Coherus BioSciences. 35 th Annual J.P. Morgan Healthcare Conference. January 10, Copyright 2016 All Rights Reserved.

Transcription

1 Coherus BioSciences 35 th Annual J.P. Morgan Healthcare Conference January 10, 2017 Copyright 2016 All Rights Reserved.

2 Forward Looking Statements Except for the historical information contained herein, the matters set forth in this presentation, including statements regarding Coherus plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, clinical studies, product development, release of data 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 expectations regarding its ability to advance its intellectual strategy for CHS-1420, its ability to advance its CHS-1701, CHS-0214,CHS-1420, CHS-5217 and CHS-3351 biosimilar drug candidates, complete bridging studies for CHS-0214 and CHS-1420, obtain BLA approval for CHS-1701, submit a BLA for CHS-1420 in the U.S., file an MAA for CHS-0214 in the E.U., file at least one IND on a second wave biosimilar pipeline candidate and enter into collaborations for CHS-1701 commercialization ex-u.s., for CHS-131 and for its immunology (Anti-TNF) pipeline. 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 Quarterly Report on Form 10-Q for the period ended September 30, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission. 2 Copyright 2016 All Rights Reserved.

3 Agenda Introduction and Company Summary CHS-1701 Program Highlights and Commercial Readiness Pipeline Update 3 Copyright 2016 All Rights Reserved.

4 Coherus BioSciences is a Leading Biosimilars Company Team Platform Leadership team includes pioneers of top-selling biologics Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property Market Opportunity >$100 billion in biologics revenues facing patent expiration by 2020 Decreasing commercial, regulatory and IP uncertainties Pipeline Strategy Commercialize U.S. oncology Out-license global anti-tnfs Out-license CHS-131 in MS Expect 1 to 2 new INDs per year 4 Copyright 2016 All Rights Reserved.

5 Key Biosimilar Uncertainties Continue to Decline over Time Uncertainty Higher Lower Affordable Care Act Evolving payor / provider sentiment Patent dance rulings Zarxio launch IPR institutions Inflectra launch Commercial Patent Approval Pathway Zarxio now on CVS formulary Neupogen lost 40% of share Pfizer launched infliximab biosimilar in Oct 16 Extension IP is a key issue Formulation patents key hurdle for anti-tnfs SCOTUS deliberating 6-month pre-marketing notice ruling Zarxio, Inflectra, Amjevita and Erelzi approved with full label under 351(k) pathway Zarxio is a registered trademark of Novartis AG; Inflectra is a registered trademark of Pfizer; trend lines illustrative in nature 5 Copyright 2016 All Rights Reserved.

6 2017 is a Transformational Year with First Product Approval and Potential Launch CHS-1701 pegfilgrastim biosimilar CHS-1420 adalimumab biosimilar CHS-0214 etanercept biosimilar 3Q BLA (1) Ph 3 top-line data 4Q 166 IPR denied MAA Regained major global rights (2) 1Q PK study 2Q Anticipated U.S. approval BLA 3Q 135 patent invalidity decision MAA Launch 4Q Anticipated EU approval MAA Wave 2/other CHS-131 Ph 2b data positive Avastin and Lucentis biosimilar programs ongoing Unless otherwise noted, catalysts placed within 3 month achievement windows 6 Copyright 2016 All Rights Reserved. (1) BLA accepted on October 6, 2016 (2) Excluding Japan and LATAM ex-brazil

7 Differentiated Platform Navigates the Pathway to Approval Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property 3 IPRs Instituted, 1 denied 4 formulation patents issued 7 Copyright 2016 All Rights Reserved.

8 Agenda Introduction and Company Summary CHS-1701 Program Highlights and Commercial Readiness Pipeline Update 8 Copyright 2016 All Rights Reserved.

