Leerink Global Healthcare Conference -...
Transcript of Leerink Global Healthcare Conference -...
Non-ConfidentialNon-Confidential
Leerink Global Healthcare ConferenceFebruary 12, 2015
Amit Munshi, President & Chief Executive OfficerTom Shea, Chief Financial Officer
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Forward Looking Statement
Any statements made herein relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this document, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants,as they relate to EPIRUS or its management may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators and single-source contract manufacturing; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS’ proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; risks related to the loss of any of our key management personnel; and risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations. The forward-looking statements represent the estimates of EPIRUS as of the date hereof only, and EPIRUS specifically disclaims any duty or obligation to update forward-looking statements.
Other risks and uncertainties are more fully described in EPIRUS’ filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made herein speak only as of the date stated herein, and subsequent events and developments may cause EPIRUS’ expectations and beliefs to change.
While EPIRUS may elect to update these forward-looking statements publicly at some point in the future, EPIRUS specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing EPIRUS’ views as of any date after the date stated herein.
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EPIRUS Overview
Building a profitable, sustainable, pure-play, global biosimilar business
Developing an operationally synergistic pipeline
Addressing a diverse global landscape
Operating with world-class expertise
Inflammation focused pipeline with 3 candidates -$20B+ market opportunity ; BOW015 (infliximab) launched in first market
Accessing $70B+ global opportunity requires regional partnerships, technology transfer to local production markets and direct sales strategies in select markets
Boston-based company with expertise from cell line generation to process development through clinical, regulatory and commercial
Remicade is a registered trademark of Johnson and Johnson, Humira is a registered trademark of AbbVie; Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group
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Major Biologic Medicines Will Lose Patent Protection in the Next Decade - $70B+ Market
2008 2013 2020 2025
Source: EvaluatePharma based on data pulled January 25, 2015Sales for Epogen and Neupogen based on actual 2012 sales; All other products based on 2018 forecasted sales
$3B+
$57B+
$21B+
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Top Selling Biologic Drugs
Innovator Company Indication Global Sales 2013
Forecasted Sales 2020
Approximate # of Biosimilar
Competitors
Humira (adalimumab)
AbbVie RA, CD, UC, PsO, PsA, AS $11B $14.2B 10
Enbrel (etanercept)
Amgen RA, PsO, PsA, AS $8.8B $8.1B 25
Remicade (infliximab)
Janssen RA, CD, UC, PsO, PsA, AS $8.4B $7.8B <5
Lantus (insulin glargine)
Sanofi Type 2 Diabetes $7.6B $5.5B <5
Rituxan (rituximab)
Genentech / Biogen
NHL, CLL, RA, GPA, MPA $7.5B $5.4B 30
Avastin (bevacizumab)
Genentech mCRC, NSCLC, mRCC, rGBM $6.8B $6.1B 15
Herceptin(trastuzumab)
Genentech Breast Cancer, Metastatic Gastric / GEJ Cancer $6.6B $5.3B 20
Neulasta (pegfilgrastim)
Amgen Neutropenia related to cancer chemotherapy $4.4B $3.5B 5
Lucentis (ranibizumab)
Genentech wAMD, macular edema following RVO, DME $4.2B $3.9B <5
Actemra (tocilizumab)
Genentech RA $1.1B $2.2B <5
Sources: EvaluatePharma based on data pulled January 25, 2015, company websites
