Slide 1: Q323 Financial Results
Q323 Financial Results November 7, 2023
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 Q323 Key Takeaways 4-6 Commercial Results 7-15 Pipeline Updates 16-22 Financial Results 23-29 Appendix 31-38
Slide 4: Q323 Key Takeaways
Q323 Key Takeaways Daniel O’Day Chairman and Chief Executive Officer
Slide 5: Gilead Q323 Key Takeaways
Gilead Q323 Key Takeaways • Q323 Total Product Sales excl. Veklury +5% YoY to $6.36B • Total HIV +4% YoY due to higher demand & inventory, offset by price; Biktarvy +12% YoY to $3.09B Financial Results • Oncology +33% YoY to $769M driven by ongoing demand across Trodelvy and Cell Therapy • YTD Total
Slide 6: 2023 Focus: Select Key Catalysts Across Portfolio
2023 Focus: Select Key Catalysts Across Portfolio 1H23 Completed Completed, not progressing On Track Program Trial Indication Update Status Program Trial Indication Update Status TROPiCS-02 HR+/HER2- mBC sBLA decision ZUMA-23 1L HR LBCL Phase 3 FPI Yescarta Trodelvy EVOKE-03 1L mNSCLC Phase 3 FPI ZU
Slide 7: Commercial Results & Market Dynamics
Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer
Slide 8: Solid Q323 Base Business Performance
Solid Q323 Base Business Performance Total Product Sales $7.0B Flat YoY, 7% QoQ $6.4B Total Product Sales excluding Veklury Veklury $636M -31% YoY 5% YoY, 1% QoQ Trodelvy $283M 58% YoY HIV HIV Product Sales $4.7B Cell Therapy $4.67B $486M 4% YoY 22% YoY 4% YoY, 1% QoQ Liver Disease $706M -10% YoY On
Slide 9: HIV: Solid Growth Across PrEP & Treatment
HIV: Solid Growth Across PrEP & Treatment Product Sales ($M) $4,772 $4,487 $293 $4,626 $4,667 Q323 Growth of 4% YoY & 1% QoQ $4,190 $326 $341 $285 $566 $519 $541 $298 $521 • YoY primarily driven by higher demand and channel $528 inventory, partially offset by lower average realized price due to chan
Slide 10: Leading Market Shares Across Treatment & PrEP
Leading Market Shares Across Treatment & PrEP Q323 sales: $3.1B; +12% YoY, +4% QoQ Q323 sales: $511M; +2% YoY, -1% QoQ >47% >2% >40% +15% U.S. Treatment U.S. Market Share U.S. PrEP U.S. PrEP Market Market Share Gain YoY Market Share Growth YoY YoY due to higher demand as well as higher channel YoY d
Slide 11: Liver Disease: Steady Growth in HCV New Starts
Liver Disease: Steady Growth in HCV New Starts Product Sales ($M) $788 $12 $711 $706 $694 $675 $20 $13 $19 $11 $251 $242 $240 $249 $219 Q323 sales -10% YoY; -1% QoQ $524 • YoY primarily due to a favorable resolution of a rebate $439 $445 $452 $438 claim in Europe in Q322 as well as other pricing dyn
Slide 12: Veklury: Established Role in COVID-19 Treatment
Veklury: Established Role in COVID-19 Treatment Product Sales ($M) $1,000 $925 $462 $458 $573 $636 >50% >13M U.S. hospitalized patients People treated with $142 $209 $313 treated for COVID1 remdesivir to date2 $130 $111 $256 $65 • Received U.S. FDA and EC approval to extend indication for $395 $107
Slide 13: Accelerating Oncology Business
Accelerating Oncology Business Product Sales ($M) $769 $728 $670 $614 $578 $283 $260 $195 $222 $769M +33% $180 Sales in Q323 Q323 YoY Growth $486 • Annual run-rate exceeds $3B $448 $469 $398 $419 • Oncology portfolio on-track to meet goal of contributing ~1/3 Gilead product revenue by 2030 Q322 Q422
Slide 14: Trodelvy: Continued Strength in Breast Cancer
Trodelvy: Continued Strength in Breast Cancer Product Sales ($M) $283 $260 $21 $17 $222 $62 $6 +58% +9% $53 $180 $195 $4 $54 $283M $3 $44 Sales in Q323 YoY Growth QoQ Growth $38 • YoY and QoQ primarily driven by increased uptake $201 $189 in pre-treated HR+/HER2- mBC $162 $139 $146 • Strong awarenes
Slide 15: Cell Therapy: Expanding Demand Globally
