Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q1 2021 Earnings Presentation

32 slides from Gilead Sciences's earnings presentation, Apr 29, 2021

  1. Slide 1: Q121 Financial Results

    Q121 Financial Results April 29, 2021 Confidential – Internal Use Only

  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 Q121 Highlights 4-5 Commercial Highlights 7-13 CMO Update 15-19 Financial Performance 21-23 Appendix 26-32 3

  4. Slide 4: Gilead Q121 Key Takeaways

    Gilead Q121 Key Takeaways • Q121 total product sales in-line with our internal expectations Solid Start to 2021 • Slower than expected COVID-19 pandemic recovery modestly impacted core business • Trodelvy® granted FDA full approval in 2L+ mTNBC and accelerated approval in 2L+ mUC • Merck partnership

  5. Slide 5: Select 2021 Oncology and Virology Milestones

    Select 2021 Oncology and Virology Milestones Program Trial Anticipated Milestone STATUS 1H21 ASCENT Full approval for 2L+ mTNBC TRODELVY TROPHY U-01 sBLA Accelerated Approval in 2L+ mUC YESCARTA® ZUMA-7 Phase 3 data readout for 2L DLBCL (potential submissions in 2H21) DOMVANALIMAB1 ARC-7 Phase 2 NSC

  6. Slide 6: Commercial Highlights & Market Dynamics

    Commercial Highlights & Market Dynamics Confidential – Confidential Internal Use Only – Internal Use Only

  7. Slide 7: Commercial Revenue Highlights Q121

    Commercial Revenue Highlights Q121 Veklury® $6.3B Total Product Sales Up 16% YoY $1,456 NM YoY $4.9B Trodelvy $72 HCV HIV Total Product Sales excluding Veklury $3,650 NM YoY $510 -30% YoY -12% YoY Down 11% YoY Cell Therapy $191 36% YoY HBV/HDV $3.7B HIV Product Sales $220 18% YoY Down 12% YoY Other

  8. Slide 8: HIV: Biktarvy Remains Strong Despite Seasonality

    HIV: Biktarvy Remains Strong Despite Seasonality Product Sales ($M) $4,547 ~3 in 4 initiate or switch to Gilead products 1 $256 $4,257 $4,134 $4,000 $252 $242 $569 $250 $3,650 $567 $639 $512 $286 8% YoY sales growth #1 prescribed regimen in $578 US and other regions 2 $3,722 $3,253 $3,438 $3,238 $2,

  9. Slide 9: HCV: COVID-19 Continues to Impact Patient Starts

    HCV: COVID-19 Continues to Impact Patient Starts Product Sales1 ($M) $729 $183 $510 $464 $448 $148 $423 $117 $125 $158 $96 $135 Down 30% YoY; up 21% QoQ $98 $70 $98 • On-going pandemic impact but portfolio remains robust $398 with 50-60% share across core markets $258 • Sequential growth in part due

  10. Slide 10: HBV / HDV: Expanding Portfolio with Hepcludex

    HBV / HDV: Expanding Portfolio with Hepcludex Product Sales1 ($M) >$1B in HBV franchise sales by 2022 $244 $219 $220 $211 $186 $115 Grew 33% YoY; down 6% QoQ $91 $116 $122 $81 • Growth driven by demand in China and US $16 • US seasonal inventory dynamics impacted Q1 $18 $20 $23 $17 $102 $113 $85 $80

  11. Slide 11: Trodelvy: Patient Population Expanding

    Trodelvy: Patient Population Expanding Product Sales1 ($M) $72 $64 FDA full approval for 2L+ mTNBC and $53 accelerated approval in 2L+ mUC2 $72M 100% Product Sales in Q121 Top 150 Breast Cancer Accounts Ordered3 $20 European approval in mTNBC expected as soon as Dec 2021 COVID-19 INSIGHT: Slower acc

