gilead’s next chapter
TRANSCRIPT
Confidential – Internal Use Only
Gilead’s Next ChapterDaniel O’DayChairman and Chief Executive OfficerJanuary 13, 2020
Confidential – Internal Use Only
Forward-Looking StatementsStatements included in this presentation that are not historical in nature could be deemed forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could causeactual results to differ materially from those referred to in the forward-looking statements. These risks and uncertainties include: Gilead’s ability to successfullyexecute its corporate strategy in its currently anticipated timelines; Gilead’s ability to accelerate or sustain revenues for its HIV and other programs; Gilead’sability to initiate clinical trials in its currently anticipated timelines; Gilead’s ability to realize the potential benefits of collaborations or licensing arrangements,including with Galapagos and other partners; Gilead’s ability to submit new drug applications for new product candidates in the timelines currently anticipated,including additional indications for filgotinib and Kite’s cell therapy candidates; Gilead’s ability to receive regulatory approvals in a timely manner or at all, fornew and current products, including regulatory approval of filgotinib for the treatment of RA and KTE-X19 for the treatment of mantle cell lymphoma; Gilead’sability to successfully commercialize its products, including expansion in China; safety and efficacy data from clinical studies may not warrant furtherdevelopment of Gilead’s product candidates, including filgotinib, GS-6207 capsid inhibitor and Kite’s cell therapy candidates; the risk that private and publicpayers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products; market share and price erosion caused by theintroduction of generic versions of our products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies andmay therefore be reluctant to prescribe the products; and other risks identified from time to time in Gilead’s reports filed with the U.S. Securities and ExchangeCommission (the SEC). There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statementsand may also cause actual results to differ significantly from these estimates. Gilead directs readers to its press releases, Quarterly Report on Form 10-Q forthe quarter ended September 30, 2019 and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harborcontained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on informationcurrently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law.Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements.
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Three Pillars of Gilead’s Next Chapter
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Strategy to Drive Additional Growth
Durable Core Business
Existing Pipeline Opportunities
+ +
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Key Decisions Have Laid the Foundation for Change
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2020Mar Jul Sep Oct Dec
Made KiteSeparate Operating
Company
Expanded Galapagos Partnership
Established External Innovation
Group
Completed New Leadership
Team
Defined New Corporate Strategy
2019
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Diverse, Highly Experienced Leadership Team
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Merdad Parsey, MD, PhD
Chief Medical Officer
Brett A. PletcherExecutive Vice President,
Corporate Affairs and General Counsel
Christi ShawChief Executive Officer, Kite
Taiyin Yang, PhDExecutive Vice President,
Pharmaceutical Development and Manufacturing
Daniel O’DayExecutive Chairman and Chief Executive Officer
Andrew DickinsonChief Financial Officer
Jyoti MehraExecutive Vice President,
Human Resources
Johanna MercierChief Commercial Officer
William A. Lee, PhDExecutive Vice President,
Research
Confidential – Internal Use Only
Building from Durable Core Business
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Strategy to Drive Additional Growth
Durable Core Business
Existing Pipeline Opportunities
+ +
Confidential – Internal Use Only
Robust Growth of HIV Business Despite Competitor Launches
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2011 2019
• Antiviral world-leader
‒ 15 launches in 10 years1
• Robust HIV growth‒ 14% CAGR since 20112
‒ 13% growth Q3’18 – Q3’19
Prepared for Truvada U.S. LOE
HCVOtherHIV
• Treatment - 90-95% Gilead patients expected on F/TAF-based regimens by Q4’203
• Prevention - 40-45% individuals on PrEP expected to be on Descovy by Q4’203
1 Complera, Viread, Truvada for PrEP, Stribild, Tybost, Vitekta, Sovaldi, Harvoni, Genvoya, Odefsey, Epclusa, Vemlidy, Vosevi, Biktarvy, Descovy for PrEP. 2 Q1 2011 through Q3 2019. 3 Expectations for U.S. patients.
