0001193125-16-476000.txt : 20160224 0001193125-16-476000.hdr.sgml : 20160224 20160224171800 ACCESSION NUMBER: 0001193125-16-476000 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160223 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160224 DATE AS OF CHANGE: 20160224 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: 161452936 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 d124482d8k.htm FORM 8-K Form 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): February 23, 2016

 

 

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 1.01. Entry Into a Material Definitive Agreement.

On February 23, 2016, Repligen Corporation (the “Company”) entered into an amendment (the “Lund Amendment”) to its Strategic Supplier Alliance Agreement, effective July 7, 2011 (the “Lund Supply Agreement”), with GE Healthcare Bio-Sciences AB, a GE Healthcare company (“GEHC”) and an amendment (the “Waltham Amendment”) to its Strategic Supplier Alliance Agreement, effective January 1, 2010 (the “Waltham Supply Agreement” and, together with the Lund Supply Agreement as amended, the “Supply Agreements”), with GEHC. The Lund Amendment extends the term of the Lund Supply Agreement until December 31, 2019, and the Waltham Supply Agreement expires on December 31, 2021, each unless terminated earlier, including for material breach or other specified reasons, pursuant to their terms.

The Company manufactures and sells to GE Healthcare proprietary Protein A ligands (the “Products”), which are reagents used in the purification of monoclonal antibody therapeutics. GEHC is required to provide forecasts of its anticipated purchases of the Products, and the average price charged by the Company for the Products is subject to volume-based prices, all as set forth in the Supply Agreements. Under the terms of the Supply Agreements and consistent with the agreements prior to the Waltham Amendment and the Lund Amendment, GEHC is required to purchase the vast majority of GEHC’s worldwide requirement for the Products from the Company, subject to GEHC’s right to reduce such percentage in certain circumstances.

The Company expects to file the Lund Amendment and the Waltham Amendment as exhibits to its Quarterly Report on Form 10-Q for the first quarter ending March 31, 2016 and intends to seek confidential treatment for certain terms and provisions of such amendments. The foregoing descriptions of the Lund Amendment and Waltham Amendment are qualified in their entirety by reference to the complete text of such amendments when filed.

 

Item 7.01. Regulation FD Disclosure.

On February 24, 2016, the Company issued a press release relating to the Lund Amendment and the Waltham Amendment with GEHC. 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 provided in this Item 7.01 and the Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of 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, February 24, 2016.


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: February 24, 2016     By:  

/s/ Tony J. Hunt

      Tony J. Hunt
      President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

No.

   Exhibit
99.1    Press Release by Repligen Corporation, dated February 24, 2016.
EX-99.1 2 d124482dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO   

Repligen Corporation

41 Seyon Street

Building #1, Suite 100

Waltham. Massachusetts 02453

 

 

Repligen Announces Extension of Long Term Supply Agreement for Protein A

- Reaffirms position as strategic supplier of affinity ligands to GE Healthcare -

WALTHAM, MA – February 24, 2016 – Repligen Corporation (NASDAQ:RGEN) today announced that it has extended through 2019 a key long-term supply agreement with GE Healthcare for the manufacture of Protein A ligands at the Company’s facility in Lund, Sweden. In extending this agreement, the Company aligned important manufacturing and supply terms with its existing GE Healthcare long-term supply agreement, which runs through 2021, for production out of the Company’s Waltham, MA facility. The combined agreements maintain Repligen as the main strategic supplier of recombinant and native forms of Protein A ligands to GE Healthcare.

Tony J. Hunt, President and Chief Executive Officer of Repligen said, “This agreement ensures the supply of high quality Protein A ligands to GE Healthcare. Our longtime collaboration is supported by Repligen’s business continuity plans, quality systems and access to our research and development team. We are proud of our Protein A manufacturing expertise and look forward to continuing this important relationship with GE Healthcare.”

Protein A ligands are the critical component of Protein A chromatography media that bind and allow for the affinity purification of monoclonal antibodies. Protein A media is used in the manufacture of nearly all monoclonal antibody-based biologic drugs. Repligen is a leading supplier of Protein A affinity ligands, which the Company has manufactured for GE Healthcare for more than 15 years.

There are currently more than 50 monoclonal antibodies that have received regulatory approval and more than 300 are at various stages of clinical development. Worldwide revenues from this class of drug exceeded $85 billion in 2015.

About Repligen Corporation

Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development 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 affinity ligands, a critical component of Protein A media that is used to separate and purify monoclonal

 

- more -


antibody therapeutics. Our ATF System and our growth factor products are used to increase product yield during the fermentation stage of biologic drug manufacturing. In addition, we developed and market an innovative line of “ready-to-use” chromatography columns under our OPUS® brand that we deliver pre-packed with our customers’ choice of purification media. Repligen’s corporate headquarters are in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA and Lund, Sweden.

The following constitutes a “Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995: 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 current or future financial performance and position, including management’s strategy, plans and objectives for future operations, product development and sales, and development and manufacturing plans, constitute forward-looking 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 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; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; our compliance with all Food and Drug Administration and EMEA regulations; our volatile stock price; and other risks detailed in Repligen’s most recent 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.

Source:

Repligen Corporation

Sondra Newman

Senior Director Investor Relations

(781) 419-1881

snewman@repligen.com

# # #

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