Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q3 2022 Earnings Presentation

38 slides from Gilead Sciences's earnings presentation, Oct 27, 2022

  1. Slide 1: Q322 Financial Results

    Q322 Financial Results October 27, 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 Q322 Key Takeaways 4 Commercial Results 6-14 CMO Updates 15-23 Financial Results 24-29 Appendix 30-38

  4. Slide 4: Gilead Q322 Key Takeaways

    Gilead Q322 Key Takeaways • Total Product Sales, excluding Veklury, grew 11% YoY to $6.1B • Total HIV grew 7% YoY reflecting channel mix and demand; Biktarvy grew 22% YoY to $2.8B Financial Results • Oncology grew 10% QoQ and 79% YoY with strong contributions from Trodelvy and cell therapy • Increas

  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 sBLA submission TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout Trodelvy EVOKE-03 1L NSCLC Phase 3 FPI Magrolimab ENHANCE-3 1L Unfit AML

  6. Slide 6: Commercial Results & Market Dynamics

    Commercial Results & Market Dynamics Johanna Mercier Chief Commercial Officer

  7. Slide 7: Strong Commercial Growth in Q322

    Strong Commercial Growth in Q322 Veklury $4.5B $925 -52% YoY HIV Product Sales Up 7% YoY, up 6% QoQ HCV $524 +22% YoY Trodelvy $6.1B Total Product Sales excluding Veklury HIV $180 $4,487 +78% YoY +7% YoY Up 11% YoY, up 6% QoQ Cell Therapy $398 +79% YoY HBV/HDV $7.0B Total Product Sales $264 +7% YoY

  8. Slide 8: HIV: Channel Mix & Demand Drive Growth

    HIV: Channel Mix & Demand Drive Growth Product Sales ($M) Excluding FX and Truvada & Atripla LOE Impact, $4,538 $4,487 Q322 HIV Revenue +10% YoY $4,189 $252 $4,228 $285 $285 $282 $590 $3,707 $541 +22% YoY due to higher demand in U.S. $602 $295 $562 & Europe as well as favorable pricing dynamics $550

  9. Slide 9: Biktarvy: Leadership Continues

    Biktarvy: Leadership Continues U.S. Treatment TRx Share1 45% 40% 45% BVY Q322 sales: $2.8B; +22% YoY; +8% QoQ 35% 4pp Share Gain vs. 30% Q3’21 45% U.S. Market Share TRx Share 25% 20% ~4% U.S. Market Share Gain vs Q321 15% 10% HIV Treatment Market 5% 8% New Entrants 0% +2% Growth in U.S. & EU Market

  10. Slide 10: HCV: Maintaining Stable Market Share

    HCV: Maintaining Stable Market Share Product Sales1 ($M) $524 $448 $98 $429 $393 $399 $91 $111 $85 $105 $143 $94 $94 $99 $95 Q322 sales +22% YoY; +17% QoQ $283 • Primarily due to a resolution of a prior year rebate claim in $263 $224 $209 Europe and other favorable pricing dynamics in the U.S. $199

  11. Slide 11: HBV / HDV: Strong US Performance

    HBV / HDV: Strong US Performance Product Sales1 ($M) $265 $264 Q322 sales +7% YoY; +13% QoQ $247 $235 $234 • Driven by favorable inventory dynamics $115 $106 $114 $128 $104 Q322 sales +10% YoY; +17% QoQ • Driven by U.S. seasonal inventory build, $28 $28 demand and pricing favorability $29 $30 $28 $1

  12. Slide 12: Veklury: Omicron Variant Drives Sequential Growth

    Veklury: Omicron Variant Drives Sequential Growth Product Sales ($M) $1,923 $287 $1,535 $109 $1,357 $430 $146 • Updated WHO Guidelines conditionally recommend Veklury for Severe COVID $334 $925 $304 • EMA CHMP Positive Opinion for use in pediatric patients $1,527 $458 • Continue to show antiviral ac

  13. Slide 13: Trodelvy: Solid Demand Continues in 2L+ mTNBC

    Trodelvy: Solid Demand Continues in 2L+ mTNBC Product Sales ($M) $180 $3 $159 $146 $3 $38 $2 $118 $25 $35 $180M 78% 13% $101 $9 Sales in Q322 YoY Growth QoQ Growth $1 • Reimbursement secured in 12 countries outside $139 the U.S., with additional expected shortly $119 $120 $109 $100 • sBLA for pre-tr

