Coherus BioSciences - Jefferies · Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its CHS-1701,CHS-0214, and CHS-1420 biosimilar

Copyright ©2015 All Rights Reserved.

Coherus BioSciences

November 2015

2 Copyright ©2015 All Rights Reserved. |

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,

and CHS-1420 biosimilar drug candidates, recruit patients in biologic license application enabling studies for CHS-1701,

complete its Phase 3 clinical development of CHS-1420 and develop its 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 forward-

looking 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 September 30, 2015 and its future periodic reports to be filed

with the Securities and Exchange Commission.


Agenda

• Company and Opportunity

• Development Pathway and Platform

• Pipeline Status and Activity


Coherus BioSciences: A Leading Pure Play Biosimilars Company

• Three products in Phase 3 or BLA-enabling trials

• Three BLA/MAA filings targeted within next two

years aimed at worldwide market opportunity of

$24bn in 2017

• Expect to submit at a minimum one new IND per

year from a range of originator drugs coming off

patent

Pipeline Significant Experience in Pioneering

Biologics Companies

Partners

Etanercept: EU, Brazil,

Canada, China Etanercept: Japan

Name Prior Experience

Denny Lanfear President and CEO

Jean Viret, Ph.D. Chief Financial Officer

Alan Herman, Ph.D. Chief Scientific Officer

Barbara Finck, M.D. Chief Medical Officer

Peter Watler, Ph.D. Chief Technical Officer

Michael Fleming SVP, Commercial Strategy

Aaron Schuchart SVP, Business Development


Converging Trends Create a Significant Near-Term

Global Market Opportunity for Biosimilar Development

~$108 Billion In 2014 Originator

Global Sales

Healthcare Reform/

Regulatory Enablement

Payer Need for

Biologics Cost Control

Surge in 2012 – 2017

Patent Expirations

Better Analytic Tools

Enable Comparability

Source: EvaluatePharma: 30 originator products with > 1 $Bn in global sales losing patent exclusivity in at least one major market through 2020 had ~$108 billion in 2014 global sales


Over $108 Billion in Pipeline Candidate Selection

Opportunities

Source: EvaluatePharma. Represents biologics with 2014 WW sales of greater than $1bn

Brand Generic 2014 WW Sales ($mm)

Humira adalimumab $12,543

Enbrel etanercept 8,538

Lantus insulin glargine recombinant 8,428

Remicade infliximab 8,162

Rituxan rituximab 7,547

Avastin bevacizumab 7,018

Herceptin trastuzumab 6,863

Neulasta pegfilgrastim 4,596

Lucentis ranibizumab 4,301

NovoRapid insulin aspart recombinant 3,109

Avonex interferon beta-1a 3,013

Humalog insulin lispro recombinant 2,785

Levemir insulin detemir recombinant 2,533

Rebif interferon beta-1a 2,444

Advate factor VIII (procoagulant) 2,348

Botox onabotulinumtoxinA 2,231

Synagis palivizumab 2,169

Epogen epoetin alfa 2,031

Tysabri natalizumab 1,960

Erbitux cetuximab 1,924

Xolair omalizumab 1,843

NovoMix 30 insulin: insulin aspart 1,759

Orencia abatacept 1,652

Kogenate octocog alfa 1,473

Pediarix DTP, hepatitis B & polio vaccine 1,364

Procrit epoetin alfa 1,238

Norditropin SimpleXx somatropin recombinant 1,159

Neupogen filgrastim 1,159

Pegasys peginterferon alfa-2a 1,110

Actemra Toclizumab 1,105

• Thirty originator products

• Each with >$1 billion in 2014 WW sales

• Losing or lost patent exclusivity in at

least one major market through 2020

• Total ~ $108 billion in 2014 WW sales

• Coherus’s pipeline

• Three in late stages of development

• At least three earlier stages of

development

• Ample substrate

• For further candidates using the

Coherus platform


CHS-1701 (pegfilgrastim

Biosimilar)

CHS-0214 (etanercept

Biosimilar)

CHS-1420

(adalimumab

Biosimilar)

Regulatory

Data

Other

3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16

1Q ‘16 – Anticipates submitting BLA

4Q ‘15: – Projects completion of dosing for Immunogenicity study

10/1/15: Announced positive data from PK/PD study

Late Stage Wave 1 Pipeline and Anticipated

Milestones

3Q ’15: Initiated Ph 3 Psoriasis study

1H ’16: Plans to initiate PK study

2H ’16: Anticipates

submitting BLA

Projected milestones placed at midpoints of achievement windows

4Q ’15: Expects data from Ph 3 Psoriasis study

1Q ’16: Expects data from Ph 3 RA study 2H ’16: Anticipates

submitting MAA


CHS-1701 Pegfilgrastim Biosimilar:

