Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q1 2022 Earnings Presentation

35 slides from Gilead Sciences's earnings presentation, Apr 28, 2022

  1. Slide 1: Q122 Financial Results

    Q122 Financial Results April 28, 2022

  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 Q122 Key Takeaways 4-5 Commercial Results 6-14 CMO Updates 15-22 Financial Results 23-26 Appendix 28-35

  4. Slide 4: Gilead Q122 Key Takeaways

    Gilead Q122 Key Takeaways • Total Product Sales of $6.5B grew 3% YoY • Total HIV grew 2% YoY, or 5% excluding LOEs; Biktarvy grew 18% YoY to $2.2B Financial Results • Strong Qtr for Oncology: Cell Therapy up 43% YoY to $274M; Trodelvy up 103% YoY to $146M • Strong Veklury performance, up 5% YoY to $

  5. 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 TROPiCS-02 HR+/HER2- mBC Potential sBLA/MAA sub. TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout Trodelvy EVOKE-03 1L NSCLC Phase 3 FPI Magrolimab ENHANCE-3 1L U

  6. Slide 6: Commercial Results & Market Dynamics

    Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer

  7. Slide 7: Commercial Revenue Highlights Q122

    Commercial Revenue Highlights Q122 Veklury $1,535 $3.7B HIV Product Sales Up 2% YoY, down 18% QoQ +5% YoY HCV $399 Trodelvy $5.0B -22% YoY $146 HIV Total Product Sales excluding Veklury $3,707 +103% YoY +2% YoY Up 2% YoY, down 14% QoQ Cell Therapy $274 +43% YoY HBV/HDV $6.5B Total Product Sales $235

  8. Slide 8: HIV: Strong Biktarvy Growth Despite Inventory Dynamics

    HIV: Strong Biktarvy Growth Despite Inventory Dynamics Product Sales ($M) Excluding Truvada & Atripla LOE Impact, $4,538 Q122 HIV Revenue +5% YoY $4,189 $252 $3,938 $285 $3,650 $590 $3,707 +18% YoY due to market share $298 $286 $602 $295 gains and market growth $596 $578 $550 $2.2B -15% QoQ driven b

  9. Slide 9: Biktarvy: Leading and Growing in Market Share

    Biktarvy: Leading and Growing in Market Share U.S. Treatment TRx Share1 HIV Treatment Market 45% 43% BVY • Still below pre-pandemic levels 40% • US Market +3% YoY; ex-U.S. flat YoY 35% ~5% Share Gain vs. Q121 30% TRx Share 25% 20% 15% 43% U.S. Market Share ~8x U.S. Market Share vs Nearest Competitor

  10. Slide 10: HCV: Stable Market Share

    HCV: Stable Market Share Product Sales1 ($M) $549 $510 $129 $117 $429 $393 $399 $93 $111 $85 $105 $135 $94 $99 $95 Sales -22% YoY; +2% QoQ $327 • YoY change driven by unfavorable pricing dynamics $258 $224 $209 $199 • QoQ change reflects unfavorable seasonal inventory dynamics and pricing more than

  11. Slide 11: HBV / HDV: Leveraging Commercial Footprint

    HBV / HDV: Leveraging Commercial Footprint Product Sales1 ($M) $265 $237 $247 $235 Sales +10% YoY; -11% QoQ $220 • YoY growth driven by ex-U.S. demand $115 • QoQ decline due to seasonal inventory and pricing $114 $123 dynamics in the U.S. partially offset by ex-U.S. growth $128 $116 $28 $29 $24 $23

  12. Slide 12: Veklury: Mix Shifts to ex-U.S. in Q122

    Veklury: Mix Shifts to ex-U.S. in Q122 Product Sales ($M) $1,923 ~50% Updated World Health Organization $287 US Hospitalized Guidelines now conditionally $1,535 $1,456 $109 Patients Treated recommend Veklury for patients $1,357 with Veklury1 with non-severe COVID-19 at highest $248 $430 $146 risk of

