Attached files

file filename
EX-21 - EXHIBIT 21 - Teligent, Inc.v433664_ex21.htm
EX-32.1 - EXHIBIT 32.1 - Teligent, Inc.v433664_ex32-1.htm
EX-31.2 - EXHIBIT 31.2 - Teligent, Inc.v433664_ex31-2.htm
EX-23.1 - EXHIBIT 23.1 - Teligent, Inc.v433664_ex23-1.htm
EX-31.1 - EXHIBIT 31.1 - Teligent, Inc.v433664_ex31-1.htm

 

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

 

For the transition period from _________ to _________

 

Commission file number: 001-08568

 

Teligent, Inc.

(Formerly IGI Laboratories, Inc.)

(Exact name of registrant as specified in its charter)

 

Delaware   01-0355758
(State or other jurisdiction   (I.R.S. Employer Identification No.)
of incorporation or organization)    
     
105 Lincoln Ave., Buena, NJ   08310
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code (856) 697-1441

 

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

 

Title of each class   Name of each exchange on which registered
     
Common Stock, $0.01 Par Value Per Share   The NASDAQ Stock Market

 

Securities registered pursuant to Section 12(g) of the Exchange 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 Exchange 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 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 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 Exchange Act). Yes  ¨    No  x

 

The aggregate market value of the registrant’s voting and non-voting common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold, as of the last business day of the registrant’s most recently completed second fiscal quarter was $158.8 million.

 

As of March 10, 2016, the registrant had 53,005,689 shares of common stock outstanding.

 

APPLICABLE ONLY TO REGISTRANTS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.     Yes  ¨    No  ¨

 

DOCUMENTS INCORPORATED BY REFERENCE

 

The following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required in Part III of this Annual Report on Form 10-K is incorporated from the Registrant’s Proxy Statement for the Annual Meeting of Stockholders to be held on May 25, 2016.

 

 

 

 

PART I

 

Item 1.BUSINESS

 

Our Company

 

Strategic Overview

 

Teligent, Inc., or the Company, is a specialty generic pharmaceutical company. Our mission is to become a leader in the specialty generic pharmaceutical market. Under our own label, we currently market and sell generic topical and branded generic injectable pharmaceutical products in the United States and Canada. In the United States we are currently marketing eight generic topical pharmaceutical products and four branded generic pharmaceutical products. Through the completion of an acquisition, we now sell a total of nineteen generic and branded generic injectable products and medical devices in Canada. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide development, formulation, and manufacturing services to the pharmaceutical, over-the-counter, or OTC, and cosmetic markets. We operate our business under one segment. Effective October 23, 2015, we changed our name from IGI Laboratories, Inc. to Teligent, Inc. On October 26, 2015, our common stock, which was previously listed on the NYSE MKT, began trading on the NASDAQ Global Select Market, under the trading symbol “TLGT.” Our office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey.

 

Currently, we have two platforms for growth:

 

·Developing, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms; and

 

·Managing our current contract manufacturing and formulation services business.

 

We have been in the contract manufacturing and development of topical products business since the early 1990s, but our strategy since 2010 has been focused on the growth of our own generic pharmaceutical business. Since 2010, we have focused on transitioning our business to include more customers in the topical pharmaceutical industry. In 2014, we broadened our target product focus from topical pharmaceuticals to include a wider specialty pharmaceutical approach. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, complex generics and ophthalmic generics (what we call our “TICO strategy”), will leverage our existing expertise and capabilities, and broaden our platform for more diversified strategic growth.

 

As of the date of this report, we have acquired 25 drug products that have been previously approved by the FDA. Our pipeline includes 31 Abbreviated New Drug Applications, or ANDAs filed with the United States Food and Drug Administration, or FDA, for additional pharmaceutical products. In addition, we have four abbreviated new drug submissions, or ANDSs, on file with Health Canada. We have an additional 39 product candidates at various stages of our development pipeline, ten of which are on stability testing. In December 2015, we announced the approval by the FDA of Cefotan® (Cefotan for Injection). This was our first product approved from the portfolio of discontinued and withdrawn new drug applications, or NDAs, and ANDAs that we purchased from Astra Zeneca on September 25, 2014. We have also experienced an increased rate of review by the FDA of applications filed in Generic Drug User Fee Amendments, or GDUFA, Year 3 and Year 4, which began October 1, 2014, and October 1, 2015, respectively. We submitted fifteen topical ANDAs in 2015. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA and the subsequent launch of products as these applications are approved. Our target is to file at least fifteen ANDAs in total in 2016 through our internal product development program, and we plan to file at least 8 ANDSs with Health Canada in 2016. We will also seek to license or acquire further products, intellectual property, or pending applications to expand our portfolio.

 

Teligent Canada. On November 13, 2015, we acquired all of the rights, title and interest in the development, production, marketing, import and distribution of all injectable pharmaceutical products of Alveda Pharmaceuticals Inc., or Alveda, pursuant to two asset purchase agreements, one relating to the acquisition of all of the intellectual property-related assets of Alveda and the other relating to the acquisition of all other assets of Alveda.

 

 2 

 

 

In connection with the closing of the acquisition, we formed three subsidiaries: Teligent Luxembourg S.à.r.l., or LuxCo, a private limited company incorporated under the laws of the Grand Duchy of Luxembourg and wholly-owned by the Company; Teligent OÜ, a private limited company incorporated under the laws of Estonia that is wholly-owned by LuxCo; and Teligent Canada Inc., a company incorporated under the laws of the Province of British Columbia that is wholly-owned by LuxCo.

 

Teligent Canada currently has seven employees, including a general manager of Teligent Canada, located in our offices in Toronto, Canada. Teligent Canada acquired all of the Alveda working capital, including accounts receivable, inventory, accounts payable, and capital assets. In addition, Teligent Canada acquired Alveda’s existing customer relations, all contracts necessary to execute the Canadian distribution activities, the existing work force, operational permits, and all intellectual property required to operate the marketing and distributions of products in Canada. Teligent Canada currently markets and distributes nineteen products. We plan to transition these products to distribute them under a Teligent Canada label later this year.

 

Teligent OÜ. We hired our general manager of Teligent OÜ in the first quarter of 2016. Teligent OÜ will be responsible for the development, enhancement, maintenance, protection and exploitation functions related to the intellectual property-related assets acquired from Alveda. In addition, Teligent OÜ will be responsible for the management of the supply chain function and procurement of products for sale to Teligent Canada. In 2016, we intend to hire additional headcount in Teligent OÜ and secure a quality control laboratory space in preparation to support our Teligent US supply chain management and technical services teams.

 

Teligent Jersey Limited. On October 5, 2015, we, together with our wholly-owned subsidiary incorporated under the laws of Jersey, or Teligent Jersey, entered into and closed an Asset Purchase Agreement and certain other ancillary agreements with Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, or Concordia, pursuant to which we acquired all rights, title and interests of Concordia in the existing inventory and certain contracts associated with three currently marketed injectable pharmaceutical products (Fortaz®, Zinacef TM , and Zantac® Injection), and Teligent Jersey acquired all rights, title and interests of Concordia in, among other things, certain other contracts, product registrations and books and records associated with those products. In consideration for the purchase of those assets, we paid Concordia an aggregate of $10,100,000 in cash. The transaction is accounted for as a purchase of the product and product rights. In addition, we purchased approximately $1.2 million of inventory related to the three products acquired.

 

Facility Expansion. With the ongoing expansion activities at our facility of our research and development laboratories, as well as our manufacturing capabilities, we believe that, based on current forecasts, capacity at our existing facility would be sufficient for our topical manufacturing needs into 2017. In 2014, we initiated the planning phase of the expansion of our facility in Buena, New Jersey. Planning continued throughout 2015, and we acquired the building adjacent to our manufacturing facility in August 2015. We have commenced the construction project at 101 Lincoln Avenue, in Buena, New Jersey, which will be the future home to our brand new product development laboratory, in addition to our regulatory affairs, supply chain and corporate services teams. We expect this phase of the project to be completed in the summer of 2016. We intend to begin the expansion of the existing manufacturing facility at 105 Lincoln Avenue, in Buena, New Jersey in April 2016. This expansion will increase our manufacturing capacity for topical products, and also enable our production of sterile injectable products. In order to begin development, registration and manufacture of some of our sterile injectable and ophthalmic products, we are partnering with contract manufacturing organizations. The current plans consider a total capital outlay of approximately $45 million to complete this project. Upon completion of the site expansion, we may transfer the manufacturing of some of those products back to our Buena, New Jersey facility.

 

In addition, we may continue to explore ways to accelerate our growth through the creation of unique opportunities from the acquisition of additional intellectual property, and the expansion of the use of our existing intellectual property.

 

 3 

 

 

Our Generic Pharmaceutical Business

 

In September 2010, we leveraged our existing formulation and manufacturing capabilities to begin the Company’s transformation from being solely a contract manufacturing and development company into a generic pharmaceutical company with our own portfolio of products, as recognized by our first ANDA submission to the FDA. ANDAs are submitted to the FDA for generic drug products that have the same active ingredient, strength, dosage form, and route of administration as brand name innovator drug products to which they are bioequivalent, meaning that there is no significant difference between the drugs in their rate and extent of absorption in the body. In the United States, approved ANDA generic drugs are usually interchangeable with the innovator drug. This means that the generic version may generally be substituted for the branded product by either a physician or pharmacist when dispensing a prescription. Our commercialization of each of these product candidates requires approval of the respective ANDA by the FDA.

 

Since September 2010, we have expanded our generic topical pharmaceutical pipeline of prescription products by submitting 35 ANDAs to the FDA, of which four have been approved. We submitted fifteen ANDAs in 2015, and expect to file at least fifteen ANDAs in 2016 for topical generic pharmaceutical products.

 

In December 2012, we launched our first generic topical pharmaceutical products under our own label. In March 2014, we received our first approval from the FDA for an ANDA for the generic equivalent of lidocaine hydrochloride USP 4% topical solution. In May 2014, we received tentative approval for our second ANDA, the generic equivalent of diclofenac sodium topical solution 1.5%, which received final approval from the FDA in July 2015. We also have a number of additional product candidates in various stages of development.

 

Based on IMS Health Reports data, the addressable market, as of January 2016, for the 31 products we have pending at the FDA totals approximately $1.4 billion in annual sales. We expect to continue to expand our presence in the generic topical pharmaceutical market through the submission of additional ANDAs to the FDA and the subsequent launch of products if and when these applications are approved by the FDA. We also plan to file at least 8 ANDSs with Health Canada in 2016.

 

As part of our growth strategy, we also seek opportunities to acquire additional products and ANDAs or ANDSs. On February 1, 2013, we acquired assets and intellectual property, including an approved ANDA, for econazole nitrate cream 1%, which we launched under our label in September 2013. On September 24, 2014, we acquired from AstraZeneca previously approved ANDAs and NDAs associated with eighteen products, seventeen of which are injectable products and one non-injectable product for pain management. On September 30, 2014, we acquired previously marketed and approved ANDAs associated with two ophthalmic products from Valeant Pharmaceuticals LLC and Valeant Pharmaceuticals Luxembourg SARL, or Valeant, in addition to the exclusive right to acquire three additional previously marketed and approved injectable products from Valeant. In November 2014, we completed the purchase of one of those three optioned injectable products and its related NDA from Valeant. In March 2015, we completed the purchase of the final two optioned injectable products and their related ANDAs from Valeant.

 

Our Contract Manufacturing and Development Business

 

We also develop, manufacture, fill and package topical semi-solid and liquid products for branded and generic pharmaceutical customers, as well as the OTC and cosmetic industries. These products are used in a wide range of applications, from purely cosmetic to the prescription treatment of conditions like dermatitis, psoriasis and eczema.

 

Our contract manufacturing and development business includes two services: contract formulation and contract manufacturing. These services are offered to pharmaceutical, OTC and cosmetic customers. For our pharmaceutical contract services customers, we formulate, test and/or manufacture prescription drugs and medical devices. The products include cosmetics sold by retail stores directly to the public, as well as prescription drug products promoted directly to physicians. All contract manufacturing products are produced under our customers’ labels. As a result of our commitment to file at least fifteen topical ANDAs for the Teligent portfolio in 2016, our research and development team will be focused more on the growth of our organic pipeline. Therefore, we do not expect to record significant revenues from our contract formulation services in 2016 and beyond.

 

 4 

 

 

Contract development involves developing topical formulations to satisfy a customer’s product request. Our experienced formulators can develop a novel formulation or replicate an existing formula through reverse engineering. We offer full support for the products we develop through developing test methods, full analytical services, manufacturing scale-up criteria, validation and regulatory assistance. Upon completion of our contract formulation projects, we are often successful in securing contract manufacturing services to manufacture the products we helped the customer develop. We have filed several 510(k) submissions with the FDA to obtain clearance on behalf of our customers for the marketing and distribution of certain medical devices. In addition, we have four additional ANDAs pending approval at the FDA that we submitted under joint development and commercialization agreements with our partners. In December 2012, after completion of the required formulation and regulatory requirements, we submitted two of those ANDAs on behalf of one of our pharmaceutical partners. In December 2013, we submitted another of the ANDAs associated with a generic topical pharmaceutical drug product, which, once approved, will be licensed, marketed and distributed by one of our large multi-national pharmaceutical partners, West-Ward Pharmaceuticals Corp. In June 2014, we submitted an ANDA under a joint development and commercialization agreement with Impax Laboratories, Inc.

 

We believe that our quality contract manufacturing and development business provides a consistent and reliable source of products and services to our customers. We offer flexibility in batch sizing and package design, which gives our customers the opportunity to select the appropriate presentation for each product. Our high-speed packaging lines can accommodate a variety of tubes, bottles, pumps and jars. As a result of the rollout of our TICO strategy and the increased focus and commitment of R&D and technical resources toward internal projects, we anticipate that revenue from our contract services business will decrease over time.

 

Our Financings

 

On December 22, 2014, we consummated the sale of an aggregate of $143.75 million in principal of our notes, or the Notes, to Deutsche Bank Securities Inc. and J.P. Morgan Securities LLC, as the initial purchasers, including the initial purchasers’ exercise of their option to purchase an $18.75 million in principal of Notes. The Notes were sold in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the sale of the Notes, we entered into an indenture with Wilmington Trust, National Association, as trustee. The Notes bear interest at a rate of 3.75% per year, payable semi-annually in arrears on June 15 and December 15 of each year, commencing June 15, 2015. The Notes will mature on December 15, 2019, unless earlier repurchased or redeemed by the Company or converted by holders, pursuant to the terms therein. Additionally, subject to certain conditions, we may redeem for cash any or all outstanding Notes on or after December 19, 2017 in an amount equal to the outstanding principal amount of such Notes, plus accrued and unpaid interest. No sinking fund is provided for the Notes. The Notes are the Company’s senior unsecured obligations and will not be guaranteed by any of our existing or future subsidiaries. Aggregate net proceeds were approximately $139 million, after deducting underwriter commissions and other expenses paid by us.

 

Corporate Information

 

We were incorporated in Delaware in 1977 and on May 7, 2008, our stockholders approved our name change from IGI, Inc. to IGI Laboratories, Inc. Effective October 23, 2015, we changed our name to Teligent Inc. Our principal executive offices are located at 105 Lincoln Avenue, Buena, New Jersey 08310. Our telephone number is (856) 697-1441. We maintain a website at www.teligent.com. We make available on or through our website our periodic reports that we file with the Securities and Exchange Commission, or the SEC. This information is available on our website free of charge as soon as reasonably practicable after we electronically file the information with or furnish it to the SEC. The contents of our website are not incorporated by reference into this document and shall not be deemed “filed” under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

Our Competitive Strategy

 

Our goal is to become a leader in the specialty generic pharmaceutical market. Under our own label, we currently market and sell generic topical and branded generic injectable pharmaceutical products in the United States and Canada. We also provide development, formulation, and manufacturing services to the pharmaceutical, OTC, and cosmetic industries. We have been in the contract manufacturing and development of topical products business since the early 1990s, but our strategy since 2010 has been focused on the growth of our own generic pharmaceutical business. In 2014, we started the transformation of our business from working toward being a leader in the topical generic pharmaceutical industry to becoming a leader in the specialty pharmaceutical markets. We believe that expanding our development and commercial base beyond topical generics, the cornerstone of our expertise, to injectable generics, complex generics and ophthalmic generics (what we call our TICO strategy), will leverage existing expertise and capabilities, diversify our commercial opportunities and broaden our platform for long-term strategic growth.

 

 5 

 

 

Our TICO Strategy

 

Our TICO strategy originated from our opportunity to leverage the industry value chain, which we have developed and strengthened through our topical portfolio. This value chain includes our internal expertise in product and molecule selection and development, manufacturing, sales, logistics and distribution, as well as our relationships with our customers and consumers. With the notable exception of manufacturing capabilities, we see the potential to effectively leverage our existing infrastructure across this value chain and to further expand our strategic reach to the injectable, complex and ophthalmic generic pharmaceutical markets.

 

Topical (T) - Our focus on the topical market has been the foundation for our growth. While the Company has manufactured topical products since the early 1990s, we began to focus our strategy on the topical generic market in 2010. In December 2012, we launched our first generic topical pharmaceutical products under our own label. Currently, we market eight topical products under our own label. We have recently received FDA approvals for lidocaine ointment 5%, which we plan to launch in the first quarter of 2016, and desoximetasone ointment 0.25%, which we plan to launch in the second quarter of 2016. In our topical pipeline, we have 31 ANDAs submitted to the FDA that are awaiting approval, and an additional 39 product candidates in our development pipeline, 10 of which are on stability testing. We intend to continue to develop topical generic products and utilize our expertise in drug formulation and manufacture to expand our own generic topical prescription drug portfolio. We are targeting to develop and file regulatory submissions with the FDA for at least fifteen topical products in 2016 through the ANDA process. Upon regulatory approval, we would market these products under the Teligent label to national chain drug stores and drug wholesalers through our internal sales efforts. Based on IMS Health Reports data, the addressable market, as of January 2016, for the 31 products we have pending at the FDA totals approximately $1.4 billion in annual sales.

 

In our topical contract services business, we have developed strong customer relationships that we believe provide us with both recurring revenue streams from those customers and opportunities to selectively increase our product offerings to our customers. We intend to continue to capitalize on our strong customer relationships to maintain some contract manufacturing and development revenues.

 

We have an FDA-registered, cGMP-compliant facility that is equipped for manufacturing topical, semi-solid and liquid products. The design and configuration of our manufacturing facility provides flexibility in manufacturing batch sizes from 250 kg up to 4,000 kg. We intend to leverage this flexibility and capacity to support our growth in the topical prescription markets. We are finalizing the planning phase of expanding this facility to increase our topical manufacturing capacity and warehousing capacity to accommodate the expected growth created by the eventual commercial launch of the 31 topical generic pharmaceutical products in our pipeline.

 

Injectable (I) - As part of the injectable phase of our TICO strategy, on September 24, 2014, we acquired from AstraZeneca previously approved ANDAs and NDAs associated with eighteen products, seventeen of which are injectable products and one of which is a non-injectable product for pain management. Of the products we acquired, five of the products are currently on the FDA drug shortage list. We have received FDA approval for our first product in this portfolio, Cefotan® (Cefotetan for Injection), and we are working with our manufacturing partner to launch the product in the first quarter of 2016.

 

On November 13, 2015, we formed Teligent Canada, and completed the acquisition of Alveda. Teligent Canada currently has seven employees, including a general manager located in our offices in Toronto, Canada. Teligent Canada acquired all of the Alveda working capital, including accounts receivable, inventory, accounts payable, and capital assets. In addition, Teligent Canada acquired Alveda’s existing customer relations, all contracts necessary to execute the Canadian distribution activities, the existing work force, operational permits, and all intellectual property required to operate the marketing and distributions of Alveda’s products in Canada. Teligent Canada currently markets and distributes nineteen injectable products.

 

On October 5, 2015, we acquired three currently marketed injectable pharmaceutical products (Fortaz®, Zinacef TM and Zantac® Injection) from Concodia Pharmaceuticals Inc., S.à.r.l., Barbados Branch.

 

 6 

 

 

On September 30, 2014, we acquired previously marketed and approved ANDAs associated with two ophthalmic products from Valeant, in addition to the exclusive right to acquire three additional previously marketed and approved injectable products from Valeant. In November 2014, we completed the purchase of one of those three optioned injectable products and its related NDA from Valeant. In March 2015, we completed the purchase of the final two optioned injectable products and their related ANDA from Valeant.

 

We intend to leverage our existing topical value chain as we build our injectable generic portfolio. In 2015, we entered into partnerships with contract manufacturing organizations, or CMOs, for the manufacture of some of our products in our portfolio of sterile products. Longer term, we expect to bring much of this production capability in-house.

 

In 2015, we have performed extensive analysis on the expansion of our existing facility in Buena, New Jersey, and the addition of sterile manufacturing capabilities to our facility. We have completed the concept, design, equipment ordering and construction planning activities necessary to qualify a facility for both pilot- and commercial-scale operations, including an R&D laboratory, sterile manufacturing and packaging capabilities, and warehouse and administrative space. We intend to begin construction in April 2016.

 

We plan to continue to review business development opportunities to expand our injectable portfolio.

 

Complex (C) - We have begun three projects that we consider to be part of the complex portfolio of our TICO strategy. We consider our focus on complex products or markets to be broadly defined to include potential complexity in one of the critical areas of our industry value chain. As part of our complex program, we are researching two 505(b)(2) projects. A 505(b)(2) submission is an NDA that contains full safety and effectiveness reports, but permits some of the information required for approval to come from studies not conducted by or for the applicant, thereby avoiding unnecessary duplication of studies already performed on a product. In addition, we are currently working with a contract research organization to develop a generic equivalent of a pharmaceutical drug product designated for a chronic rare disease.  The intent of this opportunity is to provide patients with a lower cost alternative of an approved orphan drug. The Orphan Drug Designation program at the FDA provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons, but are not expected to recover the costs of developing and marketing a treatment drug. We will continue to seek opportunities relevant to building our complex portfolio of products.

 

Ophthalmic (O) - As part of the ophthalmic portfolio of our TICO strategy, on September 30, 2014, we acquired previously marketed and approved ANDAs associated with two ophthalmic products from Valeant. Similar to our injectable portfolio, we are forming partnerships with CMOs for near-term commercial production, but plan to eventually manufacture these products within our own facility. We plan to continue to review business development opportunities to expand our ophthalmic portfolio.

 

Our Customers

 

Generic Pharmaceutical Business. The manufacturing and commercialization of generic specialty pharmaceutical markets is competitive, and there are established manufacturers, suppliers and distributors actively engaged in all phases of our business. We currently only manufacture and sell topical generic pharmaceutical products under our own label. In October 2015, we acquired and began to sell our first generic injectable products. The injectable products are currently sold under another company’s label and will be transitioned to our label in accordance with FDA guidance in 2016. In Canada, we currently market nineteen products in the Alveda label which will be transitioned to the Teligent label in 2016. As we continue to execute our TICO strategy, we will compete in other markets, including the injectable and ophthalmic generic pharmaceutical markets, and expect to face other competitors.

 

For the years ended December 31, 2015, and 2014, 43% and 44% of our total product sales, net, respectively, were to the three large wholesale drug distributors: AmerisourceBergen Corporation, or ABC; Cardinal Health, Inc., or Cardinal; and McKesson Drug Company, or McKesson. ABC accounted for approximately 28% and 42% of our accounts receivable as of December 31, 2015 and 2014, respectively.

  

 7 

 

 

ABC, Cardinal and McKesson are key distributors of our products, as well as a broad range of health care products for many other companies. None of these distributors is an end user of our products. Generally, if sales to any one of these distributors were to diminish or cease, we believe that the end users of our products would likely find little difficulty obtaining our products either directly from us or from another distributor. However, the loss of one or more of these distributors, together with a delay or inability to secure an alternative distribution source for end users, could have a material adverse effect on our revenue, business, financial condition and results of operations. Furthermore, ABC, Cardinal and McKesson have entered into strategic alliances with Walgreens, CVS Caremark and Rite-Aid, respectively.  Since Walgreens, CVS Caremark and Rite-Aid are customers for several of our products, the loss of our distributor relationship with any of the three large wholesalers could result in a reduction to our revenues.

