JP Morgan Healthcare Conference Daniel O’Day Chairman and Chief Executive Officer
J a n u a r y 1 1 th, 2 0 2 1 Forward-Looking Statements
Statements included in this presentation that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward- looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include: the risks and uncertainties related to the impact of the COVID-19 pandemic on Gilead’s business, financial condition and results of operations; the risks and uncertainties related to the development, manufacturing and distribution of Veklury as a treatment for COVID-19, including the uncertainty of the amount and timing of future Veklury revenues and the risk that Gilead may be unable to recoup the expenses incurred to date and future expenses related to the development and production of Veklury and Gilead may be unable to effectively manage the global supply and distribution of Veklury; Gilead’s ability to achieve its anticipated full year 2020 financial results, including as a result of potential adverse revenue impacts from COVID-19, increases in R&D expenses and potential revenues from Veklury; Gilead’s ability to make progress on and achieve its 2021 strategic business development and capital allocation goals; Gilead’s ability to make progress on any of its long-term ambitions laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its antiviral and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements; the ability of the parties to complete the MYR GmbH acquisition in a timely manner or at all; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes; the possibility of unfavorable results from ongoing and additional clinical trials; the risk that safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates in the currently anticipated timelines; Gilead’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approval may be subject to significant limitations on use; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products; the risk that efforts to control prescription drug prices could have a material adverse effect on Gilead’s business; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of these products over other therapies and may 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 Exchange Commission (the “SEC”). In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. These forward-looking statements should also be considered in light of various important factors, including, but not limited to, the following: completion of Gilead’s final closing procedures, final adjustments and other developments that may arise in the course of audit procedures. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Information about these and other risks, uncertainties and factors can be found in Gilead’s periodic reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently 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. This presentation includes U.S. GAAP and non-GAAP financial measures, and a reconciliation between these two measures is available on Gilead’s Investors page at investors.gilead.com. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under U.S. GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, TECARTUS™, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®.
2 Maintaining the highest bar for innovation, combining entrepreneurial biotech spirit with global scale and disciplined focus Building on our legacy to create new possibilities… To meet significant patient need in virology, oncology, and inflammation
Transformative Employer & Shareholder Therapies Partner of Choice Value
3 2020: Building for Growth 2020 Strategy Execution Highlights
