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8-K - FORM 8-K - Sagent Pharmaceuticals, Inc.d485981d8k.htm

Exhibit 99.1

 

LOGO

For Immediate Release

SAGENT CONTACT:

Jonathon Singer

jsinger@sagentpharma.com

(847) 908-1605

SAGENT PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2012 RESULTS

Record quarterly revenue and earnings driven by new product launches

Company achieves revised Fiscal Year 2012 Guidance

SCHAUMBURG, Ill., February 14, 2013 – Sagent Pharmaceuticals, Inc. (NASDAQ: SGNT), a leader of specialty pharmaceutical products with a specific emphasis on the injectable market, today announced financial results for the fourth quarter and fiscal year ended December 31, 2012.

Fourth Quarter 2012 Highlights

 

   

Revenue increased 10% to $53.2 million driven by products launched in the last twelve months;

 

   

Reported gross profit increased 159% to $11.6 million, or 21.8% of net revenue;

 

   

Adjusted gross profit1 increased 152% to $13.1 million, or 24.6% of net revenue;

 

   

Earnings per share increased 100% to essentially breakeven; and

 

   

Seven new products launched, including Calcium Leucovorin, Nafcillin and Ondansetron increasing total for fiscal 2012 to 16 new product launches.

“We are pleased with the strong revenue growth and substantial margin expansion achieved this quarter,” said Jeffrey M. Yordon, president, chief executive officer, and chairman of the board of Sagent. “We ended the year on a high note with our first quarter of positive EBITDA1, and breakeven earnings per share. These results substantiate further the strength of our unique operating model and demonstrate the value of our growing product portfolio.”

Yordon added, “2012 has been a year of significant accomplishments for Sagent, including the launch of 16 new products and the continued development of our product pipeline through the filing of 16 new ANDAs. We finished the year with 46 marketed products in 122 presentations and 39 products represented by 70 ANDAs either pending launch or awaiting approval with the FDA. The strong year over year revenue growth and the improvement of our bottom line is a direct result of our commitment to executing against our key strategic initiatives to build a long-term, profitable business for our shareholders. Building on this positive momentum, we will continue to invest in our business model and are focused on positioning Sagent for long-term success in the injectable pharmaceutical market.”

 

1  Adjusted gross profit and EBITDA are non-GAAP measures. Please see discussion of Non-GAAP Financial Measures at the end of this press release.


Financial Results for the Quarter Ended December 31, 2012

Net revenue for the fourth quarter of 2012 was $53.2 million, an increase of $4.7 million, or 10%, compared to $48.5 million in the fourth quarter of 2011. The increase was driven by $10.4 million in revenue from the launch of 37 new codes or presentations of 16 new products since December 2011, partially offset by declines in revenue from existing products. Gross profit for the fourth quarter of 2012 was $11.6 million, or 21.8% of net revenue, compared to $4.5 million, or 9.3% of net revenue, in the fourth quarter of 2011. Adjusted gross profit for the fourth quarter of 2012 was $13.1 million, or 24.6% of net revenue, compared to $5.2 million, or 10.7% of net revenue in the fourth quarter of 2011.

Total operating expenses for the fourth quarter of 2012 decreased 7% to $11.7 million, compared to $12.5 million for the same period in 2011. Product development expense totaled $4.4 million and $4.6 million in the fourth quarter of 2012 and 2011, respectively. Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2012 totaled $8.0 million compared to $7.0 million in the fourth quarter of 2011, with the increase due primarily to higher payroll related costs. The equity in net income of joint ventures for the fourth quarter of 2012 totaled $0.7 million compared to a loss of $0.9 million in the fourth quarter of 2011.

Including the impact of interest and other non-operating expenses, the net loss for the three months ended December 31, 2012 decreased $9.0 million to $0.1 million compared to the fourth quarter of 2011.

Financial Results for the Fiscal Year Ended December 31, 2012

Net revenue for the fiscal year ended December 31, 2012 was $183.6 million, an increase of $31.2 million, or 20%, compared to $152.4 million in fiscal 2011. Product launches since December 2011 contributed $20.8 million of the net revenue increase. Gross profit for fiscal 2012 was $31.1 million, or 16.9% of net revenue, compared to $18.8 million, or 12.3% of net revenue, in fiscal 2011. Adjusted gross profit in fiscal 2012 was $36.7 million, or 20.0% of net revenue, compared to $20.8 million, or 13.7% of net revenue in 2011.

