Slide 1: Q4 & FY22 Financial Results
Q4 & FY22 Financial Results February 2, 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 Q4 & FY22 Key Takeaways 4 Commercial Results 6-14 CMO Updates 15-23 Financial Results 24-29 Appendix 30-38
Slide 4: Gilead Q422 & FY22 Key Takeaways
Gilead Q422 & FY22 Key Takeaways • FY22 Total Product Sales, excl. Veklury, grew 8% YoY to $23.1B, or 11% excluding Fx & LOE impact • Strongest FY22 Base Business Growth Since 2015 Financial Results • FY22 Oncology sales grew 71% YoY to $2.1B, exceeding $2B for first time • FY22 Biktarvy sales grew
Slide 5: 2022 Focus: Select Key Catalysts Across Portfolio
2022 Focus: Select Key Catalysts Across Portfolio 1H22 2H22 Program Trial Indication Update Status Program Trial Indication Update Status Phase 3 topline TROPiCS-02 HR+/HER2- mBC sBLA submission TROPiCS-02 HR+/HER2- mBC Trodelvy readout EVOKE-03 1L NSCLC Phase 3 FPI 1H23 EVOKE-02 1L NSCLC Phase 2 FP
Slide 6: Commercial Results & Market Dynamics
Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer
Slide 7: Strong Commercial Growth in Q422
Strong Commercial Growth in Q422 Veklury HCV $439 +12% YoY $1.0B -26% YoY $4.8B HIV Product Sales Up 5% YoY, up 6% QoQ Trodelvy Total Product Sales excluding Veklury $195 +65% YoY HIV $6.3B Up 9% YoY, up 5% QoQ Cell Therapy $4.8B $419 +5% YoY +75% YoY HBV/HDV $7.3B Total Product Sales $255 -4% YoY U
Slide 8: HIV: Seasonal Dynamics & Demand Drive Growth
HIV: Seasonal Dynamics & Demand Drive Growth Product Sales ($M) Solid Q422 & FY22 Growth of +5% YoY $4,772 $4,538 $4,487 +15% YoY due to higher demand and $293 $4,228 $252 $285 $566 favorable pricing dynamics, offset by $590 $3,707 $282 lower channel inventory $541 $295 $562 $2.9B +6% QoQ due to hig
Slide 9: Biktarvy: Exceeded $10B in FY22 Sales
Biktarvy: Exceeded $10B in FY22 Sales U.S. Treatment TRx Share1 45% >45% BVY FY22 sales: $10.4B; +20% YoY 40% Q422 sales: $2.9B; +15% YoY, +6% QoQ 35% >3pp Share Gain vs. Q421 30% TRx Share >45% U.S. Market Share >3% U.S. Market Share 25% 20% Gain vs Q422 15% 10% FY22 HIV Treatment Market 9% New 5%
Slide 10: HCV: Maintaining >50% Share
HCV: Maintaining >50% Share Product Sales1 ($M) $524 $448 $98 $439 $393 $399 $91 $98 $85 $105 $143 $94 $80 $99 $95 • +12% YoY primarily due to timing of DOC purchases and favorable pricing dynamics in the U.S. $283 $263 $260 • -16% QoQ primarily due to resolution of a rebate claim in $209 $199 Europ
Slide 11: HBV / HDV: Vemlidy Dynamics Impact Q422
HBV / HDV: Vemlidy Dynamics Impact Q422 Product Sales1 ($M) $265 $264 $255 $235 $234 Q422 sales -4% YoY; -3% QoQ $115 $106 $103 $128 $104 Q422 sales -2% YoY; -3% QoQ • Primarily driven by lower demand and $28 $28 $28 unfavorable pricing dynamics outside the U.S. $30 $28 $122 $131 $124 Q422 sales of
Slide 12: Veklury: Continued Role Against COVID-19
Veklury: Continued Role Against COVID-19 Product Sales ($M) $1,535 $1,357 $430 $146 $334 $304 $925 $1,000 >50% ~13M U.S. hospitalized patients People treated $462 treated for COVID1 with remdesivir2 $458 $445 $142 • Continue to show antiviral activity against major variants $877 $801 $130 and subvar
Slide 13: Trodelvy: Solid Demand Continues
Trodelvy: Solid Demand Continues Product Sales ($M) $195 $180 $4 $146 $159 $3 $3 $38 $44 $195M 65% 8% $2 Sales in Q422 YoY Growth QoQ Growth $35 $118 $25 • Solid U.S. demand, up 13% QoQ $9 • Trodelvy for mTNBC now reimbursed across all major $146 European markets1 $139 $119 $120 $109 • FDA decision
