Coherus BioSciences. Jefferies 2016 Healthcare Conference. June 8, Copyright 2016 All Rights Reserved.

Transcription

1 Coherus BioSciences Jefferies 2016 Healthcare Conference June 8, 2016 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 CHS-1701, CHS- 0214,CHS-1420, CHS-5217 and CHS-3351 biosimilar drug candidates, complete bridging studies for CHS-0214 and CHS- 1420, complete its follow-on PK/PD study for CHS-1701, file BLAs for CHS-1701 and 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. 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 forwardlooking 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 March 31, 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 Program Highlights The Commercial Opportunity 3 Copyright 2016 All Rights Reserved.

4 Coherus BioSciences is a Leading Pure Play Biosimilars Company Team Platform Leadership team includes pioneers of top-selling biologics Market Opportunity >$100 billion in biologics revenues facing patent expiration by 2020 Decreasing commercial, regulatory and IP uncertainties Pipeline Strategy Commercialize US oncology Out-license global anti-tnfs Expect 1 to 2 new INDs per year 4 Copyright 2016 All Rights Reserved.

5 Megatrends Drive >$100 Billion Opportunity Surge in patent expirations Healthcare reform / regulatory enablement Better analytic tools enable comparability >$100 Billion In 2015 Originator Global Sales Payer need for biologics cost control Source: EvaluatePharma: 29 originator products with > $1 B in global sales losing patent exclusivity in at least one major market through 2020 had ~$106 B in 2015 global sales 5 Copyright 2016 All Rights Reserved.

6 Key Uncertainties Continue to Decline and Path to Market has Become More Clear Uncertainty (1) Higher Lower Affordable Care Act Zarxio is a registered trademark of Novartis AG (1) Trend lines illustrative in nature (2) Anticipated 6 Copyright 2016 All Rights Reserved. Zarxio approval Zarxio launch Evolving payor / provider sentiment Patent dance rulings CHRS 135 IPR institution IPR wins for biosimilars (2) Celltrion approval Additional launches (2) We are persuaded that there is a reasonable likelihood that [Coherus] would prevail in showing claims 1 5 of the 135 patent are unpatentable USPTO Institution decision IPR vs. AbbVie patent 135 Commercial Patent Approval Pathway Time

7 2016 is a Transformational Year with Multiple Program Milestones and Catalysts CHS-1701 pegfilgrastim biosimilar 1Q 2Q Immuno data positive (2) PD data positive (3) Follow-up PK/PD read-out (1) BLA (1) 3Q 4Q 1Q 2Q Anticipated approval 3Q 4Q CHS-1420 adalimumab biosimilar Ph 3 top-line data Completed Ph 3 enrollment 135 IPR institution 166 IPR decision Ph 3 study read-out BLA 135 patent invalidity decision Anticipated approval 166 patent invalidity decision CHS-0214 etanercept biosimilar Ph 3 RA data positive (2) Ph 3 Psoriasis data positive (3) MAA Anticipated approval Wave 2 Announced Lucentis and Avastin biosimilar programs Unless otherwise noted, catalysts placed within 3 month achievement windows (1) Expect to complete study late in the first half of this year & move forward with BLA filing directly thereafter; (2) Announced in 1Q 16; (3) Announced in 4Q 15 7 Copyright 2016 All Rights Reserved.

8 US Regulatory Pathway is Established and Full-label Extrapolation is Achievable Concentration (µg/ml) Time (hr) Phase 3 Clinical Trials Pivotal Phase 1 Human PK/PD Study In vivo Animal Comparability Analytical Characterization and in vitro Comparability Cell Line Development and Manufacturing Concentration (µg/ml) Enbrel (EU) CHS-0214 DP Enbrel (EU) Time (hr) Critical quality attributes determine biological activity Deep understanding of the originator attributes is critical for regulatory success Totality of the data drives fullindication labeling Zarxio and Celltrion both approved with full label under 351(k) pathway 8 Copyright 2016 All Rights Reserved.

9 Differentiated Platform Navigates the Pathway to Approval Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property Highly engaged SAB Develop own IP 9 Copyright 2016 All Rights Reserved.

10 Agenda Introduction and Company Summary Program Highlights The Commercial Opportunity 10 Copyright 2016 All Rights Reserved.

