply us with our finished product requirements, typically under its ANDA, or in circumstances where we are seeking an alternate manufacturing site under one of our own ANDAs;

 

   

we generally obtain the exclusive right to sell, market and distribute these products in the U.S., with, in some cases, such exclusivity subject to our obtaining and maintaining a specified market share. Under the terms of exclusive agreements, we are required to obtain all of our product requirements from the supplier;

 

   

the term of the agreement is typically seven years, varying from three to ten years from the date of product launch, and thereafter automatically renews for periods of one or two years unless either party provides prior notice of termination;

 

   

we agree to use commercially reasonable efforts to market the products, consistent with our usual methods of commercializing, marketing and selling other pharmaceutical products;

 

   

we pay a specified transfer price for each unit of each product;

 

   

the supplier has the right to change the transfer price to reflect actual changes in the costs of its raw materials, packaging, storage or regulatory compliance, from time to time;

 

   

we and the supplier agree to discuss reductions in the transfer price due to changes in market conditions as may be required to keep the product competitively priced in the U.S. market;

 

   

the terms may include our payment of a percentage of the net profit from sales of products covered by the agreement; and

 

   

termination may generally be initiated by: (i) either party upon the uncured breach of a material provision of the agreement by the other party; (ii) either party if the other party files a petition for bankruptcy, is or becomes insolvent or makes an assignment for the benefit of its creditors; and, in certain agreements, (iii) us if we decide, in our sole discretion, to no longer market the product or if a regulatory body denies or revokes approval for or otherwise attempts to restrict or prohibit the manufacture, packaging, labeling, storage, importation, sale or use of the product.

Development, Manufacture and Supply Agreements. In addition to the preceding provisions relating to the manufacture and supply of a product, some agreements also include provisions under which the supplier will develop the product on our behalf. Such development terms typically include the following provisions:

 

   

in collaboration with our technical, quality and regulatory teams, the supplier develops, produces exhibit batches and provides us with data necessary for the preparation and filing of an ANDA for a product;

 

   

our regulatory group compiles and submits the ANDA to the FDA in our name;

 

   

we pay the supplier specified portions of agreed development fees upon successful completion of certain development activities, typically including: (i) execution of the definitive development agreement; (ii) completion of stability batches; (iii) submission of the ANDA to the FDA; and (iv) approval of the ANDA by the FDA; and

 

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in certain circumstances, we may agree to pay for or provide the API and innovator product samples used in the development.

Joint Venture

In addition to the foregoing types of agreements, we also utilize joint venture arrangements in sourcing our products. We currently have one joint venture which is summarized below.

Sagent Agila LLC

In January 2007, we and Strides Arcolab International Limited, a company based in the United Kingdom and a wholly-owned subsidiary of Strides Arcolab Limited (“Strides”), entered into a joint venture agreement pursuant to which the parties formed Sagent Agila LLC (formerly known as Sagent Strides LLC) (“Sagent Agila”). The joint venture was formed for the purpose of selling into the U.S. market a wide variety of generic injectable products manufactured by Strides in their Indian facilities. Thereafter, we and Sagent Agila entered into a number of agreements relating to distribution, manufacture, supply and quality, and, as of December 31, 2015, these agreements covered a total of 17 different products represented by 35 ANDA filings, owned by Sagent Agila . As of December 31, 2015, there were five products under review by the FDA, two product had been approved by the FDA and were pending commercial launch and ten currently marketed products. Products from the Sagent Agila joint venture accounted for less than 10% of our consolidated net revenue in the years ended December 31, 2015, 2014 and 2013. In December 2013, Mylan Inc. acquired Agila Specialties Private Limited (“Agila”), the manufacturer of products for Sagent Agila, and Strides Inc., our joint venture partner, in Sagent Agila, from Strides. This transaction did not have a material impact on our operations or financial position.

In September 2013, a facility owned by Agila, the manufacturer of products for Sagent Agila, received a warning letter from the FDA related to the FDA inspection of Agila’s Specialty Formulation Facility (“SFF”) in Bangalore, India. Following an FDA Inspection, in August 2015 Agila received another warning letter related to both SFF and Agila’s Sterile Products Division (“SPD”), which reiterated the findings from 2013. The warning letters identified violations of current good manufacturing practice (“cGMP”) related to the prevention of microbiological contamination of sterile drug products and systems to monitor environmental conditions in aseptic processing. The warning letters also described other deficiencies in the quality management function of the facilities. The warning letters stated that new drug applications may not be approved until the facility has completed and the FDA has confirmed the remediation efforts and compliance with cGMP. As of December 31, 2015, the SFF and the SPD facilities remains subject to the warning letters. Delays in the approval of the five Sagent Agila ANDAs currently being reviewed by the FDA for new products to be manufactured by SFF or SPD, or limitations on the importation of products from the SFF or SPD facility, did not have a material effect on the results of our operations for the year ended December 31, 2015. However, if the SFF or SPD facility does not timely or adequately complete its remediation efforts, or otherwise fails to comply with our quality standards or cGMP requirements in the future, our business, financial position or results of operations could be materially adversely affected.

Key Suppliers and Marketing Partners

Two of our business partners, A.C.S. Dobfar S.p.a. (“Dobfar”) and Gland Pharma Limited (“Gland”), provided us with products that collectively accounted for approximately 30% and 17%, respectively, of our consolidated net revenue for the year ended December 31, 2015, approximately 34% and 17%, respectively, of our consolidated net revenue for the year ended December 31, 2014, and approximately 30% and 20%, respectively, of our consolidated net revenue for the year ended December 31, 2013. Set forth below is a brief discussion of the terms of our arrangements with these two partners.

 

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Dobfar

In 2007, we entered into manufacture and supply agreements with ACS Dobfar SpA-Italy (“Dobfar”) and with ACS Dobfar SA-Switzerland (“Info”).

We have supply agreements or other purchase commitments with Dobfar covering seven currently marketed products – ampicillin, ampicillin sulbactam, cefazolin, cefepime, cefoxitin, ceftazadime and ceftriaxone, as well as additional products currently in initial development.

Pursuant to the Info agreement, Info develops, manufactures and supplies us with presentations of levofloxacin in premix bags. Under this agreement, we pay a transfer price for each unit of levofloxacin supplied, plus a percentage of the net profit from the sales of levofloxacin in premix bags. In addition, we have agreed to share equally with Info the cost of development activities. The initial term of the agreement expires on July 7, 2016, after which we have the option to renew the agreement for successive additional two year terms unless Info provides notice of its intent to terminate the agreement at least two years prior to its initial expiration date or the expiration date of a renewal term. We intend to renew the agreement for an additional two year term before the expiry date. In addition to levofloxacin, we also have supply agreements with Info covering three currently marketed products – ciprofloxacin, fluconazole, and zoledronic acid bags, in both 4mg and 5mg presentations. We also have additional products currently under review by the US FDA and in initial development with Info.

For the year ended December 31, 2015, net gross profit from products marketed under our agreements with Dobfar and its affiliates, including Info, ranged from -26% to 172%. Net gross profit represents: (i) net sales less the cost of finished goods and inbound freight, which ranges from -8% to 63% of net sales, and (ii) applicable profit sharing due to Dobfar and its affiliates, including Info, which ranges from -3% to 31% of net sales.

Gland

In June 2008, we entered into a development and supply agreement with Gland. Pursuant to the agreement, we and Gland jointly developed our heparin products, and Gland agreed to supply us heparin for sale in the U.S. market. In addition, we have agreed to use Gland as our exclusive supplier for heparin and Gland has agreed not to, directly or indirectly, sell heparin to any other person or entity that markets or makes use of or sells heparin in the U.S., subject to certain exceptions. We have agreed to pay a transfer price for each unit of heparin supplied under the agreement, plus a percentage of the net profit from the sales of heparin. The initial term of the agreement expires in June 2016, after which, the term automatically renews for consecutive periods of one year unless (a) a third party has rights to market heparin in the U.S. as a result of our discontinuing active sales of heparin there or (b) either party provides notice to terminate the agreement at least 24 months prior to the desired date of termination. As we continue to market heparin and notice to terminate the agreement has not been provided, we expect the agreement to renew through June 2017 on the expiry date of the initial term.

In addition to heparin, we also have other supply agreements with Gland covering five currently marketed products, adenosine, amiodarone, chlorothiazide, ondansetron and vancomycin, and additional products currently under review by the FDA and in initial development.

For the year ended December 31, 2015, net gross profit from products marketed under our agreements with Gland ranged from -27% to 101%. Net gross profit represents: (i) net sales less the cost of finished goods and inbound freight, which ranges from -2% to 69% of net sales, and (ii) applicable profit sharing due to Gland which ranges from -1% to 21% of net sales.

Quality Assurance and Facility Compliance

An important component of our strategy is to actively partner with our international network of collaborators to focus on quality assurance (“QA”), U.S. cGMP compliance, regulatory affairs and product development. We have developed and implemented quality management systems, including our in-house QA and facility

 

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compliance teams, to audit, assess, train and qualify our vendors’ facilities, work to ensure that the facilities and the products manufactured in those facilities for us are cGMP compliant, and provide support for product launches and regulatory agency facility inspections. Our QA team provides product shipment authorization for finished products before they are shipped under our name, releases product for distribution upon receipt at our Memphis distribution center and monitors on-going product quality throughout the product lifecycle. Our in-house facility compliance team qualifies new vendors through an extensive audit process, implements our quality control systems and monitors on-going vendor compliance with cGMPs through on-going surveillance and periodic performance evaluations. We work with our business partners to evaluate facility design, systems and capabilities to ensure that their manufacturing facilities meet or exceed industry standards and are capable of maintaining on-going FDA compliance. As of December 31, 2015, our in-house facility compliance team had qualified over 135 suppliers. We are committed to upholding and enforcing our quality standards and only establish collaboration with those business partners who we believe share our commitment to quality and regulatory compliance. In addition, we have robust on-going qualification and compliance procedures in place, which include routine audits, performance evaluations and for-cause audits. We have undergone four FDA inspections at our corporate headquarters, in 2007, 2010, 2013 and 2015, and two FDA inspections, in 2013 and 2015, at our Chinese manufacturing facility. We have no open items from FDA Form 483s, which identify compliance concerns or objectionable conditions arising out of such inspections. Our Omega facilities were most recently inspected by Health Canada in 2015. As a result of the inspection, the establishments were assigned a compliant (c) rating (in compliance with the Canadian Food and Drug Act).

Financial Information on Geographic Areas

During 2015, 10% of our sales were made outside the U.S. and its territories, predominately in Canada through our Omega segment. In 2014, 3% of our sales were made outside the U.S. and its territories, predominately in Canada. In 2013, 0.2% of our sales were made outside the United States of America and its territories.

For further financial information relating to our reportable segments, principal product lines, and other geographic information, see Note 20 to the consolidated financial statements included in “Item 8. Financial Statements and Supplementary Data” of this report.

Employees

As of December 31, 2015, we had a total of 440 full-time employees, of which 114 were employed in Sagent US, 175 by our Chengdu, China manufacturing facility and 151 employed at Omega. None of our employees are represented by a labor union or subject to a collective bargaining agreement. We have not experienced any work stoppage and consider our relations with our employees to be good.

Corporate Information

Sagent Pharmaceuticals, Inc. is a Delaware corporation that was incorporated in 2011. We are a publicly traded company with Common Stock listed on the NASDAQ Global Market under the symbol “SGNT.” Our executive offices are located at 1901 N. Roselle Road, Suite 700, Schaumburg, Illinois. Our telephone number is (847) 908-1600. Our website is www.sagentpharma.com. The information contained on our website is not included as a part of, or incorporated by reference into, this Annual Report on Form 10-K.

Available Information

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC. You can access our filings with the SEC by visiting www.sagentpharma.com.

 

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Item 1A. Risk Factors.

You should read the following risk factors carefully in connection with evaluating our business and the forward-looking information contained in this Annual Report on Form 10-K. Any of the following risks could materially and adversely affect our business, operating results, financial condition and the actual outcome of matters as to which forward-looking statements are made in this Annual Report on Form 10-K. While we believe we have identified and discussed below the key risk factors affecting our business, there may be additional risks and uncertainties that are not presently known or that are not currently believed to be significant that may adversely affect our business, operating results or financial condition in the future.

We rely on our business partners for the manufacture of a significant portion of our products, and if our business partners fail to supply us with high-quality API or finished products in the quantities we require on a timely basis, sales of our products could be delayed or prevented, and our revenues and margins could decline, which could have a material adverse effect on our business, financial condition and results of operations.

We rely upon our third-party business partners, principally located outside of the U.S., for the supply of all API and a significant portion of our finished products in our Sagent US segment. In most cases, we rely upon a limited number of business partners to supply us with the API or finished products for each of our products. If our business partners do not continue to provide these services or products to us we might not be able to obtain these services or products from others in a timely manner or on commercially acceptable terms. Likewise, if our business partners encounter delays or difficulties in producing API or our finished products, the distribution, marketing and subsequent sales of these products could be adversely affected. If, for any reason, our business partners are unable to obtain or deliver sufficient quantities of API or finished products on a timely basis or we develop any significant disagreements with our business partners, the manufacture or supply of our products could be disrupted, which may decrease our sales revenue, increase our operating expenses or otherwise negatively impact our operations. In addition, if we are unable to engage and retain business partners for the supply of API or finished product manufacturing on commercially acceptable terms, we may not be able to sell our products as planned.

Substantially all of our products are sterile injectable pharmaceuticals. The manufacture of our products is highly exacting and complex and we or our business partners may experience problems during the manufacture of API or finished products for a variety of reasons, including, but not limited to equipment malfunction, failure to follow specific protocols and procedures, manufacturing quality concerns, problems with raw materials, natural disaster related events or other environmental factors. In addition, the manufacture of certain API that we require for our products or the finished products require dedicated facilities and we may rely on a limited number or, in most cases, single vendors for these products and services. If problems arise during the production, storage or distribution of a batch of product, that batch of product may have to be discarded. If we are unable to find alternative qualified sources of API or finished products, this could, among other things, lead to increased costs, lost sales, damage to customer relations, time and expense spent investigating the cause and, depending upon the cause, similar losses with respect to other batches or products. If problems are not discovered before the product is released to market, voluntary recalls, corrective actions or product liability related costs may also be incurred. For example, in February 2015, we initiated a voluntary recall of certain lots of a critical care product due to FDA observations regarding aseptic and GMP practices at our partner’s manufacturing site. Problems with respect to the manufacture, storage or distribution of our products could have a material adverse effect on our business, financial condition and results of operations.

While large finished product manufacturers have historically purchased API from foreign manufacturers and then manufactured and packaged the finished product in their own facility, recent growth in the number of foreign manufacturers capable of producing high-quality finished products at low cost have provided these finished product manufacturers opportunities to outsource the manufacturing of their products at lower costs than manufacturing such products in their own facilities. If the large finished product manufacturers continue to shift production from their own facilities to companies that we contract with to provide product development services, API or finished product manufacturing, we may experience added competition in obtaining these services which we rely upon to meet our customers’ demands.

 

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If we or any of our business partners are unable to comply with the quality and regulatory standards applicable to pharmaceutical drug manufacturers, or if approvals of pending applications are not granted or are delayed we may be unable to meet the demand for our products, may lose potential revenues and may incur penalties and our business, financial position and results of operations may be materially adversely affected.

All of our business partners who supply us with API or finished products as well as our owned manufacturing facilities are subject to extensive regulation by governmental authorities in the U.S., Canada and in other countries. Regulatory approval to manufacture a drug is site-specific. Both our and our suppliers’ facilities and procedures are subject to ongoing regulation, including periodic inspection by the FDA and other relevant regulatory agencies. Following an inspection, an agency may issue a notice listing conditions that are believed to violate current good manufacturing practice (“cGMP”) or other regulations, or a warning letter for violations of “regulatory significance” that may result in enforcement action if not promptly and adequately cured. If any regulatory body were to require us or one of our business partners to cease or limit production, our business could be adversely affected.

In the event of any such regulatory action, identifying alternative vendors and obtaining regulatory approval to change or substitute API or a manufacturer of a finished product can be time consuming and expensive. Any resulting delays and costs could have a material adverse effect on our business, financial position and results of operations. We cannot assure you that we or our business partners will not be subject to such regulatory action in the future.

The FDA and other relevant regulatory agencies have the authority to revoke drug approvals previously granted and remove from the market previously approved products for various reasons, including issues related to cGMP.

We may be subject from time to time to product recalls initiated by us or by the FDA or other regulatory agencies. Delays in obtaining regulatory approvals, the revocation of prior approvals, or product recalls could impose significant costs on us and adversely affect our ability to generate revenue.

Furthermore, violations by us or our business partners of U.S. or other governmental regulations and other regulatory requirements could subject us to, among other things:

 

   

warning letters;

 

   

fines and civil penalties;

 

   

total or partial suspension of production or sales;

 

   

product seizure or recall;

 

   

withdrawal of product approval; and,

 

   

criminal prosecution.

Any of these or any other regulatory action could have a material adverse effect on our business, financial position and results of operations.

In September 2013, a facility owned by Agila received a warning letter from the FDA related to the FDA inspection of Agila’s Specialty Formulation Facility (“SFF”) in Bangalore, India. Following an FDA Inspection, in August 2015 Agila received another warning letter related to both SFF and Agila’s Sterile Products Division (“SPD”), which reiterated the findings from 2013. The warning letters identified violations of cGMP related to the prevention of microbiological contamination of sterile drug products and systems to monitor environmental conditions in aseptic processing. The warning letters also described other deficiencies in the quality management function of the facilities. The warning letters stated that new drug applications may not be approved until the facilities have completed and the FDA has confirmed the remediation efforts and compliance with cGMP. Delays in the approval of the five Sagent Agila ANDAs currently being reviewed by the FDA, or limitations on the importation of products from the SFF or SPD facilities, could have a material adverse effect on our business, financial position and results of operations.

 

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We maintain our own in-house quality assurance and facility compliance teams that inspect, assess and qualify our and our business partners’ facilities, work to ensure that the facilities and the products manufactured in those facilities are cGMP compliant, and provide support for product launches and regulatory agency facility inspections. Despite these comprehensive efforts and our and our suppliers’ extensive quality systems, we cannot assure you that our business partners will adhere to our quality standards or that our compliance teams will be successful in ensuring that our business partners’ or our own facilities and the products manufactured in those facilities will be cGMP compliant. If any of our business partners fail to comply with our quality standards, or if our facilities do not comply with cGMP requirements, our ability to compete may be significantly impaired and our business, financial position and results of operations may be materially adversely affected.

Any change in the regulations, enforcement procedures or regulatory policies established by the FDA and other regulatory agencies could increase the costs or time of development of our products and delay or prevent sales of our products and our revenues could decline and, as a result, our business, financial condition and results of operations may be materially adversely affected.

Our products generally must receive appropriate regulatory clearance from the FDA or relevant regulatory agencies before they can be sold. Any change in the regulations, enforcement procedures or regulatory policies set by the FDA and other regulatory agencies could increase the costs or time of development of our products and delay or prevent sales of our products. For instance, beginning in June 2014, the FDA required new ANDA submissions to include enhanced documentation, and beginning in November 2017, all products sold in the U.S. will be required to be serialized by manufacturers. We cannot determine what effect further changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted, may have on our business in the future. Such changes could, among other things, require:

 

   

changes to manufacturing methods;

 

   

expanded or different labeling;

 

   

recall, replacement or discontinuance of certain products;

 

   

additional record keeping; and

 

   

changes in methods to determine bio-equivalents

Such changes, or new legislation, could increase the costs of, delay or prevent sales of our products and, as a result, our business, financial position and results of operations may be materially adversely affected. In addition, increases in the time that is required for us to obtain approval of regulatory submissions could delay our commercialization of new products. Approval times in the U.S. could continue to increase as a result of the upcoming expiration of the U.S. patents covering a number of key injectable pharmaceutical products. No assurance can be given that our regulatory submissions will receive approval on a timely basis, if at all, nor can we estimate the timing of approvals with any reasonable degree of certainty.

A relatively small group of products supplied by a limited number of our vendors represents a significant portion of our net revenue. If the volume or pricing of any of these products declines, or we are unable to satisfy market demand for these products, it could have a material adverse effect on our business, financial position and results of operations.

Sales of a limited number of our products collectively represent a significant portion of our consolidated net revenue. If the volume or pricing of our largest selling products declines in the future or we are unable to satisfy market demand for these products, our business, financial position and results of operations could be materially adversely affected. Should market prices of any of our products decline more rapidly than anticipated, our financial position and results of operations could be materially adversely affected.

One of our products, heparin, accounted for 13% of our consolidated net revenue for the year ended December 31, 2015, two of our products, heparin and levofloxacin in premix bags, collectively accounted for

 

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approximately 28% of our consolidated net revenue for the year ended December 31, 2014, while three of our products, heparin, levofloxacin in premix bags and zoledronic acid vials accounted for approximately 46% of our consolidated net revenue for the year ended December 31, 2013. Our ten largest products accounted for approximately 59%, 69% and 70% of our consolidated net revenue for the years ended December 31, 2015, 2014 and 2013, respectively. We expect that heparin will continue to represent a significant portion of our net revenues for the foreseeable future. We currently rely on single vendors to supply us with API and finished product manufacturing with respect to heparin. If we are unable to maintain our relationships with these business partners on commercially acceptable terms, it could have a material adverse effect on our business, financial position and results of operations.

These and our other key products could be rendered obsolete or uneconomical by numerous factors, many of which are beyond our control, including:

 

   

pricing actions by competitors;

 

   

development by others of new pharmaceutical products that are more effective than ours;

 

   

entrance of new competitors into our markets;

 

   

loss of key relationships with suppliers, GPOs or end-user customers;

 

   

technological advances;

 

   

manufacturing or supply interruptions;

 

   

changes in the prescribing practices of physicians;

 

   

changes in third-party reimbursement practices;

 

   

product liability claims; and

 

   

product recalls or safety alerts.

Any factor adversely affecting the sale of our key products may cause our revenues to decline, and our business, financial position and results of operations may be materially adversely affected.

In March 2014, we entered an agreement with Actavis to terminate our Manufacturing and Supply Agreement, effective December 31, 2015. In the aggregate, products sourced from Actavis accounted for approximately 19% and 18% of our consolidated net revenue for the years ended December 31, 2014 and 2013, respectively.

Our markets are highly competitive and, if we are unable to compete successfully, our revenues could decline and our business, financial condition and results of operations may be materially adversely affected.

The injectable pharmaceutical market is highly competitive. Our competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies and generic drug companies. Our principal competitors include Fresenius, Pfizer, Sandoz, Teva and West-Ward. In most cases, these competitors have access to greater financial, marketing, technical and other resources than we do. As a result, they may be able to devote more resources to the development, manufacture, marketing and sale of their products, receive a greater share of the capacity from API suppliers and finished product manufacturers, obtain more support from independent distributors, initiate or withstand substantial price competition or more readily take advantage of acquisition or other growth opportunities.

The generic segment of the injectable pharmaceutical market is characterized by a high level of price competition, as well as other competitive factors including reliability of supply, quality and enhanced product features. To the extent that any of our competitors are more successful with respect to any key competitive factor, our business, results of operations and financial position could be adversely affected. Pricing pressure could arise from, among other things, limited demand growth or a significant number of additional competitive products

 

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being introduced into a particular product market, price reductions by competitors, the ability of competitors to capitalize on their economies of scale and create excess product supply, the ability of competitors to produce or otherwise secure API and/or finished products at lower costs than what we are required to pay to our business partners under our manufacturing agreements and the access of competitors to new technology that we do not possess.

The generic injectable pharmaceutical market has experienced a number of significant merger and acquisition transactions that are driving consolidation in the markets in which we compete. Such consolidations may create larger companies with which we must compete, eliminate actual or potential sources for API and finished products, reduce the number of vendors willing to supply us with products, and provide further pressure on prices, development activities or customer retention. The impact of consolidation in the industry could have a material adverse impact on our business, results of operations and financial position.

In addition to competition from established market participants, new entrants to the generic injectable pharmaceutical market could substantially reduce our market share, prevent us from attaining market share or render our products obsolete. Most of our products are generic injectable versions of branded products. As patents for branded products and related exclusivity periods expire or are ruled invalid, the first generic pharmaceutical manufacturer to receive regulatory approval for a generic version of the reference product is generally able to achieve significant market penetration and higher margins on that product. As competing generic manufacturers receive regulatory approval of, and begin to market, this product, market share, revenue and gross profit typically decline for the original generic entrant. In addition, as more competitors enter a specific generic market, the average selling price per unit dose of the particular product typically declines for all competitors. Our ability to sustain our level of market share, revenue and gross profit attributable to a particular generic pharmaceutical product is significantly influenced by the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch in relation to competing approvals and launches, as to which we have no control.

Branded pharmaceutical companies often take aggressive steps to thwart competition from generic companies. The launch of our generic products could be delayed because branded drug manufacturers may, among other things:

 

   

make last minute modifications to existing product claims and labels, thereby requiring generic products to reflect this change prior to the drug being approved and introduced in the market;

 

   

file new patents for existing products prior to the expiration of a previously issued patent, which could extend patent protection for additional years;

 

   

file patent infringement suits that automatically delay for a specific period the approval of generic versions by the FDA or other regulatory bodies;

 

   

develop and market their own generic versions of their products, either directly or through other generic pharmaceutical companies; and

 

   

file citizens’ petitions with the FDA contesting generic approvals on alleged health and safety grounds.

Furthermore, the FDA may grant a single generic manufacturer other than us a 180-day period of marketing exclusivity under the Drug Price Competition and Patent Term Restoration Act of 1984 as patents or other exclusivity periods for branded products expire.

If we are unable to continue to develop and commercialize new products in a timely and cost-effective manner, our business, results of operations and financial position could be adversely affected.

Our future success will depend to a significant degree on our ability to continue to develop and commercialize new products in a timely and cost-effective manner. The development and commercialization of new products is

 

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complex, time-consuming and costly and involves a high degree of business risk. As of December 31, 2015, we actively marketed 55 products in our Sagent US segment and 48 products in our Omega segment. Our US segment new product pipeline included 67 ANDAs that we had filed, or licensed rights to, and were under review by the FDA, six ANDAs that have been recently approved by the FDA and are pending commercial launch and 31 ANDAs under initial development. We had an additional 14 filings under review by regulatory agencies in our Omega segment, primarily in Canada, or under initial development. We may, however, encounter unexpected delays in the launch of these products, or these products, if and when fully commercialized by us, may not perform as we expect. For example, our pending regulatory filings may not receive approval on a timely basis, if at all.

The success of our new product offerings will depend upon several factors, including our ability to anticipate customer needs, obtain timely regulatory approvals and locate and establish collaborations with suppliers of API, product development and finished product manufacturing in a timely and cost-effective manner. In addition, the development and commercialization of new products is characterized by significant up-front costs, including costs associated with product development activities, sourcing API and manufacturing capability, obtaining regulatory approval, building inventory and sales and marketing. Furthermore, the development and commercialization of new products is subject to inherent risks, including the possibility that any new product may:

 

   

fail to receive or encounter unexpected delays in obtaining necessary regulatory approvals;

 

   

be difficult or impossible to manufacture on a large scale;

 

   

be uneconomical to market;

 

   

fail to be developed prior to the successful marketing of similar or superior products by third parties; and,

 

   

infringe on the proprietary rights of third parties.

Our business, results of operations and financial position could be adversely affected if we are not successful in continuing to develop and commercialize new products.

If we are unable to maintain our GPO relationships, our results of operations could be adversely affected.

Most of the end-users of injectable pharmaceutical products have relationships with GPOs whereby such GPOs provide such end-users access to a broad range of pharmaceutical products from multiple suppliers at competitive prices and, in certain cases, exercise considerable influence over the drug purchasing decisions of such end-users. Hospitals and other end-users contract with the GPO of their choice for their purchasing needs. We currently derive, and expect to continue to derive, a large percentage of our revenue from end-user customers that are members of a small number of GPOs, and we anticipate this concentration will increase as the industry continues to consolidate. For example, the five largest U.S. GPOs represented end-user customers that collectively accounted for approximately 35%, 44% and 39% of our Sagent US segment net contract revenue for the years ended December 31, 2015, 2014 and 2013, respectively. Maintaining our strong relationships with these GPOs will require us to continue to be a reliable supplier, offer a broad product line, remain price competitive, comply with FDA regulations and provide high-quality products. Although our GPO pricing agreements in both our Sagent US and Omega segments typically are multi-year in duration, most of them may be terminated by either party with 60 or 90 days notice. The GPOs with whom we have relationships may have relationships with manufacturers that sell competing products, and such GPOs may earn higher margins from these products or combinations of competing products or may prefer products other than ours for other reasons. If we are unable to maintain our GPO relationships, sales of our products and revenue could decline and our results of operations could be materially adversely affected.

We rely on a limited number of pharmaceutical wholesalers to distribute our products.

As is typical in the pharmaceutical industry, we rely upon a limited number of pharmaceutical wholesalers in connection with the distribution of our products. We currently derive, and expect to continue to derive, a large

 

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percentage of our sales through the three largest wholesalers in the U.S. market, Amerisource, Cardinal Health and McKesson. For the year ended December 31, 2015, the products we sold through these wholesalers accounted for approximately 28%, 23% and 27%, respectively, of our consolidated net revenue. Collectively, our sales to these three wholesalers represented approximately 78%, 85% and 84% of our net revenue for the years ended December 31, 2015, 2014 and 2013, respectively. If we are unable to maintain our business relationships with these major pharmaceutical wholesalers on commercially acceptable terms, it could have a material adverse effect on our sales and results of operations.

We depend upon our key personnel, the loss of whom could adversely affect our operations. If we fail to attract and retain the talent required for our business, our business could be materially harmed.

We are a relatively small company and we depend to a significant degree on the principal members of our management and sales teams. The loss of services from our key employees may significantly delay or prevent the achievement of our product development or business objectives. We have entered into employment agreements with certain of our key employees that contain restrictive covenants relating to non-competition and non-solicitation of our customers and employees for a period of up to 12 months after termination of employment. Nevertheless, each of our officers and key employees may terminate his or her employment at any time without notice and without cause or good reason, and so as a practical matter these agreements do not guarantee the continued service of these employees. Our success depends upon our ability to attract and retain highly qualified personnel. Competition among pharmaceutical and biotechnology companies for qualified employees is intense, and the ability to attract and retain qualified individuals is critical to our success. We may not be able to attract and retain these individuals on acceptable terms or at all, and our inability to do so could significantly impair our ability to compete.

Our inability to manage our planned growth or successfully integrate newly acquired businesses could harm our business.

As we expand our business we expect that our operating expenses and capital requirements will increase. As our in-house manufacturing capabilities, product portfolio and product pipeline grow, we may require additional personnel on our operations, project management, in-house quality assurance and facility compliance teams to work on manufacturing, quality assurance, cGMP compliance, regulatory affairs and product development matters. As a result, our operating expenses and capital requirements may increase significantly. In addition, we may encounter unexpected difficulties managing our worldwide network of relationships with API suppliers and finished product developers and manufacturers as we seek to expand such network in order to expand our product portfolio. Our ability to manage our growth effectively requires us to forecast accurately our sales growth and global manufacturing capacity and to expend funds to improve our operational, manufacturing financial and management controls, reporting systems and procedures.

Additionally, if we are unable to successfully integrate our recent acquisitions and achieve our expected efficiencies and synergies, our business could be harmed and our financial position and results of operations could be materially adversely affected. The integration of international acquisitions can involve cultural, monetary and systems challenges among others. Our personnel, systems, procedures or controls may not be adequate to support both our ongoing business and the integration of newly acquired businesses.

If we are unable to manage our anticipated growth and the integration of newly acquired businesses effectively, our business could be harmed.

We may be exposed to product liability claims that could cause us to incur significant costs or cease selling some of our products.

Our business inherently exposes us to claims for injuries allegedly resulting from the use of our products. We may be held liable for, or incur costs related to, liability claims if any of our products cause injury or are found

 

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unsuitable during development, manufacture, sale or use. These risks exist even with respect to products that have received, or may in the future receive, regulatory approval for commercial use. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

   

decreased demand for our products;

 

   

injury to our reputation;

 

   

initiation of investigations by regulators;

 

   

costs to defend the related litigation;

 

   

a diversion of management’s time and resources;

 

   

compensatory damages and fines;

 

   

product recalls, withdrawals or labeling, marketing or promotional restrictions;

 

   

loss of revenue; and,

 

   

exhaustion of any available insurance and our capital resources.

Our product liability insurance may not be adequate and, at any time, insurance coverage may not be available on commercially reasonable terms or at all. A product liability claim could result in liability to us greater than our insurance coverage or assets. Even if we have adequate insurance coverage, product liability claims or recalls could result in negative publicity or force us to devote significant time and attention to those matters or have a material adverse effect on our business.

If our products conflict with the intellectual property rights of third parties, we may incur substantial liabilities and we may be unable to commercialize products in a profitable manner or at all.

We seek to launch generic pharmaceutical products either where patent protection or other regulatory exclusivity of equivalent branded products has expired, where patents have been declared invalid or where products do not infringe on the patents of others. However, at times, we may seek approval to market generic products before the expiration of patents relating to the branded versions of those products, based upon our belief that such patents are invalid or otherwise unenforceable or would not be infringed by our products. Our success depends in part on our ability to operate without infringing the patents and proprietary rights of third parties. The manufacture, use and sale of generic versions of products has been subject to substantial litigation in the pharmaceutical industry. These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties. If our products were found to be infringing on the intellectual property rights of a third-party, we could be required to cease selling the infringing products, causing us to lose future sales revenue from such products and face substantial liabilities for patent infringement, in the form of either payment for the innovator’s lost profits or a royalty on our sales of the infringing product. These damages may be significant and could materially adversely affect our business. Any litigation, regardless of the merits or eventual outcome, would be costly and time consuming and we could incur significant costs and/or a significant reduction in revenue in defending the action and from the resulting delays in manufacturing, marketing or selling any of our products subject to such claims.