 

We consider our business relationships with ABC, Cardinal and McKesson to be in good standing and have fee for services contracts with each of them. However, a change in purchasing patterns, a decrease in inventory levels, an increase in returns of our products, delays in purchasing products and delays in payment for products by one or more of these distributors could have a material adverse effect on our revenue, business, financial condition and results of operations. For example, we experienced a change in purchasing patterns at ABC in April 2015. We continue to analyze the market for other opportunities to expand our current relationships with other customers, while we continue to seek to diversify our existing portfolio of specialty generic drug products through internal research and development. In addition, we continue to explore business development opportunities to add additional products and /or capabilities to our existing portfolio.

 

Contract Manufacturing and Development Business. Our customers in the contract manufacturing business generally consist of pharmaceutical companies, as well as cosmetic and OTC product marketers, who require product development/manufacturing support. For the year ended December 31, 2015, approximately 86% of our contract services revenue was derived from pharmaceutical customers, as compared to 79% of total contract services revenue for the year ended December 31, 2014. One contract manufacturing customer represented 11% of total revenue for the year ended December 31, 2015, and one of our contract manufacturing services customers represented 13% of total revenue for the year ended December 31, 2014. We do not expect any contract manufacturing or formulation services customers to exceed 10% of revenue for 2016 and beyond.

 

Concentration of credit risk. In 2015, we had sales to three customers which individually accounted for more than 10% of our total revenue. These customers had sales of $12.3 million, $5.8 million and $5.0 million, respectively, and represented 52% of total revenues in the aggregate. Accounts receivable related to these major customers comprised 83% of all accounts receivable as of December 31, 2015.

 

In 2014, we had sales to two customers which individually accounted for more than 10% of our total revenue. These customers had sales of $10.5 million and $4.4 million, respectively, and represented 44% of total revenues in the aggregate. Accounts receivable related to these major customers comprised 42% of all accounts receivable as of December 31, 2014.

 

In 2013, we had sales to three customers which individually accounted for more than 10% of our total revenue. These customers had sales of $2.8 million, $2.2 million and $2.1 million, respectively, and represented 39% of total revenues in the aggregate.

 

Our Products

 

We recorded net revenue from one product, econazole nitrate cream, which accounted for 45% and 38% of total revenues in 2015 and 2014, respectively.  The Company did not have significant revenue from any one product in 2013.

 

Teligent United States Topical Pharmaceutical Products

 

Product   Formulation   Presentations   Brand equivalent
             
Desoximetasone 0.25% (1)   Ointment   15g, 60g, 100g   Topicort®
             
Diclofenac Sodium 1.5%   Topical Solution   150mL   Pennsaid®
             
Fluocinolone Acetonide 0.01% (2)   Topical Solution   60mL   Synalar®
             
Fluocinolone Acetonide 0.025% (2)   Ointment   15g, 60g   Synalar®
             
Fluocinolone Acetonide 0.025% (2)   Cream   15g, 60g   Synalar®
             
Fluocinolone Acetonide 0.01% (2)   Cream   15g, 60g   Synalar®
             
Econazole Nitrate 1%   Cream   15g, 30g, 85g   Spectazole®
             
Lidocaine 5% (3)   Ointment   35.44g   Xylocaine®
             
Lidocaine 4%   Topical Solution   50mL   Xylocaine®

 

(1)ANDA approved by the FDA on February 26, 2016, we expect to launch the product in the second quarter of 2016.
(2)Teligent is the authorized generic to the Synalar NDA held by Medimetriks Pharmaceuticals, Inc.
(3)ANDA approved by the FDA on February 2, 2016, we expect to launch this product in the first quarter of 2016.

 

 8 

 

 

Teligent United States Injectable Products

 

Product   Strength   Formulation   Presentations   Dossier type
held by Teligent
                 
Cefotan (Cefotetan) (4)   1g, 2g   Injectable   Vial   NDA
                 
Fortaz (Ceftazidime)    500mg, 1g, 2g, 6g   Injectable   Vial, Twist Vial, Frozen Bag   NDA
                 
Zantac (Ranitidine)    25mg/ml   Injectable   2ml, 6ml, 40ml Vials   NDA
                 
Zinacef (Cefuroxime)    750mg, 1.5g, 7.5g   Injectable   Vial, Twist Vial   NDA

 

(4)The Prior Approval Supplement approved by the FDA on December 10, 2015. We expect to launch this product in the first quarter of 2016.

 

Teligent Canada Injectable Products

 

Product   Strength   Formulation   Presentations   Brand equivalent   Dossier type
held by Teligent
                     
Acetylcysteine   2g, 6g   Injectable   10ml and 30 ml vials   Mucomyst® Parvolex®   ANDS
                     
Atropine   0.4 mg, 0.6 mg   Injectable   1 ml vials   N/A   ANDS
                     
Caldolor/Ibuprofen   800 mg   Injectable   8 ml vials   N/A   NDS
                     
Dimenhydrinate   50 mg, 250 mg   Injectable   1 ml ampoule, 5 ml vial   Gravol®   ANDS
                     
Epinephrine   1 mg   Injectable   1 ml ampoule   Adrenalin®   ANDS
                     
Erogonovine Maleate   0.25 mg   Injectable   1 ml ampoule   N/A   ANDS
                     
Furosemide   20 mg   Injectable   2 ml ampoule   Lasix®   ANDS
                     
Irinotecan Hydrochloride   40 mg, 100 mg, 500 mg   Injectable   2 ml, 5 ml, 25 ml vials   Camptosar®   ANDS
                     
Lidocaine 1%   50 mg, 100 mg   Injectable   5 ml and 10 ml polyampoule   Xylocaine®   ANDS
                     
Lidocaine 1%   200 mg, 500 mg   Injectable   20 ml and 50 ml vials   Xylocaine®   ANDS
                     
Lidocaine 2%   100 mg, 200 mg   Injectable   5 ml and 10 ml polyampoule   Xylocaine®   ANDS
                     
Lidocaine 2%   400 mg, 1 g   Injectable   20 ml and 50 ml vials   Xylocaine®   ANDS
                     
Lidocaine 2% with epinephrine   400 mg, 1 g   Injectable   20 ml and 50 ml vials   Xylocaine®   ANDS
                     
Methylene Blue   50mg   Injectable   5mL ampoule   N/A   ANDS
                     
Naloxone   0.4mg   Injectable   1mL ampoule   Narcan   ANDS
                     
Piperacillin and Tazobactam   2g, 0.25 g, 3 g, 0.375 g, 4 g, 0.5 g   Injectable   2.25 g, 3.375 g, 4.5 g vials   Tazocin®   ANDS
                     
Sodium Cloride   90 mg   Injectable   10 ml vials   N/A   ANDS
                     
Sterile Water for Injection   100%   Injectable   10 ml polyampoule   N/A   ANDS
                     
Succinylcholine Chloride   200 mg, 400 mg   Injectable   10 ml and 20 ml vials   Quelicin®   ANDS

 

 9 

 

 

Teligent United States Other Products

 

Below is a listing of the previously marketed products that were purchased from AstraZeneca and Valeant, along with a description of each respective formulation, presentation, brand equivalent, dossier and indication.

 

Product   Strength   Formulation   Presentations   Brand equivalent   Dossier type
 held by Teligent
Ciprofloxacin   0.3%   Ophthalmic Solution   2.5ml, 5ml, 10ml bottles   Ciloxan ®   ANDA
                     
Betaxolol   0.5%   Ophthalmic Solution   5ml, 7.5ml, 15ml bottles   Betopic ®   ANDA
                     
Phytonadione   10mg, 1mg   Injectable   0.5ml, 1ml ampoules; 3cc, 6cc vials   AquaMephyton ®   NDA
                     
Amikacin Sulfate   50mg/ml, 250mg/ml   Injectable   2ml, 4ml vials   Amikacin Sulfate ®   ANDA
                     
Calcitonin Salmon    200IU/ml   Injectable   2ml vials   Miacalcin ®   ANDA
                     
Cefotetan Disodium    20mg/ml   Injectable (bag)   50ml bags   Cefotetan ®   NDA
                     
Clindamycin Phosphate   150mg/ml   Injectable   2ml, 4ml, 6ml, 60ml vials    Cleocin ®   ANDA
                     
Dobutamine HCl   12.5mg/ml   Injectable   20ml, 40ml vials   Dobutamine HCl ®   ANDA
                     
Dopamine HCl   40mg/ml   Injectable   5ml, 10ml (vials and syringes)   Dopamine HCl ®   NDA / ANDA
                     
Dopamine HCl   80mg/ml   Injectable   5ml, 10ml (vials, ampoules, and syringes)   Dopamine HCl ®   NDA / ANDA
                     
Dopamine HCl   160mg/ml   Injectable   5ml (vials and ampoules)   Dopamine HCl ®   NDA / ANDA
                     
Droperidol    2.5mg/ml   Injectable   10ml vials, 2ml and 5ml ampoules, and 2ml syringes   Inapsine ®   ANDA
                     
Furosemide   10mg/ml   Injectable   2ml, 4ml, 8ml, and 10ml vials, 4ml and 10ml syringes   Furosemide ®   ANDA
                     
Mannitol   USP 25%   Injectable   50ml (vials and syringes)   Mannitol ®   ANDA
                     
Meperidine HCl   25mg/ml, 50mg/ml, 75mg/ml, 100mg/ml   Injectable   1ml and 30ml vials, 1ml and 1.5ml ampoules, and 1ml syringes   Demerol ®   ANDA
                     
Midazolam HCl   5mg/ml   Injectable   2ml syringe   Midazolam ®   ANDA
                     
Orphenadrine   30 mg/mL   Injectable   2 mL ampule   Orphenadrine Citrate   ANDA
                     
Edrophonium   10 mg/mL   Injectable   1 mL ampule and 10 mL vial   Enlon®   NDA
                     
MVI-12   N/A   Injectable   10 mL ampules and 5 mL vials   N/A   NDA
                     
Naloxone HCl   0.4 mg/mL, 1 mg/mL   Injectable   1 mL 5 mLand 10 mL vials   N/A   ANDA
                     
Naloxone HCl (preservative free)   0.4 mg/mL   Injectable   1 mL vials   N/A   ANDA
                     
Tobramycin Sulfate   10 mg/mL, 40 mg/mL   Injectable   2 mLand 35 mL vials   N/A   ANDA
                     
Nalbuphine   10 mg/mL and 20 mg/mL   Injectable   1 mL and 10 mL vials   Nubain®   ANDA

 

Our Suppliers

 

We require a supply of quality raw materials and components to manufacture and package pharmaceutical products for ourselves and third parties with which we have contracted. The principal components of our products are active and inactive pharmaceutical ingredients and certain packaging materials. The APIs and other materials and supplies used in our pharmaceutical manufacturing operations are generally available and purchased from many different U.S. and non-U.S. suppliers. However, in some cases, the raw materials used to manufacture pharmaceutical products are available only from a single supplier. Even when more than one supplier exists, we may choose, and in some cases have chosen, only to list one supplier in our applications submitted to the FDA. Any change in a supplier not previously approved must then be submitted through a formal approval process with the FDA. No supplier represented 10% or more of our purchases in 2015, 2014 or 2013.

 

 10 

 

 

Research and Development

 

Our R&D activities are integral to our business and are conducted at our facility in Buena, New Jersey. Our R&D department is led by our Chief Scientific Officer, Stephen Richardson, who joined the Teligent team in October 2015. The R&D team consists of 26 full-time employees and their responsibilities include: formulation, reverse engineering, methods development, analytical and microbiologic testing and scale up, and regulatory expertise. Our employees have specific expertise in developing topical products in a wide range of dosage forms, including simple solutions through complex creams. All ANDA topical development is conducted in-house except for bioequivalence testing, which is performed by what we believe to be a qualified contract research organization. In 2015, Teligent added injectable development capabilities to the team.

 

We have been steadily increasing our investment in R&D as we believe that R&D is the future of the Company. We incurred $13.2, $6.9, and $2.7 million on R&D expenses in 2015, 2014, and 2013, respectively. We expect to increase our R&D spending in 2016 to approximately 28 to 32% of revenue in 2016 to expand our ANDA submissions and pipeline. As the business continues to grow over the next three to five years, we expect research and development costs as a percentage of revenue to decline.

 

Product Development and Government Regulation

 

United States

 

Prescription pharmaceutical products in the U.S. are generally marketed as either brand or generic drugs. Brand products are usually marketed under brand names through marketing programs that are designed to generate physician and consumer loyalty. Brand products generally are patent protected, which provides a period of market exclusivity during which time they are sold with little or no competition for the compound, although there typically are other participants in the therapeutic area. Additionally, brand products may benefit from other periods of non-patent market exclusivity. Exclusivity normally provides brand products with the ability to maintain their profitability for relatively long periods of time and brand products typically continue to play a significant role in the market due to physician and consumer loyalties after the end of patent protection or other market exclusivities.

 

Generic pharmaceutical products are the pharmaceutical and therapeutic equivalents of the brand product, also known as the reference listed drug, or RLD. A reference listed brand drug is an approved drug product listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, popularly known as the Orange Book. The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, provides that generic drugs may enter the market after the approval of an ANDA, An ANDA approval requires that bioequivalence to the reference listed drug be demonstrated and also requires that any patents on the corresponding reference listed drug be expired, invalidated, non-infringed and/or any other relevant market exclusivity periods related to the reference listed drug be expired as well. Generic drugs are bioequivalent to their reference brand name counterparts. Accordingly, generic products provide a safe, effective and cost-efficient alternative to users of these reference brand products. Branded generic pharmaceutical products are generic products in that they are approved for marketing under an ANDA, but they may be more responsive to promotion efforts generally used to promote branded pharmaceutical products. Growth in the generic pharmaceutical industry has been, and will continue to be, driven by the increased market acceptance of generic drugs, as well as the number of brand drugs for which patent terms and/or other market exclusivities have expired.

 

We obtain new generic products primarily through internal product development. Additionally, we license or co-develop products through arrangements with other companies. All applications for FDA approval must contain information relating to product formulation, raw material suppliers, stability, manufacturing processes, packaging, labeling and quality control. Information to support the bioequivalence of generic drug products or the safety and effectiveness of new drug products for their intended use is also required to be submitted. There are generally two types of applications used for obtaining FDA approval of new products:

 

·New Drug Application — An NDA is filed when approval is sought to market a newly developed branded product and, in certain instances, for a new dosage form, a new delivery system or a new indication for a previously approved drug.

 

 11 

 

 

·ANDA — An ANDA is filed when approval is sought to market a generic equivalent of a drug product previously approved under an NDA and listed in the FDA’s Orange Book or for a new dosage strength for a drug previously approved under an ANDA.

 

The ANDA development process is generally less time-consuming and complex than the NDA development process. It typically does not require new preclinical and clinical studies, because it relies on the studies establishing safety and efficacy conducted for the RLD previously approved through the NDA process. The ANDA process, however, does typically require one or more bioequivalence studies to show that the ANDA drug is bioequivalent to the previously approved reference listed brand drug. Bioequivalence studies compare the bioavailability of the proposed drug product with that of the RLD product containing the same active ingredient. Bioavailability is a measure of the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. Thus, a demonstration of bioequivalence confirms the absence of a significant difference between the proposed product and the reference listed brand drug in terms of the rate and extent to which the active ingredient or active moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions.

 

Generic products are generally introduced to the marketplace at the expiration of patent protection for the brand product or at the end of a period of non-patent market exclusivity. However, if an ANDA applicant files an ANDA containing a certification of invalidity, non-infringement or unenforceability related to a patent listed in the Orange Book with respect to a reference drug product, the applicant may be able to market the generic equivalent prior to the expiration of patent protection for the brand product. Such patent certification is commonly referred to as a Paragraph IV certification. If the holder of the NDA sues, claiming infringement or invalidation, within 45 days of notification by the applicant, the FDA may not approve the ANDA application until the earlier of the rendering of a court decision favorable to the ANDA applicant or the expiration of 30 months. An ANDA applicant that is first to file a Paragraph IV certification is eligible for a period of generic marketing exclusivity. This exclusivity, which under certain circumstances may be required to be shared with other ANDA sponsors that have made Paragraph IV certifications, lasts for 180 days, during which the FDA cannot grant final approval to other ANDA applications for a generic equivalent to the same reference drug.

 

In addition to patent exclusivity, the holder of the NDA for the listed drug may be entitled to a period of non-patent market exclusivity, during which the FDA cannot approve an application for a generic version product. If the reference drug is a new chemical entity, the FDA may not accept an ANDA for a generic product for up to five years following approval of the NDA for the new chemical entity. If it is not a new chemical entity, but the holder of the NDA conducted clinical trials essential to approval of the NDA or a supplement thereto, the FDA may not approve an ANDA for reference NDA product before the expiration of three years. Certain other periods of exclusivity may be available if the RLD is indicated for treatment of a rare disease or the sponsor conducts pediatric studies in accordance with FDA requirements.

 

Supplemental ANDAs are required for approval of various types of changes to an approved application and these supplements may be under review for six months or more. In addition, certain types of changes may only be approved once new bioequivalence studies are conducted or other requirements are satisfied.

 

An additional requirement for FDA approval of NDAs and ANDAs is that our manufacturing procedures and operations conform to FDA requirements and guidelines, generally referred to as current Good Manufacturing Practices, or cGMPs. The requirements for FDA approval encompass all aspects of the production process, including validation and recordkeeping, the standards around which are continuously changing and evolving.

 

Facilities, procedures, operations and/or testing of products are subject to periodic inspection by the FDA, the U.S. Drug Enforcement Administration, or DEA, and other authorities. In addition, the FDA conducts pre-approval and post-approval reviews and plant inspections to determine whether our systems and processes are in compliance with cGMP and other FDA regulations. Our suppliers are subject to similar regulations and periodic inspections.

 

In 2012, the U.S. Food and Drug Administration Safety and Innovation Act, or the FDASIA, was enacted into law. FDASIA is intended to enhance the safety and security of the U.S. drug supply chain by holding all drug manufacturers supplying products to the U.S. to the same FDA inspection standards and schedules. Specifically, prior to the passage of FDASIA, U.S. law required U.S. based manufacturers to be inspected by FDA every two years but remained silent with respect to foreign manufacturers, causing some foreign manufacturers to go as many as nine years without a routine FDA cGMP inspection, according to the Government Accountability Office.

 

 12 

 

 

FDASIA also included GDUFA, a novel user fee program to provide FDA with approximately $1.5 billion in total user fees through 2018 focused on three key aims:

 

·Safety – Ensure that industry participants, foreign or domestic, are held to consistent quality standards and are inspected with parity using a risk-based approach.

 

·Access – Expedite the availability of generic drugs by bringing greater predictability to the review times for abbreviated new drug applications, amendments and supplements and improving timeliness in the review process.

 

·Transparency – Enhance FDA’s visibility into the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated APIs, and improve FDA’s communications and feedback with industry.

 

Under GDUFA, 70% of the total fees are being derived from facility fees paid by Finished Dosage Form manufacturers and API facilities listed in pending or approved generic drug applications. The remaining 30% of the total fees are being derived from application fees, including generic drug application fees, prior approval supplement fees and fees for certain types of Drug Master Files, or DMFs.

 

Canada

 

In Canada, the registration process for approval of all generic pharmaceuticals has two tracks that proceed in parallel. The first track of the process involves an examination of the proposed generic product by Health Canada, the Federal department responsible for national public health, to ensure that the quality, safety and efficacy of the proposed generic product meets Canadian standards and bioequivalence requirements. The second track concerns patent rights of the brand drug owner. Companies may submit an application called an abbreviated new drug submission, or ANDS to Health Canada that compares the proposed generic drug to another drug marketed in Canada under a Notice of Compliance, or NOC, issued to a first person. When Health Canada is satisfied that the generic pharmaceutical product described in the ANDS satisfies the statutory requirements, it issues an NOC for that product for the uses specified in the ANDS, subject to any court order that may be made in the second track of the approval process.

 

The second track of the approval process is governed by the Patented Medicines NOC Regulations, or the Regulations. The owner or exclusive licensee of patents relating to the brand drug for which it has an NOC may have established a list of patents administered by Health Canada that enumerates all the patents claiming the medicinal ingredient, formulation, dosage form or the use of the medicinal ingredient. It is possible that even though the patent for the API may have expired, the originator may have other patents on the list which relate to new forms of the API, a formulation or additional uses. Most brand name drugs have an associated patent list containing one or more unexpired patents claiming the medicinal ingredient itself or a use of the medicinal ingredient (a claim for the use of the medicinal ingredient for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms). In its ANDS, a generic applicant must make at least one of the statutory allegations with respect to each patent on the patent list, for example, alleging that the patent is invalid or would not be infringed and explaining the basis for that allegation. In conjunction with filing its ANDS, the generic applicant is required to serve the originator a Notice of Allegation, or NOA, which gives a detailed statement of the factual and legal basis for its allegations in the ANDS. The originator may commence a court application within 45 days after it has been served with the NOA, if it takes the position that the allegations are not justified. When the application is filed in court and served on Health Canada, Health Canada may not issue an NOC until the earlier of the determination by the court after a hearing or the expiration of 24 months from the commencement of the generic drug application. The period may be shortened or lengthened by the court in certain circumstances. An NOC can be obtained for a generic product only if the generic respondent is successful in dismissing the application under the Regulations in court. The legal costs incurred in connection with the application could be substantial.

 

 13 

 

 

Section C.08.004.1 of the Canadian Food and Drug Regulations is the so-called data protection provision, and the current version of this section applies in respect of all drugs for which an NOC was issued on or after June 17, 2006. A subsequent applicant for approval to market a drug for which an NOC has already been issued does not need to perform duplicate clinical trials similar to those conducted by the first NOC holder, but is permitted to demonstrate safety and efficacy by submitting data demonstrating that its formulation is bioequivalent to the formulation that was issued for the first NOC. The first party to obtain an NOC for a drug will have an eight-year period of exclusivity starting from the date it received its NOC based on those clinical data. A subsequent applicant for approval that seeks to establish safety and efficacy by comparing its product to the product that received the first NOC will not be able to file its own application until six years after the issuance of the first NOC. The Minister of Health will not be permitted to issue an NOC to that applicant until eight years after the issuance of the first NOC — this additional two-year period will correspond in most cases to the 24-month automatic stay under the Regulations. If the first person provides the Minister with the description and results of clinical trials relating to the use of the drug in pediatric populations, it will be entitled to an extra six months of data protection. A drug is only entitled to data protection so long as it is being marketed in Canada.

 

Facilities, procedures, operations and/or testing of products are subject to periodic inspection by Health Canada and the Health Products and Food Branch Inspectorate. In addition, Health Canada conducts pre-approval and post-approval reviews and plant inspections to determine whether our systems are in compliance with the good manufacturing practices in Canada, Drug Establishment Licensing, or the EL, requirements and other provisions of the Regulations. Competitors are subject to similar regulations and inspections.

 

The federal government, provinces and territories in Canada operate drug benefit programs through which eligible recipients receive drugs through public funding; these drugs are listed on provincial or territorial Drug Benefit Formularies (each, a “Formulary”). Eligible recipients include First Nations and Inuit clients, seniors, persons on social assistance, low-income earners, and those with certain specified conditions or diseases. Formulary listings are also used by private payors to reimburse generic products. To be listed in a Formulary, drug products must have received an NOC from Health Canada and must comply with each jurisdiction’s individual review process.

 

The primary regulatory approval for pharmaceutical manufacturers, distributors and importers selling pharmaceuticals to be marketed in Canada is the issuance of an establishment license, or EL. An EL is issued once Health Canada has approved the facility in which the pharmaceuticals are manufactured, distributed or imported. A key requirement for approval of a facility is compliance with the good manufacturing practices in Canada. For pharmaceuticals that are imported, the license for the importing facility must list all foreign sites at which imported pharmaceuticals are manufactured. To be listed, a foreign site must demonstrate compliance with the good manufacturing practices in Canada.

