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Copyright ©2016 All Rights Reserved.
Coherus BioSciences
35th Annual J.P. Morgan Healthcare Conference
January 10, 2017
2 Copyright ©2016 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 intellectual strategy for
CHS-1420, its ability to advance its CHS-1701, CHS-0214,CHS-1420, CHS-5217 and CHS-3351 biosimilar drug
candidates, complete bridging studies for CHS-0214 and CHS-1420, obtain BLA approval for CHS-1701, submit a BLA for
CHS-1420 in the U.S., file an MAA for CHS-0214 in the E.U., file at least one IND on a second wave biosimilar pipeline
candidate and enter into collaborations for CHS-1701 commercialization ex-U.S., for CHS-131 and for its immunology
(Anti-TNF) 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, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.
3 Copyright ©2016 All Rights Reserved.|
Agenda
• Introduction and Company Summary
• CHS-1701 Program Highlights and Commercial Readiness
• Pipeline Update
4 Copyright ©2016 All Rights Reserved.|
Coherus BioSciences
is a Leading Biosimilars Company
Market Opportunity
Platform
Pipeline Strategy
Team
 Commercialize U.S. oncology
 Out-license global anti-TNFs
 Out-license CHS-131 in MS
 Expect 1 to 2 new INDs per year
 >$100 billion in biologics revenues
facing patent expiration by 2020
 Decreasing commercial, regulatory
and IP uncertainties
 Leadership team includes
pioneers of top-selling biologics
Cutting Edge
Analytics
Process Science
and Molecular
Tuning
Clinical and
Regulatory
Intellectual
Property
5 Copyright ©2016 All Rights Reserved.|
Key Biosimilar Uncertainties Continue to Decline over Time
Zarxio® is a registered trademark of Novartis AG; Inflectra® is a registered trademark of Pfizer; trend lines illustrative in nature
Uncertainty
Higher
Lower
2010 2020
Commercial
Approval
Pathway
Patent
Evolving payor /
provider sentiment
Patent
dance rulings
IPR
institutions
Affordable
Care Act
Zarxio®
launch
Inflectra®
launch
• Zarxio now on CVS formulary
• Neupogen lost 40% of share
• Pfizer launched infliximab
biosimilar in Oct ’16
• Extension IP is a key issue
• Formulation patents key
hurdle for anti-TNFs
• SCOTUS deliberating 6-month
pre-marketing notice ruling
• Zarxio, Inflectra, Amjevita
and Erelzi approved with full
label under 351(k) pathway
6 Copyright ©2016 All Rights Reserved.|
4Q 2Q1Q 4Q3Q
2016 2017
3Q
2017 is a Transformational Year with First Product
Approval and Potential Launch
Anticipated
U.S. approvalBLA(1)
Unless otherwise noted, catalysts placed within 3 month achievement windows
Ph 3 top-line data
‘135 patent
invalidity decision
CHS-1701
pegfilgrastim
biosimilar
CHS-0214
etanercept
biosimilar
CHS-1420
adalimumab
biosimilar
Wave 2/other CHS-131 Ph 2b data positive
MAA
(1) BLA accepted on October 6, 2016
BLA
’166 IPR
denied
Avastin and Lucentis biosimilar programs ongoing
MAA
Regained
major global
rights(2)
Launch
(2) Excluding Japan and LATAM ex-Brazil
PK
study MAA
Anticipated
EU approval
7 Copyright ©2016 All Rights Reserved.|
Differentiated Platform Navigates the Pathway to Approval
Intellectual
Property
Process Science
and Molecular
Tuning
Cutting Edge
Analytics
Clinical and
Regulatory  3 IPRs Instituted, 1 denied
 4 formulation patents issued
8 Copyright ©2016 All Rights Reserved.|
Agenda
• Introduction and Company Summary
• CHS-1701 Program Highlights and Commercial Readiness
• Pipeline Update
9 Copyright ©2016 All Rights Reserved.|
2015
4.6 4.8
2014
CHS-1701 Pegfilgrastim Biosimilar:
Significant Near-term Commercial Opportunity
Large Revenue Opportunity
Favorable Competitive Profile
Neulasta WW
revenues, $ B
Status late-stage biosimilar pipeline(1)
 Complex, well defined molecule with
limited heterogeneity
 Achieved high-level of analytical similarity
 Successful scale-up, stable formulation
 Secured commercial supply through
long-term agreement with KBI
 Efficacy demonstrated in healthy volunteers
 Successful immunogenicity trial
 BLA and MAA accepted BLA accepted in Oct’ 16
Approval anticipated June 9, 2017
File accepted in Oct’15 –
CRL in July ’16, refiling in 2018
File accepted in Nov’14 –
BSUFA date passed in mid 2015
 Key patents either expired or avoided
• CHS-1701 projected first
biosimilar to launch in
the U.S. in ~$5B market
Source: EvaluatePharma, First Word (1) With U.S. FDA registration focus
Cutting Edge
Analytics
Process Science
and Molecular
Tuning
Clinical and
Regulatory
Intellectual
Property
10 Copyright ©2016 All Rights Reserved.|
CHS-1701 Pegfilgrastim Biosimilar:
Positive Pivotal PK/PD Study Results
• 122 healthy subjects
• Randomized, single-
blind, three-sequence,
three-period crossover
study
• Study assessed PK, PD,
and safety (incl.