9 CHS-1701 Pegfilgrastim Biosimilar: Significant Near-term Commercial Opportunity Cutting Edge Analytics Process Science and Molecular Tuning Complex, well defined molecule with limited heterogeneity Achieved high-level of analytical similarity Successful scale-up, stable formulation Secured commercial supply through long-term agreement with KBI Large Revenue Opportunity Neulasta WW revenues, $ B CHS-1701 projected first biosimilar to launch in the U.S. in ~$5B market Clinical and Regulatory Efficacy demonstrated in healthy volunteers Successful immunogenicity trial Favorable Competitive Profile Status late-stage biosimilar pipeline (1) BLA and MAA accepted BLA accepted in Oct 16 Approval anticipated June 9, 2017 Intellectual Property Key patents either expired or avoided File accepted in Oct 15 CRL in July 16, refiling in 2018 File accepted in Nov 14 BSUFA date passed in mid 2015 Source: EvaluatePharma, First Word 9 Copyright 2016 All Rights Reserved. (1) With U.S. FDA registration focus

10 CHS-1701 Pegfilgrastim Biosimilar: Positive Pivotal PK/PD Study Results CHS study 122 healthy subjects Randomized, singleblind, three-sequence, three-period crossover study Study assessed PK, PD, and safety (incl. immunogenicity) of CHS compared to Neulasta Positive topline results PK results Mean (±SD) pegfilgrastim concentration Neulasta and CHS-1701 (ng/ml) PD results Mean (±SD) absolute neutrophil count Neulasta and CHS-1701 (10^9/L) Study met all co-primary endpoints: PK: C max and Area Under the Curve (AUC) PD: absolute neutrophil count (ANC) and AUC 90% CI for the GMR well contained within the pre-specified margins of 80% to 125% Similar safety profiles of CHS-1701 and Neulasta with no serious adverse events or study discontinuations for either arm 10 Copyright 2016 All Rights Reserved.

11 CHS-1701 Strategic Manufacturing Agreement: Prepared for Market Launch and Ample Future Supply Key Partnership Terms with KBI Term Location 3 years with options to extend Boulder, CO Cornerstone of U.S. oncology franchise Unencumbered global rights to ~$5B market opportunity Current capacity commitment Readiness status ~$1B in annual sales Qualification lots completed Loading supply chain to support mid 2017 launch In-market manufacturing secures long-term sustainability 11 Copyright 2016 All Rights Reserved.

12 CHS-1701 Pegfilgrastim Biosimilar: Well Positioned to Deliver on the Promise of Biosimilars Very large market Top-selling oncology drug in the U.S., ~$4B in sales in 2015 Ideal structure and dynamics Episodic, supportive care, price-sensitive and concentrated, with aligned incentives across the value chain Validated globally Proven biomarker for efficacy, validated by worldwide filgrastim biosimilar uptake Limited competition Delays in competitive programs improved order of entry for CHS-1701 Coherus well positioned Right timing, right product, and right commercial capability for competitive advantage 12 Copyright 2016 All Rights Reserved.

13 Very large market Neulasta is the Top-Selling Oncology Drug in the U.S. Top oncology drugs by sales in the U.S. in 2015 $ billion Neulasta Historical Revenues in the U.S. $ billion Neulasta Revlimid Avastin Rituxan (1) Gleevec Herceptin Xtandi Velcade E Neulasta is a cornerstone of cancer care, mainstay treatment to prevent febrile neutropenia and enable the delivery of cytotoxic chemotherapy U.S. Neulasta revenues growing over past years, stable at ~$4B Growth supported by stable use (units) and increasing prices (both WAC and ASP increased over this time period) (1) Assumes that 80% of US sales are in oncology and 20% in RA Source: IMS DDD, MAT Feby 2015, Market $, Neulasta, Granix & Leukine; Medispan PriceRx; EvaluatePharma 13 Copyright 2016 All Rights Reserved.

