Gilead Sciences, Inc. · NASDAQ:GILD
Gilead Sciences — Q1 2024 Earnings Presentation
38 slides from Gilead Sciences's earnings presentation, Apr 25, 2024
Slide 1: Q124 Financial Results
Q124 Financial Results April 25, 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 Q124 Key Takeaways 4-6 Commercial Results 7-15 Pipeline Updates 16-21 Financial Results 22-29 Appendix 31-38
Slide 4: Q124 Key Takeaways
Q124 Key Takeaways Daniel O’Day Chairman and Chief Executive Officer
Slide 5: Gilead Q124 Key Takeaways
Gilead Q124 Key Takeaways • Total Product Sales excl. Veklury +6% YoY to $6.1B, driven by HIV, Oncology and Liver Disease • HIV +4% YoY driven by demand, QoQ decline reflects seasonality; Oncology +18% YoY driven by demand Financial Results • CymaBay acquired IPR&D of $3.9B lowers diluted EPS by $3.
Slide 6: Key 2024 Milestones
Key 2024 Milestones 1H24 Completed On Track 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 update Trodelvy ARTISTRY-1 HIV VS TE Phase 3 FPI EVOKE-02 1L mNSCLC Phase 2 update LEN/BIC Oral ARTIST
Slide 7: Commercial Results & Market Dynamics
Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer
Slide 8: Strong YoY Commercial Performance in Q124
Strong YoY Commercial Performance in Q124 Total Product Sales $6.6B +5% YoY, -6% QoQ Veklury $555M $6.1B Total Product Sales excluding Veklury +6% YoY, -4% QoQ -3% YoY Trodelvy $309M +39% YoY HIV Product Sales Cell Therapy $480M +7% YoY HIV $4.3B +4% YoY $4.3B +4% YoY, -7% QoQ Liver Disease $737M On
Slide 9: HIV: Robust Underlying Demand
HIV: Robust Underlying Demand Product Sales ($M) $4,626 $4,667 $4,693 $261 $4,342 +4% $341 -7% $4,190 $326 $533 $342 $298 $521 $519 $596 Sales growth Sales growth $528 YoY QoQ • YoY growth primarily driven by higher demand, as well as favorable pricing dynamics in Europe that are not expected to rep
Slide 10: Leading Market Share in HIV Treatment & PrEP
Leading Market Share in HIV Treatment & PrEP Q124 sales: $2.9B; +10% YoY, -5% QoQ Q124 sales: $426M; -5% YoY, -16% QoQ ~49% • Remains #1 regimen for new starts across all major markets >40% • Descovy for PrEP maintaining share despite other regimens, including generics U.S. Market U.S. Market Share
Slide 11: Liver Disease: Solid Demand & Utilization
Liver Disease: Solid Demand & Utilization Product Sales ($M) $737 $711 $706 $691 $27 $675 $11 $20 $19 $22 >60% >50% $243 U.S. HCV Europe HCV $240 $249 market share market share $219 $238 • +9% YoY primarily driven by favorable inventory dynamics, timing of DOC purchases and higher demand, partially
Slide 12: Veklury: Leadership in Hospitalized Settings
Veklury: Leadership in Hospitalized Settings Product Sales ($M) $720 $573 $636 $175 >60% >14M $555 U.S. hospitalized patients People treated with treated for COVID-191 remdesivir to date2 $209 $313 $169 $181 • -3% YoY and -23% QoQ reflecting lower COVID-19 $70 related hospitalizations $111 $256 $65
Slide 13: Oncology Sales: Extending Reach to New Patients
Oncology Sales: Extending Reach to New Patients Product Sales ($M) $789 $769 $765 +18% +3% $728 $670 $283 $309 Sales growth Sales growth $260 $299 YoY QoQ $222 >50K ~50 Patients treated Countries approved $469 $486 $466 $480 $448 Q123 Q223 Q323 Q423 Q124 Cell Therapy Trodelvy 13 Note: YoY reflects Q
Slide 14: Trodelvy: Strong Share in Breast Cancer
Trodelvy: Strong Share in Breast Cancer Product Sales ($M) $309 $299 $283 $260 $21 $24 $36 >30K #1 $17 $48 Patients treated Regimen for $222 $68 $62 across tumor types 2L mTNBC1 $6 $53 $54 • +39% YoY primarily driven by higher demand across the U.S., Europe, and other markets $226 • +3% QoQ primaril