immunogenicity) of CHS-
1701 compared to
Neulasta
CHS-1701-05 study Positive topline results
• Study met all co-primary
endpoints:
‒ PK: Cmax and Area Under the
Curve (AUC)
‒ PD: absolute neutrophil count
(ANC) and AUC
• 90% CI for the GMR well
contained within the pre-specified
margins of 80% to 125%
• Similar safety profiles of
CHS-1701 and Neulasta with no
serious adverse events or study
discontinuations for either arm
PK results – Mean (±SD) pegfilgrastim concentration Neulasta and CHS-1701 (ng/mL)
PD results – Mean (±SD) absolute neutrophil count Neulasta and CHS-1701 (10^9/L)
11 Copyright ©2016 All Rights Reserved.|
CHS-1701 Strategic Manufacturing Agreement:
Prepared for Market Launch and Ample Future Supply
Key Partnership Terms with KBI
Term
Location
Current
capacity
commitment
3 years with options
to extend
Boulder, CO
~$1B in annual sales
Readiness
status
Qualification lots
completed
Cornerstone of U.S. oncology
franchise
Unencumbered global rights to
~$5B market opportunity
In-market manufacturing secures
long-term sustainability
Loading supply chain to support
mid 2017 launch
12 Copyright ©2016 All Rights Reserved.|
CHS-1701 Pegfilgrastim Biosimilar:
Well Positioned to Deliver on the Promise of Biosimilars
Top-selling oncology drug in the U.S., ~$4B in sales in 2015
Very large
market
Validated
globally
Proven biomarker for efficacy, validated by worldwide filgrastim
biosimilar uptake
Episodic, supportive care, price-sensitive and concentrated, with
aligned incentives across the value chain
Ideal structure
and dynamics
Delays in competitive programs improved order of entry for CHS-1701Limited
competition
Right timing, right product, and right commercial capability for
competitive advantage
Coherus well
positioned
13 Copyright ©2016 All Rights Reserved.|
Neulasta is the Top-Selling Oncology Drug in the U.S.
Source: IMS DDD, MAT Feby 2015, Market $, Neulasta, Granix & Leukine; Medispan PriceRx; EvaluatePharma
Neulasta Historical Revenues in the U.S.
$ billion
3.5
20152014
3.93.93.6
2016E2013
Top oncology drugs by sales in the U.S. in 2015
$ billion
(1) Assumes that 80% of US sales are in oncology and 20% in RA
Neulasta is a cornerstone of cancer care, mainstay
treatment to prevent febrile neutropenia and enable the
delivery of cytotoxic chemotherapy
• U.S. Neulasta revenues growing over
past years, stable at ~$4B
• Growth supported by stable use (units)
and increasing prices (both WAC and
ASP increased over this time period)
Very large
market
3.9
Revlimid Velcade
1.3
2.5
Xtandi
3.2
Herceptin
1.2
GleevecRituxan(1)
2.5
3.1
AvastinNeulasta
3.5
14 Copyright ©2016 All Rights Reserved.|
Neulasta Price History has Driven Up Cost of Care,
Creating an Environment Receptive to Biosimilars
Neulasta Historical Prices in the U.S.
US$ per unit (WAC)
2,500
3,000
3,500
4,000
4,500
5,000
5,500
20161507 08 10 12 1309 112006 14
Consumer Price Index(1)
Neulasta WAC
Source: SHA National Data, MAT Nov’2016, U.S. Bureau of Labor Statistics
(1) Indexed to Neulasta WAC in November 2006
• Neulasta WAC ~2X since 2006
• New value-based models incentivize
care providers to reduce overall spend
per patient (e.g., Oncology Care Model)
• Biosimilars are a key free market
mechanism to introduce competition for
expensive injectable biologics and to
control prices
• Strong public policy support for
biosimilars. SCOTUS may consider 6
month waiting period.
+98%
+20%
Ideal structure
and dynamics
15 Copyright ©2016 All Rights Reserved.|
Straightforward Buying Process
IDN
GPO
Hospital
Retail/Other)
Clinic
Physician Patient
Payers (CMS & Commercial)
Manufacturer
Wholesaler/
Specialty Dist.