14 Neulasta Price History has Driven Up Cost of Care, Creating an Environment Receptive to Biosimilars Ideal structure and dynamics Neulasta Historical Prices in the U.S. US$ per unit (WAC) 5,500 5,000 Neulasta WAC Consumer Price Index (1) +98% Neulasta WAC ~2X since 2006 New value-based models incentivize care providers to reduce overall spend per patient (e.g., Oncology Care Model) 4,500 4,000 3,500 3,000 2, % Biosimilars are a key free market mechanism to introduce competition for expensive injectable biologics and to control prices Strong public policy support for biosimilars. SCOTUS may consider 6 month waiting period. (1) Indexed to Neulasta WAC in November 2006 Source: SHA National Data, MAT Nov 2016, U.S. Bureau of Labor Statistics 14 Copyright 2016 All Rights Reserved.

15 Ideal structure and dynamics Straightforward Buying Process Schematic of Key Stakeholders in Neulasta Buying Process Payers (CMS & Commercial) IDN GPO Clinic Simple process: providers purchase product, pay for it, administer it, and submit for reimbursement Manufacturer Wholesaler/ Specialty Dist. Hospital Retail/Other) Physician Product flow Patient Few intermediaries: buying decisions taken directly by providers, and or their intermediaries (GPOs or by Parent Entities / IDNs) GPO = Group Purchasing Organization, IDN = Integrated Delivery Network 15 Copyright 2016 All Rights Reserved.

16 Key Decision-Maker Incentives Well Aligned with the Biosimilar Value Proposition Ideal structure and dynamics Standalone Oncology Clinics Hospital Outpatient Oncology Clinics Share of Neulasta 60% 33% Main Driver for Biosimilar Adoption Margin preservation Outcomes Acquisition cost Margin preservation Outcomes Health System under pressure to support new oncology treatment (e.g., immuno-oncology) Market incentivizing outcomes at lower costs (e.g., CMS Oncology Care Model with ~25% of Neulasta share) Value drivers in these markets fundamentally aligned with CHS-1701 value proposition 16 Copyright 2016 All Rights Reserved.

17 Pegfilgrastim Market Research indicates Economics is the dominant market value driver Ideal structure and dynamics Product Attribute Importance for Hospitals and Clinics Percentage, n=96 46% Differentiation potential through multiple attributes but economics trumps all 21% 17% Onpro uptake driven primarily by economics and secondarily by patient convenience Economics Manufacturing Site Location Data Supporting Approval 8% Order of Entry 8% Dosing Format (PFS vs. On-body) CHS-1701 expected to be competitive with respect to all Neulasta formats currently available Source: Coherus CHS-1701 Market Research 17 Copyright 2016 All Rights Reserved.

18 ,001 1,501 2,001 2,501 3,001 3,501 4,001 4,501 5,001 5,501 6,001 6,501 7,001 7,501 8,001 8,501 9,001 9,501 10,001 10,501 Ideal structure and dynamics Concentrated Market Enables Efficient Commercial Effort Neulasta Account Concentration Curve % of sales, all segments 100% 80% 60% 40% 20% 0% Highly concentrated market, with >80% of Neulasta sales managed by roughly: 2000 clinics and hospitals 800 IDNs/Corporations 7 GPOs Concentration of Neulasta sales allow for manageable commercial footprint Source: SHA Sub National Data, IMS Nov 2014-Oct Copyright 2016 All Rights Reserved. Number of accounts

19 Strong Market Adoption of Filgrastim Biosimilar Demonstrates Receptivity to Biosimilar Switch Short Acting Biosimilar filgrastim Share Biosimilar end-of-year unit share in % EU-5 U.S. (1) Validated globally Biosimilar switch willingness is higher in supportive care due to perceived lower patient risk Biosimilars experienced steady uptake in Europe, first U.S. biosimilar launch (Zarxio) on track Year 1 Year 2 Year 3 Year 4 Year 5 Provider indicate higher willingness to switch for Neulasta (vs Neupogen) due to significantly larger Neulasta expenditures (1) Share of Zarxio 12 months after launch in October 2016, does not include Granix (not a biosimilar) Source: IMS, EvaluatePharma 19 Copyright 2016 All Rights Reserved.