  13. Slide 13: Trodelvy: Strong Start to 2022

    Trodelvy: Strong Start to 2022 Product Sales ($M) $146 $2 $25 $118 $101 $9 $146M • Strong Q122 European sales $1 Sales in Q122 $89 • U.S. sales force at scale in Q222 $72 103% $119 • 2L mTNBC approved in the U.S., EU, $109 YoY Growth $100 Great Britain, Switzerland, Australia & Canada 24% • 2L mUC a

  14. Slide 14: Cell Therapy: Strong Q1 Momentum with 43% YoY Growth

    Cell Therapy: Strong Q1 Momentum with 43% YoY Growth Product Sales ($M) $274 $239 $63 Sales grew 32% YoY; Up 16% QoQ $222 $219 $57 • YoY growth driven by continued demand in LBCL and $191 $41 $47 expansion into FL $31 • Approved by FDA for 2L r/r LBCL in April 2022 $211 $178 $175 $182 $160 Sales gre

  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: Lenacapavir: Robust Virologic Suppression in Multi-Drug Resistance

    Lenacapavir: Robust Virologic Suppression for Persons with Multi-Drug Resistance in Phase 2/3 Trial Efficacy in Randomized Cohort (n=36) 100% 50 c/mL 200 c/mL HTE PLWH with limited treatment 90% 83% 86% Week 52 80% options due to multi-drug resistance 70% Participants, % • 52-Week data presented at

  17. Slide 17: Building Long-Acting Portfolio Around Lenacapavir

    Building Long-Acting Portfolio Around Lenacapavir Reverse Transcription Integration Islatravir1 LA Bictegravir Virus Entry NRTI | Phase 2 Lenacapavir INSTI | Phase 1 Maturation Class: CAI GS-5894 GS-6212 GS-2872 + GS-5423 Phase: 2-3, NDA GS-1156 NNRTI | Phase 1 INSTI | Pre-IND bNAb | Phase 1b PI | D

  18. Slide 18: Continuing Investment in COVID-19

    Continuing Investment in COVID-19 GS-5245 New Approvals & Recommendations Phase 1 Underway FDA sNDA approval1 for younger pediatric patients • Trial of investigational oral COVID-19 WHO Conditional Recommendation for Patients nucleoside with non-severe COVID-19 at risk of hospitalization • Possible

  19. Slide 19: Sacituzumab Govitecan (Trodelvy) Pipeline

    Sacituzumab Govitecan (Trodelvy®) Pipeline Strategic Imperative Phase 1 Phase 2 Phase 3 Expand Global TROPHY Cohort 1 ASCENT Approvals for Primary Indications ASCENT-J02 TROPiCS-04 ASCENT-03 Advance to Earlier Lines of Therapy TROPHY EVOKE-02 Multicohort Lung Platform Study Study Trodelvy Morpheus T

  20. Slide 20: ZUMA-7: Shifting the Paradigm in 2L R/R LBCL

    ZUMA-7: Shifting the Paradigm in 2L R/R LBCL First 2L LBCL treatment to improve upon SOC in nearly 30 years • First and largest Phase 3 CAR T RCT in LBCL; the only primary analysis with the longest Median EFS (95% CI), mo 24-mo EFS Rate (95% CI), % follow up of 2yrs Axi-cel (N=180) 8.3 (4.5-15.8) 40

  21. Slide 21: Partial Clinical Holds for Magro MDS & AML Trials Lifted

    Partial Clinical Holds for Magro MDS & AML Trials Lifted Hematology Trials Solid Tumor Trials Indication Stage Update Magrolimab Indication Stage Update 1L HR MDS Enrollment has resumed 1L Head and Ph 3 Ph 2 FPI completed in Q321 (ENHANCE) Interim Early 2023 Neck 1L TP53mt AML Enrollment has resumed

  22. Slide 22: 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 TROPiCS-02 HR+/HER2- mBC Potential sBLA/MAA sub. TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout Trodelvy EVOKE-03 1L NSCLC Phase 3 FPI Magrolimab ENHANCE-3 1L U

