Slide 1: Q324 Financial Results
Q324 Financial Results November 6, 2024
Slide 2: Forward-Looking Statements
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 un
Slide 3: Contents
Contents Q324 Key Takeaways 4-6 Commercial Results 7-16 Pipeline Updates 17-23 Financial Results 24-30 Appendix 32-39
Slide 4: Q324 Key Takeaways
Q324 Key Takeaways Daniel O’Day Chairman and Chief Executive Officer
Slide 5: Gilead Q324 Key Takeaways
Gilead Q324 Key Takeaways • Total product sales excl. Veklury +7% YoY to $6.8B; Non-GAAP diluted EPS $2.02 • HIV +9% YoY driven by higher average realized price and demand; Biktarvy +13% YoY Financial Results • Oncology +6% YoY to $816M; Trodelvy +17% YoY and Cell Therapy flat YoY • FY24 Guidance Ra
Slide 6: Key 2024 Milestones
Key 2024 Milestones 1H24 Completed Completed (see footnote) Program Trial Indication Update Status Program Trial Indication Update Status LEN/ISL Oral NCT05052996 HIV LA VS Phase 2 update TROPiCS-04 2L mUC Phase 3 update1 Trodelvy ARTISTRY-1 HIV VS TE Phase 3 FPI EVOKE-02 1L mNSCLC Phase 2 update LE
Slide 7: Commercial Results & Market Dynamics
Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer
Slide 8: Strong Q324 YoY & QoQ Performance
Strong Q324 YoY & QoQ Performance $7.5B Total Product Sales +7% YoY, +9% QoQ Veklury $692M $6.8B Total Product Sales excluding Veklury +7% YoY, +2% QoQ +9% YoY Trodelvy $332M HIV Product Sales $5.1B +17% YoY Cell Therapy HIV +9% YoY, +7% QoQ $485M $5.1B Flat YoY +9% YoY Liver Disease Product Sales L
Slide 9: HIV: Market Leadership and Growth Continues
HIV: Market Leadership and Growth Continues Product Sales ($M) $5,073 $4,667 $341 $4,693 $261 $4,342 $4,745 $353 $342 +9% +7% $570 $533 $342 Sales growth Sales growth $519 $571 YoY QoQ $596 • YoY and QoQ increase primarily driven by higher average realized price due to shifts in channel mix and high
Slide 10: Delivering Double-Digit YoY Growth
Delivering Double-Digit YoY Growth Q324 sales: $3.5B; +13% YoY, +7% QoQ Q324 sales: $586M; +15% YoY, +21% QoQ >49% • Remains #1 regimen for new starts and treatment switches across major >40% • Descovy for PrEP maintaining share despite availability of other regimens, U.S. Market markets U.S. Market
Slide 11: Liver Disease: Global Leadership Across Viral Hep
Liver Disease: Global Leadership Across Viral Hep Product Sales ($M) $832 $706 $737 $733 >60% >50% $691 $259 U.S. HCV Europe HCV $215 $207 market share market share $211 $200 $142 $132 • +4% YoY primarily driven by increased demand across the $119 $137 $121 viral hepatitis portfolio, partially offse
Slide 12: Livdelzi: Building Momentum in PBC
Livdelzi: Building Momentum in PBC FDA Accelerated Approval Mid-August 2024 U.S. Launch prescription written within hours of Mid-August 2024 1st receiving U.S. accelerated approval target prescribers reached within European Regulatory Decision >1,000 first several weeks of launch Expected Early 2025
Slide 13: Veklury: Leading Role in Dynamic Environment
Veklury: Leading Role in Dynamic Environment Product Sales ($M) $720 $692 $636 $175 >60% $1.5B $555 $219 U.S. hospitalized patients 2024 sales treated for COVID-191 year-to-date $313 $169 $181 $81 • +9% YoY and +223% QoQ reflects increased COVID-19 $70 hospitalization rates during higher-than-expect
Slide 14: Oncology: Expanding Patient Reach Across Markets
Oncology: Expanding Patient Reach Across Markets Product Sales ($M) $841 $816 $789 $769 $765 +6% -3% $320 Sales growth Sales growth $309 $332 $283 $299 YoY QoQ >65K >50 Patients treated Countries approved $486 $521 $485 $466 $480 Q323 Q423 Q124 Q224 Q324 Trodelvy Cell Therapy 14 Note: YoY reflects Q