 

Sales and Marketing

 

We make, sell, distribute and market our prescription drug products to national chain drug stores and drug wholesalers and distributors and group purchasing organizations, or GPOs, in the United States and Canada. This commercialization infrastructure includes satisfying our state, provincial, territorial, or national licensing requirements, implementing procedures with our third-party logistics partners, and maintaining appropriate sales order to cash administrative processes and a manager of national accounts to manage our sales.

 

Competition

 

In our generic topical prescription drug business, we face competition from other generic drug manufacturers and brand-name pharmaceutical companies through authorized generics. Although there are a significant number of competitors in the generic drug market, there are fewer competitors in the topical generic drug market. The six dominant companies in the topical generic drug market are: Taro Pharmaceutical Industries, Ltd., Sandoz (the generic pharmaceutical division of Novartis AG), Allergan, Inc., Perrigo Company, Mylan, Inc. and Akorn, Inc. Collectively, these six competitors control approximately 65% of the generic topical market by value based on IMS data from January 2016. We believe the concentrated nature of the topical generic drug market creates an opportunity for us to be able to compete based on a variety of factors, including our focus on niche opportunities within the market segment and our dedication to quality in every area of our business.

 

 14 

 

 

In our generic injectable prescription drug business, we also face competition from other generic drug manufacturers and brand-name pharmaceutical companies through authorized generics. Although there are a significant number of competitors in the generic drug market, there are fewer dominant competitors in the injectable generic drug market. The 6 dominant companies in the injectable generic drug market in the United States consist of Hospira, Inc. (a subsidiary of Pfizer, Inc.), Fresenius Kabi USA, Sandoz (the generic pharmaceutical division of Novartis AG), Mylan, Inc., Dr. Reddy’s Laboratories Limited, and West-Ward (a subsidiary of Hikma Pharmaceuticals PLC). Collectively, these six competitors control approximately 59% of the generic injectable market by value based on IMS data from January 2016. In Canada, we face competition from largely the same firms as in the United States as well as certain Canada-only firms.  The Canadian generic injectable market is dominated by Sandoz (the generic pharmaceutical division of Novartis AG), Pfizer Injectables, and Fresenius Kabi Canada. 

 

Our generic injectable strategy is focused on injectable products with limited competition, and products that have a history of lack of supply, or instability in the supply chain, where we can add value and leverage on our ability to be a reliable supplier to the marketplace.  We believe the concentrated nature of some molecules within the injectable generic drug market, and history of lack of supply of certain molecules in the marketplace, create opportunities for us that we believe will enable us to compete based on a variety of factors, including our focus on niche opportunities within the market segment and our dedication to quality in every area of our business.

 

The contract manufacturing services market is highly competitive and includes larger organizations with substantially greater resources than us. Many of our competitors are companies that commercialize and/or manufacture their required products at their own facilities. These competitors include major pharmaceutical companies, generic drug manufacturers and consumer health product companies that generally have substantially greater manufacturing, R&D, marketing and financial resources than us and, in some cases, have more geographically diversified international operations. We compete specifically with a number of different privately-held contract manufacturing companies, including DPT Laboratories, Ltd. Although this market is competitive, the competition is limited due to the need for specific expertise in topical formulations and cGMP facilities. We believe that we have the expertise required and we will continue to service our existing customers in this market by providing high quality, customer-oriented service, complemented by our contract development expertise in topical formulations.

 

Environmental Matters

 

Our operations are subject to a variety of environmental, health and safety laws and regulations, including those of the United States Environmental Protection Agency and equivalent state and local regulatory agencies. These laws and regulations govern, among other things, air emissions, wastewater discharges, the use, handling and disposal of hazardous substances and wastes, soil and groundwater contamination and employee health and safety. Our manufacturing facility uses, in varying degrees, hazardous substances in its processes. Contamination at our facility can result and has resulted in liability to us, for which we have recorded appropriate reserves as needed. For example, two of the Company’s facilities have undergone remediation of environmental contamination. See Note 16 to the Company’s Consolidated Financial Statements included elsewhere in this Annual Report.

 

Intellectual Property

 

To compete effectively, we need to develop and maintain a proprietary position with regard to our own technology, product candidates and business. Our goal is to safeguard our trade secrets and know-how, attain, maintain and enforce patent protection for our product candidates, formulations, processes, methods and other proprietary technologies, and operate without infringing on the proprietary rights of others. We seek to obtain, where appropriate, the broadest intellectual property protection possible for our current product candidates and any future product candidates, proprietary information and proprietary technology. We seek to achieve this protection through a combination of contractual arrangements and patents.

 

We depend upon the skills, knowledge, experience and know-how of our management and R&D personnel, as well as that of our consultants, advisors and collaborators. To help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to enforce, we currently rely, and will continue to rely in the future, on confidentiality agreements to protect our interests. We require our employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure of confidential information to any other parties. We also require our employees and consultants to disclose and assign to us their ideas, developments, discoveries and inventions. We understand that these agreements may not provide us with adequate protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure.

 

 15 

 

 

We also seek to obtain patent protection when necessary, and we understand that this may not provide us with complete protection against competitors who may attempt to circumvent our patents.

 

Facility and Operations

 

The Company’s executive administrative offices are located in Buena, New Jersey, in two facilities of approximately 33,000 square feet built on 8.44 acres of land in 1995, which we own. This facility is used for production, product development, marketing and warehousing for our pharmaceutical, cosmeceutical and cosmetic products. Our manufacturing capabilities encompass a full suite of competencies, including regulatory, quality assurance and in-house validation.

 

The facility is equipped to manufacture semi-solids, ointments, gels and liquids in solution form. The facility is also configured to provide flexibility in manufacturing. Pilot batches typically range from 30 kg to 250 kg, while commercial batches may range from 250 kg to 4,000 kg.

 

We operate our facility in accordance with cGMP, utilizing the same high standards as our pharmaceutical customers. Our facility is registered with the FDA. We believe that our facility and equipment are in good condition, are well-maintained and are able to operate at present levels. Our manufacturing operations are focused on regulatory compliance, continuous improvement, process standardization and excellence in quality and execution across the organization.

 

We also own four acres of land adjacent to our main facility that can be used for future expansion. We also lease an additional 11,000 square feet of warehouse space in Vineland, New Jersey.

 

The Company also leases approximately 7,500 square feet of corporate office space in Iselin, New Jersey, and will soon occupy approximately 4,000 square feet of office space in Toronto, Canada. The Company currently subleases office space in Toronto, Canada.

 

Employees

 

On December 31, 2015, we had a total of 107 full-time employees, including five full-time employees in Canada. In addition, as the need arises, we occasionally utilize short-term, part-time employees who are paid on an hourly basis. We also utilize temporary employees provided by a third-party on a regular basis, primarily in our production department. We do not have a collective bargaining agreement with our employees and we believe that our employee relations are good.

 

 16 

 

 

Item 1A.RISK FACTORS

 

Our current business and future results may be affected by a number of risks and uncertainties, including those described below. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not currently known to us or that we currently deem immaterial also may impair our business operations. If any of the following risks actually occur, our business, results of operations and financial condition could suffer. The risks discussed below also include forward-looking statements and our actual results may differ substantially from those discussed in these forward-looking statements.

 

Risks Related to Our Business

 

We have a history of losses and cannot assure you that we will become profitable. As a result, we may have to cease operations and liquidate our business.

 

Prior to 2014, our expenses exceeded our revenue in each of the last nine years, and no net income was been available to common stockholders during each of these years. As of December 31, 2015, our stockholders’ equity was $66.8 million and we had an accumulated deficit of $33.0 million. Our future profitability depends on revenue exceeding expenses, but we cannot assure you that this will occur. If we do not become profitable or continue to raise external financing, we could be forced to curtail operations and sell or liquidate our business, and you could lose some or all of your investment.

 

We rely on a limited number of customers for a large portion of our revenues.

 

We depend on a limited number of customers for a large portion of our revenue. Three of our customers accounted for 52% of our revenue for the year ended December 31, 2015, and two of our customers accounted for 44% of our revenue for the year ended December 31, 2014. The loss of one or more of these customers could have a significant impact on our revenues and harm our business and results of operations.

 

Due to our dependence on a limited number of products, our business will be materially adversely affected if these products do not perform as well as expected.

 

We expect to generate a significant portion of our total revenues and gross margin from the sale of a limited number of products. While we continue to diversify our product portfolio, one of our products accounted for 45% and 38% of our revenue for the years ended December 31, 2015 and 2014, respectively. Any material adverse developments, including increased competition, loss of customers, pricing pressures and supply shortages, with respect to the sale or use of our products and prospective products, or our failure to successfully introduce such products, could have a material adverse effect on our revenues and gross margin.

 

The pharmaceutical industry in which we operate is intensely competitive. We are particularly subject to the risks of competition. For example, the competition we encounter may have a negative impact upon the prices we may charge for our products, the market share of our products and our revenue and profitability.

 

The pharmaceutical industry in which we operate is intensely competitive. The competition that we encounter has an effect on our product prices, market share, revenue and profitability. Depending upon how we respond to this competition, its effect may be materially adverse to us.

 

We compete with:

 

  · the original manufacturers of the brand-name equivalents of our generic products; and

 

  · other generic drug manufacturers.

 

 17 

 

 

Most of the products that we are developing are either generic drugs or products without patent protection. These drugs and products do not benefit from patent protection and are therefore more subject to the risk of competition than patented products. In addition, because many of our competitors have substantially greater financial, production and research and development resources, substantially larger sales and marketing organizations, and substantially greater name recognition than we have, we are particularly subject to the risks inherent in competing with them. For example, many of our competitors may be able to develop products and processes competitive with, or superior to, our own. Furthermore, we may not be able to successfully develop or introduce new products that are less costly than those of our competitors or offer purchasers of our products payment and other commercial terms as favorable as those offered by our competitors.

 

Furthermore, in the current political climate in which drug prices are a focus of 2016 Presidential Candidates, Congress, government and private payors, and the public more broadly, we cannot predict whether new legislative, regulatory, or other measures related to drug pricing may be enacted. If enacted, such drug pricing measures could have an impact on our drug prices or our gross margins from product sales, which could significantly and adversely impact our financial condition and cash flows.

 

As our competitors introduce their own generic equivalents of our generic pharmaceutical products, our revenues and gross margin from such products may decline, potentially rapidly.

 

Revenues and gross margin derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors that we believe are unique to the generic pharmaceutical industry. As the patent(s) for a brand name product and the statutory marketing exclusivity period (if any) expires, the first generic manufacturer to receive regulatory approval for a generic equivalent of the product often is able to capture a substantial share of the market. However, as other generic manufacturers receive regulatory approvals for identical competing products, that market share, and the price of that product, may decline depending on several factors, including the number of competitors, the price of the brand product and the pricing strategy of the new competitors. In addition, the FDA has continued to shorten the review and response time to certain ANDAs, as a result of their guidelines established under GDUFA. If this trend continues, and the FDA is successful in reducing the current backlog of unapproved ANDAs, currently pending approval at the FDA, competitors could potentially enter the markets in which we compete more quickly. We cannot provide assurance that we will be able to continue to develop such products or that the number of competitors with such products will not increase to such an extent that we may stop marketing a product for which we previously obtained approval, which may have a material adverse impact on our revenues and gross margin.

 

If pharmaceutical companies are successful in limiting the use of generics through their legislative, regulatory and other efforts, sales of our generic products may be adversely impacted.

 

Many pharmaceutical companies increasingly have used state and federal legislative and regulatory means to delay generic competition. These efforts have included:

 

  · pursuing new patents for existing products that may be granted just before the expiration of earlier patents, which could extend patent protection for additional years or otherwise delay the launch of generics;

 

  · selling the brand product as an “authorized generic,” either by the brand company directly, through an affiliate or by a marketing partner;

 

  · using the Citizen Petition process to request amendments to FDA standards or otherwise delay generic drug approvals;

 

  · seeking changes to the U.S. Pharmacopeia, an FDA- and industry-recognized compendia of drug standards;

 

  · attaching patent extension amendments to non-related federal legislation;

 

  · engaging in state-by-state initiatives to enact legislation that restricts the substitution of some generic drugs, which could have an impact on products that we are developing; and

 

  · seeking patents on methods of manufacturing certain active pharmaceutical ingredients.

 

If pharmaceutical companies or other third parties are successful in limiting the use of generic products through these or other means, our sales of our generic products may decline. If we experience a material decline in generic product sales, our results of operations, financial condition and cash flows may be significantly and adversely impacted.

 

 18 

 

 

Our generics business also faces increasing competition from brand-name manufacturers that do not face any significant regulatory approval or other barriers to enter into the generics market.

 

Our generics business also faces increasing competition from brand-name manufacturers that do not face any significant regulatory approval or other barriers to enter into the generics market. These brand-name companies sell “authorized generic” versions of their products to the market directly, acquire or form strategic alliances with our competitor generic pharmaceutical companies, or grant them rights to sell “authorized generics.” Moreover, brand-name companies continually seek new ways to delay the introduction of generic products and decrease the impact of generic competition, such as filing new patents on drugs whose original patent protection is about to expire, developing patented controlled-release products, changing product claims and product labeling, or developing and marketing as over-the-counter products those branded products that are about to face generic competition, when feasible (given that significant new clinical data must be provided to FDA in a “switch” application and some drug products are not safe enough to be sold over-the-counter). Our competitors, which include major multinational corporations, are consolidating in both the branded and generics industries, and the strength of the combined companies could affect our competitive position in all of our business areas. Furthermore, if one of our competitors or its customers acquires any of our customers or suppliers, we may lose business from the customer or lose a supplier of a critical raw material.

 

We may need to raise additional capital that will be required to operate and grow our business, and we may not be able to raise capital on terms acceptable to us or at all.

 

Operating our business and maintaining our growth efforts will require additional cash outlays and capital expenditures. If cash on hand and cash generated from operations are not sufficient to meet our cash requirements, we will need to seek additional capital, potentially through debt or equity financings, to fund our growth. We cannot assure you that we will be able to raise needed cash on terms acceptable to the Company, our significant stockholders, or at all. Financings may be on terms that are dilutive or potentially dilutive to our stockholders, and the prices at which new investors would be willing to purchase our securities may be lower than the current price per share of our common stock. The holders of new securities may also have rights, preferences or privileges which are senior to those of existing holders of common stock. If new sources of financing are required, but are insufficient or unavailable, we will be required to modify our growth and operating plans based on available funding, if any, which would harm our ability to grow our business or even stay in business.

 

Sales of our products may continue to be adversely affected by the continuing consolidation of our distribution network and the concentration of our customer base. The result of such developments could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our ordinary shares to decline.

 

Our principal customers are wholesale drug distributors and major retail drug store chains. These customers comprise a significant part of the distribution network for pharmaceutical products in the U.S. This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions, alliances and partnerships among wholesale distributors and the growth of large retail drug store chains. As a result, a small number of large wholesale distributors control a significant share of the market, and the number of independent drug stores and small drug store chains has decreased. We expect that consolidation of drug wholesalers and retailers will increase pricing and other competitive pressures on drug manufacturers. In addition, the Company generally does not enter into long-term supply agreements with its customers that would require them to purchase our products. The result of these developments may have a material adverse impact on our business, financial position and results of operations, and could cause the market value of our ordinary shares to decline.

 

We face intense competition in the consumer products business.

 

Our business competes with large, well-financed cosmetic, pharmaceutical and consumer products companies with development and marketing groups that are experienced in the industry and possess far greater resources than those available to us. There is no assurance that we can compete successfully against our competitors or that we can develop and market products that will be favorably received in the marketplace.

 

 19 

 

 

Lack of availability, issues with quality or significant increases in the cost of raw materials used in manufacturing our products could adversely impact our profit margins and operating results.

 

Affordable, high quality raw materials and packaging components are essential to our business due to the nature of the products we manufacture. Raw materials and packaging components are generally available from multiple suppliers. Supplies of certain raw materials, and finished goods purchased by us are limited, or are available from one or only a few suppliers that have been pre-approved by FDA for use in the manufacture of our products. In this type of limited-supplier situation, increased prices, rationing and/or shortages can occur. In response to the situation, we try to identify alternative materials or suppliers for such raw materials and finished goods like containers and closures. However, FDA requirements for products approved through the ANDA or NDA process could substantially lengthen the time for approval of an alternate material source. Certain material shortages and approval of alternate sources could adversely affect our financial results. The rapid increase in cost of many raw materials from inflationary forces, such as increased energy costs, and our ability or inability to pass on these increases to our customers, could have a material impact on our financial results.

 

In addition, raw materials purchased from third parties, including those from foreign countries, may contain counterfeit ingredients or other adulterants. We maintain a strict program of verification and product testing throughout the ingredient sourcing and manufacturing process to identify potential counterfeit ingredients, adulterants and toxic substances. Nevertheless, discovery of previously unknown problems with the raw materials or product manufacturing processes or new data suggesting an unacceptable safety risk associated therewith, could result in a voluntary or mandatory withdrawal of a potentially contaminated product from the marketplace, either temporarily or permanently. In addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers or the quality of their products may result in production delays or higher raw material costs. Also, any future recall or removal would result in additional costs to us, and may give rise to product liability or other litigation, either of which could have a material adverse effect on our operating results.

 

Our products, and the raw materials used to make those products, generally have limited shelf lives. Our inventory levels are based, in part, on expectations regarding future sales. We may experience build-ups in inventory if sales slow. Any significant shortfall in sales may result in higher inventory levels of raw materials and finished products, thereby increasing the risk of inventory spoilage and corresponding inventory write-downs and write-offs, which may materially and adversely affect our results of operations. Additionally, labeling changes required for regulatory compliance could render packaging inventories obsolete. Cargo thefts and/or diversions and economically or maliciously motivated product tampering in store shelves may be experienced from time to time, causing unexpected shortages.

 

We depend on a limited number of suppliers for API. Generally, only a single source of API is qualified for use in each product due to the costs and time required to validate a second source of supply. Changes in API suppliers must usually be approved through a Prior Approval Supplement by the FDA.

 

We maintain several single-source supplier relationships, either because alternative sources are not available or because the relationship is advantageous due to regulatory, performance, quality, support, or price considerations. Unavailability or delivery delays of single-source components or products could adversely affect our ability to ship the relevant product in a timely manner. The effect of unavailability or delivery delays would be more severe if associated with our higher volume or more profitable products. Even where alternative sources of supply are available, qualifying the alternate suppliers and establishing reliable supplies could cost more or could result in delays and a loss of revenues. As a result, the loss of a single-source supplier could have a material adverse effect on our results of operations.

 

Incidents related to hazardous materials could materially adversely affect our reputation, business, financial condition, operating results and cash flows.

 

There are portions of our operations that require the controlled use of hazardous materials. Although we are diligent in designing and implementing safety procedures to comply with the standards prescribed by federal, state, and local regulations, the risk of accidental contamination of property or injury to individuals from these materials cannot be completely eliminated. In the event of such an incident, we could be liable for any damages that result, which could materially adversely affect our reputation, business, financial condition, operating results and cash flows.

 

 20 

 

 

We are subject to stringent regulatory requirements. Failure to adhere to such requirements could harm our business and results of operations.

 

In the United States, we and our suppliers of raw materials are also subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other current and potential future federal, state or local regulations. Failure to adhere to such regulations, by either us or our suppliers, could harm our business and results of operations. In addition, our analytical department uses certain hazardous materials and chemicals in limited and controlled quantities. We have implemented safety procedures for handling and disposing of such materials, however, such procedures may not comply with the standards prescribed by federal, state and local regulations. Even if we follow such safety procedures for handling and disposing of hazardous materials and chemicals and such procedures comply with applicable law, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages and any such liability could exceed our resources.

 

Our operations and properties are also subject to a wide variety of increasingly complex and stringent federal, state and local environmental laws and regulations, including those governing the remediation of contaminated soil and groundwater. Such environmental laws may apply to conditions at properties and facilities presently or formerly owned or operated by us, as well as to conditions at properties at which wastes or other contamination attributable to us have been sent or otherwise come to be located. One of our facilities has undergone remediation of environmental contamination, and one of our facilities is currently undergoing remediation of environmental contamination. The total estimated costs for the clean-up and remediation is $0.9 million as of December 31, 2015, and remaining costs accrued at December 31, 2015 totaled $0.1 million. Based on information provided to us from our environmental consultants and what is known to date, we believe the reserves are sufficient for the remaining remediation of the environmental contamination. There is a possibility, however, that the remediation costs may exceed our estimates. In addition, we can give no assurance that the future cost of compliance with existing environmental laws will not give rise to additional significant expenditures or liabilities that would be material to us. Future events, such as new information, changes in existing environmental laws or their interpretation, and more vigorous enforcement policies of federal, state or local regulatory agencies, may have a material adverse effect on our business, financial condition and results of operations.

 

In Canada, we and our suppliers of raw materials are also subject to regulation under Hazardous Products Act, Controlled Products Regulations, Consumer Product Safety Act. Canadian Environmental Protection Act and other current and potential future federal, provincial/territorial or local regulations. Failure to adhere to such regulations, by either us or our suppliers, could harm our business and results of operations. In addition, our analytical department uses certain hazardous materials and chemicals in limited and controlled quantities. We have implemented safety procedures for handling and disposing of such materials, however, such procedures may not comply with the standards prescribed by federal, provincial/territorial and local regulations. Even if we follow such safety procedures for handling and disposing of hazardous materials and chemicals and such procedures comply with applicable law, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages and any such liability could exceed our resources.

 

Future events, such as new information, changes in existing environmental laws or their interpretation, and more vigorous enforcement policies of federal, provincial/territorial or local regulatory agencies, may have a material adverse effect on our business, financial condition and results of operations.

 

We are subject to extensive government regulation by the FDA and other federal, state and local regulatory authorities that increases our costs and could prevent us from marketing or selling our products.

 

The manufacturing, processing, formulation, packaging, labeling, testing, storing, distributing, marketing, advertising and sale of our products, among other things, are subject to extensive regulation by one or more U.S. agencies, including the FDA, the Federal Trade Commission and the Consumer Products Safety Commission, as well as by several state and local agencies in localities where our products are stored, distributed or sold. In addition, we manufacture and market certain of our products in accordance with standards set by organizations, such as the United States Pharmacopeial Convention, or USP, a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the FDA.

 

 21 

 

 

The FDA regulates the testing, manufacture, labeling, marketing and sale of pharmaceutical products. Approval by the FDA is required before any new drug, including any new generic drug, may be marketed or sold in the United States. In order to receive approval from the FDA for our product candidates that are generic versions of brand-name drugs, we intend to use the Abbreviated New Drug Application, or ANDA, route, which requires us to demonstrate to the FDA that each generic product candidate has the same active ingredient, strength, dosage form, route of administration and intended use as a corresponding approved drug product and is bioequivalent to the branded drug product (approved under a New Drug Application, or NDA), meaning that there is no significant difference between the drugs in their rate and extent of absorption in the body. However, if the FDA determines that an ANDA for a generic drug product is not adequate to support approval, it could deny our application or request additional data or information, which could delay approval of the product and impair our ability to compete with the brand-name drug product and/or other generic versions of the product.

 

If our product candidates receive FDA approval through the ANDA process, the labeling claims and marketing statements that we can make for our generic drugs are generally limited to the claims approved by the FDA for use in the brand-name product’s label. In addition, following regulatory approval, the labeling, packaging, adverse event reporting, storage, advertising and promotion for the product will be subject to extensive and ongoing regulatory requirements.

 

As a manufacturer of pharmaceutical products, we must also comply with cGMPs, or current Good Manufacturing Practices, which include requirements related to production processes, quality control and assurance and recordkeeping. Our manufacturing facilities and procedures and those of our suppliers are subject to periodic inspection by the FDA and foreign regulatory agencies. Any material deviations from pharmaceutical cGMPs or other applicable requirements identified during such inspections may result in recalls or other enforcement actions, including warning letters, a delay or suspension in manufacturing operations, consent decrees or civil or criminal penalties. Further, discovery of previously unknown problems with a product or manufacturer may result in restrictions or sanctions, including suspension or withdrawal of marketing approvals, seizures or recalls of products from the market, or civil or criminal fines or penalties, any of which could significantly and adversely affect supplies of our products.

