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): September 26, 2016
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 1.02 | Termination of a Material Definitive Agreement |
On August 30, 2013, Coherus BioSciences, Inc. (“Coherus”) and Baxter International Inc., Baxter Healthcare Corporation, and Baxter Healthcare SA (together “Baxter”), entered into a License Agreement (the “Agreement”) pursuant to which Coherus and Baxter collaborated to develop and commercialize CHS-0214, an etanercept (Enbrel®) biosimilar candidate, for Europe, Canada, Brazil, the Middle East and other territories. On April 10, 2015, Coherus and Baxter amended and restated the Agreement to revise the milestone payment structures. On June 8, 2015, Baxter’s Board of Directors approved the spin-out of Baxalta Incorporated, and the Agreement was assigned to Baxalta Incorporated, Baxalta US Inc., and Baxalta GmbH (together “Baxalta”). On June 3, 2016, Shire plc (“Shire”) completed its acquisition of Baxalta Incorporated.
On September 26, 2016, Shire’s subsidiaries, Baxalta Incorporated and Baxalta US Inc., notified Coherus that Baxalta had terminated the Agreement in its entirety, pursuant to sections 12.3(b)(ii) and 12.3(b)(iii) of the Agreement.
On September 27, 2016, Coherus issued a press release reporting it regained development and commercial rights to CHS-0214. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Press release dated September 27, 2016. | |
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: September 27, 2016 | COHERUS BIOSCIENCES, INC. | |||||
| By: | /s/ Jean-Frédéric Viret | |||||
| Name: | Jean-Frédéric Viret | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release dated September 27, 2016. | |
Exhibit 99.1
Coherus BioSciences Regains Development and Commercial
Rights to CHS-0214 From Shire
No Payment Due upon Return, no Obligations for Future Payments or Royalties
REDWOOD CITY, Calif., September 27, 2016 – Coherus BioSciences, Inc. (Nasdaq: CHRS) today announced that it has regained from Shire plc all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel®, for Europe, Canada, Brazil, the Middle East and other territories. Reconveyance of CHS-0214 rights to Coherus results from Shire’s strategic portfolio review, following its June 2016 acquisition of Baxalta Incorporated, and includes no present or future payments from Coherus.
“Good companies properly exercise discipline around their chosen strategic focus, and we are very grateful to our colleagues at Baxalta and Shire for their assistance in advancing the CHS-0214 Enbrel biosimilar program,” said Denny Lanfear, President and CEO of Coherus BioSciences. “These reacquired geographical rights fit well with our existing U.S. CHS-0214 rights, and we now have the opportunity to license throughout Europe, U.S. and other key commercial geographies two complimentary Anti-TNF assets— CHS-0214, an Enbrel® biosimilar candidate and CHS-1420, a Humira® biosimilar candidate. We remain on track for submission of a CHS-0214 Marketing Authorization Application (MAA) to the European Medicines Agency in the fourth quarter of 2016.”
As of June 30, 2016, Coherus’ condensed consolidated balance sheet reflected deferred revenue of $85.8 million and $76.8 million for a contingent payment in the event Coherus commercially launched CHS-0214 in the United States under the Shire collaboration. As a result of the termination agreement with Shire, Coherus expects to recognize the $162.6 million as collaboration and license revenues in 2016.
About CHS-0214
CHS-0214 has successfully completed two Phase 3 studies, one in chronic plaque psoriasis, data released in November 2015, and one in rheumatoid arthritis, data released in January 2016. Data from these Phase 3 studies as well as two pivotal clinical pharmacokinetic studies will support the MAA. Coherus has partnered with Daiichi Sankyo for the development and commercialization of CHS-0214 in Japan.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
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 including market opportunities, expectations, goals, objectives, strategies, product pipeline, clinical studies, product development, and the potential benefits of 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’ ability to license its Anti-TNF assets, CHS-1420 and CHS-0214. 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 June 30, 2016, filed with the Securities and Exchange Commission on August 9, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.
Enbrel® is a registered trademark of Amgen, Inc.
Humira® is a registered trademark of AbbVie, Inc.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527