  12. Slide 12: Cell Therapy: Delivering 36% YoY Growth

    Cell Therapy: Delivering 36% YoY Growth Product Sales ($M) $191 $31 Grew 14% YoY; up 24% QoQ $163 $157 $140 $147 $34 $160 • Growing Yescarta demand, notably in Europe $156 $9 $138 • Expanding indication with FDA accelerated approval for $129 the first and only cell therapy in 3L+ follicular lymphoma

  13. Slide 13: Veklury: Tracking to Hospitalization Trends

    Veklury: Tracking to Hospitalization Trends US COVID-19 Hospitalizations 118K 111K 110K 96K 82K 71K $1.5B Q121 Sales 57K 47K 43K 36K 34K 33K 35K 37K 39K 40K ~1 in 2 ~4M 40+ Patients Patients globally Interventional hospitalized in treated with or observational the US treated remdesivir1 studies2 wit

  14. Slide 14: CMO Updates

    CMO Updates Confidential – Confidential Internal Use Only – Internal Use Only

  15. Slide 15: Strengthening HIV Portfolio Across Spectrum

    Strengthening HIV Portfolio Across Spectrum Lenacapavir1: Lenacapavir + islatravir: Phase 2 CALIBRATE long-acting oral and injection Partner Phase 2/3 CAPELLA Phase 2a AELIX-003 Partner Lenacapavir: 2 upcoming Phase 33 Treatment SAM2 Partner Prevention Cure 1 CALIBRATE is studying HIV treatment in a

  16. Slide 16: Extending Trodelvy's Potential to Transform Care

    Extending Trodelvy’s Potential to Transform Care US 2021 Est. Population1 2L+ mTNBC ASCENT 10k 2L+ mUC TROPHY U-01, TROPiCS-04 8k GRANTED 2 • FDA full approval for 2L+ mTNBC APPROVALS • FDA accelerated approval in 2L+ mUC Secured in 1H21 HR+/HER2- 2 TROPiCS-02 17k UPCOMING • 4 Phase 3 TROPiCS-02 PFS

  17. Slide 17: New Indications To Drive Cell Therapy Adoption

    New Indications To Drive Cell Therapy Adoption INDICATION 3 APPROVALS P R O G R E S S T O D AT E Granted FDA and EMA approval; updated E X P E C T E D 2 0 2 1 U P D AT E S 3L DLBCL - US label with ZUMA-1 Cohort 4 safety Phase 3 readout in 1H21; potential 2L DLBCL - sBLA/MAA filing in 2H21 1L DLBCL P

  18. Slide 18: Select 2021 Oncology and Virology Milestones

    Select 2021 Oncology and Virology Milestones Program Trial Anticipated Milestone Primary Endpoints1 STATUS 1H21 ASCENT Full FDA approval for 2L+ mTNBC - TRODELVY TROPHY U-01 sBLA Accelerated Approval in 2L+ mUC - Phase 3 data readout for 2L DLBCL (potential YESCARTA ZUMA-7 EFS submissions in 2H21) D

  19. Slide 19: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts PHASE 1 PHASE 2 PHASE 3 or FILED Sacituzumab govitecan-hziy Basket study (incl. NSCLC) Sacituzumab govitecan-hziy2 (+ CPI) 1L mTNBC, mUC, mNSCLC Sacituzumab govitecan-hziy HR+/ HER2-mBC3 Trodelvy® 2L+ mTNBC (ASCENT) Trodelvy® 2L+ mUC 47 Sacituzumab govitecan-h

  20. Slide 20: Financial Performance

    Financial Performance Confidential – Confidential Internal Use Only – Internal Use Only

  21. Slide 21: First Quarter Results: Solid Start to 2021

    First Quarter Results: Solid Start to 2021 YoY Q120 Q121 Non-GAAP; in millions, except percentages and per share amounts Change Product Sales: Up 16% YoY Product Sales excluding Veklury $5,467 4,884 -11% • Growth driven by higher sales of Veklury, Veklury - 1,456 NM Biktarvy, HBV and Cell Therapy wi