Slide 15: Cell Therapy: Driving Global Leadership
Cell Therapy: Driving Global Leadership Product Sales ($M) $486 $480 $469 $466 $448 $88 $96 $100 >21K 14-day $98 $89 Patients treated Yescarta median U.S. to date turnaround time • Strong demand for both Yescarta and Tecartus outside the U.S., partially offset by U.S. dynamics for Yescarta $359 $380
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: CROI Data Highlight Momentum of HIV Pipeline
CROI Data Highlight Momentum of HIV Pipeline ~80 Virology Abstracts at CROI 2024 2 Late-Breaking HIV Oral Presentations 13 Clinical Programs in HIV Lenacapavir + Lenacapavir + GS-1720 + Lenacapavir bictegravir (STR) islatravir (STR) capsid inhibitor (STR) + bNAbs Once-daily oral First QW INSTI-based
Slide 18: Trodelvy: Expanding Potential to Reach More Patients
Trodelvy: Expanding Potential to Reach More Patients Breast Bladder Lung Endometrial ASCENT-03 TROPiCS-04 EVOKE-01 ASCENT-GYN-01 1L PD-L1- mTNBC 2L+ mUC 2L+ mNSCLC 2L+ mEC Trodelvy Trodelvy Trodelvy Trodelvy Update in 2H24 Update in 1H24 ASCO Late-Breaker FPI 2H24 5 Potential Tumor ASCENT-04 TROPHY-
Slide 19: Expanding Our Leadership in Cell Therapy
Expanding Our Leadership in Cell Therapy Anito-cel K-Gen 1 Mono-CAR Approved in Accelerated Accelerated Approved Ph1 ARC-101 Earlier Line MM Ph3 FPI Example: Yescarta, R/R DLBCL Approval in R/R MCL Approval in R/R FL in R/R ALL Update Ph2 iMMagine-1 Update Tecartus, anito-cel Oct 2017 Jul 2020 Mar 2
Slide 20: Advancing Inflammation Pipeline
Advancing Inflammation Pipeline Key Updates: Suite of Oral Small Molecules in Inflammation Phase 1 Phase 2 or Phase 3 Registrational Seladelpar’s NDA/MAA Filings Accepted Hepatology Cilo/Fir/Sema Seladelpar (Ph2 WAYFIND) PDUFA Q324 NASH PBC GS-1427 Phase 2 SWIFT FPI Gastroenterology GS-5290 (Ph2 PAL
Slide 21: Key 2024 Milestones
Key 2024 Milestones 1H24 Completed On Track 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 update Trodelvy ARTISTRY-1 HIV VS TE Phase 3 FPI EVOKE-02 1L mNSCLC Phase 2 update LEN/BIC Oral ARTIST
Slide 22: Financial Results
Financial Results Andrew Dickinson Chief Financial Officer
Slide 23: Continued Base Business Traction
Continued Base Business Traction Product Sales excluding Veklury $6,994 $7,070 $6,564 $6,647 $6,306 +6% YoY -4% QoQ • HIV increased 4% YoY with Biktarvy up 10% YoY • Higher Oncology sales (+18% YoY) driven by higher $6,358 $6,350 $6,092 demand for Trodelvy (+39% YoY) and Cell Therapy (+7% YoY) $5,73
Slide 24: Q124 GAAP & Non-GAAP EPS Bridges
Q124 GAAP & Non-GAAP EPS Bridges Non-GAAP1 EPS Bridge GAAP EPS Bridge $1.82 $1.26 $1.46 $3.14 -$3.14 $3.14 $(1.32) $(3.34) Q124 CymaBay Q124 Q124 CymaBay IPR&D Q124 Actual Acquisition ($3.9B) Illustrative Actual Acquisition Impairment Illustrative ($3.9B) ($2.4B) 1 Non-GAAP financial information gen
Slide 25: Q124 Non-GAAP Data
Q124 Non-GAAP Data Q124 Q123 YoY Change In millions, except percentages and per share amounts Higher Acquired IPR&D COGS $974 $871 12% Product Gross Margin 85% 86% -83 bps • $3.9B related to CymaBay acquisition R&D $1,403 $1,439 -2% • ~$200M related to Arcus, Merus, Xilio Acquired IPR&D $4,131 $481
Slide 26: 2024 Guidance
2024 Guidance No Change to FY24 Revenue Guidance February 6, 2024 April 25, 2024 • Continue to expect FY24 Total Product Sales, excl. Veklury, to grow in 4-6% range vs FY23 Total Product Sales $27.1B - $27.5B No Change • Continue to expect FY24 HIV sales to grow ~4% YoY Product Sales ex-Veklury $25.