Healthcare reform legislation or other policy changes may adversely affect our business

We expect both federal and state governments in the U.S. and foreign governments to continue to propose and pass new legislation, rules and regulations designed to contain or reduce the cost of healthcare while expanding individual healthcare benefits. Existing regulations that affect the price of pharmaceutical and other medical products may also change before any of our products are approved for marketing. Cost control initiatives could decrease the price that we receive for any product we develop in the future. In addition, third-party payors are increasingly challenging the price and cost-effectiveness of medical products and services. Significant

 

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uncertainty exists as to the reimbursement status of newly approved pharmaceutical products, including injectable products. Our products may not be considered cost effective, or adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize a return on our investments.

If reimbursement for our current or future products is reduced or modified, our business could suffer.

Sales of our products depend, in part, on the extent to which the costs of our products are paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or are reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. These healthcare management organizations and third-party payors are increasingly challenging the prices charged for medical products and services. Additionally, as discussed above, the containment of healthcare costs has become a priority of federal and state governments in the U.S., and the prices of drugs and other healthcare products have been targeted in this effort. Accordingly, our current and potential products may not be considered cost effective, and reimbursement to the consumer may not be available or sufficient to allow us to sell our products on a competitive basis. Legislation and regulations affecting reimbursement for our products may change at any time and in ways that are difficult to predict, and these changes may have a material adverse effect on our business. Any reduction in Medicare, Medicaid or other third-party payor reimbursements could have a material adverse effect on our business, financial position and results of operations.

In Canada and certain other international markets, the government provides healthcare at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for government-sponsored healthcare system. Many countries are currently reducing their public expenditures and we expect to continue to see strong efforts to reduce healthcare costs in international markets for the foreseeable future. In markets outside the U.S., our business could experience downward pressure on product pricing as a result of the concentrated buying power of governments as principal customers and the use of bid-and-tender sales methods whereby we are required to submit a bid for the sale of our products. The failure to offer acceptable prices to these customers could have a material adverse effect on our business, financial position and results of operations outside the U.S.

Any failure to comply with the complex reporting and payment obligations under Medicare, Medicaid and other government programs may result in litigation or sanctions.

We are subject to various federal, state and foreign laws pertaining to foreign corrupt practices and healthcare fraud and abuse, including anti-kickback, marketing and pricing laws. Violations of these laws are punishable by criminal and/or civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs such as Medicare and Medicaid, as well as exclusion from bid-and-tender processes for sales to the U.S. government. If there is a change in laws, regulations or administrative or judicial interpretations, we may have to change our business practices, or our existing business practices could be challenged as unlawful, which could materially adversely affect our business, financial position and results of operations.

We may need to raise additional capital in the event we change our business plan or encounter unexpected developments, which may cause dilution to our existing stockholders or restrict or limit our operations.

We may require significant additional funds earlier than we currently expect in the event we change our business plan, execute further strategic acquisitions, or encounter unexpected developments, including unforeseen competitive conditions within our markets, changes in the general economic climate, changes in the regulatory environment, the loss of key relationships with suppliers, GPOs or end-user customers or other unexpected developments that may have a material effect on the cash flows or results of operations of our business. If required, additional funding may not be available to us on acceptable terms or at all. Our ability to raise additional funding, if necessary, is subject to a variety of factors that we cannot predict with certainty, including our future results of operations, our relative levels of debt and equity, the volatility and overall condition of the

 

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capital markets and the market prices of our securities. We may seek additional capital through a combination of private and public equity offerings, debt financings and collaboration arrangements. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. In addition, additional debt financing may only be available to us on less favorable terms than our revolving loan credit facility with JPMorgan Chase Bank, N.A. (“Chase”), including higher interest rates or greater exposure to interest rate risk. We may elect to raise additional funds even before we need them if the conditions for raising capital are favorable.

We are subject to a number of risks associated with managing our international network of business relationships.

We have an international network of business relationships that includes 47 partners worldwide as of December 31, 2015, including 16 in the Americas, 12 in China and Taiwan, 11 in Europe, seven in India and one in the Middle East. As part of our business strategy, we intend to continue to identify further business relationships involving API sourcing, product development, finished product manufacturing and product licensing. We expect that a significant percentage of these new relationships will be with business partners located outside the U.S. Managing our existing and future international network of business relationships could impose substantial burdens on our resources, divert management’s attention from other areas of our business and otherwise harm our business. In addition, our international network of relationships subjects us to certain risks, including:

 

   

legal uncertainties regarding, and timing delays associated with, tariffs, export licenses and other trade barriers;

 

   

increased difficulty in operating across differing legal regimes, including resolving legal disputes that may arise between us and our business partners;

 

   

difficulty in staffing and effectively monitoring our business partners’ facilities and operations across multiple geographic regions;

 

   

workforce uncertainty in countries where labor unrest is more common than in the U.S.;

 

   

unfavorable tax or trade restrictions or currency calculations;

 

   

production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

 

   

changes in diplomatic and trade relationships.

Any of these or other factors could adversely affect our ability to effectively manage our international network of business relationships and our operating results.

Approval by the Chinese government of the sale of SCP may be delayed or not be received.

On February 3, 2016, we entered into a Share Purchase Agreement with Hong Kong King-Friend Industrial Company Limited., a wholly-owned subsidiary of Nanjing King-Friend Pharmaceutical Co., Ltd., (“NKF”) to sell all of our ownership interest in SCP to NKF in exchange for $0.5 million. The transaction is subject to approval by an agency of the Chinese government. We currently anticipate the transaction to close in the second quarter of 2016. Any delay in obtaining the required regulatory approval and closing the transaction could adversely affect us, as we will continue to bear the operating costs of the facility until the transaction closes. If the transaction is not approved by the Chinese government, we would be required to re-evaluate whether to close the facility or identify another buyer. A delay in closing of the transaction, or failure of Chinese authorities to approve the transaction could be costly and we could incur significant costs in identifying a new plan of action with respect to SCP.

 

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We may never realize the expected benefits from our acquisition of Omega and it may require substantial additional capital resources.

Omega is a specialty pharmaceutical company based in Montreal, Canada, which we acquired on October 1, 2014. Omega has served the Canadian and select international markets for over 60 years, with a historic focus on niche generic injectable pharmaceutical products. Prior to our acquisition, Omega had initiated a capacity expansion program, including installing an additional manufacturing line in a recently acquired building adjacent to its existing facility. We currently expect the new manufacturing capacity to be operational for the Canadian market by early 2018, and for the U.S. market in 2019; however, there can be no assurances the new manufacturing capacity will be operational by such time or at all.

If we are unable to achieve the efficiencies and synergies we projected, or if the new manufacturing line does not receive appropriate regulatory approvals to manufacture products, our business could be harmed and our financial position and results of operations could be materially adversely affected.

We may never realize the expected benefits of our Omega acquisition due to, among other things:

 

   

our personnel, systems, procedures or controls may not be adequate to support both our ongoing business and the integration of Omega;

 

   

the Omega facility may cease to be commercially viable for a variety of reasons in and/or beyond our control;

 

   

the additional manufacturing capacity may never receive appropriate Health Canada, FDA or other regulatory approvals to manufacture products or such approvals may be delayed;

 

   

we may be required to incur substantial expenses and make further substantial capital investments to enable the Omega facility to operate efficiently and to continue to contribute positively to our revenue or earnings;

 

   

general political and economic uncertainty could impact operations at the Omega facility, including multiple regulatory requirements that are subject to change, any future implementation of trade protection measures and import or export licensing requirements between the U.S. and Canada, labor regulations or work stoppages at the facility, fluctuations in the foreign currency exchange rates and complying with U.S. regulations that apply to international operations, including trade laws and the U.S. Foreign Corrupt Practices Act; and,

 

   

operations at the facility may be disrupted for any reason, including natural disaster, local or international political disputes, or other similar factors.

Any of these or any other action that results in Omega being unable to operate as anticipated could materially adversely affect our business, financial position and results of operations.

We rely on a single vendor to manage our order to cash cycle and our distribution activities in the U.S., and the loss or disruption of service from this vendor could adversely affect our operations and financial condition

Our U.S. customer service, order processing, invoicing, cash application, chargeback and rebate processing and distribution and logistics activities are managed by Dohman Life Science Services (“DLSS”). DLSS’s Business Process Outsourcing solution to life science companies connects finance, information systems, commercialization, supply chain, drug safety and sales support processes. If we were to lose the availability of DLSS’s services due to fire, natural disaster or other disruption, such loss could have a material adverse effect on our operations. Although multiple providers of such services exist, there can be no assurance that we could secure another source to handle these transactions on acceptable terms or otherwise to our specifications in the event of a disruption of services at either their Memphis, Tennessee logistics center or Milwaukee, Wisconsin order to cash cycle processing center.

 

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Our revenue growth may not continue at historical rates, we may never achieve our business strategy of optimizing our gross and operating margins, and our business may suffer as a result of our limited operating history or lack of public company operating experience.

Since our inception in 2006, we have experienced rapid growth in our net revenue. Although we expect our revenue to continue to grow over the long term due to both continued commercial success with our existing products and the launch of new products, we cannot provide any assurances that our revenue growth will continue at historical rates, if at all. In addition, as part of our business strategy we intend to seek to optimize our gross and operating margins by improving the commercial terms of our supply arrangements and to gain access to additional, more favorable API, product development and manufacturing capabilities, including launching products from our wholly-owned manufacturing facilities. We may, however, encounter unforeseen difficulties in improving the commercial terms of our current supply arrangements, in gaining access to additional arrangements, or in successfully manufacturing products from our wholly-owned facilities, and, as a result, cannot provide any assurances that we will be successful in optimizing our margins. Finally, we have a limited operating history at our current scale of operations, and as a public company. Our limited operating history and public company operating experience may make it difficult to forecast and evaluate our future prospects. If we are unable to execute our business strategy and grow our business, either as a result of our inability to manage our current size, effectively manage the business in a public company environment, manage our future growth or for any other reason, our business, prospects, financial condition and results of operations may be harmed.

Currency exchange rate fluctuations may have an adverse effect on our business.

We generally record sales and pay our expenses in the local currency of the applicable Sagent entity. Substantially all of our business partners that supply us with API, product development services and finished product manufacturing are located in foreign jurisdictions, such as India, China, Romania and Brazil, and we believe they generally incur their respective operating expenses in local currencies, and we generally pay for such API, services and products in U.S. dollars. As a result, both we and our business partners may be exposed to currency rate fluctuations and experience an effective increase in operating expenses in the event local currencies appreciate against the U.S. dollar. In this event, the cost of manufacturing product from our Omega facility may increase or our business partners may elect to stop providing us with these services or attempt to pass these increased costs back to us through increased prices for product development services, API sourcing or finished products that they supply to us, any of which could have an adverse effect on our business.

We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.

The U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. Our internal control policies mandate compliance with these laws. Many of our business partners who supply us with product development services, API sourcing and finished product manufacturing are located in parts of the world that have experienced governmental corruption to some degree, and, in certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices. Despite our compliance policies, we cannot be assured that our internal control policies and procedures always will protect us from reckless or negligent acts committed by our employees or agents. Violations of these laws, or allegations of such violations, could have a negative impact on our business, results of operations and reputation.

We may seek to engage in strategic transactions that could have a variety of negative consequences, and we may not realize the benefits of such transactions.

From time to time, we may seek to engage in strategic transactions with third parties, such as strategic partnerships, joint ventures, restructurings, divestitures, acquisitions and other investments. Any such transaction may require us to incur non-recurring and other charges, increase our near and long-term expenditures, pose significant integration challenges, require additional expertise and disrupt our management and business, which

 

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could harm our business, financial position and results of operations. We may face significant competition in seeking appropriate strategic partners and transactions, and the negotiation process for any strategic transaction could be time-consuming and complex. There is no assurance that, following the consummation of a strategic transaction, we will achieve the anticipated revenues, profits or other benefits from the transaction, and we may incur greater costs than expected.

Our inability to protect our intellectual property in the U.S. and foreign countries could limit our ability to manufacture or sell our products.

We have limited intellectual property surrounding our generic injectable products. However, in the normal course of our business, we develop specialized devices, systems and branding strategies that we will seek to protect through trade secrets, unpatented proprietary know-how, continuing technological innovation, and traditional intellectual property protection through trademarks, copyrights and patents to preserve our competitive position. Despite these measures, we may not be able to prevent third parties from using our intellectual property, copying aspects of our products and packaging, or obtaining and using information that we regard as proprietary, which could materially adversely affect our business.

Unforeseen problems with the implementation and maintenance of our equipment and information systems could interfere with our operations.

In the normal course of business, we must record and process significant amounts of data quickly, accurately and relying on various computer and telecommunications equipment and information technology systems. Any failure of such equipment or systems could adversely affect our operations.

As part of our initiative to update our business processes and information technology systems, we are in the process of implementing new enterprise resource planning software and other related applications across our global operations. We will incur substantial costs associated with both implementation and maintenance of these new applications, and unforeseen problems could arise. We have engaged third-party consultants and service providers for the development and implementation of the new systems, and if these parties fail to perform their obligations, development and implementation of the project could be delayed. If the new systems do not perform as originally planned, our business, financial position and results of operations could be adversely affected.

Investment funds managed by Vivo Ventures, LLC own a substantial percentage of our CommonSstock, which may prevent other investors from influencing significant corporate decisions.

Investment funds managed by Vivo Ventures, LLC (“Vivo Ventures”) beneficially own approximately 6,499,737 shares, or approximately 19.8% of our outstanding Common Stock as of December 31, 2015. As a result, Vivo Ventures will, for the foreseeable future, have significant influence over all matters requiring stockholder approval, including election of directors, adoption of or amendments to equity-based incentive plans, amendments to our certificate of incorporation and certain mergers, acquisitions and other change-of-control transactions. Vivo Ventures’ ownership of a large amount of our voting power may have an adverse effect on the price of our Common Stock. The interests of Vivo Ventures may not be consistent with your interests as a stockholder.

Consolidation of Customers

Many healthcare organizations are consolidating to create healthcare delivery systems with greater market power. As group purchasing organizations consolidate, thus decreasing the number of market participants, competition to provide products and services like ours will become more intense, and the importance of establishing and maintaining relationships with key industry participants will become greater. These industry participants may try to use their market power to negotiate price reductions for our products and services. Any of these factors could materially and adversely impact our business, financial condition, and operating results.

 

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Item 1B. Unresolved Staff Comments.

Not applicable.

 

Item 2. Properties.

As of December 31, 2015, we conducted substantially all of our corporate operations through an aggregate of approximately 23,500 square feet of office space in our headquarters in Schaumburg, Illinois under a lease that expires on December 31, 2016. We believe that our current facility is adequate for our corporate needs for the immediate future and that suitable space will be available to accommodate our operations on commercially reasonable terms following the expiry of our current lease.

Our SCP subsidiary occupies approximately 300,000 square feet in Chengdu, China. In December 2013, we entered an initial two year lease on approximately 10,000 square feet of space in the Chengdu Hi-Tech Development Zone, where we performed product development activities in conjunction with SCP, which has been extended to December 2016. On December 29, 2015, the Board of Directors authorized the Company to proceed with a sale of all of the Company’s interests in SCP. On February 3, 2016, the Company entered into a Share Purchase Agreement with NKF whereby NKF will acquire 100% of the outstanding shares.

Our Omega subsidiary occupies three owned and two leased facilities in Montreal, Quebec, where it performs the manufacturing and distribution of products for our Omega segment. The three owned facilities occupy approximately 62,000 square feet, and the leased facilities occupy approximately 45,000 square feet.

 

Item 3. Legal Proceedings.

We are from time to time subject to claims and litigation arising in the ordinary course of business. These claims may include assertions that our products infringe existing patents and claims that the use of our products has caused personal injuries. We intend to defend vigorously any such litigation that may arise under all defenses that would be available to us.

Zoledronic Acid (Generic versions of Zometa ® and Reclast ®). On February 20, 2013, Novartis Pharmaceuticals Corporation (“Novartis”) sued the Company and several other defendants in the U.S. District Court for the District of New Jersey, alleging, among other things, that sales of the Company’s (i) zoledronic acid product under FDA NDA No. 203231, made by ACS Dobfar Info S.A. (“Info”), also a defendant, a generic bioequivalent version of Novartis’ Zometa ® Ready-to-Use product, would infringe U.S. Patent No. 7,932,241 (the “241 Patent”) and U.S. Patent No. 8,324,189 (the “189 Patent”) and (ii) zoledronic acid product under FDA ANDA No. 202828, also made by Info, a generic version of Novartis’ Reclast ® product, would infringe U.S. Patent No. 8,052,987 (the “987 Patent”) and the 241 Patent, and (iii) zoledronic acid product under FDA ANDA No. 202472, made by Actavis LLC, also a defendant, a generic version of Novartis’ Zometa ® Pre Concentrate product, would infringe the 189 Patent. (In Re: Certain Consolidated Zoledronic Acid Cases; Consolidated Civil Action No. 12-03967(SDW)(SCM) [Consolidated with Civil Action Nos. 12-cv-04393, 13-cv-01028, 13-cv-02379, 13-cv-4669, 13-cv-5125, 13-cv-6835, 13-cv-7914 and 14-cv-18411]). On March 1, 2013, the District Court denied Novartis’ request for a temporary restraining order against the Company and the other defendants, including Actavis and Info. On March 6, 2013 the Company, began selling Actavis’ zoledronic acid vial, the generic version of Zometa. Also, as of August 27, 2013 and October 1, 2013, the Company began selling zoledronic acid premix bags in 4mg/100ml and 5mg/100ml presentations, respectively. On December 3, 2014, Novartis sued the Company, alleging, among other things, that sales of the Company’s zoledronic acid product under FDA ANDA No. 091493, made by Hameln RDS GMBH, a generic version of Novartis’ Zometa ® Pre-concentrate product, would infringe the 189 Patent. (Novartis Pharmaceuticals Corporation v. Sagent Pharmaceuticals, Inc. et. al., Case No. 2: 14-cv-07556(SDW)(SCM) and together with the Consolidated Civil Action Case No. 13-cv-1028, the “Litigation”).

 

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On October 13, 2015, the Company and Novartis agreed to settle the Litigation (“Settlement”). Pursuant to the terms of the Settlement, the Company paid Novartis $5 million in exchange for a release of claims associated with the 241, 987 and 189 Patents pertaining to the following regulatory submissions: FDA NDA No. 203231, FDA ANDA No. 202828, FDA ANDA No. 202472 and FDA ANDA No. 091493 (collectively the “Regulatory Submissions”), and acquired a license to sell the zoledronic acid products as approved by their Regulatory Submissions (excluding sales of product manufactured under FDA ANDA No. 202472 after December 31, 2014) in the U.S. Concurrent with the Settlement, the Company received $1.5 million from Info and Actavis, representing their collective share of the $5 million.

We have determined that $1.7 million of the Settlement represents a future license to sell the zoledronic acid products. This amount has been recorded within Other assets on the Consolidated Balance Sheet as of December 31, 2015, partially offset by the portion of the Info reimbursement, $0.6 million, related to the license period. The remaining net settlement amount of $2.4 million paid to Novartis is recorded as Legal settlement within the Consolidated Statement of Operations for the year ended December 31, 2015.

At this time, there are no other proceedings of which we are aware that are considered likely to have a material adverse effect on our consolidated financial position or results of operations.

 

Item 4. Mine Safety Disclosures.

Not applicable.

 

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PART II

 

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Our Common Stock is listed on the NASDAQ Global Market and trades under the symbol “SGNT”. At February 28, 2016, there were approximately 8,123 holders of record of our Common Stock.

The high and low market price for our Common Stock during each of the quarterly periods in 2015 and 2014 is included below:

 

     2015 Quarters  
     First      Second      Third      Fourth  

Market price(1)

           

High

   $ 28.50       $ 26.49       $ 26.21       $ 17.23   

Low

   $ 22.83       $ 22.26       $ 15.20       $ 14.30   
     2014 Quarters  
     First      Second      Third      Fourth  

Market price(1)

           

High

   $ 25.30       $ 25.86       $ 31.10       $ 32.81   

Low

   $ 18.00       $ 19.73       $ 23.98       $ 24.04   

Since our inception, we have not paid a dividend on our Common Stock, and we have no intention to do so in the near future.

 

 

LOGO

 

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Issuer Purchases of Equity Securities during the Quarter ended December 31, 2015

There are currently no share repurchase programs authorized by our Board of Directors. No purchases of our Common Stock were made in the fourth quarter of 2015.

Recent Sales of Unregistered Securities

None.

 

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Item 6. Selected Financial Data.

The following table sets forth selected financial data as of and for the periods indicated. The selected financial data set forth below has been derived from our consolidated financial statements as of and for the years ended December 31, 2015, 2014, 2013, 2012 and 2011, which have been audited by our independent registered public accounting firm. The data presented below should be read in conjunction with our consolidated financial statements, the notes to our consolidated financial statements and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

     Year ended December 31,  
     2015     2014
As restated
    2013     2012     2011  
     (in thousands, except per share data)  

Statement of Operations Data:

          

Net revenue

   $ 318,296      $ 288,983      $ 244,750      $ 183,615      $ 152,405   

Cost of sales

     230,557        202,821        167,228        152,508        65,013   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

   $ 87,739      $ 86,162      $ 77,522      $ 31,107      $ 18,769   

Gross margin

     27.6     29.8     31.7     16.9     12.3

Operating expenses

          

Product development

     29,145        26,809        20,275        17,136        12,763   

Selling, general and administrative

     49,931        43,227        36,198        30,093        25,148   

Management reorganization

     5,310        —          —          708        —     

Acquisition-related costs

     2,838        1,069        —          —          —     

Equity in net (income) loss of joint ventures

     (2,569     (3,987     (2,395     (1,337     2,531   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     84,655        67,118        54,078        46,600        40,442   

Impairment of SCP

   $ 45,158        —          —          —          —     

Net income (loss)

   $ (21,882   $ 36,951      $ 29,594      $ (16,817   $ (26,422

Income (loss) per share – basic

   $ (0.67   $ 1.16      $ 1.01      $ (0.60   $ (1.31

Income (loss) per share – diluted

   $ (0.67   $ 1.13      $ 0.99      $ (0.60   $ (1.31

Weighted-average shares – basic

     32,439        31,882        29,213        27,980        20,105   

Weighted-average shares – diluted

     32,439        32,745        29,937        27,980        20,105   

Balance Sheet Data:

          

Cash and cash equivalents

   $ 28,962      $ 55,633      $ 42,332      $ 27,687      $ 52,203   

Short-term investments

     20,060        18,473        113,810        36,605        73,761   

Working capital

     107,937        100,832        172,267        106,815        116,704   

Total assets

     352,980        379,958        310,208        172,315        230,508   

Total long-term debt

     1,623        7,952        10,333        —          37,140   

Total stockholder’s equity (deficit)

     251,093        273,802        236,026        131,856        141,669   

 

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following is a discussion and analysis of the consolidated operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in Item 8 under the heading “Financial Statements and Supplementary Data”. This discussion contains forward-looking statements that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in the section entitled “Risk Factors.”

Overview

We are a leading provider of affordable pharmaceuticals to the hospital market, which we sell primarily throughout North America. With a primary focus on generic injectable pharmaceuticals, which provide customers a lower-cost alternative to branded products when applicable patents have expired or been declared invalid, or when the products are determined not to infringe the patents of others. We offer our customers a broad range of products across anti-infective, oncology and critical care indications in a variety of presentations, including single- and multi-dose vials, pre-filled ready-to-use syringes and premix bags. We seek generally to develop injectable products where the form or packaging of the product can be enhanced to improve delivery, product safety or end-user convenience. Our management team includes industry veterans who have served critical functions at other pharmaceutical companies or key customer groups and have long-standing relationships with customers, regulatory agencies, and suppliers.

We have rapidly established a growing and diverse product portfolio and product pipeline as a result of our innovative business model. The model combines an extensive network of business relationships with API suppliers and finished product developers and manufacturers in Asia, Europe, the Middle East, Australia and the Americas with our proven and experienced regulatory, quality assurance, business development, project management, and sales and marketing teams. As of December 31, 2015, our network provided us access to over 100 worldwide manufacturing and development facilities, including several dedicated facilities used to manufacture specific complex APIs and finished products. Our 50/50 joint venture known as Sagent Agila LLC (formerly known as Sagent Strides LLC) with Agila Specialities Pvt. Ltd., a subsidiary of Mylan Inc. (“Agila”), was established to facilitate the sale in the U.S. market of a wide variety of generic injectable products manufactured by Agila.

In June 2013, we acquired the remaining 50% interest in Kanghong Sagent (Chengdu) Pharmaceutical Co. Ltd., (“KSCP”) from our former joint venture partner. The entity, which has been renamed Sagent (China) Pharmaceuticals Co. Ltd. (“SCP”) provides us with a dedicated, state-of-the-art manufacturing facility. The facility received its Establishment Inspection Report in April 2013, and its first product approval in June 2013. We launched our first product from this facility, carboplatin, in the fourth quarter of 2013. On December 29, 2015, the Board of Directors authorized the Company to proceed with a sale of all of the Company’s interests in SCP. On February 3, 2016, the Company entered into a Share Purchase Agreement with Hong Kong King-Friend Pharmaceutical Co., Ltd., a subsidiary of Nanjing King-Friend Pharmaceutical Co., Ltd., (“NKF”) whereby NKF will acquire 100% of the outstanding shares of SCP in exchange for $0.5 million. We expect this transaction to close in the second quarter of 2016, at which time SCP will cease to be a subsidiary of the Company.

On October 1, 2014, we, through our wholly-owned subsidiary, Sagent Acquisition Corp., a Canadian company, acquired all of the issued and outstanding shares of the capital stock of 7685947 Canada Inc., and its subsidiary, Omega Laboratories Limited (collectively, “Omega”), a privately held Canadian pharmaceutical and specialty healthcare products company. Omega represents our first international market, and the facility provides us with the ability to manufacture products for the Canadian and other international markets.

Following our acquisition of Omega, we are organized as two operating segments – Sagent US, consisting of our U.S. operations and the SCP manufacturing facility, and Omega, focused on the Canadian and international markets.

 

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We are developing an extensive injectable product portfolio encompassing multiple presentations of a broad range of products across anti-infective, oncology and critical care indications. Our Sagent US product portfolio has grown to a total of 55 marketed products that we offer in an aggregate of 181 presentations in the U.S., and our Omega segment offered 48 products offered in an aggregate of 98 presentations as of December 31, 2015.

We maintain an active product development program. Our Sagent US new product pipeline can be generally classified into two categories: (i) products we developed or acquired and for which regulatory submissions (Abbreviated New Drug Applications (“ANDAs”) or NDA 505(b)(2)s) have been filed with the FDA and are currently under review; and (ii) products which are considered in development, meaning work is currently at a stage between initial development activities, such as sourcing of API, and compilation of the ANDA or NDA 505(b)(2) documentation prior to submission to the FDA. As of December 31, 2015, our Sagent U.S. new product pipeline included 67 ANDAs that we had filed, or licensed rights to, that were under review by the FDA, and two products represented by six ANDAs that have been recently approved by the FDA and are pending commercial launch.

The new product pipeline as of December 31, 2015 for our Omega segment included 14 products in development or submitted for review to Health Canada.

Our 67 Sagent US ANDAs under review by the FDA as of December 31, 2015 have been on file for an average of approximately 38 months, with two of them being on file for less than 12 months, 24 of them being on file for between 12 and 24 months and 41 of them being on file for longer than 24 months. We also had approximately 31 additional products under initial development by Sagent US, and 13 products under initial development by Omega as of December 31, 2015. Our product development activities also include expanding our product portfolio by adding new products through in-licensing and similar arrangements with foreign manufacturers and domestic virtual pharmaceutical development companies that seek to utilize our sales and marketing expertise.

The specific timing of our new product launches is subject to a variety of factors, some of which are beyond our control, including the timing of FDA or Health Canada approval for regulatory filings currently under review or that we file with respect to new products. The timing of these and other new product launches will have a significant impact on our future results of operations.

The following table provides a summary of certain aspects of our product development efforts for the periods presented:

 

     For the year ended December 31,  
     2015      2014      2013  

Products launched during the period

     3         7         12   

ANDAs submitted or licensed during the period

     4         15         13   

ANDAs under FDA review at end of period

     67         64         62   

Filings under review by other regulatory agencies at end of period

     1         1         —     

The table below sets forth our ANDAs that are under review by the FDA and under initial development as of December 31, 2015 by product category:

 

     Number of Products  
     Under FDA
review
     Initial
development –
Sagent US
 

Product category

     

Anti-infective

     17         5   

Oncology

     18         12   

Critical care

     32         14   
  

 

 

    

 

 

 
     67         31   
  

 

 

    

 

 

 

 

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Product Competition and Development Costs

Within the generic pharmaceutical industry, the level of market share, revenue and gross profit attributable to a particular generic product is influenced significantly by the number of competitors in that product’s market and the timing of the product’s regulatory approval and launch in relation to competing approvals and launches. In order to establish market presence, we initially selected products for development based in large part on our ability to rapidly secure API sourcing, finished product manufacturing and regulatory approvals despite such products facing significant competition from existing generic products at their time of launch. As a result, our gross margins associated with such products have been, and remain, adversely impacted by competitive conditions. As we have continued to grow, we have focused on developing value-added differentiated products where we can compete on many factors in addition to price. Specifically, we have targeted injectable products where the form or packaging of the product can be enhanced to improve delivery, patient safety or end-user convenience and where generic competition is likely to be limited by product manufacturing complexity or lack of API supply. In addition, we may challenge proprietary product patents to seek first-to-market rights.

The development of generic injectable products is characterized by significant up-front costs, including costs associated with evaluating the patent landscape, developing products, sourcing API and manufacturing capability and obtaining regulatory approvals. As a result, we have made, and we expect to continue to make, substantial investments in product development. We expect that our overall level of product development activity in any specific period may vary significantly based upon our business strategy to continue to identify and source new product opportunities. We anticipate our spending on product development activities will, over time, continue to increase, as we invest in additional opportunities arising from market consolidation and development activities in our international subsidiaries, and we incur costs associated with patent-related litigation. Product development expenses for the years ended December 31, 2015, 2014 and 2013 totaled approximately $29.1 million, $26.8 million and $20.3 million, respectively. Our product development expense included $3.4 million and $0.9 million from our Omega segment, for the years ended December 31, 2015 and 2014, respectively.

Critical Accounting Policies and Estimates

The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. The most significant estimates in our consolidated financial statements are discussed below. Actual results could vary from those estimates.

Revenue Recognition

We recognize revenue when our obligations to a customer are fulfilled relative to a specific product and all of the following conditions are satisfied: (i) persuasive evidence of an arrangement exists; (ii) the price is fixed or determinable; (iii) collectability is reasonably assured; and (iv) delivery has occurred. Delivery is deemed to have occurred upon customer receipt of product, upon fulfillment of acceptance terms, if any, and when no significant contractual obligations remain. Net sales reflect reductions of gross sales for estimated wholesaler chargebacks, estimated contractual allowances, and estimated early payment discounts. We provide for estimated returns at the time of sale based on historic product return experience. Subsequent adjustments to our prior year provisions and reserve requirements for chargebacks, allowances, discounts and returns have been less than 1% of total consolidated net revenue on an annual basis in each of the three fiscal years ended December 31, 2015.

In the case of new products for which the product introduction is not an extension of an existing line of product, where we determine that there are not products in a similar therapeutic category, or where we determine the new product has dissimilar characteristics with existing products, such that we cannot reliably estimate expected returns of the new product, we defer recognition of revenue until the right of return no longer exists or until we have developed sufficient historical experience to estimate sales returns.

 

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Shipping and handling fees billed to customers are recognized in net revenue. Other shipping and handling costs are included in cost of goods sold.

Revenue Recognition – Chargebacks

The majority of our products are distributed through independent pharmaceutical wholesalers. In accordance with industry practice, sales to wholesalers are transacted initially at wholesale list price. The wholesalers then generally sell to an end user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price contractually established previously between the end user and Sagent.

When we record initially a sale to a wholesaler, the sale and resulting receivable are recorded at our list price. However, experience indicates that most of these selling prices will eventually be reduced to a lower, end-user contract price. Therefore, at the time of the sale, a contra asset is recorded for, and revenue is reduced by, the difference between the list price and the estimated average end-user contract price. This contra asset is calculated by product code, taking the expected number of outstanding wholesale units sold that will ultimately be sold under end-user contracts multiplied by the anticipated, weighted – average contract price. When the wholesaler ultimately sells the product, the wholesaler charges us, or issues a chargeback, for the difference between the list price and the end-user contract price and such chargeback is offset against the initial estimated contra asset. Periodically, we review the wholesale list prices for our products, and from time to time may reduce list prices based on market conditions or competitive pricing pressures. Reductions in the wholesale list price of our products reduce both our gross sales and the revenue reduction recorded upon initial product sale, but do not change the end-user contract selling price.

The significant estimates inherent in the initial chargeback provision relate to wholesale units pending chargeback and to the end-user contract-selling price. We base the estimate for these factors on product-specific sales and internal chargeback processing experience, estimated wholesaler inventory stocking levels, current contract pricing and expectations for future contract pricing changes. Our chargeback provision is potentially impacted by a number of market conditions, including: competitive pricing, competitive products, and other changes impacting demand in both the distribution channel and with end users.