Product flow
Ideal structure
and dynamics
Schematic of Key Stakeholders in Neulasta Buying Process
• Simple process:
providers purchase
product, pay for it,
administer it, and submit
for reimbursement
• Few intermediaries:
buying decisions taken
directly by providers, and
or their intermediaries
(GPOs or by Parent
Entities / IDNs)
GPO = Group Purchasing Organization, IDN = Integrated Delivery Network
16 Copyright ©2016 All Rights Reserved.|
Key Decision-Maker Incentives Well Aligned with
the Biosimilar Value Proposition
Hospital
Outpatient
Oncology
Clinics
Standalone
Oncology
Clinics
Share of
Neulasta
Main Driver for
Biosimilar Adoption
60%
• Margin preservation
• Outcomes
• Acquisition cost
• Margin preservation
• Outcomes
• Health System under
pressure to support new
oncology treatment
(e.g., immuno-oncology)
• Market incentivizing outcomes
at lower costs (e.g., CMS’
Oncology Care Model with
~25% of Neulasta share)
• Value drivers in these markets
fundamentally aligned with
CHS-1701 value proposition
Ideal structure
and dynamics
33%
17 Copyright ©2016 All Rights Reserved.|
Pegfilgrastim Market Research indicates
Economics is the dominant market value driver
Product Attribute Importance for Hospitals and Clinics
Percentage, n=96
• Differentiation potential
through multiple attributes
but economics trumps all
• Onpro uptake driven
primarily by economics
and secondarily by
patient convenience
• CHS-1701 expected to be
competitive with respect
to all Neulasta formats
currently available
Source: Coherus CHS-1701 Market Research
Ideal structure
and dynamics
Manufacturing
Site Location
8%
Data
Supporting
Approval
17%
Dosing
Format (PFS
vs. On-body)
Order
of Entry
8%
46%
21%
Economics
18 Copyright ©2016 All Rights Reserved.|
Concentrated Market Enables Efficient Commercial Effort
0%
20%
40%
60%
80%
100%
1
501
1,001
1,501
2,001
2,501
3,001
3,501
4,001
4,501
5,001
5,501
6,001
6,501
7,001
7,501
8,001
8,501
9,001
9,501
10,001
10,501
Neulasta Account Concentration Curve
% of sales, all segments
• Highly concentrated market,
with >80% of Neulasta sales
managed by roughly:
− 2000 clinics and hospitals
− 800 IDNs/Corporations
− 7 GPOs
• Concentration of Neulasta
sales allow for manageable
commercial footprint
Number of accounts
Ideal structure
and dynamics
Source: SHA Sub National Data, IMS Nov 2014-Oct 2015
19 Copyright ©2016 All Rights Reserved.|
Strong Market Adoption of Filgrastim Biosimilar
Demonstrates Receptivity to Biosimilar Switch
Short Acting Biosimilar filgrastim Share
Biosimilar end-of-year unit share in %
• Biosimilar switch willingness is
higher in supportive care due to
perceived lower patient risk
• Biosimilars experienced steady
uptake in Europe, first U.S.
biosimilar launch (Zarxio) on track
• Provider indicate higher
willingness to switch for Neulasta
(vs Neupogen) due to significantly
larger Neulasta expenditures
Validated
globally
79
72
57
41
21 20
Year 4 Year 5Year 3Year 2Year 1
EU-5 U.S.(1)
Source: IMS, EvaluatePharma
(1) Share of Zarxio 12 months after launch in October 2016, does not include Granix (not a biosimilar)
20 Copyright ©2016 All Rights Reserved.|
Competitive Landscape Continues to Evolve
Favorably; CHS-1701 BUSFA in June 2017
Coherus is only player
with immunogenicity
pivotal trial disclosed(1)
(1) With immunogenicity as primary endpoint, disclosed in clinicaltrials.gov
Recent developments in Neulasta biosimilar competitive landscape
BSUFA date
passed
FDA Complete
Response Letter
Announced need
for additional study
– refiling in 2018
7/16
Announced
withdrawal of
MAA in Europe
Source: Press releases, clinicaltrials.gov
Limited
competition
6/15 12/16
BLA
filing
8/16 1H ‘17
AdCom
window
BLA
acceptance
10/16
BSUFA
date
June 9,
2017
2H ‘17
Launch
window
21 Copyright ©2016 All Rights Reserved.|
Coherus Oncology Commercial Leadership Team
Commercial Expertise Focused on Commercial
Launch and Brand Building
Coherus well
positioned
Previous experience
Michael Fleming
Role
SVP Commercial
Chris Thompson VP Sales
Jim Hassard VP Marketing
Michael Chen VP Commercial
Analytics
Product highlightsLeadership team
• Neulasta 10 years,
Onpro launch
• Neulasta 10 years,
Neupogen, Aranesp
• Aranesp, Tamiflu
Olux, Soriatane
• Zofran, Tysabri,
Rituxan, Trizivir
22 Copyright ©2016 All Rights Reserved.|
Coherus Well-Positioned to Maximize $4B Opportunity
and to Deliver on the Promise of Biosimilars
BSUFA in June 2017, competitor delays
continue across major markets
Timing
Veteran commercial team proficient with
branded oncology buying process
People
Quality /
Reliability
Highly-matched molecule, U.S.-based
manufacturing
Customer
Focus
Commercial model designed to deliver brand
benefits at biosimilar value
Contracting
Strategy
Disciplined pricing and contracting approach to
deliver sustainable economics to key segments
Very large
market
Validated
globally
Ideal structure
and dynamics
Limited
competition
Coherus well
positioned
23 Copyright ©2016 All Rights Reserved.|
Agenda
• Introduction and Company Summary
• CHS-1701 Program Highlights and Commercial Readiness
• Pipeline Update
24 Copyright ©2016 All Rights Reserved.|
CHS-0214 Etanercept Biosimilar:
Addresses Large Commercial Opportunity
Modest Competition
Status late-stage biosimilar pipeline(2)
 A very complex biologic
 Extensive similarity analysis completed
 Commercial process validated, with
inventory build in 2017