Slide 27: FY24 Non-GAAP EPS Guidance Bridge
FY24 Non-GAAP EPS Guidance Bridge $7.25 (top end) ~$0.05 ~$7.09 $7.05 (midpoint) ~$0.25 $3.14 $6.85 ~$0.10 (bottom end) $3.85 (top end) $3.65 (midpoint) $3.45 (bottom end) April CymaBay CymaBay-Related Other Q124 Illustrative February Guidance Acquisition Expenses1 Acquired IPR&D2 Guidance Range Gui
Slide 28: Capital Priorities Unchanged: Returned ~$1.4B in Q1
Capital Priorities Unchanged: Returned ~$1.4B in Q1 $990M Dividends Paid in Q124 Continue to invest in our business and R&D pipeline while managing expenses +2.7% Continue ordinary course partnerships and business development transactions Dividend Increase Grow our dividend $400M Repurchase shares t
Slide 29: Completed Acquisition of CymaBay
Completed Acquisition of CymaBay Acquisition closed in March Acquired IPR&D impact of $3.9B ($3.14 per share) reflected in Q124 results and 2024 guidance Additional ~$0.25 impact to EPS reflected in 2024 guidance Due to incremental operating expenses and other P&L items Expect FDA approval of selade
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 54 Clinical stage programs1 10 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Trodelvy® sacituzumab govitecan-hziy dom + zim + chemo 2L mUC HR+/HER2- chemo-naïve mBC 1L mNSCLC sacituzumab govitecan-hziy sacituzumab govitecan
Slide 33: Oncology Cell Therapy Pipeline
New listing since Q4’23 Change since Q4’23 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q4’23 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicab
Slide 34: Oncology Pipeline 1/2
New listing since Q4’23 Change since Q4’23 Oncology Pipeline 1/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q4’23 Sacituzumab govitecan-hziy (ASCENT-03) 1L mTNBC (PD-L1-) Sacituzumab govitecan-hziy + pembrolizumab (ASC
Slide 35: Oncology Pipeline 2/2
New listing since Q4’23 Change since Q4’23 Oncology Pipeline 2/2 Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q4’23 Domvanalimab + zimberelimab + chemotherapy (STAR-221)1 1L Upper GI intestinal Gastro- Etrumadenant + zim
Slide 36: Viral Diseases Pipeline
New listing since Q4’23 Change since Q4’23 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q4’23 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 Q4’23 Breakthrough Therapy Designation Change since Q4’23 P PRIME Designation Clinical Program Indication Phase 1 Phase 2 Phase 3 Filed Updates since Q4’23 Seladelpar (RESPONSE) PBC P CymaBay acquisition Inflammatory Disease NDA and MAA submitted Edec
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 As of in billions where applicable Mar 31, 2023 Jun 30, 2023 Sep 30, 2023 Dec 31, 2023 Mar 31, 2024 Total Debt, net $25.24 $25.25 $24.98 $24.99 $25.19 Debt Discounts, Premiums and Issuance Costs 0.16 0.15 0.17 0.17 $0.1