We rely on internal data, external data from our wholesaler customers and management estimates to estimate the amount of inventory in the channel subject to future chargeback. The amount of product in the channel is comprised of both product at the wholesaler and product that the wholesaler has sold, but not yet reported as end-user sales. Physical inventory in the channel is estimated by the evaluation of our monthly sales to the wholesalers and our knowledge of inventory levels and estimated inventory turnover at these wholesalers.

Our total chargeback accrual was $48.6 million and $63.1 million at December 31, 2015 and December 31, 2014, respectively, and is included as a reduction of accounts receivable. Our total chargeback expense was $318.6 million and $403.5 million for the years ended December 31, 2015 and 2014, respectively. Our chargeback accrual and related chargeback expense decreased in 2015 due to the impact of discontinuing certain products previously supplied to us by Actavis, principally docetaxel, with a relatively high list price, and list price reductions on certain products, including zoledronic acid. A 1% decrease in estimated end-user contract-selling prices would reduce net revenue for the year ended December 31, 2015, by $0.3 million and a 1% increase in wholesale units pending chargeback for the year ended December 31, 2015, would reduce net revenue by $0.3 million.

Revenue Recognition – Cash Discounts

We offer cash discounts, approximating 2% of the gross sales price, as an incentive for prompt payment and occasionally offer greater discounts and extended payment terms in support of product launches or other promotional programs. Our wholesale customers typically pay within terms, and we account for cash discounts by reducing net sales and accounts receivable by the full amount of the discount offered at the time of sale. We consider payment performance and adjust the accrual to reflect actual experience.

 

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Revenue Recognition – Sales Returns

Consistent with industry practice, our return policy permits customers to return products within a window of time before and after the expiration of product dating. We provide for product returns and other customer credits at the time of sale by applying historical experience factors. We provide specifically for known outstanding returns and credits. The effect of any changes in estimated returns is taken in the current period’s income.

For returns of established products, we determine our estimate of the sales return accrual primarily based on historical experience, but also consider other factors that could impact sales returns. These factors include levels of inventory in the distribution channel, estimated shelf life, timing of product returns relative to expiry, product recalls, product discontinuances, price changes of competitive products, and introductions of competitive new products.

Revenue Recognition – Contractual Allowances

Contractual allowances, generally rebates or administrative fees, are offered to certain wholesale customers, GPOs, and end-user customers, consistent with pharmaceutical industry practices. Settlement of rebates and fees may generally occur from one to five months from date of sale. We provide a provision for contractual allowances at the time of sale based on the historical relationship between sales and such allowances. Contractual allowances are reflected in the consolidated financial statements as a reduction of revenues and as a current accrued liability.

Inventories

Inventories are stated at the lower of cost (first in, first out) or market value. Inventories consist of products currently approved for marketing and may include certain products pending regulatory approval. From time to time, we capitalize inventory costs associated with products prior to receiving regulatory approval based on our judgment of probable future commercial success and realizable value. Such judgment incorporates management’s knowledge and best judgment of where the product is in the regulatory review process, market conditions, competing products and economic expectations for the product post-approval relative to the risk of manufacturing the product prior to approval. If final regulatory approval for such products is denied or delayed, we may need to provide for and expense such inventory.

We establish reserves for our inventory to reflect situations in which the cost of the inventory is not expected to be recovered. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand, estimated time required to sell such inventory, remaining shelf life and current expected market conditions, including level of competition. We record provisions for inventory to cost of goods sold.

Income Taxes

Provisions for federal, state and foreign taxes are calculated based on pre-tax earnings at currently enacted tax rates.

Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases as well as net operating loss and capital loss carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the financial statements in the period that includes the legislative enactment date.

In assessing the potential for realization of deferred tax assets and establishing valuation allowances, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. We also consider the scheduled reversal of deferred tax liabilities, projected future taxable income or losses, and tax planning strategies in making this assessment.

 

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Furthermore, our ability to use our deferred tax assets, such as our net operating losses, to reduce future federal income tax liability may be limited as a result of previous or future changes in equity ownership of our company or change of corporate status.

Stock-Based Compensation

We recognize compensation cost for all share-based payments (including employee stock options) at fair value. We use the straight-line attribution method to recognize share-based compensation expense over the vesting period of the award.

We measure and recognize stock based compensation expense for performance based options if the performance measures are considered probable of being achieved. We evaluate the probability of the achievement of the performance measures at each balance sheet date. If it is not probable that the performance measures will be achieved, any previously recognized compensation cost would be reversed.

We estimate the value of stock options on the date of grant using a Black-Scholes option pricing model that incorporates various assumptions. The risk-free rate of interest for the average contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The dividend yield is zero as we have not paid nor do we anticipate paying any dividends. For service-based awards, we use the “simplified method” described in SEC Staff Accounting Bulletin Topic 14 where the expected term of awards granted is based on the midpoint between the vesting date and the end of the contractual term, as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. For performance-based awards, we determine the expected term based on the anticipated achievement and exercise pattern of the underlying options. Our expected volatility is based on a weighted average of the historical volatility of similar companies’ stock and the historical volatility of our stock since our IPO. The weighted-average estimated values of employee stock option grants and rights granted under our 2007 Global Share Plan and 2011 Incentive Compensation Plan (the “Plans”) as well as the weighted-average assumptions that were used in calculating such values during the last three years were based on estimates at the date of grant as follows:

 

     Risk free
interest rate
    Expected life      Expected
dividend yield
    Expected
volatility
    Fair value at
grant date
 

2015

     1.74     6 years         0     52   $ 10.92   

2014

     1.92     6 years         0     61   $ 11.81   

2013

     1.24     6 years         0     62   $ 9.31   

We have also granted performance based stock options with terms that allow the recipient to vest in a specific number of shares based upon the achievement of certain performance measures, as specified in the grants. Share-based compensation expense associated with these stock options is recognized over the requisite service period of the awards or the implied service period, if shorter, to the extent the performance condition is expected to be achieved. No compensation expense is recognized for performance based stock options where the performance criteria are not expected to be achieved.

While the assumptions used to calculate and account for share-based compensation awards represent management’s best estimates, these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if revisions are made to our underlying assumptions and estimates, our share-based compensation expense could vary significantly from period-to-period.

Valuation and Impairment of Marketable Securities

Our investments in available-for-sale securities are reported at fair value. Unrealized gains and losses related to changes in the fair value of investments are included in accumulated other comprehensive income, net of tax, as reported in our consolidated balance sheets. Changes in the fair value of investments impact our net income only

 

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when such investments are sold or an other-than-temporary impairment is recognized. Realized gains and losses on the sale of securities are determined by specific identification of each security’s cost basis. We regularly review our investment portfolio to determine if any investment is other-than-temporarily impaired due to changes in credit risk or other potential valuation concerns, which would require us to record an impairment charge in the period any such determination is made. In making this judgment, we evaluate, among other things, the duration and extent to which the fair value of an investment is less than its cost, the financial condition of the issuer and any changes thereto, and our intent to sell, or whether it is more likely than not it will be required to sell the investment before recovery of the investment’s amortized cost basis. Our assessment on whether an investment is other-than-temporarily impaired or not could change in the future due to new developments or changes in assumptions related to any particular investment.

Product Development

Product development costs are expensed as incurred. These expenses include the costs of our internal product development efforts and acquired in-process research and development, as well as product development costs incurred in connection with our third-party contract research and development efforts. Non-refundable contractual payments made under contract research and development arrangements for future research and development activities prior to regulatory approval, including payments made upon execution of a definitive contract research and development agreement or in advance of stability batch testing, may be deferred and are expensed as the related services are delivered. If we determine that it is no longer probable that the product will be pursued, any related capitalized amount is expensed in the current period.

Once a product receives regulatory approval, we record any contractual payments for the license to sell the developed product as an intangible asset to be amortized on a straight-line basis as a component of cost of sales over the shorter of the related license period or the estimated life of the acquired product. At December 31, 2015, the amortization period for intangible assets arising from approved products ranges from four to six years with a weighted-average period prior to the next renewal or extension of 4.3 years. We make the determination whether to capitalize or expense amounts related to the development of new products and technologies through agreements with third parties based on our ability to recover our cost in a reasonable period of time, generally the initial license term, from the estimated future cash flows anticipated to be generated pursuant to each agreement. Market, regulatory and legal factors, among other things, may affect the realizability of the projected cash flows that an agreement was initially expected to generate. We regularly monitor these factors and subject capitalized costs to periodic impairment testing.

Intangible Assets

Certain amounts paid to third parties related to the development of new products and technologies, as described above, are capitalized and included in intangible assets in the accompanying consolidated balance sheets. In addition, we capitalize intangible assets acquired through acquisitions. Acquired intangible assets include product rights, trade names and in-process research and development (“IPR&D”). IPR&D is not amortized, but rather tested for impairment on an annual basis and more often if circumstances require. Impairment losses are recognized whenever the implied fair value of IPR&D is less than its carrying value. We test IPR&D for impairment at least annually on October 1. IPR&D intangible assets are transferred to a definite-lived intangible asset upon approval of the associated product.

Consolidations

The consolidated financial statements of Sagent include the assets, liabilities, and results of operations of Sagent Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation.

On June 4, 2013, we acquired the remaining 50% equity interest in KSCP from our former joint venture partner. Prior to the SCP Acquisition, we accounted for our investment in KSCP using the equity method of accounting,

 

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as our interest in the entity provided for joint financial and operational control. Operating results of KSCP prior to the SCP Acquisition were reported on a one-month lag. On December 29, 2015, our Board of Directors authorized us to proceed with a sale of all of the Company’s ownership interests in SCP. Following this decision, we have classified SCP as held for sale in our Consolidated Balance Sheet as of December 31, 2015.

On October 1, 2014, we acquired 100% of the outstanding shares of capital stock of Omega. Omega is included within our results of operations from the date of acquisition.

We account for investments in joint ventures, including Sagent Agila LLC and, prior to the SCP Acquisition, KSCP, under the equity method of accounting, as our interest in each entity provides for joint financial and operational control. Our equity in the net income (loss) of Sagent Agila LLC and, prior to the SCP Acquisition, KSCP, is included in the consolidated financial statements as equity in net income of joint ventures.

Goodwill

Goodwill is recognized as the excess cost of an acquired entity over the net amount assigned to assets acquired and liabilities assumed. Goodwill is not amortized, but rather tested for impairment on an annual basis and more often if circumstances require. Impairment losses are recognized whenever the implied fair value of goodwill is less than its carrying value. We test goodwill for impairment at least annually on October 1.

Recently Adopted and Pending Accounting Standards

In May 2014, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. In July 2015, the FASB approved a one year deferral to the new revenue guidance, and are therefore required to adopt the new guidance on January 1, 2018 using one of the two prescribed retroactive methods. We are evaluating the impact of the amended revenue recognition guidance on our consolidated financial statements.

In February 2015, the FASB issued amended guidance on the model used to evaluate whether certain legal entities should be consolidated. This guidance is effective for the Company in the first quarter of 2017. Early adoption is permitted. Adoption of this guidance when it occurs, is not expected to have a material impact on our financial statements.

In April 2015, the FASB issued amended guidance, which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective for annual and interim periods beginning after December 15, 2015. Adoption of this guidance in the first quarter 2016, is not expected to have a material impact on our financial statements.

In September 2015, the FASB issued guidance that eliminates the requirement to restate prior period financial statements for measurement period adjustments related to business combinations. The new guidance requires that the cumulative impact of a measurement period adjustment (including the impact on prior periods) be recognized in the reporting period in which the adjustment is identified. In addition, separate presentation on the face of the income statement or disclosure in the notes to the financial statements is required regarding the portion of the adjustment recorded in current period earnings. We are required to adopt this guidance prospectively for measurement period adjustments that occur after the effective date. This guidance is effective for the Company in the first quarter of 2016. Early adoption is permitted. We have adopted this guidance in the current period. There was no material impact of adoption.

 

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In November 2015, the FASB issued guidance that requires all deferred tax assets and liabilities to be presented as non-current in a classified statement of financial position. We are required to adopt this guidance in the first quarter of 2017, with early adoption permitted. We have adopted this guidance in our Consolidated Balance Sheet as of December 31, 2015 and retrospectively for December 31, 2014. Adoption of this standard resulted in the reclassification of $12,185 of current deferred tax assets to long term deferred tax assets at December 31, 2014.

In February 2016, the FASB issued lease guidance, which is intended to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. In order to meet that objective, the new standard requires recognition of the assets and liabilities that arise from leases. A lessee will be required to recognize on the balance sheet the assets and liabilities for leases with lease terms of more than 12 months. Accounting by lessors will remain largely unchanged from current U.S. generally accepted accounting principles. The new standard is effective for public companies for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. The Company is currently evaluating the effect that adopting this standard will have on our financial statements and related disclosures.

 

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Non-GAAP Financial Measures

We report our financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Adjusted Gross Profit

We use the non-GAAP financial measure “Adjusted Gross Profit” and corresponding ratios. We define Adjusted Gross Profit as gross profit plus our share of the gross profit earned through our Sagent Agila joint venture which is included in the Equity in net (income) loss of joint ventures line on the consolidated statements of operations and the impact of product-related non-cash charges arising from business combinations. We believe that Adjusted Gross Profit is relevant and useful supplemental information for our investors. Our management believes that the presentation of this non-GAAP financial measure, when considered together with our GAAP financial measures and the reconciliation to the most directly comparable GAAP financial measure, provides a more complete understanding of the factors and trends affecting Sagent than could be obtained absent these disclosures. Management uses Adjusted Gross Profit and corresponding ratios to make operating and strategic decisions and evaluate our performance. We have disclosed this non-GAAP financial measure so that our investors have the same financial data that management uses with the intention of assisting you in making comparisons to our historical operating results and analyzing our underlying performance. Our management believes that Adjusted Gross Profit provides a useful supplemental tool to consistently evaluate the profitability of our products that have profit sharing arrangements. The limitation of this measure is that it includes an item that does not have an impact on gross profit reported in accordance with GAAP. The best way that this limitation can be addressed is by using Adjusted Gross Profit in combination with our GAAP reported gross profit. Because Adjusted Gross Profit calculations may vary among other companies, the Adjusted Gross Profit figures presented below may not be comparable to similarly titled measures used by other companies. Our use of Adjusted Gross Profit is not meant to and should not be considered in isolation or as a substitute for, or superior to, any GAAP financial measure. You should carefully evaluate the following tables reconciling Adjusted Gross Profit to our GAAP reported gross profit for the periods presented (dollars in thousands).

 

     Year ended
December 31,
                

% of net revenues, year

ended December 31,

 
     2015      2014      $ Change     % Change     2015     2014     Change  

Adjusted Gross Profit

   $ 90,949       $ 91,429       $ (480     -1     28.6     31.6     -3.0

Sagent share of gross profit earned by Sagent Agila joint venture

     2,570         3,160         (590     -19     0.8     1.1     -0.3

Product-related non-cash charges arising from business combinations

     640         2,107         (1,467     -70     0.2     0.7     -0.5
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross Profit

   $ 87,739       $ 86,162       $ 1,577        2     27.6     29.8     -2.2
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

     Year ended
December 31,
                 

% of net revenues, year

ended December 31,

 
     2014      2013      $ Change      % Change     2014     2013     Change  

Adjusted Gross Profit

   $ 91,429       $ 80,249       $ 11,180         14     31.6     32.8     -1.2

Sagent share of gross profit earned by Sagent Agila joint venture

     3,160         2,727         433         16     1.1     1.1     0.0

Product-related non-cash charges arising from business combinations

     2,107         —           2,107         n/m        0.7     —          0.7
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Gross Profit

   $ 86,162       $ 77,522       $ 8,640         11     29.8     31.7     -1.9
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

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EBITDA and Adjusted EBITDA –

We use the non-GAAP financial measures “EBITDA” and “Adjusted EBITDA” and corresponding growth ratios. We define EBITDA as net income (loss) less interest expense, net of interest income, provision for income taxes, depreciation and amortization. We define Adjusted EBITDA as net income (loss) less interest expense, net of interest income, provision for income taxes, depreciation and amortization, stock-based compensation expense, the gain recorded on product rights acquired from our Sagent Agila joint venture, the gain recorded on our previously held equity interest in KSCP in connection with the acquisition of the remaining 50% equity interest in KSCP, the equity in net loss of our KSCP joint venture prior to the acquisition, management transition costs, acquisition-related costs, the impact of unrealized foreign currency gains or losses, the impact of product-related non-cash charges arising from business combinations, impairment charges and the impact of legal settlements. We believe that EBITDA and Adjusted EBITDA are relevant and useful supplemental information for our investors. Our management believes that the presentation of these non-GAAP financial measures, when considered together with our GAAP financial measures and the reconciliation to the most directly comparable GAAP financial measures, provides a more complete understanding of the factors and trends affecting Sagent than could be obtained absent these disclosures. Management uses EBITDA, Adjusted EBITDA and corresponding ratios to make operating and strategic decisions and evaluate our performance. We have disclosed these non-GAAP financial measures so that our investors have the same financial data that management uses with the intention of assisting you in making comparisons to our historical operating results and analyzing our underlying performance. Our management believes that EBITDA and Adjusted EBITDA are useful supplemental tools to evaluate the underlying operating performance of the company on an ongoing basis. The limitation of these measures is that they exclude items that have an impact on net income (loss). The best way that these limitations can be addressed is by using EBITDA and Adjusted EBITDA in combination with our GAAP reported net income (loss). Because EBITDA and Adjusted EBITDA calculations may vary among other companies, the EBITDA and Adjusted EBITDA figures presented below may not be comparable to similarly titled measures used by other companies. Our use of EBITDA and Adjusted EBITDA is not meant to and should not be considered in isolation or as a substitute for, or superior to, any GAAP financial measure. You should carefully evaluate the following tables reconciling EBITDA and Adjusted EBITDA to our GAAP reported net income (loss) for the periods presented (dollars in thousands).

 

     Year ended December 31,                
     2015     

2014

As restated

     $ Change      % Change  

Adjusted EBITDA

   $ 29,674       $ 32,296       $ (2,622      -8

Stock-based compensation expense

     3,835         2,683         1,152         43

Management transition costs

     5,310         —           5,310         n/m   

Acquisition-related costs

     2,838         1,069         1,769         165

Gain on Sagent Agila joint venture product acquisitions1

     —           (880      880         n/m   

Unrealized foreign exchange losses3

     3,195         —           3,195         n/m   

Impairment charges

     45,158         —           45,158         n/m   

Product-related non-cash charges arising from business combinations

     640         2,107         (1,467      -70

Legal settlement

     2,447         —           2,447         n/m   
  

 

 

    

 

 

    

 

 

    

 

 

 

EBITDA

   $ (33,749    $ 27,317       $ (61,066      n/m   
  

 

 

    

 

 

    

 

 

    

 

 

 

Depreciation and amortization expense2

     13,681         9,308         4,373         47

Interest expense, net

     651         1,831         (1,180      -64

Provision for income taxes

     (26,199      (20,773      (5,426      26
  

 

 

    

 

 

    

 

 

    

 

 

 

Net income (loss)

   $ (21,882    $ 36,951       $ (58,833      n/m   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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     Year ended December 31,                
     2014
As restated
     2013      $ Change      % Change  

Adjusted EBITDA

   $ 32,296       $ 40,764       $ (8,468      -21

Stock-based compensation expense

     2,683         5,369         (2,686      -50

Gain on previously held equity interest

     —           2,936         (2,936      n/m   

Acquisition-related costs

     1,069         —           1,069         n/m   

Gain on Sagent Agila joint venture product acquisitions1

     (880      (1,700      820         -48

Product-related non-cash charges arising from business combinations

     2,107         —           2,107         n/m   

Equity in net loss of KSCP joint venture

     —           1,825         (1,825      n/m   
  

 

 

    

 

 

    

 

 

    

 

 

 

EBITDA

   $ 27,317       $ 38,206         (10,889      -29
  

 

 

    

 

 

    

 

 

    

 

 

 

Depreciation and amortization expense2

     9,308         6,984         2,324         33

Interest expense, net

     1,831         733         1,098         150

Provision for income taxes

     (20,773      895         (21,668      n/m   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net income

   $ 36,951       $ 29,594       $ 7,357         25
  

 

 

    

 

 

    

 

 

    

 

 

 

 

1 

Upon obtaining the controlling interest in the rights to certain products from our Sagent Agila joint venture in December 2014, we recorded non-cash accounting gains of $880 reported as part of equity in net income of joint ventures in the Consolidated Statements of Operations for the year ended December 31, 2014.

2 

Depreciation and amortization expense excludes $85, $216 and $90 in the years ended December 31, 2015, 2014 and 2013, respectively, related to deferred financing fees, which is included within interest expense and other in our Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013.

3 

Unrealized foreign exchange losses reflect the impact of foreign currency movements on intercompany loans, primarily related to the devaluation of the Canadian dollar relative to the US dollar, and are included in Interest income and other income (expense), net, in our Consolidated Statements of Operations for the year ended December 31, 2015.

 

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Results of Operations

Our financial statements for the year ended December 31, 2014 have been restated for the correction of errors primarily related to our previous tax filing position related to SCP during the time SCP was 50% owned and prior to our acquisition of 100% ownership of SCP in June 2013.

The following compares our consolidated results of operations for the year ended December 31, 2015 with those of the year ended December 31, 2014 (in thousands, except per share amounts):

 

     Year ended December 31,               
     2015     2014     $ change      % change  
           As Restated               

Net revenue

         

Sagent US

   $ 287,613      $ 280,422      $ 7,191         3

Omega

     30,683        8,561        22,122         258
  

 

 

   

 

 

   

 

 

    

 

 

 

Consolidated net revenue

   $ 318,296      $ 288,983      $ 29,313         10

Cost of sales

     230,557        202,821        27,736         14
  

 

 

   

 

 

   

 

 

    

 

 

 

Gross profit

     87,739        86,162        1,577         2

Gross profit as % of net revenue

     27.6     29.8     

Operating expenses:

         

Product development

     29,145        26,809        2,336         9

Selling, general and administrative

     49,931        43,227        6,704         16

Acquisition-related costs

     2,838        1,069        1,769         165

Management transition costs

     5,310        —          5,310         n/m   

Equity in net income of joint ventures

     (2,569     (3,987     (1,418      -36
  

 

 

   

 

 

   

 

 

    

 

 

 

Total operating expenses

     84,655        67,118        17,537         26
  

 

 

   

 

 

   

 

 

    

 

 

 

Impairment of SCP

     45,158        —          45,158         n/m   

Legal settlement

     2,447        —          2,447         n/m   
  

 

 

   

 

 

   

 

 

    

 

 

 

Income (loss) from operations

         

Sagent US

     (43,769     21,700        (65,469      n/m   

Omega

     (752     (2,656     1,904         72
  

 

 

   

 

 

   

 

 

    

 

 

 

Consolidated income (loss) from operations

     (44,521     19,044        (63,565      n/m   

Interest income and other income (expense)

     (2,790     (678     (2,112      312

Interest expense

     (770     (2,188     (1,418      -65
  

 

 

   

 

 

   

 

 

    

 

 

 

Income before income taxes

     (48,081     16,178        (64,259      n/m   

Benefit for income taxes

     (26,199     (20,773     5,426         26
  

 

 

   

 

 

   

 

 

    

 

 

 

Net income (loss)

   $ (21,882   $ 36,951      $ (58,833      n/m   
  

 

 

   

 

 

   

 

 

    

 

 

 

Net income per common share:

         

Basic

   $ (0.67   $ 1.16      $ (1.83      n/m   

Diluted

   $ (0.67   $ 1.13      $ (1.80      n/m   

Net revenue: Net revenue for the year ended December 31, 2015 totaled $318.3 million, an increase of $29.3 million, or 10%, as compared to $289.0 million for the year ended December 31, 2014. Net revenue in the Sagent US segment totaled $287.6 million, an increase of $7.2 million, or 3% as compared to $280.4 million for the year ended December 31, 2014. The launch of seven new codes or presentations of three products during 2015, contributed $6.4 million of the net revenue increase in 2015. Net revenue from our Omega segment totaled $30.7 million, an increase of $22.1 million, or 258%, as compared to $8.6 million for the year ended December 31, 2014, as we originally acquired Omega on October 1, 2014.

Cost of sales: Cost of sales for the year ended December 31, 2015 totaled $230.6 million, inclusive of $23.4 million of cost of sales incurred in our Omega segment, an increase of $27.7 million, or 14%, as compared to $202.8 million for the year ended December 31, 2014. Gross profit as a percentage of net revenue was 27.6%

 

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for the year ended December 31, 2015, and 29.8% for the year ended December 31, 2014. Adjusted Gross Profit as a percentage of net revenue was 28.6% for the year ended December 31, 2015, and 31.6% for the year ended December 31, 2014. The decrease in gross profit as a percentage of net revenue is due primarily to the loss of a key oncolytic product supplied by Actavis during 2014 and the full year impact of purchased product rights amortization from our acquisition of Omega, partially offset by the benefit of $0.7 million from the receipt of payment from certain manufacturing partners for the settlement of certain supply issues. Cost of sales in the Sagent US segment totaled $207.1 million, an increase of $7.7 million, or 4.0%, as compared to $194 million for the year ended December 31, 2014. Cost of sales from our Omega segment totaled $23.4 million, an increase of $14.6 million, or 166%, as compared to 8.8 million for the year ended December 31, 2014, as we acquired Omega on October 1, 2014.

Product development: Product development expense for the year ended December 31, 2015 totaled $29.1 million, an increase of $2.3 million, or 9%, as compared to $26.8 million for the year ended December 31, 2014. Product development expense in the Sagent US segment totaled $25.7 million, a increase of $0.2 million, or 1%, as compared to $25.5 million for the year ended December 31, 2014. Product development expense for our Omega segment totaled $3.2 million, an increase of $2.3 million, or 258%, as compared to $0.9 million for the year ended December 31, 2014, as we originally acquired Omega on October 1, 2014.

As of December 31, 2015, our US new product pipeline included 67 ANDAs which we had filed, or licensed rights to, that were under review by the FDA and six ANDAs that have been recently approved and were pending commercial launch. We also had an additional 31 products under initial development at December 31, 2015. At December 31, 2015, our Omega segment had an additional 13 products in development or under review by the relevant regulatory authority, generally Health Canada.

Selling, general and administrative: Selling, general and administrative expenses for the year ended December 31, 2015, totaled $49.9 million, an increase of $6.7 million, or 16%, as compared to $43.2 million for the year ended December 31, 2014. Selling, general and administrative expenses in the Sagent US segment totaled $45.1 million, an increase of $3.4 million, or 8%, as compared to $41.7 million for the year ended December 31, 2014. The increase was primarily due to increased public company costs and an increase in non-cash employee-related stock compensation expense. Selling, general and administrative expenses for our Omega segment totaled $4.8 million, an increase of $3.3 million, or 216%, as compared to $1.5 million for the year ended December 31, 2014, as we originally acquired Omega on October 1, 2014. Selling, general and administrative expense as a percentage of net revenue was 16% and 15% for the year ended December 31, 2015 and 2014, respectively.

Acquisition-related costs: Acquisition-related costs for the year ended December 31, 2015 totaled $2.8 million, an increase of $1.7 million, or over 100%, as compared to $1.1 million for the year ended December 31, 2014. All acquisition-related costs were incurred in our Sagent US segment. Acquisition-related costs in 2015 related primarily to costs associated with the evaluation of various acquisition opportunities and the divestiture of SCP, while 2014 costs related to the October 1, 2014 acquisition of Omega.

Management transition costs: Management transition costs for the year ended December 31, 2015 totaled $5.3 million. The costs are primarily severance related charges following the retirement of our founder and Chief Executive Officer and resignation of our President, severance charges related to the elimination of certain other positions in the US and transition costs associated with our new Chief Executive Officer. No management transition costs were incurred in year ended December 31, 2014.

Equity in net income of joint ventures: Equity in net income of joint ventures for the year ended December 31, 2015 totaled $2.6 million, a decrease of $1.4 million, or 36%, as compared to $4.0 million for the year ended December 31, 2014, and was reported in our Sagent US segment. The decrease is the result of a decrease in sales of Sagent Agila products in 2015. Included in this amount are the following (amounts in thousands of dollars):

 

     Year Ended December 31,  
         2015              2014      

Earnings directly related to the sale of product

   $ (2,569    $ (3,160

Product development costs

     —           20   

Gain on sale of products

     —           (847
  

 

 

    

 

 

 

Equity in net income of joint ventures

   $ (2,569    $ (3,987
  

 

 

    

 

 

 

 

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Impairment of SCP: In conjunction with our Board of Directors’ approval of a plan of sale related to SCP, management determined the estimated fair value less costs to sell SCP was lower than its carrying value, resulting in an impairment charge in 2015 of $45.2 million, recorded in our Sagent US segment.

Legal settlement: Legal settlement of $2.4 million for the year ended December 31, 2015 represents the $5.0 million settlement of our outstanding patent infringement lawsuit with Novartis, net of $1.5 million of recoveries from our manufacturing partners associated with the settlement and $1.1 million of acquired product licensing rights within our Sagent US segment.

Interest income and other income (expense), net: Interest income and other income (expense), net for the year ended December 31, 2015 totaled $2.8 million of expense, as compared to $0.7 million of expense in the year ended December 31, 2014. The increase in expense primarily relates to unrealized foreign exchange losses on intercompany financing, primarily related to the devaluation of the Canadian dollar versus the US dollar.

Interest expense: Interest expense for the year ended December 31, 2015 totaled $0.8 million, a decrease of $1.4 million, or 65%, as compared to $2.2 million for the year ended December 31, 2014. The decrease was primarily due to $1.1 million of deferred financing costs incurred in connection with the early termination our former SVB revolving loan facility in October 2014.

Provision (benefit) for income taxes: We recorded a benefit from income taxes of $26.2 million for the year ended December 31, 2015, as compared to a restated benefit of $20.8 million for the year ended December 31, 2014. In connection with the decision to sell SCP, we determined that SCP’s capital stock and the intercompany loans from our US parent company to SCP were impaired. We made tax elections to realize this value through deductions for worthless stock and bad debt totaling a one time permanent benefit of $30.0 million.

In the first quarter of 2014, we moved from a cumulative loss position over the previous three years to a cumulative income position for the first time in our history. As of December 31, 2014, we had cumulative domestic income over the prior three years, had completed eight consecutive quarters of domestic pre-tax earnings, and forecasted continued domestic profitability in future periods. Accordingly, we concluded that the valuation allowance previously recorded against our domestic net deferred tax assets should be released as of December 31, 2014, resulting in a restated net $23.8 million benefit in our provision for income taxes. We retained a full valuation allowance against our net deferred tax assets in SCP, given the history of losses in that entity. We recorded a $0.7 million benefit for income taxes in our Omega segment, primarily due to the reversal of deferred tax liabilities established during the accounting for the Omega acquisition.

Net income and net income per common share: The net loss for the year ended December 31, 2015 was $21.9 million, a decrease of $58.8 million as compared to restated net income of $37.0 million for the year ended December 31, 2014. Diluted net earnings per common share decreased by $1.80. The decrease in diluted net earnings per common share is due to the following factors:

 

Restated Diluted EPS for the year ended December 31, 2014

   $ 1.13   

Decrease in earnings

     (1.80

Decrease in diluted common shares outstanding

     (0.00
  

 

 

 

Diluted EPS for the year ended December 31, 2015

   $ (0.67
  

 

 

 

Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2015 was $29.7 million, a decrease of $2.6 million, or 8%, compared to adjusted EBITDA of $32.3 million for the year ended December 31, 2014. The decrease in Adjusted EBITDA is driven predominately by increased employee-related costs.

 

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The following compares our consolidated results of operations for the year ended December 31, 2014 with those of the year ended December 31, 2013 (in thousands, except per share amounts):

 

     Year ended December 31,              
     2014     2013     $ change     % change  
     As Restated                    

Net revenue

        

Sagent US

   $ 280,422      $ 244,750      $ 35,672        15

Omega

     8,561        —          8,561        n/m   
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated net revenue

   $ 288,983      $ 244,750      $ 44,233        18

Cost of sales

     202,821        167,228        35,593        22
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     86,162        77,522        8,640        11

Gross profit as % of net revenue

     29.8     31.7     31.7  

Operating expenses:

        

Product development

     26,809        20,275        6,534        32

Selling, general and administrative

     43,227        36,198        7,029        19

Acquisition-related costs

     1,069        —          1,069        n/m   

Equity in net income of joint ventures

     (3,987     (2,395     1,592        66
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     67,118        54,078        13,040        24
  

 

 

   

 

 

   

 

 

   

 

 

 

Termination Fee

     —          5,000        5,000        n/m   

Gain on previously held equity interest

     —          2,936        2,936        n/m   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

        

Sagent US

     21,700        31,380        (9,680     (31 )% 

Omega

     (2,656     —          (2,656     n/m   
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated income from operations

     19,044        31,380        (12,336     (39 )% 

Interest income and other income (expense)

     (678     39        (717     n/m   

Interest expense

     (2,188     (930     1,258        135
  

 

 

   

 

 

   

 

 

   

 

 

 

Income before income taxes

     16,178        30,489        (14,311     (47 )% 

Provision (benefit) for income taxes

     (20,773     895        (21,668     n/m   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 36,951      $ 29,594      $ 7,357        25
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income per common share:

        

Basic

   $ 1.16      $ 1.01      $ 0.15        15

Diluted

   $ 1.13      $ 0.99      $ 0.14        14

Net revenue: Net revenue for the year ended December 31, 2014 totaled $289.0 million, an increase of $44.2 million, or 18%, as compared to $244.8 million for the year ended December 31, 2013. The launch of 17 new codes or presentations of seven products during 2014, contributed $13.8 million of the net revenue increase in 2014. Net revenue for products launched before January 1, 2014 increased by $23.0 million, or 9%, to $267.4 million during 2014, due primarily to the impact of the annualization of revenue for products launched during fiscal 2013, primarily docetaxel and propofol, partially offset by the impact of price and volume declines in the balance of the portfolio and $0.8 million related to the February 2015 recall of Atracurium Besylate. Net revenue from our Omega segment from the date of acquisition of October 1, 2014 contributed $8.6 million of the net revenue increase.