Slide 15: Trodelvy: Strong Position in Breast Cancer
Trodelvy: Strong Position in Breast Cancer Product Sales ($M) $332 $320 $309 >40K #1 $26 $299 $26 $283 $36 $24 $21 $80 Patients treated Regimen for $69 $48 across tumor types 2L mTNBC1 $68 $62 • +17% YoY and +4% QoQ primarily driven by higher demand in all regions • Standard of care for 2L mTNBC1 an
Slide 16: Cell Therapy: Evolving Competitive Landscape
Cell Therapy: Evolving Competitive Landscape Product Sales ($M) $521 $486 $466 $480 $107 $485 >25K >500 $96 Patients treated to date ATCs Globally $100 $98 $98 • Flat YoY, reflecting strong growth outside of the U.S., offset by the U.S. • -7% QoQ, reflecting both in- and out-of-class competition in
Slide 17: Pipeline Updates
Pipeline Updates M e r d a d P a r s e y, M D , P h D Chief Medical Officer
Slide 18: Unprecedented Results with Lenacapavir for PrEP
Unprecedented Results with Lenacapavir for PrEP 4.0 4.0 Cisgender Women Cisgender Men & 3.5 3.5 Gender Diverse People Incidence of HIV Infection Incidence of HIV Infection 3.0 3.0 per 100 Person-Yr per 100 Person-Yr 2.41 2.37 2.5 2.5 2.02 2.0 2.0 1.69 1.5 100% 1.5 99.9% did not did not 0.93 1.0 have
Slide 19: Novel HIV Treatment Pipeline Gaining Momentum
Novel HIV Treatment Pipeline Gaining Momentum Rapidly Advancing Gilead’s Most Comprehensive HIV Treatment Pipeline Ever 7 • Combinations of CIs with Phase 2 Lencapavir + Islatravir Switch Trial Data bNAbs, INSTIs, or NRTTIs • QW orals, Q3M injectables LEN/ISL maintained viral suppression comparable
Slide 20: Developing Livdelzi To Reach More Patients Globally
Developing Livdelzi To Reach More Patients Globally Differentiated Selective PPARδ Agonist Expanding Livdelzi with Global Filings Rapid and sustained reduction FDA Accelerated Approval Lower ALP in mean ALP from baseline Based on Ph3 RESPONSE Trial Data (Published in NEJM) through 12 months European
Slide 21: Evolving Phase 3 Oncology Programs
Evolving Phase 3 Oncology Programs Phase 2 Data Support Ongoing Phase 3 Trodelvy and Dom/Zim Trials in 1L mNSCLC Trodelvy + Similar efficacy across histology in Ph2 EVOKE-021: 1L mNSCLC patients Totality of EVOKE-02 data Pembro + Cohorts A-D • SQ: 39% ORR & 8.3 months mPFS support ongoing EVOKE-03 t
Slide 22: ASH to Reinforce Kite's CAR T Leadership
ASH to Reinforce Kite’s CAR T Leadership Abstract 1031 Anito-cel Phase 2 iMMagine-1 18 Abstracts Accepted Including: 4L+ R/R MM (N=58) 10.3 months median follow-up (June 2024 cutoff) ZUMA-5: 5-Year follow- 95% Objective Response Rates (ORR) up in R/R iNHL 62% Complete Response (CR) ZUMA-2: Primary 9
Slide 23: Key 2024 Milestones
Key 2024 Milestones 1H24 Completed Completed (see footnote) Program Trial Indication Update Status Program Trial Indication Update Status LEN/ISL Oral NCT05052996 HIV LA VS Phase 2 update TROPiCS-04 2L mUC Phase 3 update1 Trodelvy ARTISTRY-1 HIV VS TE Phase 3 FPI EVOKE-02 1L mNSCLC Phase 2 update LE
Slide 24: Financial Results
Financial Results Andrew Dickinson Chief Financial Officer
Slide 25: Strong Growth Across Both Base & Total Business
Strong Growth Across Both Base & Total Business Product Sales ($M) Product Sales, excluding Veklury $7,515 $6,994 $7,070 $6,647 $6,912 +7% YoY +2% QoQ • YoY growth across HIV, Oncology, and Liver Disease • QoQ growth in HIV partially offset by Liver Disease and Oncology $6,823 $6,358 $6,350 $6,092 $
Slide 26: Q324 Illustrative GAAP EPS Bridge
Q324 Illustrative GAAP EPS Bridge $2.04 • With the discontinuation of the 2L+ NSCLC Trodelvy lung program, IPR&D indefinite- +$1.04 lived asset reduced by $1.8B ($1.04 per share net of tax) $1.00 • Remaining carrying value for Trodelvy IPR&D indefinite-lived is $1.8B, reflecting only the 1L NSCLC pr
