Jefferies Financial Group Inc. · NYSE:JEF
Jefferies Financial — Coherus BioSciences — Conference Presentation (November 2015)
31 slides from Jefferies Financial's conference presentation, November 2015
Slide 1: Coherus BioSciences
Coherus BioSciences November 2015 Copyright ©2015 All Rights Reserved.
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 • Company and Opportunity • Development Pathway and Platform • Pipeline Status and Activity 3 | Copyright ©2015 All Rights Reserved.
Slide 4: Coherus BioSciences: A Leading Pure Play Biosimilars Company
Coherus BioSciences: A Leading Pure Play Biosimilars Company Significant Experience in Pioneering Pipeline Biologics Companies • Three products in Phase 3 or BLA-enabling trials Name Prior Experience • Three BLA/MAA filings targeted within next two Denny Lanfear President and CEO years aimed at worl
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 Surge in 2012 – 2017 Patent Expirations Healthcare Reform/ Regulatory Enablement ~$108 Billion In 2014 Originator Better Analytic Tools Enable Comparability Global Sales Payer Need for Biologics Cos
Slide 6: Over $108 Billion in Pipeline Candidate Selection Opportunities
Over $108 Billion in Pipeline Candidate Selection Opportunities • Thirty originator products Brand Generic 2014 WW Sales ($mm) Humira adalimumab $12,543 Enbrel Lantus etanercept insulin glargine recombinant 8,538 8,428 • Each with >$1 billion in 2014 WW sales Remicade infliximab 8,162 Rituxan rituxi
Slide 7: Late Stage Wave 1 Pipeline and Anticipated Milestones
Late Stage Wave 1 Pipeline and Anticipated Regulatory Data Milestones Other 3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16 10/1/15: Announced positive data from PK/PD study CHS-1701 (pegfilgrastim 4Q ‘15: – Projects completion of dosing for Immunogenicity study Biosimilar) 1Q ‘16 – Anticipates submitting
Slide 8: CHS-1701 Pegfilgrastim Biosimilar: Near Term Commercial Opportunity & Value Driver
CHS-1701 Pegfilgrastim Biosimilar: Near Term Commercial Opportunity & Value Driver Market & Molecular/ Scientific/ Legal Financial Commercial CMC Clinical Relatively Strong existing Well defined Patent Near term modest CHRS scientific mechanism of expirations launch to fund competition kno
Slide 9: Growth in Biologics Spend Puts Biosimilars Firmly on Payer Radars
Growth in Biologics Spend Puts Biosimilars Firmly on Payer Radars Biologics Landscape Total Global Biologics Spend Anti-TNF Pricing History 220% PI since 2009 $250 +201% $221 200% WAC Growth from 2009 Baseline +188% $200 180% US $ in Billions $169 160% +154% $150 $106 140% $100 120% $46 $50 100% Jan
Slide 10: Many Leading Payers Have Signaled Strong Support and Willingness to Cooperate
Many Leading Payers Have Signaled Strong Support and Willingness to Cooperate “ Collaboration Opportunities We share a joint commitment • • Educational programs Consultation on Phase 3 “ with companies like Coherus to create a vibrant biosimilars market place. design to deliver data required by Phar
Slide 11: Agenda
Agenda • Company and Opportunity • Development Pathway and Platform • Pipeline Status and Activity 11 | Copyright ©2015 All Rights Reserved.
Slide 12: Originator Heterogeneity Creates Significant Challenges and Determines Market Characteristics
Originator Heterogeneity Creates Significant Challenges and Determines Market Characteristics GENERIC BIOSIMILAR IMPLICATIONS • Higher Entry Barriers – More sophisticated skills – Complex technological base Small Molecule Complex Biologic – Larger investments for longer time Heterogeneity • Extended
Slide 13: Demonstrating Biosimilarity: Established Five Step Process
Demonstrating Biosimilarity: Established Five Step Process Platform: Navigating the pathway to approval CHS-0214 DP Enbrel (EU) 5 Phase 3 4 Concentration Clinical (g/mL) 3 CHS-0214 DP Trials 25 Enbrel (EU) 50 CHS0214_Lot 133-002-12-290028 (GR. 2) 1 Cutting Edge Process Science 40 4 Analytics and Mo
Slide 14: Platform: Sophisticated Analytics Define Originator Ranges
Platform Sophisticated Analytics Define Originator Ranges Cutting Edge Analytics Biosimilar to What? Clinical and Regulatory Internal Capability is Essential 14 Copyright ©2015 All Rights Reserved.