Cost of sales: Cost of sales for the year ended December 31, 2014 totaled $202.8 million, inclusive of $8.8 million of cost of sales incurred in our Omega segment following its acquisition on October 1, 2014, an increase of $35.6 million, or 22%, as compared to $167.2 million for the year ended December 31, 2013. Gross profit as a percentage of net revenue was 29.8% for the year ended December 31, 2014, and 31.7% for the year ended December 31, 2013. Adjusted Gross Profit as a percentage of net revenue was 31.6% for the year ended December 31, 2014, and 32.8% for the year ended December 31, 2013. The decrease in gross profit as a percentage of net revenue is due primarily to $2.1 million of costs associated with the purchase accounting revaluation of Omega inventory, $1.4 million of incremental costs associated with the amortization of product rights arising from our recent acquisitions and approximately $2.7 million of incremental unabsorbed manufacturing costs at our SCP facility.

 

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Product development: Product development expense for the year ended December 31, 2014 totaled $26.8 million, an increase of $6.5 million, or 32%, as compared to $20.3 million for the year ended December 31, 2013. The increase in product development expense was primarily due to $1.6 million of incremental costs associated with development activities at SCP, increased milestone expense for projects in our pipeline, costs associated with the write-off of inventory manufactured at-risk, increased patent-related legal expenses, and $0.9 million of product development costs incurred in our Omega segment following its acquisition on October 1, 2014.

Selling, general and administrative: Selling, general and administrative expenses for the year ended December 31, 2014, totaled $43.2 million, an increase of $7.0 million, or 19%, as compared to $36.2 million for the year ended December 31, 2013. The increase in selling, general and administrative expense was primarily due to increases in employee-related cash costs, $2.3 million of incremental costs associated with our SCP facility, $1.5 million of costs incurred by Omega following its acquisition on October 1, 2014, and higher public company costs, partially offset by a reduction in non-cash employee-related stock compensation expense. Selling, general and administrative expense as a percentage of net revenue was 15% and 15% for the year ended December 31, 2014 and 2013, respectively.

Acquisition-related costs: Acquisition-related costs for the year ended December 31, 2014 totaled $1.1 million, related primarily to costs associated with the acquisition of Omega on October 1, 2014. No acquisition-related costs were incurred in the year ended December 31, 2013.

Equity in net income of joint ventures: Equity in net income of joint ventures for the year ended December 31, 2014 totaled $4.0 million, an increase of $1.6 million, or 66%, as compared to $2.4 million for the year ended December 31, 2013. The increase was primarily due to the inclusion in 2013 of six months of equity losses of our KSCP joint venture, prior to the SCP Acquisition, partially offset by a smaller non-cash accounting gain on our acquisition of products from Sagent Agila LLC in 2014. Included in this amount are the following (amounts in thousands of dollars):

 

     Year Ended December 31,  
         2014              2013      

Sagent Agila LLC – Earnings directly related to the sale of product

   $ (3,160    $ (2,777

Sagent Agila LLC – Product development costs

     20         243   

Sagent Agila LLC – Gain on sale of products

     (847      (1,686

Kanghong Sagent (Chengdu) Pharmaceutical Co – net loss

     —           1,825   
  

 

 

    

 

 

 

Equity in net income of joint ventures

   $ (3,987    $ (2,395
  

 

 

    

 

 

 

Termination fee: Termination fee for 2013 represents the $5.0 million one-time termination fee received in connection with our agreement in March 2013 to terminate our Manufacturing and Supply Agreement with Actavis effective December 31, 2014.

Gain on previously held equity interest: As a result of the 2013 SCP Acquisition, our previously held equity interest was remeasured to fair value, resulting in a gain of $2.9 million reported as gain on previously held equity interest in the consolidated statements of operations. The gain includes $2.8 million reclassified from accumulated other comprehensive income, and previously recorded as currency translation adjustments.

Interest expense: Interest expense for the year ended December 31, 2014 totaled $2.2 million, an increase of $1.3 million, or 135%, as compared to $0.9 million for the year ended December 31, 2013. The increase was due to $1.1 million of deferred financing costs incurred in connection with the early termination our former SVB revolving loan facility in October 2014 and $0.2 million of interest costs on debt assumed as part of our acquisition of Omega in October 2014.

 

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Provision (benefit) for income taxes: We recorded a restated benefit from income taxes of $20.8 million for the year ended December 31, 2014, compared to a provision for income taxes of $0.9 million for the year ended December 31, 2013. In the first quarter of 2014, we moved from a cumulative loss position over the previous three years to a cumulative income position for the first time in our history. As of December 31, 2014, we had cumulative domestic income over the prior three years, had completed eight consecutive quarters of domestic pre-tax earnings, and forecasted continued domestic profitability in future periods. Accordingly, we concluded that the valuation allowance previously recorded against our domestic net deferred tax assets should be released as of December 31, 2014, resulting in a restated net $23.8 million benefit in our provision for income taxes. We have retained a full valuation allowance against our net deferred tax assets in SCP, given the history of losses in that entity. We recorded a $0.7 million benefit for income taxes in our Omega segment, primarily due to the reversal of deferred tax liabilities established during the accounting for the Omega acquisition.

Our provision for income taxes for the year ended December 31, 2013, was $0.9 million, representing the alternative minimum tax (“AMT”) payable in the United States for 2013. As we had recorded a full valuation allowance against our deferred tax assets as of December 31, 2013, our AMT payable was recorded as tax expense in 2013.

Net income and net income per common share: The restated net income for the year ended December 31, 2014 was $37.0 million, an increase of $7.4 million, or 25%, as compared to $29.6 million for the year ended December 31, 2013. Diluted net earnings per common share increased by $0.14. The increase in diluted net earnings per common share is due to the following factors:

 

Diluted EPS for the year ended December 31, 2013

   $ 0.99   

Increase in earnings

     0.23   

Increase in diluted common shares outstanding

     (0.09
  

 

 

 

Restated Diluted EPS for the year ended December 31, 2014

   $ 1.13   
  

 

 

 

Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2014 of $32.3 million decreased by $8.5 million, or 21%, from $40.8 million for the year ended December 31, 2013. The decrease in Adjusted EBITDA is driven predominately by the $5.0 million one-time termination fee received in connection with our agreement to terminate our Manufacturing and Supply Agreement with Actavis effective December 31, 2014.

Liquidity and Capital Resources

Funding Requirements

Our future capital requirements will depend on a number of factors, including the continued commercial success of our existing products, launching the products that have been recently approved and are pending commercial launch or are pending approval as of December 31, 2015, successfully identifying and sourcing other new product opportunities, capital expansion at our Omega facility and further business development activity.

Based on our existing business plan, we expect that cash, cash equivalents and short-term investments, together with operating cash flows and borrowings available under our Amended Chase Agreement, will be sufficient to fund our planned operations, the continued development of our product pipeline, investments in working capital, joint venture distributions and capital expansion at our Omega facility, for at least the next 12 months. However, we may require additional funds in the event that we change our business plan, pursue additional strategic transactions, including the acquisition of businesses or products, or encounter unexpected developments, including unforeseen competitive conditions within our product markets, changes in the general economic climate, changes in the regulatory environment, the loss of or negative developments affecting key relationships with suppliers, group purchasing organizations or end-user customers or other unexpected developments that may have a material effect on the cash flows or results of operations of our business.

 

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To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings or debt financings, which may not be available to us on terms we consider acceptable or at all. Our ability to raise additional funding, if necessary, is subject to a variety of factors that we cannot predict with certainty, including our future results of operations, our relative levels of debt and equity, the volatility and overall condition of the capital markets and the market prices of our securities. Debt financing, if available, may only be available to us on less favorable terms than our existing Chase credit facilities, including higher interest rates or greater exposure to interest rate risk. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders.

If additional funding is not available, we may be required to terminate, significantly modify or delay the development or commercialization of new products and may not be able to achieve the manufacturing potential of our Omega facility. We may elect to raise additional funds even before we need them if we believe that the conditions for raising capital are favorable.

Cash Flows

Overview

On December 31, 2015, cash, cash equivalents and short term investments totaled $49.0 million, working capital totaled $107.9 million and our current ratio (current assets to current liabilities) was approximately 2.2 to 1.0.

Sources and Uses of Cash

Operating activities: Net cash used in operating activities was $7.5 million for the year ended December 31, 2015, as compared to net cash provided by operating activities of $22.2 million for the year ended December 31, 2014 and $49.6 million for the year ended December 31, 2013. The reduction in cash provided by operations in 2015 is primarily due to the impacts of management transition, acquisition-related and legal settlement costs as well as increased investment in working capital, while the decrease in cash provided by operations in 2014 is primarily due to the $8.5 million reduction in Adjusted EBITDA and increased investment in working capital.

Investing activities: Net cash used in investing activities was $22.0 million in 2015, $0.9 million in 2014 and $97.2 million in 2013. The change in cash flows in 2015 is primarily related to $12.0 million used to acquire businesses, primarily the final installment payment for the SCP Acquisition, and $6.7 million of capital expenditures, primarily related to the construction of the new manufacturing line at Omega. The change in cash flows in 2014 is primarily related to $86.5 million used to acquire businesses, primarily Omega on October 1, 2014, offset by the redemption of available-for-sale securities, which were used to fund the Omega acquisition. The cash used in investing activities in 2013 is primarily related to the investment of $70.6 million of proceeds from our September 2013 secondary stock offering in short-term available-for-sale securities and $13.0 million paid related to the SCP Acquisition and product acquisitions from Sagent Agila during the year.

Financing activities: Net cash provided by financing activities was $3.5 million in 2015, compared to net cash used in financing activities of $7.6 million in 2014 and net cash provided by financing activities of $62.3 million in 2013. The change in cash flows in 2015 is primarily related to $9.3 million of proceeds from stock option exercises, partially offset by the repayment in full of borrowings from the National Bank of Canada (“NBC”) in January 2015. The change in cash flows in 2014 is primarily related to the repayment in full of borrowings from the Agricultural Bank of China (“ABC”) in January 2014. The cash used in financing activities in 2013 is primarily related to the $70.6 million of net proceeds received from our September 2013 secondary stock offering, partially offset by the repayment of $9.0 million of borrowings under the ABC Loans in November 2013.

 

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Credit facilities

In February 2012, we repaid all of our outstanding borrowings and replaced our previous facilities with an asset based revolving loan facility with Silicon Valley Bank (“SVB”). In September 2013, we entered into a Second Loan Modification agreement with SVB, subsequently, on October 31, 2014, we terminated our asset based revolving loan facility with SVB and replaced it with a new asset based revolving loan credit facility with JPMorgan Chase Bank, N.A. (“Chase”).

In June 2013, our SCP subsidiary had two loan facilities with the Agricultural Bank of China (“ABC”) that existed prior to the SCP Acquisition. We repaid in full the amounts outstanding under these facilities in January 2014. In October 2014, our Omega subsidiary had a series of loan facilities that existed prior to the Omega Acquisition. Refer below for a description of our facilities with Chase, Omega’s facilities, and the SVB and ABC facilities which were terminated in 2014.

Asset based revolving credit loan facility

On October 31, 2014, we entered into a credit agreement with Chase, (the “Chase Agreement”). The Chase Agreement provides for an $80.0 million asset based revolving credit loan facility, with availability subject to a borrowing base consisting of eligible cash, short-term investments, accounts receivable and inventory and the satisfaction of conditions precedent specified in the Chase Agreement. The Chase Agreement provides for an accordion feature, whereby we may increase the revolving commitment up to an additional $25.0 million subject to certain customary terms and conditions including pro forma compliance with a fixed charge coverage ratio (as defined in the Chase Agreement) of 1.00 to 1.00. The Chase Agreement matures on October 31, 2019, at which time all amounts outstanding will be due and payable. Borrowings under the Chase Agreement may be used for general corporate purposes, including funding working capital. Amounts drawn bear an interest rate equal to, at our option, either a Eurodollar rate plus 2.00% per annum or an alternative base rate plus 1.00% per annum. We also incur a commitment fee on undrawn amounts equal to 0.25% per annum.

The Chase Agreement is guaranteed by us and is secured by a lien on substantially all of our and our principal domestic subsidiary’s assets and any future domestic subsidiary guarantors’ assets. The Chase Agreement includes customary covenants and also imposes a financial covenant requiring compliance with a minimum fixed charge coverage ratio of 1.00 to 1.00 during certain covenant testing times triggered if availability under the Chase Agreement is below the greater of 10% of the revolving commitment and $8.0 million.

Loans under the Chase Agreement are secured by a lien on substantially all of our and our principal domestic operating subsidiary’s assets.

As of December 31, 2015, there were no borrowings outstanding under our Chase Agreement, and we were in compliance with all covenants. Total availability under our Chase Agreement was $79.9 million at December 31, 2015, which is subject to adjustment on a monthly basis under our borrowing base calculation.

On January 7, 2016, we amended and restated the Chase Agreement with Chase (the “Amended Chase Agreement”) by adding a Canadian tranche and joining Omega as a borrower. The Amended Chase Agreement adds a C$30.0 million term loan (including a delayed draw term loan) to fund, among other things, Omega’s construction of a facility in Quebec. The Amended Chase Agreement also adds a C$10.0 million revolving facility sublimit to the existing revolving facility, with the total revolving commitment amount remaining at $80.0 million. The applicable margins for the Canadian prime rate and Canadian Dollar Offered Rate (“CDOR”) revolving loans are the same as the base rate and Eurodollar rates for the U.S. revolving loans at 1.00% and 2.00%, respectively. The margins for the Canadian term loans are 1.25% and 2.25% for Canadian prime rate and CDOR, respectively. The commitment fee rate remains 0.25%. The fixed charge coverage ratio remains at 1.00x. The Canadian term loans are to be repaid in certain increments pursuant to the Amended Chase Agreement as the facility in Quebec is completed.

 

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SVB asset based revolving loan facility

On February 13, 2012, we entered into a Loan and Security Agreement with SVB (the “SVB Agreement”). The SVB Agreement provided for a $40.0 million asset based revolving loan facility, with availability determined by a borrowing base consisting of eligible accounts receivable and inventory and subject to certain conditions precedent specified in the SVB Agreement. The SVB Agreement terminated on October 31, 2014, at which time all outstanding amounts became due and payable. Borrowings under the SVB Agreement could be used for general corporate purposes, including funding working capital. Amounts drawn bear an interest rate equal to, at our option, either a Eurodollar rate plus 2.50% per annum or an alternative base rate plus 1.50% per annum. We also pay a commitment fee on undrawn amounts equal to 0.30% per annum. During the continuance of an event of default, at SVB’s option, all obligations would bear interest at a rate per annum equal to 5.00% per annum above the otherwise applicable rate.

Loans under the SVB Agreement were secured by substantially all of our and our principal domestic operating subsidiary’s assets, other than our equity interests in our joint ventures and certain other limited exceptions.

The SVB Agreement contained various customary affirmative and negative covenants. The negative covenants restrict our ability to, among other things, incur additional indebtedness, create or permit to exist liens, make certain investments, dividends and other payments in respect of capital stock, sell assets or otherwise dispose of our property, change our lines of business, or enter into a merger or acquisition, in each case, subject to thresholds and exceptions as set forth in the SVB Agreement. The financial covenants in the original SVB Agreement are limited to maintenance of a minimum adjusted quick ratio and a minimum free cash flow. The SVB Agreement also contains customary events of default, including non-payment of principal, interest and other fees after stated grace periods, violations of covenants, material inaccuracy of representations and warranties, certain bankruptcy and liquidation events, certain material judgments and attachment events, cross-default to other debt in excess of a specified amount and material agreements, failure to maintain certain material governmental approvals, and actual or asserted invalidity of subordination terms, guarantees and collateral, in each case, subject to grace periods, thresholds and exceptions as set forth in the SVB Agreement.

In September 2013, we entered into the Second Loan Modification Agreement (the “Second Modification Agreement”) to the SVB Agreement. The Second Modification Agreement made certain amendments to the SVB Agreement, including: modifying the calculation methodology of the borrowing base that is used to determine our borrowing availability; eliminating the covenant to maintain a specified level of free cash flow in quarters where we maintain eligible cash balances of $30.0 million or greater and modifying the covenant for the adjusted quick ratio to be tested at the end of each month; and providing us additional flexibility to make certain investments. The Second Modification Agreement did not amend the term of the SVB Agreement, the maximum availability under the SVB Agreement, or the interest rate applicable to amounts drawn under the SVB Agreement.

Concurrent with entering the Chase Agreement, we terminated our existing revolving credit facility with SVB and repaid certain associated fees. Included with the fees was $1.1 million of deferred costs triggered by the early termination of the agreement. This amount is included within interest expense in the condensed consolidated statement of operations in the fourth quarter of 2014. Concurrent with the repayment and termination of the agreement, all liens and security interests against our property that secured the obligations under our existing revolving credit facility were released and discharged.

Chinese loan facilities

SCP had outstanding debt obligations with ABC at the time of the SCP Acquisition. SCP originally entered into two loan contracts with ABC for RMB 83.0 million ($13.6 million) and RMB 37.0 million ($6.1 million) in August 2010 and June 2011, respectively (the “ABC Loans”). In November 2013, we repaid RMB 55.0 million ($9.0 million) of the then outstanding balance. The ABC Loans were used for the construction of the SCP facility

 

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and funding of the ongoing operations of SCP up to the date of the SCP Acquisition. Amounts outstanding under the ABC Loans bear an interest rate equal to the benchmark lending interest rate published by the People’s Bank of China. During the term of the loan, the rate is subject to adjustment every three months. The ABC Loans are secured by the property, plant and equipment of SCP. The ABC Loans contain various covenants, including covenants that restrict SCP’s ability to incur additional indebtedness, provide guarantees, pledge or incur liens on assets, enter into merger, consolidation or acquisition transactions, or transfer assets. In addition, the ABC Loans contain financial covenants that require SCP to achieve specified minimum revenue levels and to maintain a specified liability to assets ratio.

On January 2, 2014, we repaid in full all outstanding amounts (RMB 63.0 million, $10.3 million) under the ABC Loans, and the loan contracts were terminated.

Omega credit facilities

In connection with the acquisition of Omega on October 1, 2014, we assumed a series of credit facilities and mortgages with the National Bank of Canada (“NBC”) and the Business Development Bank of Canada (“BDC”), as described below.

Omega has an authorized credit facility (the “Omega operating credit facility”) in the amount of C$8.2 million ($7.3 million) with the NBC. The Omega operating credit facility can be utilized in the form of floating-rate advances for an amount not exceeding C$7.0 million ($6.2 million as of the acquisition date) and advances in the form of letters of guarantee or letters of credit, within that limit for an amount not exceeding C$2.0 million ($1.8 million as of the acquisition date). The Omega operating credit facility can also be utilized in the form of advances to cover Omega’s currency risk for an amount not to exceed C$1.2 million ($1.1 million as of the acquisition date). On October 1, 2014, the Omega operating credit facility had floating-rate advances in the amount of C$1.5 million ($1.4 million) bearing interest at the lender’s prime rate plus 0.50%, (or an effective rate of 3.5%) which we assumed as part of the acquisition.

In July 2014, Omega obtained a C$3.0 million demand loan (the “Omega demand loan”), from the NBC bearing interest at the prime rate of the lender, plus a premium of 1.75% (effective rate 4.75%). The Omega demand loan is secured by all of the assets of Omega for C$3.0 million plus an additional security interest of 20% of this amount, bearing interest at 4.75% per annum and matured in November 2014. We assumed the Omega demand loan ($2.7 million as of the acquisition date) in connection with the acquisition and subsequently extended the maturity date to January 2015. The Omega operating credit facility and the Omega demand loan are secured by a first ranking security interest in the amount of C$8.3 million ($7.4 million as of the acquisition date) in Omega’s inventories, trade receivables and on the intellectual property of Omega, present and future.

Omega also had C$0.3 million ($0.2 million) outstanding on a decreasing revolving credit facility with the NBC (the “Omega decreasing revolving credit facility”) bearing interest at the prime rate of the lender, plus 1.0% (or an effective rate equal to 4.0%). The Omega decreasing revolving credit facility is secured by a first ranking security interest of C$1.0 million ($0.9 million as of the acquisition date) on the equipment, tooling and office furniture financed by the credit facility.

The Omega credit facilities are subject to certain restrictions, including the obligation to maintain certain financial ratios. In January 2015, we repaid in full all outstanding amounts ($5.6 million) under the Omega operating credit facility, the Omega demand loan and the Omega decreasing revolving credit facility, and the loan contracts were terminated.

In addition to the above, Omega had five mortgage loans with the BDC (collectively the “Omega mortgages”) which we assumed in connection with the acquisition. The Omega mortgages, which require monthly installments and which are secured by specific Omega buildings and equipment, range in amount from C$0.1 million to C$1.3 million ($0.1 million to $1.1 million as of the acquisition date) and bear interest at the lender’s prime rate (5% as of

 

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the acquisition date) plus a premium ranging from 0% - 1.5%. The Omega mortgages mature at various times from August 2019 through November 2036. In January 2016, in connection with entering the Amended Chase Agreement, we repaid the Omega mortgages in full, and refinanced them under the Chase term loan.

Aggregate Contractual Obligations:

The following table summarizes our long-term contractual obligations and commitments as of December 31, 2015.

 

     Payments due by period  

Contractual obligations(1)

   Total      Less than
one year
     1-3
years
     3-5 years      More than
five years
 

Long-term debt obligations(2)

   $ 1,623       $ —         $ —         $ 1,623       $ —     

Capital lease obligations

     —           —           —           —           —     

Operating lease obligations(3)

     2,892         805         1,017         936         134   

Purchase obligations

     —           —           —           —           —     

Contingent contractual payments(4)

     27,721         18,037         7,850         769         1,065   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
   $ 32,236       $ 18,842       $ 8,867       $ 3,328       $ 1,199   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) 

We had no material purchase commitments, individually or in the aggregate, under our manufacturing and supply agreements.

(2)

No amounts were drawn under the Chase Agreement at December 31, 2015. Includes amounts due under Omega facilities assuming period-end foreign exchange rates. We repaid and refinanced the Omega mortgages in January 2016 ($1.6 million).

(3) 

Includes annual minimum lease payments related to non-cancelable operating leases.

(4) 

Includes management’s estimate for contingent potential contractual payments and fees pursuant to strategic business agreements for the development and marketing of finished dosage form pharmaceutical products assuming all contingent future contractual payments occur. Does not include contingent royalty payments, which are dependent on the introduction of new products.

Off-Balance Sheet Arrangements

At December 31, 2015, we were not party to any off-balance sheet arrangements, nor have we created any special-purpose or off-balance sheet entities for the purpose of raising capital, incurring debt or operating our business. With the exception of operating leases, we do not have any off-balance sheet arrangements or relationships with entities that are not consolidated into or disclosed on our financial statements that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues, expenses, results of operations, liquidity, capital expenditures or capital resources. In addition, we do not engage in trading activities involving non-exchange traded contracts.

Effects of Inflation

We do not believe that our sales or operating results have been materially impacted by inflation during the periods presented in our financial statements. There can be no assurance, however, that our sales or operating results will not be impacted by inflation in the future.

 

Item 7A. Quantitative and Qualitative Disclosures about Market Risk.

Our market risks relate primarily to changes in interest rates and currency fluctuations between the Chinese Renminbi and the US dollar, and following our acquisition of Omega, between the Canadian dollar and US dollar.

 

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The revolving loan facility under our Chase Agreement and substantially all of Omega’s debt facilities bear floating interest rates that are tied to LIBOR or an alternate base rate, and therefore, our statements of operations and our cash flows are exposed to changes in interest rates. Based on the amounts outstanding at December 31, 2015, a one percentage point increase in LIBOR would increase our ongoing interest expense by $0.1 million per year, and a 10% strengthening of the Canadian dollar relative to the US dollar, would increase our ongoing interest expense by less than $0.1 million per year. We historically have not engaged in hedging activities related to our interest rate or foreign exchange risks.

At December 31, 2015, we had cash and cash equivalents, and short-term investments of $29.0 million and $20.1 million, respectively. Our cash and cash equivalents are held primarily in cash and money market funds, and our short-term investments are held primarily in corporate debt securities and commercial paper. We do not enter into investments for trading or speculative purposes. Due to the short-term nature of these investments, we believe that we do not have any material exposure to changes in the fair value of our investment portfolio as a result of changes in interest rates.

We generally record sales and pay our expenses in the local currency of the legal entity that incurs the expense. Substantially all of our business partners that supply us with API, product development services and finished product manufacturing are located in a number of foreign jurisdictions, and we believe those business partners generally incur their respective operating expenses in local currencies. As a result, both we and our business partners may be exposed to currency rate fluctuations and experience an effective increase in operating expenses in the event local currencies appreciate against the U.S. dollar. In this event, the cost of manufacturing product from our SCP facility may increase or such business partners may elect to stop providing us with these services or attempt to pass these increased costs back to us through increased prices for product development services, API sourcing or finished products that they supply to us. Historically we have not used derivatives to protect against adverse movements in currency rates.

We do not have any foreign currency or any other material derivative financial instruments.

 

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Item 8. Financial Statements and Supplementary Data.

Sagent Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

 

     December 31,  
     2015     2014
(As restated)
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 28,962      $ 55,633   

Short-term investments

     20,060        18,473   

Accounts receivable, net of chargebacks and other deductions

     51,425        42,780   

Inventories, net

     76,453        61,781   

Due from related party

     2,678        2,156   

Prepaid expenses and other current assets

     7,388        5,560   

Assets held for sale

     4,626        —     
  

 

 

   

 

 

 

Total current assets

     191,592        186,383   

Property, plant, and equipment, net

     19,761        71,153   

Investment in joint ventures

     7,108        4,539   

Goodwill

     25,184        28,155   

Intangible assets, net

     53,166        65,575   

Non-current deferred tax assets

     50,808        23,778   

Other assets

     2,113        375   
  

 

 

   

 

 

 

Total assets

   $ 349,732      $ 379,958   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 43,703      $ 32,710   

Due to related party

     13,754        8,079   

Accrued profit sharing

     7,582        10,684   

Accrued liabilities

     15,706        19,346   

Current portion of deferred purchase consideration

     —          8,725   

Current portion of long-term debt

     —          508   

Notes payable

     —          5,499   

Liabilities held for sale

     2,910        —     
  

 

 

   

 

 

 

Total current liabilities

     83,655        85,551   

Long term liabilities:

    

Long-term debt

     1,623        1,945   

Deferred income taxes

     12,021        15,706   

Other long-term liabilities

     1,340        2,954   
  

 

 

   

 

 

 

Total liabilities

     98,639        106,156   

Stockholders’ equity:

    

Common stock – $0.01 par value, 100,000,000 authorized, and 32,801,896 and 31,976,661 outstanding at December 31, 2015 and December 31, 2014, respectively

     328        320   

Additional paid-in capital

     367,235        353,962   

Accumulated other comprehensive income (loss)

     (17,482     (3,374

Accumulated deficit

     (98,988     (77,106
  

 

 

   

 

 

 

Total stockholders’ equity

     251,093        273,802   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 349,732      $ 379,958   
  

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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Sagent Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

 

     Year ended December 31,  
     2015     2014
(As restated)
    2013  

Net revenue

   $ 318,296      $ 288,983      $ 244,750   

Cost of sales

     230,557        202,821        167,228   
  

 

 

   

 

 

   

 

 

 

Gross profit

     87,739        86,162        77,522   

Operating expenses:

      

Product development

     29,145        26,809        20,275   

Selling, general and administrative

     49,931        43,227        36,198   

Acquisition-related costs

     2,838        1,069        —     

Management transition

     5,310        —          —     

Equity in net income of joint ventures

     (2,569     (3,987     (2,395
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     84,655        67,118        54,078   
  

 

 

   

 

 

   

 

 

 

Impairment of SCP long-lived assets

     45,158        —          —     

Legal Settlement

     2,447        —          —     

Termination fee

     —          —          5,000   

Gain on previously held equity interest

     —          —          2,936   
  

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     (44,521     19,044        31,380   

Interest income and other income (expense)

     (2,790     (678     39   

Interest expense

     (770     (2,188     (930
  

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     (48,081     16,178        30,489   

Provision (benefit) for income taxes

     (26,199     (20,773     895   
  

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (21,882   $ 36,951      $ 29,594   
  

 

 

   

 

 

   

 

 

 

Net income (loss) per common share:

      

Basic

   $ (0.67   $ 1.16      $ 1.01   

Diluted

   $ (0.67   $ 1.13      $ 0.99   

Weighted-average shares used to compute net income (loss) per common share:

      

Basic

     32,439        31,882        29,213   

Diluted

     32,439        32,745        29,937   

See accompanying notes to consolidated financial statements.

 

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Sagent Pharmaceuticals, Inc.

Consolidated Statements of Comprehensive Income (Loss)

(in thousands)

 

     Year ended December 31,  
     2015     2014
(As restated)
    2013  

Net income (loss)

   $ (21,882   $ 36,951      $ 29,594   

Other comprehensive income (loss), net of tax

      

Foreign currency translation adjustments

     (14,080     (3,830     790   

Reclassification of cumulative currency translation gain

     —          —          (2,782

Unrealized gains (losses) gains on available for sale securities

     (28     (31     (21
  

 

 

   

 

 

   

 

 

 

Total other comprehensive income (loss), net of tax

     (14,108     (3,861     (2,013
  

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

   $ (35,990   $ 33,090      $ 27,581   
  

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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Sagent Pharmaceuticals, Inc.

Consolidated Statements of Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

 

    Common Stock     Additional
Paid-In
Capital

(As Restated)
    Accumulated
Other
Comprehensive
Income (Loss)
    Accumulated
Deficit

(As Restated)
    Total  
    Shares     Amount          

Balance as of January 1, 2013

    28,116,489      $ 281      $ 272,725      $ 2,500      $ (143,651   $ 131,855   

Issuance of common stock

    3,542,470        36        70,544        —          —          70,580   

Exercise of stock options

    130,389        1        716        —          —          717   

Stock compensation expense

    —          —          5,293        —          —          5,293   

Comprehensive income (loss)

          (2,013     29,594        27,581   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2013

    31,789,348      $ 318      $ 349,278      $ 487      $ (114,057   $ 236,026   

Exercise of stock options

    178,313        2        1,021        —          —          1,023   

Stock compensation expense

    —          —          2,683        —          —          2,683   

Tax benefit from stock exercises

    —          —          980        —          —          980   

Comprehensive income (loss)

          (3,861     36,951        33,090   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2014 (As restated)

    31,976,661      $ 320      $ 353,962      $ (3,374   $ (77,106   $ 273,802   

Exercise of stock options

    825,235        8        9,345            9,353   

Stock compensation expense

        3,836            3,836   

Tax benefit from stock exercises

    —          —          92        —          —          92   

Comprehensive income (loss)

          (14,108     (21,882     (35,990
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2015

    32,801,896      $ 328      $ 367,235      $ (17,482   $ (98,988   $ 251,093   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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Sagent Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(in thousands)

 

     Year ended December 31,  
     2015     2014
(As restated)
    2013  

Cash flows from operating activities

      

Net income (loss)

   $ (21,882   $ 36,951      $ 29,594   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

      

Depreciation and amortization

     13,681        9,524        7,074   

Stock-based compensation

     3,836        2,683        5,293   

Equity in net income of joint ventures

     (2,569     (3,987     (2,395

Dividends from unconsolidated joint ventures

     —          1,511        4,318   

Gain on previously held equity interest

     —          —          (2,936

Deferred income taxes, net

     (28,025     (23,732  

Impairment charge

     45,158        —          —     

Other

     1,117        (1,180     (115

Changes in operating assets and liabilities, net of effect of acquisition:

      

Accounts receivable

     (9,250     (16,442     8,578   

Inventories, net

     (20,564     (1,713     3,053   

Prepaid expenses and other current assets

     (2,571     2,171        (3,466

Due from related party

     (522     (1,208     (6,924

Accounts payable and other accrued liabilities

     14,068        17,621        7,477   
  

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     (7,523     22,199        49,551   
  

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

      

Capital expenditures

     (6,711     (4,242     (1,103

Acquisition of business, net of cash acquired

     (11,785     (86,467     (12,996

Purchases of investments

     (13,212     (87,171     (275,198

Sale of investments

     11,420        181,352        196,728   

Purchase of product rights

     (1,707     (4,404     (5,174

Other

     —          —          586   
  

 

 

   

 

 

   

 

 

 

Net cash (used in) provided by investing activities

     (21,995     (932     (97,157
  

 

 

   

 

 

   

 

 

 

Cash flows from financing activities

      

Increase (reduction) in short-term borrowings

     (5,189     1,152        —     

Repayment of long-term debt

     (471     (10,420     (8,961

Proceeds from issuance of common stock, net of issuance costs

     9,345        1,023        71,247   

Payment of deferred financing costs

     (274     (285     (28

Excess tax benefits on stock option exercises

     92        980     
  

 

 

   

 

 

   

 

 

 

Net cash (used in) provided by financing activities

     3,503        (7,550     62,258   
  

 

 

   

 

 

   

 

 

 

Effect of exchange rate movements in cash

     (656     (416     (7
  

 

 

   

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     (26,671     13,301        14,645   

Cash and cash equivalents, at beginning of period

     55,633        42,332        27,687   
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents, at end of period

   $ 28,962      $ 55,633      $ 42,332   
  

 

 

   

 

 

   

 

 

 

Supplemental disclosure of cash flow information

      

Acquisition of property, plant and equipment in accounts payable

   $ (856   $ 934      $ —     

Cash paid for interest

   $ 414      $ 1,361      $ 652   

Cash paid for taxes

   $ 4,340      $ 2,555      $ —     

See accompanying notes to consolidated financial statements

 

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Sagent Pharmaceuticals, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

(amounts in thousands)

Note 1. Summary of Significant Accounting Policies:

Nature of Operations

Sagent Pharmaceuticals, Inc. (“Sagent”, “we”, “us” or “our”) is a leading provider of affordable pharmaceuticals to the hospital market, which we sell primarily throughout North America. We completed our initial public offering (“IPO”) on April 26, 2011. In connection with our IPO, we incorporated (the “Reincorporation”) in Delaware as Sagent Pharmaceuticals, Inc. Prior to the Reincorporation, we were a Cayman Islands company, and our corporate name was Sagent Holding Co. (“Sagent Holding”). Our products are typically sold to pharmaceutical wholesale companies which then distribute the products to end-user hospitals, long-term care facilities, alternate care sites, and clinics. The injectable pharmaceutical marketplace is comprised of end users who have relationships with group purchasing organizations (GPOs) or specialty distributors that focus on a particular therapeutic class. GPOs enter into product purchasing agreements with Sagent and other pharmaceutical suppliers for products in an effort to secure favorable drug pricing on behalf of their end-user members.