Completed Increased pipeline Re-prioritized Five new product Recruited key talent significant BD size by 50% overall1 programs and created approvals2, including (research, clinical activity to enhance with notable opt-in new governance for COVID-19 treatment, development, data commercial portfolio opportunities the portfolio Veklury science, commercial and clinical pipeline strategy) with significant build in oncology
2020 Select Milestones
Select BD:
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Product Approvals: FDA FDA EMA EMA FDA
4 1 Measured by asset-indication projects, net change today vs. JPM 2020 2. Includes Hepcludex. Agreement to acquire Myr has been announced but not yet closed. Closing of transaction subject to antitrust clearance and other conditions Full Year 2020 Guidance
Updated in millions, except percentages and per share amounts Comments October 28, 2020 January 11, 2021
Product Sales $23,000 - $23,500 $24,300 - $24,350 • Reflects strong performance in-line with prior Product Sales excluding Veklury $21,500 - $21,525 expectations • Reflects increased hospitalization rates and utilization Veklury $2,800 - $2,825 during the most recent COVID surge Non-GAAP
Product Gross Margin 86% - 87% ~86.5% • Reflects expense for obligations under the previously Mid-teens R&D Expense1 ~20% growth disclosed new commercialization and development percentage growth agreement for Jyseleca® (filgotinib) with Galapagos NV Low double-digit SG&A Expense2 ~10% growth • In-line with prior expectations percentage growth Operating Income $10,700 - $11,200 $11,650 - $11,750
Effective Tax Rate ~20% ~19% - 19.5%
Diluted EPS $6.25 - $6.60 $6.98 - $7.08
GAAP Diluted Earnings (Loss) Per Share $(0.25) - $0.10 $(0.08) - $0.02
1. Full year R&D expense includes approximately $700M for clinical trial and manufacturing ramp-up expenses related to our COVID-19 treatment remdesivir, obligations under the previously disclosed new commercialization and development agreement for 5 Jyseleca® (filgotinib) with Galapagos NV, and investments in Trodelvy and magrolimab. 2. Full year SG&A expense includes approximately $200M relating to a legal settlement, Veklury and our acquisition of Immunomedics Role of Veklury (remdesivir) More Critical Than Ever
US COVID-19 Hospitalizations increased 4x in Q4 Only FDA Approved Antiviral for COVID-19
Q4 2020 US Hospitalizations1
140k US Hospitalizations 120k 111k 105k 101k 104k 100k 94k 85k 81k ~1 in 2 80k 69k Patients hospitalized in the 55k 60k 2 46k US treated with Veklury 41k 36k 40k 33k US US Hospitalizations (thousands) 27k 20k ~1M 40+
0 US Patients treated Interventional or 2-Oct 9-Oct 16-Oct 23-Oct 30-Oct 6-Nov 13-Nov 20-Nov 27-Nov 4-Dec 11-Dec 18-Dec 25-Dec 1-Jan with Veklury2 observational studies3
1. Source: Johns Hopkins University COVID-19 Tracker, COVID Tracking Project, IntegriChain 852 and 867 and HHS admissions; 2. Patients treated and utilization estimates based on volume donated and shipped for distribution within the US, assumed average treatment course of 6.25 vials/patient); 3. Interventional or observational studies registered on clinicaltrials.gov either completed, underway or planned evaluating the use of remdesivir alone; as background 6 therapy; or in combination with other agents in patients with COVID-19 Clear Path to Near and Long-Term Growth
Excluding Veklury (remdesivir)
Deliver on Opportunities in New Therapeutic Areas Illustrative Growth (Excluding Veklury)
New Therapeutic Areas Continue Leadership (Oncology + Inflammation) Diverse and Sustainable in Antivirals Portfolio
Existing Antiviral Base (Excluding Veklury) Prioritize and Execute Across Portfolio
7 Growth Driven by Internal and External Innovation Near- to Mid-term Growth1 Mid- to Long-term Growth1
magrolimab Cell Therapy
Internal assets + Opt-ins: Internal assets + magrolimab Opt-in Opportunities
Inflammation
Illustrative Growth Oncology Grow Oncology