 

We are subject to extensive government regulation by Health Canada and other federal, state provincial/territorial and local regulatory authorities that increases our costs and could prevent us from marketing or selling our products.

 

The manufacturing, processing, formulation, packaging, labeling, testing, storing, distributing, marketing, advertising and sale of our products, among other things, are subject to extensive regulation by one or more Canadian agencies, including Health Canada, as well as by several state and local agencies in localities where our products are stored, distributed or sold. In addition, we market certain of our products in accordance with standards set by organizations, such as the United States Pharmacopeial Convention, or USP, and the British Pharmacopeia, or BP, scientific nonprofit organizations that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Adherence to USP and BP published drug standards are prescribed by the Food and Drug Regulations.

 

Health Canada regulates the testing, manufacture, labeling, marketing and sale of pharmaceutical products. Approval by Health Canada is required before any new drug, including any new generic drug, may be marketed or sold in the Canada. In order to receive approval from Health Canada for our product candidates that are generic versions of brand-name drugs, we intend to use the ANDS,  or Drug Identification Number Application, or DINA, routes, which requires us to demonstrate to Health Canada that each generic product candidate has the same active ingredient, strength, dosage form, route of administration and intended use as a corresponding approved drug product and is bioequivalent to the branded drug product (approved under a New Drug Submission or NDS or Drug Identification Number Application, or DINA), meaning that there is no significant difference between the drugs in their rate and extent of absorption in the body. However, if Health Canada determines that an ANDS or DINA for a generic drug product is not adequate to support approval, it could deny our application or request additional data or information, which could delay approval of the product and impair our ability to compete with the brand-name drug product and/or other generic versions of the product.

 

 22 

 

 

If our product candidates receive Health Canada approval through the ANDS or DINA process, the labeling claims and marketing statements that we can make for our generic drugs are generally limited to the claims approved by Health Canada for use in the brand-name product’s label. In addition, following regulatory approval, the labeling, packaging, adverse event reporting, storage, advertising and promotion for the product will be subject to extensive and ongoing regulatory requirements.

 

As an importer and distributor of pharmaceutical products, we must also comply with cGMPs, or current Good Manufacturing Practices, which include requirements related to production processes, quality control and assurance and recordkeeping. Our facilities and procedures and those of our suppliers are subject to periodic inspection by Health Canada and foreign regulatory agencies. Any material deviations from pharmaceutical cGMPs or other applicable requirements identified during such inspections may result in recalls or other enforcement actions, including non-compliance ratings, a delay or suspension in manufacturing operations. Further, discovery of previously unknown problems with a product or manufacturer may result in restrictions or sanctions, including suspension or withdrawal of marketing approvals, seizures or recalls of products from the market, and revoking of licenses, any of which could significantly and adversely affect supplies of our products.

 

Violations of cGMP and other government regulations could have a material adverse effect on our reputation, business, financial condition and results of operations.

 

All facilities and manufacturing techniques used to manufacture pharmaceutical products for clinical use or for commercial sale in the United States and other Teligent markets must be operated in conformity with cGMP regulations as required by the FDA and other regulatory bodies. Our suppliers’ facilities are subject to scheduled periodic regulatory and customer inspections to ensure compliance with cGMP and other requirements applicable to such products. A finding that we or one or more of our suppliers had materially violated these requirements could result in one or more regulatory sanctions, loss of a customer contract, disqualification of data for client submissions to regulatory authorities and a mandated closing of our suppliers’ facilities, which in turn could have a material adverse effect on our reputation, business, financial condition, operating results and cash flows.

 

During our efforts to expand our existing manufacturing facility, as well as potentially select and build out an additional manufacturing facility, we could experience business interruptions, as well as incur significant capital expenditures to complete the expansions, which may have a material adverse effect on our business, financial position and results of operations.

 

We manufacture drug products at one domestic manufacturing facility. This facility may be forced to shut down or may be unable to operate at full capacity as a result of potential expansion plans. A significant disruption at this facility, even on a short-term basis, could impair our ability to produce and ship drug products to the market on a timely basis, which may have a material adverse effect on our business, financial position and results of operations.

 

We could experience business interruptions at our manufacturing facility, which may have a material adverse effect on our business, financial position and results of operations.

 

We manufacture drug products at one domestic manufacturing facility. This facility may be forced to shut down or may be unable to operate at full capacity as a result of hurricanes, tornadoes, earthquakes, storms and other extreme weather events as well as strikes, war, violent upheavals, terrorist acts and other force majeure events. A significant disruption at this facility, even on a short-term basis, could impair our ability to produce and ship drug products to the market on a timely basis, which may have a material adverse effect on our business, financial position and results of operations.

 

 23 

 

 

Our reporting and payment obligations related to our participation in federal health care programs, including Medicare and Medicaid, are complex and often involve subjective decisions that could change. Any failure to comply with those obligations could subject us to investigation, penalties, and sanctions.

 

Federal laws regarding reporting and payment obligations with respect to a pharmaceutical company’s participation in federal health care programs, including Medicare and Medicaid, are complex. These programs generally require us to pay rebates or provide discounts to government payors in connection with our products that are dispensed to beneficiaries of these programs. In some cases, such as with the Medicaid Drug Rebate Program, the rebates are based on pricing and rebate calculations that we report on a monthly and quarterly basis to the government agencies that administer the programs. Because our processes for calculating applicable government prices and the judgments involved in making these calculations involve subjective decisions and complex methodologies, these calculations are subject to risk of errors and differing interpretations. In addition, they are subject to review and challenge by the applicable governmental agencies, and it is possible that such reviews could result in changes that may have material adverse legal, regulatory, or economic consequences. Responding to current and future changes may increase our costs and the complexity of compliance will be time-consuming, and could have a material adverse effect on our results of operations.

 

In addition, the Office of Inspector General has recently increased its focus on the methodologies used by manufacturers to calculate the average manufacturer price, or AMP, and best price, or BP, to assess manufacturer compliance with reporting requirements under the Medicaid Drug Rebate Program. We are liable for errors associated with our submission of pricing data and for overcharging government payors. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in a civil monetary penalty of $10,000 per day for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the Federal False Claims Act and other laws and regulations.

 

Our policies regarding returns, allowances and chargebacks, failure to supply penalties and marketing programs adopted by wholesalers may reduce revenues in future fiscal periods.

 

We, like other generic drug manufacturers, have agreements with customers allowing chargebacks, product returns, administrative fees, failure to supply penalties and other rebates. Under many of these arrangements, we may match lower prices offered to customers by competitors. If we choose to lower our prices, we generally give the customer a credit on the products that the customer is holding in inventory, which could reduce sales revenue and gross margin for the period the credit is provided. Under many of these arrangements, we may have failure to supply penalties, which in the event we are unable to supply a certain product and are unable to meet the needs of our customers, we may incur failure to supply penalties which may be significant. Like our competitors, we also give credits for chargebacks to wholesalers with whom we have contracts for their sales to hospitals, group purchasing organizations, pharmacies or other customers.  A chargeback is the difference between the price at which we invoice the wholesaler and the price that the wholesaler’s end-customer pays for a product. Although we establish reserves based on prior experience and our best estimates of the impact that these policies may have in subsequent periods, we cannot ensure that our reserves are adequate or that actual product returns, allowances, and chargebacks will not exceed our estimates. As we continue to experience the consolidation of our customers, which may result in changes to previous patterns of ordering and/or pricing of our products, this could disrupt our established methodologies for calculating our provisions for chargebacks and other accruals.

 

We are subject to federal and state healthcare fraud and abuse and false claims laws and may be subject to related litigation brought by the government or private individuals.

 

We are subject to state and federal healthcare laws pertaining to fraud and abuse, physician payment transparency and laws that govern the submission of claims for reimbursement. These laws include the following:

 

  · the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as Medicare and Medicaid. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

 

 24 

 

 

  · the federal False Claims Act, or FCA, which imposes civil liability and criminal fines on individuals or entities that knowingly submit, or cause to be submitted, false or fraudulent claims for payment to the government. The FCA also allows private individuals to bring a suit on behalf of the government against an individual or entity for violations of the FCA. These suits, also known as qui tam actions, may be brought by, with only a few exceptions, any private citizen who believes that he has material information of a false claim that has not yet been previously disclosed. These suits have increased significantly in recent years because the FCA allows an individual to share in any amounts paid to the federal government in fines or settlement as a result of a successful qui tam action;

 

  · federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters;

 

  · the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations to report annually ownership and investment interests held by physicians (as defined above) and their immediate family members and payments or other “transfers of value” to such physician owners and their immediate family members;

 

  · the Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and

 

  · analogous state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

 

If our past or present operations are found to be in violation of any of such laws or any other governmental regulations that may apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from federal health care programs, and/or the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment, or restructuring of our operations could adversely affect our ability to operate our business and our financial results, action against us for violation of these laws, even if we successfully defend against them, it could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

 

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

 

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or the Affordable Care Act, was passed, which substantially changes the way health care is financed by both governmental and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act, among other things, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures.

 

 25 

 

 

Even after our products receive regulatory approval, such products may not achieve expected levels of market acceptance.

 

Even if we are able to obtain regulatory approvals for our generic pharmaceutical products the success of those products is dependent upon market acceptance. Levels of market acceptance for our products could be impacted by several factors, including but not limited to:

 

  · the availability of alternative products from our competitors;

 

  · the price of our products relative to that of our competitors;

 

  · the timing of our market entry;

 

  · the ability to market our products effectively to the different levels in the distribution chain;

 

  · other competitor actions; and

 

  · the continued acceptance of and/or reimbursement for our products by government and private formularies and/or third party payors.

 

Additionally, studies of the proper utilization, safety, and efficacy of pharmaceutical products are being conducted by the industry, government agencies, and others. Such studies, which increasingly employ sophisticated methods and techniques, including methods to investigate the comparative effectiveness of different products used for similar indications, can call into question the utilization, safety, and efficacy of previously marketed as well as future products. In some cases, studies have resulted, and may in the future result, in the discontinuance of product marketing or other risk management programs, such as the need for a patient registry, as well as delays in approvals. The occurrence of any of the above risks could adversely affect our profitability, business, financial position, results of operations and/or cash flow, and could cause the market value of our common stock to decline.

 

Product recalls could harm our business.

 

Product recalls or product field alerts may be issued at our discretion or required by the FDA and Health Canada, other governmental agencies or other companies having regulatory authority for pharmaceutical product sales. From time to time, we may recall products for various reasons, including failure of our products to maintain their stability through their expiration dates or other quality issues. Any recall or product field alert has the potential of damaging our reputation or the reputation of the product. Any significant recalls could materially affect our sales. In these cases, our business, financial condition, results of operations and cash flows could be materially adversely affected.

 

We are susceptible to product liability claims that may not be covered by insurance and could require us to pay substantial sums.

 

We face the risk of loss resulting from, and adverse publicity and reputational harm associated with, product liability lawsuits, whether or not such claims are valid. We may not be able to avoid such claims. In addition, our product liability insurance may not be adequate to cover such claims and we may not be able to obtain adequate insurance coverage in the future at acceptable costs. A successful product liability claim that exceeds our policy limits could require us to pay substantial sums. In addition, product liability coverage for pharmaceutical companies is becoming more expensive and increasingly difficult to obtain and, as a result, we may not be able to obtain the type and amount of coverage we desire or to maintain our current coverage.

 

The manufacture and storage of pharmaceutical and other products are subject to inherent risk.

 

Because chemical ingredients are used in the manufacture of our products and due to the nature of the manufacturing process itself, there is a risk of incurring liability for damages caused by or during the storage or manufacture of both the chemical ingredients and the finished products. Although we have never incurred any material liability for damages of that nature, we may be subject to liability in the future. In addition, while we believe our insurance coverage is adequate, it is possible that a successful claim would exceed our coverage, requiring us to pay a substantial sum.

 

 26 

 

 

Counterfeit versions of our products could harm our patients and reputation.

 

Our industry has been increasingly challenged by the vulnerability of distribution channels to illegal counterfeiting and the presence of counterfeit products in a growing number of markets and over the Internet. Third parties may illegally distribute and sell counterfeit versions of our products that do not meet the rigorous manufacturing and testing standards our products undergo. Counterfeit products are frequently unsafe or ineffective, and can be potentially life-threatening. Counterfeit medicines may contain harmful substances, the wrong dose of the active pharmaceutical ingredient, or API, or no API at all. However, to distributors and patients, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product, and harm the business of companies such as ours. Additionally, it is possible that adverse events caused by unsafe counterfeit products would mistakenly be attributed to the authentic product. In addition, there could be thefts of inventory at warehouses, plants or while in-transit, which are not properly stored and which are sold through unauthorized channels. Public loss of confidence in the integrity of pharmaceutical products as a result of counterfeiting or theft could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.

 

The testing required for the regulatory approval of our products is conducted by independent third parties. Any failure by any of these third parties to perform this testing properly and in a timely manner may have an adverse effect upon our ability to obtain regulatory approvals.

 

Our applications for the regulatory approval of our products incorporate the results of testing and other information that is conducted or gathered by independent third parties (including, for example, manufacturers of raw materials, testing laboratories, contract research organizations or independent research facilities). Our ability to obtain regulatory approval of the products being tested is dependent upon the quality of the work performed by these third parties, the quality of the third parties’ facilities, and the accuracy of the information provided to us by third parties. We have little or no control over any of these factors. If this testing is not performed properly, our ability to obtain regulatory approvals could be restricted or delayed. In addition, if third party fraud or other recordkeeping problems are discovered after our products are approved for marketing, any government investigations or findings could result in any products that incorporated those fraudulent results having their regulatory approvals withdrawn.

 

The failure to obtain, maintain or protect patents, trade secrets, know-how and other intellectual property could impact our ability to compete effectively.

 

To compete effectively, we need to develop and maintain a proprietary position with regard to our own technology, products and business. We rely on a combination of patents, trade secrets, proprietary know-how and other intellectual property to protect our proprietary technology and rights. We also maintain a number of trade secrets, know-how and other intellectual property.

 

The risks and uncertainties that we face with respect to patents and other proprietary rights include the following:

 

  · the pending patent applications we have filed or may file, or to which we have exclusive rights, may not result in issued patents, or may take longer than we expect to result in issued patents;

 

  · changes in U.S. patent laws may adversely affect our ability to obtain or maintain our patent protection;

 

  · we may be subject to interference proceedings;

 

  · the claims of any patents that are issued may not provide meaningful protection;

 

  · we may not be able to develop additional proprietary technologies that are patentable;

 

  · the patents licensed or issued to us or our collaborators may not provide a competitive advantage;

 

 27 

 

 

  · other companies may challenge patents licensed or issued to us or our collaborators;

 

  · other companies may independently develop similar or alternative technologies, or duplicate our technology;

 

  · other companies may design around technologies we have licensed or developed; and

 

  · enforcement of patents is complex, uncertain and expensive.

 

The trademark applications we have filed or may file may not result in trademark registrations, which would result in lesser protections for our brands.

 

If we are unable to effectively enforce our proprietary rights, or if we are found to infringe the rights of others, we may be in breach of our license agreements with our partners.

 

Our success also depends upon trade secrets, proprietary know-how and the skills, knowledge and experience of our personnel. As a result, we require our employees, consultants, advisors, and collaborators to enter into confidentiality agreements that prohibit the disclosure of confidential information to any other parties. We also require our employees and consultants to disclose and assign to us their ideas, developments, discoveries, and inventions. These agreements may not, however, provide adequate protection for our trade secrets, know-how, or other proprietary information in the event of any unauthorized use or disclosure. If any material trade secret or proprietary know-how were to be disclosed to or independently developed by a competitor, our competitive position may be materially harmed.

 

Our product offerings and our customers’ products may infringe on the intellectual property rights of third parties.

 

From time to time, third parties have asserted intellectual property infringement claims against us and our customers and there can be no assurance that third parties will not assert infringement claims against either us or our customers in the future. While we believe that our product offerings do not infringe in any material respect upon proprietary rights of other parties and/or that meritorious defenses would exist with respect to any assertions to the contrary, there can be no assurance that we would not be found to infringe on the proprietary rights of others.

 

Patent applications in the U.S. and some foreign countries are generally not publicly disclosed until they are published or the patent is issued, and we may not be aware of currently filed patent applications that relate to our offerings or processes. If patents later issue on these applications, we may be found liable for subsequent infringement. There has been substantial litigation in the pharmaceutical and biotechnology industries with respect to the manufacture, use and sale of products and processes that are the subject of conflicting patent rights.

 

Any claims that our product offerings or processes infringe these rights, regardless of their merit or resolutions, could be costly and may divert the efforts and attention of our management and technical personnel. We may not prevail in such proceedings given the complex technical issues and inherent uncertainties in intellectual property litigation. If such proceedings result in an adverse outcome, we could, among other things, be required to:

 

  · pay damages in the form of lost profits and/or a reasonable royalty for any infringement;

 

  · pay substantial damages (potentially treble damages in the U.S. if any such infringement is found to be willful);

 

  · pay attorney fees of a prevailing party, if the case is found to be exceptional;

 

  · cease the manufacture, use or sale of the infringing offerings or processes;

 

  · discontinue the use of the infringing technology;

 

  · expend significant resources to design around patented technology and develop non-infringing technology; and

 

 28 

 

 

  · license patented technology from the third party claiming infringement, which license may not be available on commercially reasonable terms, or may not be available at all.

 

In addition, our customers’ products may be subject to claims of intellectual property infringement and such claims could materially affect our business if their products cease to be manufactured and they have to discontinue the use of the infringing technology which we may provide. Further, depending on the particular circumstances of any given claim, it may be the case that we may be responsible for indemnifying our customers for a claim of intellectual property infringement.

 

If we were to assert any of our own intellectual property against third parties and the third parties were found not to infringe our intellectual property or our intellectual property was found to be invalid, and/or unenforceable, we would lose the opportunity to leverage our own intellectual property, for example, through licensing of our technology to others, collection of damages and/or royalty payments based upon successful assertion of our intellectual property rights via enjoining others from practicing the technology at issue.

 

Any of the foregoing could affect our ability to compete or have a material adverse effect on our business, financial condition and results of operations.

 

Significant balances of intangible assets, including goodwill, are subject to impairment testing and may result in impairment charges, which may materially and adversely affect our results of operations and financial condition.

 

A significant amount of our total assets is related to goodwill and intangible assets. As of December 31, 2015 the value of our goodwill and intangible assets net of accumulated amortization was $54.7 million. Goodwill and other intangible assets are tested for impairment annually when events occur or circumstances change that could potentially reduce the fair value of the reporting unit or intangible asset. Impairment testing compares the fair value of the reporting unit or intangible asset to its carrying amount. Any future goodwill or other intangible asset impairment, if any, would be recorded in operating income and could have a material adverse effect on our results of operations and financial condition.

 

The expiration of certain patents related to the Novasome® technology could negatively impact our ability to generate income from the Novasome products.

 

We have licensed certain patents related to the Novasome® technology platform pursuant to a license agreement. Many of the patents under this license have expired. The loss of patent protection could allow additional competition. To the extent such competition develops, it could negatively impact the income we generate from the Novasome® technology platform.

 

We may not be able to fully realize the expected benefits from the acquisition of certain products and or companies.

 

Our recent acquisition of certain products and a company subjects us to additional operational and financial risks, including the following:

 

  · additional costs that we may need to incur in order to return the products to the market and to comply with regulatory requirements;

 

  · difficulties in coordinating research and development activities;

 

  · uncertainties in the business relationships with our customers and suppliers; and

 

  · lack of previous experiences in manufacturing, commercializing, and distributing products in therapeutic areas outside of the topical generic pharmaceutical market and in markets outside of the United States.

 

 29 

 

 

Our approved products may not achieve commercialization at levels of market acceptance that allow us to achieve profitability, which could have a material adverse effect on our business, financial position and results of operations.

 

We seek to develop, license or acquire products that we can commercialize at levels of market acceptance that would allow us to recoup the costs of development and commercialization, grow market share, and achieve profitability. Even if we are able to obtain regulatory approvals for certain pharmaceutical products, if we fail to accurately predict demand for such products, our business, financial position, and results of operations could be adversely impacted. Levels of market acceptance for products could be impacted by several factors, including but not limited to:

 

  · the availability of alternative products from our competitors;

 

  · the price of our products relative to that of our competitors;

 

  · the effectiveness of our marketing relative to that of our competitors;

 

  · the timing of our market entry;

 

  · the ability to market our products effectively to the retail level; and

 

  · the acceptance of our products by government and private formularies.

 

Some of these factors are not within our control and, if any arises, our profitability, business, financial position and results of operations could be materially adversely affected.

 

Future acquisitions and investments could disrupt our business and harm our financial condition and operating results.

 

Our growth will depend, in part, on our continued ability to develop, commercialize and expand our drug products, including in response to changing regulatory and competitive pressures. In some circumstances, we accelerate our growth through the acquisition of complementary products and technologies rather than through internal development. The identification of suitable products to be acquired can be difficult, time-consuming and costly, and we may not be able to successfully complete or successfully execute strategies for identified acquisitions. The risks faced in connection with acquisitions include:

 

  · diversion of management time and focus from operating our business to addressing acquisition and/or product integration challenges;

 

  · coordination of research and development and sales and marketing functions;

 

  · retention of key employees from the acquired company;

 

  · integration of the acquired company’s accounting, management information, human resources and other administrative systems;

 

  · the need to implement or improve controls, procedures, and policies at a business that prior to the acquisition may have lacked effective controls, procedures and policies;

 

  · liability for activities of the acquired company and/or products before the acquisition, including patent infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities;

 

  · unanticipated write-offs or charges; and

 

  · litigation or other claims in connection with the acquired company or product, including claims from product users, former stockholders or other third parties.

 

 30 

 

 

In any acquisition that we may undertake, our failure to address these risks or other problems encountered in connection with any acquisitions and investments could cause us to fail to realize the anticipated benefits of these acquisitions or investments, cause us to incur unanticipated liabilities, and harm our business generally.

 

We may become involved in legal proceedings from time to time which may result in losses, damage to our business and reputation and place a strain on our internal resources.

 

In the ordinary course of our business, we may be involved in legal proceedings with both private parties and certain government agencies, including FDA. Enforcement actions and litigation may result in verdicts against us, which may include significant monetary awards, judgments that certain of our intellectual property rights are invalid or unenforceable and injunctions preventing the manufacture, marketing and sale of our products. If disputes are resolved unfavorably, our business, financial condition and results of operations may be adversely affected.

 

Any government enforcement action or litigation, whether or not successful, may damage our reputation. Furthermore, we are likely to incur substantial expense in defending these actions and lawsuits, and the time demands of such enforcement actions and lawsuits could divert management’s attention from ongoing business concerns and interfere with our normal operations.

 

In the normal course of business, we periodically enter into employment agreements, legal settlements, and other agreements which incorporate indemnification provisions. We maintain insurance coverage which we believe will effectively mitigate our obligations under these indemnification provisions. However, should our obligation under an indemnification provision exceed our coverage or should coverage be denied, it could have a material adverse effect on our business, financial position and results of operations.

 

Our business and operations would suffer in the event of system failures.

 

Despite the implementation of security measures, our internal computer systems are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our product development programs. To the extent that any disruption or security breach results in a loss or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur liability and the further development of our product candidates may be delayed.

 

In addition, we rely on complex information technology systems, including Internet-based systems, to support our supply chain processes as well as internal and external communications. The size and complexity of our systems make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes that may result in the loss of key information or the impairment of production and other supply chain processes. Such disruptions and breaches of security could adversely affect our business.

 

Compliance with ongoing post-marketing obligations for our approved ANDAs, NDAs, NDSs, and ANDSs may uncover new safety information that could give rise to a product recall, updated warnings, or other regulatory actions that could have an adverse impact on our business.   

 

After FDA or Health Canada approve a drug for marketing under an NDA, ANDA, NDS, or ANDS, the product’s sponsor must comply with several post-marketing obligations that continue until the product is discontinued.  These post-marking obligations include the prompt reporting of serious adverse events to the agency, the submission of product-specific annual reports that include changes in the distribution, manufacturing, and labeling information, and notification when a drug product is found to have significant deviations from its approved manufacturing specifications (among others).  Our ongoing compliance with these types of mandatory reporting requirements could result in additional requests for information from FDA or Health Canada and, depending on the scope of a potential product issue that FDA or Health Canada may decide to pursue, potentially also result in a request from the agency to conduct a product recall or to strengthen warnings and/or revise other label information about the product.  Any of these post-marketing regulatory actions could materially affect our sales and, therefore, they have the potential to adversely affect our business, financial condition, results of operations and cash flows.

