Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q2 2023 Earnings Presentation

39 slides from Gilead Sciences's earnings presentation, Aug 3, 2023

  1. Slide 1: Q223 Financial Results

    Q223 Financial Results August 3, 2023

  2. 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

  3. Slide 3: Contents

    Contents Q223 Key Takeaways 4 Commercial Results 6-14 CMO Updates 15-23 Financial Results 24-30 Appendix 32-39

  4. Slide 4: Gilead Q223 Key Takeaways

    Gilead Q223 Key Takeaways • Total Product Sales, excl. Veklury, +11% YoY to $6.3B, driven by Virology & Oncology • Increased FY23 base business guidance by $550M at midpoint, more than offsets lower Veklury Financial Results • Total HIV +9% YoY due to favorable pricing and higher demand, with Biktar

  5. Slide 5: 2023 Focus: Select Key Catalysts Across Portfolio

    2023 Focus: Select Key Catalysts Across Portfolio 1H23 Completed On Track New Since Last Update 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

  6. Slide 6: Commercial Results & Market Dynamics

    Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer

  7. Slide 7: Strong Q223 Performance Across Base Business

    Strong Q223 Performance Across Base Business $4.6B HIV Product Sales +9% YoY, +10% QoQ $728M Oncology Product Sales Veklury $256M -43% YoY +38% YoY, +9% QoQ Trodelvy $260M +63% YoY HIV Cell Therapy Total Product Sales excluding Veklury $6.3B $4,626M $469M +9% YoY +27% YoY +11% YoY, +10% QoQ Liver Di

  8. Slide 8: HIV: Strong Growth Continues

    HIV: Strong Growth Continues Product Sales ($M) $4,772 $4,487 $293 $4,626 Strong Q223 Growth of 9% YoY & 10% QoQ $4,228 $4,190 $326 $285 $566 $282 $541 $298 $521 • YoY due to favorable pricing dynamics and higher $562 $528 demand, partially offset by lower channel inventory • QoQ due to favorable pr

  9. Slide 9: Delivering Double-Digit Growth in Tx & PrEP

    Delivering Double-Digit Growth in Tx & PrEP Q223 sales: $3.0B; +17% YoY, +11% QoQ Q223 sales: $516M; +12% YoY, +15% QoQ >46% ~3% >40% +14% U.S. Treatment U.S. Market Share U.S. PrEP U.S. Descovy for PrEP Market Share Gain YoY Market Share Demand Growth YoY YoY due to higher demand and favorable pric

  10. Slide 10: Liver Disease: Maintaining Solid Performance

    Liver Disease: Maintaining Solid Performance Product Sales ($M) $788 $12 $711 $682 $694 $675 $20 $14 $13 $11 $251 $220 $242 $240 $219 Q223 sales +4% YoY; +5% QoQ $524 • YoY & QoQ primarily due to higher demand, partially offset $448 $439 $445 $452 by pricing dynamics • Hepcludex granted full marketi

  11. Slide 11: Veklury: Providing More Tx Options for COVID-19

    Veklury: Providing More Tx Options for COVID-19 Product Sales ($M) $1,000 $925 $462 $458 >50% >13M $573 U.S. hospitalized patients People treated with $445 treated for COVID1 remdesivir to date2 $142 $209 $130 $278 $111 $256 • Received U.S. FDA and European Commission approvals $395 $107 to extend i

  12. Slide 12: Rapidly Growing Oncology Portfolio

    Rapidly Growing Oncology Portfolio Product Sales ($M) $728 $670 $614 $578 $260 $1.4B +48% $527 $222 $195 $180 $159 Sales in 1H23 1H23 YoY Growth • Approaching annualized ~$3B run-rate $448 $469 $398 $419 $368 • Oncology portfolio on-track to meet goal of contributing ~1/3 Gilead product revenue by 2

  13. Slide 13: Trodelvy: Solid Momentum in Breast Cancer

    Trodelvy: Solid Momentum in Breast Cancer Product Sales ($M) $260 $17 $222 $6 $53 $195 $180 $3 $4 $54 $260M +63% +17% $159 $44 $3 $38 Sales in Q223 YoY Growth QoQ Growth $35 $189 • U.S. demand +16% QoQ, primarily driven by launch $162 in pre-treated HR+/HER2- mBC $139 $146 $120 • Maintaining strong