Antivirals Maintain Antiviral Leadership (Excluding Veklury) 2021 2030+ 8 1. Excluding Veklury (remdesivir) Clear Path to Near and Long-Term Growth
Excluding Veklury (remdesivir)
Deliver on Opportunities in New Therapeutic Areas Illustrative Growth (Excluding Veklury)
New Therapeutic Areas Continue Leadership (Oncology + Inflammation) Diverse and Sustainable in Antivirals Portfolio
Prioritize and Execute Across Portfolio
9 Oncology Now an Important New Pillar of Growth
Key Oncology Portfolio Features P H A S E 1 P H A S E 2 P H A S E 3 MARKETED
Trodelvy Trodelvy Trodelvy Trodelvy‡ Trodelvy (+ CPI) Basket study mTNBC 1L, mUC, 3L+ HR+/ 3L mTNBC mTNBC, mUC, Ovarian (+ PARPi) • Multiple new, high-quality therapies (incl. NSCLC) mNSCLC HER2-mBC (ASCENT)
across all stages of development and Zimberelimab Magrolimab‡ Magrolimab CD73/TGFβ Magrolimab Magrolimab Trodelvy (PD-1) DLBCL Solid Tumors Solid tumors AML MDS 3L+ UC with diverse MOAs NSCLC1
Yescarta c-KIT Flt3R agonist PD-L1 Yescarta Yescarta Yescarta (+rituximab) TCR Oncology NSCLC 1L DLBCL iNHL2 2L DLBCL • Approved transformational medicines 3L DLBCL
provide benefit in hematology and Additional late stage trials for SIRP-α HPV-16 E7 MAGE-A3/A6 Brexu-cel Brexu-cel Trodelvy across multiple tumor Oncology Solid Tumors Solid Tumors Pediatric ALL3 Adult ALL3 solid tumors types to be planned in 2021
Yescarta Yescarta Arcus AB928 Arcus AB154 Brexu-cel (+utomilumab)4 (+lenzilumab) 5 TIGIT CLL Adenosine • Enhanced oncology expertise 3L DLBCL 3L DLBCL mCRC, PDAC, NSCLC NSCLC
through acquisitions supplement AGEN1223 AGEN2373 Arcus CD73 KEY Bi-specific CD137 Solid tumors Gilead’s capability and improve Solid tumors Solid tumors Gilead Program
ability to execute for growth Kite Program Tizona TTX- PY159 TREM1 PY314 TREM2 080 HLA-G Solid tumors Solid tumors Optionable Partner Program Solid tumors
10 ‡ Ph1b/2 study; 1. In-licensed from Arcus; 2. sBLA filed and priority review granted; 3. Pivotal P2 study; 4. Partnership with Pfizer; 5. Partnership with Humanigen. TrodelvyTM as a Cornerstone With Immediate Benefits and Long-Term Potential
ASCENT (Ph3): 100 Results in 3L+ mTNBC1
• is a foundational therapy Increased median Overall offering immediate transformational 80 Survival to 12.1 from 6.7
benefits in 3L+ mTNBC months (p<0.0001)
(%) 2 • sBLAs filed with FDA for full approval in 3L 60 mTNBC and accelerated approval in mUC 3L
40
• EMA MAA filing in 3L+ mTNBC expected Q1’21 Probability of OS
20 • PFS data readout in 2H 2021 for TROPiCS-02 SG3 Phase 3 trial in 3L+ HR+/HER2- mBC (OS data TPC4 in 2023) + Censored 0 0 3 6 9 12 15 18 21 24 27 Time (months)
11 1. Assessed by independent central review in the brain metastases-negative population 2. OS, overall survival 3. SG, sacituzumab govitecan 4. TPC, treatment of physician’s choice. (ESMO 2020 presentation, Bardia et al). Expansion Plans Across Multiple Tumor Types and Lines of Therapy
Later Lines Earlier Lines 2025 of Therapy of Therapy Market Size1
Triple-negative Broad Applicability Breast Cancer $40B+ Trodelvy targets Trop-2 Breast Cancer HR+/HER2- Total which is expressed in Breast Cancer multiple cancers suggesting broad $8B+ Bladder Cancer Bladder Cancer applicability Total
Lung Cancer $40B+ Combination Potential NSCLC Total Opportunity to combine Other Trop-2+ with checkpoint inhibitors, tumors targeted agents, and/or Monotherapy and combinations being explored chemotherapy and across indications and lines of therapy
12 1. Evaluate Pharma, December 2020 Clear Path to Near and Long-Term Growth
Excluding Veklury (remdesivir)
Deliver on Opportunities in New Therapeutic Areas Illustrative Growth (Excluding Veklury)
Continue Leadership Diverse and Sustainable in Antivirals Portfolio
Existing Antiviral Base (Excluding Veklury) Prioritize and Execute Across Portfolio