  22. Slide 22: No Change to 2021 Sales & Non-GAAP Outlook

    No Change to 2021 Sales & Non-GAAP Outlook in millions, except percentages and per share amounts Provided on February 4, 2021 Updated on April 29, 2021 1-3% Growth in Product Sales ex-Veklury Product Sales ex-Veklury $21,700 – $22,100 Unchanged • Growth driven by Biktarvy, Trodelvy, Cell Therapy, an

  23. Slide 23: $1.2B Returned to Shareholders in Q121

    $1.2B Returned to Shareholders in Q121 $917M 2021 Capital Allocation Priorities Q121 Dividend $0.71 per share Continue to invest in our business and R&D pipeline while managing expenses Grow our dividend and pay down at least $4B in debt $309M Repurchase shares to offset dilution and opportunistical

  24. Slide 24: Confidential – Internal Use Only

    24 Confidential – Internal Use Only

  25. Slide 25: Appendix

    Appendix Confidential – Internal Use Only

  26. Slide 26: 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, 2020 Jun 30, 2020 Sep 30, 2020 Dec 31, 2020 Mar 31, 2021 Total Debt, net $24.10 $24.10 $29.29 $31.40 $30.17 Debt Discounts, Premiums and Issuance Costs 0.15 0.15 0.21 0.20 0.20 Liabi

  27. Slide 27: Overview of Clinical Pipeline

    Phase 1 Phase 2 Phase 3 NDA/BLA/MAA Overview Phase 2/3 of Clinical Viral Diseases Pipeline Today MAA Filed; Pivotal Inflammatory Diseases 47 Clinical stage programs1 18 through BD since Jan '19 sBLA Approved; MAA Filed NDA/BLA/MAA filings, P3 15 sBLA for AA Approved and Registrational P2 sBLA for AA

  28. Slide 28: Pipeline Summary

    Pipeline Summary Lenacapavir capsid inhibitor (GS-6207) Potential NDA submission for heavily treatment experienced population Lenacapavir capsid inhibitor (GS-6207) Phase 2 read out in virologically suppressed population2 Lenacapavir/islatravir combination Phase 2 initiation in long-acting oral trea

  29. Slide 29: Viral Diseases Pipeline

    Viral Diseases Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q4’20 1 Veklury® (remdesivir injectable form) COVID-19 outpatient EV Remdesivir inhaled form (GS-5734) COVID-19 Lenacapavir capsid inhibitor (GS-6207) HIV LA HTE Phase 2/3 Lenacapavir capsid inhibitor (GS-6207) HIV LA V

  30. Slide 30: Inflammatory Diseases Pipeline

    Inflammatory Diseases Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q4’20 Filgotinib JAK-1 inhibitor (GS-6034) Ulcerative colitis MAA filed Filgotinib JAK-1 inhibitor (GS-6034) Crohn's Disease TPL2 inhibitor (GS-5290) Inflammatory Bowel Disease Inflammatory Disease IRAK4 inhibito

  31. Slide 31: Oncology Cell Therapy Pipeline

    Oncology Cell Therapy Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q4’20 Yescarta® (Axi-cel) R/R FL sBLA Approved FDA accelerated approval granted Yescarta® (Axi-cel) 2L DLBCL Yescarta® (Axi-cel) 1L DLBCL Brexu-cel Adult ALL sBLA for AA; Pivotal sBLA filed for accelerated approv

  32. Slide 32: Oncology Non-Cell Therapy Pipeline

    Oncology Non-Cell Therapy Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q4’20 Full FDA approval granted 07Apr2021, Trodelvy® Sacituzumab govitecan-hziy1 mTNBC (2L+) sBLA Approved; MAA Filed MAA filing completed Sacituzumab govitecan-hziy (GS-0132)2 Urothelial (2L+) sBLA Approved

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