 Stable proprietary formulation
 Positive top-line Ph 3 results in RA
 Positive top-line Ph 3 results in psoriasis
Expect to file MAA in 1H ‘17
Approved in U.S. in 2016
Approved in EU in 2016
 Key EU patents either expired or avoided
 Issued patent on non-infringing formulation
Large Revenue Opportunity
• ~$9B global opportunity
• Coherus regained major
global rights(1)
9.0
Ex-US
U.S. 5.1
3.9
2015
Enbrel WW
revenues, $ B
Source: EvaluatePharma, First Word (2) With U.S. FDA registration focus
Cutting Edge
Analytics
Process Science
and Molecular
Tuning
Clinical and
Regulatory
Intellectual
Property
(1) Excluding Japan and LATAM ex-Brazil
25 Copyright ©2016 All Rights Reserved.|
CHS-1420 Adalimumab Biosimilar:
Good Progress
IP Hurdles Expected to Limit Competition
Status late-stage biosimilar pipeline(1)
 High-level of analytical similarity achieved
 Scale-up according to plan
 CMO pre-agreements for commercial supply
 Positive Ph 3 in patients with psoriasis
 BLA filing expected in 1H ‘17
Expect to file 1H ‘17 after study
completion and reg. interactions
Approved in 2016 –
formulation IPRs not instituted
In different development stages –
unclear IP strategy
 CHRS wins IPR institution vs. AbbVie ‘135
 Coherus awarded 4 formulation patents
х Adverse ‘166 IPR Decision
 Scientific and legal strategy in-place to support
launch once approved
Several
others
Large Revenue Opportunity
2014
12.9 14.4
2015
Ongoing IP issues continue
in key areas and may impact
market timing
Humira WW
revenues, $ B
Source: EvaluatePharma, First Word (1) With U.S. FDA registration focus
Cutting Edge
Analytics
Process Science
and Molecular
Tuning
Clinical and
Regulatory
Intellectual
Property
26 Copyright ©2016 All Rights Reserved.|
CHS-1420 Adalimumab Biosimilar
U.S. Patent Office Instituted ’135, ‘680 and ‘987 IPRs
“Petitioner [Coherus] establishes a reasonable
likelihood that it will prevail in showing that claims
1–5 of the ’135 patent are unpatentable.”
The Decision of the US Patent Office (USPTO) on ‘135 IPR
“[AbbVie’s] arguments are
premised on a claim construction
that we do not adopt…”
“…a skilled artisan would have
been led to optimize the
dosing regimens disclosed in
[van de Putte and Kempeni] ”
“…we are unpersuaded
by [AbbVie’s]
arguments regarding
superiority of the 40
and 80 mg doses to the
20 mg dose ”
Note: A different PTAB panel of the USPTO also instituted CHRS IPRs filed in December 2015 against AbbVie’s U.S. Patents 9,017,680 and 9,073,987.
Both are in the same patent family as the ‘135 patent claiming insignificant variations of a 40 mg biweekly dosage for RA. Boehringer Ingelheim IPRs
against the ‘135 patent were instituted in June, 2016
• Two independent PTAB
judge panels agreed with
Coherus
• Final decision expected
no later than mid-May
2017
• IPRs cover key RA
dosing indication 40mg
bi-weekly
27 Copyright ©2016 All Rights Reserved.|
CHS-1420 Adalimumab Biosimilar
Additional Strategies to Support Path to Market in 2018
• Technical and Scientific: Alternative formulations addressing the ‘166
patent are designed to support a 2018 path to market
• Legal: Continue advancement of defensive and offensive IP strategies
to address ongoing formulation IP risks
• Clinical: Plan to initiate PK study in 1H 2017
Intellectual Property issues and risks will likely remain an industry-
wide concern, pending further definition of the legal landscape
Additional legal actions may be filed in the near term
The information contained in this presentation is not intended to communicate any legal opinion on the infringement or validity of any patents
28 Copyright ©2016 All Rights Reserved.|
• Unique mechanism of action with potent
anti-inflammatory effects without evidence of
immunosuppression
• Potential first-line therapy alone or in
combination with other MS disease modifying
therapies
• Safety demonstrated with no serious adverse
events in over 600 patients, and no signs of
leukopenia
CHS-131 proposition – oral formulation with
differentiated safety profile
CHS-131 Novel Oral Therapy in RRMS:
Target Product Profile Addresses Important Patient Needs
• Safety profile and infections similar across all groups
with no new safety signals
• No evidence of immunosuppression
4.2
7.67.8
CHS-131 1mg
(n=70)
CHS-131 3mg
(n=70)
Placebo
(n=69)
Mean of Number of New CE T1-weighted Lesions on Monthly
MRI over 6 Months(1)
(1) Sensitivity Analysis for Subjects with Complete Data, full analysis population (2) Least-squares mean
3 mg vs.
placebo: 52%
reduction in
CE lesions(2)
Positive Phase 2b Efficacy Data in 227 RRMS
patients
Abbreviations: RRMS = Relapsing-Remitting Multiple Sclerosis, CE = Contrast-Enhancing, DMT = Disease Modifying Treatment, MRI = Magnetic Resonance Imaging
29 Copyright ©2016 All Rights Reserved.|
Coherus is Delivering on the Potential of the Platform and
Laying the Foundation for Continued Growth
Strong Execution:
Delivering on the Platform
Strategic Framework:
Long Term Value Creation
 CHS-1701 BLA and MAA
accepted
 CHS-1701 ideally positioned for
competitive advantage
 Positive Phase 3 topline data with
CHS-0214 and CHS-1420
 Positive Phase 2b data for novel
oral treatment for RRMS CHS-131
 Therapeutic area franchises
providing value creation focus
 Oncology commercial strategy in
execution
 Licensing efforts for immunology
and MS assets underway
 Wave 2 progress on track
Copyright ©2016 All Rights Reserved.