Confidential – Internal Use Only
Expect Biktarvy® to remain preferred treatment option for majority of patients through 2033
HIV Franchise is Robust and Sustainable
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• Zero cases of treatment-emergent resistanceand rapid start recommended1,2
• #1 prescribed HIV regimen and best HIV launch in history3,4
• ~80% average QoQ growth since launch
Highly effective single tablet regimen for treatment
Statistically significant safety improvements in prevention5
• ~20% at-risk individuals on PrEP today6
• ~25% PrEP scripts are for Descovy®
1 Biktarvy demonstrated zero cases of treatment-emergent resistance through 3 years in P3 clinical trials. 2 2018 DHHS treatment guidelines. 3 Biktarvy #1 prescribed HIV regimen in U.S. in Q3 2019. 4 Biktarvy best HIV launch in history in U.S. and certain other countries basedon prescription volume. 5 Statistically significant advantages with respect to all six pre-specified secondary endpoints for renal and bone laboratory parameters in patients receiving Descovy compared to Truvada. 6 ~1.1m at-risk individuals in U.S., 224k on PrEP, Q3 2019.
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Capsid has the potential to be first- and best-in-class with multiple dosing options
Reinforcing Commitment to HIV Leadership With Innovative Long-Acting Programs
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1 GS-6207 received breakthrough therapy designation from FDA as a potential therapy for heavily treatment-experienced (HTE) people living with multi-drug resistant HIV. 2 Pivotal for HTE patients. Selected pre-clinical assets displayed. INSTI - Integrase Strand Transfer Inhibitor. NRTI - Nucleoside reverse transcriptase inhibitor. NNRTI - Non-nucleoside reverse transcriptase inhibitor. bNAbs - Broadly neutralizing antibodies.
• Weekly oral potential
• Monthly 6 month SQ with self-admin potential
• Breakthrough Designation1
HTE2 P2/3
Virologically Suppressed P2
PrEP PC
Current Clinical Programs
Treatment+
Prevention
Capsid Inhibitor as the Foundation
Committed to Developing Multiple Partner Agents
LA INSTI • LA NRTI • LA NNRTI • bNAbs
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Additional Opportunities to Grow Antiviral Business
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1 Combined market share of Gilead branded or authorized generic partner products in U.S. 2 8 products approved in China since Sept 2017 including Sovaldi, Epclusa, Genvoya, Vemlidy, Harvoni, Descovy, Biktarvy and Vosevi and 4 products added to National ReimbursementDrug List (NRLD) including Vemlidy, Epclusa, Genvoya, Harvoni for Jan 2020 reimbursement.
Sustain HCV Revenues
Key market leadership~60% U.S. market share today1
Accelerate HBV
Achieve $1bn+ franchise by 2022 through U.S. and China Vemlidy
growth
Drive China Growth
8 products approved since 20174 listed on NRDL for Jan 2020
reimbursement2
Confidential – Internal Use Only
Executing on Existing Pipeline Opportunities
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Strategy to Drive Additional Growth
Durable Core Business
Existing Pipeline Opportunities
+ +
Confidential – Internal Use Only
Clinical Stage Programs
NDA/BLA/MAA, P3 and Registrational P2 trials
NMEs via in-licensing, options, and product acquisitions
Breakthrough Therapy Designations
Overview of Clinical Pipeline Today
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Phase 1 Phase 2 Phase 3 NDA/BLA/MAA
Viral Diseases
Fibrotic Diseases
Inflammatory Diseases
Oncology
Confidential – Internal Use Only
Filgotinib Marks Expansion into Inflammation with Potential for 5 Launches in Next 4 Years
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RA P3
UC P3
CD P3
PsA P3
AS P2
Uveitis P2
Selective JAK-1 inhibitor with potential best-in-class profile
Strong efficacy for remission and demonstrated safety at both doses; favorable benefit/risk profile at high dose
Submitted for RA in U.S., Europe and Japan
P3 UC data in H1 2020
Filgotinib
Prepared for competitive RA launch with highly experienced team
RA - Rheumatoid Arthritis. UC - Ulcerative Colitis. CD - Crohn’s Disease. PsA - Psoriatic Arthritis. AS - Ankylosing Spondylitis.