Slide 27: Q324 Non-GAAP Data
Q324 Non-GAAP Data In millions, except percentages and per share amounts Q324 Q323 YoY Change Disciplined Expense Management COGS $995 $985 1% • 84 bps increase in gross margin primarily driven by product mix Product Gross Margin 87% 86% 84 bps R&D $1,382 $1,453 -5% • R&D down 5% primarily due to ti
Slide 28: Year-To-Date Non-GAAP Data
Year-To-Date Non-GAAP Data In millions, except percentages and per share amounts YTD 2024 YTD 2023 YoY Change COGS $2,933 $2,717 8% Product Sales, excl. Veklury, Up 7% YoY Product Gross Margin 86% 86% -24 bps • Growth in HIV (+5%), Oncology (+13%), and Liver Disease (+10%) R&D $4,120 $4,268 -3% Acqu
Slide 29: 2024 Guidance Improved Across Non-GAAP P&L
2024 Guidance Improved Across Non-GAAP P&L Aug 8, 2024 Nov 6, 2024 FY24 Sales Guidance Increased Total Product Sales $27.1B - $27.5B $27.8B - $28.1B • Product Sales ex-Veklury increased +$150M at midpoint and expected to grow 5-6% YoY (previously 4-6%) Product Sales ex-Veklury $25.8B - $26.2B $26.0B
Slide 30: Capital Priorities Unchanged: Returned $1.3B in Q3
Capital Priorities Unchanged: Returned $1.3B in Q3 Continue to invest in our business and R&D pipeline $983M while managing expenses Dividends Paid in Q324 Continue ordinary course partnerships and business development transactions $300M Grow our dividend Shares Repurchased in Q3241 3.9M shares at a
Slide 31: Q&A
Daniel O’Day Andrew Dickinson Q&A Chairman and Chief Financial Officer Chief Executive Officer Johanna Mercier Merdad Parsey, MD, PhD Cindy Perettie Chief Commercial Officer Chief Medical Officer Executive Vice President, Kite
Slide 32: Appendix
Creating Possible Appendix
Slide 33: Robust Pipeline with Upcoming Catalysts
Robust Pipeline with Upcoming Catalysts 50 Clinical stage programs1 13 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED sacituzumab govitecan-hziy sacituzumab govitecan-hziy dom + zim + chemo 1L mTNBC (PD-L1-) HR+/HER2- chemo-naïve mBC 1L mNSCLC sacituzumab goviteca
Slide 34: Oncology Cell Therapy Pipeline
New listing since Q2’24 Change since Q2’24 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’24 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicab
Slide 35: Oncology Pipeline 1/2
New listing since Q2’24 Change since Q2’24 Oncology Pipeline 1/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’24 Sacituzumab govitecan-hziy (ASCENT-03) 1L mTNBC (PD-L1-) Sacituzumab govitecan-hziy + pembrolizumab (ASC
Slide 36: Oncology Pipeline 2/2
New listing since Q2’24 Change since Q2’24 Oncology Pipeline 2/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’24 Domvanalimab + zimberelimab + chemotherapy (STAR-221)1 1L Upper GI ST intestinal Other Gastro- Etrumaden
Slide 37: Viral Diseases Pipeline
New listing since Q2’24 Change since Q2’24 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’24 Obeldesivir (OAKTREE) COVID-19 Removed from pipeline EV Lenacapavir (PURPOSE 1 & 2) HIV PrEP Lenacapav
Slide 38: Inflammatory Diseases Pipeline
Inflammatory Diseases Pipeline New listing since Q2’24 Breakthrough Therapy Designation Change since Q2’24 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’24 Livdelzi® (RESPONSE) PBC P NDA for AA approved Inflammatory Disease NDA for AA approved and MAA
Slide 39: GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA
GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA As of in billions where applicable Sep 30, 2023 Dec 31, 2023 Mar 31, 2024 Jun 30, 2024 Sep 30, 2024 Total Debt, net $24.98 $24.99 $25.19 $23.35 $23.25 Debt Discounts, Premiums and Issuance Costs 0.17 0.17 0.16 0.16 0.16