RA (Rheumatoid Arthritis), CD (Crohn’s Disease), UC (Ulcerative Colitis), PsO (Plaque Psoriasis), PsA (Psoriatic Arthritis), AS (Ankylosing Spondylitis), NHL (Non-Hodgkin’s Lymphoma), CLL (Chronic Lymphocytic Leukemia), GPA (Granulomatosis with Polyangiltis), MPA (Microscopic Polyangiltis), mCRC (Metastatic Colorectal Cancer), NSCLC (Non-Squamous Non-Small Cell Lung Cancer), mRCC (Metastatic Renal Cell Carcinoma), rGBM (Glioblastoma), wAMD (Wet Age-Related Macular Degeneration), RVO (Retinal Vein Occlusion), DME (Diabetic Macular Edema)
Focus on High Value / Lesser Competitive Intensity Products with Therapeutic Area Overlap
BOW050
BOW015
BOW070
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Top Selling Biologic Drugs
Innovator Company Indication Global Sales 2013
Forecasted Sales 2020
Approximate # of Biosimilar
Competitors
Humira (adalimumab)
AbbVie RA, CD, UC, PsO, PsA, AS $11B $14.2B 10
Enbrel (etanercept)
Amgen RA, PsO, PsA, AS $8.8B $8.1B 25
Remicade (infliximab)
Janssen RA, CD, UC, PsO, PsA, AS $8.4B $7.8B <5
Lantus (insulin glargine)
Sanofi Type 2 Diabetes $7.6B $5.5B <5
Rituxan (rituximab)
Genentech / Biogen
NHL, CLL, RA, GPA, MPA $7.5B $5.4B 30
Avastin (bevacizumab)
Genentech mCRC, NSCLC, mRCC, rGBM $6.8B $6.1B 15
Herceptin(trastuzumab)
Genentech Breast Cancer, Metastatic Gastric / GEJ Cancer $6.6B $5.3B 20
Neulasta (pegfilgrastim)
Amgen Neutropenia related to cancer chemotherapy $4.4B $3.5B 5
Lucentis (ranibizumab)
Genentech wAMD, macular edema following RVO, DME $4.2B $3.9B <5
Actemra (tocilizumab)
Genentech RA $1.1B $2.2B <5
Sources: EvaluatePharma based on data pulled January 25, 2015, company websites
RA (Rheumatoid Arthritis), CD (Crohn’s Disease), UC (Ulcerative Colitis), PsO (Plaque Psoriasis), PsA (Psoriatic Arthritis), AS (Ankylosing Spondylitis), NHL (Non-Hodgkin’s Lymphoma), CLL (Chronic Lymphocytic Leukemia), GPA (Granulomatosis with Polyangiltis), MPA (Microscopic Polyangiltis), mCRC (Metastatic Colorectal Cancer), NSCLC (Non-Squamous Non-Small Cell Lung Cancer), mRCC (Metastatic Renal Cell Carcinoma), rGBM (Glioblastoma), wAMD (Wet Age-Related Macular Degeneration), RVO (Retinal Vein Occlusion), DME (Diabetic Macular Edema)
Focus on High Value / Lesser Competitive Intensity Products with Therapeutic Area Overlap
BOW050
BOW015
BOW070
Our pipeline leverages cell technologies (immunoglobulin G monoclonal antibodies), assays, clinical databases and
investigators, and commercial footprint to reduce timelines and costs
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Operationally Synergistic Pipeline Focused on Immunology / Inflammation
Candidate Originator Comparability Pre-clinical Clinical Launch
BOW015InfliximabEmerging Markets*
Remicade
BOW015InfliximabUS & Europe
Remicade
BOW050AdalimumabGlobal
Humira
BOW070TocilizumabGlobal
Actemra
~18 months ~18 months~6 months ~8 months
Comparability
Comparability / CTA
Comparability / CTA
2015 1H16
US/EU
Filings
2017Filings
2018Filings
2019Filings
2015Filings
Global
Global
*Emerging markets targeted for near-term MAA filings for BOW015 include: Indonesia, Mexico, Thailand, Korea, Argentina and Malaysia 7
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Accessing this Opportunity Requires Navigating Regulatory, Legal and Commercial Challenges
US EUROPE
LOCAL PRODUCTION
MARKETS(Brazil, China,
Russia)
ACCESSIBLE MARKETS(SE Asia,
LATAM, India)
Cha
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Regulatory Clarity / Precedence
FDA in process of implementing the Biologics Price Competition and Innovation Act
Existing frameworks, multiple approved productsStrong government support for product approvalMay require local patients, presence – e.g., China, Japan, Brazil
Legal Challenges / Encumbrances