Total operating expenses for the fiscal year ended December 31, 2012 increased 15% to $46.6 million, compared with $40.4 million for the same period in 2011. Product development expense for fiscal 2012 totaled $17.1 million compared to $12.8 million in 2011. SG&A expenses for fiscal 2012 totaled $30.1 million compared to $25.1 million in the prior year. The equity in net income of joint ventures for fiscal 2012 totaled $1.3 million compared to a loss of $2.5 million for 2011.

Including the impact of interest and other non-operating expenses, the net loss for the fiscal year ended December 31, 2012 and 2011 was $16.8 million and $26.4 million, respectively.

Liquidity

Our cash and cash equivalents and short term investments at December 31, 2012 were $64.3 million, and our working capital totaled $106.8 million.

Fiscal 2013 Guidance

Yordon concluded, “Our strong finish to fiscal 2012 lays the foundation for continued revenue growth, margin expansion, and positive cash flow and earnings in fiscal 2013. As in past years, our outlook is influenced by product launches and to a lesser degree, market shortages. The continued strong contributions from calcium leucovorin, the market formation for zoledronic acid and the approval of our iron sucrose ANDA are key drivers of performance for Sagent in the current fiscal year.”


Sagent’s business plan for fiscal 2013 currently anticipates:

 

   

Net revenue for the year to be in the range of $220 to $250 million driven by 13 to 15 product launches;

 

   

Adjusted gross profit as a percentage of net revenues in the range of 23% to 28%;

 

   

Product development expense in the range of $20 to $22 million; and

 

   

Selling, general and administrative expenses in the range of $32 to $35 million.

Based upon the above assumptions, the Company anticipates reported net income for fiscal 2013 to be in the range of breakeven to $5 million.

Conference Call Information

Sagent will host its 2012 fourth quarter and fiscal year end conference call today beginning at 9:00 a.m. Eastern Standard Time. Please call 877-293-5456 from the United States or +1-707-287-9357 internationally. In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website, www.sagentpharma.com. A replay also will be available for 14 days following the live call, and may be accessed via the Company’s website or by calling 855-859-2056, passcode 93294023.

About Sagent Pharmaceuticals

Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a unique, global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.

Forward-Looking Statements

Statements contained in this press release contain forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact, including our fiscal 2013 guidance, included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give Sagent’s current expectations and projections relating to its financial condition, results of operations, plans, objectives, future performance and business as of the date of this release. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Sagent’s expectations are not predictions of future performance, and future results may substantially differ from current expectations based upon a variety of factors, risks and uncertainties affecting Sagent’s business, including, among others, our reliance upon our business partners for timely supply of sufficient high quality API and finished products in the quantities we require; the difficulty of predicting the timing or outcome of product development efforts and FDA approvals; the difficulty of predicting the timing and outcome of any pending litigation including litigation involving third parties that may have an impact on the timing of Sagent’s product launches; the impact of competitive products and pricing and actions by Sagent’s competitors with respect thereto; the timing of product launches;


compliance with FDA and other governmental regulations by Sagent and its third party manufacturers; changes in laws and regulations; our ability to realize expected benefits from our investment in our KSCP joint venture in China; the potential that we may be required to make additional capital investments in KSCP to continue its operations; and such other risks detailed in Sagent’s periodic public filings with the Securities and Exchange Commission, including but not limited to Sagent’s most recent annual report on Form 10-K. Sagent disclaims and does not undertake any obligation to update or revise any forward-looking statement in this press release, except as required by applicable law.

Non-GAAP Financial Measures

Sagent reports its financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

The press release and the accompanying schedules, as well as earnings discussions, include a discussion of Adjusted Gross Profit, EBITDA and Adjusted EBITDA, which are non-GAAP financial measures provided as a complement to the results provided in accordance with GAAP. We define Adjusted Gross Profit as gross profit plus our share of the gross profit earned through our Sagent Agila joint venture which is included in the Equity in net (income) loss of joint ventures line on the Condensed Consolidated Statements of Operations. We define EBITDA as net loss less interest expense, net of interest income, provision for income taxes, depreciation and amortization. We define Adjusted EBITDA as net loss less interest expense, net of interest income, provision for income taxes, depreciation and amortization, stock-based compensation expense and the equity in net loss of our KSCP joint venture.

