0001193125-13-431659.txt : 20131107 0001193125-13-431659.hdr.sgml : 20131107 20131107083734 ACCESSION NUMBER: 0001193125-13-431659 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20131107 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131107 DATE AS OF CHANGE: 20131107 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIGEN CORP CENTRAL INDEX KEY: 0000730272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042729386 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14656 FILM NUMBER: 131198591 BUSINESS ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 BUSINESS PHONE: 7814499560 MAIL ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 8-K 1 d626545d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 7, 2013

 

 

REPLIGEN CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   0-14656   04-2729386

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

41 Seyon Street, Bldg. 1, Suite 100, Waltham, MA   02453
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code (781) 250-0111

 

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On November 7, 2013, Repligen Corporation announced its financial results and corporate update for the third quarter ended September 30, 2013. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1     Press Release by Repligen Corporation, dated November 7, 2013.

 

2


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    REPLIGEN CORPORATION
Date: November 7, 2013     By:  

/s/ Walter C. Herlihy

      Walter C. Herlihy
      President and Chief Executive Officer

 

3


EXHIBIT INDEX

 

Exhibit
No.

  

Exhibit

99.1    Press Release by Repligen Corporation, dated November 7, 2013

 

4

EX-99.1 2 d626545dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

RepliGen    Repligen Corporation
   41 Seyon Street
   Building #1, Suite 100
   Waltham, Massachusetts 02453
   Telephone: (781) 250-0111
   Telefax: (781) 250-0115

 

 

Repligen Reports Third Quarter 2013 Financial Results

- Product Revenue Grows 10% for the Quarter -

- Net Income Grows 226% to $5.9 Million -

- Earnings Conference Call and Webcast Today at 9:00 a.m. EST -

WALTHAM, MA – November 7, 2013 – Repligen Corporation (NASDAQ:RGEN) today reported financial results for the third quarter ended September 30, 2013. Below are the Company’s financial and business highlights for the third quarter, financial guidance for the year and dial-in numbers for today’s conference call.

Third Quarter 2013 Financial Highlights

 

    Bioprocessing product revenue for the third quarter of 2013 was $12.2 million, an increase of approximately 10% over the third quarter of 2012.

 

    Total revenue for the third quarter of 2013 was $18.8 million, an increase of approximately 25% over the third quarter of 2012.

 

    Bioprocessing product gross profit margin was 53.5% for the third quarter of 2013, compared to 42.3% during the third quarter of 2012.

 

    Net income increased to $5.9 million for the third quarter of 2013 compared to $1.8 million for the third quarter of 2012; earnings per diluted share were $0.18 for the third quarter of 2013 compared to $0.06 for the third quarter of 2012.

 

    Cash and investments as of September 30, 2013 totaled $67.1 million compared to $50.0 million as of December 31, 2012.

Operating expenses for the three-month period ended September 30, 2013 were $10.8 million compared to $12.9 million for the same period in 2012, a decrease of $2.1 million or 17%. This decrease was driven by across-the-board reductions in operating expenses during the third quarter of 2013 compared to the same period in 2012. Cost of product revenue decreased by $759,000 or 12% due to product mix and improved process yields and capacity utilization. Research and development (R&D) expense decreased by $1.0 million or 41%; and sales, general and administrative (SG&A) expense decreased by $224,000 or 7%. The reductions in R&D and SG&A expense were primarily due to lower spending on clinical development programs as a result of the Company’s strategic realignment announced in August 2012 to focus on building its bioprocessing business.

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Repligen Reports Third Quarter 2013 Financial Results

November 7, 2013

Page 2 of 5

 

Year-to-Date Financial Summary

Bioprocessing product revenue for the nine-month period ended September 30, 2013 was $37.1 million compared to $32.1 million for the same period in 2012, an increase of 16%. Total revenue for the nine-month period ended September 30, 2013 was $52.8 million compared to $43.5 million during the same period in 2012, an increase of 21%. Operating expenses for the nine-month period ended September 30, 2013 were $35.1 million compared to $38.8 million for the same period in 2012, a decrease of $3.7 million or 10%. For the first nine months of 2013 compared to the same period in 2012, R&D expense decreased by $2.2 million or 27%, and SG&A expense decreased by $639,000 or 6%. Net income for the nine-month period ended September 30, 2013 was $12.8 million compared to $4.6 million for the same period in 2012. Earnings per diluted share for the nine-month period ended September 30, 2013 were $0.40 compared to $0.15 for the same period in 2012.

Third Quarter Business Updates

 

    We successfully completed the technical development of our first 45 cm diameter columns which have more than double the capacity of the largest column size currently marketed by ourselves or any competitor. We developed this product in response to the larger-scale downstream purification needs of our customers as a result of higher upstream fermentation volumes. We are planning for commercial launch of our 45 cm OPUS® columns during the first quarter of 2014.

 

    In October, we completed a 9,000 square foot expansion at our Waltham, MA headquarters to ensure that the quality, capacity and support needs of our customers continue to be met. A dedicated production suite more than doubles the manufacturing capacity for our OPUS® line of pre-packed chromatography columns, with new cleanrooms providing an appropriately controlled environment to satisfy the Good Manufacturing Practices (GMP) standards of our biopharmaceutical customers.