20 Competitive Landscape Continues to Evolve Favorably; CHS-1701 BUSFA in June 2017 Limited competition Recent developments in Neulasta biosimilar competitive landscape BLA filing BLA acceptance 6/15 7/16 12/16 AdCom window BSUFA date Launch window BSUFA date passed (1) With immunogenicity as primary endpoint, disclosed in clinicaltrials.gov Source: Press releases, clinicaltrials.gov FDA Complete Response Letter 20 Copyright 2016 All Rights Reserved. 8/16 10/16 1H 17 Announced need for additional study refiling in 2018 Announced withdrawal of MAA in Europe June 9, H 17 Coherus is only player with immunogenicity pivotal trial disclosed (1)

21 Commercial Expertise Focused on Commercial Launch and Brand Building Coherus well positioned Coherus Oncology Commercial Leadership Team Leadership team Role Previous experience Product highlights Michael Fleming SVP Commercial Zofran, Tysabri, Rituxan, Trizivir Jim Hassard VP Marketing Neulasta 10 years, Onpro launch Chris Thompson VP Sales Neulasta 10 years, Neupogen, Aranesp Michael Chen VP Commercial Analytics Aranesp, Tamiflu Olux, Soriatane 21 Copyright 2016 All Rights Reserved.

22 Coherus Well-Positioned to Maximize $4B Opportunity and to Deliver on the Promise of Biosimilars Very large market Ideal structure and dynamics Validated globally Limited competition Coherus well positioned Timing People Quality / Reliability Customer Focus Contracting Strategy BSUFA in June 2017, competitor delays continue across major markets Veteran commercial team proficient with branded oncology buying process Highly-matched molecule, U.S.-based manufacturing Commercial model designed to deliver brand benefits at biosimilar value Disciplined pricing and contracting approach to deliver sustainable economics to key segments 22 Copyright 2016 All Rights Reserved.

23 Agenda Introduction and Company Summary CHS-1701 Program Highlights and Commercial Readiness Pipeline Update 23 Copyright 2016 All Rights Reserved.

24 CHS-0214 Etanercept Biosimilar: Addresses Large Commercial Opportunity Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property A very complex biologic Extensive similarity analysis completed Commercial process validated, with inventory build in 2017 Stable proprietary formulation Positive top-line Ph 3 results in RA Positive top-line Ph 3 results in psoriasis Key EU patents either expired or avoided Issued patent on non-infringing formulation Large Revenue Opportunity Enbrel WW revenues, $ B 9.0 U.S. 5.1 Ex-US Modest Competition ~$9B global opportunity Coherus regained major global rights (1) (1) Excluding Japan and LATAM ex-brazil Status late-stage biosimilar pipeline (2) Expect to file MAA in 1H 17 Approved in U.S. in 2016 Approved in EU in 2016 Source: EvaluatePharma, First Word 24 Copyright 2016 All Rights Reserved. (2) With U.S. FDA registration focus

25 CHS-1420 Adalimumab Biosimilar: Good Progress Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory High-level of analytical similarity achieved Scale-up according to plan CMO pre-agreements for commercial supply Positive Ph 3 in patients with psoriasis BLA filing expected in 1H 17 Large Revenue Opportunity Humira WW revenues, $ B Ongoing IP issues continue in key areas and may impact market timing IP Hurdles Expected to Limit Competition Status late-stage biosimilar pipeline (1) Intellectual Property CHRS wins IPR institution vs. AbbVie 135 Coherus awarded 4 formulation patents х Adverse 166 IPR Decision Scientific and legal strategy in-place to support launch once approved Several others Expect to file 1H 17 after study completion and reg. interactions Approved in 2016 formulation IPRs not instituted In different development stages unclear IP strategy Source: EvaluatePharma, First Word 25 Copyright 2016 All Rights Reserved. (1) With U.S. FDA registration focus