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Building a Broad Inflammation and Fibrosis Portfolio with Galapagos Beyond Filgotinib
141 Excluding filgotinib. 2 Autotaxin inhibitor. 3 GPR84 antagonist. 4 Toledo – dual mechanism anti-inflammatory. IPF - Idiopathic Pulmonary Fibrosis. OA – Osteoarthritis. Selected pre-clinical and P1 assets displayed.
Selected programs
8 clinical programs1
>20 pre-clinical programs
Doubles Gilead’s R&D footprint and accelerates transformational
therapy development
GLPG-43994 – Inflammation PCGLPG-4124 – Fibrosis PCGLPG-4259 – Inflammation PCGLPG-4471 – Inflammation PC
GLPG-16902 – IPF P3GLPG-1972 – OA P2GLPG-12053 – IPF P2
GLPG-39704 – Inflammation P1GLPG-33124 – Inflammation P1
GLPG-16902 – Systemic Sclerosis P2GLPG-0555 – Inflammation P1
GS-4997 (ASK1 inhibitor) – DKD P2
SM inh. (Neutrophil target) – Inflam. PCSM inh. (Innate immunity target) – Inflam. PC
GS-4875 (TPL2 inhibitor) – UC P2GS-5718 (IRAK4) – Inflammation PCGS-1427 (α4β7) – Inflammation PC
Cilo/Firco/Sel (FXR, ACC, ASK1) Combination – NASH P2
Key: Fibrotic Diseases; Inflammatory Diseases
GLPG-3667 – Inflammation P1
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Building transformative therapies across complementary Immuno-Oncology platforms
Oncology Strategy Focused onImmuno-Oncology
1 Nearly half of r/r DLBCL patient alive three years after treatment with Yescarta in ZUMA-1 study. IO – Immuno-Oncology.
Pioneering platform to advance new therapies and
drive long-term growth
Apply small molecule and biologics development capabilities to IO
Transformative therapy with potential for earlier lines and additional indications1
Cell Therapy Non-Cell Therapy
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Cell Therapy Non-Cell Therapy
Oncology Pipeline Consists of 15 Clinical Programs and Growing
Building transformative therapies across complementary Immuno-Oncology platforms
KTE-X19 CD-19 r/r MCL BLA
Axi-cel CD-19 2L DLBCL P3
Axi-cel CD-19 iNHL P21
Axi-cel CD-19 1L DLBCL P2
Axi-cel CD-19 DLBCL (+ritux. or lenal.) P21
KTE-X19 Adult ALL P21
KTE-X19 Pediatric ALL P21
KTE-X19 CLL P1
Axi-cel DLBCL (+4-1BB mAb) P1
MAGE A3/A6 TCR Solid tumors P1
HPV-16 E7 TCR Solid tumors P1
Allogeneic CD-19 r/r DLBCL PC
CLL-1 CAR T AML PC
Dual antigen CAR T r/r DLBCL PC
Oral PD-L1 inhibitor (GS-4224) Solid tumors P1
Anti-CD73/TGFβ TRAP (GS-1423)2 Solid tumors P1
Bi-specific mAb (AGEN1223)3,4 Multiple P1
Anti-CD137 mAb (AGEN2373)4 Multiple P1
Flt3R agonist (GS-3583) Solid tumors PC
MCL1 inhibitor (GS-9716) Multiple PC
Small molecule inh. (T cell target) Solid tumors PC
Small molecule inh. (TME target) Solid tumors PC
Monoclonal antibody (TME target) Solid tumors PC
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1 Pivotal P2 study. 2 TME conditioning anti-CD73/TGFβ TRAP bifunctional fusion protein (GS-1423). 3 Bi-specific mAb targeting immunosuppressive regulatory T cells (AGEN1223). 4 Exclusive option to license rights from Agenus upon proof of concept data. ALL - Acute lymphocytic leukemia. CLL - Chronic lymphocytic leukemia. DLBCL - Diffuse large B-cell lymphoma. iNHL - Indolent non-Hodgkin lymphoma. MCL - Mantle cell lymphoma. r/r - relapsed refractory. iNHL - Indolent non-Hodgkin lymphoma. Selected pre-clinical assets displayed.