 

 31 

 

 

Economic conditions could severely impact us.

 

Current economic conditions may cause a decline in business and consumer spending which could adversely affect our business and financial performance. Our operating results are impacted by the health of the North American economies. Our business and financial performance, including collection of our accounts receivable, realization of inventory, recoverability of assets including investments, may be adversely affected by current and future economic conditions, such as a reduction in the availability of credit, financial market volatility and recession.

 

Adverse conditions in the economy and disruption of financial markets could negatively impact our customers and therefore our results of operations.

 

An economic downturn in the businesses or geographic areas in which we sell our products could reduce demand for these products and result in a decrease in sales volume that could have a negative impact on our results of operations. Volatility and disruption of financial markets could limit our customers’ ability to obtain adequate financing or credit to purchase and pay for our products in a timely manner, or to maintain operations, and result in a decrease in sales volume that could have a negative impact on our results of operations. Additionally, economic conditions and market turbulence may also impact our suppliers causing them to be unable to supply in a timely manner sufficient quantities of product components, thereby impairing our ability to manufacture on schedule and at commercially reasonable costs.

 

If the U.S. economy rapidly contracts or expands, we may have difficulty quickly scaling our operations in response, which may negatively impact our business and financial position.

 

If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.

 

We will need to hire additional qualified personnel with expertise in nonclinical testing, government regulation, formulation and manufacturing, sales and marketing and finance. We compete for qualified individuals with numerous pharmaceutical and consumer products companies, universities and other research institutions. Competition for such individuals is intense, and we cannot be certain that our search for such personnel will be successful. Attracting and retaining qualified personnel will be critical to our success.

 

Our ability to market products successfully depends, in part, upon the acceptance of the products not only by consumers, but also by independent third-parties.

 

Our ability to market generic pharmaceutical products successfully depends, in part, on the acceptance of the products by independent third-parties (including pharmacies, government formularies, managed care providers, insurance companies and retailers), as well as patients. In addition, unanticipated side effects or unfavorable publicity concerning any of our products, or any brand-name product of which our generic product is the equivalent, could have an adverse effect on our ability to achieve acceptance by managed care providers, pharmacies and other retailers, customers and patients.

 

If we are unable to satisfy regulatory requirements relating to internal controls, our stock price could suffer.

 

Section 404 of the Sarbanes-Oxley Act of 2002 requires companies to conduct a comprehensive evaluation of the effectiveness of their internal control over financial reporting. At the end of each fiscal year, we must perform an evaluation of our internal control over financial reporting, include in our annual report the results of the evaluation and have our external auditors also publicly attest to the effectiveness of our internal control over financial reporting. If material weaknesses are found in our internal controls in the future, if we fail to complete future evaluations on time or if our external auditors cannot attest to the effectiveness of our internal control over financial reporting, we could fail to meet our regulatory reporting requirements and be subject to regulatory scrutiny and a loss of public confidence in our internal controls, which could have an adverse effect on our stock price.

 

 32 

 

 

Currency fluctuations and changes in exchange rates could adversely affect our business, financial condition, results of operations, cash flows, and/or common stock price.

 

Although we report our financial results in U.S. Dollars, a portion of our revenues and other liabilities and our costs are denominated in non-U.S. currencies, including the Euro and Canadian Dollar. Our results of operations and, in some cases, cash flows, have in the past been and may in the future be adversely affected by certain movements in currency exchange rates. The occurrence of any of the above risks could cause a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.

 

Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited.

 

As of December 31, 2015, we had federal net operating loss carry forwards, or NOLs, of approximately $35.6 million which expire from 2020 through 2032. Our ability to utilize our NOLs may be limited under Section 382 of the Internal Revenue Code. The limitations apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders increase their aggregate ownership by more than 50 percentage points over their lowest ownership percentage in a testing period (typically three years). Our ability to use net operating loss carry forwards is subject to substantial limitation in future periods under certain provisions of Section 382 of the Internal Revenue Code, which limit the utilization of net operating losses upon a more than 50% change in ownership of our stock that is held by 5% or greater stockholders. We examined the application of Section 382 with respect to an ownership change that took place during 2010, as well as the limitation on the application of net operating loss carry forwards. We believe that operating losses subsequent to the change date in 2010 (aggregating $15.1 million) are not subject to Section 382 limitations. We have estimated that the annual limitation starting in 2010 aggregates from $1.0 million to $2.3 million per year including the effect of amortization of built in gains.

 

Risks Related to Our Common Stock

 

Shares of our common stock can be relatively illiquid which may affect the trading price of our common stock.

 

For the twelve months ended December 31, 2015, the average daily trading volume of our common stock on the NYSE MKT (from January 2, 2015 through October 23, 2015) and subsequently on the NASDAQ Global Select Market following the transfer of our listing (from October 26, 2015 through December 31, 2015) was approximately 702,000 shares. As a result of our relatively small public float, our common stock may be less liquid than the stock of companies with broader public ownership. Among other things, trading of a relatively small volume of our common stock may have a greater impact on the trading price for our shares than would be the case if our public float were larger.

 

We have not paid dividends to our common stockholders in the past nor do we expect to pay dividends in the foreseeable future, and any return on investment may be limited to potential future appreciation on the value of our common stock.

 

We currently intend to retain any future earnings to support the development and expansion of our business and do not anticipate paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our Board of Directors after taking into account various factors, including without limitation, our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. To the extent we do not pay dividends, our stock may be less valuable because a return on investment will only occur if and to the extent our stock price appreciates, which may never occur. In addition, investors must rely on sales of their common stock after price appreciation as the only way to realize their investment, and if the price of our stock does not appreciate, then there will be no return on investment. Investors seeking cash dividends should not purchase our common stock.

 

If we fail to comply with the reporting obligations of the Exchange Act and Section 404 of the Sarbanes-Oxley Act of 2002, or if we fail to achieve and maintain adequate disclosure controls and procedures and internal control over financial reporting, our business results of operations and financial condition, and investors’ confidence in us, could be materially adversely affected.

 

As a public company, we are required to comply with the periodic reporting obligations of the Exchange Act including preparing annual reports, quarterly reports and current reports. Our failure to prepare and disclose this information in a timely manner could subject us to penalties under federal securities laws, expose us to lawsuits and restrict our ability to access financing. In addition, we are required under applicable law and regulations to integrate our systems of disclosure controls and procedures and internal control over financial reporting. Our management assessed our existing disclosure controls and procedures as of December 31, 2015 and December 31, 2014, and our management concluded that our disclosure controls and procedures were effective as of such times. The year ended December 31, 2014 was the first year in which we were required to have our external auditors issue an attestation report on the effectiveness of internal controls over financial reporting.

 

 33 

 

 

If we fail to achieve and maintain the adequacy of our disclosure controls and procedures and internal control over financial reporting, we may not be able to ensure that we can conclude that we have effective disclosure controls and procedures and internal control over financial reporting in accordance with the Sarbanes-Oxley Act of 2002. Moreover, effective disclosure controls and procedures and internal control over financial reporting are necessary for us to produce reliable financial reports and are important to help prevent fraud. As a result, our failure to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 on a timely basis could result in the loss of investor confidence in the reliability of our financial statements, which in turn could harm our business and negatively impact the trading price of our common stock.

 

Our principal stockholders, directors and executive officers own a significant percentage of our stock and will be able to exercise significant influence over our affairs.

 

Our current principal stockholders, directors and executive officers own in the aggregate a significant portion of the voting power of our capital stock. As a result, these stockholders, if acting together, would be able to influence or control matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions. They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock. If such stockholders sold a significant amount of stock it could have an adverse effect on the price of the stock.

 

Due to the concentration of common stock owned by significant stockholders, the sale of such stock might adversely affect the price of our common stock.

 

Our largest stockholders own shares of common stock that have been registered for resale under the Securities Act. The sale of such stock, depending on the interplay of numerous factors, including, without limitation, the method and timing of the sales, could substantially depress the value of our common stock.

 

Our stock price is, and we expect it to remain, volatile and subject to wide fluctuations, which may make it difficult for stockholders to sell shares of common stock at or above the price for which they were acquired.

 

Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit. During the last two fiscal years, our stock price has closed at a low of $2.93 in the first quarter of 2014 and a high of $12.05 in the first quarter of 2015. The volatile price of our stock makes it difficult for investors to predict the value of their investment, to sell shares at a profit at any given time, or to plan purchases and sales in advance. A variety of factors may affect the market price of our common stock. These include, but are not limited to:

 

  · publicity regarding actual or potential clinical results relating to products under development by our competitors or us;

 

  · delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials;

 

  · achievement or rejection of regulatory approvals by our competitors or us;

 

  · announcements of technological innovations or new commercial products by our competitors or us;

 

  · developments concerning proprietary rights, including patents;

 

  · developments concerning our collaborations;

 

 34 

 

 

  · regulatory developments in the U.S. and foreign countries;

 

  · economic or other crises, especially given the recent financial deterioration in the markets in which we compete, and other external factors;

 

  · stock market price and volume fluctuations of other publicly traded companies and, in particular, those that are in the cosmetic, pharmaceutical and consumer products industry;

 

  · actual or anticipated sales of our common stock, including sales by our directors, officers or significant stockholders;

 

  · period-to-period fluctuations in our revenues and other results of operations;

 

  · speculation about our business in the press or the investment community;

 

  · changes in financial estimates by us or by any securities analysts who might cover our stock; and

 

  · sales of our common stock, including sales by our significant holders.

 

In the past, securities class action litigation has often been instituted against companies following periods of volatility in their stock price. This type of litigation, even if it does not result in liability for us, could result in substantial costs to us and divert management’s attention and resources.

 

If we fail to meet the continued listing standards of the NASDAQ Global Select Market, our common stock could be delisted and our liquidity and stock price could suffer.

 

Our common stock is listed on the NASDAQ Global Select Market, a national securities exchange, which imposes continued listing requirements with respect to listed shares. If we fail to meet the continued listing standards of the NASDAQ Global Select Market, our common stock could be delisted and our stock price could suffer. A delisting of our shares of common stock could negatively impact us by further reducing the liquidity and market price of our shares of common stock and the number of investors willing to hold or acquire our shares of common stock, which could negatively impact our ability to raise equity financing.

 

Risks Related to the Notes

 

We may not have the ability to raise the funds necessary to settle conversions of the Notes, purchase the Notes as required pursuant to the terms of the indenture governing the Notes or pay the redemption price for any Notes we redeem, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Notes.

 

On December 16, 2014, we completed the sale of $125 million aggregate principal amount of our 3.75% Convertible Senior Notes due 2019, or the Notes, to Deutsche Bank Securities Inc. and J.P. Morgan Securities LLC as the initial purchasers and on December 22, 2014, we issued to the initial purchasers an additional $18.75 million aggregate principal amount of the Notes. Pursuant to the terms of the indenture governing the Notes, following certain events, holders of Notes will have the right to require us to purchase their Notes for cash. Such event may also constitute an event of default or prepayment under, and result in the acceleration of the maturity of, our then-existing indebtedness. We cannot assure you that we will have sufficient financial resources, or will be able to arrange financing, to pay the purchase price in cash with respect to any Notes surrendered by holders for purchase at that time, make cash payments upon conversions or pay the redemption price for any Notes we redeem. In addition, restrictions in our then existing credit facilities or other indebtedness, if any, may not allow us to purchase the Notes (even if required pursuant to the terms of the indenture), make cash payments upon conversions of the Notes or pay the redemption price for any Notes we redeem would result in an event of default with respect to the Notes which could, in turn, constitute a default under the terms of our other indebtedness, if any. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and purchase the Notes, make cash payments upon conversions thereof or pay the redemption price for any Notes we redeem.

 

 35 

 

 

Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our debt.

 

Our ability to make scheduled payments of the principal of, to pay interest on, to pay any cash due upon conversion of or to refinance our indebtedness, including the Notes, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not continue to generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.

 

To the extent we issue shares of our common stock to satisfy all or a portion of our conversion obligation, conversions of the Notes will dilute the ownership interest of our existing stockholders, including holders who had previously converted their Notes.

 

The holders of our Notes can require us, under certain circumstances, to convert their Notes. We have the option to satisfy this conversion obligation with cash, shares of our common stock or a combination of cash and shares of our common stock at our election. To the extent we issue shares of our common stock to satisfy all or a portion of our conversion obligation, the conversion of some or all of the Notes will dilute the ownership interests of our existing stockholders. Any sales in the public market of our common stock issuable upon such conversion could adversely affect prevailing market prices of our common stock. In addition, the existence of the Notes may encourage short selling by market participants because the conversion of the Notes could depress the price of our common stock.

 

Our substantial indebtedness could materially adversely affect our business, financial condition or results of operations and prevent us from fulfilling our obligations under the Notes.

 

After giving effect to the issuance of the Notes, we will have a substantial amount of indebtedness. As of December 31, 2015, our total consolidated indebtedness was $143.7 million. Our substantial level of indebtedness increases the possibility that we may be unable to generate cash sufficient to pay, when due, the principal of, interest on, or other amounts due in respect of our indebtedness. Our substantial indebtedness, combined with our other financial obligations and contractual commitments, may have a material adverse impact on us. For example, it could

 

  · make it difficult for us to satisfy our obligations with respect to our outstanding and other future debt obligations;

 

  · increase our vulnerability to general adverse economic conditions or a downturn in the industries in which we operate;

 

  · impair our ability to obtain additional financing in the future for working capital, investments, acquisitions and other general corporate purposes;

 

  · require us to dedicate a substantial portion of our cash flows to the payment to our financing sources, thereby reducing the availability of our cash flows to fund working capital, investments, acquisitions and other general corporate purposes; and

 

  · place us at a disadvantage compared to our competitors.

  

 36 

 

 

We will continue to have the ability to incur debt; if we incur substantial additional debt, these higher levels of debt may affect our ability to pay the principal of and interest on the Notes.

 

We and our subsidiaries may be able to incur substantial additional debt in the future, subject to the restrictions contained in our debt instruments, some of which may be secured debt. The indenture governing the Notes does not restrict our ability to incur additional indebtedness or require us to maintain financial ratios or specified levels of net worth or liquidity. If we incur substantial additional indebtedness in the future, these higher levels of indebtedness may affect our ability to pay the principal of and interest on the Notes, or any fundamental change purchase price or any cash due upon conversion, and our creditworthiness generally.

 

Item 1B.UNRESOLVED STAFF COMMENTS

 

None.

 

Item 2.PROPERTIES

 

The Company’s executive administrative offices are located in Buena, New Jersey, in two facilities of approximately 33,000 square feet built on 8.44 acres of land in 1995, which we own. This facility is also used for production, product development, marketing and warehousing for our own generic prescription pharmaceutical products and pharmaceutical, cosmeceutical and cosmetic products. We believe this facility is in good operating condition and adequately serving our current needs. The Company owns four acres of land adjacent to our main facility that can be used for future expansion. We lease an additional 11,000 square feet of warehouse space in Vineland, New Jersey, and lease approximately 7,500 square feet of corporate office space in Iselin, New Jersey, and will soon occupy approximately 4,000 square feet of office space in Toronto, Canada. The Company currently subleases office space in Toronto, Canada.

 

Item 3.LEGAL PROCEEDINGS

 

On March 2, 2001, the Company became aware of environmental contamination resulting from an unknown heating oil leak at its former manufacturing facility. The Company immediately notified the New Jersey Department of Environmental Protection, or NJ DEP, and the local authorities, and hired a contractor to assess the exposure and required clean up. The total estimated costs for the clean-up and remediation was $889,000, of which approximately $123,000 remains accrued as of December 31, 2015. Based on information provided to the Company from its environmental consultant and what is known to date, the Company believes the reserve is sufficient for the remaining remediation of the environmental contamination. There is a possibility, however, that the remediation costs may exceed the Company’s estimates.

 

 37 

 

 

The restricted cash, included in other assets on the Consolidated Balance Sheet of $124,000 as of December 31, 2015 and $54,000 as of December 31, 2014, represents a restricted escrow account set up on the requirement of the NJ DEP for the soil remediation work. These funds will be released to the Company upon the NJ DEP approval when the remediation is completed.

 

On December 19, 2013, we filed a complaint in the United States District Court for the District of Delaware against Mallinckrodt LLC, Mallinckrodt, Inc. and Nuvo Research Inc., which we collectively refer to as Mallinckrodt, seeking a declaration of non-infringement of United States Patent Nos. 8,217,078 and 8,546,450 so that we can bring our generic diclofenac sodium topical solution 1.5% to market at the earliest possible date under applicable statutory and FDA regulatory provisions. On January 10, 2014, Mallinckrodt filed an answer and counterclaim alleging that we infringed the patents at issue. On June 26, 2014, we entered into a settlement agreement with Mallinckrodt, pursuant to which Mallinckrodt granted us a non-exclusive license to launch our diclofenac sodium topical solution 1.5% product on March 28, 2015.  There was no material impact on our financial statements as a result of the settlement. We received tentative approval to sell our diclofenac sodium topical solution 1.5% from the FDA on May 7, 2014.

 

On May 21, 2015, Horizon Pharma Ireland Limited, HZNP Limited and Horizon Pharma USA, Inc., which we collectively refer to as Horizon, filed a complaint in the United States District Court for the District of New Jersey against us alleging infringement of certain United States patents based upon our submission to the FDA of an ANDA seeking FDA approval to market diclofenac topical solution 2% w/w before the expiration of the patents asserted in the complaint. On June 30, 2015, August 11, 2015, September 17, 2015, October 27, 2015 and February 5, 2016, Horizon filed additional complaints in the United States District Court for the District of New Jersey against the Company alleging infringement of other of its United States patents in relation to the Company’s submission of the same ANDA. On July 21, 2015, September 11, 2015, October 6, 2015, October 21, 2015 and December 17, 2015, we filed answers, affirmative defenses and counterclaims with respect to the first five complaints filed by Horizon.  In those filings, we asserted that the patents alleged to be infringed in the complaints filed by Horizon are invalid and not infringed by us. We believe the complaint has no merit, and we intend to continue to vigorously defend our position. Based on the early stage of these complaints and counterclaims, we are unable to predict the outcome

 

On December 4, 2015, Galderma Laboratories, L.P. and Galderma S.A., which we collectively refer to as Galderma, filed a complaint in the United States District Court for the Northern District of Texas against us alleging infringement of United States Patent No. 6,106,848 based upon our submission to the FDA of an ANDA seeking FDA approval to market clobetasol propionate lotion 0.05% before the expiration patent asserted in the complaint. On January 5, 2016, Galderma and the Company entered into a Settlement and License Agreement, the terms of which are confidential. On January 22, 2016, the case was dismissed with prejudice.

 

Item 4.MINE SAFETY DISCLOSURES

 

Not applicable.

 

 38 

 

 

PART II

 

Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

We transferred the listing of our common stock from the NYSE MKT to the NASDAQ Global Select Market. Our common stock ceased trading on the NYSE MKT under the symbol “IG” at the close of business on October 23, 2015 and began trading on the NASDAQ Global Select Market under the symbol “TLGT” on October 26, 2015.

 

The following table sets forth, for the periods indicated, the high and low sales prices for our common stock, as reported by the NYSE MKT and the NASDAQ Global Select Market, as applicable.

 

   Common Stock 
   High   Low 
2015:          
First Quarter   12.05    7.75 
Second Quarter   9.40    4.75 
Third Quarter   8.98    6.13 
Fourth Quarter   9.18    5.90 
2014:          
First Quarter   6.14    2.93 
Second Quarter   6.07    3.84 
Third Quarter   9.89    4.94 
Fourth Quarter   11.28    7.60 

 

Stockholders

 

As of March 10, 2016, there were approximately 410 stockholders of record of the 53,005,689 outstanding shares of common stock.

 

Dividends

 

We have not paid cash dividends to our stockholders since inception and we do not plan to pay cash dividends in the foreseeable future. We currently intend to retain earnings, if any, to finance the growth of the Company.

 

Equity Compensation Plans

 

The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.

 

 39 

 

 

Performance Graph

 Comparison of Cummulative Total Return among Teligent, Inc.,

the S&P500 Index and the Dow Jones - US Healthcare Index

 

 

Unregistered Sales of Securities

 

None.

 

Issuer Purchases of Equity Securities

 

None.

 

 40 

 

 

 

Item 6. SELECTED FINANCIAL DATA

 

The following table sets forth consolidated financial data with respect to the Company for each of the five-year periods ended December 31. The selected financial data for each of the five-year periods ended December 31 have been derived from the consolidated financial statements of the Company, which financial statements have been audited by EisnerAmper LLP, independent registered public accounting firm. The foregoing consolidated financial statements and the report thereon are included elsewhere in this Annual Report on Form 10-K. The information below should be read in conjunction with the consolidated financial statements (and notes thereon) and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in Item 7.

 

   As of and For the Years Ended December 31, 
   2015   2014   2013   2012   2011 
(In thousands, except per share data)                         
Revenues  $44,250   $33,740   $18,224   $8,563   $7,806 
Gross profit   21,315    16,972    6,145    2,776    2,260 
Operating income (loss)   (3,192)   3,906    (82)   (3,136)   (2,969)
Interest and other non-operating income (expense)   9,895    1,518    (199)   (975)   (264)
Pretax income (loss)   6,703    5,424    (281)   (4,111)   (3,233)
Income tax provision (benefit)   35    173    (197)   (184)   (226)
Net income (loss)  $6,668   $5,251   $(84)  $(3,927)  $(3,007)
Preferred stock dividend   -    -    (1,308)   -    - 
Net income (loss) attributable to common stockholders  $6,668   $5,251   $(1,392)   (3,927)  $(3,007)
Weighted average shares outstanding:                         
Basic   52,873    49,818    43,518    39,786    39,449 
Diluted   67,112    64,207    43,518    39,786    39,449 
PER SHARE:                         
Net income (loss):                         
Basic   0.13    0.11    (0.03)   (0.10)   (0.08)
Diluted   (0.07)   0.09    (0.03)   (0.10)   (0.08)
                          
Share Price: High   12.05    11.28    3.39    1.48    1.8 
Low   4.75    2.93    1    0.94    0.85 
BALANCE SHEET DATA:                         
Current assets  $116,801   $177,218   $10,558   $6,139   $5,686 
Net property, plant & equipment   8,706    3,262    2,623    2,691    2,800 
Total assets   184,762    197,078    15,427    9,427    9,636 
Current liabilities   10,768    13,002    5,221    1,976    1,316 
Long-term obligations, less current installments   107,235    144,942    3,015    1,024    555 
Shareholders’ equity   66,759    39,134    7,191    6,427    7,765 
CASH FLOW DATA:                         
Cash used in operating activities  $(15,513)  $(3,891)  $(618)  $(2,373)  $(2,394)
Cash used in investing activities   (53,068)   (3,792)   (2,113)   (342)   (350)
Cash provided by financing activities   (3,111)   164,465    2,296    2,337    542 
Increase/(Decrease) in cash and cash equivalents   (71,692)   156,782    (435)   (378)   (2,202)

 

 41 

 

 

Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Forward-Looking Statements

 

This “Management’s Discussion and Analysis of Financial Condition and Results of Operation” section and other sections of this Annual Report on Form 10-K contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and on management’s beliefs and assumptions. In addition, other written or oral statements, which constitute forward-looking statements, may be made by or on behalf of the Company. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance, and involve certain risks, uncertainties and assumptions, which are difficult to predict. See “Item 1A: Risk Factors” above. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Company Overview

 

Strategic Overview

 

Teligent, Inc., or the Company, is a specialty generic pharmaceutical company. Our mission is to become a leader in the specialty generic pharmaceutical market. Under our own label, we currently market and sell generic topical and branded generic injectable pharmaceutical products in the United States and Canada.  In the United States we are currently marketing eight generic topical pharmaceutical products and four branded generic pharmaceutical products.  Through the completion of an acquisition, we now sell a total of seventeen generic and branded generic injectable products and medical devices in Canada.  Generic pharmaceutical products are bioequivalent to their brand name counterparts.  We also provide development, formulation, and manufacturing services to the pharmaceutical, over-the-counter, or OTC, and cosmetic markets.  We operate our business under one segment. Effective October 23, 2015, we changed our name from IGI Laboratories, Inc. to Teligent, Inc.  On October 26, 2015, our common stock, which was previously listed on the NYSE MKT, began trading on the NASDAQ Global Select Market under the trading symbol “TLGT.”  Our office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey.