  14. Slide 14: Cell Therapy: Continued Demand Growth

    Cell Therapy: Continued Demand Growth Product Sales ($M) $469 $448 $419 $398 $88 $368 $89 Q223 sales +29% YoY; +6% QoQ $82 $81 • YoY growth driven by higher demand across 2L and 3L $73 R/R large B-cell lymphoma $359 $380 $317 $337 $295 Q223 sales +21% YoY; flat QoQ • YoY growth driven by higher dema

  15. 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

  16. Slide 16: Broadest Long-Acting and Daily Oral HIV Portfolio

    Broadest Long-Acting and Daily Oral HIV Portfolio Pre-IND Phase 1 Phase 2 Phase 3 On Market Lenacapavir + Lenacapavir + Bictegravir + Lenacapavir1 Lenacapavir2 GS-1614 (NRTI) GS-6212 (INSTI) Q3M INJECTION Q3M INJECTION DAILY ORAL Q6M INJECTION DAILY ORAL Treatment Treatment Treatment Prevention Lena

  17. Slide 17: Showcasing Leadership in Viral Liver Diseases

    Showcasing Leadership in Viral Liver Diseases New 96W Data at EASL & New EASL Guidelines on HDV1 48W Data Published in NEJM2 • 48W data demonstrate reduced HDV RNA • Recommends all HBsAg+ patients and ALT after bulevirtide treatment3 should be screened for HDV • 96W data3 support ongoing bulevirtide

  18. Slide 18: Trodelvy is the Only Approved TROP2-Directed ADC

    Trodelvy is the Only Approved TROP2-Directed ADC Cornerstone of Gilead’s Solid Tumor Program with Pan-Tumor Potential Pre-treated Post-platinum/ Advanced endometrial HR+/HER2- mBC IO mUC2 cancer TROPiCS-02 Final OS TROPHY-U-01 Analysis TROPiCS-03 Analysis • 3.3 mo mOS benefit1 • TROP2 highly express

  19. Slide 19: Comprehensive Clinical Program Across NSCLC

    Comprehensive Clinical Program Across NSCLC Innovative Pipeline Could Bring New Options to >300,0001 NSCLC Patients Trodelvy Backbone TIGIT-PD1 Backbone Exploratory Combinations Ph2 VELOCITY-Lung Stage IV Ph2 TROPiCS-03 T Post-IO Ph2 ELEVATE-Lung 2L Ph3 EVOKE-01 T Ph2 EVOKE-02 T K Ph2 VELOCITY-Lung

  20. Slide 20: Next Lung Pipeline Update at World Lung

    Next Lung Pipeline Update at World Lung Building Momentum With First Trodelvy Data Expected Later This Year 2023 2024 2025+ Phase 3 EVOKE-01 Stage IV Update 2L+ Phase 2 ELEVATE Lung & UC NSCLC Update Phase 2 VELOCITY Lung Substudy 2 Update Phase 2 ARC-7 Phase 3 EVOKE-03 Stage IV IA5 Data: ASCO 2023

  21. Slide 21: Solid Dom Data Ahead of Pivotal Updates in 2025+

    Solid Dom Data Ahead of Pivotal Updates in 2025+ ARC-7 Established Dom Proof-of-Concept in NSCLC Updated ARC-7 IA5 Data at ASCO 2023 Analysis of Full Trial Population: (N=150) • 33% reduction of risk in progression or death with addition of Dom to Zim vs. Zim alone • Potentially differentiated safet

  22. Slide 22: ASCO Data Reinforce Yescarta LBCL Positioning

    ASCO Data Reinforce Yescarta LBCL Positioning First Treatment in Nearly 30 Years to Demonstrate Significant Survival Improvement HR 0.726 • Only LBCL cell therapy product to demonstrate (95% CI, 0.540-0.977); one-sided P=0.0168 clinically significant OS vs. SoC • Median follow-up 4 years Yescarta –

  23. Slide 23: 2023 Focus: Select Key Catalysts Across Portfolio

    2023 Focus: Select Key Catalysts Across Portfolio 1H23 Completed On Track New Since Last Update 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

  24. Slide 24: Financial Results

    Financial Results Andrew Dickinson Chief Financial Officer

  25. Slide 25: Strong Q223 Base Business Drives YoY Growth

    Strong Q223 Base Business Drives YoY Growth Product Sales ($M) $6,564 $6,138 Total Product Sales +7% YoY • Strong performance across base business, partially offset by a decline in Veklury sales due to lower hospitalizations • Excluding FX impact of $82M, Total Product Sales +8% YoY $5,693 $6,308 Pr