Coherus BioSciences
35th Annual J.P. Morgan Healthcare Conference
January 10, 2017

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Coherus' CHS-1701 Pegfilgrastim Biosimilar Poised for U.S. Launch in Large Oncology Market

  • 1. Copyright ©2016 All Rights Reserved. Coherus BioSciences 35th Annual J.P. Morgan Healthcare Conference January 10, 2017
  • 2. 2 Copyright ©2016 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 intellectual strategy for CHS-1420, its ability to advance its CHS-1701, CHS-0214,CHS-1420, CHS-5217 and CHS-3351 biosimilar drug candidates, complete bridging studies for CHS-0214 and CHS-1420, obtain BLA approval for CHS-1701, submit a BLA for CHS-1420 in the U.S., file an MAA for CHS-0214 in the E.U., file at least one IND on a second wave biosimilar pipeline candidate and enter into collaborations for CHS-1701 commercialization ex-U.S., for CHS-131 and for its immunology (Anti-TNF) 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, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.
  • 3. 3 Copyright ©2016 All Rights Reserved.| Agenda • Introduction and Company Summary • CHS-1701 Program Highlights and Commercial Readiness • Pipeline Update
  • 4. 4 Copyright ©2016 All Rights Reserved.| Coherus BioSciences is a Leading Biosimilars Company Market Opportunity Platform Pipeline Strategy Team  Commercialize U.S. oncology  Out-license global anti-TNFs  Out-license CHS-131 in MS  Expect 1 to 2 new INDs per year  >$100 billion in biologics revenues facing patent expiration by 2020  Decreasing commercial, regulatory and IP uncertainties  Leadership team includes pioneers of top-selling biologics Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property
  • 5. 5 Copyright ©2016 All Rights Reserved.| Key Biosimilar Uncertainties Continue to Decline over Time Zarxio® is a registered trademark of Novartis AG; Inflectra® is a registered trademark of Pfizer; trend lines illustrative in nature Uncertainty Higher Lower 2010 2020 Commercial Approval Pathway Patent Evolving payor / provider sentiment Patent dance rulings IPR institutions Affordable Care Act Zarxio® launch Inflectra® launch • Zarxio now on CVS formulary • Neupogen lost 40% of share • Pfizer launched infliximab biosimilar in Oct ’16 • Extension IP is a key issue • Formulation patents key hurdle for anti-TNFs • SCOTUS deliberating 6-month pre-marketing notice ruling • Zarxio, Inflectra, Amjevita and Erelzi approved with full label under 351(k) pathway
  • 6. 6 Copyright ©2016 All Rights Reserved.| 4Q 2Q1Q 4Q3Q 2016 2017 3Q 2017 is a Transformational Year with First Product Approval and Potential Launch Anticipated U.S. approvalBLA(1) Unless otherwise noted, catalysts placed within 3 month achievement windows Ph 3 top-line data ‘135 patent invalidity decision CHS-1701 pegfilgrastim biosimilar CHS-0214 etanercept biosimilar CHS-1420 adalimumab biosimilar Wave 2/other CHS-131 Ph 2b data positive MAA (1) BLA accepted on October 6, 2016 BLA ’166 IPR denied Avastin and Lucentis biosimilar programs ongoing MAA Regained major global rights(2) Launch (2) Excluding Japan and LATAM ex-Brazil PK study MAA Anticipated EU approval
  • 7. 7 Copyright ©2016 All Rights Reserved.| Differentiated Platform Navigates the Pathway to Approval Intellectual Property Process Science and Molecular Tuning Cutting Edge Analytics Clinical and Regulatory  3 IPRs Instituted, 1 denied  4 formulation patents issued
  • 8. 8 Copyright ©2016 All Rights Reserved.| Agenda • Introduction and Company Summary • CHS-1701 Program Highlights and Commercial Readiness • Pipeline Update
  • 9. 9 Copyright ©2016 All Rights Reserved.| 2015 4.6 4.8 2014 CHS-1701 Pegfilgrastim Biosimilar: Significant Near-term Commercial Opportunity Large Revenue Opportunity Favorable Competitive Profile Neulasta WW revenues, $ B Status late-stage biosimilar pipeline(1)  Complex, well defined molecule with limited heterogeneity  Achieved high-level of analytical similarity  Successful scale-up, stable formulation  Secured commercial supply through long-term agreement with KBI  Efficacy demonstrated in healthy volunteers  Successful immunogenicity trial  BLA and MAA accepted BLA accepted in Oct’ 16 Approval anticipated June 9, 2017 File accepted in Oct’15 – CRL in July ’16, refiling in 2018 File accepted in Nov’14 – BSUFA date passed in mid 2015  Key patents either expired or avoided • CHS-1701 projected first biosimilar to launch in the U.S. in ~$5B market Source: EvaluatePharma, First Word (1) With U.S. FDA registration focus Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property