Basis of Presentation

The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP).

The consolidated financial statements include the assets, liabilities, and results of operations of Sagent Pharmaceuticals, Inc. and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation.

Sagent Agila LLC (“Sagent Agila”) is a joint venture incorporated in Wyoming with Strides Inc., a wholly-owned subsidiary of Strides Arcolab International Limited (“Strides”), established in January 2007 with the principal business of development, manufacturing, marketing, distribution and sale of generic pharmaceutical products to the U.S. market. In December 2013, Mylan Inc. (“Mylan”) acquired Strides’ Agila Specialities Pvt. Ltd., subsidiary (“Agila”), including Strides’ ownership share of the Sagent Agila joint venture.

We account for our 50% interest in Sagent Agila under the equity method of accounting as our interest in the entity provides for joint financial and operational control. Sagent’s equity in the net income (loss) of Sagent Agila is included in the accompanying consolidated statements of operations as equity in net income (loss) of joint ventures.

On June 4, 2013, we acquired the remaining 50% equity interest in Kanghong Sagent (Chengdu) Pharmaceutical Co. Ltd. (“KSCP”) from our former joint venture partner (the “SCP Acquisition”), and accordingly, the consolidated financial statements since that date include KSCP as a wholly-owned subsidiary. Prior to the SCP Acquisition, we accounted for our investment in KSCP using the equity method of accounting, as our interest in the entity provided for joint financial and operational control, and the operating results of KSCP were reported on a one-month lag. In August 2013, we formally changed the name of this entity to Sagent (China) Pharmaceuticals Co., Ltd. (“SCP”).

On October 1, 2014, we, through our wholly-owned subsidiary, Sagent Acquisition Corp., a Canadian company, acquired all of the issued and outstanding shares of the capital stock of 7685947 Canada Inc., and its subsidiary, Omega Laboratories Limited (collectively, “Omega”), a privately held Canadian pharmaceutical and specialty healthcare products company for C$92.8 million ($82.7 million). As a result of the completion of the transaction, Omega became a wholly-owned subsidiary of the Company effective October 1, 2014.

 

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As a result of the Omega acquisition on October 1, 2014, we began operating in two reportable segments comprised of operations in the United States, including our Chinese manufacturing site, (Sagent US segment) and Canada (Omega segment), each of which develop, source, manufacture and market generic injectable products for sale within the their respective countries, each segment deriving a significant portion of its revenues from a single class of pharmaceutical wholesale customers within that country.

On December 29, 2015, our Board of Directors authorized us to proceed with a sale of all of the Company’s ownership interests in SCP. Following this decision, we have classified SCP as held for sale in our Consolidated Balance Sheet as of December 31, 2015.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Foreign Currencies

We translate the results of operations of our foreign subsidiaries using average exchange rates during each period, whereas balance sheet accounts are translated using exchange rates at the end of each period. We record currency translation adjustments as a component of equity. Transaction gains and losses are recorded in interest income and other in the statements of operations, and were $2,838 and $1,075 of transaction losses in the year ended December 31, 2015 and 2014, respectively. Transaction gains and losses were not significant for the year ended December 31, 2013.

Fair Value of Financial Instruments

The carrying amounts reported in the balance sheets for cash and cash equivalents and other current monetary assets and liabilities approximate fair value because of the immediate or short-term maturity of these financial instruments.

Cash and Cash Equivalents

These amounts are stated at cost, which approximates fair value. At December 31, 2015, cash equivalents were deposited in financial institutions and consisted of immediately available fund balances. The majority of our funds at December 31, 2015 were maintained at stable financial institutions, in amounts in excess of federally insured limits. This represents a concentration of credit risk. We have not experienced any losses on our deposits of cash and cash equivalents to date.

Cash collateral pledged under various lease agreements and cash restricted by financing agreements is classified as restricted cash within the other assets caption in the accompanying consolidated balance sheets as our ability to withdraw the funds is contractually limited.

Financial Instruments

We consider all highly liquid money market investments with a maturity of three months or less at the date of purchase to be cash equivalents. The carrying values of these investments approximate their fair values. Investments with original maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year are classified as short-term based on their highly liquid nature and because such marketable securities represent the investment of cash that is

 

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available for current operations. All cash equivalents and short-term investments are classified as available-for-sale and realized gains and losses are recorded using the specific identification method. Changes in market value, excluding other-than-temporary impairments, are reflected in other comprehensive income (“OCI”).

Investments are considered to be impaired when a decline in fair value is judged to be other-than-temporary. Fair value is calculated based on publicly available market information or other estimates determined by management. We employ a systematic methodology on a quarterly basis that considers available quantitative and qualitative evidence in evaluating potential impairment of our investments. If the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, credit quality of debt instrument issuers, the duration and extent to which the fair value is less than cost, and for equity securities, our intent and ability to hold, or plans to sell, the investment. For fixed income securities, we also evaluate whether we have plans to sell the security or it is more likely than not that we will be required to sell the security before recovery.

We also consider specific adverse conditions related to the financial health of and business outlook for the investee, including industry and sector performance, changes in technology, and operational and financing cash flow factors. Once a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded to other expense and a new cost basis in the investment is established.

Inventories

Inventories are stated at the lower of cost (first in, first out) or market value. Inventories consist of products currently approved for marketing and may include certain products pending regulatory approval. From time to time, we capitalize inventory costs associated with products prior to receiving regulatory approval based on our judgment of probable future commercial success and realizable value. Such judgment incorporates management’s knowledge and best judgment of where the product is in the regulatory review process, market conditions, competing products and economic expectations for the product post-approval relative to the risk of manufacturing the product prior to approval. If final regulatory approval for such products is denied or delayed, we may need to reserve for and expense such inventory. We record inventory provisions for products which have not received regulatory approval within product development expense.

We establish reserves for inventory to reflect situations in which the cost of the inventory is not expected to be recovered. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand, estimated time required to sell such inventory, remaining shelf life and current expected market conditions, including level of competition. We record provisions for inventory to cost of goods sold.

Property, Plant, and Equipment

Property, plant, and equipment is stated at cost, less accumulated depreciation. The cost of repairs and maintenance is expensed when incurred, while expenditures for refurbishments and improvements that significantly add to the productive capacity or extend the useful life of an asset are capitalized. Provisions for depreciation are computed for financial reporting purposes using the straight-line method over the estimated useful life of the related asset and for leasehold improvements over the lesser of the estimated useful life of the related asset or the term of the related lease as follows:

 

Land and land improvements

   Indefinite, except with respect to the Chinese land use right (through remaining term, June 2057)

Building and improvements

   5 to 40 years or remaining term of lease

Machinery, equipment, furniture, and fixtures

   3 to 10 years

Software

   3 to 5 years

 

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Property, plant and equipment that is purchased or constructed which requires a period of time before the assets are ready for their intended use are accounted for as construction-in-progress. Construction-in-progress is recorded at acquisition cost, including installation costs and associated interest costs. Construction-in-progress is transferred to specific property, plant and equipment accounts and commences depreciation when these assets are ready for their intended use. The capitalization of interest costs commences when expenditures for the asset have been made, activities that are necessary to prepare the asset for its intended use are in progress and interest cost is being incurred. The capitalization period ends when the asset is substantially complete and ready for its intended use.

Deferred Financing Costs

Deferred financing costs related to the issuance of debt are amortized using the straight-line method over the term of the related debt instrument, which approximates the effective interest method. We capitalized deferred financing costs of $274 in 2015 in connection with our amended and restated senior secured credit facility with Chase (the “Amended Chase Agreement”) and $285 in 2014 in connection with our new revolving loan credit facility with Chase (the “Chase Agreement”). Deferred financing costs are recorded within Other Assets on our consolidated balance sheets, as there are no outstanding balances related to these loans, and totaled $468 and $275 at December 31, 2015 and 2014, respectively.

Impairment of Long-Lived Assets

We evaluate long-lived assets, including intangible assets with definite lives, for impairment whenever events or other changes in circumstances indicate that the carrying value of an asset may no longer be recoverable. An evaluation of recoverability is performed by comparing the carrying values of the assets to projected future undiscounted cash flows, in addition to other quantitative and qualitative analyses. Judgments made by management related to the expected useful lives of long-lived assets and the ability to realize undiscounted cash flows in excess of the carrying amounts of such assets are affected by factors such as changes in economic conditions and changes in operating performance. Upon indication that the carrying values of such assets may not be recoverable, we recognize an impairment loss as a charge against current operations. We recorded an impairment charge within cost of sales of $200 related to one product license right in the year ended December 31, 2014. In December 2015, we recorded an impairment charge within operating expense of $45,158 related to classifying SCP as held for sale.

Product Development Agreements

Product development costs are expensed as incurred. These expenses include the costs of our internal product development efforts and acquired in-process research and development, as well as product development costs incurred in connection with our third-party contract research and development efforts. Non-refundable contractual payments made under contract research and development arrangements for future research and development activities prior to regulatory approval, including payments made upon execution of a definitive contract research and development agreement, are deferred and are expensed as the related services are performed. If we determine that it is no longer probable that the product will be pursued, any related capitalized amount is expensed in the current period. Contractual payments due to a counterparty for development efforts that are contingent upon the successful completion of certain activities are expensed when the successful completion is considered probable.

Once a product receives regulatory approval, we record any contractual payments for the license to sell the developed product as an intangible asset to be amortized on a straight-line basis as a component of cost of sales over the shorter of the related license period or the estimated life of the acquired product. At December 31, 2015, the amortization period for intangible assets arising from approved products ranges from four to six years with a weighted-average period prior to the next renewal or extension of 4.3 years. We make the determination whether to capitalize or expense amounts related to the development of new products and technologies through agreements with third parties based on our ability to recover our cost in a reasonable period of time, generally the initial license term, from the estimated future cash flows anticipated to be generated pursuant to each agreement.

 

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Market, regulatory and legal factors, among other things, may affect the realizability of the projected cash flows that an agreement was initially expected to generate. We regularly monitor these factors and subject capitalized costs to periodic impairment testing.

Goodwill and Intangible Assets

Goodwill is recognized as the excess of fair value of consideration transferred to acquire an entity over the fair values assigned to assets acquired and liabilities assumed. Goodwill is not amortized, but rather tested for impairment on an annual basis and more often if circumstances require. We assess goodwill impairment risk by first performing a qualitative review of entity-specific, industry, market and general economic factors for each of our reporting units. If significant potential goodwill impairment risk exists, we apply a two-step quantitative test. Impairment losses are recognized whenever the implied fair value of goodwill is less than its carrying value. We test goodwill for impairment at least annually on October 1.

Certain amounts paid to third parties related to the development of new products and technologies are capitalized and included within intangible assets. We determine the estimated fair values of certain intangible assets with definitive lives utilizing valuations performed by management at the time of their acquisition, based on anticipated future cash flow activity.

We test indefinite-lived intangible assets for impairment by first performing a qualitative review by assessing events and circumstances that could affect the fair value or carrying value of the indefinite-lived intangible asset. If significant potential impairment risk exists for a specific indefinite-lived intangible asset, we quantitatively test for impairment by comparing the fair value of each intangible asset with its carrying value. Fair value of non-amortizable intangible assets is determined using planned growth rates, market-based discount rates and estimates of royalty rates. If the carrying value of the asset exceeds its fair value, the intangible asset is considered impaired and is reduced to its estimated fair value.

Definite-lived intangible assets are amortized over their estimated useful lives and evaluated for impairment on a quarterly basis as long-lived assets.

Acquired In-Process Research and Development

The fair value of in-process research and development (“IPR&D”) projects acquired in a business combination are capitalized and accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a definite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off to product development expense. Development costs incurred after the acquisition are expensed as incurred.

Advertising and Promotion Expense

All advertising and promotion costs are expensed as selling, general, and administrative expenses when incurred. Total direct advertising and promotion expense incurred was $1,173, $1,112, and $766 for the years ended December 31, 2015, 2014 and 2013, respectively.

Income Taxes

Provisions for federal, state and foreign taxes are calculated based on pre-tax earnings at currently enacted tax rates.

Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss and capital loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the financial statements in the period that includes the legislative enactment date. We recognize the financial statement effects of a tax position only when it is more likely than not that the position will be sustained

 

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upon examination and recognize any interest and penalties accrued in relation to unrecognized tax benefits in income tax expense. We establish valuation allowances against deferred tax assets when it is more likely than not that the realization of those deferred tax assets will not occur.

In assessing the realizability of deferred tax assets, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. We also consider the scheduled reversal of deferred tax liabilities, projected future taxable income or losses, and tax planning strategies in making this assessment.

Revenue Recognition – General

We recognize revenue when our obligations to a customer are fulfilled relative to a specific product and all of the following conditions are satisfied: (i) persuasive evidence of an arrangement exists; (ii) the price is fixed or determinable; (iii) collectability is reasonably assured; and (iv) delivery has occurred. Delivery is deemed to have occurred upon customer receipt of product, upon fulfillment of acceptance terms, if any, and when no significant contractual obligations remain. Net sales reflect reductions of gross sales for estimated wholesaler chargebacks, estimated contractual allowances, estimated product returns and estimated early payment discounts. We provide for estimated product returns at the time of sale based on historic product return experience.

In the case of new products for which the product introduction is not an extension of an existing line of product, where we determine that there are not products in a similar therapeutic category, or where we determine the new product has dissimilar characteristics with existing products, such that we cannot reliably estimate expected returns of the new product, we defer recognition of revenue until the right of return no longer exists or until we have developed sufficient historical experience to estimate sales returns.

Shipping and handling fees billed to customers are recognized in net revenue. Other shipping and handling costs are included in cost of goods sold.

Revenue Recognition – Chargebacks

The majority of our products are distributed through independent pharmaceutical wholesalers. In accordance with industry practice, sales to wholesalers are initially transacted at wholesale list price. The wholesalers then generally sell to an end user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously contractually established between the end user and Sagent.

When we initially record a sale to a wholesaler, the sale and resulting receivable are recorded at our list price. However, experience indicates that most of these selling prices will eventually be reduced to a lower, end-user contract price. Therefore, at the time of the sale, a contra asset is recorded for, and revenue is reduced by, the difference between the list price and the estimated average end-user contract price. This contra asset is calculated by product code, taking the expected number of outstanding wholesale units sold that will ultimately be sold under end-user contracts multiplied by the anticipated, weighted-average contract price. When the wholesaler ultimately sells the product, the wholesaler charges us, or issues a chargeback, for the difference between the list price and the end-user contract price and such chargeback is offset against the initial estimated contra asset. Periodically, we review the wholesale list prices for our products, and from time to time may reduce list prices based on market conditions or competitive pricing pressures. Reductions in the wholesale list price of our products reduce both our gross sales and the revenue reduction recorded upon initial product sale, but do not change the end-user contract selling price.

The significant estimates inherent in the initial chargeback provision relate to wholesale units pending chargeback and to the ultimate end-user contract-selling price. We base the estimate for these factors on product-specific sales and internal chargeback processing experience, estimated wholesaler inventory stocking levels,

 

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current contract pricing and our expectation for future contract pricing changes. Our chargeback provision is potentially impacted by a number of market conditions, including: competitive pricing, competitive products, and other changes impacting demand in both the distribution channel and end users.

We rely on internal data, external data from our wholesaler customers, and management estimates to estimate the amount of inventory in the channel subject to future chargeback. The amount of product in the channel is comprised of both product at the wholesaler and product that the wholesaler has sold, but not yet reported as end-user sales. Physical inventory in the channel is estimated by the evaluation of our monthly sales to the wholesalers and our knowledge of inventory levels and estimated inventory turnover at these wholesalers.

Our total chargeback accrual was $48,588 and $63,088 at December 31, 2015 and 2014, respectively, and is included as a reduction of accounts receivable. Our total chargeback expense was $318,605, $403,493, and $300,835 for the years ended December 31, 2015, 2014 and 2013, respectively.

Revenue Recognition – Cash Discounts

We offer cash discounts, approximating 2% of the gross sales price, as an incentive for prompt payment and occasionally offer greater discounts and extended payment terms in support of product launches or other promotional programs. Our wholesale customers typically pay within terms, and we account for cash discounts by reducing net sales and accounts receivable by the full amount of the discount offered at the time of sale. We consider payment performance and adjust the accrual to reflect actual experience.

Our total accrual for cash discounts was $3,917 and $2,440 at December 31, 2015 and 2014, respectively, and is included as a reduction of accounts receivable.

Revenue Recognition – Sales Returns

Consistent with industry practice, our return policy permits customers to return products within a window of time before and after the expiration of product dating. We provide for product returns and other customer credits at the time of sale by applying historical experience factors. We provide specifically for known outstanding returns and credits. The effect of any changes in estimated returns is taken in the current period’s income.

We determine our estimate of the sales return accrual primarily based on historical experience, but also consider other factors that could impact sales returns. These factors include levels of inventory in the distribution channel, estimated shelf life, product recalls, timing of product returns relative to expiry, product discontinuances, price changes of competitive products, and introductions of competitive new products.

Our total accrual for returns and credits was $7,042 and $15,860 at December 31, 2015 and 2014, respectively, and is included as a reduction of accounts receivable.

Revenue Recognition – Contractual Allowances

Contractual allowances, generally rebates or administrative fees, are offered to certain wholesale customers, GPOs, and end-user customers, consistent with pharmaceutical industry practices. Settlement of rebates and fees may generally occur from one to five months from date of sale. We provide a provision for contractual allowances at the time of sale based on the historical relationship between sales and such allowances. Contractual allowances are reflected in the consolidated financial statements as a reduction of revenues and as a current accrued liability.

Stock Based Compensation

We recognize compensation cost for all share-based payments (including employee stock options) at fair value. We use the straight-line attribution method to recognize stock based compensation expense over the vesting period of the award. Options currently granted generally expire ten years from the grant date and vest ratably over a four-year period.

 

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Stock based compensation expense for performance based options is measured and recognized if the performance measures are considered probable of being achieved. We evaluate the probability of the achievement of the performance measures at each balance sheet date. If it is not probable that the performance measures will be achieved, any previously recognized compensation cost would be reversed.

We use the Black-Scholes option pricing model to estimate the fair value of options granted under our equity incentive plans and rights to acquire stock granted under the stock participation plan. Stock-based compensation expense was $3,836, $2,683 and $5,293 for the years ended December 31, 2015, 2014 and 2013, respectively.

Recently Adopted and Pending Accounting Standards

In May 2014, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. In July 2015, the FASB approved a one year deferral to the new revenue guidance, and we are therefore required to adopt the new guidance on January 1, 2018 using one of the two prescribed retroactive methods. We are evaluating the impact of the amended revenue recognition guidance on our consolidated financial statements.

In February 2015, the FASB issued amended guidance on the model used to evaluate whether certain legal entities should be consolidated. This guidance is effective for the Company in the first quarter of 2017. Early adoption is permitted. Adoption of this guidance is not expected to have a material impact on our financial statements.

In April 2015, the FASB issued amended guidance, which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective for annual and interim periods beginning after December 15, 2015. Adoption of this guidance in the first quarter 2016, is not expected to have a material impact on our financial statements.

In September 2015, the FASB issued guidance that eliminates the requirement to restate prior period financial statements for measurement period adjustments related to business combinations. The new guidance requires that the cumulative impact of a measurement period adjustment (including the impact on prior periods) be recognized in the reporting period in which the adjustment is identified. In addition, separate presentation on the face of the income statement or disclosure in the notes to the financial statements is required regarding the portion of the adjustment recorded in current period earnings. We are required to adopt this guidance prospectively for measurement period adjustments that occur after the effective date. This guidance is effective for the Company in the first quarter of 2016. Early adoption is permitted. We have adopted this guidance in the current period. There was no material impact of adoption.

In November 2015, the FASB issued guidance that requires all deferred tax assets and liabilities to be presented as non-current in a classified statement of financial position. We are required to adopt this guidance by the first quarter of 2017, with early adoption permitted. We have adopted this guidance in our Consolidated Balance Sheet as of December 31, 2015 and retrospectively for December 31, 2014. Adoption of this standard resulted in the reclassification of $12,135 of current deferred tax assets to long term deferred tax assets at December 31, 2014.

In February 2016, the FASB issued lease guidance, which is intended to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. In order to meet that objective, the new standard requires recognition of the assets and liabilities that arise from leases. A lessee will be required to recognize on the

 

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balance sheet the assets and liabilities for leases with lease terms of more than 12 months. Accounting by lessors will remain largely unchanged from current U.S. generally accepted accounting principles. The new standard is effective for public companies for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. The Company is currently evaluating the effect that adopting this standard will have on our financial statements and related disclosures.

Note 2. Restatement:

We have restated our financial statements for the year ended December 31, 2014 for the correction of errors primarily related to our previous tax filing position relating to SCP during the time SCP was 50% owned and prior to our acquisition of 100% ownership of SCP in June 2013. The error resulted in our incorrectly claiming net operating loss carryforward benefits in the U.S. related to SCP, resulting in an overstatement of deferred tax asset, for which there was a full valuation allowance reserve. In December 2014, we concluded that the valuation allowance against our net U.S. deferred tax assets was no longer required, based on our then recent income and projections of sustained profitability. As a result, we released the allowance in full, including $2,538 related to net operating loss carryforward benefits recognized as a result of the incorrect SCP tax filing position, which resulted in the improper recognition of net income in the year ended December 31, 2014.

We also corrected individually immaterial adjustments as part of this restatement related to the overstatement of federal and state net operating losses. The correction of errors resulted in a reduction of $2,930 to net income, or $0.09 per diluted share, for the year ended December 31, 2014.

 

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The account balances labeled “As Reported” in the following tables for the year ended December 31, 2014 represent the previously reported financial statements as presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. The effects of these prior period errors on the consolidated financial statements after the retrospective adoption of deferred tax asset and liability presentation guidance as described in Note 1, are as follows:

Consolidated Statements of Operations

(in thousands, except per share amounts)

 

     Year ended December 31, 2014  
     As reported     Adjustments     As restated  

Net revenue

   $ 288,983      $ —        $ 288,983   

Cost of sales

     202,821        —          202,821   
  

 

 

   

 

 

   

 

 

 

Gross profit

     86,162        —          86,162   

Operating expenses:

      

Product development

     26,809        —          26,809   

Selling, general and administrative

     43,227        —          43,227   

Acquisition-related costs

     1,069        —          1,069   

Equity in net income of joint ventures

     (3,987     —          (3,987
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     67,118        —          67,118   
  

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     19,044        —          19,044   

Interest income and other income (expense)

     (678     —          (678

Interest expense

     (2,188     —          (2,188
  

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     16,178        —          16,178   

Provision (benefit) for income taxes

     (23,703     2,930        (20,773
  

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 39,881      $ (2,930   $ 36,951   
  

 

 

   

 

 

   

 

 

 

Net income (loss) per common share:

      

Basic

   $ 1.25      $ (0.09   $ 1.16   

Diluted

   $ 1.22      $ (0.09   $ 1.13   

Weighted-average of shares used to compute net income (loss) per common share:

      

Basic

     31,882        —          31,882   

Diluted

     32,745        —          32,745   

Consolidated Statements of Comprehensive Income (Loss)

(in thousands)

 

     Year ended December 31, 2014  
     As reported     Adjustments     As restated  

Net income (loss)

   $ 39,881      $ (2,930   $ 36,951   

Other comprehensive income (loss), net of tax

    

Foreign currency translation adjustments

     (3,830     —          (3,830

Unrealized gains (losses) gains on available for sale securities

     (31     —          (31
  

 

 

   

 

 

   

 

 

 

Total other comprehensive income (loss), net of tax

     (3,861     —          (3,861
  

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

   $ 36,020      $ (2,930   $ 33,090   
  

 

 

   

 

 

   

 

 

 

 

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Consolidated Balance Sheet

(in thousands, except per share amounts)

 

     As of December 31, 2014  
     As reported     Adjustments     As restated  

Assets

      

Current assets:

      

Cash and cash equivalents

   $ 55,633      $ —        $ 55,633   

Short-term investments

     18,473        —          18,473   

Accounts receivable, net of chargebacks and other deductions

     42,780        —          42,780   

Inventories, net

     61,781        —          61,781   

Due from related party

     2,156        —          2,156   

Prepaid expenses and other current assets

     5,560        —          5,560   
  

 

 

   

 

 

   

 

 

 
     186,383        —          186,383   

Property, plant, and equipment, net

     71,153        —          71,153   

Investment in joint ventures

     4,539        —          4,539   

Goodwill

     28,155        —          28,155   

Intangible assets, net

     65,575        —          65,575   

Non-current deferred tax assets

     25,308        (1,530     23,778   

Other assets

     375        —          375   
  

 

 

   

 

 

   

 

 

 

Total assets

   $ 381,488      $ (1,530   $ 379,958   
  

 

 

   

 

 

   

 

 

 

Liabilities and stockholders’ equity

      

Current liabilities:

      

Accounts payable

   $ 32,710      $ —        $ 32,710   

Due to related party

     8,079        —          8,079   

Accrued profit sharing

     10,684        —          10,684   

Accrued liabilities

     19,346        —          19,346   

Current portion of deferred purchase consideration

     8,725        —          8,725   

Current portion of long-term debt

     508        —          508   

Notes payable

     5,499        —          5,499   
  

 

 

   

 

 

   

 

 

 

Total current liabilities

     85,551        —          85,551   

Long term liabilities:

      

Long-term debt

     1,945        —          1,945   

Deferred income taxes

     15,706        —          15,706   

Other long-term liabilities

     2,534        420        2,954   
  

 

 

   

 

 

   

 

 

 

Total liabilities

     105,736        420        106,156   

Stockholders’ equity:

      

Common stock – $0.01 par value, 100,000,000 authorized, and 32,801,896 and 31,976,661 outstanding at December 31, 2015 and December 31, 2014, respectively

     320        —          320   

Additional paid-in capital

     352,982        980        353,962   

Accumulated other comprehensive income (loss)

     (3,374     —          (3,374

Accumulated deficit

     (74,176     (2,930     (77,106
  

 

 

   

 

 

   

 

 

 

Total stockholders’ equity

     275,752        (1,950     273,802   
  

 

 

   

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 381,488      $ (1,530   $ 379,958   
  

 

 

   

 

 

   

 

 

 

 

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Consolidated Statements of Cash Flows

(in thousands)

 

     Year ended December 31,  
     As reported     Adjustments     As restated  

Cash flows from operating activities

      

Net income (loss)

   $ 39,881      $ (2,930   $ 36,951   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

      

Depreciation and amortization

     9,524        —          9,524   

Stock-based compensation

     2,683        —          2,683   

Equity in net income of joint ventures

     (3,987     —          (3,987

Dividends from unconsolidated joint ventures

     1,511        —          1,511   

Gain on previously held equity interest

     —          —          —     

Deferred income taxes, net

     (26,242     2,510        (23,732

Other

     (200     (980     (1,180

Changes in operating assets and liabilities, net of effect of acquisition:

      

Accounts receivable

     (16,442     —          (16,442

Inventories, net

     (1,713     —          (1,713

Prepaid expenses and other current assets

     2,171        —          2,171   

Due from related party

     (1,208     —          (1,208

Accounts payable and other accrued liabilities

     17,201        420        17,621   
  

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     23,179        (980     22,199   
  

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

      

Capital expenditures

     (4,242     —          (4,242

Acquisition of business, net of cash acquired

     (86,467     —          (86,467

Purchases of investments

     (87,171     —          (87,171

Sale of investments

     181,352        —          181,352   

Purchase of product rights

     (4,404     —          (4,404

Other

     —          —          —     
  

 

 

   

 

 

   

 

 

 

Net cash (used in) provided by investing activities

     (932     —          (932
  

 

 

   

 

 

   

 

 

 

Cash flows from financing activities

      

Increase (reduction) in short-term borrowings

     1,152        —          1,152   

Repayment of long-term debt

     (10,420     —          (10,420

Proceeds from issuance of common stock, net of issuance costs

     1,023        —          1,023   

Payment of deferred financing costs

     (285     —          (285

Excess tax benefits on stock option exercises

     —          980        980   
  

 

 

   

 

 

   

 

 

 

Net cash (used in) provided by financing activities

     (8,530     980        (7,550
  

 

 

   

 

 

   

 

 

 

Effect of exchange rate movements in cash

     (416     —          (416
  

 

 

   

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     13,301        —          13,301   

Cash and cash equivalents, at beginning of period

     42,332        —          42,332   
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents, at end of period

   $ 55,633      $ —        $ 55,633   
  

 

 

   

 

 

   

 

 

 

Supplemental disclosure of cash flow information

      

Acquisition of property, plant and equipment in accounts payable

   $ 934      $ —        $ 934   

Cash paid for interest

   $ 1,361      $ —        $ 1,361   

Cash paid for taxes

   $ 2,555      $ —        $ 2,555   

Note 3. Assets Held for Sale:

On December 29, 2015, the Board of Directors authorized us to proceed with a sale of all of the Company’s interests in SCP. As of December 31, 2015, SCP is reported as held for sale in our Consolidated Balance Sheet. In

 

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conjunction with the decision to proceed with the sale of SCP we assessed the long-lived assets for impairment and determined their carrying value was higher than the fair value less cost to sell the related assets. Fair value was determined based on a level 3 measurement, for which limited market data existed. As such, we recorded an impairment charge of $45,158 in the year ended December 31, 2015. This charge is included in Impairment of SCP long-lived assets in the Consolidated Statement of Operations. Condensed balance sheet information of SCP as of December 31, 2015 is presented below.

 

     December 31,
2015
 

Condensed balance sheet information

  

Accounts receivable, net

     8   

Inventories, net

     3,529   

Property, plant, and equipment, net

     500   

Other assets

     589   
  

 

 

 

Total assets of SCP as held for sale in the Balance Sheet

   $ 4,626   
  

 

 

 

Accounts payable

   $ 722   

Accrued liabilities

     1,876   

Other liabilities

     312   
  

 

 

 

Total liabilities of SCP as held for sale in the Balance Sheet

   $ 2,910   
  

 

 

 

On February 3, 2016, the Company entered into a Share Purchase Agreement whereby Hong Kong King-Friend Pharmaceutical Co., Ltd., a subsidiary of Nanjing King-Friend Pharmaceutical Co., Ltd., (“NKF”) will acquire 100% of the outstanding shares of SCP in exchange for $500. We expect this transaction to close in the second quarter of 2016, at which time SCP will cease to be a subsidiary of the Company.

In connection with the closing of the transaction, we may incur additional charges related to employee severance, cumulative currency translation adjustments or transferred working capital that is not recovered through operations subsequent to December 31, 2015.

Note 4. Acquisitions:

Omega Acquisition

On October 1, 2014, we, through our wholly-owned Canadian subsidiary, Sagent Acquisition Corp., entered into a Share Purchase Agreement to acquire all of the issued and outstanding shares of the capital stock of Omega for C$92,768 ($82,693), after accounting for net post-closing adjustments of C$191 ($170). In September 2015, we finalized the post-closing adjustments resulting in a reduction of total purchase consideration of C$241 ($215). Under the acquisition method of accounting, the total consideration transferred for the 100% equity interest has been preliminarily allocated to the net identifiable assets based on the estimated fair value at the date of acquisition. Except as it relates to inventory, property, plant and equipment, and intangible assets, the carrying value of assets and liabilities in Omega’s historical financial statements have been determined to approximate fair value due to their short term nature. The excess of the consideration transferred over the net identifiable assets, after considering the tax effects of temporary differences due to the fair value adjustments, has been recorded as goodwill as of the acquisition date. The goodwill associated with this acquisition has all been assigned to the Omega operating segment; none of the goodwill is tax-deductible.

The acquisition date fair value transferred for the purchase of Omega is as follows:

 

     (in thousands)  

Cash

   $ 82,863   

Net working capital adjustments receivable from the sellers

     (170
  

 

 

 

Total purchase consideration

   $ 82,693   
  

 

 

 

 

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The fair value of identifiable assets acquired and liabilities assumed for the Omega acquisition is shown in the table below:

 

     (in thousands)  

Cash

   $ 3   

Accounts receivable, net

     3,419   

Inventory

     14,014   

Prepaid and other current assets

     1,295   

Property, plant and equipment

     14,307   

Definite-lived intangible assets

     49,918   

In-process research and development

     7,666   

Goodwill

     22,842   

Accounts payable

     (2,410

Other accrued liabilities

     (4,090

Long-term debt and notes payable

     (7,095

Deferred income tax liabilities

     (17,176
  

 

 

 

Total allocation of fair value

   $ 82,693   
  

 

 

 

We recorded goodwill of $22,842 due to synergies achieved by having control over the products and manufacturing at Omega. We increased goodwill in 2015 by $649 to reflect the final allocation of in-process research and development and post-closing adjustments.