13 Pioneering in HIV: Past, Present, and Future
Once-a-Day Oral Long-Acting
Legacy Single- Current Single- Investigational Tablet Regimens Tablet Regimens Long-Acting Agent Lenacapavir for treatment 6-month dosing
Being studied for for prevention treatment and prevention
for prevention
First STR
Launched Launched Future 2006-2016 2018-2019 Launches
ATRIPLA (efavirenz 600 mg / emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg tablets), BIKTARVY (bictegravir 50mg / emtricitabine 200mg / tenofovir alafenamide 25mg tablets), COMPLERA (emtricitabine 200mg / rilpivirine 25mg / tenofovir disoproxil fumarate 300mg tablets), DESCOVY (emtricitabine 200mg / tenofovir alafenamide 25mg tablets), GENVOYA (elvitegravir 150mg / cobicistat 150mg / emtricitabine 200mg /tenofovir alafenamide 25mg tablets), ODEFSEY (emtricitabine 200mg / rilpivirine 25mg / 14 tenofovir alafenamide 25mg tablets), STRIBILD (elvitegravir 150mg / cobicistat 150mg / emtricitabine 200mg / tenofovir disoproxil fumarate 300mg), TRUVADA (emtricitabine 200mg / tenofovir disoproxil fumarate 300 mg tablets) Confident in Biktarvy Near- and Mid-Term Growth
#1 64% Prescribed Regimen in y/y Revenue Growth US and Other Regions1 Q3’20 vs. Q3‘19 is a standard of care once-a-day oral option: safe, efficacious, & convenient Consensus Projected US Market Peak Sales2 of Exclusivity Through $>10B 2033
1. Biktarvy #1 prescribed HIV regimen in U.S. in Q3 '20, source Ipsos. US Source: Ipsos Healthcare U.S. HIV Monitor & Scope Study Q3 ‘20. EU5 comprised of France, Spain, Italy, UK and Germany. EU Naïve & Switch Source: Ipsos HIV 15 Scope Q3 '20. EU All Patient Source: Ipsos HIV Monitor Q3 2. Evaluate Pharma, Dec 2020 Lenacapavir Could Be A Long-Acting Game-Changer
Lenacapavir Profile Highlights 6-month Dosing Unlocks Significant Potential
• Potential first-in-class HIV capsid inhibitor • Assuming equal safety, efficacy, and cost, more people prefer 6-month dosing option • Highly potent investigational agent, dosing 3 as infrequently as every 6 months Consumer Preference for Prevention Options 49% • Significantly reduced viral load in proof-of- 42% concept Phase 2/3 hTE1 trial − Anticipate FDA submission in 2H 2021 8% • FDA Breakthrough Designation2 Daily Oral Intramuscular Sub-cutaneous Therapy Injection Every Injection Every 2 Months 6 Months
1. hTE = Heavily Treatment Experienced 2. GS-6207 received breakthrough therapy designation from FDA as a potential therapy for heavily treatment-experienced (hTE) people living with multi-drug resistant HIV 3. Q2 2020 Gilead HIV 16 prevention market research of at-risk individuals conducted across US (n=120), EU4 (n=120), UK (n=30), Canada (n=30) and Australia (n=30) Accelerating Development of Lenacapavir in HIV Long-Acting Treatment and Prevention
Treatment Prevention
• 6-month data in treatment naïve population • Monotherapy may be sufficient expected 2H 2021 • 6-month dosing could meet significant unmet • Exploring internal and external partners for need, materially increasing market size optimal combination regimens • Studies to initiate in 2021: − Flexible dosing profile (oral and − Cisgender men, transgender women, parenteral) supports possibility of transgender men, and gender non-binary multiple long-acting duration options people who have sex with men 1H 2021 − Potential combination regimen(s) expected − Adolescent girls and young women 2H 2021 to enter clinic in next 12-18 months
17 1. hTE = Heavily Treatment Experienced Progress in Viral Hepatitis Further Strengthens Core Antiviral Business
Expected HBV Sales of $1B+ by 20221 Novel HDV Therapy, Synergies with HBV
is a first-in-class and potentially $1B+ best-in-class treatment for HDV2
Hepcludex+ TDF $743M 54% TDF 43%
7% 4%