 

Currently, we have two platforms for growth:

 

·Developing, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms; and

 

·Managing our current contract manufacturing and formulation services business.

 

We have been in the contract manufacturing and development of topical products business since the early 1990s, but our strategy since 2010 has been focused on the growth of our own generic pharmaceutical business. Since 2010, we have focused on transitioning our business to include more customers in the topical pharmaceutical industry. In 2014, we broadened our target product focus from topical pharmaceuticals to include a wider specialty pharmaceutical approach. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, complex generics and ophthalmic generics (what we call our “TICO strategy”), will leverage our existing expertise and capabilities, and broaden our platform for more diversified strategic growth.

 

 42 

 

 

As of the date of this report, we have acquired 25 drug products that have been previously approved by the FDA. Our pipeline includes 31 Abbreviated New Drug Applications, or ANDAs filed with the United States Food and Drug Administration, or FDA, for additional pharmaceutical products. In addition, we have four abbreviated new drug submissions, or ANDS, on file with Health Canada. We have an additional 39 product candidates at various stages of our development pipeline, ten of which are on stability testing. In December 2015, we announced the approval by the FDA of Cefotan® (Cefotan for Injection). This was our first product approved from the portfolio of discontinued and withdrawn new drug applications, or NDAs, and ANDAs that we purchased from Astra Zeneca on September 25, 2014. We have also experienced an increased rate of review by the FDA of applications filed in Generic Drug User Fee Amendments, or GDUFA, Year 3 and Year 4, which began October 1, 2014, and October 1, 2015, respectively. We submitted fifteen topical ANDAs in 2015. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA and the subsequent launch of products as these applications are approved. Our target is to file at least fifteen ANDAs in total in 2016 through our internal product development program, and we plan to file at least eight ANDSs with Health Canada in 2016. We will also seek to license or acquire further products, intellectual property, or pending applications to expand our portfolio.

 

Effective October 26, 2015, we transferred the listing of our common stock from the NYSE MKT to the NASDAQ Global Select Market. Our common stock ceased trading on the NYSE MKT under the symbol “IG” at the close of business on October 23, 2015 and began trading on the NASDAQ Global Select Market under the symbol “TLGT” on October 26, 2015.

 

On November 13, 2015, we acquired all of the rights, title and interest in the development, production, marketing, import and distribution of all pharmaceutical products of Alveda Pharmaceuticals Inc., or Alveda, pursuant to two asset purchase agreements, one relating to the acquisition of all of the intellectual property-related assets of Alveda and the other relating to the acquisition of all other assets of Alveda.

 

We also develop, manufacture, fill, and package topical semi-solid and liquid products for branded and generic pharmaceutical customers, as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. We are currently exploring various options to enable us to expand our development and manufacturing capabilities to include sterile injectable and ophthalmic products.

 

Results of Operations

 

Fiscal Year 2015 Compared to Fiscal Year 2014

 

We had net income of $6,668,000 in 2015 compared to net income of $5,251,000 in 2014. Net income attributable to common stockholders was $6,668,000, or $0.13 per basic share in 2015, and net income applicable to common stockholders was $5,251,000, or $0.11 per share, in 2014:

 

Revenues (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
Components of Revenue:  2015   2014   $   % 
Product sales  $43,497   $32,104   $11,393    35%
Research and development income   578    1,490    (912)   (61)%
Licensing, royalty, and other income   175    146    29    20%
Total Revenues  $44,250   $33,740   $10,510    31%

 

The increase in product sales for the year ended December 31, 2015 as compared to the same period in 2014 was primarily due to the increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, the launch of an additional Company label product in July 2015, the purchase of three commercialized injectable products in October 2015 and the launch of two additional Company label products in June 2014. There was a decrease in product sales in our contract services business to three of our pharmaceutical customers and one cosmetic customer, which was only partially offset by increased sales to three of our pharmaceutical customers. Research and development income will not be consistent and will vary, from period to period, depending on the required timeline of each development project. Licensing, royalty and other revenue decreased slightly due to a decrease in other revenue, while licensing and royalty revenue remained the same.

 

 43 

 

 

Costs and expenses (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
   2015   2014   $   % 
Cost of revenues  $22,935   $16,948   $5,987    35%
Selling, general and administrative   11,336    5,976    5,360    90%
Product development and research   13,171    6,910    6,261    91%
Totals costs and expenditures  $47,442   $29,834   $17,608    59%

 

Cost of sales increased for the year ended December 31, 2015 as compared to the same period in 2014 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 52% for the year ended December 31, 2015 as compared to 50% for 2014. During 2015, approximately 86% of our revenue from contract and formulation services came from pharmaceutical customers as compared to 79% in 2014. Our research and development income results primarily from services rendered under contractual agreements and, therefore, cost of sales as a percentage of our research and development income is relatively low. Consistent with our strategy, we expect cost of sales as a percentage of total revenue to decline over time.

 

Selling, general and administrative expenses for the year ended December 31, 2015 increased by $5,354,000 as compared to the same period in 2014. During the fourth quarter the Company recorded acquisition related costs in the amount of $2,256,000, In addition, in 2015 there were increases of $1,056,000 from the issuance of stock-based compensation related to options and restricted stock, other corporate expenses of $519,000, professional fees of $431,000, amortization of product acquired in 2015 of $392,000, expenses related to Canadian operations of $171,000, travel-related costs of $153,000, website expenses of $121,000, overhead costs of $106,000, recruiting and human resources expenses of $76,000, contributions of $50,000 and stockholder relations expense of $44,000 during the year ended December 31, 2015 as compared to the same period in 2014. These increases were partially offset by a decrease of $47,000 in salaries and related costs.

 

Product development and research expenses for the year ended December 31, 2015 increased by $6,261,000 as compared to the same period in 2014. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased headcount, including hiring our Chief Scientific Officer in October of 2015, which resulted in an increase of $781,000 in salaries and related costs; we increased spending on clinical studies by $2,687,000, costs related to our exhibit batches by $976,000, contract research by $857,000, professional fees by $272,000, $164,000 in expenses related to Canadian operations, stock based compensation related to options and restricted stock of $162,000, consulting fees by $83,000 and overhead costs by $147,000. In addition, fees related to GDUFA, and the associated filing of our applications with the FDA, increased by $129,000.

 

Interest and Other Expense, net (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
   2015   2014   $   % 
Interest and other expense, net  $(13,358)  $(782)  $12,576    1608%
Foreign exchange gain (loss)  $109   $-   $109    100%
Change in the fair value of derivative liability  $23,144   $2,300   $20,844    906%

 

Interest expense increased for the year ended December 31, 2015 as compared to the same period in 2014, primarily due to the inclusion in 2015 of approximately $12,799,000 of interest expense, amortization of debt discount and amortization of debt issuance costs related to the Convertible 3.75% Senior Notes (see Note 6 to the Company’s Consolidated Financial Statements. Loss on foreign exchange in 2015 resulted from the change in exchange rates applied to funds due from Teligent Canada at December 31, 2015. We also recorded a $23.1 million change in the fair value of the derivative liability as a result in the change in the fair value of our derivative liability, caused primarily by the decrease in the price of our common stock in 2015.

 

 44 

 

 

Net income attributable to common stockholders (in thousands, except per share numbers):

 

   Year Ended December 31,   Increase/(Decrease) 
   2015   2014   $   % 
Net income attributable to common stockholders  $6,668   $5,251   $1,417    27%
Basic income per share  $0.13   $0.11   $0.02    18%
Diluted income (loss) per share  $(0.07)  $0.09   $(0.16)   (178)%

 

Net income for the year ended December 31, 2015 increased as compared to the year ended December 31, 2014 due to the change in the fair value of the derivative liability, partially offset by the increase in revenues and the increase in costs and expenses noted above.

 

Fiscal Year 2014 Compared to Fiscal Year 2013

 

We had net income of $5,251,000 in 2014 compared to a net loss of $84,000 in 2013. Net income attributable to common stockholders was $5,251,000, or $0.11 per basic share in 2014, and net loss applicable to common stockholders was $1,392,000, or ($0.03) per share, in 2013:

 

Revenues (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
Components of Revenue:  2014   2013   $   % 
Product sales  $32,104   $16,981   $15,123    89%
Research and development income   1,490    1,094    396    36%
Licensing, royalty, and other income   146    149    (3)   (2)%
Total Revenues  $33,740   $18,224   $15,516    85%

 

The increase in product sales for the year ended December 31, 2014 as compared to the same period in 2013 was primarily due to the increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, the launch of econazole nitrate cream 1% in September 2013 and the launch of two additional IGI label products in June 2014. In addition, we increased product sales in our contract services business to three of our pharmaceutical customers, which was only partially offset by decreased sales to two of our cosmetic customers. Research and development income will not be consistent and will vary, from period to period, depending on the required timeline of each development project. Licensing, royalty and other revenue decreased slightly due to a decrease in other revenue, while licensing and royalty revenue remained the same.

 

Costs and expenses (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
   2014   2013   $   % 
Cost of revenues  $16,948   $12,079   $4,869    40%
Selling, general and administrative   5,976    3,484    2,492    72%
Product development and research   6,910    2,743    4,167    152%
Totals costs and expenditures  $29,834   $18,306   $11,528    63%

 

Cost of sales increased for the year ended December 31, 2014 as compared to the same period in 2013 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 50% for the year ended December 31, 2014 as compared to 66% for 2013. The decrease in cost of sales as a percentage of product sales for 2014 was attributable to increased revenue from our Company label products, which have higher margins, and a shift in the mix of our product sales to include greater higher-margin pharmaceutical products. During 2014, approximately 79% of our revenue from contract and formulation services came from pharmaceutical customers as compared to 61% in 2013. Our research and development income results primarily from services rendered under contractual agreements and, therefore, cost of sales as a percentage of our research and development income is relatively low. Consistent with our strategy, we expect cost of sales as a percentage of total revenue to decline over time.

 

 45 

 

 

Selling, general and administrative expenses for the year ended December 31, 2014 increased by $2,492,000 as compared to the same period in 2013. There were increases in salaries and related costs of $1,038,000 due to an increase in headcount, professional fees of $561,000, $271,000 in expense from the issuance of stock-based compensation related to options and restricted stock, $255,000 in dues, subscriptions and corporate fees, $129,000 in recruiting expenses and $118,000 in travel-related costs during the year ended December 31, 2014 as compared to the same period in 2013. These increases were partially offset by a decrease of $35,000 in trade show expenses.

 

Product development and research expenses for the year ended December 31, 2014 increased by $4,167,000 as compared to the same period in 2013. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased headcount, which resulted in an increase of $225,000 in salaries and related costs; we increased spending on clinical studies by $1,122,000, pilot batch expense by $963,000, outside testing and supplies by $859,000 and consulting fees by $299,000. In addition, fees related to the Generic Drug User Fee Act, and the associated filing of our applications with the FDA, increased by $680,000.

 

Interest and Other Expense, net (in thousands):

 

   Year Ended December 31,   Increase/(Decrease) 
   2014   2013   $   % 
Interest and other expense, net  $(782)  $(199)  $583    293%
                     
Change in the fair value of derivative liability  $2,300   $-   $2,300    100%

 

Interest expense increased for the year ended December 31, 2014 as compared to the same period in 2013, primarily due to the inclusion in 2014 of approximately $513,000 of interest expense; amortization of debt discount and amortization of debt issuance costs related to the Convertible 3.75% Senior Notes (see Note 6 to the Company’s Consolidated Financial Statements). In addition, there was approximately $42,000 amortization of debt issuance costs related to the payoff of the note payable to Square 1 Bank in 2014 (see Note 8 to the Company’s Consolidated Financial Statements). We also recorded a $2.3 million change in the fair value of the derivative liability as a result in the change in the fair value of our derivative liability, caused primarily by the decrease in the price of our common stock in December 2014.

 

Net income (loss):

 

   Year Ended December 31,   Increase/(Decrease) 
   2014   2013   $   % 
Net income (loss)  $5,251   $(84)  $5,335    6,351%

 

Net income for the year ended December 31, 2014 as compared to net loss for the year ended December 31, 2013 is due to the increase in revenues partially offset by the increase in costs and expenses noted above.

 

Net income (loss) attributable to common stockholders (in thousands, except per share numbers):

 

   Year Ended December 31,   Increase/(Decrease) 
   2014   2013   $   % 
Net income (loss) attributable to common stockholders  $5,251   $(1,392)  $6,643    477%
Basic net income (loss) per share  $0.09   $(0.03)  $0.12    400%
Diluted net income (loss) per share  $0.11   $(0.03)  $0.14    467%

 

The net income attributable to common stockholders for the year ended December 31, 2014 as compared to the net loss attributable to common stockholders for the year ended December 31, 2013 is due to the increase in revenues partially offset by the increase in costs and expenses noted above. For the year ended December 31, 2013, there was a preferred stock dividend recorded on December 6, 2013 in connection with the mandatory conversion of our Series C preferred stock. This dividend of $1,308,000 was recorded upon conversion of our Series C preferred stock into common stock.

 

 46 

 

 

Liquidity and Capital Resources

 

Our principal sources of liquidity were cash and cash equivalents of approximately $87 million at December 31, 2015, $10 million available under the $10 million General Electric Capital Corporation credit facility and cash from operations. We had working capital of $106.0 million at December 31, 2015. We may require additional funding and this funding will depend, in part, on the timing and structure of potential business arrangements. If necessary, we may continue to seek to raise additional capital through the sale of our equity or through a strategic alliance with a third party. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to us, or at all. We believe that our existing capital resources will be sufficient to support our current business plan beyond March 2017.

 

On December 10, 2014, we entered into a purchase agreement, pursuant to which we agreed to sell $125 million aggregate principal amount of our 3.75% Convertible Senior Notes due 2019, or the Notes, to Deutsche Bank Securities Inc. and J.P. Morgan Securities LLC, as the initial purchasers (See Note 21 to the Company’s Consolidated Financial Statements). In addition, we granted the initial purchasers a 30-day option to purchase up to an additional $18.75 million aggregate principal amount of the Notes on the same terms and conditions. The Notes were sold in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.

 

On November 18, 2014, we entered into a $10 million line of credit with General Electric Capital Corporation (See Note 7 to the Company’s Consolidated Financial Statements). As of December 31, 2015, the outstanding principal balance on the line of credit was $0. The Company terminated the line in February 2016.

 

On June 27, 2014, we announced the pricing of our underwritten public offering of 4,650,000 shares of our common stock at a price to the public of $5.00 per share (See Note 19 to the Company’s Consolidated Financial Statements). The offering closed on July 2, 2014, and, after giving effect to the underwriters’ exercise of the over-allotment option in full, we sold an aggregate of 5,347,500 shares of common stock. The net proceeds of the offering were approximately $24.9 million, after deducting the underwriters’ commission and offering expenses.

 

Our operating activities used $15.5 million, $3.9 million and $.6 million of cash during the years ended December 31, 2015, 2014 and 2013, respectively. The use of cash for the year ended December 31, 2015 was a result of $5.2 million paid related to Canadian goods and services tax (GST) and the harmonized sales tax (HST), which we expect to be refunded in 2016. We also paid interest expense in the amount of $6.7 million related to our Notes. In connection with the acquisition of Alveda, we paid $2.2 million in acquisition costs. The remaining use of cash was primarily a result of the $3.8 million in changes in operating assets and liabilities, which included a $6.0 million payment related to the AstraZeneca assets acquired in September of 2015, offset by the net income for the year. The use of cash for the year ended December 31, 2014 was substantially a result of the changes in operating assets and liabilities offset by the net income for the year. The use of cash for the year ended December 31, 2013 was substantially a result of the net loss for the period offset by non-cash expense items.

 

Our investing activities used $53.1 million during the year ended December 31, 2015 compared to $3.8 million of cash used in the year ended December 31, 2014 and $2.1 million of cash used in the year ended December 31, 2013. We paid $35.4 million in cash to acquire the assets of Alveda in November 2015. We completed the acquisition of five products, which used $11.7 million in cash in 2015. We also used $6.0 million for the purchase of capital expenditures related to additional scientific and manufacturing equipment and costs related to the planning phase of our expansion. The equipment purchased in manufacturing, will automate certain aspects of our manufacturing processes, and allow us to continue to increase efficiency. The funds used during the year ended December 31, 2014 were for the purchase of products (see Note 7 to the Company’s Condensed Consolidated Financial Statements) and capital expenditures related to additional computer equipment and scientific equipment and improvements incurred to expand our R & D. In 2013, we used $1.8 million to acquire econazole nitrate cream 1%, which we launched in September 2013. The remaining funds used in 2013 were for additional equipment and related services for our analytical and compounding functions, packaging and filling lines.

 

Our financing activities used $3.1 million of cash during the year ended December 31, 2015 compared to $164.5 million of cash provided by financing activities in the year ended December 31, 2014 and $2.3 million of cash provided by financing activities in the year ended December 31, 2013. The cash used during the year ended December 31, 2015 in the amount of $3.1 million was used to pay down debt. The cash provided for the year ended December 31, 2014 was mainly $139 million net proceeds from the Notes, $24.9 million net proceeds from the public offering of common stock and $0.8 million proceeds from the exercise of common stock warrants and options. The cash provided for the year ended December 31, 2013 was primarily related to the $2.0 million we drew down on our existing credit line in 2013.

 

 47 

 

 

Off-Balance Sheet Arrangements

 

We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our shareholders.

 

Contractual Obligations

 

As more fully described under Item 2, Properties, we lease the facilities that we occupy in one building in Buena, New Jersey, a warehouse in Vineland, New Jersey and office space in Iselin, New Jersey. Our remaining obligations under these leases are summarized in the table below.

 

As of December 31, 2015, our principal outstanding debt obligation related to our Notes is a total of $143.75 million and are due in December of 2019.

 

   Payments Due by Period 
   (in thousands) 
Contractual Obligations  Total   Less than 1 Year   1-3 Years   3-5 Years   More than 5
Years
 
Convertible Senior Notes  $143,750   $-   $-   $143,750   $- 
Capital Lease   71    71    -    -    - 
Operating Lease   2,898    408    794    632    1,064 
                          
Total  $146,719   $479   $794   $144,382   $1,064 

 

Critical Accounting Policies and Estimates

 

Our consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles, which require us to make subjective decisions, assessments and estimates about the effect of matters that are inherently uncertain. As the number of variables and assumptions affecting the judgment increases, such judgments become even more subjective. While we believe our assumptions are reasonable and appropriate, actual results may be materially different than estimated.

 

Fair Value of Financial Instruments

 

The Company measures fair value in accordance with ASC 820-10, Fair Value Measurements and Disclosures (formerly SFAS 157, Fair Value Measurements). ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:

 

Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

 

Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

 

 48 

 

 

Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

 

The Company measures its derivative liability at fair value. The derivative convertible option related to Convertible Notes issued December 16, 2014 was valued using the “with” and “without” analysis. A “with” and “without” analysis is a standard valuation technique for valuing embedded derivatives by first considering the value of the Convertible Notes with the option and then considering the value of the Convertible Notes without the option. The difference is the fair value of the embedded derivatives. The convertible note derivative is classified within Level 3 because it is valued using the “with” and “without” method, which does utilize inputs that are unobservable in the market.

 

On May 20, 2015, the Company received approval to increase its authorized shares sufficient to allow for the conversion of the embedded option into equity at the annual shareholders meeting. Therefore, the derivative liability of $18.3 million was reclassified into stockholders equity. Based on the closing price of the Company’s common stock as of December 31, 2015, the fair value of the Notes was approximately $107 million compared to their face value of $143.75 million as of December 31, 2015. However, this variance is due to the conversion feature in the Notes rather than to changes in market interest rates. The Notes carry a fixed interest rate and therefore do not subject the Company to interest rate risk. The Company recorded a change in the fair value of the derivative liability through May 20, 2015 of $23.1 million for the year ended December 31, 2015 on the condensed consolidated statements of operations. On May 20, 2015, the Company recorded the final change in fair value and subsequently reclassified the value of the derivative liability into stockholders equity due to the approval of sufficient shares.

 

Allowance for Doubtful Accounts

 

The Company extends credit to its contract services customers, based upon credit evaluations, in the normal course of business, primarily with 30-day terms. The Company does not require collateral from its customers. Bad debt provisions are provided for on the allowance method based on historical experience and management’s evaluation of outstanding accounts receivable. The Company reviews the allowance for doubtful accounts regularly, and past due balances are reviewed individually for collectability. The Company charges off uncollectible receivables against the allowance when the likelihood of collection is remote.

 

The Company extends credit to wholesaler and distributor customers and national retail chain customers, based upon credit evaluations, in the normal course of business, primarily with 60-day terms. The Company maintains customer-related accruals and allowances that consist primarily of chargebacks, rebates, sales returns, shelf stock allowances, administrative fees and other incentive programs. Some of these adjustments relate specifically to the generic prescription pharmaceutical business. Typically, the aggregate gross-to-net adjustments related to these customers can exceed 50% of the gross sales through this distribution channel. Certain of these accruals and allowances are recorded in the balance sheet as current liabilities and others are recorded as a reduction to accounts receivable.

 

Revenue Recognition

 

The Company considers revenue realized or realizable and earned when it has persuasive evidence of an arrangement, delivery has occurred or contractual services rendered, the sales price is fixed or determinable, and collection is reasonably assured in conformity with ASC 605, Revenue Recognition.

 

The Company derives its revenues from three basic types of transactions: sales of its own generic pharmaceutical topical products, sales of manufactured product for its customers included in product sales, and research and product development services performed for third parties. Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition policies for each.

 

Product Sales: Product Sales includes Company Product Sales and Contract Manufacturing Sales.

 

Company Product Sales: The Company records revenue from Company product sales when title and risk of ownership have been transferred to the customer, which is typically upon delivery of products to the customer.

 

 49 

 

 

Revenue and Provision for Sales Returns and Allowances

 

As customary in the pharmaceutical industry, the Company’s gross product sales from Company label products are subject to a variety of deductions in arriving at reported net product sales. When the Company recognizes revenue from the sale of products, an estimate of sales returns and allowances, or SRA, is recorded, which reduces product sales. Accounts receivable and/or accrued expenses are also reduced and/or increased by the SRA amount. These adjustments include estimates for chargebacks, rebates, cash discounts and returns and other allowances. These provisions are adjusted as estimates are based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The estimation process used to determine our SRA provision has been applied on a consistent basis and no material adjustments have been necessary to increase or decrease our reserves for SRA as a result of a significant change in underlying estimates. The Company will use a variety of methods to assess the adequacy of our SRA reserves to ensure that our financial statements are fairly stated. These will include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience and product pricing trends to analyze and validate the SRA reserves.

 

The provision for chargebacks is our most significant sales allowance. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company will validate the chargeback accrual quarterly through a review of the inventory reports obtained from our largest wholesale customers. This customer inventory information is used to verify the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent 90% - 95% of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.

 

Net revenues and accounts receivable balances in the Company’s consolidated financial statements are presented net of SRA estimates. Certain SRA balances are included in accounts payable and accrued expenses.

 

Contract Manufacturing Sales: The Company recognizes revenue when title transfers to its customers, which is generally upon shipment of products. These shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. The revenues associated with these transactions, net of appropriate cash discounts, product returns and sales reserves, are recorded upon shipment of the products included in Product Sales in the statement of operations.

 

Research and Development Income: The Company establishes agreed upon product development agreements with its customers to perform product development services. Product development revenues are recognized in accordance with the product development agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Revenue recognition requires the Company to assess progress against contracted obligations to assure completion of each stage. These payments are generally non-refundable and are reported as deferred until they are recognizable as revenue. If no such arrangement exists, product development fees are recognized ratably over the entire period during which the services are performed.