Near Term Commercial Opportunity & Value Driver

Market &

Commercial

Molecular/

CMC

Scientific/

Clinical

Legal

Financial

Relatively

modest

competition

Strong existing

CHRS scientific

knowledge base

Well defined

mechanism of

action

Patent

expirations

appear clear

Near term

launch to fund

wave 2 pipeline

Reasonably

sized

commercial

footprint

Complex but

well defined;

limited

heterogeneity

Clear efficacy

end point

Excellent

antigenicity

profile

Line extension

strategy

expiration

Potentially

substantial

revenue

opportunity

Relatively

stable

treatment

paradigm

Existing

formulation

stable, available

Executable

and

reasonably

sized studies

Relatively well

controlled

“moderate”

Low

manufacturing

cost of goods


Growth in Biologics Spend Puts Biosimilars

Firmly on Payer Radars

Biologic agents expected to represent 19-

20% of the total market value by 2017

Biologics Landscape

Source: IMS Health; Credit Suisse research; Evaluate Pharma

Total Global Biologics Spend

$46

$106

$169

$221

$0

$50

$100

$150

$200

$250

2002 2007 2012 2017

US

$ in

Bill

ions

Anti-TNF Pricing History

100%

120%

140%

160%

180%

200%

220%

Jan-09 Jan-10 Jan-11 Jan-12 Jan-13 Jan-14 Jan-15

WA

C G

row

th f

rom

20

09

Ba

se

line

Humira 40mg Kit Enbrel 25mg Prefilled SyringeRemicade 100mg Vial

PI since 2009

+201%

+188%

+154%

Aggressive US price increases have become

a major growth driver of biologic spend


Collaboration Opportunities

• Educational programs

• Consultation on Phase 3

design to deliver data required

by Pharmacy & Therapeutics

Committees

• Joint public affairs outreach

Many Leading Payers Have Signaled Strong

Support and Willingness to Cooperate

We share a joint commitment

with companies like Coherus to

create a vibrant biosimilars

market place.

− Steve Miller,

SVP & Chief Medical Officer,

Express Scripts

“ “ Some Payers Have Publicly Expressed Their Interest

in Biosimilars and Intent to Drive Adoption


Agenda





Originator Heterogeneity Creates Significant

Challenges and Determines Market Characteristics

Small Molecule

GENERIC BIOSIMILAR

Complex Biologic

Heterogeneity

• Observed between manufacturing plants, among

batches and within single vials

• Characterized with ranges, not absolutes

• Biosimilarity is defined by originator variability

IMPLICATIONS

• Higher Entry Barriers

– More sophisticated

skills

– Complex technological

base

– Larger investments for

longer time

• Extended Development

• Fewer Competitors

• Relatively Stable Pricing

13 Copyright ©2015 All Rights Reserved.

0 20 40 60 80

0

10

20

30

40

50CHS0214_Lot 133-002-12-290028 (GR. 2)

Enbrel_lot G47931_EU2 (GR. 10)

Enbrel_Lot 1033363_US1 (GR. 6)

Time (hr)

Co

ncen

tra

tio

n

( g/m

L)

Demonstrating Biosimilarity: Established Five Step Process

Platform: Navigating the pathway to approval

0 48 96 144 192 240 288 336 384 432 480

1

2

3

4

5

CHS-0214 DP

Enbrel (EU)

Time (hr)

Co

ncen

trati

on

( g/m

L)

0 48 96 144 192 240 288 336 384 432 480

1

2

3

4

5

CHS-0214 DP

Enbrel (EU)

Time (hr)

Co

ncen

trati

on

( g/m

L)

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

Intellectual

Property

Clinical and Regulatory

Process Science and Molecular

Tuning


Platform Sophisticated Analytics Define Originator Ranges


Cutting Edge Analytics

Internal Capability is Essential

Biosimilar to What?


Platform: Process Science and Cell Biology Molecular tuning is validated in non-clinical models

Process

Process Science and Molecular

Tuning 0 20 40 60 80

0

10

20

30

40

50CHS0214_Lot 133-002-12-290028 (GR. 2)

Enbrel_lot G47931_EU2 (GR. 10)

Enbrel_Lot 1033363_US1 (GR. 6)

Time (hr)

Co

ncen

tra

tio

n

( g/m

L)

Intracellular metabolism directly impacts glycosylation and

biologic actively at various scales



Platform: Clinical and Global Regulatory Clarify Requirements, Mitigate Regulatory Risk

ENBREL

2012 2013

J J A S O N D J F M A

2013 2014

M J J A S O N D J F M

2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)