Confidential – Internal Use Only17HTE – heavily treatment-experienced.
Anticipated Milestones Through 2021
2021H2 2020H1 2020
FilgotinibP3 UC data
FilgotinibExpected RA approvals in U.S., Europe, Japan
FilgotinibP3 enrollment completion for CD
GLPG-1972P2 OA data
Capsid inhibitorP1 initiation for PrEP
GLPG-1690P3 IPF futility analysis data
Capsid inhibitorExpected HTE submission
Axi-celExpected iNHL approval
KTE-X19Expected aALL approval
Axi-celP2 1L DLBCL data
Axi-celExpected 2L DLBCL submission
KTE-X19Expected MCL approval
Axi-celP3 2L DLBCL data
Axi-celP2 iNHL data
FilgotinibMANTA/MANTA-RAy enrollment completion
Confidential – Internal Use Only
Strategy to Drive Additional Growth
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Strategy to Drive Additional Growth
Durable Core Business
Existing Pipeline Opportunities
+ +
Confidential – Internal Use Only
New Corporate Strategy to Drive Future Growth
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Long
-Ter
m
Ambi
tions
Stra
tegi
c
Prio
ritie
s
Bring 10+ Transformative Therapies to Patients by 2030
Be the Biotech Employer and Partner of Choice
Deliver Shareholder Value in a Sustainable, Responsible Manner
Strengthen Portfolio Strategy and Decision-
Making
Increase Patient Accessand Benefit
Continue to Evolveour Culture
Expand Internal andExternal Innovation
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Focused on Growing from Core Areas of Strength
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AntiviralsDeep Expertise
Immuno-modulationEmerging Expertise
Core Strengths Disease Areas
ViralDiseases
InflammatoryDiseases
Oncology FibroticDiseases
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We Will Continue to Pursue Tailored Transactions That Drive Strategic Value
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Guiding Principles for Future Deals
• Focus on high quality science that build upon core areas of strength
• Prioritize clinical and commercial opportunities
• Pursue and execute:
‒ Partnerships from small to transformative in size
‒ Bolt-on acquisitions from small to medium in size
32Strategic Partnerships
& Investment TransactionsOver the Past Two Years
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Three Pillars of Gilead’s Next Chapter
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Well positioned to maximize near-term opportunities and achieve long-term success
Strategy to Drive Additional Growth
Durable Core Business
Existing Pipeline Opportunities
+ +
Confidential – Internal Use Only
Gilead’s Next ChapterDaniel O’DayChairman and Chief Executive OfficerJanuary 13, 2020
Confidential – Internal Use Only
Viral Disease Pipeline
251 Biktarvy HIV treatment pediatric label extension. 2 Registrational for heavily treatment-experienced (HTE) patients. Selected pre-clinical assets displayed.
Pre-Clinical Phase 1 Phase 2 Phase 3
HIV
Biktarvy HIV treatment pediatric1
Capsid inhibitor (GS-6207) HIV HTE Registrational for HTE2
Capsid inhibitor (GS-6207) HIV virologically suppressedVesatolimod (GS-9620, TLR-7 agonist) HIV cureElipovimab (GS-9722, bNAb) HIV cureCapsid inhibitor (GS-6207) PrEPUnboosted protease inhibitor (GS-1156) HIV treatmentLong-acting oral combination therapy HIV treatmentHookipa vaccine HIV cure
HBV
Selgantolimod (GS-9688,TLR-8 agonist) HBV cureSpringBank compound (GS-9992) HBV curePD-L1 inhibitor (GS-4224) HBV cureHookipa vaccine (GS-6679) HBV cure
Confidential – Internal Use Only26^ Optionable partner program. Selected pre-clinical assets displayed.