Omega’s revenues of $8,561 and losses of $2,126 from the date of acquisition are included in the Company’s consolidated results for the year ended December 31, 2014.

The following unaudited pro forma financial information reflects the consolidated results of operations of Sagent as if the Omega acquisition had taken place on January 1, 2014. The pro forma information includes acquisition and integration expenses. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transaction been effected on the assumed date.

 

     Year Ended
December 31,
 
     2014  
     (As Restated)  

Condensed statement of operations information

  

Net revenues

   $ 312,853   

Net income

     35,462   

Diluted income per common share

   $ 1.08   

Remaining equity interest of SCP

On April 30, 2013, we entered into a Share Purchase Agreement with Chengdu Kanghong Pharmaceuticals (Group) Co. Ltd. (“CKT”) to acquire CKT’s 50% equity interest in KSCP for $25,000, payable in installments through September 2015. The SCP Acquisition closed on June 4, 2013, following approval by the Chengdu Hi-Tech Industrial Development Zone Bureau of Investment Services. Concurrent with the closing of the SCP Acquisition, we paid $10,000 of the aggregate purchase consideration, and recorded a liability of $13,836 representing the fair value of our future payments as of the acquisition date to CKT under the terms of the Share Purchase Agreement. In December 2013 and September 2014, we paid $2,500 and $3,500, respectively, of the installment payment obligation. As of December 31, 2014, a final installment payment remained of $9,000, which was paid in September 2015.

 

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The SCP Acquisition was financed with cash and short term investments. The SCP Acquisition provided us with full control of the SCP manufacturing facility and served our long term strategic goals of additional investment in product development and vertically integrated capacity expansion.

As a result of the SCP Acquisition, we remeasured the previously held equity interest in KSCP to fair value, resulting in a gain of $2,936 reported as gain on previously held equity interest in the consolidated statements of operations. The gain includes $2,782 reclassified from accumulated other comprehensive income (loss), and previously recorded as currency translation adjustments. Both the gain on previously held equity interest and the fair value of the non-controlling interest in SCP that we acquired were based on an asset approach valuation method. Acquisition related costs of $479 were recognized as product development expenses.

The acquisition date fair value transferred for the purchase of SCP is as follows:

 

     (in thousands)  

Cash

   $ 10,000   

Present value of remaining purchase consideration

     13,836   

Previously held equity interest

     15,949   

Gain on remeasurement of previously held equity interest in KSCP

     154   
  

 

 

 

Total purchase consideration

   $ 39,939   
  

 

 

 

The fair value of identifiable assets acquired and liabilities assumed for the SCP Acquisition is shown in the table below:

 

     (in thousands)  

Goodwill

   $ 6,038   

Acquired tangible assets, net of assumed liabilities

     33,901   
  

 

 

 

Total allocation of fair value

   $ 39,939   
  

 

 

 

The net tangible assets acquired consisted primarily of cash of $2,704, inventory of $2,396, prepaid assets of $196, and property, plant and equipment of $56,654, net of assumed liabilities, primarily long term bank loans of $19,095 and accrued compensation and other liabilities of $8,954. We recorded goodwill of $6,038 due to the synergies achieved by having control over the products and manufacturing at the SCP facility. The goodwill associated with this acquisition has all been assigned to the Sagent US operating segment; none of the goodwill is tax-deductible.

SCP’s revenues of $344 and losses of $6,137 from the date of acquisition are included in the company’s consolidated results for the year ended December 31, 2013 from the date of acquisition.

The following unaudited pro forma financial information reflects the consolidated results of operations of Sagent as if the SCP acquisition had taken place on January 1, 2013. The pro forma information includes acquisition and integration expenses. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transaction been effected on the assumed date.

 

     Year Ended
December  31,
 
     2013  

Condensed statement of operations information

  

Net revenues

   $ 244,750   

Net income

     25,881   

Diluted income per common share

   $ 0.86   

 

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Product rights acquisitions

On August 5, 2015, we entered into and closed an agreement with Mustafa Nevzat Ilac Sanayii A.S., a subsidiary of Amgen, Inc., (“MN”) to acquire the rights to three products: Methylprednsilone Sodium Succinate, Vecuronium and Pamidronate Disodium. The total fair value of consideration transferred was $3,000, consisting of cash. The product rights have been recognized in our Sagent US segment.

The transaction was accounted for as a purchase of a business. The acquisition of these three products provides us with full control of and access to the product rights. The acquisition was financed with cash. Acquisition related costs related to this transaction were nominal. The weighted average life of these three acquired products rights is approximately 84 months.

The estimated fair value of identifiable assets acquired for these product rights is shown in the table below:

 

     (in thousands)  

Definite-lived intangible assets

   $ 3,000   
  

 

 

 

Total allocation of fair value

   $ 3,000   
  

 

 

 

On December 19, 2014, we entered into and closed an agreement with Mylan to acquire three products rights, Rocuronium, Clindamycin, and Cisatracurium, owned by Sagent Agila. The total fair value of consideration transferred was $1,760, consisting of $1,155 of cash and $605 of contingent consideration. Sagent Agila deconsolidated its ownership in the product rights, recognizing a gain on sale of $1,760, which the joint venture partners shared through their equity interests in Sagent Agila. The products rights have been recognized in our Sagent US segment.

We estimated the fair value of the contingent consideration to be $605 using a probability weighting approach that considered the possible outcomes based on assumptions related to the timing and probability of the Cisatracurium product approval date. The transaction was accounted for as a purchase of a business, and consequently, results of operations reflect the new basis of accounting from the date of the acquisition. The acquisition of these three products provides us with full control of the product rights and enhanced profitability, as we will no longer be required to share the profitability with our joint venture partner. The acquisition was financed with cash. Acquisition related costs related to this transaction were nominal.

The estimated fair value of identifiable assets acquired and liabilities assumed for Rocuronium, Clindamycin, and Cisatracurium is shown in the table below:

 

     (in thousands)  

Definite-lived intangible assets

   $ 720   

In-process research and development

     1,040   
  

 

 

 

Total allocation of fair value

   $ 1,760   
  

 

 

 

On August 30, 2013, we entered into an agreement with Mylan to acquire two products rights, Mesna and Acetylcysteine, owned by Sagent Agila. The acquisition closed on December 12, 2013, following the completion of Mylan’s acquisition of Agila from Strides. Under the terms of the agreement, we acquired the product rights from Sagent Agila. The total fair value of consideration transferred was $3,400, consisting of $3,200 of cash and $200 of contingent consideration. Sagent Agila deconsolidated its ownership in the product rights, recognizing a gain of $3,400, which the joint venture partners shared through their equity interests in Sagent Agila. The product rights have been recognized in our Sagent US segment.

We estimated the fair value of the contingent consideration to be $200 using a probability weighting approach that considered the possible outcomes based on assumptions related to the timing and probability of the

 

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Acetylcysteine product approval date. The transaction was accounted for as a purchase of a business, and consequently, results of operations reflect the new basis of accounting from the date of the acquisition. The acquisition of these two products provides us with full control of the product rights and enhanced profitability, as we will no longer be required to share the profitability with our joint venture partner. The acquisition was financed with cash. Acquisition related costs related to this transaction were nominal.

The fair value of identifiable assets acquired and liabilities assumed for Mesna and Acetylcysteine is shown in the table below:

 

     (in thousands)  

Definite-lived intangible asset

   $ 2,180   

In-process research and development

     1,220   
  

 

 

 

Total allocation of fair value

   $ 3,400   
  

 

 

 

Note 5. Investments

Our investments at December 31, 2015 were comprised of the following:

 

     Cost basis      Unrealized
gains
     Unrealized
losses
    Carrying
value
     Cash and
cash

equivalents
     Short term
investments
 

Assets

                

Cash

   $ 15,124       $ —         $ —        $ 15,124       $ 15,124       $ —     

Money market funds

     13,838         —           —          13,838         13,838         —     

Corporate bonds and notes

     20,128         —           (68     20,060         —           20,060   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
   $ 49,090       $ —         $ (68   $ 49,022       $ 28,962       $ 20,060   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Our investments at December 31, 2014 were comprised of the following:

 

     Cost basis      Unrealized
gains
     Unrealized
losses
    Carrying
value
     Cash and
cash
equivalents
     Short term
investments
 

Assets

                

Cash

   $ 42,494       $ —         $ —        $ 42,494       $ 42,494       $ —     

Money market funds

     13,139         —           —          13,139         13,139         —     

Corporate bonds and notes

     18,513         1         (41     18,473         —           18,473   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
   $ 74,146       $ 1       $ (41   $ 74,106       $ 55,633       $ 18,473   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Investments with continuous unrealized losses for less than twelve months and their related fair values were as follows:

 

     December 31, 2015      December 31, 2014  
      Fair value      Unrealized
losses
     Fair value      Unrealized
losses
 

Corporate bonds and notes

     20,060         (68      16,468         (41

Unrealized losses from fixed-income securities are primarily attributable to changes in interest rates. Because we do not intend to sell these investments, and it is not more likely than not that we will be required to sell our investments before recovery of their amortized cost basis, which may be maturity, we do not consider these investments to be other-than-temporarily impaired at December 31, 2015 or 2014.

 

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The original cost and estimated current fair value of our fixed-income securities as of December 31, 2015 are set forth below.

 

     Cost basis      Estimated fair
value
 

Due in one year or less

   $ 9,417       $ 9,406   

Between one and five years

     10,710         10,654   

Note 6. Accounts Receivable and Concentration of Credit Risk

We typically establish multi-year contractual agreements with GPOs and individual hospital groups to offer our products to end-user customers. As is common in the pharmaceutical industry, a significant amount of our pharmaceutical products are sold to end users under these GPO contracts through a relatively small number of drug wholesalers. Three wholesalers collectively represented approximately 78%, 85%, and 84% of our consolidated net revenue in 2015, 2014 and 2013, respectively, and represented approximately 89% and 90% of our consolidated accounts receivable at December 31, 2015 and 2014, respectively. To help control our credit exposure, we routinely monitor the creditworthiness of customers, review outstanding customer balances, and record allowances for bad debts as necessary. Historical credit loss has not been significant. We had a reserve of $43 and $1,433 for bad debts as of December 31, 2015 and 2014, respectively. We do not require collateral.

Note 7. Inventories

Inventories at December 31, 2015 and 2014 were as follows:

 

     December 31, 2015     December 31, 2014  
     Approved     Pending
regulatory
approval
     Inventory     Approved     Pending
regulatory
approval
     Inventory  

Raw materials

   $ 4,855        2,800         7,655      $ 10,203      $ 2,848       $ 13,051   

Work in process

     433        —           433        2,012        —           2,012   

Finished goods

     73,365        —           73,365        49,960        —           49,960   

Inventory reserve

     (5,000     —           (5,000     (3,242     —           (3,242
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 
   $ 73,653        2,800         76,453      $ 58,933      $ 2,848       $ 61,781   
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

We have $2,800 of pre-launch inventory, predominately active pharmaceutical ingredient related to Iron Sucrose, recorded in raw material inventory as of December 31, 2015. In December 2015, we received a Complete Response Letter (“CRL”) from the US FDA related to our ANDA for Iron Sucrose regarding our pending ANDA. We are evaluating the CRL to determine our response and the impact that the CRL may have on the ultimate commercialization of the product. Depending on the outcome of the CRL response, we may change our plans regarding this inventory, which may result in our not realizing its full value. We expect the outcome of this process to be resolved in 2016.

Note 8. Property, plant and equipment

Property, plant and equipment at December 31, 2015 and 2014 were as follows:

 

     December 31,  
     2015      2014  

Land and land improvements

   $ 1,102       $ 3,519   

Buildings and improvements

     6,713         26,605   

Machinery, equipment, furniture and fixtures, and software

     9,233         42,124   

Construction in process

     6,535         6,175   
  

 

 

    

 

 

 
     23,583         78,423   

Less: accumulated depreciation

     (3,822      (7,270
  

 

 

    

 

 

 
   $ 19,761       $ 71,153   
  

 

 

    

 

 

 

 

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Depreciation expense was $5,815, $4,355, and $1,620 in the years ended December 31, 2015, 2014 and 2013, respectively. In 2014, we acquired C$16,050 ($14,307) of property plant and equipment in connection with the Omega acquisition.

Note 9. Investment in Sagent Agila

We account for our 50% interest in Sagent Agila under the equity method of accounting. Under the equity method of accounting, our share of income or loss was recorded as “equity in net income of joint ventures” in the consolidated statements of operations.

Changes in the carrying value of Sagent Agila consist of the following:

 

     December 31,  
     2015      2014  

Investment in Sagent Agila at beginning of year

   $ 4,539       $ 2,063   

Equity in net income of Sagent Agila

     2,569         3,987   

Dividend paid

     —           (1,511
  

 

 

    

 

 

 

Investment in Sagent Agila at end of year

   $ 7,108       $ 4,539   
  

 

 

    

 

 

 

Condensed statement of operations and balance sheet information of Sagent Agila is presented below. All amounts are presented in accordance with accounting principles generally accepted in the United States.

 

     Year Ended December 31,  
     2015      2014      2013  

Condensed statement of operations information

        

Net revenues

   $ 9,063       $ 8,093       $ 16,927   

Gross profit

     5,140         6,321         5,454   

Net income

     5,138         7,975         8,440   

 

     December 31,  
     2015      2014  

Condensed balance sheet information

     

Current assets

   $ 17,036       $ 11,333   

Noncurrent assets

     303         360   
  

 

 

    

 

 

 

Total assets

   $ 17,339       $ 11,693   
  

 

 

    

 

 

 

Current liabilities

   $ 3,144       $ 2,636   

Long-term liabilities

     —           —     

Stockholders’ equity

     14,195         9,057   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 17,339       $ 11,693   
  

 

 

    

 

 

 

Note 10. Goodwill and Intangible assets, net

Goodwill by reportable segment at December 31, 2015 and 2014 was as follows:

 

     2015      2014  

Sagent US

   $ 6,038       $ 6,038   

Omega

     19,146         22,117   
  

 

 

    

 

 

 

Goodwill

   $ 25,184       $ 28,155   
  

 

 

    

 

 

 

The decrease in goodwill during 2015 reflects a $3,620 reduction related to the Omega acquisition due to foreign currency translation impact and a $649 increase for final post-closing adjustments, consisting of an $864 increase

 

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following the final purchase accounting allocation to in-process research and development and a $215 reduction following the final post-closing working capital adjustment. The increase in goodwill for 2014 reflects $22,842 related to the Omega acquisition less $725 due to foreign currency translation impact. There were no reductions of goodwill relating to impairments.

Intangible assets at December 31, 2015 and 2014 were as follows:

 

     December 31, 2015      December 31, 2014  
     Gross carrying
amount
     Accumulated
amortization
    Intangible
assets, net
     Gross carrying
amount
     Accumulated
amortization
    Intangible
assets, net
 

Product licensing rights

   $ 4,533         (2,998     1,535       $ 4,707       $ (2,878   $ 1,829   

Product development rights

     2,890         —          2,890         4,191         —          4,191   

Purchased product rights and other

     46,238         (5,087     41,151         51,245         (1,375     49,870   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total definite-lived intangible assets

     53,661         (8,085     45,576         60,143         (4,253     55,890   

In-process research and development (IPR&D)

     7,590         —          7,590         9,685         —          9,685   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total intangible assets

   $ 61,251       $ (8,085   $ 53,166       $ 69,828       $ (4,253   $ 65,575   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Movements in intangible assets were due to the following:

 

     2015  
     Product
licensing
rights
     Product
development
rights
     Purchased
product
rights and
other
     IPR&D  

Balance at January 1

   $ 1,829       $ 4,191       $ 49,870       $ 9,685   

Acquisition of product rights

     100         1,607         3,000         (864

Amortization

     (394      (2,908      (4,183      —     

Foreign currency movements

     —           —           (7,536      (1,231
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance at December 31

   $ 1,535       $ 2,890       $ 41,151       $ 7,590   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     2014  
     Product
licensing
rights
     Product
development
rights
     Purchased
product
rights and
other
     IPR&D  

Balance at January 1

   $ 1,690       $ 3,252       $ 2,164       $ 1,220   

Acquisition of product rights

     946         2,576         —           —     

Sagent Agila product acquisitions

     —           —           720         1,040   

Omega acquisition

     —           —           49,918         7,666   

Amortization

     (807      (1,637      (1,380      —     

Foreign currency movements

     —              (1,552      (241
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance at December 31

   $ 1,829       $ 4,191       $ 49,870       $ 9,685   
  

 

 

    

 

 

    

 

 

    

 

 

 

Amortization expense related to our product licensing rights was $394, $807, and $529 for the years ended December 31, 2015, 2014 and 2013, respectively. Amortization expense related to our product development rights was $2,908, $1,637, and $3,980 for the years ended December 31, 2015, 2014 and 2013, respectively. The weighted-average period prior to the next extension or renewal for the 21 products comprising our product licensing rights intangible asset was 53 months and the weighted-average remaining life of our purchased product rights and other definite-lived intangibles was 110 months at December 31, 2015.

 

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We currently estimate amortization expense over each of the next five years as follows:

 

     Amortization
expense
 

For the year ending December 31,

  

2016

   $ 7,132   

2017

     4,223   

2018

     4,192   

2019

     4,121   

2020

     3,971   

Note 11. Accrued liabilities

Accrued liabilities at December 31, 2015 and 2014 were as follows:

 

     December 31,  
     2015      2014  

Payroll and employee benefits

   $ 6,512       $ 9,329   

Sales and marketing

     7,308         6,964   

Taxes payable

     131         1,040   

Other accrued liabilities

     1,755         2,013   
  

 

 

    

 

 

 
   $ 15,706       $ 19,346   
  

 

 

    

 

 

 

Note 12. Debt

JPMorgan Chase Revolving Credit Loan Facility

On October 31, 2014, we entered into a credit agreement with JPMorgan Chase Bank, N.A., (the “Chase Agreement”). The Chase Agreement provides for an $80,000 asset based revolving credit loan facility, with availability subject to a borrowing base consisting of eligible cash, short-term investments, accounts receivable and inventory and the satisfaction of conditions precedent specified in the Chase Agreement. The Chase Agreement provides for an accordion feature, whereby we may increase the revolving commitment up to an additional $25,000, subject to certain customary terms and conditions, including pro-forma compliance with a fixed charge coverage ratio (as defined in the Chase Agreement) of 1.00 to 1.00. The Chase Agreement matures on October 31, 2019, at which time all amounts outstanding will be due and payable. Borrowings under the Chase Agreement may be used for general corporate purposes, including funding working capital. Amounts drawn bear an interest rate equal to, at our option, either a Eurodollar rate plus 2.00% per annum or an alternative base rate plus 1.00% per annum. We also incur a commitment fee on undrawn amounts equal to 0.25% per annum.

The Chase Agreement was guaranteed by our parent company at the time of closing and is secured by a lien on substantially all of our parent company and our principal domestic subsidiary’s assets and any future domestic subsidiary’s guarantor’s assets. The Chase Agreement includes customary covenants and also imposes a financial covenant requiring compliance with a minimum fixed charge coverage ratio of 1.00 to 1.00 during certain covenant testing times triggered if availability under the Chase Agreement is below the greater of 10% of the revolving commitment and $8,000.

As of December 31, 2015, there were no borrowings outstanding under our Chase Agreement, and we were in compliance with all covenants under this loan agreement. Total availability under our Chase revolving loan facility was $79.9 million at December 31, 2015, which is subject to adjustment on a monthly basis under our borrowing base calculation.

On January 7, 2016, we amended and restated our Chase Agreement (the “Amended Chase Agreement”) by adding a Canadian tranche and joining Omega as a borrower. The Amended Chase Agreement adds a C$30.0 million term

 

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loan (including a delayed draw term loan) to fund, among other things, Omega’s construction of a facility in Quebec. The Amended Chase Agreement also adds a C$10.0 million revolving facility sublimit to the existing revolving facility, with the total revolving commitment amount remaining at $80.0 million. The applicable margins for the Canadian prime rate and CDOR revolving loans are the same as the base rate and Eurodollar rates for the U.S. revolving loans at 1.00% and 2.00%, respectively. The margins for the Canadian term loans are 1.25% and 2.25% for Canadian prime rate and CDOR, respectively. The commitment fee rate remains 0.25%. The fixed charge coverage ratio remains at 1.00x. The Canadian term loans are to be repaid in certain increments pursuant to the Amended Chase Agreement as the facility in Quebec is completed.

Silicon Valley Bank Loan and Security Agreement

In February 2012, we entered into a Loan and Security Agreement (the “SVB Agreement”) with Silicon Valley Bank (“SVB”). The SVB Agreement provided for a $40,000 asset based revolving loan facility, with availability subject to a borrowing base consisting of eligible accounts receivable and inventory and the satisfaction of conditions precedent specified in the SVB Agreement. The SVB Agreement matured on February 13, 2016, at which time all outstanding amounts will become due and payable. Borrowings under the SVB Agreement could have been used for general corporate purposes, including funding working capital. Amounts drawn bear an interest rate equal to, at our option, either a Eurodollar rate plus 2.50% per annum or an alternative base rate plus 1.50% per annum. We also pay a commitment fee on undrawn amounts equal to 0.30% per annum.

The SVB Agreement contains various customary affirmative and negative covenants. The negative covenants restrict our ability to, among other things, incur additional indebtedness, create or permit to exist liens, make certain investments, dividends and other payments in respect of capital stock, sell assets or otherwise dispose of our property, change our lines of business, or enter into a merger or acquisition, in each case, subject to thresholds and exceptions as set forth in the SVB Agreement. The financial covenants in the SVB Agreement are limited to maintenance of a minimum adjusted quick ratio and a minimum free cash flow. The SVB Agreement also contains customary events of default, including non-payment of principal, interest and other fees after stated grace periods, violations of covenants, material inaccuracy of representations and warranties, certain bankruptcy and liquidation events, certain material judgments and attachment events, cross-default to other debt in excess of a specified amount and material agreements, failure to maintain certain material governmental approvals, and actual or asserted invalidity of subordination terms, guarantees and collateral, in each case, subject to grace periods, thresholds and exceptions as set forth in the SVB Agreement.

On September 23, 2013, we entered into a Second Loan Modification Agreement to the SVB Agreement with SVB (the “Modification”). The Modification altered the calculation methodology of the borrowing base that is used to determine our borrowing availability and the covenant for the Adjusted Quick Ratio tested at the end of each month and eliminated the covenant to maintain a specified level of free cash flow in quarters where we maintain eligible cash balances of $30 million or greater. We did not amend the term, the maximum availability, or the interest rate applicable to the amounts drawn under the SVB Agreement.

Concurrent with entering the Chase Agreement, we terminated our prior revolving loan facility under the SVB Agreement, and repaid certain associated fees. Included with the fees was $1,050 of early termination fees that had previously been deferred by SVB as part of entering into the SVB Agreement in February 2012. This amount is included within interest expense in the consolidated statement of operations for the year ended December 31, 2014. Concurrent with the repayment and termination of the SVB Agreement, all liens and security interests against our property that secured the obligations under our prior revolving loan facility were released and discharged.

Credit facilities acquired under the SCP Acquisition

In connection with the acquisition of the remaining 50% equity interest in SCP, we assumed two loan contracts with the Agricultural Bank of China Ltd. in the amount of RMB 37,000 ($6,069) and RMB 83,000 ($13,613)

 

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originally entered into in June 2011 and August 2010, respectively, (the “ABC Loans”) each with a five year term. Amounts outstanding under the ABC Loans bear an interest rate equal to the benchmark lending interest rate published by the People’s Bank of China. During the term of the loan, the rate is subject to adjustment every three months. The ABC Loans are secured by the property, plant and equipment of SCP. As of December 31, 2013, RMB 63,000 ($10,333) was outstanding under the ABC Loans, at an interest rate of 6.00% per annum. As the interest rate resets on a quarterly basis, the fair value of our long-term debt approximates its carrying value. Repayment will be accelerated if the liabilities to assets ratio exceed 70% and 80% during the term of the RMB 37,000 and RMB 83,000 credit facilities, respectively, or if our SCP subsidiary is unable to achieve 50% of its projected revenues when it commences commercial activities.

On January 2, 2014, we repaid in full the then-outstanding balance of the ABC Loans, totaling RMB 63.0 million ($10.3 million). Upon prepayment of the ABC Loans, the loan contracts were terminated. No early termination fees were incurred as part of the prepayment of the ABC Loans.

Credit facilities acquired under the Omega acquisition

In connection with the acquisition of Omega on October 1, 2014, we assumed a series of credit facilities and mortgages with the National Bank of Canada (“NBC”) and the Business Development Bank of Canada (“BDC”), as described below.

Omega has an authorized credit facility (the “Omega operating credit facility”) in the amount of C$8,200 ($7,309) with the NBC. The Omega operating credit facility can be utilized in the form of floating-rate advances for an amount not exceeding C$7,000 ($6,239 as of the acquisition date) and advances in the form of letters of guarantee or letters of credit, within that limit for an amount not exceeding C$2,000 ($1,782 as of the acquisition date). The Omega operating credit facility can also be utilized in the form of advances to cover Omega’s currency risk for an amount not to exceed C$1,200 ($1,070 as of the acquisition date). On October 1, 2014, the Omega operating credit facility had floating-rate advances in the amount of C$1,530 ($1,364) bearing interest at the lender’s prime rate plus 0.50%, (or an effective rate of 3.5%) which we assumed as part of the acquisition.

In July 2014, Omega obtained a C$3,000 demand loan (the “Omega demand loan”), from the NBC bearing interest at the prime rate of the lender, plus a premium of 1.75% (effective rate 4.75%). The Omega demand loan is secured by all of the assets of Omega for C$3,000 plus an additional security interest of 20% of this amount, bearing interest at 4.75% per annum and matured in November 2014. We assumed the Omega demand loan ($2,674 as of the acquisition date) in connection with the acquisition and subsequently extended the maturity date to January 2015. The Omega operating credit facility and the Omega demand loan are secured by a first ranking security interest in the amount of C$8,250 ($7,354 as of the acquisition date) in Omega’s inventories, trade receivables and on the intellectual property of Omega, present and future.

Omega also had C$267 ($238) outstanding on a decreasing revolving credit facility with the NBC (the “Omega decreasing revolving credit facility”) bearing interest at the prime rate of the lender, plus 1.0% (or an effective rate equal to 4.0%). The Omega decreasing revolving credit facility is secured by a first ranking security interest of C$1,000 ($891 as of the acquisition date) on the equipment, tooling and office furniture financed by the credit facility.

The Omega credit facilities are subject to certain restrictions, including the obligation to maintain certain financial ratios. As of October 1, 2014, Omega had not met certain financial ratios. As a result, the Omega decreasing revolving credit facility was classified as a current liability as of the acquisition date. In January 2015, we paid off all amounts outstanding under the Omega operating credit facility, the Omega demand loan and the Omega decreasing revolving credit facility with available cash on hand. As a result, all amounts outstanding under these instruments were classified as current liabilities at December 31, 2014.

In addition to the above, Omega had five mortgage loans with the BDC (collectively the “Omega mortgages”) which we assumed in connection with the acquisition. The Omega mortgages, which require monthly

 

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installments and which are secured by specific Omega buildings and equipment, range in amount from C$70 to C$1,250 ($62 to $1,114 as of the acquisition date) and bear interest at the lender’s prime rate (5% as of the acquisition date) plus a premium ranging from 0%—1.5%. The carrying value of the mortgages approximates fair value. The Omega mortgages mature at various times from August 2019 through November 2036. In January 2016, in connection with entering the Amended Chase Agreement, we repaid the Omega mortgages in full, and refinanced them under the Chase term loan. As a result, all amounts outstanding under these instruments are classified as long term liabilities at December 31, 2015.

Debt maturities by year are as follows:

 

December 31,

   Amount  

2016

   $ —     

2017

     —     

2018

     —     

2019

     1,623   

2020

     —     

2021 and thereafter

     —     
  

 

 

 

Total long-term debt

     1,623   

Less: Current maturities of long-term debt

     —     
  

 

 

 

Long-term portion of long-debt

   $ 1,623   
  

 

 

 

Note 13. Fair Value Measurements

Assets and liabilities measured at fair value on a recurring basis as of December 31, 2015 consisted of the following:

 

     Total fair value      Quoted prices in
active markets
for identical
assets (Level 1)
     Significant other
observable
inputs (Level 2)
     Significant
unobservable
inputs
(Level 3)
 

Assets

           

Money market funds

   $ 13,838       $ 13,838         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Corporate bonds and notes

     20,060         —         $ 20,060         —     

Commercial paper

     —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Short-term investments

   $ 33,898       $ 13,838       $ 20,060         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 33,898       $ 13,838       $ 20,060         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities

           

Contingent purchase consideration

   $ 50         —           —         $ 50   
  

 

 

    

 

 

    

 

 

    

 

 

 

The fair value of our Level 2 investments is based on a combination of quoted market prices of similar securities and matrix pricing provided by third-party pricing services utilizing securities of similar quality and maturity.

 

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Assets and liabilities measured at fair value on a recurring basis as of December 31, 2014 consisted of the following:

 

     Total fair value      Quoted prices in
active markets
for identical
assets (Level 1)
     Significant other
observable
inputs (Level 2)
     Significant
unobservable
inputs
(Level 3)
 

Assets

           

Money market funds

   $ 13,139       $ 13,139       $ —         $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Corporate bonds and notes

     18,513         —           18,513         —     

Commercial paper

     —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Short-term investments

   $ 18,513       $ —         $ 18,513       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 31,652       $ 13,139       $ 18,513       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities

           

Contingent purchase consideration

   $ 605       $ —         $ —         $ 605   
  

 

 

    

 

 

    

 

 

    

 

 

 

During the year ended December 31, 2015, changes in the fair value of our contingent purchase consideration measured using significant unobservable inputs (Level 3), were comprised of the following:

 

     Year ended
December 31, 2015
 

Balance at beginning of period

   $ 605   

Issuance of contingent purchase consideration

     —     

Change in fair value of contingent purchase consideration

     (555

Payment of contingent purchase consideration

     —     
  

 

 

 

Balance at end of period

   $ 50   
  

 

 

 

The change in fair value of contingent purchase consideration of $555 relates to the likelihood of seller meeting the contractual FDA approval timeline related to the December 2014 acquisition of Cisatracurium from Sagent Agila LLC.

Note 14. Employee Benefit Plan

We sponsor a 401(k) defined-contribution plan (the “401(k) Plan”) covering substantially all eligible US employees. Employee contributions to the 401(k) Plan are voluntary. We contribute an amount equal to 50% of a covered employee’s eligible contribution up to 6% of a participant’s compensation. Employer contributions vest over a period of three years. Participants’ contributions are limited to their annual tax deferred contribution limit as allowed by the Internal Revenue Service. The Company’s total matching contributions to the 401(k) Plan were $430, $391, and $338 for years ended December 31, 2015, 2014 and 2013, respectively. We may contribute additional amounts to the 401(k) Plan at our discretion. Discretionary employer contributions vest over the same three-year period. We made no discretionary contributions to the 401(k) Plan during the three-year period ended December 31, 2015.

Note 15. Stockholders’ Equity

Common Stock

We are authorized to issue 100,000,000 shares of common stock as of both December 31, 2015 and 2014. We have reserved 5,892,670 shares at December 31, 2015 and 2014, for the issuance of common stock upon the exercise of outstanding stock options.

 

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On September 16, 2013, we completed a registered equity offering, issuing 3,542,470 new shares of our common stock at $21.25 per share in exchange for total consideration of $75,277. We received proceeds from the offering, net of the underwriting discount and expenses, of $70,580.

Note 16. Accumulated Comprehensive Income (Loss)

Accumulated comprehensive income (loss) at December 31, 2015, 2014 and 2013 is comprised of the following:

 

     December 31,  
     2015      2014      2013  

Currency translation adjustment, net of tax

   $ (17,414    $ (3,334    $ 496   

Unrealized gain (loss) on available for sale securities, net of tax

     (68      (40      (9
  

 

 

    

 

 

    

 

 

 
   $ (17,482    $ (3,374    $ 487   
  

 

 

    

 

 

    

 

 

 

The following table summarizes the changes in balances of each component of accumulated other comprehensive income, net of tax as of December 31, 2015.

 

     Currency
translation
adjustment
     Unrealized gains
(losses) on
available for sale
securities
     Total  

Balance as of December 31, 2014

   $ (3,334    $ (40    $ (3,374
  

 

 

    

 

 

    

 

 

 

Other comprehensive income (loss) before reclassifications

     (14,080      (28      (14,108

Amounts reclassified from accumulated other comprehensive income (loss)

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Net current-period other comprehensive loss

     (14,080      (28      (14,108
  

 

 

    

 

 

    

 

 

 

Balance as of December 31, 2015

   $ (17,414      (68      (17,482
  

 

 

    

 

 

    

 

 

 

 

     Currency
translation
adjustment
     Unrealized gains
(losses) on
available for sale
securities
     Total  

Balance as of December 31, 2013

   $ 496       $ (9    $ 487   
  

 

 

    

 

 

    

 

 

 

Other comprehensive income (loss) before reclassifications

     (3,830      (31      (3,861

Amounts reclassified from accumulated other comprehensive income (loss)

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Net current-period other comprehensive loss

     (3,830      (31      (3,861
  

 

 

    

 

 

    

 

 

 

Balance as of December 31, 2014

   $ (3,334    $ (40    $ (3,374
  

 

 

    

 

 

    

 

 

 
     Currency
translation
adjustment
     Unrealized gains
(losses) on
available for sale
securities
     Total  

Balance as of December 31, 2012

   $ 2,488       $ 12       $ 2,500   
  

 

 

    

 

 

    

 

 

 

Other comprehensive income (loss) before reclassifications

     790         (21      769   

Amounts reclassified from accumulated other comprehensive income (loss)

     (2,782      —           (2,782
  

 

 

    

 

 

    

 

 

 

Net current-period other comprehensive loss

     (1,992      (21      (2,013
  

 

 

    

 

 

    

 

 

 

Balance as of December 31, 2013

   $ 496       $ (9    $ 487   
  

 

 

    

 

 

    

 

 

 

 

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No amounts were reclassified out of accumulated other comprehensive income for the years ended December 31, 2015 and 2014. The table below presents the amounts reclassified out of each component of accumulated other comprehensive income for the year ended December 31, 2013.