  26. Slide 26: Q223 Non-GAAP Data

    Q223 Non-GAAP Data YoY Operating Expenses Q222 Q223 In millions, except percentages and per share amounts Change • Higher R&D primarily driven by continued clinical COGS 886 861 -3% activities, including the acceleration of certain Product Gross Margin 86% 87% 131bps late-stage trials R&D 1,102 1,37

  27. Slide 27: 1H23 Non-GAAP Data

    1H23 Non-GAAP Data YoY Total Product Sales up 2% YoY 1H 2022 1H 2023 Change In millions, except percentages and per share amounts • Excluding Veklury, Total Product Sales up 13% YoY, primarily driven by strong growth across HIV, Cell COGS 1,711 1,732 1% Therapy and Trodelvy Product Gross Margin 87%

  28. Slide 28: 2023 Guidance Update

    2023 Guidance Update 2 February 2023 27 April 2023 3 August 2023 Base Business & Total Product Sales Total Product Sales $26.0B - $26.5B - $26.3B - $26.7B Guidance Raised Product Sales ex- $24.0B - $24.5B - $24.6B - $25.0B • Base business growth of 6.5% to 8% YoY, up from 4% to 6%, Veklury reflectin

  29. Slide 29: FY23 Non-GAAP EPS Guidance Bridge

    FY23 Non-GAAP EPS Guidance Bridge $7.00 ~$0.33 (top end) $6.80 (top end) $6.80 (midpoint) $0.17 $6.63 (midpoint) $0.32 $6.60 (bottom end) $6.45 (bottom end) Higher Total Product Sales, Lower Tax Rate 29

  30. Slide 30: Capital Priorities Unchanged: Returned ~$1.1B in Q2

    Capital Priorities Unchanged: Returned ~$1.1B in Q2 $944M Continue to invest in our business and R&D pipeline while managing expenses Dividends Paid in Q223 Continue ordinary course partnerships and business development transactions $150M Grow our dividend Shares Repurchased in Q223 Repurchase share

  31. 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

  32. Slide 32: Appendix

    Creating Possible Appendix

  33. Slide 33: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts 64 Clinical stage programs1 11 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Trodelvy® sacituzumab govitecan-hziy magrolimab + aza 2L mUC 2-3L mNSCLC 1L HR MDS Trodelvy® sacituzumab govitecan-hziy + pembro magrolimab + vene

  34. Slide 34: Oncology Cell Therapy Pipeline

    New listing since Q1’23 Change since Q1’23 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q1’23 Axicabtagene ciloleucel (ZUMA-22) 2L+ HR FL Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicabtagene ciloleucel (ZUMA-24)

  35. Slide 35: Oncology Pipeline 1/2

    New listing since Q1’23 Change since Q1’23 Oncology Pipeline 1/2 Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q1’23 Trodelvy® (TROPiCS-02) HR+/HER2- mBC sBLA Approved & MAA Filed Sacituzumab govitecan-hziy (ASCENT-03) 1L mTNBC (PD-L1-) Sacituzumab

  36. Slide 36: Oncology Pipeline 2/2

    New listing since Q1’23 Change since Q1’23 Oncology Pipeline 2/2 Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q1’23 Domvanalimab + zimberelimab + chemotherapy (STAR-221)2 1L Upper GI intestinal Gastro- Etrumadenant + zimberelimab combinations (ARC-

  37. Slide 37: Viral Diseases Pipeline

    New listing since Q1’23 Change since Q1’23 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q1’23 Obeldesivir (BIRCH, OAKTREE) COVID-19 EV Lenacapavir (PURPOSE 1 & 2) HIV PrEP Lenacapavir/bictegravir oral combination (ARTISTRY-1

  38. Slide 38: Inflammatory Diseases Pipeline

    New listing since Q1’23 Change since Q1’23 Inflammatory Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q1’23 Edecesertib (COSMIC) Lupus P1  P2 Opt- Fib- Inflammatory Disease Tilpisertib fosmecarbil Inflammatory Bowel Disease α4β7 i

  39. 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 in billions where applicable Jun 30, 2022 Sep 30, 2022 Dec 31, 2022 Mar 31, 2023 Jun 30, 2023 Total Debt, net $26.22 $25.22 $25.23 $25.24 $25.25 Debt Discounts, Premiums and Issuance Costs 0.17 0.17 0.16 0.16 0.15 Liabi

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