% Patients with % Patients with Normalized 2019 2022 Reduced Viral RNA3 Liver Function4
Continuing to lead in HBV Cure: US BLA submission expected in 2H 2021; more Ph2 combination studies to initiate this year approvals, including in Asia, expected in 2023+
1 Potential to achieve $1 billion+ franchise by 2022 through U.S. and China Vemlidy growth 2. From agreement to acquire Myr. Transaction has been announced but not yet closed. Closing of transaction subject to antitrust clearance and 18 other conditions.3. Undetectable HDV RNA or >2log decline 4. ALT normalization Clear Path to Near and Long-Term Growth
Excluding Veklury (remdesivir)
Deliver on Opportunities in New Therapeutic Areas Illustrative Growth (Excluding Veklury)
Continue Leadership Diverse and Sustainable in Antivirals Portfolio
Prioritize and Execute Across Portfolio
19 Sustainable, More Diverse Portfolio
Key Features of Transformed Portfolio Prioritization to Drive Value
Growth drivers have high probability of >50% expansion of pipeline1 with higher success from on-market status (e.g. value programs provides opportunity to Trodelvy) or compelling data (e.g. re-prioritize programs of less value lenacapavir) Select re-prioritization examples: • Filgotinib: stopped clinical trials in psoriatic arthritis, ankylosing Smart deal structures de-risk spondylitis, and non-infectious uveitis investments, providing opt-in rights after • NASH: not pursuing pivotal trial in proof-of-concept data is in hand favor of Phase 2b • Outlicensing of SYK inhibitor
20 1 As measured by asset-indication projects, net change from today vs. JPM 2020 Select 2021 Milestones
Lenacapavir capsid inhibitor COVID-19 Impact: Some clinical trials continue to be impacted by Phase 3 initiation for PrEP the pandemic, which may result in delays in achieving milestones. Hepcludex1 (Bulevirtide) Phase 3 data readout in HDV Regulatory approval Viral Diseases Inflammatory Diseases Oncology Trodelvy (Sacituzumab govitecan-hziy) or pivotal readout MAA filing in 3L mTNBC Trodelvy (Sacituzumab govitecan-hziy) Lenacapavir capsid inhibitor Anticipated sBLA full approval in 3L mTNBC Anticipated NDA submission in heavily treatment experienced population Trodelvy (Sacituzumab govitecan-hziy) Lenacapavir capsid inhibitor Anticipated sBLA approval in 3L mUC Phase 2 data read out for virologically suppressed population Magrolimab Hepcludex1 (Bulevirtide) Phase 3 initiation in AML Anticipated BLA submission for HDV Yescarta (Axi-cel) Trodelvy (Sacituzumab govitecan-hziy) Phase 3 data read out in 2L DLBCL Anticipated MAA approval in 3L mTNBC Yescarta (Axi-cel) Trodelvy (Sacituzumab govitecan-hziy) Anticipated MAA filing in iNHL Phase 3 data read out in HR+/HER2- mBC Yescarta (Axi-cel) Magrolimab Anticipated sBLA approval in iNHL Phase 1b data read out in MDS Tecartus (Brexu-cel) Magrolimab Anticipated sBLA/MAA submission in adult ALL Potential BLA/MAA submission for accelerated approval in MDS Domvanilimab (TIGIT) Magrolimab + rituximab Phase 2 interim read out in NSCLC (ARC-7) Phase 1b/2 interim data read out in 3L+ DLBCL Ziritaxestat ATX inhibitor Yescarta (Axi-cel) Phase 3 futility analysis data read out in IPF Phase 2 data read out in 1L DLBCL
1H 2021 2H 2021
21 1 From agreement to acquire Myr. Transaction has been announced but not yet closed. Closing of transaction subject to antitrust clearance and other conditions. 2021 Strategic Business Development
2020 2021 18 Strategic Partnerships & Acquisitions1 Continued focus Execute on Pursue bolt-ons with on transformative opportunities very high bar, remain science from recent BD opportunistic re: 12 Gilead Molecules2 activity exceptional medicines 14+ Opt-in Molecules2
22 1. Excludes divestitures, equity investments and GLPG restructuring; 2. Includes preclinical, excludes target discovery deals 2021 Capital Allocation