Cell Therapy: Expanding Demand Globally Product Sales ($M) $486 $469 $448 $419 $96 $398 $89 $88 Q323 sales +23% YoY; +3% QoQ $82 $81 • YoY growth driven by strong underlying demand in R/R large B-cell lymphoma outside of the U.S. $380 $391 $337 $359 $317 Q323 sales +18% YoY; +8% QoQ • YoY growth dri
Slide 16: 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 17: Industry Leading HIV Clinical Development Portfolio
Industry Leading HIV Clinical Development Portfolio Pre-IND Phase 1 Phase 2 Phase 3 Lenacapavir + Lenacapavir + Lenacapavir + Lenacapavir GS-1219 (INSTI) GS-6212 (INSTI) Islatravir (NRTI) Lenacapavir2 Q6M INJECTION Q3M INJECTION WEEKLY ORAL Q6M INJECTION Treatment Treatment Treatment Prevention 10 C
Slide 18: Trodelvy is First and Only Approved TROP2 ADC
Trodelvy is First and Only Approved TROP2 ADC >30 Active or Planned Clinical Trials by YE2023 Solid Foundation in Pan-Tumor Multiple Tumor Types Opportunities Encouraging Early Results Across: >20K Patients Treated ~50 Countries Head and Neck Small Cell Cancer Lung Cancer • Clinically meaningful mOS
Slide 19: Promising Responses Seen in 1L mNSCLC
Promising Responses Seen in 1L mNSCLC Established Proof-of-Concept in 1L PD-L1 High mNSCLC Best overall response Percent change from baseline – target lesions • Phase 2 EVOKE-02 demonstrated antitumor 100 Partial response (n = 18) activity of Trodelvy plus pembrolizumab across 80 Stable disease (n =
Slide 20: EDGE-Gastric Provides PoC for Phase 3 STAR-221
EDGE-Gastric Provides PoC for Phase 3 STAR-221 Dom + zim + FOLFOX shows encouraging ORR & 6-month PFS in 1L metastatic upper GI cancers PD-L1 High PD-L1 Low Overall (TAP≥5%) (TAP<5%) n=41 n=15 n=24 ORR1 59% 80% 46% Complete response1 7% 7% 4% Partial response1 51% 73% 42% 6-Month PFS Rate 77% 93% 68
Slide 21: Cell Therapy: Driving Future Growth
Cell Therapy: Driving Future Growth 8 Clinical trials 4 Line extensions & 4 New indications Next-Generation Programs • Autologous and allogeneic LoT Extensions New Indications • Across HD, iPSC, iNKT and NK 1L HR LBCL constructs Phase 3 ZUMA-23 2L LBCL Outpatient • Manufacturing innovations Phase 2
Slide 22: 2023 Focus: Select Key Catalysts Across Portfolio
2023 Focus: Select Key Catalysts Across Portfolio 1H23 Completed Completed, not progressing On Track Program Trial Indication Update Status Program Trial Indication Update Status TROPiCS-02 HR+/HER2- mBC sBLA decision ZUMA-23 1L HR LBCL Phase 3 FPI Yescarta Trodelvy EVOKE-03 1L mNSCLC Phase 3 FPI ZU
Slide 23: Financial Results
Financial Results Andrew Dickinson Chief Financial Officer
Slide 24: Solid Base Business Growth
Solid Base Business Growth Product Sales ($M) $6,978 $6,994 Product Sales excluding Veklury +5% YoY • Strong growth across HIV, Trodelvy and Cell Therapy +5% $6,053 $6,358 Total Product Sales flat YoY • Strong performance across base business, offset by a decrease in Veklury sales due to lower hospi
Slide 25: Q323 Non-GAAP Data
Q323 Non-GAAP Data YoY Product Sales excl. Veklury up 5% YoY Q322 Q323 In millions, except percentages and per share amounts Change • Growth in Oncology and HIV, offset by lower COGS 923 985 7% HCV sales Product Gross Margin 87% 86% -85bps R&D 1,173 1,453 24% Higher Operating Expenses Acquired IPR&D
Slide 26: Strong Non-GAAP Results Year-to-Date
Strong Non-GAAP Results Year-to-Date YoY Product Sales excl. Veklury up 10% YoY 2022 YTD 2023 YTD Change In millions, except percentages and per share amounts • Growth in HIV, Cell Therapy and Trodelvy COGS 2,634 2,717 3% • HIV up 9% YoY and Oncology up 42% YoY Product Gross Margin 87% 86% -27bps R&
Slide 27: 2023 Guidance Update
2023 Guidance Update 2 Feb 2023 27 Apr 2023 3 Aug 2023 7 Nov 2023 Base Business & Total Product Total Product Sales $26.0B - $26.5B No change $26.3B - $26.7B $26.7B - $26.9B Sales Guidance Raised Product Sales ex- • Base business growth of 7% to 8% YoY, $24.0B - $24.5B No change $24.6B - $25.0B $24.