 

Type of reclassification

   Amount
reclassified from
accumulated other
comprehensive
income
    

Affected line item in the condensed

consolidated statement of operations

Currency translation adjustment – reclassification of cumulative currency translation gain

   $ 2,782       Gain on previously held equity interest

Total reclassification for the year ended December 31, 2013, net of tax

   $ 2,782      

Note 17. Earnings Per Share

Basic earnings per share is computed by dividing income available to common shareholders by the weighted average number of common shares outstanding for the period. Because of their anti-dilutive effect, 1,859,247, 705,150, and 1,194,717 of common share equivalents, comprised of unexercised stock options, have been excluded from the diluted earnings per share calculation for the years ended December 31, 2015, 2014 and 2013, respectively. The table below presents the computation of basic and diluted earnings per share for the years ended December 31, 2015, 2014 and 2013.

 

     Year Ended December 31,  
      2015     2014
(Restated)
     2013  

Basic and dilutive numerator

       

Net income (loss), as reported

   $ (21,882   $ 36,951       $ 29,594   
  

 

 

   

 

 

    

 

 

 

Denominator

       

Weighted average common shares outstanding – basic (in thousands)

     32,439        31,882         29,213   

Net effect of dilutive securities

       

Stock options and restricted stock

     —          863         724   
  

 

 

   

 

 

    

 

 

 

Weighted average common shares outstanding – diluted (in thousands)

     32,439        32,745         29,937   
  

 

 

   

 

 

    

 

 

 

Net income (loss) per common share (basic)

   $ (0.67   $ 1.16       $ 1.01   
  

 

 

   

 

 

    

 

 

 

Net income (loss) per common share (diluted)

   $ (0.67   $ 1.13       $ 0.99   
  

 

 

   

 

 

    

 

 

 

Note 18. Stock-Based Compensation

Prior to the initial public offering, we had a stock plan, the 2007 Global Share Plan (the “2007 Plan”), for key employees and nonemployees, which provided for the grant of nonqualified and incentive stock options and/or shares of restricted stock, deferred stock, and other equity awards in our common stock. Concurrent with the initial public offering, our Board adopted the 2011 Incentive Compensation Plan (the “2011 Plan”, with the 2007 Plan, the “Plans”), for employees and nonemployees, which provides for the grant of nonqualified and incentive stock options and/or shares of restricted stock, deferred stock and other equity awards in our common stock. The Board administers the Plans. A total of 2,475,184 and 4,000,000 shares are authorized under the 2007 Plan and 2011 Plan, respectively, as of December 31, 2015. At December 31, 2015, we had 417,280 shares of common stock available for grant under the 2007 Plan and 2,215,631 shares of common stock available for grant under the 2011 Plan.

Stock options, exercisable for shares of our common stock, generally vest over a four-year period from the grant date and expire ten years from the grant date. The strike price of the stock options granted under the 2007 Plan is established at or above the fair value of our stock as of the grant date. The strike price of stock options granted under the 2011 Plan is established as the closing price of our stock on the business day prior to the grant date.

 

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In 2010, the Board approved an amendment to the 2007 Plan which permitted employees to exercise their stock options prior to vesting. Once purchased, we have the right to repurchase unvested stock from the employee upon termination of their services. The repurchase price is equal to the original exercise price of the option.

Restricted Stock

The Company measures the fair value of the restricted stock on the date of grant based on the estimated fair value of the common stock on that day. The fair value is amortized to stock-based compensation expense, net of estimated forfeitures, ratably over the vesting period. As of December 31, 2015, the total amount of unrecognized stock-based compensation related to grants of restricted stock was approximately $2,770. The Company expects to recognize this expense over an average period of approximately 29 months. The following table summarizes restricted stock activity during the year ended December 31, 2015:

 

     Restricted
stock
     Weighted-Average
Grant Date Fair
Value
 

Balance at January 1, 2015

     128,209       $ 19.32   

Granted

     140,971         24.59   

Vested

     (40,496      19.42   

Forfeited

     (48,476      22.10   
  

 

 

    

 

 

 

Balance at December 31, 2015

     180,208       $ 22.91   
  

 

 

    

 

 

 

Stock Options – Valuation Information

We estimate the value of stock options on the date of grant using a Black-Scholes option pricing model. The risk-free rate of interest for the average contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The dividend yield is zero as we have not paid nor do we anticipate paying any dividends. For service-based awards, we used the “simplified method” described in Staff Accounting Bulletin (“SAB”) Topic 14, Share-Based Payment, where the expected term of awards granted is based on the midpoint between the vesting date and the end of the contractual term, as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. For performance-based awards, we determine the expected term based on the anticipated achievement and exercise pattern of the underlying options. Our expected volatility is based on a weighted average of the historical volatility of similar companies’ stock and the historical volatility of our stock since our IPO. The weighted-average estimated values of employee stock option grants and rights granted under the Plans as well as the weighted-average assumptions that were used in calculating such values during the last three years were based on estimates at the date of grant as follows:

 

     Risk free
interest  rate
    Expected life      Expected
dividend  yield
    Expected
volatility
    Fair value at
grant date
 

2015

     1.74     6 years         0     52   $ 10.92   

2014

     1.92     6 years         0     61   $ 11.81   

2013

     1.24     6 years         0     62   $ 9.31   

Stock options outstanding that have vested and are expected to vest as of December 31, 2015, were as follows:

 

     Number of
shares
     Weighted-Average
Exercise Price
     Weighted-Average
Remaining
Contractual Term
     Aggregate
Intrinsic
Value(1)
 

Vested

     1,021,292       $ 12.96         5.3         4,503   

Expected to vest

     600,054       $ 22.27         8.5         18   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

     1,621,346       $ 16.61         6.5         4,521   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) 

The Aggregate Intrinsic Value amounts represent the difference between the exercise price and $15.91, the fair value of our stock on December 31, 2015, for in-the-money options.

 

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In December 2014, we reversed $1,901 of stock compensation expense related to a performance-based award, as achievement of the performance criteria was no longer probable.

Stock Option Activity

The following table sets forth stock option activity for the year ended December 31, 2015:

 

     Options Outstanding      Exercisable Options  
     Number of
shares
    Weighted-Average
Exercise Price
     Number of shares      Weighted-Average
Exercise Price
 

Outstanding at January 1, 2015

     2,543,362        14.71         1,622,212         12.04   

Granted

     411,743        25.11         

Exercised

     (794,528     12.32         

Forfeited

     (481,538     20.93         
  

 

 

   

 

 

    

 

 

    

 

 

 

Outstanding at December 31, 2015

     1,679,039        16.61         1,021,292         12.96   
  

 

 

   

 

 

    

 

 

    

 

 

 

As of December 31, 2013, the weighted-average remaining contractual lives of options outstanding and options exercisable were 7.2 years and 6.5 years, respectively. As of December 31, 2014, the weighted-average remaining contractual lives of options outstanding and options exercisable were 6.6 years and 5.9 years, respectively. As of December 31, 2015, the weighted-average remaining contractual lives of options outstanding and options exercisable were 6.6 years and 5.3 years, respectively.

The total intrinsic value of options exercised in 2015, 2014 and 2013 was $9,169, $3,147, and $1,860, respectively. The total fair value of options vested was approximately $2,900, $3,327, and $5,036 in 2015, 2014 and 2013, respectively. As of December 31, 2015, there was $5,853 of unrecognized stock-based compensation expense related to unvested stock options, which will be recognized over a weighted-average period of 1.4 years.

Note 19. Net Revenue by Product

We are focused on developing, manufacturing, sourcing and marketing injectable pharmaceutical products to the hospital market. Our anti-infective products assist in the treatment of various infections and related symptoms, our oncology products are used in the treatment of cancer and cancer-related medical problems, and our critical care products are used in a variety of critical care applications and include anesthetics, cardiac medications, steroidal products, sedatives and certain allergy products. Net revenue by product category is as follows:

 

     2015      2014      2013  

Therapeutic Class

        

Anti-Infective

   $ 128,517       $ 102,078       $ 90,604   

Critical Care

     120,157         87,143         65,612   

Oncology

     69,622         99,762         88,534   
  

 

 

    

 

 

    

 

 

 

Total

   $ 318,296       $ 288,983       $ 244,750   
  

 

 

    

 

 

    

 

 

 

Note 20. Segment and Geographic Data

Management uses segment information to evaluate segment performance and allocate resources. Historically we have operated in a single reportable segment, the United States. Effective October 1, 2014, in connection with the Omega acquisition, we began operating in two reportable segments comprised of operations organized geographically within the United States (Sagent US segment) and Canada (Omega segment), each of which develop, source, manufacture and market generic injectable products for sale within the their respective countries. Each segment derives a significant portion of its revenues from a single class of pharmaceutical wholesale customers within that country. Management utilizes segment operating income as its measure of segment profitability.

 

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Segment and geographic data for the year ended December 31, 2014 includes the impact of Omega from the date of acquisition, October 1, 2014, through December 31, 2014. Shared costs for certain corporate functions, including but not limited to, corporate finance and legal, are included within the Sagent US segment profitability that management reviews. We use the same accounting policies for the segments as disclosed in Note 1, Summary of Significant Accounting Policies.

Geographic and segment data is as follows:

 

     2015      2014      2013  

Net revenue:

        

United States

   $ 286,773       $ 280,339       $ 244,272   

Others

     839         83         478   
  

 

 

    

 

 

    

 

 

 

Sagent US segment

     287,612         280,422         244,750   

Canada (Omega segment)

     30,684         8,561         —     
  

 

 

    

 

 

    

 

 

 

Total net revenue

   $ 318,296         288,983         244,750   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Long-lived assets:

        

United States

   $ 80,947       $ 37,252       $ 17,401   

China

     —           52,635         57,016   
  

 

 

    

 

 

    

 

 

 

Sagent US segment

     80,947         91,417         74,417   

Canada (Omega segment)

     77,193         91,553         —     
  

 

 

    

 

 

    

 

 

 

Total long-lived assets

   $ 158,140       $ 181,440       $ 74,417   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Depreciation and amortization expense:

        

Sagent US

     8,826         8,188         7,074   

Omega

     4,855         1,336         —     
  

 

 

    

 

 

    

 

 

 

Total depreciation and amortization expense

   $ 13,681       $ 9,524       $ 7,074   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Equity in net income of joint ventures:

        

Sagent US

   $ 2,569       $ 3,987       $ 2,395   

Omega

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Total equity in net income of joint ventures

   $ 2,569       $ 3,987       $ 2,395   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Operating income (loss):

        

Sagent US

   $ (43,769    $ 21,700       $ 31,380   

Omega

     (752      (2,656      —     
  

 

 

    

 

 

    

 

 

 

Total operating income (loss)

   $ (44,521    $ 19,044       $ 31,380   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Interest expense:

        

Sagent US

   $ 564       $ 1,979       $ 930   

Omega

     206         209         —     
  

 

 

    

 

 

    

 

 

 

Total interest expense

   $ 770       $ 2,188       $ 930   
  

 

 

    

 

 

    

 

 

 

 

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     2015      2014      2013  
     2015      2014      2013  

Interest income and other:

        

Sagent US

   $ (2,495    $ 375       $ 205   

Omega

     (295      —           —     
  

 

 

    

 

 

    

 

 

 

Total interest income

   $ (2,790    $ 375       $ 205   
  

 

 

    

 

 

    

 

 

 
     2015      2014
(Restated)
     2013  

Income tax provision (benefit):

        

Sagent US

   $ (25,993    $ (20,034    $ 895   

Omega

     (206      (739      —     
  

 

 

    

 

 

    

 

 

 

Total income tax provision (benefit)

   $ (26,199    $ (20,773    $ 895   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Capital expenditures:

        

Sagent US

   $ (1,447    $ (3,510    $ (1,103

Omega

     (5,264      (732      —     
  

 

 

    

 

 

    

 

 

 

Total capital expenditures

   $ (6,711    $ (4,242    $ (1,103
  

 

 

    

 

 

    

 

 

 
     2015      2014
(Restated)
     2013  

Deferred tax assets:

        

Sagent US

   $ 50,808       $ 23,778       $ 6   

Omega

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Total deferred tax assets

   $ 50,808       $ 23,778       $ 6   
  

 

 

    

 

 

    

 

 

 
     2015      2014      2013  

Investment in joint ventures:

        

Sagent US

   $ 7,108       $ 4,539       $ 2,063   

Omega

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Total investment in joint ventures

   $ 7,108       $ 4,539       $ 2,063   
  

 

 

    

 

 

    

 

 

 
     2015      2014
(Restated)
     2013  

Total assets:

        

Sagent US

   $ 258,275       $ 272,283       $ 310,208   

Omega

     91,457         107,675         —     
  

 

 

    

 

 

    

 

 

 

Total assets

   $ 349,732       $ 379,958       $ 310,208   
  

 

 

    

 

 

    

 

 

 

Note 21. Management Transition:

Throughout 2015, we incurred costs related to the transition of our senior management team, following the retirement of our founder and Chief Executive Officer and resignation of our President in March 2015, and the elimination of certain positions in the US as part of the ongoing review of our business. Costs associated with these matters, primarily severance related charges and costs associated with recruiting and retaining a new CEO

 

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totaled $5,310, were all incurred in the Sagent US reportable segment, and are reflected in the management transition caption of the consolidated statement of operations for the year ended December 31, 2015. Of the charges, $4,019 were paid during the year ended December 31, 2015. Total costs accrued within the Accounts Payable and Accrued liabilities captions of the balance sheet at December 31, 2015 were $1,291.

Note 22. Income Taxes:

Components of income (loss) before income taxes are as follows:

 

     Year Ended December 31,  
     2015      2014
(Restated)
     2013  

Domestic

   $ 8,931       $ 30,200       $ 36,671   

Foreign

     (57,012      (14,022      (6,182
  

 

 

    

 

 

    

 

 

 

Income (loss) before income taxes

   $ (48,081    $ 16,178       $ 30,489   
  

 

 

    

 

 

    

 

 

 

Provision (benefit) for income taxes:

        

United States federal:

        

Current

   $ 20       $ 943       $ 895   

Deferred

     (25,887      (21,089      —     
  

 

 

    

 

 

    

 

 

 
     (25,867      (20,146      895   

State and local:

        

Current

     937         1,853         —     

Deferred

     (1,063      (1,740      —     
  

 

 

    

 

 

    

 

 

 
     (126      (113      —     
  

 

 

    

 

 

    

 

 

 

Total United States

     (25,993      (22,964      895   
  

 

 

    

 

 

    

 

 

 

Outside United States:

        

Current

     898         205         —     

Deferred

     (1,104      (944      —     
  

 

 

    

 

 

    

 

 

 

Total outside United States

     (206      (739      —     
  

 

 

    

 

 

    

 

 

 

Total provision (benefit) for income taxes

   $ (26,199    $ (20,773    $ 895   
  

 

 

    

 

 

    

 

 

 

Deferred income tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and net operating loss and other tax credit carryforwards. These items are measured using the enacted tax rates applicable to the period when the differences are expected to reverse. We record a valuation allowance to reduce the deferred income tax assets to the amount that is more likely than not to be realized.

 

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As of December 31, 2014, we had cumulative domestic income over the prior three years, had completed eight consecutive quarters of domestic pretax earnings, and forecasted continued domestic profitability in future periods. Accordingly, we concluded that the valuation allowance previously recorded against our domestic deferred tax assets should be released as of December 31, 2014, resulting in a net $25,308 benefit in our provision for income taxes that has been restated to $23,778, as described in Note 2. Restatement. As of December 31, 2015, we continue to be in a three year cumulative income position in the US.

In connection with the decision to sell SCP in December 2015, we determined that SCP’s capital stock and the intercompany loans from our US parent company to SCP were impaired. We made tax elections to realize this value through deductions for worthless stock and bad debt. In 2015, due to the one-time permanent benefit of $30,041 related to the SCP disposition, we recorded a taxable loss in the U.S. Since, prior to 2015, we have generated significant US taxable income and are forecasting US taxable income in the future, the Company believes it is more likely than not that it will utilize the NOL generated in 2015.

Domestic net operating losses and carryforwards are available for use against our consolidated federal taxable income. A summary of our remaining domestic net operating loss carryforwards, including the timing of expiry, is as follows:

 

Year of Expiry

   Net Operating
Loss
Carryforwards
 

2032

     300   

2034

     410   

2036

     80,325   
  

 

 

 

Total

   $ 81,035   
  

 

 

 

In addition, we have retained a full valuation allowance against our net deferred tax assets in SCP, including $14,126 recognized in 2015, given the history of losses in that entity. Net operating loss carryforwards of $48,904 related to SCP, will expire between 2016 and 2020.

As of December 31, 2015, the Company’s U.S. income tax returns for 2012 and subsequent years remain subject to examination by the Internal Revenue Service (“IRS”). The Company’s 2013 income tax return is currently under examination by the IRS. State and foreign income tax returns generally have statute of limitations for periods between three and five years from the filing date. The Company is not currently under examination by any state or foreign taxing authorities.

The following is a reconciliation of our income tax provision (benefit) computed at the U.S. federal statutory rate to the income tax provision (benefit) reported in the consolidated statements of operations:

 

     Year Ended December 31,  
     2015      2014
(Restated)
     2013  

Provision (benefit) at statutory rate

   $ (16,828    $ 5,662       $ 10,366   

State income taxes, net of federal income tax

     (373      1,750         230   

Foreign rate differential

     5,731         1,392         560   

Valuation allowance

     14,126         (28,672      (9,998

Worthless stock and bad debt deductions

     (30,041      —           —     

Uncertain tax positions

     101         541         —     

Permanent book / tax differences

     164         172         (263

Change in tax rate

     89         (1,498      —     

Other

     832         (120      —     
  

 

 

    

 

 

    

 

 

 

Provision (benefit) for income taxes

   $ (26,199    $ (20,773    $ 895   
  

 

 

    

 

 

    

 

 

 

 

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The tax effects of temporary differences giving rise to deferred income tax assets and liabilities were:

 

     December 31,  
     2015      2014
(Restated)
 

Deferred tax assets:

     

Product development and start-up costs

   $ 14,005       $ 12,702   

Inventory

     3,539         2,493   

Loss and credit carryforwards

     40,358         9,664   

Bad debt reserves

     16         549   

Accrued expenses / other

     4,373         5,244   

Deferred compensation

     2,979         3,155   

Depreciation and amortization

     11,482         —     

Alternative minimum tax carryforwards

     1,555         1,546   
  

 

 

    

 

 

 

Total deferred tax assets

   $ 78,307       $ 35,353   
  

 

 

    

 

 

 

Deferred tax liabilities:

     

Depreciation and amortization

   $ (3,850    $ (2,799

Intangible assets

     (11,070      (14,351

Inventory

     (99      (180
  

 

 

    

 

 

 

Total deferred tax liabilities

     (15,019      (17,330
  

 

 

    

 

 

 

Net deferred tax asset

     63,288         18,023   

Valuation allowance

     (24,501      (9,950
  

 

 

    

 

 

 

Net deferred tax assets (liabilities)

   $ 38,787       $ 8,073   
  

 

 

    

 

 

 

The Company has gross unrealized tax benefits of $3,100 arising from tax deductions for share based compensation in excess of the compensation recognized for financial reporting purposes. Realization of this excess tax benefit will occur when current taxes payable are reduced with a corresponding credit to additional paid in capital.

Our unrecognized tax benefits of $726 at December 31, 2015 are included in other long-term liabilities. If we had recognized all of these benefits, the net impact on our income tax provision would have been $588. Of the net unrecognized tax benefits, approximately $120 are expected to be resolved in the next 12 months. We include accrued interest and penalties related to uncertain tax positions in our tax provision. We have accrued interest and penalties of $24 as of December 31, 2015 and $20 as of December 31, 2014. Our provision for income taxes included expense for interest and penalties of $4 in 2015 and $20 in 2014. The changes in our unrecognized tax benefits were:

 

     Year Ended December 31,  
     2015      2014
(Restated)
     2013  

Beginning of year

   $ 659       $ —         $ —     

Increases from prior year tax positions

     136         719         —     

Decreases relating to settlements with taxing authorities

     (85      (60      —     

Increases from current year positions

     16         —           —     
  

 

 

    

 

 

    

 

 

 

End of year

   $ 726       $ 659       $ —     
  

 

 

    

 

 

    

 

 

 

We classify uncertain tax positions as noncurrent income tax liabilities unless expected to be paid within one year.

Note 23. Commitments and Contingencies

Product Development Agreements

We have entered into various business agreements for the development and marketing of finished dosage form pharmaceutical products, including (i) development and supply agreements, some of which contain contingent contract payments, as well as (ii) straight-supply agreements, which may contain minimum purchase commitments.

 

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These agreements may include future payment commitments for contingent contract payments. We will be responsible for contingent contract payments based upon the occurrence of future events. Each agreement defines the triggering event of its future payment schedule, such as meeting development progress timelines, successful product testing and validation, successful clinical studies, various FDA and other regulatory approvals, and other factors as negotiated in each case.

We have entered into significant development, marketing, and supply agreements with A.C.S. Dobfar S.p.a. (“Dobfar”), A.C.S. Dobfar SA-Switzerland (“Info”), and Gland Pharma Limited (“Gland”). Key terms of these agreements are set forth below.

Info

Under a manufacture and supply agreement with Info, Info develops, manufactures, and supplies us with presentations of levofloxacin in premix bags. We pay a transfer price for each unit of levofloxacin supplied, plus a percentage of the net profit from the sales of levofloxacin in premix bags. In addition, we have agreed to share equally with Info the cost of development activities. The initial term of the agreement expires on July 7, 2016, after which we have the option to renew the agreement for successive additional two year terms unless Info provides notice of its intent to terminate the agreement at least two years prior to its initial expiration date or the expiration date of a renewal term.

In addition, we also have supply agreements or other purchase commitments with Dobfar and/or WorldGen LLC, a distributor for Dobfar covering seven currently marketed products – ampicillin, ampicillin sulbactam, cefazolin, cefepime, cefoxitin, ceftazadime and ceftriaxone – and, with Info, covering three currently marketed products – ciprofloxacin, fluconazole, and zoledronic acid bags, in both 4mg and 5mg presentations, and additional products currently under development.

Gland

Pursuant to our development and supply agreement with Gland, we jointly developed our heparin products with Gland, and Gland agreed to supply us heparin for sale in the U.S. market. In addition, we have agreed to use Gland as our exclusive supplier for heparin and Gland has agreed not to, directly or indirectly, sell heparin to any other person or entity that markets or makes use of or sells heparin in the U.S., subject to certain exceptions.

We have agreed to pay a transfer price for each unit of heparin supplied under the agreement, plus a percentage of the net profit from the sales of heparin. In addition, each party has agreed to share the cost of development activities equally up to a specified amount.

The initial term of the agreement expires in June 2016, after which, unless a third party has rights to market heparin in the U.S. as a result of our discontinuing active sales of heparin there, the agreement automatically renews for consecutive periods of one year unless either party provides notice of its intent to terminate the agreement at least 24 months prior to the desired date of termination.

In addition, we also have other supply agreements with Gland covering five currently marketed products, adenosine, amiodarone, chlorothiazide, ondansetron and vancomycin, and additional products currently under initial development.

Contingent contractual payments are as follows at December 31, 2015:

 

2016

   $ 18,037   

2017

     4,124   

2018

     3,726   

2019

     709   

2020

     60   

2021 and Thereafter

     1,065   
  

 

 

 

Total

   $ 27,721   
  

 

 

 

 

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Leases

We have entered into various operating lease agreements for building and office space, communications, information technology equipment and software, office equipment and automobile. Total rental expense amounted to $664, $656, and $431 for the years ended December 31, 2015, 2014 and 2013, respectively.

As of December 31, 2015, total future annual minimum lease payments related to non-cancelable operating leases are as follows:

 

2016

   $ 805   

2017

     501   

2018

     516   

2019

     532   

2020

     404   

2021 and Thereafter

     134   
  

 

 

 

Total

   $ 2,892   
  

 

 

 

Regulatory Matters

We are subject to regulatory oversight by the FDA and other regulatory authorities with respect to the development, manufacturing and sale of our products. Failure to comply with regulatory requirements could have a significant adverse effect on our business and operations.

Litigation

From time to time, we are subject to claims and litigation arising in the ordinary course of business. These claims may include assertions that our products infringe existing patents and claims that the use of our products has caused personal injuries. We intend to vigorously defend any such litigation that may arise under all defenses that would be available to us. We were party to the following claim.

Zoledronic Acid (Generic versions of Zometa ® and Reclast ®). On February 20, 2013, Novartis Pharmaceuticals Corporation (“Novartis”) sued the Company and several other defendants in the United States District Court for the District of New Jersey, alleging, among other things, that sales of the Company’s (i) zoledronic acid product under FDA NDA No. 203231, made by ACS Dobfar Info S.A. (“Info”), also a defendant, a generic bioequivalent version of Novartis’ Zometa ® Ready-to-Use product, would infringe U.S. Patent No. 7,932,241 (the “241 Patent”) and U.S. Patent No. 8,324,189 (the “189 Patent”) and (ii) zoledronic acid product under FDA ANDA No. 202828, also made by Info, a generic version of Novartis’ Reclast ® product, would infringe U.S. Patent No. 8,052,987 (the “987 Patent”) and the 241 Patent, and (iii) zoledronic acid product under FDA ANDA No. 202472, made by Actavis LLC, also a defendant, a generic version of Novartis’ Zometa ® Pre Concentrate product, would infringe the 189 Patent. (In Re: Certain Consolidated Zoledronic Acid Cases; Consolidated Civil Action No. 12-03967(SDW)(SCM) [Consolidated with Civil Action Nos. 12-cv-04393, 13-cv-01028, 13-cv-02379, 13-cv-4669, 13-cv-5125, 13-cv-6835, 13-cv-7914 and 14-cv-18411]). On March 6, 2013 the Company, began selling Actavis’ zoledronic acid vial, the generic version of Zometa. Also, as of August 27, 2013 and October 1, 2013, the Company began selling zoledronic acid premix bags in 4mg/100ml and 5mg/100ml presentations, respectively. On December 3, 2014, Novartis sued the Company, alleging, among other things, that sales of the Company’s zoledronic acid product under FDA ANDA No. 091493, made by Hameln RDS GMBH, a generic version of Novartis’ Zometa ® Pre-concentrate product, would infringe the 189 Patent. (Novartis Pharmaceuticals Corporation v. Sagent Pharmaceuticals, Inc. et. al., Case No. 2:14-cv-07556(SDW)(SCM) and together with the Consolidated Civil Action Case No. 13-cv-1028, the “Litigation”).

On October 13, 2015, the Company and Novartis agreed to settle the Litigation. Pursuant to the terms of the settlement, we will pay Novartis $5,000 in exchange for a release of claims associated with the 241, 987 and 189

 

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Patents pertaining to the following regulatory submissions: FDA NDA No. 203231, FDA ANDA No. 202828, FDA ANDA No. 202472 and FDA ANDA No. 091493 (collectively the Regulatory Submissions”), and acquire a license to sell the zoledronic acid products as approved by their Regulatory Submissions (excluding sales of product manufactured under FDA ANDA No.202472 after December 31, 2014) in the U.S.. Concurrent with the settlement, the Company received $1,477 from Info and Actavis, representing their collective share of the $5,000.

We have determined that $1,683 of the Settlement represents a future license to sell the zoledronic acid products. This amount has been recorded within Other assets on the Consolidated Balance Sheet as of December 31, 2015, offset by the portion of the Info reimbursement, $607, related to the license period. The remaining net settlement amount of $2,447 paid to Novartis is recognized as legal settlement expense within the Consolidated Statement of Operations for the year ended December 31, 2015.

At this time, there are no other proceedings of which we are aware that are considered likely to have a material adverse effect on the consolidated financial position or results of operations.

Note 24. Related Party Transactions:

As of December 31, 2015 and 2014, respectively, we had a receivable of $2,678 and $2,156 from Sagent Agila LLC, which is expected to offset future profit-sharing payments. These amounts are classified as due from related party on the consolidated balance sheet. As of December 31, 2015 and 2014, respectively, we had a payable of $13,754 and $8,079 to Sagent Agila LLC, principally for the acquisition of inventory and amounts due under profit-sharing arrangements that are classified as due to related party on the consolidated balance sheet. During the year ended December 31, 2015 there were no distributions from Sagent Agila LLC. During the year ended December 31, 2014, Sagent Agila LLC distributed $3,022 to its joint venture partners.

Note 25. Quarterly Financial Data (Unaudited)

 

     2015 Quarters  
     First     Second     Third     Fourth  

Net revenue

   $ 82,645      $ 77,345      $ 75,199      $ 83,107   

Gross profit

   $ 21,925      $ 18,441      $ 24,362      $ 23,011   

Income (loss) from continuing operations

   $ (189   $ 1,191      $ 1,742      $ (47,265
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ 1,894      $ 256      $ 1,795      $ 17,937   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares used to compute net income per share

        

Basic

     32,043        32,161        32,747        32,793   

Diluted

     32,043        32,161        32,747        32,793   

Net income per share

        

Basic

   $ (0.06   $ (0.01   $ (0.05   $ (0.55

Diluted

   $ (0.06   $ (0.01   $ (0.05   $ (0.55

 

     2014 Quarters  
     First      Second      Third      Fourth
(Restated)
 

Net revenue

   $ 70,869       $ 69,194       $ 65,359       $ 83,561   

Gross profit

   $ 20,384       $ 22,592       $ 18,770       $ 24,416   

Income from continuing operations

   $ 6,632       $ 3,318       $ 4,044       $ 5,050   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net income

   $ 5,119       $ 3,069       $ 1,926       $ 26,837   
  

 

 

    

 

 

    

 

 

    

 

 

 

Weighted-average shares used to compute net loss per share

           

Basic

     31,814         31,873         31,895         31,945   

Diluted

     32,614         32,665         32,960         33,031   

Net income per share

           

Basic

   $ 0.16       $ 0.10       $ 0.06       $ 0.84   

Diluted

   $ 0.16       $ 0.09       $ 0.06       $ 0.81   

In connection with the restatement as described in Note 2. Restatement, on Net Income, Net income per share (basic) and Net income per share (diluted) were adjusted by $2,930, $0.09 and $0.09, respectively.

 

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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

 

Item 9A. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures (a) were effective to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and (b) include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. Our internal control over financial reporting includes those written policies and procedures that:

 

   

pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets;

 

   

provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America;

 

   

provide reasonable assurance that receipts and expenditures are being made only in accordance with management and director authorization; and

 

   

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on the consolidated financial statements.

Internal control over financial reporting includes the controls themselves, monitoring and internal auditing practices and actions taken to correct deficiencies as identified.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2015. Management based this assessment on criteria for effective internal control over financial reporting described in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework) (“COSO”). Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of our internal control over financial reporting.

 

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Management reviewed the results of our assessment with the Audit Committee of our Board of Directors. Based on this assessment, management determined that, as of December 31, 2015, we maintained effective internal control over financial reporting.

Ernst & Young LLP, independent registered public accounting firm, who audited and reported on the consolidated financial statements included in this report, has issued an audit report on their assessment of our internal control over financial reporting as of December 31, 2015, which is included elsewhere in this Annual Report.

March 7, 2016

/s/ Allan Oberman, Chief Executive Officer

/s/ Jonathon Singer, Executive Vice President and Chief Financial Officer

Changes in Internal Control Over Financial Reporting

Management, together with our CEO and CFO, evaluated the changes in our internal control over financial reporting during the quarter ended December 31, 2015 and noted the following significant change:

 

   

During the quarter ended December 31, 2015, in recognition of our expanding global footprint, we enhanced both our tax technical expertise and controls to annually validate underlying deferred tax balances. Concurrent with these enhancements, we evaluated the tax treatment of SCP in connection with the Board of Directors’ approval of the sale of SCP. These enhanced controls identified that an error occurred in the Company’s previous tax filing position relating to SCP. The error related to the period when SCP was 50% owned by the Company and prior to the Company acquiring 100% ownership of SCP in June 2013. This error resulted in the Company overstating net operating loss carryforward benefits related to SCP. As a result, we overstated the related net operating loss deferred tax asset, for which there was a full valuation allowance reserve.

The Audit Committee, in consultation with management, determined the incorrect tax filing position had an immaterial impact on the fiscal years ended December 31, 2011, 2012 and 2013, respectively, as all net operating loss carryforward benefits were fully reserved against by a valuation allowance for such periods. In December 2014, management concluded that the valuation allowance against its net U.S. deferred tax assets was no longer required. As a result, the Company released the allowance in full, including amounts related to net operating loss carryforward benefits recognized as a result of the incorrect SCP tax filing position.

This accounting error occurred due to a deficiency in our internal control over financial reporting—specifically, a design defect in our internal control over financial reporting relating to the precision of controls to ensure that all deferred tax balances are properly validated on an annual basis. Following the identification of this error, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, re-evaluated the effectiveness of the design and operation of our controls and procedures as of December 31, 2014. Based on this re-evaluation, our Chief Executive Officer and Chief Financial Officer have now concluded that our controls and procedures as of such date were not effective at a reasonable assurance level, resulting in a material weakness in internal control over financial reporting.

