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Repligen Reports Fourth Quarter And Full Year 2012 Financial Results And Provides Financial Guidance For 2013

Stocks in this article: RGEN

Repligen's Bioprocessing Business

Our acquisition of Novozymes Biopharma Sweden AB (now Repligen Sweden AB) in December 2011 positioned Repligen as a world-leading manufacturer of high-value consumable bioprocessing products. We currently manufacture and sell Protein A ligands and media, growth factors, and chromatography products, all of which are used in the production of biologic drugs (monoclonal antibodies, vaccines and other protein therapeutics). Demand for these bioprocessing products is expected to be driven by the continued expansion of the global market for biologics, particularly monoclonal antibodies. Over 35 monoclonal antibodies are currently approved for commercialization, and an industry pipeline of over 350 monoclonal antibodies in clinical development is expected to generate additional approvals and global market expansion.

In total, we have a portfolio of over 15 bioprocessing products, many of which have been incorporated into established biopharmaceutical manufacturing processes. Consistent with our focus on the growth of our bioprocessing business, we are currently exploring opportunities to expand our portfolio through product or company acquisitions.

Conference Call

Repligen will host a conference call and webcast today, March 7, at 9:00 a.m. EST, to discuss its fourth quarter and full year 2012 financial results and corporate developments. The live call can be accessed by dialing (800) 291-5365 for domestic callers or (617) 614-3922 for international callers. Dial-in participants must provide the passcode 66969032. Alternatively, an audio webcast will be accessible via the Investor section of Repligen's website www.repligen.com . Both the conference call and webcast will be archived for a period of time following the live event. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. Replay listeners must provide the passcode 97774715.

About Repligen Corporation

Repligen Corporation (Nasdaq:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide. We are a leading manufacturer of Protein A, a critical reagent used to separate and purify monoclonal antibody therapeutics. We also supply several growth factor products used to increase cell culture productivity during the fermentation stage of drug manufacturing. In addition, we have developed and market our OPUS ® series of pre-packed "plug-and-play" chromatography columns, and we provide test kits to ensure final product quality. Aside from our core bioprocessing business, we have a portfolio of clinical-stage partnering assets, including a pancreatic imaging agent in Phase 3 development and an orphan drug candidate in Phase 1 development. Repligen's corporate headquarters are located in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA and Lund, Sweden.

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, constitute forward-looking statements, including, without limitation, express or implied statements regarding future financial performance and position, our strategic decision to focus on the growth of our bioprocessing business, the future demand for our bioprocessing, growth factor and chromatography products, plans and objectives for future operations, our ability to successfully negotiate and consummate partnering transactions for our clinical stage assets, specifically RG1068 and RG2833, the clinical success of RG3039 and its further clinical development and our receipt of any future payments under the terms of our agreement with Pfizer, Pfizer's ability to terminate the license for convenience, plans and objectives for product development and acquisitions, our market share and product sales and other statements identified by words like "believe," "expect," "may," "will," "should," "seek," "anticipate," or "could" and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to successfully grow our bioprocessing business, including as a result of acquisition, commercialization or partnership opportunities; our ability to successfully negotiate and consummate development and commercialization partnerships for our portfolio of clinical-stage assets on acceptable terms, if at all; the success of our clinical trials, including our Phase 1b clinical trial of RG3039 in patients with SMA; our ability to develop and commercialize products and the market acceptance of our products; reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; the success of current and future collaborative or supply relationships, including our agreement with Pfizer; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; our ability to successfully integrate Repligen Sweden AB; our compliance with all Food and Drug Administration and EMEA regulations; new approaches to the treatment of our targeted diseases; our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our intellectual property rights; our limited sales capabilities; our volatile stock price; and other risks detailed in Repligen's Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. These forward looking statements reflect management's current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law .

 
 
REPLIGEN CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
 
         
   Three months ended December 31,   Year ended December 31,   Nine months ended December 31, 
  2012 2011 2012 2011
Revenue:        
Product revenue  $ 9,709,113  $ 3,114,741  $ 41,834,188  $ 13,215,053
Royalty and other revenue  9,104,848  4,050,403  20,432,348  10,235,194
Total revenue  18,813,961  7,165,144  62,266,536  23,450,247
         
Operating expenses:        
Cost of product revenue  5,920,481  1,511,511  24,957,243  5,157,135
Cost of royalty and other revenue  619,577  481,026  2,213,004  1,315,315
Research and development  2,342,647  2,869,874  10,489,811  9,461,960
Selling, general and administrative  3,253,719  4,268,172  13,226,732  9,050,382
Contingent consideration - fair value adjustments  266,945  --   610,877  -- 
Gain on bargain purchase  --   (427,478)  (314,244)  (427,478)
Total operating expenses  12,403,369  8,703,105  51,183,423  24,557,314
         
Income (loss) from operations  6,410,592  (1,537,961)  11,083,113  (1,107,067)
Investment income  61,858  42,870  218,604  161,053
Interest expense  (14,178)  (27,773)  (56,714)  (27,773)
Other (expense) income  (40,742)  (623,094)  26,403  (623,094)
         
Income (loss) before income taxes  6,417,530  (2,145,958)  11,271,406  (1,596,881)
Income tax (benefit) provision  (3,135,584)  15,744  (2,884,631)  15,744
         
Net income (loss)  $ 9,553,114  $ (2,161,702)  $ 14,156,037  $ (1,612,625)
         
Earnings (loss) per share:        
Basic  $ 0.31  $ (0.07)  $ 0.46  $ (0.05)
Diluted  $ 0.30  $ (0.07)  $ 0.45  $ (0.05)
         
Weighted average shares outstanding:        
Basic  31,132,075  30,714,757  30,914,424  30,774,467
Diluted  31,600,260  30,714,757  31,253,434  30,774,467
         
Comprehensive income (loss)  $ 9,885,680  $ (2,050,762)  $ 15,954,380  $ (1,498,998)
         
         
Balance Sheet Data: December 31, 2012 December 31, 2011    
Cash, cash equivalents and marketable securities*  $ 49,969,871  $ 36,024,531    
Working capital  55,457,223  39,431,285    
Total assets  97,010,163  76,056,814    
Long-term obligations  2,133,339  2,606,293    
Accumulated deficit  (105,150,577)  (119,306,614)    
Stockholders' equity  84,124,596  65,987,000    
         
*does not include restricted cash        
CONTACT: Sondra S. Newman
         Director Investor Relations
         Repligen Corporation
         (781) 419-1881
         snewman@repligen.com

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