EU National scientific advice

for one product plan


for second product plan

PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2

meeting for Clinical

Development Plan

EMA Central Advice and

FDA BSUFA Type 2 meeting

for Product Development Plan

2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




2012 2013


2013 2014


Guidance on

two

harmonized

clinical

programs

Advised one

program on

351(a)

Advised one

program to go

from 351 (a) to

351(k)





PMDA consultation

on product plan for

Japan

FDA BSUFA Type 2


Development Plan




PMDA consultation

On product plan for Japan FDA BSUFA Type 2

Meeting for Clinical

Development Plan


FDA BSUFA Type 2

meeting for Product

Development Plan

Guidance on two

harmonized clinical programs

Advised one

program on

351(a)

Advised one

program to go

from 351(a)

to 351(k)

EU National scientific

advice for one product plan

EU National

scientific advice



Platform Scientific Expertise Focused on Intellectual Property

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 Carpenter, Ph.D. Member Protein Formulation,

Aggregation

James Miller, Ph.D. Member Protein Chemistry

Carl Ware, Ph.D. Member Inflammatory Disease



Platform Scientific Expertise Focused on IP Risk Mitigation

Intellectual property presents potential barriers to entry

Patent

Landscape

Assessment

• Comp of Matter

• Indications

• Formulation

• Process

• Dosing

Scientific

Advisory

Board

• Reference

Experts

• Industry

Knowledge

• Technical

Assessment

• Feasible

Alternatives

Innovation

And

IP Creation

• Stable

Formulations

• Cost Effective

Processes

• Protein Structure /

Characterization

• Global Filings

Intellectual

Property



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 out of the dance must give 180 days prior launch notice.

– Fed Circuit refused further “en banc” review.

• Amgen and Apotex are now engaged in patent dance litigation.

– Two Apotex biosimilars at issue: (Biosimilars of Neulasta and Neupogen)

– Amgen has sued Apotex for patent infringement on several process patents.

• Other biosimilars currently going through the patent dance:

– Celltrion (Infliximab)

– Hospira (Epoetin alfa)


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 dosing regimen in a related EP filing

(a “divisional application”).

– We expect the divisional filing to be opposed by some or all of the same parties using essentially the

same arguments.

• On September 14, 2015 an AbbVie formulation patent was revoked in Europe.

• On June 26, 2015 Amgen filed two Inter Partes Review (“IPR”) petitions against

two of AbbVie’s U.S. formulation patents.

• On November 9, 2015, Coherus filed an IPR petition against AbbVie’s US patent

8,889,135 directed to a bi-weekly dosing regiment for RA.


IPR Timeline: Final Decision within 18 Months

IPR

Request

(“Petition”)

filed.

USPTO Decision

whether to proceed

(“institute”) must

occur within six

months

December

1, 2015

June 1,

2016

Final decision by

USPTO (must

occur within 12

months of

institution)

June 1,

2017

Notes:

1. IPR may take less than 18 months, but not longer.

2. Appeal to Federal Circuit is possible. However, Fed. Cir. has rarely reversed PTO final

decisions (one instance).

3. Challenger’s burden to prove invalidity is easier than in District Court.

Example


Agenda





Good Early Stage Pipeline Candidate Selection

Opportunities

Source: EvaluatePharma. Represents biologics with 2014 WW sales of greater than $1bn

Brand Generic 2014 WW Sales ($mm)