  14. Slide 14: Cell Therapy: Strong 79% YoY Sales Growth

    Cell Therapy: Strong 79% YoY Sales Growth Product Sales ($M) $398 $368 $81 $73 Q322 sales grew 81% YoY; Up 8% QoQ $274 • YoY growth driven by continued R/R LBCL demand and geographic/Authorized Treatment Center expansion $239 $222 $63 • Received MAA in 2L LBCL in October 2022 $57 $47 $317 $295 $211

  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: 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 sBLA submission TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout Trodelvy EVOKE-03 1L NSCLC Phase 3 FPI Magrolimab ENHANCE-3 1L Unfit AML

  17. Slide 17: Gilead's First Long-Acting SubQ Approved in EU

    Gilead’s First Long-Acting SubQ Approved in EU European Commission Approval for Adults Living with MDR1 Approval in 30 European countries Additional regulatory filings anticipated FDA Decision Expected on December 27, 2022 FDA accepted NDA resubmission in July 2022 Plan to Resume Phase 2 Islatravir/

  18. Slide 18: Committed to Continued Efforts in COVID-19

    Committed to Continued Efforts in COVID-19 Advancing Oral Program Positive CHMP Opinion GS-5245 • Veklury in Pediatric Patients Investigational, Oral Nucleoside Antiviral • Phase 3 study expected to start in the next several months Updated WHO Guidelines • Conditionally recommends Veklury for • Gran

  19. Slide 19: Trodelvy Demonstrated OS Benefit in TROPiCS-02

    Trodelvy Demonstrated OS Benefit in TROPiCS-02 • TROPiCS-02 met primary and key secondary SG (n=272) TPC (n=271) endpoints despite heavily pre-treated HR+/HER2- Number of events 191 199 population: Median OS, mo (95% CI) 14.4 (13.0–15.7) 11.2 (10.1–12.7) Stratified HR (95% CI) 0.79 (0.65–0.96)  Med

  20. Slide 20: Comprehensive Lung Clinical Program

    Comprehensive Lung Clinical Program PD-L1 PD-L1 PD-L1 Addressable TPS≥50% TPS 1-49% negative Population* 9 Ongoing NSCLC Trials By Year End Stage III unresectable PACIFIC-8 ~28K ARC-7 ARC-10 EVOKE-02 – B* Clinical Trials With EVOKE-02 – A* 5 Trodelvy, Including New VELOCITY Program 1L EVOKE-03** ~19

  21. Slide 21: Cell Therapy Pipeline Spans Life Cycle Management and Next-Generation Technologies

    Cell Therapy Pipeline Spans Life Cycle Management and Next-Generation Technologies Life Cycle Innovative Diversified Management Early Pipeline Allogeneic Pipeline Later Earlier Therapy Lines Therapy Lines • CD19/20 Bicistronic • Targeting Post-CD19 2L Approved KITE-363 3L+ LBCL Healthy Donor CAR T L

  22. Slide 22: Near and Long-Term Opportunities in MDS and AML

    Near and Long-Term Opportunities in MDS and AML 1 2 3 Magrolimab Trials KITE-222 Progressing Collaboration CLL-1 Targeted CAR-T • Phase 3 ENHANCE: • Exclusive option to • FDA granted orphan drug Update in early 2023 license MGD024, a Phase 1 designation to KITE-222 in CD123xCD3 DART AML • Phase 3 EN

  23. Slide 23: MiroBio Acquisition Bolsters Inflammatory Pipeline

    MiroBio Acquisition Bolsters Inflammatory Pipeline GS-0272 Lead Asset • Novel selective BTLA agonist, targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response • Founded in 2018 • Ongoing Phase 1 trial • 40 employees in Oxford, UK • Scientific appro

  24. Slide 24: Financial Results

    Financial Results Andrew Dickinson Chief Financial Officer

  25. Slide 25: Q322 Strong Underlying Growth of 15% YoY

    Q322 Strong Underlying Growth of 15% YoY 15% ~$55M ~$130M 11% HIV +8% HIV +5% Oncology +5% Oncology +5% All Other +2% All Other +1% Q322 Product Sales Growth FX Headwind HIV LOEs Q322 Product Sales Growth (ex. Veklury) (ex. Veklury) (ex. Veklury, FX & HIV LOE) 25 Note: HIV, Oncology and All Other pe