  • 10. 10 Copyright ©2016 All Rights Reserved.| CHS-1701 Pegfilgrastim Biosimilar: Positive Pivotal PK/PD Study Results • 122 healthy subjects • Randomized, single- blind, three-sequence, three-period crossover study • Study assessed PK, PD, and safety (incl. immunogenicity) of CHS- 1701 compared to Neulasta CHS-1701-05 study Positive topline results • Study met all co-primary endpoints: ‒ PK: Cmax and Area Under the Curve (AUC) ‒ PD: absolute neutrophil count (ANC) and AUC • 90% CI for the GMR well contained within the pre-specified margins of 80% to 125% • Similar safety profiles of CHS-1701 and Neulasta with no serious adverse events or study discontinuations for either arm PK results – Mean (±SD) pegfilgrastim concentration Neulasta and CHS-1701 (ng/mL) PD results – Mean (±SD) absolute neutrophil count Neulasta and CHS-1701 (10^9/L)
  • 11. 11 Copyright ©2016 All Rights Reserved.| CHS-1701 Strategic Manufacturing Agreement: Prepared for Market Launch and Ample Future Supply Key Partnership Terms with KBI Term Location Current capacity commitment 3 years with options to extend Boulder, CO ~$1B in annual sales Readiness status Qualification lots completed Cornerstone of U.S. oncology franchise Unencumbered global rights to ~$5B market opportunity In-market manufacturing secures long-term sustainability Loading supply chain to support mid 2017 launch
  • 12. 12 Copyright ©2016 All Rights Reserved.| CHS-1701 Pegfilgrastim Biosimilar: Well Positioned to Deliver on the Promise of Biosimilars Top-selling oncology drug in the U.S., ~$4B in sales in 2015 Very large market Validated globally Proven biomarker for efficacy, validated by worldwide filgrastim biosimilar uptake Episodic, supportive care, price-sensitive and concentrated, with aligned incentives across the value chain Ideal structure and dynamics Delays in competitive programs improved order of entry for CHS-1701Limited competition Right timing, right product, and right commercial capability for competitive advantage Coherus well positioned
  • 13. 13 Copyright ©2016 All Rights Reserved.| Neulasta is the Top-Selling Oncology Drug in the U.S. Source: IMS DDD, MAT Feby 2015, Market $, Neulasta, Granix & Leukine; Medispan PriceRx; EvaluatePharma Neulasta Historical Revenues in the U.S. $ billion 3.5 20152014 3.93.93.6 2016E2013 Top oncology drugs by sales in the U.S. in 2015 $ billion (1) Assumes that 80% of US sales are in oncology and 20% in RA Neulasta is a cornerstone of cancer care, mainstay treatment to prevent febrile neutropenia and enable the delivery of cytotoxic chemotherapy • U.S. Neulasta revenues growing over past years, stable at ~$4B • Growth supported by stable use (units) and increasing prices (both WAC and ASP increased over this time period) Very large market 3.9 Revlimid Velcade 1.3 2.5 Xtandi 3.2 Herceptin 1.2 GleevecRituxan(1) 2.5 3.1 AvastinNeulasta 3.5
  • 14. 14 Copyright ©2016 All Rights Reserved.| Neulasta Price History has Driven Up Cost of Care, Creating an Environment Receptive to Biosimilars Neulasta Historical Prices in the U.S. US$ per unit (WAC) 2,500 3,000 3,500 4,000 4,500 5,000 5,500 20161507 08 10 12 1309 112006 14 Consumer Price Index(1) Neulasta WAC Source: SHA National Data, MAT Nov’2016, U.S. Bureau of Labor Statistics (1) Indexed to Neulasta WAC in November 2006 • Neulasta WAC ~2X since 2006 • New value-based models incentivize care providers to reduce overall spend per patient (e.g., Oncology Care Model) • Biosimilars are a key free market mechanism to introduce competition for expensive injectable biologics and to control prices • Strong public policy support for biosimilars. SCOTUS may consider 6 month waiting period. +98% +20% Ideal structure and dynamics
  • 15. 15 Copyright ©2016 All Rights Reserved.| Straightforward Buying Process IDN GPO Hospital Retail/Other) Clinic Physician Patient Payers (CMS & Commercial) Manufacturer Wholesaler/ Specialty Dist. Product flow Ideal structure and dynamics Schematic of Key Stakeholders in Neulasta Buying Process • Simple process: providers purchase product, pay for it, administer it, and submit for reimbursement • Few intermediaries: buying decisions taken directly by providers, and or their intermediaries (GPOs or by Parent Entities / IDNs) GPO = Group Purchasing Organization, IDN = Integrated Delivery Network
  • 16. 16 Copyright ©2016 All Rights Reserved.| Key Decision-Maker Incentives Well Aligned with the Biosimilar Value Proposition Hospital Outpatient Oncology Clinics Standalone Oncology Clinics Share of Neulasta Main Driver for Biosimilar Adoption 60% • Margin preservation • Outcomes • Acquisition cost • Margin preservation • Outcomes • Health System under pressure to support new oncology treatment (e.g., immuno-oncology) • Market incentivizing outcomes at lower costs (e.g., CMS’ Oncology Care Model with ~25% of Neulasta share) • Value drivers in these markets fundamentally aligned with CHS-1701 value proposition Ideal structure and dynamics 33%