Slide 28: FY23 Non-GAAP EPS Guidance Bridge
FY23 Non-GAAP EPS Guidance Bridge $6.80 ~$0.05 $6.85 ~$0.07 (top end) (top end) ~$0.10 $6.75 (midpoint) ~$0.20 $6.63 (midpoint) $6.65 (bottom end) $6.45 (bottom end) August guidance Higher Total Product Sales Lower Tax Rate Acquired IPR&D R&D Expenses (including Updated guidance Magro wind-down cost
Slide 29: Capital Priorities Unchanged: Returned ~$1.3B in Q3
Capital Priorities Unchanged: Returned ~$1.3B in Q3 $953M Continue to invest in our business and R&D pipeline while managing expenses Dividends Paid in Q323 Continue ordinary course partnerships and business development transactions $300M Grow our dividend Shares Repurchased in Q3231 Repurchase shar
Slide 30: 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 31: Appendix
Creating Possible Appendix
Slide 32: Robust Pipeline with Upcoming Catalysts
Robust Pipeline with Upcoming Catalysts 60 Clinical stage programs1 8 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Trodelvy® Trodelvy® sacituzumab govitecan-hziy 2L mUC HR+/HER2- mBC HR+/HER2- chemo-naïve mBC sacituzumab govitecan-hziy sacituzumab govitecan-hziy
Slide 33: Oncology Cell Therapy Pipeline
Oncology Cell Therapy Pipeline New listing since Q2’23 Breakthrough Therapy Designation Change since Q2’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’23 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicab
Slide 34: Oncology Pipeline 1/2
Oncology Pipeline 1/2 New listing since Q2’23 Breakthrough Therapy Designation Change since Q2’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’23 Trodelvy® (TROPiCS-02) HR+/HER2- mBC sBLA & MAA Approved MAA approved Sacituzumab govitecan-hziy (ASCENT
Slide 35: Oncology Pipeline 2/2
Oncology Pipeline 2/2 New listing since Q2’23 Breakthrough Therapy Designation Change since Q2’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’23 Domvanalimab + zimberelimab + chemotherapy (STAR-221)1 1L Upper GI intestinal Gastro- Etrumadenant + zim
Slide 36: Viral Diseases Pipeline
Viral Diseases Pipeline New listing since Q2’23 Breakthrough Therapy Designation Change since Q2’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’23 Obeldesivir (OAKTREE) COVID-19 EV Lenacapavir (PURPOSE 1 & 2) HIV PrEP Lenacapavir/bictegravir oral co
Slide 37: Inflammatory Diseases Pipeline
Inflammatory Diseases Pipeline New listing since Q2’23 Breakthrough Therapy Designation Change since Q2’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q2’23 Edecesertib (COSMIC) Lupus Opt- Fib- Inflammatory Disease Tilpisertib fosmecarbil Inflammatory
Slide 38: GAAP to Non-GAAP Reconciliation of Adjusted Debt and Adjusted EBITDA
GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA in billions where applicable Sep 30, 2022 Dec 31, 2022 Mar 31, 2023 Jun 30, 2023 Sep 30, 2023 Total Debt, net $25.22 $25.23 $25.24 $25.25 $24.98 Debt Discounts, Premiums and Issuance Costs 0.17 0.16 0.16 0.15 $0.17 Liab