  26. Slide 26: Solid Third Quarter Results

    Solid Third Quarter Results Q321 Q322 YoY Product Sales excl. Veklury up 11% YoY Non-GAAP1; in millions, except percentages and per share amounts Change • Growth in all core therapeutic areas Product Sales $7,356 $6,978 -5% Veklury 1,923 • Excl. impact of LOEs2, and FX, Product 925 -52% Sales exclud

  27. Slide 27: Strong Year-to-Date Results

    Strong Year-to-Date Results 2021 YTD 2022 YTD YoY Product Sales excl. Veklury up 7% YoY Change Non-GAAP1; in millions, except percentages and per share amounts • Growth in HIV, Cell Therapy & Trodelvy Product Sales $19,848 $19,650 -1% Veklury 4,208 2,905 -31% • Excl. impact of LOEs2, and FX, YTD Pro

  28. Slide 28: 2022 Guidance

    2022 Guidance Provided on Updated on Updated on Updated on Feb 1, 2022 Apr 28, 2022 Aug 2, 2022 Oct 27, 2022 Product Sales Guidance Total Product Sales $23.8B - $24.3B No change $24.5B - $25.0B $25.9B - $26.2B • Total Product Sales, excluding Product Sales ex-Veklury $21.8B - $22.3B No change $22.0B

  29. Slide 29: No Change to Capital Allocation Priorities

    No Change to Capital Allocation Priorities $928M Continue to invest in our business and R&D pipeline Dividend Paid in Q322 while managing expenses $0.73 per share Continue ordinary course partnerships & business development transactions $1.5B FY22 Debt Repayment Target Achieved Grow our dividend $50

  30. 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

  31. Slide 31: Appendix

    Creating Possible Appendix

  32. Slide 32: 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 magrolimab + chemo/IO sacituzumab govitecan-hziy + etruma + zim combinations2 magrolimab + aza Trodelvy® Tecartus® combinations HNSCC pembro 1L NS

  33. Slide 33: Oncology Cell Therapy Pipeline

    New listing since Q2’22 Change since Q2’22 Oncology Cell Therapy Pipeline Breakthrough Therapy Designation Planned program P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q2’22 Tecartus® (ZUMA-3) R/R Adult ALL sBLA Approved; Type II Approved Type II variation approved Yescarta® (ZUMA

  34. Slide 34: Oncology Pipeline (1/2)

    New listing since Q2’22 Change since Q2’22 Oncology Pipeline (1/2) Breakthrough Therapy Designation Planned program P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q2’22 Sacituzumab govitecan-hziy (TROPiCS-02) HR+/HER2- mBC sBLA Filed sBLA filed AA based on Trodelvy® (TROPiCS-04) 2L

  35. Slide 35: Oncology Pipeline (2/2)

    New listing since Q2’22 Change since Q2’22 Oncology Pipeline (2/2) Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q2’22 Magrolimab + chemotherapy/SG combinations TNBC Magrolimab combinations mCRC P2 FPI achieved Domvanalimab + zimberelimab + etrumade

  36. Slide 36: Viral Diseases Pipeline

    New listing since Q2’22 Change since Q2’22 Viral Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q2’22 Oral CoV prodrug (GS-5245) COVID-19 EV Sunlenca® (CAPELLA) HIV LA HTE NDA Filed and MAA Approved MAA approved Lenacapavir (PURPOSE

  37. Slide 37: Inflammatory Diseases Pipeline

    New listing since Q2’22 Change since Q2’22 Inflammatory Diseases Pipeline Breakthrough Therapy Designation P PRIME Designation Phase 1 Phase 2 Phase 3 Filed Updates since Q2’22 TPL2 inhibitor (GS-5290) Inflammatory Bowel Disease Inflammatory Disease IRAK4 inhibitor (GS-5718) Inflammatory Bowel Disea

  38. 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 Sep 30, 2021 Dec 31, 2021 Mar 31, 2022 Jun 30, 2022 Sep 30, 2022 Total Debt, net $27.69 $26.70 $26.21 $26.22 $25.22 Debt Discounts, Premiums and Issuance Costs 0.19 0.18 0.17 0.17 0.17 Liabi

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