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): December 16, 2015
COHERUS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36721 | 27-3615821 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 649-3530
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:
| ¨ | 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 December 16, 2015, Coherus BioSciences, Inc. (“Company”) and KBI Biopharma, Inc. (“KBI”) executed a binding proposal (“Proposal”) for commercial cGMP manufacturing of CHS-1701 drug substance, the Company’s pegfilgrastim (Neulasta®) biosimilar candidate, which Proposal is subject to the terms of a Master Services Agreement (“MSA”) entered into between the Company and KBI on July 30, 2014 (collectively, the “Agreement”). Under the terms of the Agreement, the Company agreed to purchase several production batches of CHS-1701 drug substance, including the initial manufacturing campaign scheduled for 2016. The first installment for the initial manufacturing campaign, costing $7.8 million, is due in December 2015. A second manufacturing campaign, costing $20.2 million, is planned for 2017. The Company has the right to cancel production batches at any time by giving appropriate written notice in exchange of foregoing a portion of commitments paid for production capacity reservation.
A copy of the press release announcing the Agreement is attached hereto as Exhibit 99.1.
The foregoing is only a summary of the material terms of the Agreement and MSA, does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the MSA and Proposal, which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Agreement. The omitted material will be included in the request for confidential treatment.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release dated December 21, 2015 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 21, 2015 |
COHERUS BIOSCIENCES, INC. | |||||
| By: | /s/ Jean-Frédéric Viret | |||||
| Name: | Jean-Frédéric Viret | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release dated December 21, 2015 | |
Exhibit 99.1
Coherus BioSciences Signs Strategic Manufacturing Agreement with KBI
Biopharma for Commercial Supply of CHS-1701
REDWOOD CITY, Calif., December 21, 2015 — Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced a strategic manufacturing agreement with KBI Biopharma, Inc. (“KBI Biopharma”) for long-term commercial manufacturing of CHS-1701, its pegfilgrastim (Neulasta®) biosimilar candidate.
The KBI Biopharma agreement provides that KBI Biopharma will manufacture and deliver production quantities of CHS-1701 for the planned commercial launch of CHS-1701 and multiple years of commercial product sales. Coherus has recently indicated that it expects to file its CHS-1701 Biologics License Application (BLA) in the second quarter of 2016.
“We believe this agreement positions Coherus to supply CHS-1701 to patients globally for commercial launch and to continue to meet forecasted global demand for CHS-1701 for several years thereafter,” said Denny Lanfear, president and chief executive officer of Coherus. “Through this agreement, KBI Biopharma, a premier biologics manufacturer, has now allocated ample capacity for Coherus to address the substantial market potential of CHS-1701. We anticipate putting in place additional strategic manufacturing arrangements like this one for our other pipeline molecules.”
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, product development, and the potential benefits of and demand for its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its CHS-1701 biosimilar drug candidate, file a BLA for CHS-1701, supply enough CHS-1701 to meet global demand and enter into manufacturing and production agreements for CHS-1701 and other pipeline products. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Securities and Exchange Commission on November 10, 2015, and its future periodic reports to be filed with the Securities and Exchange Commission.
Neulasta® is a registered trademark of Amgen Inc.
CONTACT:
Keith Vendola, M.D.
Investor Relations
Coherus BioSciences, Inc.
kvendola@coherus.com
+1 (650) 437-6239