  23. Slide 23: Financial Results

    Financial Results Andrew Dickinson Chief Financial Officer

  24. Slide 24: Strong First Quarter Results

    Strong First Quarter Results YoY Q121 Q122 Non-GAAP1; in millions, except percentages and per share amounts Change Product Sales $6,340 $6,534 3% Veklury 1,456 1,535 5% Product Sales +3% YoY Product Sales excluding Veklury $4,884 $4,998 2% • Driven by growth in cell therapy, Veklury, Trodelvy & HIV,

  25. Slide 25: 2022 Guidance

    2022 Guidance Provided on Feb 1, 2022 Updated on Apr 28, 2022 Revenue Guidance Total Product Sales $23.8B - $24.3B No change • No change: Total Product Sales, excluding Veklury expected to grow 2-4% YoY Product Sales ex-Veklury $21.8B - $22.3B No change • Continue to monitor Veklury performance to V

  26. Slide 26: No Change to Capital Allocation Priorities

    No Change to Capital Allocation Priorities $945M Continue to invest in our business and R&D pipeline Dividend Paid in Q122 while managing expenses $0.73 per share Grow our dividend and pay down debt $352M Repurchase shares to offset dilution and Q122 Share Repurchase opportunistically reduce share c

  27. Slide 27: 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

  28. Slide 28: Appendix

    Creating Possible Appendix

  29. Slide 29: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts 53 Clinical stage programs1 12 Potential clinical stage opt-in assets PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Trodelvy® 1

  30. Slide 30: Oncology Pipeline (1/2)

    New listing since Q4’21 Change since Q4’21 Oncology Pipeline (1/2) Breakthrough Therapy Designation P PRIME Designation Planned program Phase 1 Phase 2 Phase 3 Filed Updates since Q4’21 AA based on Trodelvy® (TROPiCS-04) 2L mUC Phase 1b2 Sacituzumab govitecan-hziy (TROPiCS-02) HR+/HER2- mBC Primary

  31. Slide 31: Oncology Pipeline (2/2)

    New listing since Q4’21 Change since Q4’21 Oncology Pipeline (2/2) Breakthrough Therapy Designation P PRIME Designation Planned program Phase 1 Phase 2 Phase 3 Filed Updates since Q4’21 Magrolimab anti-CD47 (GS-4721) TNBC Magrolimab anti-CD47 (GS-4721)1 mCRC New Zim vs. zim + dom vs. zim + dom + etr

  32. Slide 32: Oncology Cell Therapy Pipeline

    New listing since Q4’21 Change since Q4’21 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation P PRIME Designation Planned program Phase 1 Phase 2 Phase 3 Filed Updates since Q4’21 Yescarta® (ZUMA-5) 3L+ FL sBLA Approved; Type II Filed Tecartus® (ZUMA-3) R/R Adult ALL sBLA Approved; Type

  33. Slide 33: Viral Diseases Pipeline

    New listing since Q4’21 Change since Q4’21 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q4’21 Oral CoV prodrug (GS-5245) COVID-19 EV Lenacapavir capsid inhibitor (CAPELLA)1 HIV LA HTE NDA and MAA Filed Lenacapavir capsid inh

  34. Slide 34: Inflammatory Diseases Pipeline

    New listing since Q4’21 Change since Q4’21 Inflammatory Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q4’21 Filgotinib JAK-1 inhibitor (GS-6034)1 Crohn’s Disease Inflammatory Disease TPL2 inhibitor (GS-5290) Inflammatory Bowel Dise

  35. Slide 35: 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 Mar 31, 2021 Jun 30, 2021 Sep 30, 2021 Dec 31, 2021 Mar 31, 2022 Total Debt, net $30.17 $30.18 $27.69 $26.70 $26.21 Debt Discounts, Premiums and Issuance Costs 0.20 0.19 0.19 0.18 0.17 Liabi

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