 

    We received a $1 million milestone payment from Pfizer, Inc. under the terms of our exclusive worldwide licensing agreement with Pfizer (the “Agreement”) for the development of compounds to treat spinal muscular atrophy (SMA). This first milestone payment was triggered by completion of specific program activities and coincides with the successful completion of all transition obligations by Repligen. We announced the Agreement in January 2013, at which time we received an upfront payment of $5 million. Repligen remains eligible to receive up to $64 million in additional success-based milestone payments, as well as royalties on any future sales of compounds developed under the Agreement.

 

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Repligen Reports Third Quarter 2013 Financial Results

November 7, 2013

Page 3 of 5

 

Financial Guidance for 2013

The Company is updating its financial guidance for fiscal year 2013. This guidance is based on expectations for our existing business and does not include the impact on our revenue and expenses of potential out-licensing agreements for our remaining clinical assets, potential bioprocessing acquisitions or fluctuations in foreign currency exchange rates.

 

    Total revenue for the full year 2013 is expected to be $67-$68 million, an increase from our previous guidance of $65-$67 million. This projection includes the receipt of royalties from Bristol-Myers Squibb on its U.S. sales of Orencia® which the Company will no longer receive on sales made after December 31, 2013.

 

    Our projection for bioprocessing product revenue remains unchanged at $46-$48 million for the full year 2013, reflecting product sales growth of 10%-15%.

 

    Total income from operations for the full year 2013 is expected to be $21-$22 million, narrowed from our previous guidance of $20-$22 million.

 

    Total net income for the full year 2013 is expected to be $16-$18 million.

 

    We expect to end the year 2013 with $68-$70 million in cash and investments, an increase from our previous guidance of $66-$70 million.

Conference Call

Repligen will host a conference call and webcast today, November 7, at 9:00 a.m. EST, to discuss its third quarter 2013 financial results and corporate developments. The live call can be accessed by dialing (877) 415-3180 for domestic callers or (857) 244-7323 for international callers. Dial-in participants must provide the passcode 31006698. 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 30270739.

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® line of pre-packed “plug-and-play” chromatography columns, and we provide test kits to ensure final product quality. Repligen’s corporate headquarters are located in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA and Lund, Sweden.

 

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Repligen Reports Third Quarter 2013 Financial Results

November 7, 2013

Page 4 of 5

 

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 or guidance 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, our expected launch of large-scale pre-packed chromatography columns and suitability for larger-scale manufacturing, plans and objectives for future operations, optimization of manufacturing process and assurance of GMP compliance resulting from facility expansion, our ability to successfully negotiate and consummate partnering transactions for our clinical stage assets, 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; 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 impact of the expiration on December 31, 2013 of Bristol-Meyers Squibb royalty payments from U.S. sales of Orencia®, 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, including achieving manufacturing efficiencies at Repligen Sweden AB; our ability to optimize manufacturing process; our compliance with all Food and Drug Administration and EMEA regulations; 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.

Contact:

Sondra S. Newman

Director Investor Relations

Repligen Corporation

(781) 419-1881

snewman@repligen.com

 

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Repligen Reports Third Quarter 2013 Financial Results

November 7, 2013

Page 5 of 5

 

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

 

     Three months ended September 30,     Nine months ended September 30,  
     2013     2012     2013     2012  

Revenue:

        

Product revenue

   $ 12,184,215      $ 11,123,236      $ 37,132,094      $ 32,125,076   

Royalty and other revenue

     6,637,838        3,981,059        15,654,919        11,327,500   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     18,822,053        15,104,295        52,787,013        43,452,576   

Operating expenses:

        

Cost of product revenue

     5,659,832        6,418,962        17,854,249        19,036,762   

Cost of royalty revenue

     723,777        594,406        1,943,370        1,593,427   

Research and development

     1,429,529        2,433,043        5,919,265        8,147,164   

Selling, general and administrative

     2,902,048        3,126,244        9,334,087        9,973,013   

Contingent consideration - fair value adjustments

     65,108        343,932        46,521        343,932   

Gain on bargain purchase

     —          —          —          (314,244
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     10,780,294        12,916,587        35,097,492        38,780,054   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     8,041,759        2,187,708        17,689,521        4,672,522   

Investment income

     76,046        95,807        203,170        156,747   

Interest (expense) income

     (11,704     7,205        (37,637     (42,536

Other (expense) income

     36,678        (500,414     (56,504     67,145   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income before income taxes

     8,142,779        1,790,306        17,798,550        4,853,878   

Income tax provision (benefit)

     2,254,505        (16,183     5,032,853        250,954   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 5,888,274      $ 1,806,489      $ 12,765,697      $ 4,602,924   
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per share:

        

Basic

   $ 0.18      $ 0.06      $ 0.40      $ 0.15   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ 0.18      $ 0.06      $ 0.40      $ 0.15   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

     31,858,103        30,948,062        31,583,063        30,841,344   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

     32,551,586        31,256,273        32,282,702        31,131,749   
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income

   $ 7,298,410      $ 3,913,569      $ 13,028,716      $ 6,068,700   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

    September 30, 2013     December 31, 2012  

Balance Sheet Data:

   

Cash, cash equivalents and marketable securities*

  $ 67,105,360      $ 49,969,871   

Working capital

    78,656,803        55,457,223   

Total assets

    111,636,957        97,010,163   

Long-term obligations

    2,695,521        2,133,339   

Accumulated deficit

    (92,384,880     (105,150,577

Stockholders’ equity

    100,157,121        84,124,596   

 

* does not include restricted cash

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