Leerink Global Healthcare Conference -...

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Non-Confidential Non-Confidential Leerink Global Healthcare Conference February 12, 2015 Amit Munshi, President & Chief Executive Officer Tom Shea, Chief Financial Officer [email protected]

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

[email protected]

Non-Confidential

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

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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

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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Thank You