  • 17. 17 Copyright ©2016 All Rights Reserved.| Pegfilgrastim Market Research indicates Economics is the dominant market value driver Product Attribute Importance for Hospitals and Clinics Percentage, n=96 • Differentiation potential through multiple attributes but economics trumps all • Onpro uptake driven primarily by economics and secondarily by patient convenience • CHS-1701 expected to be competitive with respect to all Neulasta formats currently available Source: Coherus CHS-1701 Market Research Ideal structure and dynamics Manufacturing Site Location 8% Data Supporting Approval 17% Dosing Format (PFS vs. On-body) Order of Entry 8% 46% 21% Economics
  • 18. 18 Copyright ©2016 All Rights Reserved.| Concentrated Market Enables Efficient Commercial Effort 0% 20% 40% 60% 80% 100% 1 501 1,001 1,501 2,001 2,501 3,001 3,501 4,001 4,501 5,001 5,501 6,001 6,501 7,001 7,501 8,001 8,501 9,001 9,501 10,001 10,501 Neulasta Account Concentration Curve % of sales, all segments • Highly concentrated market, with >80% of Neulasta sales managed by roughly: − 2000 clinics and hospitals − 800 IDNs/Corporations − 7 GPOs • Concentration of Neulasta sales allow for manageable commercial footprint Number of accounts Ideal structure and dynamics Source: SHA Sub National Data, IMS Nov 2014-Oct 2015
  • 19. 19 Copyright ©2016 All Rights Reserved.| Strong Market Adoption of Filgrastim Biosimilar Demonstrates Receptivity to Biosimilar Switch Short Acting Biosimilar filgrastim Share Biosimilar end-of-year unit share in % • Biosimilar switch willingness is higher in supportive care due to perceived lower patient risk • Biosimilars experienced steady uptake in Europe, first U.S. biosimilar launch (Zarxio) on track • Provider indicate higher willingness to switch for Neulasta (vs Neupogen) due to significantly larger Neulasta expenditures Validated globally 79 72 57 41 21 20 Year 4 Year 5Year 3Year 2Year 1 EU-5 U.S.(1) Source: IMS, EvaluatePharma (1) Share of Zarxio 12 months after launch in October 2016, does not include Granix (not a biosimilar)
  • 20. 20 Copyright ©2016 All Rights Reserved.| Competitive Landscape Continues to Evolve Favorably; CHS-1701 BUSFA in June 2017 Coherus is only player with immunogenicity pivotal trial disclosed(1) (1) With immunogenicity as primary endpoint, disclosed in clinicaltrials.gov Recent developments in Neulasta biosimilar competitive landscape BSUFA date passed FDA Complete Response Letter Announced need for additional study – refiling in 2018 7/16 Announced withdrawal of MAA in Europe Source: Press releases, clinicaltrials.gov Limited competition 6/15 12/16 BLA filing 8/16 1H ‘17 AdCom window BLA acceptance 10/16 BSUFA date June 9, 2017 2H ‘17 Launch window
  • 21. 21 Copyright ©2016 All Rights Reserved.| Coherus Oncology Commercial Leadership Team Commercial Expertise Focused on Commercial Launch and Brand Building Coherus well positioned Previous experience Michael Fleming Role SVP Commercial Chris Thompson VP Sales Jim Hassard VP Marketing Michael Chen VP Commercial Analytics Product highlightsLeadership team • Neulasta 10 years, Onpro launch • Neulasta 10 years, Neupogen, Aranesp • Aranesp, Tamiflu Olux, Soriatane • Zofran, Tysabri, Rituxan, Trizivir
  • 22. 22 Copyright ©2016 All Rights Reserved.| Coherus Well-Positioned to Maximize $4B Opportunity and to Deliver on the Promise of Biosimilars BSUFA in June 2017, competitor delays continue across major markets Timing Veteran commercial team proficient with branded oncology buying process People Quality / Reliability Highly-matched molecule, U.S.-based manufacturing Customer Focus Commercial model designed to deliver brand benefits at biosimilar value Contracting Strategy Disciplined pricing and contracting approach to deliver sustainable economics to key segments Very large market Validated globally Ideal structure and dynamics Limited competition Coherus well positioned
  • 23. 23 Copyright ©2016 All Rights Reserved.| Agenda • Introduction and Company Summary • CHS-1701 Program Highlights and Commercial Readiness • Pipeline Update
  • 24. 24 Copyright ©2016 All Rights Reserved.| CHS-0214 Etanercept Biosimilar: Addresses Large Commercial Opportunity Modest Competition Status late-stage biosimilar pipeline(2)  A very complex biologic  Extensive similarity analysis completed  Commercial process validated, with inventory build in 2017  Stable proprietary formulation  Positive top-line Ph 3 results in RA  Positive top-line Ph 3 results in psoriasis Expect to file MAA in 1H ‘17 Approved in U.S. in 2016 Approved in EU in 2016  Key EU patents either expired or avoided  Issued patent on non-infringing formulation Large Revenue Opportunity • ~$9B global opportunity • Coherus regained major global rights(1) 9.0 Ex-US U.S. 5.1 3.9 2015 Enbrel WW revenues, $ B Source: EvaluatePharma, First Word (2) With U.S. FDA registration focus Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property (1) Excluding Japan and LATAM ex-Brazil
