Slide 1: Q4 & FY23 Financial Results
Q4 & FY23 Financial Results February 6, 2024
Slide 2: Contents
Contents Q4 & FY23 Key Takeaways 4-6 Commercial Results 7-17 Pipeline Updates 18-24 Financial Results 25-31 Appendix 33-40
Slide 3: 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 4: Q4 & FY23 Key Takeaways
Q4 & FY23 Key Takeaways Daniel O’Day Chairman and Chief Executive Officer
Slide 5: Gilead Q423 & FY23 Call - Key Takeaways
Gilead Q423 & FY23 Call - Key Takeaways • FY23 Total Product Sales excl. Veklury +7% YoY to $24.7B, driven by HIV and Oncology • Total HIV +6% YoY, contributing ~$1B in FY23 sales growth driven by demand; Biktarvy +14% YoY Financial Results • Oncology +37% YoY to $2.9B driven by ongoing demand acros
Slide 6: Strong Clinical Execution on 2023 Milestones
Strong Clinical Execution on 2023 Milestones 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 ZUMA-24
Slide 7: Commercial Results & Market Dynamics
Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer
Slide 8: Strong Full Year Base Business Growth
Strong Full Year Base Business Growth $26.9B Total Product Sales flat YoY Veklury $24.7B Total Product Sales excluding Veklury +7% YoY $2.2B -44% YoY Trodelvy $1.1B HIV HIV Product Sales $18.2B +56% YoY $18.2B +6% YoY Cell Therapy +6% YoY $1.9B +28% YoY Liver Disease Oncology Product Sales $2.8B -1%
Slide 9: Consistent Base Business Performance in Q423
Consistent Base Business Performance in Q423 Total Product Sales $7.1B -4% YoY, +1% QoQ Veklury $6.3B Total Product Sales excluding Veklury flat YoY & QoQ $720M -28% YoY Trodelvy $299M HIV Product Sales $4.7B +53% YoY HIV Cell Therapy $4.7B -2% YoY, +1% QoQ $466M -2% YoY +11% YoY Liver Disease Oncol
Slide 10: HIV: Strong Full-Year Performance
HIV: Strong Full-Year Performance Product Sales ($M) FY23 Growth of 6% YoY $18,175 $16,315 $17,194 $1,155 $1,226 +$1B ~50% $1,121 $2,102 Sales growth of sales growth $2,219 YoY driven by demand $2,366 2-3% >16% Annual treatment Annual PrEP $14,848 $12,828 $13,820 market growth market growth • FY23 g
Slide 11: HIV: Demand Trends Strong & Unchanged
HIV: Demand Trends Strong & Unchanged Product Sales ($M) Q423 HIV Results $4,772 $4,693 $4,626 $4,667 $293 $4,190 $326 $341 $261 +1% -2% $566 $533 Sales growth YoY $298 $521 $519 QoQ $528 • YoY reflects strong demand offset by lower average realized price due to channel mix that was notably favorabl
Slide 12: Commanding Shares in Treatment & PrEP
Commanding Shares in Treatment & PrEP Sales Exceed $12B Annual Run-Rate Solid 2023 Demand Growth ~48% • Remains #1 regimen for new starts >40% • Descovy for PrEP maintaining share U.S. Market across all major markets U.S. Market despite new regimens, including Share Share generics • 22nd consecutive
Slide 13: Liver Disease: Stable HCV & HDV Demand & Share
Liver Disease: Stable HCV & HDV Demand & Share Product Sales ($M) Strong & Stable FY Sales Performance $711 $706 $694 $691 $675 $20 $2.8B ~10M $13 $19 $11 $22 $240 FY23 sales HCV patients treated $242 $219 $249 $238 with a Gilead regimen >60% >50% U.S. HCV Europe HCV market share market share $439 $
Slide 14: Veklury: Continued Leadership Against COVID-19
Veklury: Continued Leadership Against COVID-19 Product Sales ($M) Strong Utilization in Hospitalized Settings $1,000 >60% >14M U.S. hospitalized patients People treated with $462 $720 treated for COVID-191 remdesivir to date2 $636 $573 $175 $142 $209 $313 $2.2B $181 FY23 sales $111 $256 $65 $395 $10
Slide 15: Oncology Sales Exceed $3B Annual Run-Rate