Humira adalimumab $12,543

Enbrel etanercept 8,538

Lantus insulin glargine recombinant 8,428

Remicade infliximab 8,162

Rituxan rituximab 7,547

Avastin bevacizumab 7,018

Herceptin trastuzumab 6,863

Neulasta pegfilgrastim 4,596

Lucentis ranibizumab 4,301

NovoRapid insulin aspart recombinant 3,109

Avonex interferon beta-1a 3,013

Humalog insulin lispro recombinant 2,785

Levemir insulin detemir recombinant 2,533

Rebif interferon beta-1a 2,444

Advate factor VIII (procoagulant) 2,348

Botox onabotulinumtoxinA 2,231

Synagis palivizumab 2,169

Epogen epoetin alfa 2,031

Tysabri natalizumab 1,960

Erbitux cetuximab 1,924

Xolair omalizumab 1,843

NovoMix 30 insulin: insulin aspart 1,759

Orencia abatacept 1,652

Kogenate octocog alfa 1,473

Pediarix DTP, hepatitis B & polio vaccine 1,364

Procrit epoetin alfa 1,238

Norditropin SimpleXx somatropin recombinant 1,159

Neupogen filgrastim 1,159

Pegasys peginterferon alfa-2a 1,110

Actemra Toclizumab 1,105

• Thirty originator products

• Each with >$1 billion in 2014 WW sales

• Losing or lost patent exclusivity in at

least one major market through 2020

• Total ~ $108 billion in 2014 WW sales

• Coherus’s pipeline

• Three in late stages of development

• At least three earlier stages of

development

• Ample substrate

• For further candidates using the

Coherus platform


Coherus Applies Rigorous Selection Criteria to

Candidate Molecules

• Market Opportunity

• Patents & IP

Analysis

• Technical Analysis

• Molecule and

Analytics

• Cell line and

Manufacturing

• Clinical and

Nonclinical

• Harmonization

• Global Sites

• Co-therapies

• Payers / Providers

• Partners

• Patients

• Promotion

• Legal Defense

PRODUCT DECISION PATHWAY

1

2

3

Patent expiry

and large existing

markets are insufficient

rationale for product

selection

All technical and commercial factors must be

holistically evaluated at key decision points


• March 2015: Finalized the

Biologics License Application

(BLA) enabling clinical

program for CHS-1701 with

FDA

• No Phase 3 in patients

• Retention of global rights

CHS-1701 Development Timing and Milestones

Q2 ‘15

• PK/PD and Immunogenicity Studies Initiated

10/1/15 • Study Topline Data

Q1 ‘16 • BLA filing


• All four groups showed similar ANCmax

and ANC AUC

• Met bioequivalence for PD endpoints

CHS-1701 vs. Neulasta

Study Meets PD Endpoints, Performs as Expected

• Three out of four groups, including both

CHS-1701, performed as expected

• Demonstrated bioequivalence on Cmax

endpoint

• Period 1, Neulasta anomalous



RA FPI: Jun 2014

PsO FPI: Jul 2014

• Two ongoing Phase 3 clinical trials

in rheumatoid arthritis and psoriasis

• Phase 3 clinical trial requirements,

manufacturing strategies and

submission content discussed with

US, EU, and Japanese regulators

0 48 96 144 192 240 288 336 384 432 480

1

2

3

4

5

CHS-0214 DP

Enbrel (EU)

Time (hr)

Con

centr

atio

n

( g/m

L) z

Q2 ‘15

• Phase 3 PsO and RA Studies Enrolled

Q4 ’15 – Q1 ‘16

• Phase 3 Readouts

• Positive Ph 3 PsO Data

H2 ‘16 • MAA filing


• Initiated Phase 3 study in

psoriasis 2015

• Development plan reviewed with

regulatory authorities in United

States and Europe

z


Q3 ‘15

• Initiated Psoriasis Phase 3

MID ‘16

• Phase 3 Study Readout

H2 ‘16 • BLA filing

CHS-1420 SC 40 mg x 2 @

Week 0 / Day 0

40 mg QOW @ Weeks 1-15

N=250

Humira SC 40 mg x 2 @

Week 0 / Day 0

40 mg QOW @ Weeks 1-15

N=250

CHS-1420 SC 40 mg

QOW @ Weeks 17-23

N=250

CHS-1420 SC 40 mg

QOW @ Weeks 17-23

N=125

Humira SC 40 mg

QOW @ Weeks 17-23

N=125

Week 0 Week 16 Week 24

Treatment Period 1 Treatment Period 2


CHS-1701 (pegfilgrastim

Biosimilar)

CHS-0214 (etanercept

Biosimilar)

CHS-1420

(adalimumab

Biosimilar)

Regulatory

Data

Other

3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16

1Q ‘16 – Anticipates submitting BLA

4Q ‘15: – Projects completion of dosing for Immunogenicity study

10/1/15: Announced positive data from PK/PD study

Upcoming Wave 1 Catalysts

3Q ’15: Initiated Ph 3 Psoriasis study

1H ’16: Plans to initiate PK study

2H ’16: Anticipates

submitting BLA

Projected milestones placed at midpoints of achievement windows

4Q ’15: Expects data from Ph 3 Psoriasis study

1Q ’16: Expects data from Ph 3 RA study 2H ’16: Anticipates

submitting MAA


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

• Focused strategy

• Late stage products & near term revenue

• Market focused development platform to

deliver BLAs on best products

• Significant early stage pipeline

opportunities to fuel growth

~$108 Billion In 2014 Originator

Global Sales

Source: EvaluatePharma: 30 originator products with > 1 $Bn in global sales losing patent exclusivity in at least one major market through 2020 had ~$108 billion in 2014 global sales

Copyright ©2015 All Rights Reserved.

Coherus BioSciences November 2015

Documents

Coherus BioSciences - Jefferies · Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its CHS-1701,CHS-0214, and CHS-1420 biosimilar