We believe that Adjusted Gross Profit, EBITDA and Adjusted EBITDA are relevant and useful supplemental information for our investors. Our management believes that the presentation of these non-GAAP financial measures, when considered together with our GAAP financial measures and the reconciliation to the most directly comparable GAAP financial measures, provides a more complete understanding of the factors and trends affecting Sagent than could be obtained absent these disclosures. Management uses Adjusted Gross Profit, EBITDA and Adjusted EBITDA and corresponding ratios to make operating and strategic decisions and evaluate our performance. We have disclosed these non-GAAP financial measures so that our investors have the same financial data that management uses with the intention of assisting you in making comparisons to our historical operating results and analyzing our underlying performance. Our management believes that Adjusted Gross Profit provides a useful supplemental tool to consistently evaluate the profitability of our products that have profit sharing arrangements. The limitation of this measure is that it includes an item that does not have an impact on reported gross profit. The best way that this limitation can be addressed is by using Adjusted Gross Profit in combination with our GAAP reported gross profit. Our management believes that EBITDA and Adjusted EBITDA are useful supplemental tools to evaluate the underlying operating performance of the company on an ongoing basis. The limitation of these measures is that they exclude items that have an impact on net loss. The best way that these limitations can be addressed is by using EBITDA and Adjusted EBITDA in combination with our GAAP reported net loss. Because Adjusted Gross Profit, EBITDA and Adjusted EBITDA calculations may vary among other companies, the Adjusted Gross Profit, EBITDA and Adjusted EBITDA figures presented below may not be comparable to similarly titled measures used by other companies. Our use of Adjusted Gross Profit, EBITDA and Adjusted EBITDA is not meant to and should not be considered in isolation or as a substitute for, or superior to, any GAAP financial measure. You should carefully evaluate the attached schedule reconciling Adjusted Gross Profit to our GAAP reported gross profit and EBITDA and Adjusted EBITDA to our GAAP reported net loss for the periods presented.


 

Financial Tables   Schedule 1

Sagent Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except per share amounts) (Unaudited)

 

     Three months ended December 31,              
     2012     2011     $ change     % change  

Net revenue

   $ 53,226      $ 48,526      $ 4,700        10

Cost of sales

     41,608        44,032        (2,424     -6
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     11,618        4,494        7,124        159

Gross profit as % of net revenue

     21.8 %      9.3 %     

Operating expenses:

        

Product development

     4,436        4,572        (136     -3

Selling, general and administrative

     8,004        7,009        995        14

Management reorganization

     (31     —         (31     100

Equity in net (income) loss of joint ventures

     (748     933        (1,681     180
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     11,661        12,514        (853     -7
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (43     (8,020     7,977        99

Interest income and other

     33        105        (72     -69

Interest expense

     (52     (1,210     1,158        96
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (62     (9,125     9,063        99

Provision for income taxes

     —          —          —          0
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (62   $ (9,125   $ 9,063        99
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.00   $ (0.33   $ 0.33        100

Diluted

   $ (0.00   $ (0.33   $ 0.33        100

Weighted average shares outstanding, basic and diluted

     28,092        27,891        201     


Schedule 2

Sagent Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except per share amounts) (Unaudited)

 

     Twelve months ended December 31,              
     2012     2011     $ change     % change  
     (Unaudited)                    

Net revenue

   $ 183,615      $ 152,405      $ 31,210        20

Cost of sales

     152,508        133,636        18,872        14
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     31,107        18,769        12,338        66

Gross profit as % of net revenue

     16.9 %      12.3 %     

Operating expenses:

        

Product development

     17,136        12,763        4,373        34

Selling, general and administrative

     30,093        25,148        4,945        20

Management reorganization

     708        —         708        100

Equity in net (income) loss of joint ventures

     (1,337     2,531        (3,868     153
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     46,600        40,442        6,158        15
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (15,493     (21,673     6,180        29

Interest income and other

     243        284        (41     -14

Interest expense

     (1,567     (4,195     2,628        63

Change in fair value of preferred stock warrants

     —          (838     838        100
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (16,817     (26,422     9,605        36

Provision for income taxes

     —          —          —          0
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (16,817   $ (26,422   $ 9,605        36
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.60   $ (1.31   $ 0.71        54

Diluted

   $ (0.60   $ (1.31   $ 0.71        54

Weighted average shares outstanding, basic and diluted

     27,980        20,105        7,875     


Schedule 3

Sagent Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share amounts)

 

     December 31,      December 31,  
     2012      2011  
     (Unaudited)         

Assets

     

Current assets:

     

Cash and cash equivalents

   $ 27,687       $ 52,203   

Short term investments

     36,605         73,761   

Accounts receivable, net of chargebacks and other deductions

     31,609         29,028   

Inventories, net

     47,106         41,487   

Due from related party

     1,440         2,379   

Prepaid expenses and other current assets

     2,821         1,988   
  

 

 

    

 

 

 

Total current assets

     147,268         200,846   

Property, plant, and equipment, net

     780         884   

Investment in joint ventures

     19,622         22,762   

Intangible assets, net

     4,277         5,426   

Other assets

     368         590   
  

 

 

    

 

 

 