26 CHS-1420 Adalimumab Biosimilar U.S. Patent Office Instituted 135, 680 and 987 IPRs The Decision of the US Patent Office (USPTO) on 135 IPR Petitioner [Coherus] establishes a reasonable likelihood that it will prevail in showing that claims 1 5 of the 135 patent are unpatentable. [AbbVie s] arguments are premised on a claim construction that we do not adopt a skilled artisan would have been led to optimize the dosing regimens disclosed in [van de Putte and Kempeni] we are unpersuaded by [AbbVie s] arguments regarding superiority of the 40 and 80 mg doses to the 20 mg dose Two independent PTAB judge panels agreed with Coherus Final decision expected no later than mid-may 2017 IPRs cover key RA dosing indication 40mg bi-weekly Note: A different PTAB panel of the USPTO also instituted CHRS IPRs filed in December 2015 against AbbVie s U.S. Patents 9,017,680 and 9,073,987. Both are in the same patent family as the 135 patent claiming insignificant variations of a 40 mg biweekly dosage for RA. Boehringer Ingelheim IPRs against the 135 patent were instituted in June, Copyright 2016 All Rights Reserved.

27 CHS-1420 Adalimumab Biosimilar Additional Strategies to Support Path to Market in 2018 Technical and Scientific: Alternative formulations addressing the 166 patent are designed to support a 2018 path to market Legal: Continue advancement of defensive and offensive IP strategies to address ongoing formulation IP risks Clinical: Plan to initiate PK study in 1H 2017 Intellectual Property issues and risks will likely remain an industrywide concern, pending further definition of the legal landscape Additional legal actions may be filed in the near term The information contained in this presentation is not intended to communicate any legal opinion on the infringement or validity of any patents 27 Copyright 2016 All Rights Reserved.

28 CHS-131 Novel Oral Therapy in RRMS: Target Product Profile Addresses Important Patient Needs Positive Phase 2b Efficacy Data in 227 RRMS patients Mean of Number of New CE T1-weighted Lesions on Monthly MRI over 6 Months (1) 7.8 Placebo (n=69) 7.6 CHS-131 1mg (n=70) Safety profile and infections similar across all groups with no new safety signals 4.2 CHS-131 3mg (n=70) No evidence of immunosuppression 3 mg vs. placebo: 52% reduction in CE lesions (2) CHS-131 proposition oral formulation with differentiated safety profile Unique mechanism of action with potent anti-inflammatory effects without evidence of immunosuppression Potential first-line therapy alone or in combination with other MS disease modifying therapies Safety demonstrated with no serious adverse events in over 600 patients, and no signs of leukopenia (1) Sensitivity Analysis for Subjects with Complete Data, full analysis population (2) Least-squares mean Abbreviations: RRMS = Relapsing-Remitting Multiple Sclerosis, CE = Contrast-Enhancing, DMT = Disease Modifying Treatment, MRI = Magnetic Resonance Imaging 28 Copyright 2016 All Rights Reserved.

29 Coherus is Delivering on the Potential of the Platform and Laying the Foundation for Continued Growth Strong Execution: Delivering on the Platform CHS-1701 BLA and MAA accepted CHS-1701 ideally positioned for competitive advantage Positive Phase 3 topline data with CHS-0214 and CHS-1420 Positive Phase 2b data for novel oral treatment for RRMS CHS-131 Strategic Framework: Long Term Value Creation Therapeutic area franchises providing value creation focus Oncology commercial strategy in execution Licensing efforts for immunology and MS assets underway Wave 2 progress on track 29 Copyright 2016 All Rights Reserved.

30 Coherus BioSciences 35 th Annual J.P. Morgan Healthcare Conference January 10, 2017 Copyright 2016 All Rights Reserved.