Slide 14: Cell Therapy: LBCL Demand Fuels 75% YoY Growth
Cell Therapy: LBCL Demand Fuels 75% YoY Growth Product Sales ($M) $419 $398 $368 $82 Q422 sales grew 85% YoY; Up 6% QoQ $81 $73 • YoY growth driven by US 2L+ R/R LBCL launch execution and continued demand in 3L+ globally $274 • Received Japan MHLW approval in 2L LBCL in Dec 2022 $239 $63 $57 $337 $3
Slide 15: CMO Updates
CMO Updates M e r d a d P a r s e y, M D , P h D Chief Medical Officer
Slide 16: Lenacapavir: Foundation of HIV Long-Acting Portfolio
Lenacapavir: Foundation of HIV Long-Acting Portfolio 2022 Approved for Heavily Prevention Pivotal Trials: Multiple Studies Ongoing Treatment-Experienced PURPOSE-1 and PURPOSE-2 for Treatment ~1-2% of People Living with HIV • Lenacapavir under • 10 potential partner agents evaluation as monotherapy f
Slide 17: Birch and Oaktree Studies to Evaluate GS-5245
Birch and Oaktree Studies to Evaluate GS-5245 High-Risk Standard-Risk ~45% Diagnosed COVID patients 1 ~55% Diagnosed COVID patients 1 Phase 3 ex-U.S. Study (n=2,300) Phase 3 U.S. Study (n=1,900) • Placebo-controlled • Placebo-controlled • Enrolling non-hospitalized patients at • Plan to enroll non-h
Slide 18: Trodelvy Clinical Program Building Momentum
Trodelvy Clinical Program Building Momentum Jun 2022 Sep 2022 Q3 2022 Dec 2022 Jan 2023 Q1 2023 2023+ Positive Positive ASCENT-03 TROPiCS-02 HR+/HER2- ASCENT-05 Upcoming TROPiCS-02 TROPiCS-02 and -04 FPI Analysis at MAA FPI achieved Catalysts PFS Data OS Data SABCS validated Potential Approvals for
Slide 19: ARC-7: Dom Shows Potential to be Best-in-Class TIGIT
ARC-7: Dom Shows Potential to be Best-in-Class TIGIT Doublet and triplet showed clinically meaningful differentiation Potentially differentiated safety profile Potential for novel and differentiated IO combinations ARC-7 Interim Analysis 4 Ongoing Phase 3 Dom-Containing Trials Stage III NSCLC Gastri
Slide 20: Advancing and Investing in Magrolimab Programs
Advancing and Investing in Magrolimab Programs 8 Trials achieved FPI Advancing Hematological Studies in Pivotal Trials in 2021-22 Pivotal Trials Phase 2 6 Solid tumor indications in Ph 2 trials Trial 1L HR MDS ENHANCE 1L TP53m AML ENHANCE-2 1L Unfit AML ENHANCE-3 2 Stage Phase 3 Phase 3 Phase 3 Tria
Slide 21: Executing on Strong Cell Therapy Pipeline
Executing on Strong Cell Therapy Pipeline Key Updates: Continuing Investment in Existing and Next-Generation Assets Expanding into MM Early Research / Pre-IND Clinical Stage Pivotal Pediatric ALL 3L+ LBCL 2L+ HR FL LBCL LBCL HCC (ZUMA-4) (KITE-363) (ZUMA-22) ZUMA-23: 1L HR LBCL 2L LBCL OPT AML 1L HR
Slide 22: 2023 Focus: Select Key Catalysts Across Portfolio
2023 Focus: Select Key Catalysts Across Portfolio 1H23 Program Trial Indication Update Status Program Trial Indication Update Status TROPiCS-02 HR+/HER2- mBC sBLA decision Domvanalimab ARC-7 1L NSCLC Phase 2 update Trodelvy EVOKE-03 1L NSCLC Phase 3 FPI GS-5245 OAKTREE COVID-19 standard risk Phase 3
Slide 23: Financial Results
Financial Results Andrew Dickinson Chief Financial Officer
Slide 24: Q422 Strong Underlying Growth of 12% YoY
Q422 Strong Underlying Growth of 12% YoY 12% ~$50M Contribution ~$130M to 12% Growth 9% Contribution All Other to 9% Growth 8% All Other 50% HIV 42% 11% 44% HIV Oncology 44% Oncology Q422 Product Sales FX Impact HIV LOEs Q422 Product Sales Historical YoY Growth YoY Growth YoY Growth Q3 ’22 +15% (ex.