Total assets

   $ 172,315       $ 230,508   
  

 

 

    

 

 

 

Liabilities and stockholders’ equity

     

Current liabilities:

     

Accounts payable

   $ 21,812       $ 35,403   

Due to related party

     7,026         4,303   

Accrued profit sharing

     4,246         3,753   

Accrued liabilities

     7,369         7,634   

Current portion of long-term debt

     —           8,182   

Notes payable

     —          24,867   
  

 

 

    

 

 

 

Total current liabilities

     40,453         84,142   

Long term liabilities:

     

Long-term debt

     —          4,091   

Other long-term liabilities

     6         606   
  

 

 

    

 

 

 

Total liabilities

     40,459         88,839   

Total stockholders’ equity

     131,856         141,669   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 172,315       $ 230,508   
  

 

 

    

 

 

 


Schedule 4

Sagent Pharmaceuticals, Inc.

Reconciliations of GAAP to non-GAAP Information

(in thousands) (Unaudited)

 

     Three months ended
December 31,
                  % of net revenue, three months
ended December 31,
 
     2012      2011      $ Change      % Change     2012     2011     % Change  

Adjusted Gross Profit

   $ 13,117       $ 5,203       $ 7,914         152     24.6     10.7     13.9

Sagent portion of gross profit earned by Sagent Agila joint venture

     1,499         709         790         111     2.8     1.4     1.4
  

 

 

    

 

 

    

 

 

          

Gross Profit

   $ 11,618       $ 4,494       $ 7,124         159     21.8     9.3     12.5
  

 

 

    

 

 

    

 

 

          
     Twelve months ended
December 31,
                  % of net revenue, twelve months
ended December 31,
 
     2012      2011      $ Change      % Change     2012     2011     % Change  

Adjusted Gross Profit

   $ 36,746       $ 20,833       $ 15,913         76     20.0     13.7     6.3

Sagent portion of gross profit earned by Sagent Agila joint venture

     5,639         2,064         3,575         173     3.1     1.4     1.7
  

 

 

    

 

 

    

 

 

          

Gross Profit

   $ 31,107       $ 18,769       $ 12,338         66     16.9     12.3     4.6
  

 

 

    

 

 

    

 

 

          

Sagent’s business plan for fiscal 2013 currently anticipates:

 

     % of net revenue, twelve months
ended December 31, 2013

Adjusted Gross Profit

   23% - 28%

Sagent portion of gross profit earned by Sagent Agila joint venture

   2% - 3%

Gross Profit

   21% - 25%


Schedule 4 (continued)

 

Sagent Pharmaceuticals, Inc.

Reconciliations of GAAP to non-GAAP Information

(in thousands) (Unaudited)

 

     Three months ended December 31,              
     2012     2011     $ Change     % Change  

Adjusted EBITDA

   $ 2,677      $ (3,896   $ 6,573        169

Stock-based compensation expense

     1,255        928        327        35

Equity in net loss of KSCP joint venture

     677        1,570        (893     -57
  

 

 

   

 

 

   

 

 

   

EBITDA

   $ 745      $ (6,394   $ 7,139        112
  

 

 

   

 

 

   

 

 

   

Depreciation and amortization expense1

     788        1,411        (623     -44

Interest expense, net

     19        1,320        (1,301     -99

Provision for income taxes

     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

Net loss

   $ (62   $ (9,125   $ 9,063        99
  

 

 

   

 

 

   

 

 

   

 

     Twelve months ended December 31,              
     2012     2011     $ Change     % Change  

Adjusted EBITDA

   $ (628   $ (12,476   $ 11,848        95

Stock-based compensation expense

     5,552        2,545        3,007        118

Equity in net loss of KSCP joint venture

     3,814        4,331        (517     -12
  

 

 

   

 

 

   

 

 

   

EBITDA

   $ (9,994   $ (19,352   $ 9,358        48
  

 

 

   

 

 

   

 

 

   

Depreciation and amortization expense1

     5,499        3,159        2,340        74

Interest expense, net

     1,324        3,911        (2,587     -66

Provision for income taxes

     —          —          —       
  

 

 

   

 

 

   

 

 

   

Net loss

   $ (16,817   $ (26,422   $ 9,605        36
  

 

 

   

 

 

   

 

 

   

 

1

Depreciation and amortization expense excludes $22 and $133 of amortization in the three months ended December 31, 2012 and 2011, respectively, and $506 and $465 in the twelve months ended December 31, 2012 and 2011, respectively, related to deferred financing fees, which is included within interest expense and other in our Condensed Consolidated Statements of Operations for the three and twelve months ended December 31, 2012 and 2011.