Coherus Oncology, Inc. · NASDAQ:CHRS
Coherus Oncology — Coherus BioSciences — Bank of America Merrill Lynch Health Care Conference 2016
31 slides from Coherus Oncology's conference presentation, May 11, 2016
Slide 1: Coherus BioSciences Bank of America Merrill Lynch Health Care Conference May 2016
Coherus BioSciences Bank of America Merrill Lynch Health Care Conference May 2016 Exhibit 99.1
Slide 2: Forward looking statements
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 stud
Slide 3: Agenda
Agenda Introduction and Company Summary Addressing the Regulatory Hurdles Navigating the Legal Landscape Maximizing the Commercial Opportunity
Slide 4: Coherus BioSciences is a leading pure play biosimilars company
Coherus BioSciences is a leading pure play biosimilars company 3 products in Phase 3 or BLA-enabling trials 3 BLA/MAA filings targeted in 2016 Expect to submit 1 to 2 new INDs per year 3 Major Partnerships Name Prior experience Denny Lanfear President and CEO Jean Viret, Ph.D. Chief Financial Office
Slide 5: Converging trends create a significant near-term global market opportunity for biosimilar development
Converging trends create a significant near-term global market opportunity for biosimilar development ~$106 Billion In 2015 Originator Global Sales Payer need for biologics cost control Surge in 2012 – 2020 patent expirations Better analytic tools enable comparability Source: EvaluatePharma: 29 orig
Slide 6: Commercial Approval Pathway: three key biosimilar uncertainty issues continue to decrease
Commercial Approval Pathway The three key biosimilar uncertainty issues continue to decrease over time 2010 2015 2020 Higher Lower Affordable Care Act Evolving payor / provider sentiment Zarzio® is a registered trademark of Novartis AG (1) Trend lines illustrative in nature (2) Anticipated Patent Za
Slide 7: 2016 kicked off with positive data across programs
2016 kicked off with positive data across programs COHERUS ANNOUNCES CHS-1701 (PEGFILGRASTIM BIOSIMILAR) MET BOTH PRIMARY ENDPOINTS IN REGISTRATION-ENABLING IMMUNOGENICITY STUDY COHERUS AND BAXALTA ANNOUNCE CHS-0214 (ETANERCEPT BIOSIMILAR) MET PRIMARY EFFICACY ENDPOINT IN PHASE 3 RA STUDY Jan 2016 P
Slide 8: Coherus has strengthened its balance sheet
Coherus has strengthened its balance sheet $100M Private Placement This financing will support three value inflection points BLA for CHS-1701 MAA for CHS-0214 BLA for CHS-1420 May also contribute through first approval $30M Milestone Payment + Executed in Feb 2015 Conversion premium: 60%, >2X that o
Slide 9: Key catalysts are on the near-term horizon across multiple programs
Immunology Regulatory Positive PK/PD data Key catalysts are on the near-term horizon across multiple programs Ph 3 study start Oncology CHS-1701 (pegfilgrastim biosimilar) CHS-0214 (etanercept biosimilar) CHS-1420 (adalimumab biosimilar) Opth. Follow-up PK/PD read-out (1) Positive Ph 3 Psoriasis dat
Slide 10: CHS-1701 pegfilgrastim biosimilar provides near-term commercial opportunity
BLA-enabling clinical CHS-1701 pegfilgrastim biosimilar, provides near-term commercial opportunity Molecular / CMC Scientific / Clinical Legal Commercial / Financial Complex but well defined Limited heterogeneity Existing formulation stable, available Strong CHRS scientific knowledge base Executable
Slide 11: Agenda
Agenda Introduction and Company Summary Addressing the Regulatory Hurdles Navigating the Legal Landscape Maximizing the Commercial Opportunity
Slide 12: Demonstrating biosimilarity: totality of the data
Demonstrating biosimilarity: totality of the data Platform: navigating the pathway to approval Cell Line Development and Manufacturing Analytical Characterization and in vitro Comparability In vivo Animal Comparability Pivotal Phase 1 Human PK/PD Study Phase 3 Clinical Trials Cutting Edge Analytics
Slide 13: Sophisticated analytics define originator biologics and molecular heterogeneity
Sophisticated analytics define originator biologics and molecular heterogeneity production variability Internal Capability is Essential Internal Capability is Essential Biosimilar to What? Clinical and Regulatory Cutting Edge Analytics
Slide 14: Process science and cell biology
Process science and cell biology Molecular tuning is validated in non-clinical models Intracellular metabolism directly impacts glycosylation and biologic actively at various scales Process Process Science and Molecular Tuning Clinical and Regulatory
Slide 15: Strategic manufacturing agreement with KBI Biopharma for CHS-1701 supply
Coherus signed strategic manufacturing agreement with KBI Biopharma for commercial supply of CHS-1701 Durham, NC – 2,000L cell culture Boulder, CO – 1,500L microbial Key partnership terms KBI Biopharma Term COGS Capacity commitment 3 Years with options to extend ~5% of Sales Price ~$900 M of product
Slide 16: Clinical and global regulatory: clarify requirements, mitigate regulatory risk