11 CHS-1701 Pegfilgrastim Biosimilar Provides Near-term Commercial Opportunity Clinical and Regulatory 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 Efficacy demonstrated in healthy volunteers Successful immunogenicity trial >300 subjects Large Revenue Opportunity Neulasta WW annual revenues $ billion Favorable Competitive Profile Status late-stage biosimilar pipeline 1 Expect to file after BLA-enabling study completion in 2Q 16 Key patents either expired or avoided (1) With U.S. FDA registration focus Source: EvaluatePharma, First Word 11 Copyright 2016 All Rights Reserved. File accepted in Oct 15 no adcom. scheduled to date File accepted in Nov 14 BSUFA date passed in mid 2015

12 High-quality Commercial Manufacturing for CHS-1701 in Place to Exploit the Global Opportunity Key Partnership Terms with KBI Term COGS Current capacity commitment 3 years with options to extend ~5% of sales price ~$1B in annual sales Cornerstone of US oncology franchise Unencumbered global rights to ~$5B market opportunity Loading supply chain to support mid 2017 launch Readiness status Qualification lots completed Inspection ready Low COGS secures long-term sustainability 12 Copyright 2016 All Rights Reserved.

13 CHS-0214 Etanercept Biosimilar Addresses Large Commercial Opportunity A very complex biological on the market High similarity match with originator Large Revenue Opportunity Enbrel WW annual revenues $ billion Clinical and Regulatory Successful pre-commercial scale-up 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 Coherus holds US rights Modest Competition Status late-stage biosimilar pipeline 1 Expect to file after Ph 3 data readout in 2H 16 Filed both in EU and US in 2015 Approved in EU in 2016 (1) With U.S. FDA registration focus Source: EvaluatePharma, First Word 13 Copyright 2016 All Rights Reserved.

14 CHS-1420 Adalimumab Biosimilar Strong Analytical Match and IP Leadership Position. Top-line Ph 3 Data Mid Year High-level of analytical similarity achieved Large Revenue Opportunity Humira WW annual revenues $ billion Clinical and Regulatory Scale-up according to plan CMOs in pre-agreement for commercial supply Enrollment for Ph 3 in psoriasis completed Ph 3 read-out and subsequent filing expected in H2 16 CHRS wins IPR institution vs. AbbVie 135 Coherus awarded 3 formulation patents CHRS files IPR against AbbVie 166 (1) With U.S. FDA registration focus Source: EvaluatePharma, First Word 14 Copyright 2016 All Rights Reserved IP Hurdles Expected to Limit Competition Status late-stage biosimilar pipeline 1 Several others Expect to file after Ph 3 study completion in 2H 16 Filed in Nov 15 formulation IPRs not instituted In different development stages unclear IP strategy

15 Successful Implementation of Differentiated IP Strategy for CHS-1420 Adalimumab Biosimilar 1 Successfully instituted an IPR against AbbVie s dosing patent Worked around AbbVie formulation patents 157 and 158 and developed own IP the combination of these could represent significant hurdles for other market players 3 The rest of the IP strategy, including the 166 IPR, aims for a clear path to market 15 Copyright 2016 All Rights Reserved.

16 1 Management Experience and Legal Savvy Enabled Institution of 135 IPR Proven experience Cohesive IP strategy Validated by IPR institution Clear path to market Industry leading management team has three decades of biologics experience Understanding the difference between valid and contrived IP Awarded three patents PTAB accepted Coherus arguments for institution Plan to launch on approval IPR Institution Selected Excerpts [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 16 Copyright 2016 All Rights Reserved.

17 2 Coherus Patents for Adalimumab Formulations Excluding Polyol / Surfactant Represent Hurdle for Other Players Combined impact of Coherus and AbbVie patents related to use of surfactant and/or polyol in adalimumab formulation Use surfactant? Use polyol? Use Both? No 880 Yes 157 No Yes 158 Use Neither Yes 157 and 158 Other biosimilar players must address either AbbVie or Coherus patents to enter market before 2H 2022 CHRS potential to be only player in market if others fail to address these patents Amgen 157 and 158 IPRs were not instituted U.S. patents 8,916,157, 8,916,158, 9,346,880, 9,340,611, and 9,340,612; 17 Copyright 2016 All Rights Reserved.

18 3 Expect IPRs to Succeed, Derisk Launch, and Aim for a Clear Path to Market Timeline of Coherus IPRs filed on AbbVie Humira dosing and formulation patents 135 IPR 166 IPR 2015 Nov U.S. patents 9,114,166 and 8,889,135 (1) Must occur within six months of filing (2) Must occur within 12 months of institution 1420 approval (3) USPTO - Protecting Biopharmaceutical Innovation Litigation and Patent Office Procedures - Janet Gongola, Senior Advisor (4) Law360 March 8, Copyright 2016 All Rights Reserved May Nov 2017 May Filed Instituted Final decision (2) Filed Institution decision (1) Nov Final decision (2) Anticipated CHS- Approx. 70% of instituted IPRs result in claim invalidation or settlement (3) Appeals to Federal Circuit of PTO final IPR decisions have failed at a rate of ~90% (4)

19 There are Significant Misbeliefs Relating to Humira IP No Humira biosimilar would launch at risk IPR appeals will delay biosimilar launches Preliminary injunctions will block most biosimilar launches Risk of treble damages will dissuade launches Absent preliminary injunction, Coherus expects to launch its Humira biosimilar upon approval IPR final decisions have ~90% probability of being affirmed on appeal (1) reducing likelihood of preliminary injunction Burden for preliminary injunction is high and statistics show success is low AbbVie patents subject to strong invalidity arguments are expected to be ineligible for treble damages (1) Law360 March 8, Copyright 2016 All Rights Reserved.