Lingering IP encumbrances likely
Minimal challenges, no challenges to physician prescribing
Freedom to operate, no challenges to physician prescribing
Commercial viability / tractability
Switching at physician / patient level
Partly tender driven, physician driven
Tender driven market Market expansion
EPIRUS’ Approach to Navigating Markets
Plan for commercial partner or alternative commercial approach
Combination of partnerships and direct sales in targeted countries
Partnerships for local production and technology transfer using SCALE™
Local Partnerships with marketing and medical affairs support services
Market Segments
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Strategy
• BOW015 launched in first market, India, (Infimab™) – additional filings planned for 2015
• Complete global Phase 3 BOW015 study –2017 US and EU filings
• Partner BOW050 globally – 2018 global filings
• Retain BOW070 worldwide rights – 2019 global filings
• Positioned to be in the first wave of biosimilars for each patent expiry
• Leverage operationally synergistic pipeline with overlapping indications
• Launch into Europe with BOW015 and BOW050 with initial direct sales in select markets – BENELUX, Nordic, Switzerland; eventually expand footprint with BOW070
• Gain a competitive advantage via local production in targeted markets
• Generate cash flow and develop commercial experience with near-term filings for BOW015 in accessible markets
Clinical & Regulatory Commercial
Infimab is a trademark of Ranbaxy9
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Potential Near-Term Filings for BOW015 in Targeted Emerging Markets
Country Accessible Patients on anti TNF Biologics
Indonesia 10k
Mexico 50k
Thailand 47k
Korea 50k
Argentina 35k
Malaysia 18k
Assumptions:• Local partner required to act as Marketing Authorization Application (MAA) holder• Approximate timelines; may file at risk and provide supplement and Certificate of Pharmaceutical Product (CPP)
during review• Korea – recommended meeting with regulatory agency
Source: Campbell Alliance Group10
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Post virus removal
Thaw and scale up
Where Local Production is Required, SCALE™ Offers a Transferable, Integrated Approach
Fully integrated, transferable manufacturing platform…
…using single use manufacturing for productivity…
SCALE™Integrated
Manufacturing
Vendor Management
Staffing & Training
Product
Quality & Regulation
Facility
Technical Support
Bulk Drug Substance
PolishingStep
AnionExchange
ProductionVirus Removal
Capture
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Lead Program: BOW015 - Biosimilar to Remicade
*See SEC disclosure regarding the Company’s dispute with RLS, available on the SEC website at www.SEC.gov. Note: Remicade sales are as reported in EvaluatePharma
Marketed by Johnson & Johnson (Merck Schering, Tanabe ex-US)
2013 sales of $8.4B globally
~50% of sales ex-US
Ex-US patents expire 2014 – 2015
Major Indications: Rheumatoid Arthritis, Crohn’s Disease, Ankylosing Spoldylitis, Psoriatic Arthritis, Psoriasis
Positive Phase 1 data (UK)
Positive Phase 3 data (India)
Phase 3 data presented EULAR and ACR in 2014
Regulatory approval in India via manufacturing partner Reliance Life Sciences (RLS)*; launched in India with Ranbaxy
Developed market filings planned for 2017
Remicade (infliximab) BOW015 (infliximab)
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BOW015 Extensively Characterized for Biosimilarity
Physicochemical Analysis MethodpH, Osmolality Compendial Methods
Appearance, Color, Clarity Compendial Methods
Molecular Weight CE-SDS (± Reduction)SEC with MALS, Intact MS
Amino Acid Sequence Peptide Mapping with LC-MS/MSIntact MS with Deglycosylation