Oncology Sales Exceed $3B Annual Run-Rate Product Sales ($M) On-Track to Contribute ~1/3 of 2030 Sales $769 $765 $2.9B $765M $728 $670 $614 FY23 Sales Sales in Q423 $283 $299 $260 $222 $195 +37% +24% FY23 YoY Growth Q423 YoY Growth $469 $486 $466 $419 $448 Q422 Q123 Q223 Q323 Q423 Cell Therapy Trode
Slide 16: Trodelvy: Strong Demand in Breast Cancer
Trodelvy: Strong Demand in Breast Cancer Product Sales ($M) Strong FY23 Growth of 56% YoY $299 $1.1B +6.5% $283 $24 $260 $21 $17 $48 FY23 sales U.S. demand $222 $62 growth QoQ $6 $53 $195 >30K #1 $4 $54 $44 Patients treated Regimen for to date 2L mTNBC1 $226 $189 $201 $162 $146 Q423 Sales: $299M; +5
Slide 17: Cell Therapy: Maintaining Global Leadership
Cell Therapy: Maintaining Global Leadership Product Sales ($M) Strong FY23 Growth of 28% YoY $486 $469 $466 $419 $448 $88 $96 $1.9B ~18K $98 FY23 sales Patients treated $89 $82 to date 14-day 96% Anticipated Yescarta median Reliability rate $380 $391 turnaround time in the U.S. $359 $368 $337 Q423 S
Slide 18: 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 19: EVOKE-01 Informs Path for 2L+ mNSCLC
EVOKE-01 Informs Path for 2L+ mNSCLC Phase 3 EVOKE-01 Results No Change to EVOKE-02 & EVOKE-03 Trials • Primary endpoint of OS vs. docetaxel was not met Continue to advance Trodelvy for 1L mNSCLC Phase 2 • Numerical improvement in OS with Trodelvy 2L+ 1L All-Comers 1L PD-L1 High across both non-squa
Slide 20: OAKTREE Highlights Shorter Symptom Duration
OAKTREE Highlights Shorter Symptom Duration • Phase 3 OAKTREE evaluating obeldesivir did not meet statistically significant symptom relief • Well-tolerated safety profile in large patient population • Data to be presented at future medical meeting Standard-Risk • Standard-risk1 population now shows
Slide 21: Advancing a Comprehensive HIV Pipeline
Advancing a Comprehensive HIV Pipeline 2023 2024 PrEP Ph3 PURPOSE-1/-2 Fully Enrolled Ph2 PURPOSE-5 FPI 1H24 Long-Acting Twice-Yearly PrEP Q6M SubQ Lenacapavir for PrEP Ph2 PURPOSE-3/-4 FPI’d Ph3 PURPOSE-1 Update 2H24 Launch in Late-2025 Ph2 ARTISTRY-1 Update at CROI24 Once-Daily Oral QD Oral Bicteg
Slide 22: Cell Therapy: Driving Future Growth
Cell Therapy: Driving Future Growth 8 Clinical trials 4 Line extensions 4 New indications 26 Abstracts accepted at ASH 20231 1L HR LBCL Phase 3 ZUMA-23 2L LBCL Outpatient • FDA approved OS data in 2L LBCL Phase 2 ZUMA-24 • Long-term, 5-year OS of 43% in 3L LBCL 2L+ HR FL Phase 3 ZUMA-22 Rare B-cell
Slide 23: Strong Clinical Execution on 2023 Milestones
Strong Clinical Execution on 2023 Milestones 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 ZUMA-24
Slide 24: Key Remaining 2024 Milestones
Key Remaining 2024 Milestones 1H24 Completed On Track Program Trial Indication Update Status Program Trial Indication Update Status TROPiCS-04 2L mUC Phase 3 update LEN/ISL oral NCT05052996 HIV LA VS Phase 2 update Trodelvy EVOKE-02 1L mNSCLC Phase 2 update ARTISTRY-1 HIV VS TE Phase 3 FPI Etrumaden
Slide 25: Financial Results
Financial Results Andrew Dickinson Chief Financial Officer
Slide 26: Base Business FY23 Performance
Base Business FY23 Performance Product Sales ($M) $26,982 $26,934 FY23 Product Sales excluding Veklury +7% YoY • Growth in HIV of 6% YoY, driven by Biktarvy Base Business +7% • Oncology up 37% YoY, driven by Cell Therapy and Trodelvy $23,077 $24,750 FY23 Total Product Sales flat YoY • Reflects ~$1.7
Slide 27: Full Year Non-GAAP Data