Inflammatory Disease PipelinePre-Clinical Phase 1 Phase 2 Phase 3 NDA/BLA/MAA
Infla
mm
ator
y D
isea
se
Filgotinib (GS-6034, JAK-1 inhibitor) Rheumatoid arthritis NDA/MAA
Filgotinib (GS-6034, JAK-1 inhibitor) Ulcerative colitisFilgotinib (GS-6034, JAK-1 inhibitor) Crohn’s diseaseFilgotinib (GS-6034, JAK-1 inhibitor) Psoriatic arthritisFilgotinib (GS-6034, JAK-1 inhibitor) Ankylosing spondylitisFilgotinib (GS-6034, JAK-1 inhibitor) UveitisTPL2 inhibitor (GS-4875) Ulcerative colitisGLPG-1972^ OsteoarthritisGLPG-0555^ Inflammatory diseasesGLPG-3312^ Inflammatory diseasesGLPG-3970^ Inflammatory diseasesGLPG-3667 Inflammatory diseasesIRAK4 inhibitor (GS-5718) Inflammatory diseasesα4β7 inhibitor (GS-1427) Inflammatory diseasesSmall molecule inh. (Neutrophil target) Inflammatory diseasesSmall molecule inh. (Innate immunity target) Inflammatory diseasesGLPG-4399^ Inflammatory diseasesGLPG-4259^ Inflammatory diseasesGLPG-4471^ Inflammatory diseasesGLPG-4059^ Inflammatory diseases
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Fibrotic Disease Pipeline
27* Optioned partner program. ^ Optionable partner program. Selected pre-clinical assets displayed.
Pre-Clinical Phase 1 Phase 2 Phase 3
Fibr
otic
Dis
ease
Cilofexor (GS-9674, FXR agonist) PSCGLPG-1690* Idiopathic pulmonary fibrosisCilofexor (FXR agonist), Firsocostat (ACC inh.), Selonsertib (ASK1 inh.) combinations NASH
Selonsertib (GS-4997, ASK1 inhibitor) DKDGLPG-1690* Systemic sclerosis GLPG-1205^ Idiopathic pulmonary fibrosisGLPG-4124^ Fibrosis
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Oncology Pipeline
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1 TME conditioning anti-CD73/TGFβ TRAP bifunctional fusion protein (GS-1423). 2 Bi-specific mAb targeting immunosuppressive regulatory T cells (AGEN1223). 3 Exclusive option to license rights from Agenus upon proof of concept data. ALL - Acute lymphocytic leukemia.CLL - Chronic lymphocytic leukemia. DLBCL - Diffuse large B-cell lymphoma. iNHL - Indolent non-Hodgkin lymphoma. MCL - Mantle cell lymphoma. r/r - relapsed refractory. iNHL - Indolent non-Hodgkin lymphoma. Selected pre-clinical assets displayed.
Pre-Clinical Phase 1 Phase 2 Phase 3 NDA/BLA/MAA
Cel
l The
rapy
KTE-X19 MCL BLA
Axi-cel 2L DLBCLAxi-cel Indolent NHL Pivotal
Axi-cel 1L DLBCLAxi-cel DLBCL (+rituximab or lenalidomide) Pivotal
KTE-X19 Adult ALL Pivotal
KTE-X19 Pediatric ALL Pivotal
KTE-X19 CLLAxi-cel DLBCL (+4-1BB mAb)KITE-718 (MAGE A3/A6) Solid tumorKITE-439 (HPV E7) Solid tumorAllogeneic CD-19 r/r DLBCLCLL-1 CAR T AMLDual antigen CAR T r/r/ DLBCL
Non
-Cel
l The
rapy
Oral PD-L1 inhibitor (GS-4224) Solid tumoranti-CD73/TGFβ TRAP (GS-1423)1 Solid tumorBi-specific mAb (AGEN1223)2,3 MultipleAnti-CD137 mAb (AGEN2373)3 MultipleFlt3R agonist (GS-3583) Solid tumorsMCL1 inhibitor (GS-9716) MultipleSmall molecule inhibitor (T cell target) Solid TumorsSmall molecule inhibitor (TME target) Solid TumorsMonoclonal antibody (TME target) Solid Tumors