 

In making such assessments, judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Changes in total estimated contract cost and losses, if any, are recognized in the period they are determined. Billings on research and development contracts are typically based upon terms agreed upon by the Company and customer and are stated in the contracts themselves and do not always align with the revenues recognized by the Company.

 

 50 

 

 

Derivatives

 

The Company accounts for its derivative instruments in accordance with ASC 815-10, Derivatives and Hedging, or ASC 815-10. ASC 815-10 establishes accounting and reporting standards requiring that derivative instruments, including derivative instruments embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value. ASC 815-10 also requires that changes in the fair value of derivative instruments be recognized currently in results of operations unless specific hedge accounting criteria are met. The Company has not entered into hedging activities to date. The Company recognizes all derivative instruments as either assets or liabilities in the consolidated balance sheets at their respective fair values. The Company's derivative instruments include the embedded convertible option of its Notes issued December 16, 2014 (as defined in Note 6), all of which have been recorded as a liability at fair value, and are revalued at each reporting date, with changes in the fair value of the instruments included in the consolidated statements of operations as non-operating income (expense). Due to the approval of the sufficient shares at the Company’s annual shareholder meeting, the liability for the embedded derivative was reclassified to equity on May 20, 2015. The Company has no derivatives at December 31, 2015.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or 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. Significant estimates include derivatives, SRA allowances, allowances for excess and obsolete inventories, allowances for doubtful accounts, provisions for income taxes and related deferred tax asset valuation allowances, stock based compensation and accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates.

 

Recent Accounting Pronouncements

 

In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842): “Recognition and Measurement of Financial Assets and Financial Liabilities”. The update supersedes Topic 840, Leases and requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. Topic 842 retains a distinction between finance leases and operating leases, with cash payments from operating leases classified within operating activities in the statement of cash flows. The amendments in this update are effective for fiscal years beginning after December 15, 2018 for public business entities, which for the Company means January 1, 2019. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

 

In September 2015, the FASB issued ASU 2015-16, Business Combinations (Topic 805): “Simplifying the Accounting for Measurement-Period Adjustments”. The update eliminates the requirement to retrospectively adjust the provisional amounts recognized at the acquisition date with a corresponding adjustment to goodwill during the measurement period when new information is obtained about the facts and circumstances that existed as of the acquisition date, that if known, would have affected the measurement of the amounts initially recognized or would have resulted in the recognition of additional assets or liabilities. The amendments in this update are effective for fiscal years beginning after December 15, 2015, which for the Company means January 1, 2016, and should be applied prospectively to adjustments to provisional amounts that occur after the effective date of this update. Early application is permitted for financial statements that have not been issued. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

 

In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): “Simplifying the Measurement of Inventory”. ASU 2015-11 requires inventory measured using any method other than last-in, first out (“LIFO”) or the retail inventory method to be subsequently measured at the lower of cost or net realizable value, rather than at the lower of cost or market. Under this ASU, subsequent measurement of inventory using the LIFO and retail inventory method is unchanged. ASU 2015-11 is effective prospectively for fiscal years, and for interim periods within those years, beginning after December 15, 2016. Early application is permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

 

 51 

 

 

In April 2015, the FASB issued ASU 2015-3, “Simplifying the Presentation of Debt Issuance Costs.” The new guidance specifies that debt issuance costs under the new standard are to be netted against the carrying value of the financial liability. Under current guidance, debt issuance costs are recognized as a deferred charge and reported as a separate asset on the balance sheet. The new guidance aligns the treatment of debt issuance costs and debt discounts in that both reduce the carrying value of the liability. Amortization of debt issuance costs is to be recorded as interest expense on the income statement. ASU 2015-3 is effective fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption is permitted for financial statements that have not been issued previously. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

 

In May 2014, FASB issued ASU 2014-09, “Revenue from Contracts with Customers”. This ASU is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This ASU is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. Accordingly, the Company will adopt this ASU on January 1, 2017. Companies may use either a full retrospective or modified retrospective approach to adopt this ASU and management is currently evaluating which transition approach to use. The Company is currently evaluating the impact of ASU 2014-09.

 

In August 2014, FASB issued ASU 2014-15, “Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”.  This ASU requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable) and provide related disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter.  Early adoption is permitted.  The Company is currently evaluating the impact of ASU 2014-15.

 

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As of December 31, 2015, our principal debt obligation was related to our Notes.  Interest accrues at a fixed rate of 3.75% on the outstanding principal amount of the Notes and is paid semi-annually every June 15 and December 15 until the Notes mature on December 15, 2019.  Since the interest rate is fixed, we have no market risk related to the Notes.

 

Our revolving Credit and Security Agreement with General Electric Capital Corporation calls for interest to accrue based on a premium above either the current prime rate or current LIBOR rates.  Therefore, borrowings pursuant to this revolving credit facility would be subject to market risk.  However, as of December 31, 2015, we had no outstanding loans and therefore no market risk related to this revolving credit facility.

 

Our financial instruments include cash and cash equivalents, accounts receivable, accounts payable and the Notes. The fair values of cash and cash equivalents, accounts receivable and accounts payable approximate book value because of the short maturity of these instruments.  Based on the closing price of our common stock as of December 31, 2015, the fair value of our Notes was approximately $107 million compared to their face value of $143.75 million as of December 31, 2015.  However, this variance is due to the conversion feature in the Notes rather than to changes in market interest rates.  As noted above, the Notes carry a fixed interest rate and therefore do not subject us to interest rate risk. As a result in the change in fair value, we recorded a $23.1 million change in the fair value of the derivative liability on our consolidated statements of operations in 2015.

 

At December 31, 2015, the bulk of our cash and cash equivalents was invested in overnight instruments, the interest rates of which may change daily.  Accordingly, these overnight investments are subject to market risk.

 

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

See Index to Financial Statements on page F-1.

 

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON AUDITING AND FINANCIAL DISCLOSURE

 

None.

 

 52 

 

 

Item 9a. CONTROLS AND PROCEDURES

 

(a)  Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 

(b)  Changes in Internal Controls.  There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the fourth quarter of our last fiscal year that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

The management of the Company 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 Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel 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. The Company’s internal control over financial reporting includes those policies and procedures that:

 

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

 

·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

 

·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. 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.

 

The Company’s management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2015. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013).

 

Based on our assessment, management believes that, as of December 31, 2015, the Company’s internal control over financial reporting is effective based on those criteria.

 

EisnerAmper LLP, the independent registered public accounting firm that audited the consolidated financial statements in this Annual Report on Form 10-K for the year ended December 31, 2015, has issued a report concerning the effectiveness of our internal control over financial reporting for that year, which is included in Part II, Item 8 of this Annual Report on Form 10-K.

 

Item 9B. OTHER INFORMATION

 

None.

 

 53 

 

 

PART III

 

Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance Matters,” “Section 16(a) Beneficial Ownership Reporting Compliance,” and “Code of Conduct and Ethics” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders.

 

Item 11.EXECUTIVE COMPENSATION

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Executive Officer and Director Compensation,” “Compensation Discussion and Analysis,” “Management and Corporate Governance Matters,” “Compensation Committee Report” and “Compensation Discussion and Analysis” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders.

 

Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders.

 

Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related Person Transactions” and “Management and Corporate Governance” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders.

 

Item 14.PRINCIPAL ACCOUNTING FEES AND SERVICES

 

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Independent Registered Public Accounting Firm” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders.

 

 54 

 

 

PART IV

 

Item 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES

 

(a)The following documents are filed as part of this Annual Report on Form 10-K:

 

(a)(1)See “Index to Consolidated Financial Statements and Financial Statement Schedules” at Item 8 to this Annual Report on Form 10-K.

 

(a)(2)Other financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto.

 

(a)(3)The following is a list of exhibits filed as part of this Annual Report on Form 10-K.

 

Exhibits

 

(3.1)Amended and Restated Certificate of Incorporation of IGI Laboratories, Inc., dated May 7, 2008 (incorporated by reference to Exhibit 3.1 to the Company’s Report on Form 8-K, filed May 12, 2008).

 

(3.2)Amended and Restated Bylaws of IGI Laboratories, Inc., effective May 7, 2008 (incorporated by reference to Exhibit 3.2 to the Company’s Report on Form 8-K, filed May 12, 2008).

 

(4.1)Specimen stock certificate for shares of Common Stock, par value $.01 per share (incorporated by reference to Exhibit 4 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000, filed March 28, 2001 (“the 2000 Form 10-K”)).

 

(4.2)Indenture dated as of December 16, 2014, by and between IGI Laboratories, Inc. and Wilmington Trust, National Association (incorporated by reference to Exhibit 4.1 to the Company’s Report on Form 8-K, filed December 17, 2014).

 

(10.1)#IGI, Inc. 1998 Directors Stock Plan, as amended (incorporated by reference to Exhibit 4.1 to the Company's Registration Statement on Form S-8 (Registration No. 333-160342), filed June 30, 2009).

 

(10.2)#IGI, Inc. 1999 Director Stock Option Plan, as amended (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-8 (Registration No. 333-160342, filed June 30, 2009).

 

(10.3)#IGI, Inc. 1999 Stock Incentive Plan, as amended (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-8 (Registration No. 333-160342), filed June 30, 2009).

 

(10.4)#IGI Laboratories, Inc. 2009 Equity Incentive Plan, as amended and restated (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed June 4, 2014).

 

(10.5)#Form of Non-Qualified Stock Option Agreement under the IGI Laboratories, Inc. 2009 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Report on Form 8-K, filed July 2, 2009).

 

(10.6)#Form of Stock Option Award Agreement under the IGI Laboratories, Inc. 2009 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Report on Form 8-K, filed July 20, 2011).

 

(10.7)#Form of Award Agreement for Restricted Shares under the IGI Laboratories, Inc. 2009 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Report on Form 8-K, filed July 2, 2009).

 

 55 

 

 

(10.8)#Indemnification Agreement by and between IGI Laboratories, Inc. and Joyce Erony, dated March 13, 2009 (incorporated by reference Exhibit 10.10 to the Company’s Report on Form 8-K, filed March 19, 2009 (the “March 2009 8-K”)).

 

(10.9)#Form of Indemnification Agreement for Certain Directors (incorporated by reference to Exhibit 10.11 to the March 2009 8-K).

 

(10.10)#Employment Agreement dated July 14, 2011 between IGI Laboratories, Inc. and Jenniffer Collins (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed July 20, 2011).

 

(10.11)#Employment Agreement dated July 30, 2012 between IGI Laboratories, Inc. and Jason Grenfell-Gardner (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed July 30, 2012).

 

(10.12)+Purchase and Sale Agreement between the Company and Prasco, LLC for the purchase of econazole nitrate cream 1%, dated February 1, 2013, (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed August 9, 2013).

 

(10.13)Asset Purchase Agreement dated as of September 30, 2014, by and between IGI Laboratories, Inc. and Valeant Pharmaceuticals North America, LLC and Valeant Pharmaceuticals Luxembourg SARL (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed October 1, 2014).

 

(10.14)Asset Purchase Agreement dated as of September 30, 2014, by and between IGI Laboratories, Inc. and Valeant Pharmaceuticals North America, LLC and Valeant Pharmaceuticals Luxembourg SARL (incorporated by reference to Exhibit 10.2 to the Company’s Report on Form 8-K, filed October 1, 2014).

 

(10.15)+Asset Purchase Agreement dated as of September 24, 2014, by and between IGI Laboratories, Inc. and AstraZeneca Pharmaceuticals LP (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 10-Q, filed November 13, 2014).

 

(10.16)Credit Agreement dated as of November 18, 2014, by and among IGI Laboratories, Inc., Igen, Inc., and IGI Labs, Inc. as Borrowers, the other Persons party thereto that are designated as Credit Parties, General Electric Capital Corporation as Agent for all Lenders, GE Capital Bank as a Lender, and the other financial institutions party thereto as Lenders (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed November 24, 2014).

 

(10.17)Guaranty and Security Agreement dated as of November 18, 2014, by and among IGI Laboratories, Inc., Igen, Inc., and IGI Labs, Inc. as Borrowers and each other Grantor from time to time party thereto in favor of General Electric Capital Corporation as Agent (incorporated by reference to Exhibit 10.2 to the Company’s Report on Form 8-K, filed November 24, 2014).

 

(10.18)Purchase Agreement dated December 10, 2014, by and between IGI Laboratories, Inc. and the initial purchasers set forth on Schedule 1 thereto (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 8-K, filed December 17, 2014).

 

(21)*List of Subsidiaries.

 

(23.1)*Consent of EisnerAmper LLP.

 

(31.1)*Certification of the President and Chief Executive Officer Pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 56 

 

 

(31.2)*Certification of the Chief Financial Officer Pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

(32.1)*Certification of the President and Chief Executive Officer and of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

(101)*The following financial information from this Annual Report on Form 10-K for the year ended December 31, 2015, formatted in XBRL (Extensible Business Reporting Language) and furnished electronically herewith: (i) the Consolidated Statements of Operations; (ii) the Consolidated Balance Sheets; (iii) the Consolidated Statements of Cash Flows; and (iv) the Notes to Consolidated Financial Statements, tagged as blocks of text.

 

*Filed herewith.

#Indicates management contract or compensatory plan.

+Portions of this Exhibit were omitted and filed separately with the Secretary of the SEC pursuant to a request for confidential treatment that has been granted by the SEC.

 

 57 

 

 

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.

 

  Teligent, Inc.
   
  By: /s/ Jason Grenfell-Gardner
    Jason Grenfell-Gardner
    President and Chief Executive Officer

 

Date: March 14, 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 indicated below and on the dates indicated.

 

Signature   Title   Date
         
/s/ Jason Grenfell-Gardner   Director, President and Chief Executive Officer   March 14, 2016
Jason Grenfell-Gardner   (Principal Executive Officer)    
         
/s/ Jenniffer Collins   Chief Financial Officer   March 14, 2016
Jenniffer Collins   (Principal Financial Officer)    
         
/s/ Steven Koehler   Director   March 14, 2016
Steven Koehler        
         
/s/ James Gale   Director   March 14, 2016
James Gale        
         
/s/ Narendra Borkar   Director   March 14, 2016
Narendra Borkar        
         
/s/ Bhaskar Chaudhuri   Director   March 14, 2016
Bhaskar Chaudhuri        
         
/s/ John Celentano   Director   March 14, 2016
John Celentano        

 

58 

 

 

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

Reports of Independent Registered Public Accounting Firm   F-2
     
Consolidated Balance Sheets as of December 31, 2015 and 2014   F-4
     
Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013   F-5
     
Consolidate Statements of Comprehensive Income/(Loss)   F-6
     
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013   F-7
     
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2015, 2014 and 2013   F-8
     
Notes to Consolidated Financial Statements   F-9 - F-38
     
Financial Statement Schedule: Quarterly Results   F-39
     
Financial Statement Schedule: Schedule II - Valuation and Qualifying Accounts   F-40

 

F-1 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders

Teligent, Inc. and subsidiaries (formerly known as IGI Laboratories, Inc.)

 

 

We have audited the accompanying consolidated balance sheets of Teligent, Inc. and subsidiaries (the "Company") as of December 31, 2015 and 2014, and the related consolidated statements of operations, comprehensive income (loss), stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 2015. The financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements 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 Teligent, Inc. and subsidiaries as of December 31, 2015 and 2014, and the consolidated results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2015 in conformity with accounting principles generally accepted in the United States of America.

 

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Teligent, Inc. and subsidiaries' internal control over financial reporting as of December 31, 2015, based on criteria established in the 2013 Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"), and our report dated March 14, 2016 expressed an unqualified opinion thereon.

 

In connection with our audits of the consolidated financial statements referred to above, we also audited Schedule II - Valuation and Qualifying Accounts for each of the years in the three-year period ended December 31, 2015. In our opinion, this financial schedule, when considered in relation to the consolidated financial statements taken as a whole, presents fairly, in all material respects, the information stated therein.

 

/s/ EisnerAmper LLP

 

Iselin, New Jersey

March 14, 2016

 

F-2 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders

Teligent, Inc. and subsidiaries (formerly known as IGI Laboratories, Inc.)

 

 

We have audited Teligent, Inc. and subsidiaries' (the "Company") internal control over financial reporting as of December 31, 2015, based on criteria established in the 2013 Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"). The Company'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 Annual 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, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included 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 (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) 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 (iii) 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, Teligent, Inc. and subsidiaries maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on criteria established in the 2013 Internal Control - Integrated Framework issued by COSO.

 

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Teligent, Inc. and subsidiaries as of December 31, 2015 and 2014, and the related consolidated statements of operations, comprehensive income (loss), stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 2015, and our report dated, March 14, 2016, expressed an unqualified opinion thereon.

 

/s/ EisnerAmper LLP

 

Iselin, New Jersey

March 14, 2016

 

F-3 

 

 

TELIGENT, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share information)

 

   December 31,   December 31, 
   2015   2014 
ASSETS          
Current assets:          
Cash and cash equivalents  $87,191   $158,883 
Accounts receivable, net   14,028    14,366 
Inventories   8,985    2,784 
Prepaid expenses and other receivables   6,597    1,185 
Total current assets   116,801    177,218 
Property, plant and equipment, net   8,706    3,262 
Debt issuance costs, net   4,027    5,132 
Intangible assets, net   54,320    10,604 
Goodwill   426    - 
Other   482    862 
Total assets  $184,762   $197,078 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $3,955   $1,643 
Accrued expenses   6,267    5,141 
Payable for product acquisition costs   -    6,000 
Deferred income, current   476    87 
Capital lease obligation, current   70    131 
Total current liabilities   10,768    13,002 
           
Convertible 3.75% senior notes, net of debt discount (face of $143,750)   106,991    100,311 
Fair value of derivative liability - convertible 3.75% senior notes   -    41,400 
Note payable, bank   -    3,160 
Deferred tax liability   244    - 
Other long term liabilities   -    71 
Total liabilities   118,003    157,944 
           
Stockholders’ equity:          
Series A Convertible Preferred stock, $0.01 par value, 100 shares authorized; 0 shares issued and outstanding as of December 31, 2015 and 2014, respectively   -    - 
Series C Convertible Preferred stock, $0.01 par value, 1,550 shares authorized; 0 shares issued and outstanding as of December 31, 2015 and 2014, respectively   -    - 
Common stock, $0.01 par value, 60,000,000 shares authorized; 53,000,689 and 52,819,787 shares issued and outstanding as of December 31, 2015 and December 31, 2014, respectively   549    548 
Additional paid-in capital   99,258    78,172 
Accumulated deficit   (32,918)   (39,586)
Accumulated other comprehensive income, net of taxes   (130)   - 
Total stockholders’ equity   66,759    39,134 
Total liabilities and stockholders’ equity  $184,762   $197,078 

  

The accompanying notes are an integral part of the consolidated financial statements.

 

F-4 

 

 

TELIGENT, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

For the years ended December 31, 2015, 2014 and 2013

(in thousands, except shares and per share information)

 

   2015   2014   2013 
Revenues:               
Product sales, net  $43,497   $32,104   $16,981 
Research and development income   578    1,490    1,094 
Licensing, royalty and other revenue   175    146    149 
Total revenues   44,250    33,740    18,224 
                
Costs and Expenses:               
Cost of revenues   22,935    16,948    12,079 
Selling, general and administrative expenses   11,336    5,976    3,484 
Product development and research expenses   13,171    6,910    2,743 
Total costs and expenses   47,442    29,834    18,306 
Operating income (loss)   (3,192)   3,906    (82)
                
Other Income (Expense):               
Change in the fair value of derivative liability   23,144    2,300    - 
Foreign exchange gain (loss)   109    -    - 
Interest and other expense, net   (13,358)   (782)   (199)
Income (loss) before income tax expense (benefit)   6,703    5,424    (281)
                
Income tax expense (benefit)   35    173    (197)
                
Net income (loss)   6,668    5,251    (84)
                
Preferred stock dividend   -    -    (1,308)
                
Net income (loss) attributable to common stockholders  $6,668   $5,251   $(1,392)
                
Basic earnings (loss) per share  $0.13   $0.11   $(0.03)
Diluted earnings (loss) per share  $(0.07)  $0.09   $(0.03)
                
Weighted average shares of common stock outstanding:               
Basic   52,872,814    49,817,721    43,517,640 
Diluted   67,111,995    64,207,190    43,517,640 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-5

 

 

TELIGENT, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

For the years ended December 31, 2015, 2014 and 2013

(in thousands)

 

   2015   2014   2013 
             
Net Income (loss)  $6,668   $5,251   $(84)
                
Other Comprehensive (loss) income, net of tax               
Foreign currency translation adjustment   (130)   -    - 
Other Comprehensive loss   (130)   -    - 
                
Comprehensive income (loss)  $6,538   $5,251   $(84)

 

F-6 

 

 

TELIGENT, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the years ended December 31, 2015, 2014 and 2013

(in thousands)

 

   2015   2014   2013 
Cash flows from operating activities:               
Net income (loss)  $6,668   $5,251   $(84)
Reconciliation of net income (loss) to net cash used in operating activities:               
Depreciation and amortization of fixed assets   560    415    375 
Amortization of license fee   100    100    100 
Provision for write down of inventory   50    228    110 
Issuance of stock to consultant   -    80    - 
Stock based compensation expense   2,273    823    536 
Amortization of debt issuance costs   1,132    107    31 
Amortization of Intangibles   514    120    60 
Foreign currency exchange gain   (109)   -    - 
Amortization of debt discount on convertible 3.75% senior notes   6,680    261    - 
Change in the fair value of derivative liability   (23,144)   (2,300)   - 
Loss on abandonment of property   -    -    - 
Changes in operating assets and liabilities:               
Accounts receivable   1,250    (9,419)   (3,370)
Inventories   (3,578)   (143)   (1,206)
Prepaid expenses and other current receivables   (5,408)   (1,075)   (402)
Other assets   (14)   -    - 
Accounts payable and accrued expenses   (2,849)   2,346    2,528 
Deferred income   362    (685)   704 
                
Net cash used in operating activities   (15,513)   (3,891)   (618)
                
Cash flows from investing activities:               
Capital expenditures   (5,998)   (834)   (287)
Acquisition of product rights and other related assets   (35,418)   -    - 
Product acquisition costs, net   (11,652)   (2,958)   (1,826)
Net cash used in investing activities   (53,068)   (3,792)   (2,113)
                
Cash flows from financing activities:               
Proceeds from convertible 3.75% senior notes, net of $4,765   -    138,985    - 
Proceeds from issuance of stock, net   (3)   24,858    - 
Proceeds from note payable, net of debt issuance costs   -    2,755    2,000 
Repayment of note payable   (3,160)   (3,000)   - 
Repayment of note payable, related party   -    -    - 
(Expenses of) proceeds from sale of treasury stock, net of expenses   -    -    (63)
Proceeds from exercise of common stock options and warrants   165    837    376 
Principal payments on capital lease obligations   (132)   (64)   (17)
Recovery from stockholder, net   19    -    - 
Excess tax benefits from stock compensation   -    94    - 
Net cash (used in) provided by financing activities   (3,111)   164,465    2,296 
                
Net increase (decrease) in cash and cash equivalents   (71,692)   156,782    (435)
Cash and cash equivalents at beginning of year   158,883    2,101    2,536 
                
Cash and cash equivalents at end of year  $87,191   $158,883   $2,101 
                
Supplemental Cash flow information:               
Cash payments for interest  $5,517   $178   $142 
Cash payments for (receipts from) income taxes   123    23    (194)
                
Non cash investing and financing transactions:               
Reclassification of derivative liability to equity   18,256    -    - 
Issuance of stock to consultant   31    -    - 
Issuance of restricted stock   347    -    3 
Bifurcation of derivative from convertible 3.75% senior notes   -    41,400    - 
Payable related to product acquisition costs   -    6,000    - 
Common stock issued for conversion of Series C Convertible Preferred stock   -    -    2,825 
Common stock issued for conversion of Series A Convertible Preferred stock   -    -    500 
Equipment financed through capital lease   -    -    20 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-7 