Guiding We will: Principles Continue to invest in our business and R&D pipeline while managing expenses
Grow our dividend and pay down at least $4B of debt
Repurchase shares
23 Summary
Clear path to growth (excluding Veklury) through strategic transformation of our portfolio
Important new pillar of growth in oncology with Trodelvy as cornerstone
Strong antiviral foundation with continued leadership in HIV
Sustainable growth will be driven by continued internal and external innovation − Financial strength and flexibility to continue strategic BD investments
24 THANK YOU
CONTACT US [email protected] investors.gilead.com Phase 1 Phase 2 Phase 3 NDA/BLA/MAA
Overview Phase 2/3 of Clinical
Pipeline Viral Diseases
Today MAA Filed
Clinical stage programs1
53 18 through BD since Jan '19 Diseases Inflammatory
MAA and BLA Approved sBLA Filed sBLA NDA/BLA/MAA filings, P3 sBLA for AA 18 and Registrational P2 trials Pivotal Pivotal Clinical stage NMEs via in-licensing, and 15 acquisitions accounting Phase 1b/2 Phase 1b/2 for 23 programs Phase 1b/2 Oncology Phase 1b/2
Breakthrough Therapy 7 Designations
Phase 1a 1. Including in-licensed or acquired programs currently between Phase 1a 26 phase 1 and NDA/BLA/MAA approval. Viral Disease Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 Veklury® (remdesivir for injection) Outpatient COVID-19 Expanded indication
Remdesivir inhaled form (GS-5794) Outpatient COVID-19 EV Remdesivir sub cutaneous form (GS-5794) COVID-19 Lenacapavir capsid inhibitor (GS-6207) HIV LA HTE Phase 2/3 Lenacapavir capsid inhibitor (GS-6207) HIV LA VS bNAb combination (GS-5423, GS-2872)1 HIV Cure Lefitolimod TLR-9 agonist (GS-1703)1 HIV Cure Vesatolimod TLR-7 agonist (GS-9620) HIV Cure Elipovimab bNAb (GS-9722) HIV Cure
HIV Effector IgG #2 (GS-9723) HIV Cure PC → P1 Unboosted protease inhibitor (GS-1156) HIV Treatment Long acting bictegravir (GS-9883) HIV LA Long acting oral combination HIV LA Lenacapavir capsid inhibitor (GS-6207) HIV PrEP Hookipa HIV vaccine HIV Cure 2 Hepcludex® (bulevirtide) HDV MAA Approved Acquired from MYR2 Hepcludex® (bulevirtide)2 + PEG-INF HDV Acquired from MYR2 Selgantolimod TLR-8 agonist (GS-9688) HBV Cure
Oral PD-L1 small molecule (GS-4224) HBV Cure HBV & HDV HBV & Hookipa HBV vaccine (GS-6779) HBV Cure
New listing since Q3’20 Change since Q3’20
Breakthrough Therapy Designation
1 Non-Gilead sponsored trial(s) ongoing. 2From agreement to acquire Myr. Transaction has been announced but not yet closed. Closing of transaction subject to antitrust clearance and other conditions. EV – Emerging viruses bNAb – Broadly neutralizing antibody. HTE – Heavily treatment-experienced. LA – Long Acting. VS – Virologically suppressed. Pipeline shown above as of end of Q4’20. 27 Inflammatory Disease Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 Filgotinib JAK-1 inhibitor (GS-6034) Ulcerative colitis MAA Filed MAA filed Filgotinib JAK-1 inhibitor (GS-6034) Crohn's Disease Filgotinib JAK-1 inhibitor (GS-6034) Psoriatic arthritis Removed from pipeline Filgotinib JAK-1 inhibitor (GS-6034) Ankylosing spondylitis Removed from pipeline Filgotinib JAK-1 inhibitor (GS-6034) Uveitis Removed from pipeline TPL2 inhibitor (GS-4875) Ulcerative colitis Removed from pipeline TPL2 inhibitor (GS-5290) Inflammatory Bowel Disease New IRAK4 inhibitor (GS-5718) Inflammatory Bowel Disease IRAK4 inhibitor (GS-5718) Lupus New
Tirabrutintib BTK inhibitor (GS-4059) CSU New Inflammatory Disease α4β7 inhibitor (GS-1427) Inflammatory Bowel Disease Small molecule inhibitor (neutrophil target) Inflammatory Diseases Small molecule inhibitor (innate immunity Inflammatory Diseases target) Cilofexor FXR agonist (GS-9674) PSC Ziritaxestat ATX inhibitor (GLPG-1690) IPF
