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Expert Leadership. World-Class Science. Highest Quality Biosimilars

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Expert Leadership. World-Class Science. Highest Quality Biosimilars COHERUS BIOSCIENCES | 2014 ANNUAL REPORT ANNUAL COHERUS BIOSCIENCES | 2014 2014 ANNUAL REPORT Coherus BioSciences 201 Redwood Shores Parkway Suite 200 Expert Leadership. Redwood City, CA 94065 www.coherus.com World-Class Science. Highest Quality Biosimilars. DEAR STOCKHOLDER: CORPORATE INFORMATION 2014 was a breakout year for Coherus in terms of both its clinical and financial accomplishments. We initiated MANAGEMENT TEAM Christos Richards STOCK INFORMATION several biologics license application (BLA) enabling studies and are on track to file our first BLA in the next Dennis M. Lanfear Partner, Catalyst Advisors L.P. The common stock of the 12 months. Additionally, our initial public offering created a foundation to support continued development President, CEO and Chairman Ali J. Satvat company has traded on ® the NASDAQ Exchange of our three lead biosimilar product candidates: CHS-1701 pegfilgrastim (Neulasta ) biosimilar; CHS-1420 Barbara K. Finck, M.D. Director, Private Equity, KKR ® ® under the symbol “CHRS” adalimumab (HUMIRA ) biosimilar; and CHS-0214 etanercept (Enbrel ) biosimilar. We expect to file marketing Chief Medical Officer Mary Szela since November 6, 2014. No applications for these three candidates in the 2015-2016 period. CEO, Melinta Therapeutics, Inc. Alan C. Herman, Ph.D. dividends have been paid Chief Scientific Officer August Troendle, M.D. on the common stock since CHS-0214 ETANERCEPT BIOSIMILAR Jean-Frédéric Viret, Ph.D. President, CEO and Chairman, the company’s inception. This program is partnered with Daiichi Sankyo and Baxter, and we have two ongoing Phase 3 studies, in Chief Financial Officer Medpace, Inc. rheumatoid arthritis and psoriasis. These studies are enrolling very well. We have also completed a Phase 1 Peter Watler, Ph.D. Mats Wahlström CORPORATE COUNSEL bridging pharmacokinetic (PK) study, which compared European Union (EU)-manufactured CHS-0214 to Chief Technical Officer CEO and Chairman, Latham & Watkins LLP EU-Enbrel. We believe that this program will support the filing of a marketing authorization application (MAA) KMG Capital Partners, LLC Menlo Park, California in the EU and a new drug application (NDA) in Japan in mid-2016. Vince Anicetti SVP, Quality & Compliance CORPORATE HEADQUARTERS INDEPENDENT REGISTERED CHS-1701 PEGFILGRASTIM BIOSIMILAR Lisa M. Bell, Ph.D. Coherus BioSciences, Inc. PUBLIC ACCOUNTING FIRM SVP, Global Regulatory Affairs We have reached an understanding with the Food and Drug Administration (FDA) on the clinical development 201 Redwood Shores Parkway Ernst & Young LLP program that will support filing of a BLA with respect to CHS-1701 under the 351(k) path in the fourth quarter of Michael A. Fleming Suite 200 Redwood City, California 2015 or the first quarter of 2016. The clinical program consists of a pivotal pharmacokinetic/pharmacodynamic SVP, Commercial Strategy Redwood City, CA 94065 (PK/PD) study and an immunogenicity study. Matthew R. Hooper (800) 794-5434 phone INVESTOR RELATIONS SVP, General Counsel (866) 491-7350 fax CHS-1420 ADALIMUMAB BIOSIMILAR For further information about Aaron J. Schuchart www.coherus.com Coherus BioSciences, Inc., In September 2014, we announced that our initial pharmacokinetic/bioequivalence (PK/BE) study comparing SVP, Business Development additional copies of our Annual CHS-1420 to US-HUMIRA successfully met its endpoints. We plan to initiate a Phase 3 study in psoriasis mid-2015. TRANSFER AGENT Report on Form 10-K, or other Based on feedback from the European Medicines Agency (EMA) and the FDA, as well as discussions with financial information, please BOARD OF DIRECTORS Wells Fargo Shareowner selected major payers to address their requirements for a biosimilar, we have included a switch from HUMIRA contact the Investor Relations Dennis M. Lanfear Services department at (800) 794-5434. to CHS-1420 in the second part of the study. We believe that the Phase 3 psoriasis study and a PK bridging President, CEO and Chairman 1110 Centre Point Curve, study will support a BLA filing in the second half of 2016. Suite 101 James Healy, M.D., Ph.D. Mendota Heights, MN General Partner, 55120-4100 FOCUS ON COMMERCIAL READINESS Sofinnova Ventures Our commercial plans for 2015, which build on our 2014 activity, are composed of three areas: launch (800) 468-9716 phone V. Bryan Lawlis, Ph.D. readiness for CHS-1701, which entails a thorough evaluation of the commercial opportunity and the strategic (651) 450-4064 (outside the U.S.) President and CEO options and financial requirements for commercialization; the advancement of our CHS-1420 commercial Itero Biopharmaceuticals, LLC www.shareowneronline.com plan based on insights derived from direct engagement of payers, whom we believe will play an integral role in driving the adoption of biosimilars; and finally, the progression of our early stage pipeline candidates through the application of a rigorous framework to evaluate their technical and commercial attractiveness. Thank you for your support of Coherus and our efforts to provide the highest quality biosimilars to patients worldwide. We believe that the positive developments and accomplishments of 2014 put us on a firm path to FORWARD-LOOKING STATEMENT creating substantial value for you, our stockholders. To the extent that statements contained in this Annual Report to Stockholders are not descriptions of historical facts regarding Coherus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding Coherus’ plans to advance its CHS-0214, CHS-1420 and CHS-1701 biosimilar drug Sincerely, candidates, file BLAs for CHS-1420 and CHS-1701 in the U.S., file an MAA for CHS-0214 in the E.U., initiate a Phase 3 study in psoriasis mid-2015 for CHS-1420 and execute commercial plans outlined for 2015. 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. 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’ Annual Report on Form 10-K for the fiscal Dennis M. Lanfear year ended December 31, 2014, filed with the Securities and Exchange Commission on March 23, 2015, and its future periodic reports to be filed with the Securities President, CEO and Chairman and Exchange Commission. Enbrel® and Neulasta® are registered trademarks of Amgen Inc. HUMIRA® is a registered trademark of AbbVie Inc. March 26, 2015 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2014 OR ‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36721 Coherus BioSciences, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3615821 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 201 Redwood Shores Parkway, Suite 200 Redwood City, California 94065 (650) 649-3530 (Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on Which Registered Common Stock, $0.0001 par value per share The NASDAQ Stock Market, Inc. Securities Registered Pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ‘ No È Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ‘ No È Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period than the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ‘ No È Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes È No ‘ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. È Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act (check one): Large accelerated filer ‘ Accelerated filer ‘ Non-accelerated filer È Smaller reporting company ‘ Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
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