Full Year Non-GAAP Data YoY Product Sales excl. Veklury up 7% YoY 2022 FY 2023 FY Change In millions, except percentages and per share amounts • Growth in HIV and Oncology COGS $3,602 $3,697 3% • HIV up 6% YoY and Oncology up 37% YoY Product Gross Margin 87% 86% -38bps R&D $4,968 $5,720 15% Expense
Slide 28: Base Business Q423 Performance
Base Business Q423 Performance Product Sales ($M) Q423 Product Sales excl. Veklury Flat YoY $7,333 $7,070 • Higher Oncology sales (+24% YoY) driven by higher demand for Trodelvy (+53% YoY) and Cell Therapy (+11% YoY) Base Business • Lower HIV sales (-2% YoY) reflect strong demand flat offset by lowe
Slide 29: Q423 Non-GAAP Data
Q423 Non-GAAP Data YoY Product Sales excl. Veklury flat YoY Q422 Q423 In millions, except percentages and per share amounts Change • Higher Oncology sales, partially offset by COGS $968 $980 1% lower HIV sales Product Gross Margin 87% 86% -66bps R&D $1,544 $1,452 -6% Disciplined Expense Moderation A
Slide 30: 2024 Guidance
2024 Guidance Product Sales Guidance 6 Feb 2024 • FY24 Total Product Sales, excl. Veklury, expected to grow 4-6% Total Product Sales $27.1B - $27.5B compared to 2023 Product Sales ex-Veklury $25.8B - $26.2B • FY24 HIV sales expected to grow ~4% YoY Veklury Sales ~$1.3B • Q124 HIV sales expected to d
Slide 31: Capital Priorities Unchanged: Returned $4.8B in 2023
Capital Priorities Unchanged: Returned $4.8B in 2023 $3.8B Continue to invest in our business and R&D pipeline while managing expenses Dividends Paid in FY23 Continue ordinary course partnerships and business development transactions $1.0B Grow our dividend Shares Repurchased in FY231 Repurchase sha
Slide 32: 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 33: Appendix
Creating Possible Appendix
Slide 34: Robust Pipeline with Upcoming Catalysts
Robust Pipeline with Upcoming Catalysts 60 Clinical stage programs1 10 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Trodelvy® sacituzumab govitecan-hziy sacituzumab govitecan-hziy 2L mUC HR+/HER2- chemo-naïve mBC 1L mTNBC (PD-L1-) sacituzumab govitecan-hziy + pe
Slide 35: Oncology Cell Therapy Pipeline
New listing since Q3’23 Change since Q3’23 Oncology Cell Therapy Pipeline Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q3’23 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicabtagene ciloleucel (ZUMA-24) 2L LBCL Outpatient Cell T
Slide 36: Oncology Pipeline 1/2
New listing since Q3’23 Change since Q3’23 Oncology Pipeline 1/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q3’23 Sacituzumab govitecan-hziy (ASCENT-03) 1L mTNBC (PD-L1-) Sacituzumab govitecan-hziy + pembrolizumab (ASC
Slide 37: Oncology Pipeline 2/2
New listing since Q3’23 Change since Q3’23 Oncology Pipeline 2/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q3’23 Domvanalimab + zimberelimab + chemotherapy (STAR-221)1 1L Upper GI intestinal Gastro- Etrumadenant + zim
Slide 38: Viral Diseases Pipeline
New listing since Q3’23 Change since Q3’23 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q3’23 Obeldesivir (OAKTREE) COVID-19 EV Lenacapavir (PURPOSE 1 & 2) HIV PrEP PURPOSE 3 & 4 P2 FPI achieved L
Slide 39: Inflammatory Diseases Pipeline
Inflammatory Diseases Pipeline New listing since Q3’23 Breakthrough Therapy Designation Change since Q3’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q3’23 Edecesertib (COSMIC) Lupus Opt- Fib- Inflammatory Disease Tilpisertib fosmecarbil (PALEKONA) In
Slide 40: 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 Dec 31, 2022 Mar 31, 2023 Jun 30, 2023 Sep 30, 2023 Dec 31, 2023 Total Debt, net $25.23 $25.24 $25.25 $24.98 $24.99 Debt Discounts, Premiums and Issuance Costs 0.16 0.16 0.15 0.17 0.17