N-Terminal Heterogeneity Peptide Mapping with LC-MS/MSEdman DegradationIon-Exchange Chromatography
Spectrophotometric Properties Circular Dichroism (CD)UV Derivative Spectroscopy
Thermal Stability Differential Scanning Calorimetry
Chemical Stability Fluorescence Denaturation
Disulfide Bond Arrangement Non-Reducing Peptide Mapping with LC-MS/MS
Aggregation and Reversible Self-Association
SEC with UVDynamic Light Scattering (DLS)
Glycosylation N-Linked Glycan AnalysisIntact MS ± Deglycosylation
Deamidation Peptide Mapping with LC-MS/MS
Oxidation Peptide Mapping with LC-MS/MS
O-Glycation Peptide Mapping with LC-MS/MSFluorescence & Spectroscopy
Phosphorylation Peptide Mapping with LC-MS/MS
In vitro Biochemical Analysis MethodTNF-α Binding ELISA, Octet or Biacore
Fc Binding ELISA, Octet or Biacore(FcRn, FcγRI, FcγRIIA, FcγRIIA,FcγRIIIA, Clq)
In vitro Biological Analysis MethodBiological Potency L929 Cell-Based Proliferation Assay
Immunological Function Cell-Based Assay (ADCC, CDC,Apoptosis)
BOW015 Characterization:Similarity and Comparability
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BOW015 REMICADE
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BOW015 REMICADE
Arithmetic Mean Infliximab Serum Concentration versus Nominal Time Overlaid by Treatment: Linear Scale (PP Population)
BOW015 Demonstrated Biosimilarity to Remicade in Phase 1 and Phase 3 trials
Phase 1 Phase 3Per Protocol Analysis of ACR20 Response Rates
Over Multiple Time Points
No meaningful differences observed in safety or immunogenicityn = 189
No meaningful differences observed in safety or immunogenicityn = 84
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58 Week Data - Patients can be Started and Maintained and Safely Switched from Remicade
Open Label Phase – 58 Weeks• Durability of response
maintained out to 58 Weeks with BOW015 alone and after switching from Remicade
• BOW015 safe and well tolerated alone and after switching from Remicade
• Consistent immunogenicity between arms: BOW015 alone and BOW015 switched from Remicade
Double Blind Phase – 16 WeeksClinically equivalent:
• Efficacy for 1° and 2° endpoints
• ACR20 early time point response rates
• Immune responses
• Safe and well tolerated
EPIRUS poster published at ACR 2014; abstract is available on the ACR website at http://acrabstracts.org/abstracts/bow015-a-biosimilar-infliximab-in-patients-with-active-rheumatoid-arthritis-on-stable-methotrexate-doses-54-week-results-of-a-randomized-double-blind-active-comparator-study/.
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Experienced and Established Management
Amit MunshiPresident & Chief Executive Officer
Michael Wyand, DVM, PhDSVP, Clinical, Regulatory & Manufacturing
Tom SheaSVP, Chief Financial Officer
Nick PlumeridgeSVP, Business Development
Mary DiBiase, PhDVP, Program Management
Suman Patel, PhDVP, Manufacturing & Quality
Rob TicktinSVP, General Counsel &Secretary
Alex WaldronVP, Global Commercial Operations
Cheryl Lassen, MDVP, Clinical Development
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Recent and Upcoming Milestones
Closed a $36 million Series B financing round
Completed merger with Zalicus Inc.; Gained public listing on Nasdaq:EPRS
Entered into a multi-product collaboration agreement with Livzon Mabpharm for China
BOW015 approved and launched in first market, India, under the trade name Infimab™
2014
Complete $48M follow on offering – 1Q15
BOW015 additional market filings and partnerships (LATAM, Asia) – Filings throughout 2015
BOW050 partnership(s) – 1H15
BOW015 US / EU partnership – 2H15
Initiation of BOW015 global phase 3 –4Q15/1Q16
BOW050 enters clinical trials – 2H16
BOW015 launches in multiple South East Asian markets – throughout 2016
2015 and Beyond
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