Slide 15: Platform: Process Science and Cell Biology
Platform: Process Science and Cell Biology Molecular tuning is validated in non-clinical models 50 40 Concentration (g/mL) 30 20 10 Process Science 0 Proces and Molecular Tuning 0 20 40 60 80 Time (hr) s Clinical and Regulatory Intracellular metabolism directly impacts glycosylation and 15 Copyrigh
Slide 16: Platform: Clinical and Global Regulatory
Platform: Clinical and Global Regulatory Clarify Requirements, Mitigate Regulatory Risk 2012 2013 J J A 2012 2012 2012 2012 2012 2013 M 2013 A 2013 2013 2013 2012S O N D J 2013F JJJ J JJJJ J A AAJ A S S SSA 2012 JO JN O OOS N NN O D AD DD NJ S JF JJD O FFFJ2013 M NM MM FA DA AA M JA F M A J J A S O
Slide 17: Platform: Scientific Expertise Focused on Intellectual Property
Platform Scientific Expertise Focused on Intellectual Property Scientific Advisory Board Name Role Expertise Prior Experience Process Sciences Bryan Lawlis, Ph.D. Chairman Biochemistry Protein Chemistry Andy Jones, Ph.D. Member Glycobiology Protein Chemistry Bill Bennett, Ph.D. Member Regulatory Int
Slide 18: Platform: Scientific Expertise Focused on IP Risk Mitigation
Platform Scientific Expertise Focused on IP Risk Mitigation Intellectual property presents potential barriers to entry Patent Scientific Innovation Landscape Advisory And Assessment Board IP Creation • Comp of Matter • Reference • Stable Experts Formulations • Indications • Industry • Cost Effective
Slide 19: Recent US Legal Biosimilar Pathway Developments
Recent US Legal Biosimilar Pathway Developments • Zarxio’s FDA approval (March, 2015) marks first biosimilar approval in the US • Federal Circuit Court in Amgen v. Sandoz has now ruled on the “patent dance:” – Fed Circuit ruling (July, 2015): The BPCIA patent dance is optional. – Applicants that opt
Slide 20: Further Adalimumab Legal Developments
Further Adalimumab Legal Developments • On November 5, 2015 AbbVie withdrew its EP patent (EP 1,406,656) covering an RA dosing regimen of 40 mg bi-weekly. – Patent was opposed by 15 parties; potent invalidity arguments public – In its EP filings, AbbVie stated it will continue to pursue the same dos
Slide 21: IPR Timeline: Final Decision within 18 Months
IPR Timeline: Final Decision within 18 Months Example December June 1, June 1, 1, 2015 2016 2017 IPR Final decision by Request USPTO Decision USPTO (must (“Petition”) whether to proceed occur within 12 filed. (“institute”) must months of occur within six institution) months Notes: 1. IPR may take le
Slide 22: Agenda
Agenda • Company and Opportunity • Development Pathway and Platform • Pipeline Status and Activity 22 | Copyright ©2015 All Rights Reserved.
Slide 23: Good Early Stage Pipeline Candidate Selection Opportunities
Good Early Stage Pipeline Candidate Selection Opportunities • Thirty originator products Brand Generic 2014 WW Sales ($mm) Humira adalimumab $12,543 Enbrel Lantus etanercept insulin glargine recombinant 8,538 8,428 • Each with >$1 billion in 2014 WW sales Remicade infliximab 8,162 Rituxan rituximab
Slide 24: Coherus Applies Rigorous Selection Criteria to Candidate Molecules
Coherus Applies Rigorous Selection Criteria to Candidate Molecules • Market Opportunity • Molecule and • Harmonization • Payers / Providers Analytics • Patents & IP • Global Sites • Partners Analysis • Cell line and • Co-therapies • Patients Manufacturing • Technical Analysis • Promotion • Clinical
Slide 25: CHS-1701 Development Timing and Milestones
CHS-1701 Development Timing and Milestones • PK/PD and • March 2015: Finalized the Immunogenicity Q2 ‘15 Studies Initiated Biologics License Application (BLA) enabling clinical program for CHS-1701 • Study with Topline Data 10/1/15 FDA • No Phase 3 in patients • BLA filing • Q1Retention ‘16 of globa
Slide 26: CHS-1701 vs. Neulasta Study Meets PD Endpoints, Performs as Expected
CHS-1701 vs. Neulasta Study Meets PD Endpoints, Performs as Expected • Three out of four groups, including both • All four groups showed similar ANCmax CHS-1701, performed as expected and ANC AUC • Demonstrated bioequivalence on Cmax • Met bioequivalence for PD endpoints endpoint • Period 1, Neulast
Slide 27: CHS-0214 Development Timing and Milestones
CHS-0214 Development Timing and Milestones • Two ongoing Phase 3 clinical trials • Phase 3 PsO and RA in rheumatoid arthritis and psoriasis Q2 ‘15 Studies Enrolled • Phase 3 clinical trial requirements, manufacturing strategies and RA FPI: Jun 2014 • Phase submission 3 discussed content Readoutswith
Slide 28: CHS-1420 Development Timing and Milestones
CHS-1420 Development Timing and Milestones • Initiated• Phase 3 study Initiated in Psoriasis CHS-1420 SC 40 mg x 2 @ CHS-1420 SC 40 mg Week 0 / Day 0 QOW @ Weeks 17-23 psoriasis Q3 ‘15 Phase 2015 3 40 mg QOW @ Weeks 1-15 N=250 N=250 • Development plan reviewed with regulatory authorities in United C
Slide 29: Upcoming Wave 1 Catalysts
Regulatory Upcoming Wave 1 Catalysts Data Other 3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16 10/1/15: Announced positive data from PK/PD study CHS-1701 (pegfilgrastim 4Q ‘15: – Projects completion of dosing for Immunogenicity study Biosimilar) 1Q ‘16 – Anticipates submitting BLA 4Q ’15: Expects data fr
Slide 30: Company and Opportunity Summary
Company and Opportunity Summary • Large opportunity • Supportive, motivated payers seek competition within >$100 billion market • Experienced team • Veteran team with past and present track record of success ~$108 Billion • Focused strategy In 2014 Originator • Late stage products & near term revenu
Slide 31: Coherus BioSciences
Coherus BioSciences November 2015 Copyright ©2015 All Rights Reserved.
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