20 Agenda Introduction and Company Summary Program Highlights The Commercial Opportunity 20 Copyright 2016 All Rights Reserved.

21 Coherus Applies Rigorous Selection Criteria to Candidate Molecules Major biologics losing patent exclusivity by 2020 Generic name WW sales in 2015 (US$ billion) adalimumab 14.4 etanercept 9.1 infliximab 8.1 rituximab 7.3 insulin glargine 7.1 bevacizumab 6.9 trastuzumab 6.8 pegfilgrastim 4.8 ranibizumab 3.6 insulin aspart rec 3.1 insulin lispro rec 2.8 onabotulinumtoxina 2.8 insulin detemir rec 2.7 interferon beta-1a 2.6 factor VIII (procoag.) 2.2 omalizumab 2.1 interferon beta-1a 2.0 Coherus natalizumab 1.9 wave 1 assets epoetin alfa 1.9 insulin aspart 1.7 Coherus cetuximab 1.5 wave 2 assets Toclizumab 1.5 Assessment Development to Phase 1 Phase 3 Commercial Market Opportunity Patents & IP Analysis Technical Analysis Molecule and Analytics Cell line and Manufacturing Clinical and Nonclinical Harmonization Global Sites Co-therapies Payers, Providers, Patients Partners Promotion Legal Defense All technical and commercial factors must be holistically evaluated at key decision points Patent expiry and large existing markets are insufficient rationale for product selection Source: EvaluatePharma 21 Copyright 2016 All Rights Reserved.

22 Therapeutic Area Franchises Link Coherus Capabilities with Customer Needs Create therapeutic verticals Platform Capability Strategy Market Conversion Opportunity Platform enables development of biosimilar candidates Product pipeline to leverage commercialization infrastructure 22 Copyright 2016 All Rights Reserved.

23 Market Differences Drive Tailored Commercial Responses Oncology (CHS-1701) Inflammation (Anti-TNFs) Market Dynamics Episodic, non-chronic care Multi-indication, chronic care Concentrated sites, clinic and hospital Larger, multiple specialist prescriber base GPO and provider driven adoption Payer driven adoption, PBM intermediary Lower competitive intensity Higher competitive intensity Commercial Response Specialty sales force < 50 Specialty sales force > 150, Payer contracting GPO and provider contracting Competitive patient friendly formats / programs Education and conversion dynamics executable Strong sales pull-through driving rapid conversion 23 Copyright 2016 All Rights Reserved.

24 Potential Platform Throughput Enables Therapeutic Franchise Focus to Maximize Market Value Therapeutic Area Franchises Oncology Immunology (Anti-TNF) Ophthalmology (VEGF) Multiple Sclerosis Products CHS-1701 / BE (1) CHS-5217 / PC CHS-AAA / PC CHS-1420 / Ph 3 CHS-0214 / Ph 3 CHS-BBB / PC CHS-3351 / PC CHS-CCC / PC CHS-131 / Ph 2b CHS-DDD / PC Commercial Model Options (1) BLA enabling Wave 1 Wave 2 Potential Favorable industry structure yields reasonably sized commercial footprint Favorable Strategic Deal or Retain Open Open Pending Data 24 Copyright 2016 All Rights Reserved.

25 Program Development Timing and Milestones CHS-1701 (pegfilgrastim biosimilar) CHS-0214 (etanercept biosimilar) CHS-1420 (adalimumab biosimilar) Wave 2 assets Q2 15 PK/PD & immunogenicity studies initiated Q2 15 Phase 3 PsO & RA studies enrolled Q3 15 PsO study initiated H1 16 Bevacizumab & Ranibizumab announced Q1 16 Positive immunogenicity data Q4 15 Q1 16 Positive Ph 3 PsO data Positive Ph 3 RA data Mid IPR instituted Phase 3 readouts H2 16 Pipeline addition Q2 16 PK/PD readout (1) BLA filing directly thereafter (1) H2 16 MAA filing H2 16 BLA filing H1 17 Pipeline addition Unless otherwise noted, catalysts placed within 3 month achievement windows (1) Expect to complete study late in the first half of this year & move forward with BLA filing directly thereafter 25 Copyright 2016 All Rights Reserved.

26 Coherus BioSciences Jefferies 2016 Healthcare Conference June 8, 2016 Copyright 2016 All Rights Reserved.