Clinical and global regulatory Clarify requirements, mitigate regulatory risk Clinical and regulatory engagement is key Advised one program on 351(a) Advised one program to go from 351(a) to 351(k) Guidance on two harmonized clinical programs EU National scientific advice for one product plan EU Nat
Slide 17: Agenda
Agenda Introduction and Company Summary Addressing the Regulatory Hurdles Navigating the Legal Landscape Maximizing the Commercial Opportunity
Slide 18: Scientific expertise focused on intellectual property
Scientific expertise focused on intellectual property Scientific Advisory Board Name Role Expertise Prior Experience Bryan Lawlis, Ph.D. Chairman Process Sciences Biochemistry Andy Jones, Ph.D. Member Protein Chemistry Glycobiology Bill Bennett, Ph.D. Member Protein Chemistry Regulatory John Carpent
Slide 19: Scientific expertise is essential to intellectual property risk mitigation
Scientific expertise is essential to intellectual property risk mitigation Comp of matter Indications Formulation Process Dosing Reference experts Industry knowledge Technical assessment Feasible alternatives Clinical and Regulatory Intellectual Property Patent landscape assessment Scientific Adviso
Slide 20: Patent Issuances in May 2016: Adalimumab formulations
Coherus – Patent Issuances in May 2016: Adalimumab formulations excluding polyol / surfactant Coherus patents may afford significant commercial advantage in light of AbbVie formulation patents that require these two excipients U.S. Patent 9,340,611 Adalimumab, histidine buffer, amino acid stabilizer
Slide 21: Adalimumab IP overview – pathway to market requires IP navigation
‘880 No surfactant ‘611 No polyol ‘612 No polyol / no surfactant Adalimumab IP overview – Pathway to market requires IP navigation Primary IP considerations to market for an adalimumab biosimilar(1) $14B Market (1) Not an exhaustive list of patents relating to adalimumab ‘166 formulation ‘157 Requir
Slide 22: IPR timelines: final decisions expected within 18 months
IPR timelines: Final decision on both ‘135 and ‘166 IPRs expected within 18 months, before planned FDA approval Approx. 70% of instituted IPRs result in claim invalidation or settlement(3) Federal Circuit has rarely reversed USPTO final decisions Must occur within six months of filing Must occur wit
Slide 23: '135 IPR: Rheumatoid arthritis dosing patent
Coherus – ‘135 IPR Rheumatoid arthritis 40 mg dosing patent IPR arguments Key Arguments Obvious to extend van de Putte’s 40 mg dose “Routine Optimization” is not patentable van de Putte 1999 20, 40, 80 mgs/week efficacious in RA Kempeni 1999 Half-life of about 2 weeks Bi-weekly IV doses (.25 mg/kg-1
Slide 24: '166 IPR: Humira buffered formulation
Coherus – ‘166 IPR Humira buffered formulation IPR arguments Relton 1997 Stable IgG1 formulations (concentration, pH, buffers, excipients) U.S. Patent 9,114,166 – stable, buffered, 50 mg/ml, pH 4 to 8 van de Putte 2000 20, 40, 80 mgs/week efficacious in RA Key Arguments Obvious in view of van de Put
Slide 25: Agenda
Agenda Introduction and Company Summary Addressing the Regulatory Hurdles Navigating the Legal Landscape Maximizing the Commercial Opportunity
Slide 26: Coherus applies rigorous selection criteria to candidate molecules
Assessment Coherus applies rigorous selection criteria to candidate molecules Development to Phase 1 Phase 3 Commercial Major biologics losing patent exclusivity by 2020 All technical and commercial factors must be holistically evaluated at key decision points Patent expiry and large existing market
Slide 27: Therapeutic area franchises link Coherus capabilities with customer needs
Therapeutic area franchises link Coherus capabilities with customer needs Product pipeline to leverage commercialization infrastructure Strategy Platform Capability Market Conversion Opportunity Platform enables development of biosimilar candidates in various therapeutic verticals Create bundled pro
Slide 28: Market differences drive tailored commercial responses in the two major markets
Market differences drive tailored commercial responses in the two major markets Episodic, non-chronic care Concentrated sites, clinic and hospital GPO and provider driven adoption Lower competitive intensity Multi-indication, chronic care Larger, multiple specialist prescriber base Payer driven adop
Slide 29: Platform throughput enables therapeutic franchise focus
Potential platform throughput enables therapeutic franchise focus to maximize market value CHS-1701 / BE(1) CHS-5217 / PC CHS-AAA / PC CHS-1420 / Ph 3 CHS-0214 / Ph 3 CHS-BBB / PC CHS-131 / Ph 2b CHS-DDD / PC Oncology Immunology (Anti-TNF) Multiple Sclerosis Therapeutic Area Franchises Products Favo
Slide 30: Program development timing and milestones
Program development timing and milestones PK/PD & immunogenicity studies initiated Q2 ‘15 Positive immunogenicity data PK/PD readout(1) BLA filing directly thereafter(1) Q1 ‘16 Q2 ‘16 CHS-1701 (pegfilgrastim biosimilar) Phase 3 PsO & RA studies enrolled Q2 ‘15 Positive Ph 3 PsO data Positive Ph 3 RA
Slide 31: Coherus BioSciences May 2016
Coherus BioSciences May 2016
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