  • 25. 25 Copyright ©2016 All Rights Reserved.| CHS-1420 Adalimumab Biosimilar: Good Progress IP Hurdles Expected to Limit Competition Status late-stage biosimilar pipeline(1)  High-level of analytical similarity achieved  Scale-up according to plan  CMO pre-agreements for commercial supply  Positive Ph 3 in patients with psoriasis  BLA filing expected in 1H ‘17 Expect to file 1H ‘17 after study completion and reg. interactions Approved in 2016 – formulation IPRs not instituted In different development stages – unclear IP strategy  CHRS wins IPR institution vs. AbbVie ‘135  Coherus awarded 4 formulation patents х Adverse ‘166 IPR Decision  Scientific and legal strategy in-place to support launch once approved Several others Large Revenue Opportunity 2014 12.9 14.4 2015 Ongoing IP issues continue in key areas and may impact market timing Humira WW revenues, $ B Source: EvaluatePharma, First Word (1) With U.S. FDA registration focus Cutting Edge Analytics Process Science and Molecular Tuning Clinical and Regulatory Intellectual Property
  • 26. 26 Copyright ©2016 All Rights Reserved.| CHS-1420 Adalimumab Biosimilar U.S. Patent Office Instituted ’135, ‘680 and ‘987 IPRs “Petitioner [Coherus] establishes a reasonable likelihood that it will prevail in showing that claims 1–5 of the ’135 patent are unpatentable.” The Decision of the US Patent Office (USPTO) on ‘135 IPR “[AbbVie’s] arguments are premised on a claim construction that we do not adopt…” “…a skilled artisan would have been led to optimize the dosing regimens disclosed in [van de Putte and Kempeni] ” “…we are unpersuaded by [AbbVie’s] arguments regarding superiority of the 40 and 80 mg doses to the 20 mg dose ” Note: A different PTAB panel of the USPTO also instituted CHRS IPRs filed in December 2015 against AbbVie’s U.S. Patents 9,017,680 and 9,073,987. Both are in the same patent family as the ‘135 patent claiming insignificant variations of a 40 mg biweekly dosage for RA. Boehringer Ingelheim IPRs against the ‘135 patent were instituted in June, 2016 • Two independent PTAB judge panels agreed with Coherus • Final decision expected no later than mid-May 2017 • IPRs cover key RA dosing indication 40mg bi-weekly
  • 27. 27 Copyright ©2016 All Rights Reserved.| CHS-1420 Adalimumab Biosimilar Additional Strategies to Support Path to Market in 2018 • Technical and Scientific: Alternative formulations addressing the ‘166 patent are designed to support a 2018 path to market • Legal: Continue advancement of defensive and offensive IP strategies to address ongoing formulation IP risks • Clinical: Plan to initiate PK study in 1H 2017 Intellectual Property issues and risks will likely remain an industry- wide concern, pending further definition of the legal landscape Additional legal actions may be filed in the near term The information contained in this presentation is not intended to communicate any legal opinion on the infringement or validity of any patents
  • 28. 28 Copyright ©2016 All Rights Reserved.| • Unique mechanism of action with potent anti-inflammatory effects without evidence of immunosuppression • Potential first-line therapy alone or in combination with other MS disease modifying therapies • Safety demonstrated with no serious adverse events in over 600 patients, and no signs of leukopenia CHS-131 proposition – oral formulation with differentiated safety profile CHS-131 Novel Oral Therapy in RRMS: Target Product Profile Addresses Important Patient Needs • Safety profile and infections similar across all groups with no new safety signals • No evidence of immunosuppression 4.2 7.67.8 CHS-131 1mg (n=70) CHS-131 3mg (n=70) Placebo (n=69) Mean of Number of New CE T1-weighted Lesions on Monthly MRI over 6 Months(1) (1) Sensitivity Analysis for Subjects with Complete Data, full analysis population (2) Least-squares mean 3 mg vs. placebo: 52% reduction in CE lesions(2) Positive Phase 2b Efficacy Data in 227 RRMS patients Abbreviations: RRMS = Relapsing-Remitting Multiple Sclerosis, CE = Contrast-Enhancing, DMT = Disease Modifying Treatment, MRI = Magnetic Resonance Imaging
  • 29. 29 Copyright ©2016 All Rights Reserved.| Coherus is Delivering on the Potential of the Platform and Laying the Foundation for Continued Growth Strong Execution: Delivering on the Platform Strategic Framework: Long Term Value Creation  CHS-1701 BLA and MAA accepted  CHS-1701 ideally positioned for competitive advantage  Positive Phase 3 topline data with CHS-0214 and CHS-1420  Positive Phase 2b data for novel oral treatment for RRMS CHS-131  Therapeutic area franchises providing value creation focus  Oncology commercial strategy in execution  Licensing efforts for immunology and MS assets underway  Wave 2 progress on track
  • 30. Copyright ©2016 All Rights Reserved. Coherus BioSciences 35th Annual J.P. Morgan Healthcare Conference January 10, 2017