 

 

TELIGENT, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the years ended December 31, 2015, 2014 and 2013

(in thousands, except share information)

 

   Series A   Series C               Accumulated              
   Convertible   Convertible           Additional   Other           Total 
   Preferred Stock   Preferred Stock   Common Stock   Paid-In   Comprehensive   Accumulated   Treasury   Stockholders’ 
   Shares   Amount   Shares   Amount   Shares   Amount   Capital   Income (Loss)   Deficit   Stock   Equity 
                                             
Balance, December 31, 2012   50   $500    1,550   $1,517    42,705,032   $446   $47,409   $-   $(43,445)  $-   $6,427 
                                                        
Stock based compensation expense                                 536                   536 
Restricted stock issuance                       325,000    3    (3)                  - 
Stock warrants exercised                       427,713    5    231                   236 
Stock options exercised                       129,336    1    138                   139 
Costs related to stock issuance                                 (63)                  (63)
Common stock issued upon conversion of Series A Convertible Preferred stock   (50)   (500)             500,000    5    495                   - 
Common stock issued upon conversion of Series C Convertible Preferred stock including deemed dividend of $1,308             (1,550)   (1,517)   2,661,494    27    2,798         (1,308)        - 
Net loss   -    -    -    -    -    -    -    -    (84)   -    (84)
                                                        
Balance, December 31, 2013   -   $-    -   $-    46,748,575   $487   $51,541   $-   $(44,837)  $-   $7,191 
                                                        
Issuance of stock pursuant to a public offering, net of associated fees of $1,868                       5,347,500    53    24,805                   24,858 
Issuance of stock to consultant                       10,000         80                   80 
Stock based compensation expense                                 823                   823 
Stock warrants exercised                       270,546    3    325                   328 
Stock options exercised                       443,166    5    504                   509 
Excess tax benefits from stock compensation                                 94                   94 
Net income   -    -    -    -    -    -    -    -    5,251    -    5,251 
                                                        
Balance, December 31, 2014   -   $-    -   $-    52,819,787   $548   $78,172   $-   $(39,586)  $-   $39,134 
                                                        
Issuance of stock to consultant                       5,000         31                   31 
Stock based compensation expense                                 2,273                   2,273 
Stock warrants exercised                       67,636         82                   82 
Stock options exercised                       75,766    1    82                   83 
Issuance of restricted stock                       32,500         346                   346 
Reclassification of derivative liability to equity                                 18,256                   18,256 
Recovery from stockholder, net                                 19                   19 
Costs related to stock issuance                                 (3)                  (3)
Cumulative translation adjustment                                      (130)             (130)
Net income   -    -    -    -    -    -    -    -    6,668    -    6,668 
                                                        
Balance, December 31, 2015   -   $-    -   $-    53,000,689   $549   $99,258   $(130)  $(32,918)  $-   $66,759 

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

F-8 

 

 

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1.      Summary of Significant Accounting Policies

 

Nature of the Business

 

Teligent, Inc. (the “Company”) is a Delaware corporation incorporated in 1977. On October 22, 2015, the Company announced the change of its name from IGI Laboratories, Inc. to Teligent, Inc. effective as of October 23, 2015, at 5:00 P.M. Eastern Daylight Time. The Company’s office, research and development facilities and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. The Company is a specialty generic pharmaceutical company. Under our own label, the Company currently markets and sells generic topical and branded generic injectable pharmaceutical products in the United States and Canada. In the US, we are currently marketing eight generic topical pharmaceutical products and four branded generic pharmaceutical products. Through the completion of an acquisition, we now sell a total of nineteen generic and branded generic injectable products and medical devices in Canada. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide development, formulation, and manufacturing services to the pharmaceutical, over-the-counter, or OTC, and cosmetic markets. The Company also provides development, formulation and manufacturing services to the pharmaceutical, over-the-counter (“OTC”) and cosmetic markets. We operate our business under one segment.

  

To date, we have filed 31 Abbreviated New Drug Applications, or ANDAs, with the United States Food and Drug Administration, or FDA, for additional pharmaceutical products.

 

On October 14, 2015, the Company provided written notice to the NYSE MKT LLC (the “NYSE MKT”) that the Company intended to transfer the listing of the Company’s common stock from the NYSE MKT to the NASDAQ Global Select Market, and withdraw the listing and registration of the common stock from the NYSE MKT. The Company’s common stock ceased trading on the NYSE MKT at the close of business on October 23, 2015, and began trading on the NASDAQ Global Select Market on October 26, 2015.

 

As discussed in Note 7, on November 13, 2015, the Company acquired all of the rights, title and interest in the development, production, marketing, import and distribution of all pharmaceutical products of Alveda Pharmaceuticals Inc. (“Alveda”) pursuant to two asset purchase agreements, one relating to the acquisition of all of the intellectual property-related assets of Alveda (the “IP-Related APA”) and the other relating to the acquisition of all other assets of Alveda (the “Non-IP Related APA,” and, together with the IP-Related APA, the “APAs”).

 

Teligent also develops, manufactures, fills, and packages topical semi-solid and liquid products for branded and generic pharmaceutical customers, as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. Teligent is currently exploring various options to enable us to expand our development and manufacturing capabilities to include sterile injectable and ophthalmic products.

  

Principles of Consolidation

 

The consolidated financial statements include the accounts of Teligent, Inc. and its wholly-owned and majority-owned subsidiaries. All inter-company accounts and transactions have been eliminated. The Company consolidated the following entities: Igen, Inc., Teligent Pharma. Inc., Teligent Luxembourg S.à r.l, Teligent OÜ, Teligent Canada Inc., and Teligent Jersey Limited., in addition to the following inactive entities: Microburst Energy, Inc., Blood Cells, Inc. and Flavorsome, Ltd.

 

Cash Equivalents

 

Cash equivalents consist of short-term investments, which have original maturities of 90 days or less. These include direct obligations of the U.S. Treasury, including bills, notes and bonds, as well as obligations issued or guaranteed by agencies or instrumentalities of the U.S. government including government-sponsored enterprises, or GSEs.

  

F-9 

 

 

Fair Value of Financial Instruments

 

The carrying amounts of cash and cash equivalents, trade receivables, restricted cash, notes payable, accounts payable, capital leases and other accrued liabilities at December 31, 2015 approximate their fair value for all periods presented.

 

The Company measures fair value in accordance with ASC 820-10, “Fair Value Measurements and Disclosures”. ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:

 

Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

 

Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

 

Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

 

The Company measures its derivative liability at fair value. The derivative convertible option related to Convertible Notes issued December 16, 2014 was valued using the “with” and “without” analysis. A “with” and “without” analysis is a standard valuation technique for valuing embedded derivatives by first considering the value of the Convertible Notes with the option and then considering the value of the Convertible Notes without the option. The difference is the fair value of the embedded derivatives. The convertible note derivative is classified within Level 3 because it is valued using the “with” and “without” method, which does utilize inputs that are unobservable in the market.

 

On May 20, 2015, the Company received approval to increase its authorized shares sufficient to allow for the conversion of the embedded option into equity at the annual shareholders meeting. Therefore, the derivative liability of $18.3 million was reclassified into stockholders equity. Based on the closing price of the Company’s common stock as of December 31, 2015, the fair value of the Notes was approximately $107 million compared to their face value of $143.75 million as of December 31, 2015. However, this variance is due to the conversion feature in the Notes rather than to changes in market interest rates. The Notes carry a fixed interest rate and therefore do not subject the Company to interest rate risk. The Company recorded a change in the fair value of the derivative liability through May 20, 2015 $23.1 million for the twelve months ended December 31, 2015 on the condensed consolidated statements of operations. On May 20, 2015, the Company recorded the final change in fair value and subsequently reclassified the value of the derivative liability into stockholders equity due to the approval of sufficient shares.

 

Accounts Receivable and Allowance for Doubtful Accounts

 

The Company extends credit to its contract services customers based upon credit evaluations in the normal course of business, primarily with 30-day terms. The Company does not require collateral from its customers. Bad debt provisions are provided for on the allowance method based on historical experience and management’s evaluation of outstanding accounts receivable. The Company reviews the allowance for doubtful accounts regularly, and past due balances are reviewed individually for collectability. The Company charges off uncollectible receivables against the allowance when the likelihood of collection is remote.

 

The Company extends credit to wholesaler and distributor customers and national retail chain customers, based upon credit evaluations, in the normal course of business, primarily with 60-day terms. The Company maintains customer-related accruals and allowances that consist primarily of chargebacks, rebates, sales returns, shelf stock allowances, administrative fees and other incentive programs. Some of these adjustments relate specifically to the generic prescription pharmaceutical business. Typically, the aggregate gross-to-net adjustments related to these customers can exceed 50% of the gross sales through this distribution channel. Certain of these accruals and allowances are recorded in the balance sheet as current liabilities and others are recorded as a reduction to accounts receivable.

 

F-10 

 

 

Concentration of Credit Risk

 

Financial instruments, which subject the Company to concentrations of credit risk, consist primarily of cash equivalents and trade receivables. These include direct obligations of the U.S. Treasury, including bills, notes and bonds, as well as obligations issued or guaranteed by agencies or instrumentalities of the U.S. government including GSEs, which are not federally insured.

  

The Company maintains its cash in accounts with quality financial institutions. Although the Company currently believes that the financial institutions with which the Company does business will be able to fulfill their commitments to us, there is no assurance that those institutions will be able to continue to do so.

 

In 2015, the Company had sales to three customers which individually accounted for more than 10% of the Company’s total revenue. These customers had sales of $12.3 million, $5.8 million and $5.0 million, respectively, and represented 52% of total revenues in the aggregate. Accounts receivable related to the Company’s major customers comprised 83% of all accounts receivable as of December 31, 2015.

 

In 2014, the Company had sales to two customers which individually accounted for more than 10% of the Company’s total revenue. These customers had sales of $10.5 million and $4.4 million, respectively, and represented 44% of total revenues in the aggregate. Accounts receivable related to the Company’s major customers comprised 42% of all accounts receivable as of December 31, 2014.

 

In 2013, the Company had sales to three customers which individually accounted for more than 10% of the Company’s total revenue. These customers had sales of $2.8 million, $2.2 million and $2.1 million, respectively, and represented 39% of total revenues in the aggregate.

 

The Company had net revenue from one product, econazole nitrate cream, which accounted for 45% and 38% of total revenues in 2015 and 2014, respectively.  The Company did not have significant revenue from any one product in 2013. 

 

Inventories

 

Inventories are valued at the lower of cost, using the first-in, first-out (“FIFO”) method, or market. The Company records an inventory reserve for losses associated with dated and expired raw materials. This reserve is based on management’s current knowledge with respect to inventory levels, planned production, and extension capabilities of materials on hand. Management does not believe the Company’s inventory is subject to significant risk of obsolescence in the near term. Reserve for obsolescence included in inventory at December 31, 2015 and 2014 were $0.1 million and $0.2 million respectively.

 

Property, Plant and Equipment

 

Depreciation and amortization of property, plant and equipment is provided for under the straight-line method over the assets’ estimated useful lives as follows:

 

    Useful Lives
     
Buildings and improvements   10 - 30 years
Machinery and equipment   3 - 15 years

 

Repair and maintenance costs are charged to operations as incurred while major improvements are capitalized. When assets are retired or disposed, the related cost and accumulated depreciation thereon are removed and any gains or losses are included in operating results.

 

F-11 

 

 

Intangible Assets

 

Definite-lived intangible assets are stated at cost less accumulated amortization. Amortization of definite-lived intangible assets is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 10 to 15 years. The Company continually evaluates the reasonableness of the useful lives of these assets. Indefinite-lived intangible assets are not amortized, but instead are tested at least annually for impairment. Costs to renew or extend the term of a recognized intangible asset are expensed as incurred.

 

In-Process Research and Development

 

Amounts allocated to in-process research and development (“IPR&D”) in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets subject to the impairment testing in accordance with the Company’s impairment testing policy for indefinite-lived intangible assets. As products in development are approved for sale, amounts will be allocated to product rights and will be amortized over their estimated useful lives. These valuations reflect, among other things, the impact of changes to the development programs, the projected development and regulatory time frames and the current competitive environment. Changes in any of the Company’s assumptions may result in a reduction to the estimated fair value of the IPR&D asset and could result in future impairment charges.

 

Goodwill

 

Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is tested for impairment on an annual basis during the fourth quarter of each fiscal year or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company first performs a qualitative assessment to determine if the quantitative impairment test is required. If changes in circumstances indicate an asset may be impaired, the Company performs the quantitative impairment test. In accordance with accounting standards, a two-step quantitative method is used for determining goodwill impairment. In the first step, the Company determines the fair value. If the net book value exceeds its fair value, the second step of the impairment test which requires allocation of the fair value to all of its assets and liabilities using the acquisition method prescribed under authoritative guidance for business combinations would then be performed. Any residual fair value is allocated to goodwill. An impairment charge is recognized only if the implied fair value of our reporting unit’s goodwill is less than its carrying amount.

 

The carrying value of goodwill at December 31, 2015 was $0.4 million. We believe it is unlikely that there will be a material change in the future estimates or assumptions used to test for impairment losses on goodwill. However, if actual results were not consistent with our estimates or assumptions, we could be exposed to an impairment charge that could be material.

 

Acquisitions

 

The Company accounts for acquired businesses using the acquisition method of accounting, which requires with limited exceptions, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When net assets that do not constitute a business are acquired, no goodwill is recognized.

 

Contingent consideration, if any, is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings.

 

Long-Lived Assets

 

In accordance with the provisions of ASC 360-10-55, the Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. In performing such review for recoverability, the Company compares expected future cash flows of assets to the carrying value of the long-lived assets and related identifiable intangibles. If the expected future cash flows (undiscounted) are less than the carrying amount of such assets, the Company recognizes an impairment loss for the difference between the carrying value of the assets and their estimated fair value, with fair values being determined using projected discounted cash flows at the lowest level of cash flows identifiable in relation to the assets being reviewed. As of December 31, 2015, no impairments existed.

 

Foreign Currency Translation

 

The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recorded in the foreign currency translation account, which is included in Accumulated other comprehensive income (loss) (AOCI) and reflected as a separate component of equity. For those subsidiaries where the U.S. dollar has been determined to be the functional currency, non-monetary foreign currency assets and liabilities are translated using historical rates, while monetary assets and liabilities are translated at current rates, with the U.S. dollar effects of rate changes included in Other (income) expense, net.

 

F-12 

 

 

Accrued Expenses

 

Accrued expenses represent various obligations of the Company including certain operating expenses and taxes payable.

 

For the fiscal year ended December 31, 2015, and 2014, the largest components of accrued expenses were:

 

   2015   2014 
   (in thousands) 
         
Wholesaler fees  $2,523   $1,721 
Payroll   1,167    1,414 
Royalties   744    707 
Consulting fees   432    300 
Interest expense   240    213 
Capital expenditures   482    - 
Director's fees   -    133 
Other   679    653 
   $6,267   $5,141 

 

License Fee

 

License fee is amortized on a straight-line basis over the life of the agreement (10 years).

 

Accounting for Environmental Costs

 

Accruals for environmental remediation are recorded when it is probable a liability has been incurred and costs are reasonably estimable. The estimated liabilities are recorded at undiscounted amounts. Environmental insurance recoveries are included in the statement of operations in the year in which the issue is resolved through settlement or other appropriate legal process.

 

Income Taxes

 

The Company records income taxes in accordance with ASC 740-10, “Accounting for Income Taxes,” under the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred income taxes are recognized for the tax consequences of temporary differences by applying enacted statutory tax rates applicable to future years to operating loss and tax credit carry forwards and differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded based on a determination of the ultimate realizability of future deferred tax assets. A valuation allowance equal to 100% of the net deferred tax assets has been recognized due to uncertainty regarding the future realization of these assets.

 

The Company complies with the provisions of ASC 740-10-25 that clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with ASC 740-10, “Accounting for Income Taxes,” and prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Additionally, ASC 740-10 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. There were no unrecognized tax benefits as of the date of adoption. As such, there are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate.

 

F-13 

 

 

Revenue Recognition

 

The Company considers revenue realized or realizable and earned when it has persuasive evidence of an arrangement, delivery has occurred or contractual services rendered, the sales price is fixed or determinable, and collection is reasonably assured in conformity with ASC 605, Revenue Recognition.

 

The Company derives its revenues from three basic types of transactions: sales of its own generic pharmaceutical topical products, sales of manufactured product for its customers included in product sales, and research and product development services performed for third parties. Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition policies for each.

 

Product Sales: Product Sales includes Company Product Sales and Contract Manufacturing Sales.

 

Company Product Sales: The Company records revenue from Company product sales when title and risk of ownership have been transferred to the customer, which is typically upon delivery of products to the customer.

 

Revenue and Provision for Sales Returns and Allowances

 

As is customary in the pharmaceutical industry, the Company’s gross product sales from Company label products are subject to a variety of deductions in arriving at reported net product sales. When the Company recognizes revenue from the sale of products, an estimate of sales returns and allowances (“SRA”) is recorded, which reduces product sales. Accounts receivable and/or accrued expenses are also reduced and/or increased by the SRA amount. These adjustments include estimates for chargebacks, rebates, cash discounts and returns and other allowances. These provisions are adjusted as estimates are based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The estimation process used to determine our SRA provision has been applied on a consistent basis and no material adjustments have been necessary to increase or decrease our reserves for SRA as a result of a significant change in underlying estimates. The Company will use a variety of methods to assess the adequacy of our SRA reserves to ensure that our financial statements are fairly stated. These will include periodic reviews of customer inventory data, customer contract programs and product pricing trends to analyze and validate the SRA reserves.

 

The provision for chargebacks is our most significant sales allowance. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company will validate the chargeback accrual quarterly through a review of the inventory reports obtained from our largest wholesale customers. This customer inventory information is used to verify the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent 90% - 95% of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.

 

Net revenues and accounts receivable balances in the Company’s consolidated financial statements are presented net of SRA estimates. Certain SRA balances are included in accounts payable and accrued expenses.

 

F-14 

 

  

Gross-To-Net Sales Deductions

 

   Twelve months ended December 31, 
   2015   2014 
         
Gross Teligent product sales  $99,721   $51,136 
           
Reduction to gross product sales:          
Chargebacks and billbacks   50,127    26,940 
Sales discounts and other allowances   17,974    4,366 
Total reduction to gross product sales  $68,101   $31,306 
           
Net Teligent product sales  $31,620   $19,830 

 

The annual activity in the Company's allowance for customer deductions accounts for the three years ended December 31, 2015 is as follows (in thousands):

 

   Returns   Chargebacks & Rebates   Discounts   Doubtful Accounts   TOTAL 
Balance at December 31, 2012  $-   $-   $-   $16   $16 
Provision   218    7,704    315    -    8,237 
Charges processed   (162)   (5,958)   (173)   -    (6,293)
Balance at December 31, 2013  $56   $1,746   $142   $16   $1,960 
Provision   767    31,040    1,060    -    32,867 
Charges processed   (149)   (28,234)   (857)   -    (29,240)
Balance at December 31, 2014  $674   $4,552   $345   $16   $5,587 
Provision   1,640    65,901    2,171    -    69,712 
Charges processed   (1,464)   (57,815)   (1,754)   -    (61,033)
Balance at December 31, 2015  $850   $12,638   $762   $16   $14,266 

 

Accounts receivable are presented net of SRA balances of $14.2 million and $5.6 at December 31, 2015 and 2014, respectively. Accounts payable and accrued expenses include $2.5 million and $1.7 at December 31, 2015 and 2014, respectively, for certain fees related to services provided by the wholesalers. Wholesale fees of $6.3 million, $3.1 million and $0.9 million for the years ended December 31, 2015, 2014 and 2013, respectively, were included in cost of goods sold.

 

In addition, in connection with four of the six products the Company currently manufactures, markets and distributes in its own label, in accordance with an agreement entered into in December of 2011, the Company is required to pay a royalty calculated on the basis of net sales to one of its pharmaceutical partners. The royalty is calculated based on contracted terms of 40% of net sales for the four products which is to be paid quarterly to the pharmaceutical partner. In accordance with the agreement, net sales excludes fees related to services provided by the wholesalers. Accounts payable and accrued expenses include $0.7 million at December 31, 2015 and 2014, respectively, related to these royalties. Royalty expense of $3.6 million, $3.6 million and $2.6 million was included in cost of goods sold for the twelve months ended December 31, 2015, 2014, and 2013 respectively. The Company includes significant estimates to arrive at net product sales arising from wholesaler chargebacks, Medicaid and Medicare rebates, allowances and other pricing and promotional programs.

 

Contract Manufacturing Sales: The Company recognizes revenue when title transfers to its customers, which is generally upon shipment of products. These shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. The revenues associated with these transactions, net of appropriate cash discounts, product returns and sales reserves, are recorded upon shipment of the products included in product sales, net in the statement of operations.

 

Research and Development Income: The Company establishes agreed upon product development agreements with its customers to perform product development services. Product development revenues are recognized in accordance with the product development agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Revenue recognition requires the Company to assess progress against contracted obligations to assure completion of each stage. These payments are generally non-refundable and are reported as deferred until they are recognizable as revenue. If no such arrangement exists, product development fees are recognized ratably over the entire period during which the services are performed.

 

In making such assessments, judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Changes in total estimated contract cost and losses, if any, are recognized in the period they are determined. Billings on research and development contracts are typically based upon terms agreed upon by the Company and customer and are stated in the contracts themselves and do not always align with the revenues recognized by the Company.

 

F-15 

 

 

Licensing and Royalty Income: Revenues earned under licensing or sublicensing contracts are recognized as earned in accordance with the terms of the agreements. The Company recognizes royalty revenue based on royalty reports received from the licensee. The Company does not have current plans to have meaningful revenue from licensing and royalty agreements in 2016.

 

Stock-Based Compensation

 

ASC 718-10 defines the fair-value-based method of accounting for stock-based employee compensation plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in which the Company issues stock-based compensation to employees, directors and advisors and for goods or services received from non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in determining the fair values of options and warrants issued as stock-based compensation. These pricing models utilize the market price of the Company’s common stock and the exercise price of the option or warrant, as well as time value and volatility factors underlying the positions. Stock-based compensation expense is recognized over the vesting period of the grant.

 

Debt Issuance Costs

 

Expenses related to debt financing activities are capitalized and amortized on an effective interest method, over the term of the loan. See detailed amounts per year in Notes 6 and 9.

 

Product Development and Research

 

The Company’s research and development costs are expensed as incurred.

 

Shipping and Handling Costs

 

Costs related to shipping and handling is comprised of outbound freight and the associated labor. These costs are recorded in costs of sales.

 

Net Income (Loss) per Common Share

 

Basic net income (loss) per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share of common stock is computed using the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period. Potential dilutive common stock equivalents include shares issuable upon the conversion of the convertible 3.75% senior notes and the exercise of options and warrants and the conversion of preferred stock. Due to the net loss for the years ended December 31, 2013, the effect of the Company’s potential dilutive common stock equivalents was anti-dilutive; as a result, the basic and diluted weighted average number of common shares outstanding and net loss per common share are the same. As of December 31, 2013, the shares of common stock issuable in connection with stock options and warrants of 2,998,406 were not included in the diluted net income (loss) per common share calculation since their effect was anti-dilutive.

 

F-16 

 

 

For the years ended December 31, 2015, 2014 and 2013

(in thousands except shares and per share data)

 

   2015   2014   2013 
Basic net income (loss) per share computation:               
Net income (loss) attributable to common stockholders —basic  $6,668   $5,251   $(1,392)
Weighted average common shares —basic   52,872,814    49,817,721    43,517,640 
Basic net income (loss) per share  $0.13   $0.11   $(0.03)
                
Dillutive net income (loss) per share computation:               
Net income (loss) attributable to common stockholders —basic  $6,668   $5,251   $(1,392)
Interest expense related to convertible 3.75% senior notes   5,391    224    - 
Amortization of discount related to convertible 3.75% senior notes   6,680   $-   $- 
Change in the fair value of derivative   (23,144)  $-   $- 
Net income (loss) attributable to common stockholders —diluted  $(4,405)  $5,475&nb