Slide 25: Solid Fourth Quarter Results
Solid Fourth Quarter Results Product Sales excl. Veklury up 9% YoY YoY Q421 Q422 • Growth in HIV and Oncology Non-GAAP1; in millions, except percentages and per share amounts Change • Excl. impact of LOEs2, and FX, Product Product Sales $7,160 $7,333 2% Sales excluding Veklury was up 12% YoY Veklury
Slide 26: FY22 Strong Underlying Growth of 11% YoY
FY22 Strong Underlying Growth of 11% YoY 11% ~$350M ~$385M 8% Contribution to 11% Growth Contribution to Oncology 8% Growth 36% 64% HIV Oncology 50% 50% HIV FY22 Product Sales FX Impact HIV LOEs FY22 Product Sales YoY Growth YoY Growth Historical YoY Growth (ex. Veklury) (ex. Veklury, FX & HIV LOE)
Slide 27: Solid Full Year Results
Solid Full Year Results YoY Product Sales excl. Veklury up 8% YoY 2021 FY 2022 FY Change • Growth in HIV, Oncology & HBV/HDV Non-GAAP1; in millions, except percentages and per share amounts Product Sales $27,008 $26,982 - • Excl. impact of LOEs2, and FX, FY Product Sales excl. Veklury were up 11% Yo
Slide 28: 2023 Guidance
2023 Guidance Product Sales Guidance • FY23 Total Product Sales, excluding Veklury, expected 2 February 2023 to grow 4 to 6% compared to 2022 Total Product Sales $26.0B - $26.5B • FY23 Veklury Sales expected to be ~$2B, expected to track hospitalization rates and remain highly variable Product Sales
Slide 29: Capital Priorities Unchanged: Returned $5B+ in 2022
Capital Priorities Unchanged: Returned $5B+ in 2022 $3.7B Continue to invest in our business and R&D pipeline Dividends Paid in FY22 while managing expenses Continue ordinary course partnerships and business $1.5B development transactions Debt Repaid in FY22 Grow our dividend $1.4B Repurchase shares
Slide 30: Q&A
Daniel O’Day Andrew Dickinson Johanna Mercier Chairman and Chief Financial Officer Chief Commercial Officer Chief Executive Officer Q&A Merdad Parsey, MD, PhD Christi Shaw Chief Medical Officer Chief Executive Officer Kite Confidential – Internal Use Only
Slide 31: Appendix
Creating Possible Appendix
Slide 32: Robust Pipeline with Upcoming Catalysts
Robust Pipeline with Upcoming Catalysts 59 Clinical stage programs1 13 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED sacituzumab govitecan-hziy + quemli + zim magrolimab combinations Trodelvy® sacituzumab govitecan-hziy + magrolimab + aza pembro 1L NSCLC mPDAC mC
Slide 33: Oncology Cell Therapy Pipeline
New listing since Q3’22 Change since Q3’22 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation Planned program P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q3’22 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23)1 1L HR LBCL Axicabtagene cilo
Slide 34: Oncology Pipeline 1/2
New listing since Q3’22 Change since Q3’22 Oncology Pipeline 1/2 Breakthrough Therapy Designation Planned program P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q3’22 Sacituzumab govitecan-hziy (TROPiCS-02) HR+/HER2- mBC sBLA & MAA Filed MAA filed Sacituzumab govitecan-hziy (ASCENT-
Slide 35: Oncology Pipeline 2/2
New listing since Q3’22 Change since Q3’22 Oncology Pipeline 2/2 Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q3’22 Sacituzumab govitecan-hziy (TROPiCS-03) Basket (Solid Tumors) Other Solid Tumors Magrolimab + chemotherapy/IO combinations HNSCC Mag
Slide 36: Viral Diseases Pipeline
New listing since Q3’22 Change since Q3’22 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q3’22 Novel oral COVID-19 nucleoside (BIRCH) COVID-19 P1 → P3 EV Sunlenca® (CAPELLA) HIV LA HTE NDA and MAA Approved FDA approval grante
Slide 37: Inflammatory Diseases Pipeline
New listing since Q3’22 Change since Q3’22 Inflammatory Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q3’22 TPL2 inhibitor (GS-5290) Inflammatory Bowel Disease Inflammatory Disease IRAK4 inhibitor (GS-5718) Inflammatory Bowel Disea
Slide 38: GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA
GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA in billions where applicable Dec 31, 2021 Mar 31, 2022 Jun 30, 2022 Sep 30, 2022 Dec 31, 2022 Total Debt, net $26.70 $26.21 $26.22 $25.22 $25.23 Debt Discounts, Premiums and Issuance Costs 0.18 0.17 0.17 0.17 0.16 Liabi