Cilofexor / firsocostat combination NASH Disease Fibrotic Fibrotic Selonsertib ASK1 inhibitor (GS-4997) DKD Ziritaxestat ATX inhibitor (GLPG-1690) Systemic Sclerosis Removed from pipeline Inflammatory and Fibrosis Galapagos 8 clinical stage programs Diseases Inflammatory and Fibrosis Galapagos Multiple pre-clinical stage programs Options Diseases
New listing since Q3’20 Change since Q3’20
28 CSU - Chronic Spontaneous Urticaria. DKD – Diabetic kidney disease. IPF – Idiopathic pulmonary fibrosis. NASH – Nonalcoholic steatohepatitis. PSC – Primary sclerosing cholangitis. Pipeline shown above as of end of Q4’20. Oncology Cell Therapy Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20
TecartusTM (Brexu-cel)1 MCL MAA and BLA Approved MAA approved
Axi-cel iNHL sBLA Filed
Yescarta® (Axi-cel) 2L DLBCL
Yescarta® (Axi-cel) 1L DLBCL
Brexu-cel Adult ALL Pivotal
Brexu-cel Pediatric ALL Pivotal
Yescarta® (Axi-cel)2 3L DLBCL (+rituximab)
Yescarta® (Axi-cel)3 3L DLBCL (+lenzilumab)
Yescarta® (Axi-cel)4 3L DLBCL (+utomilumab) Cell Cell Therapy KITE-718 (MAGE-A3/A6)5 Solid Tumor
KITE-439 (HPV-16 E7)5 Solid Tumor Brexu-cel CLL
KITE-037 (Allo-HD CD19)6 R/R DLBCL
KITE-222 (CLL-1) AML
KITE-363 (Dual targeting) R/R DLBCL
New listing since Q3’20 Change since Q3’20
Breakthrough Therapy Designation
1 Conditional approvals. 2 Clinical collaboration with Genentech. 3 Clinical collaboration with Humanigen. 4 Clinical collaboration with Pfizer, 5 Collaboration with NIH. 6 Partnership with Sangamo. 29 ALL - Acute lymphocytic leukemia. AML - Acute myeloid leukemia. Axi-cel - Axicabtagene Ciloleucel. Brexu-cel - Brexucabtagene autoleucel. CLL- Chronic lymphocytic leukemia. DLBCL - Diffuse large B cell lymphoma. iNHL - indolent non-Hodgkin's lymphoma. MCL - Mantle cell lymphoma. R/R - relapsed / refractory. Pipeline shown above as of end of Q4’20. Oncology Non-Cell Therapy Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 TrodelvyTM Sacituzumab govitecan-hziy1 mTNBC (3L) sBLA sBLA filed for full approval Sacituzumab govitecan-hziy (GS-0132) Urothelial (3L+) sBLA for AA sBLA filed for accelerated approval Magrolimab anti-CD47 (GS-4721) 2 MDS P Sacituzumab govitecan-hziy (GS-0132) HR+/HER2-mBC (3L+) Sacituzumab govitecan-hziy (GS-0132) Basket (incl. NSCLC) Sacituzumab govitecan-hziy (GS-0132) + CPI mTNBC (1L), mUC, mNSCLC Phase 1b/2 Magrolimab anti-CD47 (GS-4721) AML Phase 1b/2 Zimberelimab PD1 (GS-0122)3 NSCLC Magrolimab anti-CD47 (GS-4721) DLBCL Phase 1b/2 Sacituzumab govitecan-hziy (GS-0132) + PARPi mTNBC, mUC, Ovarian Phase 1b/2 P1 → P1b/2
Oral PD-L1 small molecule inhibitor (GS-4224) NSCLC Cell Therapy Cell
- Anti-CD73/TGFβ Trap (GS-1423) ONC
Magrolimab anti-CD47 (GS-4721) Solid Tumors Non Flt3R agonist (GS-3583) ONC Anti-c-KIT (GS-0174) TCR Phase 1a PC → P1 Anti-SIRP-a (GS-0189) ONC Phase 1a PC → P1 MCL1 inhibitor (GS-9716) ONC TME target ONC T cell activator ONC CCR8 (GS-1811) Solid Tumors Arcus ONC 3 clinical stage programs Agenus Solid Tumors 2 clinical stage programs Tizona Advanced Cancers 1 clinical stage program Options Pionyr Solid Tumors 2 clinical stage programs
New listing since Q3’20 Change since Q3’20
Breakthrough Therapy Designation P PRIME Designation 1 Accelerated FDA approval granted. 2 Breakthrough and PRIME designation. 3 Non-Gilead sponsored trial(s) ongoing. AML – Acute myeloid leukemia. CPI – Checkpoint inhibitor. DLBCL – Diffuse large B cell lymphoma. HR+/HER2- mBC – Hormone Receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. MDS – Myelodysplastic syndrome. 30 mTNBC – Metastatic triple-negative breast cancer. mUC - metastatic urothelial cancer. mNSCLC - metastatic non-small cell lung cancer. NSCLC – Non small cell lung cancer. PARPi – PARP inhibitor. TCR – Transplant conditioning regimen. TME – Tumor microenvironment. Pipeline shown above as of end of Q4’20.