Our enhanced control procedures identified this error, and ensured that our deferred taxes were properly stated at December 31, 2015. We have concluded that this deficiency in our internal control over financial reporting has been remediated and tested as of December 31, 2015.

We determined that there were no other changes in our internal control over financial reporting during the quarter ended December 31, 2015 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Shareholders of Sagent Pharmaceuticals, Inc.

We have audited the accompanying consolidated balance sheets of Sagent Pharmaceuticals, Inc. as of December 31, 2015 and 2014, and the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2015. Our audits also included the financial statement schedule listed in the Index at Item 15(a). These financial statements and schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements and schedule based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Sagent Pharmaceuticals, Inc. at December 31, 2015 and 2014, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2015, in conformity with U.S. generally accepted accounting principles. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, present fairly in all material respects the information set forth therein.

As discussed in Note 2 to the consolidated financial statements, the 2014 financial statements have been restated to correct an overstatement of deferred tax assets.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Sagent Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 7, 2016 expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Chicago, Illinois

March 7, 2016

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Shareholders of Sagent Pharmaceuticals, Inc.

We have audited Sagent Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). Sagent Pharmaceuticals, Inc.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, Sagent Pharmaceuticals, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Sagent Pharmaceuticals, Inc. as of December 31, 2015 and 2014, and the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2015 of Sagent Pharmaceuticals, Inc. and our report dated March 7, 2016 expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Chicago, Illinois

March 7, 2016

 

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Item 9B. Other Information.

None.

PART III

 

Item 10. Directors, Executive Officers and Corporate Governance.

Information required by this Item 10 is included in our definitive Proxy Statement for our 2016 Annual Meeting of Shareholders to be filed within 120 days after the Company’s fiscal year end of December 31, 2015 (“2016” Proxy Statement”), and is incorporated by reference into this Annual Report.

The information on our Web site is not, and shall not be deemed to be, a part of this Annual Report or incorporated into any other filings we make with the SEC.

 

Item 11. Executive Compensation.

Information required by this Item 11 is included in our 2016 Proxy Statement and is incorporated by reference into this Annual Report.

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The number of shares to be issued upon exercise or vesting of awards issued under, and the number of shares remaining available for future issuance under, our equity compensation plans at December 31, 2015 were:

Equity Compensation Plan Information

 

     Col. A      Col. B      Col. C  
Description   

Number of Securities

to be Issued Upon
Exercise of
Outstanding Options,
Warrants and Rights

    

Weighted Average
Exercise Price of
Outstanding

Options, Warrants

and Rights

    

Number of Securities
Remaining Available

for Future Issuance

under Equity

Compensation Plans

(excluding securities

reflected in column (A)

 

Equity compensation plans approved by security holders

     1,679,039       $ 16.61         2,632,911   

Equity compensation plans not approved by security holders

     —         $ —           —     

Information related to the security ownership of certain beneficial owners and management is included in our 2016 Proxy Statement and is incorporated by reference into this Annual Report.

 

Item 13. Certain Relationships and Related Transactions, and Director Independence.

Information required by this Item 13 is included in our 2016 Proxy Statement and is incorporated by reference into this Annual Report.

 

Item 14. Principal Accountant Fees and Services.

Information required by this Item 14 is included in our 2016 Proxy Statement and is incorporated by reference into this Annual Report.

 

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PART IV

 

Item 15. Exhibits and Financial Statement Schedules.

 

  (a) Index to Consolidated Financial Statements and Schedules

 

     Page  

Consolidated Balance Sheets at December 31, 2015 and 2014

     56   

Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013

     57   

Consolidated Statements of Comprehensive Income (loss) for the years ended December 31, 2015, 2014 and 2013

     58   

Consolidated Statements of Stockholder’s Equity for the years ended December 31, 2015, 2014 and 2013

     59   

Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2015 and 2013

     60   

Report of Management on Internal Control Over Financial Reporting

     98   

Report of Independent Registered Public Accounting Firm

     100   

Report of Independent Registered Public Accounting Firm on Internal Control Over Financial Reporting

     101   

Financial Statement Schedule – Valuation and Qualifying Accounts

     108   

Financial Statements of Sagent Agila LLC, at December  31, 2015 and 2014, and for the years ended December 31, 2015, 2014, and 2013.

     S-1   

Schedules other than those listed above have been omitted either because such schedules are not required or are not applicable.

 

  (b) The following exhibits are filed as part of, or incorporated by reference into, this Annual Report

 

Exhibit No.     
  3.1    Certificate of Incorporation of Sagent Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 3.3 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
  3.2    Bylaws of Sagent Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 3.4 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
  3.3    Certificate of Amendment to the Certificate of Incorporation (Incorporated by reference to Exhibit 3.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 5, 2014).
10.1+    Sagent Holding Co. Amended and Restated 2007 Global Share Plan. (Incorporated by reference to Exhibit 10.21 in the Company’s Registration Statement on Form S-1, as amended
(File Nos. 333-170979 and 333-173597).)
10.2+    Form of Stock Option Agreement under the Sagent Holding Co. Amended and Restated 2007 Global Share Plan. (Incorporated by reference to Exhibit 10.22 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.3+    2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.8 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.4+    Form of Incentive Stock Option Agreement pursuant to the 2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.9 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.5+    Form of Restricted Stock Agreement pursuant to the 2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.10 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)

 

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Exhibit No.     
10.6+    Form of Restricted Stock Unit Agreement pursuant to the 2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.11 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.7+    Form of Stock Appreciation Rights Agreement pursuant to the 2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.12 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.8+    Form of Non-Qualified Stock Option Agreement pursuant to the 2011 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.13 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.9    Manufacture and Supply Agreement, dated as of December 17, 2007, by and among Sagent Pharmaceuticals, Inc., A.C.S. Dobfar S.p.a. and its affiliate, WorldGen LLC. (Incorporated by reference to Exhibit 10.23 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.10    Development and Supply Agreement, dated as of June 27, 2008, as amended, by and between Sagent Holding Co. and Gland Pharma Limited. (Incorporated by reference to Exhibit 10.24 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.11+    Employment Agreement, dated as of January 20, 2011, by and among Sagent Pharmaceuticals, Inc. and Jeffrey Yordon. (Incorporated by reference to Exhibit 10.25 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.12+    Employment Agreement, dated as of January 20, 2011, by and among Sagent Pharmaceuticals, Inc. and Michael Logerfo. (Incorporated by reference to Exhibit 10.27 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.13+    Employment Agreement, dated as of January 20, 2011, by and among Sagent Pharmaceuticals, Inc. and Lorin Drake. (Incorporated by reference to Exhibit 10.28 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.14+    Employment Agreement, dated as of January 20, 2011, by and among Sagent Pharmaceuticals, Inc. and Albert Patterson. (Incorporated by reference to Exhibit 10.29 in the Company’s Registration Statement on Form S-1, as amended (File Nos. 333-170979 and 333-173597).)
10.15+    Employment Agreement, dated as of September 12, 2011, by and between Sagent Pharmaceuticals, Inc. and Jonathon M. Singer (Incorporated by reference to Exhibit 10.1 in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011).)
10.16+    Offer letter, dated as of August 18, 2011, by and between Sagent Pharmaceuticals, Inc. and Jonathon M. Singer (Incorporated by reference to Exhibit 10.2 in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011).)
10.17    Loan and Security Agreement, dated February 13, 2012, by and among Sagent Pharmaceuticals, Inc., Sagent Pharmaceuticals, and Silicon Valley Bank. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed February 16, 2013).)
10.18    Second Loan Modification Agreement, dated September 23, 2013, by and among Sagent Pharmaceuticals, Inc., a Delaware corporation, Sagent Pharmaceuticals, Inc., a Wyoming corporation, and Silicon Valley Bank. (Incorporated by reference to Exhibit 10.1 in the Company’s Current Report on Form 8-K filed September 24, 2013).
10.19    Joint Venture Agreement, dated as of January 18, 2007 for Formation of Sagent Strides Inc. between Sagent Inc. and Strides Arcolab International Limited (Incorporated by reference to Exhibit 10.32 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013).

 

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Exhibit No.     
10.20+    Employment Agreement, dated as of March 25, 2013, by and between Sagent Pharmaceuticals, Inc. and James M. Hussey (Incorporated by reference to Exhibit 10.1 in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013).
10.21+    Offer Letter, dated March 12, 2013, by and between Sagent Pharmaceuticals, Inc. and James M. Hussey (Incorporated by reference to Exhibit 10.2 in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013).
10.22    Share Purchase Agreement, dated April 30, 2013, by and between Sagent Pharmaceuticals, Inc. and Chengdu Kanghong Pharmaceuticals (Group) Co. Ltd. (Incorporated by reference to Exhibit 10.1 in the Company’s Current Report on Form 8-K filed May 6, 2013).
10.23    Share Pledge Agreement, dated April 30, 2013, by and between Sagent Pharmaceuticals, Inc. and Chengdu Kanghong Pharmaceuticals (Group) Co. Ltd. (Incorporated by reference to Exhibit 10.2 in the Company’s Current Report on Form 8-K filed May 6, 2013).
10.24    Loan Contract dated August 24, 2010 by and between Kanghong Sagent (Chengdu) Pharmaceutical Co., Ltd., and the Agricultural Bank of China Ltd. (Incorporated by reference to Exhibit 10.5 in the Company’s Quarterly Report on Form 10-Q filed August 6, 2013).
10.25    Loan Contract dated June 9, 2011 by and between Kanghong Sagent (Chengdu) Pharmaceutical Co., Ltd., and the Agricultural Bank of China Ltd. (Incorporated by reference to Exhibit 10.6 in the Company’s Quarterly Report on Form 10-Q filed August 6, 2013).
10.26    Share Purchase Agreement, dated October 1, 2014, by and between Sagent Pharmaceuticals, Inc., Sagent Acquisition Corp. and the several shareholders of Omega Laboratories Limited and 7685947 Canada Inc. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 2, 2014).
10.27    Credit Agreement dated as of October 31, 2014 among Sagent Pharmaceuticals, the Lenders Party hereto and JPMorgan Chase Bank, N.A., as Administrative Agent (Incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed November 5, 2014).
10.28    Fixed Assets Committed Loan Facility Offer Letter, dated April 6, 2015, by and between Sagent (China) Pharmaceuticals Co., Ltd., and JPMorgan Chase Bank (China) Company Limited, Shanghai Branch (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed April 10, 2015).
10.29    Amendment No. 1 to Credit Agreement, dated April 6, 2015, by and among Sagent Pharmaceuticals, Inc., Sagent Pharmaceuticals, and JPMorgan Chase Bank, N.A. (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed April 10, 2015).
10.30    Guaranty, dated April 6, 2015, by Sagent Pharmaceuticals, Inc. and Sagent Pharmaceuticals, for the benefit of JPMorgan Chase Bank, N.A. and each of the Lending Installations named therein (Incorporated by reference to Exhibit 10.3 to the Form 8-K filed April 10, 2015).
10.31    Sagent Pharmaceuticals, Inc., Change of Control Severance Plan (Incorporated by reference to Exhibit 10.4 in the Company’s Quarterly Report on Form 10-Q filed May 5, 2015).
10.32+    Separation Agreement and Release of Claims dated May 4, 2015, by and among Sagent Pharmaceuticals, Inc., and Jeffrey Yordon (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed May 8, 2015)
10.33+    Amendment to Employment Agreement dated May 4, 2015, by and among Sagent Pharmaceuticals, Inc., and Michael Logerfo (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed May 8, 2015).
10.34+    Settlement Agreement and Mutual Release dated May 8, 2015, by and among Sagent Pharmaceuticals, Inc., and James Hussey (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed May 13, 2015).

 

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Exhibit No.     
10.35+    Employment Agreement dated August 3, 2015, by and among Sagent Pharmaceuticals, Inc., and Allan Oberman. (Incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed November 3, 2015).
10.36+    Letter Amendment to Employment Agreement dated December 2, 2015, by and among Sagent Pharmaceuticals, Inc., and Michael Logerfo (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 2, 2015).
10.37    Amended and Restated Credit Agreement by and between Sagent Pharmaceuticals, Omega Laboratories Limited, JP Morgan Chase Bank, N.A., and JP Morgan Securities LLC, dated January 7, 2016 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed January 11, 2016).
10.38    Share Purchase Agreement, dated February 3, 2016, by and between Sagent Pharmaceuticals, Inc., and Hong Kong King-Friend Industrial Company Limited. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 9, 2016).
21.1*    List of subsidiaries of Sagent Pharmaceuticals, Inc.
23.1*    Consent of Ernst & Young LLP, independent registered public accounting firm
23.2*    Consent of Ernst & Young LLP, independent auditors
31.1*    Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
31.2*    Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
32.1*    Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.1    The following materials from Sagent’s Annual Report on Form 10-K for the year ended December 31, 2015 are formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets as of December 31, 2015 and 2014, (ii) the Consolidated Statements of Operations for the twelve months ended December 31, 2015, 2014 and 2013, (iii) the Consolidated Statements of Comprehensive Income for the twelve months ended December 31, 2015, 2014 and 2013, (iv) the Consolidated Statements of Stockholder’s Equity for the years ended December 31, 2015, 2014 and 2013, (v) the Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013, (vi) Notes to the Consolidated Financial Statements, and (vii) document and entity information.

 

+ Indicates a management contract or compensatory plan or arrangement
* Indicates an exhibit filed herewith

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

SAGENT PHARMACEUTICALS, INC.
By:  

/S/ JONATHON M. SINGER

 

(Jonathon M. Singer,

Executive Vice President and

Chief Financial Officer)

Date: March 7, 2016

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated:

 

Signature

  

Title

 

Date

/S/ ALLAN OBERMAN

(Allan Oberman)

  

Chief Executive Officer

(principal executive officer)

  March 7, 2016

/S/ JONATHON M. SINGER

(Jonathon M. Singer)

  

Executive Vice President and Chief Financial Officer

(principal financial officer)

  March 7, 2016

/S/ JEFFREY W. GREVE

(Jeffrey W. Greve)

  

Vice President, Controller

(principal accounting officer)

  March 7, 2016

/S/ MARY TAYLOR BEHRENS

(Mary Taylor Behrens)

   Director   March 7, 2016

/S/ MICHAEL FEKETE

(Michael Fekete)

   Director   March 7, 2016

/S/ ROBERT FLANAGAN

(Robert Flanagan)

   Director   March 7, 2016

/S/ ANTHONY KRIZMAN

(Anthony Krizman)

   Director   March 7, 2016

/S/ SHLOMO YANAI

(Shlomo Yanai)

   Director   March 7, 2016

 

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Sagent Pharmaceuticals, Inc.

Valuation and Qualifying Accounts

For the years ended December 31, 2015, 2014 and 2013

(in thousands)

 

Col. A

   Col. B      Col. C      Col. D      Col. E  
Description   

Balance at

Beginning

of Period

    

Charged to

Costs and

Expenses

    

Charged to

Other

Accounts

     Deductions     

Balance at

End of

Period

 

Chargeback Allowance

              

Year ended December 31, 2015

   $ 63,088       $ 318,605       $ —         $ 333,105       $ 48,588   

Year ended December 31, 2014

   $ 43,682       $ 403,493       $ —         $ 384,087       $ 63,088   

Year ended December 31, 2013

   $ 24,265       $ 300,835       $ —         $ 281,418       $ 43,682   

Allowance for Cash Discounts

              

Year ended December 31, 2015

   $ 2,440       $ 15,655       $ —         $ 14,178       $ 3,917   

Year ended December 31, 2014

   $ 2,414       $ 13,364       $ —         $ 13,338       $ 2,440   

Year ended December 31, 2013

   $ 1,373       $ 12,204       $ —         $ 11,163       $ 2,414   

Allowance for Credits

              

Year ended December 31, 2015

   $ 15,860       $ 6,626       $ —         $ 15,444       $ 7,042   

Year ended December 31, 2014

   $ 4,895       $ 23,406       $ —         $ 12,441       $ 15,860   

Year ended December 31, 2013

   $ 3,262       $ 6,760       $ —         $ 5,127       $ 4,895   

Deferred Tax Valuation Allowance

              

Year ended December 31, 2015

   $ 9,950       $ 15,094       $ —         $ 544       $ 24,500   

Year ended December 31, 2014 (restated)

   $ 42,109       $ 11,164       $ —         $ 43,323       $ 9,950   

Year ended December 31, 2013

   $ 46,657       $ 1,158       $ 5,843       $ 11,549       $ 42,109   

Inventory Reserve Allowance

              

Year ended December 31, 2015

   $ 3,242       $ 2,097       $ —         $ 339       $ 5,000   

Year ended December 31, 2014

   $ 5,099       $ 2,238       $ 508       $ 4,603       $ 3,242   

Year ended December 31, 2013

   $ 2,021       $ 3,078       $ —         $ —         $ 5,099   

Allowance for Doubtful Accounts

              

Year ended December 31, 2015

   $ 1,433       $ 312       $ —         $ 1,702       $ 43   

Year ended December 31, 2014

   $ 23       $ 1,440       $ —         $ 30       $ 1,433   

Year ended December 31, 2013

   $ 124       $ —         $ —         $ 101       $ 23   

 

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Report of Independent Auditors

The Board of Directors and Members of Sagent Agila LLC

We have audited the accompanying financial statements of Sagent Agila LLC, which comprise the balance sheets as of December 31, 2015 and 2014, and the related statements of operations and comprehensive income, statements of members’ equity and cash flows for the two years ended December 31, 2015 and the related notes to the financial statements.

Management’s Responsibility for the Financial Statements

Management is responsible for the preparation and fair presentation of these financial statements in conformity with U.S. generally accepted accounting principles; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free of material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Opinion

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Sagent Agila LLC at December 31, 2015 and 2014, and the results of its operations and its cash flows for the two years December 31, 2015 ended in conformity with U.S. generally accepted accounting principles.

Report on summarized comparative information

We have not audited, reviewed or compiled the summarized comparative information presented herein as of and for the year ended December 31, 2013, and, accordingly, we express no opinion on it.

/s/ Ernst & Young LLP

Chicago, Illinois

March 7, 2016

 

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Table of Contents

Sagent Agila LLC

Balance Sheets

(in thousands, except share amounts)

 

     December 31,  
     2015      2014  

Assets

     

Current assets:

     

Cash

   $ 407       $ 901   

Due from Agila

     2,875         2,353   

Due from Sagent

     13,754         8,079   
  

 

 

    

 

 

 

Total current assets

     17,036         11,333   

Intangible assets, net

     303         360   
  

 

 

    

 

 

 

Total assets

   $ 17,339       $ 11,693   
  

 

 

    

 

 

 

Liabilities and members’ equity

     

Current liabilities:

     

Due to Agila

   $ 454       $ 468   

Due to Sagent

     2,690         2,168   
  

 

 

    

 

 

 

Total liabilities

     3,144         2,636   

Members’ equity:

     

Common stock – $1.00 par value, 3,400,000 authorized and outstanding at both December 31, 2015 and 2014

     3,400         3,400   

Retained earnings

     10,795         5,657   
  

 

 

    

 

 

 

Total members’ equity

     14,195         9,057   
  

 

 

    

 

 

 

Total liabilities and members’ equity

   $ 17,339       $ 11,693   
  

 

 

    

 

 

 

See accompanying notes to financial statements.

 

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Table of Contents

Sagent Agila LLC

Statements of Operations and Comprehensive Income

(in thousands)

 

     Year ended December 31,  
     2015      2014     2013  
                  (Unaudited)  

Net revenue:

       

Product revenue

   $ 3,783       $ 1,636      $ 11,242   

License fees

     5,280         6,457        5,685   
  

 

 

    

 

 

   

 

 

 

Total net revenue

     9,063         8,093        16,927   

Cost of sales

     3,923         1,772        11,473   
  

 

 

    

 

 

   

 

 

 

Gross profit

     5,140         6,321        5,454   

Operating expenses:

       

Product development

     2         40        387   
  

 

 

    

 

 

   

 

 

 

Total operating expenses

     2         40        387   
  

 

 

    

 

 

   

 

 

 

Gain on sale of products

     —           (1,694     (3,372
  

 

 

    

 

 

   

 

 

 

Income from operations

     5,138         7,975        8,439   
  

 

 

    

 

 

   

 

 

 

Income before income taxes

     5,138         7,975        8,439   

Provision for income taxes

     —           —          —     
  

 

 

    

 

 

   

 

 

 

Net Income

   $ 5,138       $ 7,975      $ 8,439   
  

 

 

    

 

 

   

 

 

 

Comprehensive Income

   $ 5,138       $ 7,975      $ 8,439   
  

 

 

    

 

 

   

 

 

 

See accompanying notes to financial statements.

 

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Sagent Agila LLC

Statements of Members’ Equity

(in thousands, except share amounts)

 

    Common Stock     Additional
Paid-In
Capital
    Other
Comprehensive
Income (Loss)
    Retained
Earnings
(Accumulated
Deficit)
    Total  
    Shares     Amount          

Balance as of January 1, 2013

    3,400,000      $ 3,400      $ 415      $ —        $ 485      $ 4,300   

Dividends and distributions (unaudited)

    —          —          (415     —          (8,220     (8,635

Comprehensive income (unaudited)

      —          —          —          8,439        8,439   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2013 (unaudited)

    3,400,000      $ 3,400      $ —        $ —        $ 704      $ 4,104   

Dividends and distributions

    —          —          —          —          (3,022     (3,022

Comprehensive income

    —          —          —          —          7,975        7,975   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2014

    3,400,000      $ 3,400      $ —        $ —        $ 5,657      $ 9,057   

Comprehensive income

    —          —          —          —          5,138        5,138   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2015

    3,400,000      $ 3,400      $ —        $ —        $ 10,795      $ 14,195   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to financial statements.

 

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Sagent Agila LLC

Statements of Cash Flows

(in thousands)

 

     Year ended December 31,  
     2015     2014     2013  
                 (Unaudited)  

Cash flows from operating activities

      

Net income

   $ 5,138      $ 7,975      $ 8,439   

Adjustments to reconcile net income to net cash provided by operating activities:

      

Amortization

     57        135        248   

Disposal of product rights

     —          67        —     

Changes in operating assets and liabilities:

      

Due from members

     (6,197     (3,665     2,655   

Other current assets

     —          —          —     

Accounts payable

     —          —          (132

Due to members

     508        (1,692     (3,025
  

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     (494     2,820        8,185   
  

 

 

   

 

 

   

 

 

 

Cash flows used in investing activities

      

Purchase of product rights

     —          (40     —     
  

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     —          (40     —     
  

 

 

   

 

 

   

 

 

 

Cash flows used in financing activities

      

Distribution of products to members

     —          (1,760     (3,400

Dividends paid to members

     —          (1,262     (5,235
  

 

 

   

 

 

   

 

 

 

Net cash used in financing activities

     —          (3,022     (8,635
  

 

 

   

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

     (494     (242     (450

Cash and cash equivalents, at beginning of period

     901        1,143        1,593   
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents, at end of period

   $ 407      $ 901      $ 1,143   
  

 

 

   

 

 

   

 

 

 

See accompanying notes to financial statements

 

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Sagent Agila LLC

Notes to Financial Statements

(amounts in thousands)

Note 1. Summary of Significant Accounting Policies:

Nature of Operations

Sagent Agila LLC (“Sagent Agila”, “we”, “us” or “our”) is a limited liability company incorporated in Wyoming between Strides Inc., a wholly-owned subsidiary of Strides Arcolab International Limited (“Strides US”), and Sagent Pharmaceuticals, Inc. (“Sagent”). Sagent Agila was established in January 2007 with the principal business of development, manufacturing, marketing, distribution and sale of generic pharmaceutical products to the U.S. market. In December 2013, Mylan Incorporated (“Mylan”) acquired Strides’ Agila Specialities (“Agila”) subsidiary, including Strides’ ownership share of the Sagent Agila joint venture.

All of our products are sold to Sagent, who sells the products into the U.S. market. The initial term of the venture expires upon the tenth anniversary of its formation. Sagent and Mylan may agree to extend the term of the venture.

Basis of Presentation

The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The financial statements as of and for the year ended December 31, 2013 and the notes related there to are unaudited.

The financial statements include the assets, liabilities, and results of operations of Sagent Agila LLC.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Cash

At December 31, 2015, our cash balances were deposited in financial institutions and consisted of immediately available funds. The majority of our funds at December 31, 2015, were maintained at one stable financial institution, in an amount in excess of federally insured limits. This represents a concentration of credit risk. We have not experienced any losses on our deposits of cash and cash equivalents to date.

Fair value of financial instruments

The carrying value of financial assets and liabilities such as cash and other current liabilities approximate their fair values due to their short-term maturities.

Impairment of Long-Lived Assets

We evaluate long-lived assets, consisting of intangible assets with definite lives, for impairment whenever events or other changes in circumstances indicate that the carrying value of an asset may no longer be recoverable. An evaluation of recoverability is performed by comparing the carrying values of the assets to projected future undiscounted cash flows, in addition to other quantitative and qualitative analyses. Judgments made by

 

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management related to the expected useful lives of long-lived assets and the ability to realize undiscounted cash flows in excess of the carrying amounts of such assets are affected by factors such as changes in economic conditions and changes in operating performance. Upon indication that the carrying values of such assets may not be recoverable, we recognize an impairment loss as a charge against current operations. There were no impairment charges for the years ended December 31, 2015 and December 31, 2013. We recorded an impairment charge of $49 for the year ended December 31, 2014.

Product Development Agreements

Product development costs are expensed as incurred. These expenses include the costs of our internal product development efforts and acquired in-process research and development, as well as product development costs incurred in connection with our third-party contract research and development efforts. Non-refundable contractual payments made under contract research and development arrangements for future research and development activities prior to regulatory approval, including payments made upon execution of a definitive contract research and development agreement, are deferred and are expensed as the related services are performed. If we determine that it is no longer probable that the product will be pursued, any related capitalized amount is expensed in the current period. Contractual payments due to a counterparty for development efforts that are contingent upon the successful completion of certain activities are expensed when the successful completion is considered probable.

Once a product receives regulatory approval, we record any contractual payments for the license to sell the developed product as an intangible asset to be amortized on a straight-line basis as a component of cost of sales over the shorter of the related license period or the estimated life of the acquired product. At December 31, 2015, the amortization period for intangible assets arising from approved products was seven years with a weighted-average period prior to the next renewal or extension of four years. We make the determination whether to capitalize or expense amounts related to the development of new products and technologies through agreements with third parties based on our ability to recover our cost in a reasonable period of time, generally the initial license term, from the estimated future cash flows anticipated to be generated pursuant to each agreement. Market, regulatory and legal factors, among other things, may affect the realizability of the projected cash flows that an agreement was initially expected to generate. We regularly monitor these factors and subject capitalized costs to periodic impairment testing.

Intangible Assets

Certain amounts paid to third parties which are capitalized related to the development of new products and technologies are included within intangible assets. We determine the estimated fair values of certain intangible assets with definitive lives utilizing valuations performed by management at the time of their acquisition, based on anticipated future cash flow activity.

Income Taxes

We are treated as a partnership for US tax purposes. Earnings of the partnership are passed through to each individual member, and as such, no income taxes are recorded in our financial statements.

Revenue Recognition – Product revenue

Product revenue represents the sale of products to Sagent. We recognize revenue when our obligations are fulfilled relative to a specific product and all of the following conditions are satisfied: (i) persuasive evidence of an arrangement exists; (ii) the price is fixed or determinable; (iii) collectability is reasonably assured; and (iv) delivery has occurred. Delivery is deemed to have occurred upon receipt of product, upon fulfillment of acceptance terms, if any, and when no significant contractual obligations remain. We do not incur shipping and handling fees.

 

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Revenue Recognition – License fees

We provide Sagent with the right to market products manufactured under our Abbreviated New Drug Application (“ANDA”) in exchange for a licensing fee. We recognize our license fee revenue based on the net gross profit earned on the sale of product by Sagent, less a marketing fee charged by Sagent on each sale.

Recently Adopted Accounting Standards

In May 2014, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. In July 2015, the FASB approved a one year deferral to the new revenue guidance, and are therefore required to adopt the new guidance on January 1, 2018 using one of the two prescribed retroactive methods. We are evaluating the impact of the amended revenue recognition guidance on our consolidated financial statements.

Note 2. Deconsolidation of product rights

On December 19, 2014, Sagent entered into and closed an agreement with Mylan to acquire the rights to our Rocuronium, Clinadmycin and Cisatracurium product rights. The fair value of purchase consideration for the transaction was $1,760, which was the aggregate purchase consideration transferred to the Company by Sagent in exchange for 100% ownership of the product rights. We accounted for the transaction as the deconsolidation of our ownership in these assets, and recognized a gain equal to the fair value of the assets less the write-off of unamortized costs or $1,694. Our distribution of the fair value of these rights to Sagent and Mylan has been reported as distribution of products to members in our statement of cash flows.

On August 30, 2013, Sagent entered into an agreement with Mylan to acquire the rights to our Mesna and Acetylcystine product rights. The fair value of purchase consideration for the transaction was $3,400, which was based on the aggregate purchase consideration transferred to the Company by Sagent in exchange for 100% ownership of the product rights. The transaction closed on December 12, 2013, subsequent to the completion of Mylan’s acquisition of Agila from Strides. We accounted for the transaction as the deconsolidation of our ownership in these assets, and recognized a gain equal to the net fair value of the assets less the write-off of remaining unamortized costs or $3,372. Our distribution of the fair value of these rights to Sagent and Mylan has been reported as distribution of products to members in our statement of cash flows.

Note 3. Intangible assets, net

Intangible assets at December 31, 2015 and 2014 were as follows:

 

     December 31, 2015      December 31, 2014  
     Gross carrying
amount
     Accumulated
amortization
    Intangible
assets, net
     Gross carrying
amount
     Accumulated
amortization
    Intangible
assets, net
 

Product licensing rights

   $ 558         (255     303       $ 558       $ (198   $ 360   

 

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Movements in intangible asset product licensing rights were due to the following:

 

     2015      2014  

Balance at January 1

   $ 360       $ 522   

Acquisition of product rights

     —           40   

Disposal of product rights

     —           (67

Amortization of product rights

     (57      (135
  

 

 

    

 

 

 

Balance at December 31

   $ 303       $ 360   
  

 

 

    

 

 

 

Amortization expense related to our product licensing rights was $57, $135 and $123 for the years ended December 31, 2015, 2014 and 2013, respectively. Included in amortization expense for the year ended December 31, 2014 is $49 of asset impairment charges. The weighted-average period prior to the next extension or renewal for the 10 products comprising our product licensing rights intangible asset was 34 months at December 31, 2015.

We currently estimate amortization expense over each of the next five years as follows:

 

For the year ending December 31,    Amortization
expense
 

2016

   $ 74   

2017

     70   

2018

     48   

2019

     33   

2020

     27   

Note 4. Members’ Equity

Common Stock

We are authorized to issue 3,400,000 shares of common stock as of both December 31, 2015 and 2014.

Voting Rights

The holders of our common stock are entitled to one vote for each share held of record upon such matters and in such manner as may be provided by law.

Dividends and distributions

We accrue dividends when, and if, declared by our Members. During the year ended December 31, 2014 and 2013, we distributed $1,262 and $5,235, respectively, of profit sharing receipts to our joint venture partners. Additionally, during the year ended December 31, 2014 and 2013, we distributed ownership in the amount of $1,760 and $3,400, respectively, of the product sold by us to our members. There were no distributions of profit sharing receipts or ownership during the year ended December 31, 2015.

Note 5. Commitments and Contingencies

Product Development Agreements

We have entered into a series of business agreements with Sagent and Agila for the development, manufacturing and marketing of finished dosage form pharmaceutical products, some of which contain contingent contractual payments.

These agreements may include future payment commitments for contingent contractual payments. We will be responsible for contingent contractual payments based upon the occurrence of future events. Each agreement

 

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defines the triggering event of its future payment schedule, such as meeting development progress timelines, successful product testing and validation, successful clinical studies, various FDA and other regulatory approvals, and other factors as negotiated in each case.

The table below summarizes our estimate for contingent potential contractual payments and fees for the year ended December 31, 2015 and beyond assuming all contingent milestone payments occur.

Contingent contract payments are as follows at December 31, 2015:

 

2016

   $ 230   

2017

     —     

2018

     —     

2019

     —     

2020

     —     

Thereafter

     —     
  

 

 

 

Total

   $ 230   
  

 

 

 

Regulatory Matters

We are subject to regulatory oversight by the FDA and other regulatory authorities with respect to the development, manufacturing and sale of our products. Failure to comply with regulatory requirements could have a significant adverse effect on our business and operations.

Litigation

From time to time, we are subject to claims and litigation arising in the ordinary course of business. These claims may include assertions that our products infringe existing patents and claims that the use of our products has caused personal injuries. We intend to vigorously defend any such litigation that may arise under all defenses that would be available to us. At this time, there are no proceedings of which we are aware that are likely to have a material adverse effect on the financial position or results of operations.

Note 6. Related party transactions:

As of December 31, 2015 and 2014, we had a receivable of $13,754 and $8,079, respectively, from Sagent, which is related to inventory shipments and license fees due. As of December 31, 2015 and 2014, we also had a deposit of $2,875 and $2,353, respectively, with Agila related to future inventory purchases and prepayment of certain license fee revenues. These amounts are included within due from Sagent and due from Agila, respectively, on the balance sheets. As of December 31, 2015 and 2014, we had a payable of $2,690 and $2,168, respectively, to Sagent for inventory markups on certain products and shipment related charges and a payable of $454 and $468, respectively, to Agila, principally related to inventory shipments.

Note 7. Subsequent events:

We evaluated subsequent events through March 7, 2016, the date the financial statements were available to be issued. No subsequent events requiring disclosure were noted.

 

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