Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q4 2021 Earnings Presentation

36 slides from Gilead Sciences's earnings presentation, Feb 1, 2022

  1. Slide 1: Q4 & FY21 Financial Results

    Q4 & FY21 Financial Results February 1, 2022 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 Q421 & FY21 Key Takeaways 4-5 Commercial Highlights 6-14 CMO Updates 15-23 Financial Performance 24-29 Appendix 30-36

  4. Slide 4: Gilead Q421 & FY21 Key Takeaways

    Gilead Q421 & FY21 Key Takeaways • Exceeded 2021 full year revenue by 11% compared to initial guidance at the midpoint • EPS impacted by legal settlement and Arcus opt-in expense Strong Financial • Veklury continued to play key role in pandemic; 2021 full year revenue of $5.6B Results • Biktarvy gre

  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 Potential sBLA/MAA TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout TROPiCS-02 HR+/HER2- mBC submission Trodelvy EVOKE-02 1L NSCLC Phase 2 FPI EVOKE-03 1L NSCLC P

  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 Q421

    Commercial Revenue Highlights Q421 Veklury® $1,357 $4.5B HIV Product Sales Up 7% YoY, up 8% QoQ -30% YoY HCV $393 Trodelvy $5.8B -7% YoY $118 HIV Total Product Sales excluding Veklury $4,538 +141% YoY +7% YoY Up 8% YoY, up 7% QoQ Cell Therapy $239 +47% YoY HBV/HDV $7.2B Total Product Sales $265 +9%

  8. Slide 8: Veklury: Continues to Play Key Role in Pandemic

    Veklury: Continues to Play Key Role in Pandemic U.S. COVID-19 Hospitalizations1 155K 139K $1,357M $5,565M Q421 Sales FY21 Sales 99K 62K >50% ~10M 55K 51K 56K 56K Patients hospitalized Patients globally 50K 45K 40K 41K 44K in the U.S. treated treated with 37K 36K 38K with Veklury2 remdesivir3 COVID-1

  9. Slide 9: HIV: Another Record Quarter of Biktarvy Sales

    HIV: Another Record Quarter of Biktarvy Sales Product Sales ($M) $4,538 $4,257 $252 $3,938 $4,189 $252 $2.5B $8.6B $285 $3,650 $590 Q421 Sales FY21 Sales $567 $298 $602 $286 $596 • 11% QoQ Growth • 19% YoY Growth $578 • 22% YoY Growth • Offsetting $1.3B LOE impact $3,696 $3,438 $3,302 $3,044 $2,786

  10. Slide 10: Biktarvy: Leading and Growing in Market Share

    Biktarvy: Leading and Growing in Market Share U.S. Treatment TRx Share1 U.S. HIV Treatment Market 45% 42% BVY • Modest recovery with overall Tx market up 40% 1.5% YoY, though down 1% QoQ 35% 30% 5% Share Gain in 2021 TRx Share 25% 20% 15% 10% #1 prescribed regimen in the U.S. 2 5% 6% New Entrants 0%

  11. Slide 11: HCV: Market Share Growth Starts

    HCV: Market Share Growth Starts Product Sales1 ($M) $549 $510 $129 $423 $117 $429 $393 $96 $93 $111 $85 $135 $98 $94 Sales declined 7% YoY; down 8% QoQ $99 • Gilead market share grew modestly sequentially in both the U.S. and EU $327 $229 $258 • Maintaining 50-60% share across core markets $224 $209

  12. Slide 12: HBV / HDV: Leveraging Commercial Footprint

    HBV / HDV: Leveraging Commercial Footprint Product Sales1 ($M) $265 $244 $247 Sales grew 17% YoY; up 8% QoQ $237 $220 • YoY growth driven by demand in all geographies $115 • Sequential growth primarily driven by seasonal $115 $114 inventory build and favorable pricing dynamics $123 $116 $28 $16 $29

  13. Slide 13: Trodelvy: Strong Momentum Heading into 2022

    Trodelvy: Strong Momentum Heading into 2022 Product Sales1 ($M) $118 $9 $101 Approved for 2L mTNBC in the U.S., EU, Great $1 Britain, Switzerland, Australia, and Canada $89 $72 $49 $100 $109 $118M 17% 84%2 Sales in Q421 QoQ Growth YoY Growth COVID-19 INSIGHT: Oncology patient visits in the U.S. for

  14. Slide 14: Cell Therapy: Strong Q4 Momentum with 47% YoY Growth

    Cell Therapy: Strong Q4 Momentum with 47% YoY Growth Product Sales ($M) $239 $222 $219 $191 $57 Sales grew 41% YoY; Up 4% QoQ $41 $47 $163 $31 • Q4 YoY growth driven by continued demand in LBCL and expansion into FL $34 • sBLA decision for 2L LBCL expected in April 2022 $178 $175 $182 $160 $129 Sale

  15. Slide 15: CMO Updates

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

  16. Slide 16: Expanding Indications for COVID-19 Treatment

    Expanding Indications for COVID-19 Treatment Advancing Oral Program Adults and adolescents requiring hospitalization (U.S.) or • GS-5245, a novel antiviral oral supplemental oxygen (EU) COVID nucleoside • FPI in Phase 1 trial in January Adults not on supplemental oxygen at increased risk of 2022 dis

  17. Slide 17: Targeting HIV Lifecycle With Long-Acting Portfolio

    Targeting HIV Lifecycle With Long-Acting Portfolio GS-2872 + GS-5423 bNAb 1 Class: bNAb Class: bNAb Phase: 1b Phase: Exploratory Islatravir1 GS-5894 GS-1614 LA Tenofovir 2 Class: NRTI Class: NNRTI Class: NRTI Class: NRTI Phase: 2 Phase: 1 Phase: Pre-IND Phase: Discovery 1 Virus Entry Human Immunodef

  18. Slide 18: Long-Acting Pipeline Positioned To Be Best-in-Disease

    Long-Acting Pipeline Positioned To Be Best-in-Disease Treatment Prevention Dosing Every Foundation Partner Dosing Every Foundation Lenacapavir NNRTI Lenacapavir2 PURPOSE 1 and 2 Phase 1 6 Months Phase 3 1 Week Lenacapavir Islatravir1 Potential Approval in 2025 Phase 2 LA Bictegravir 1-3 Months Lenac

  19. Slide 19: Growing Momentum: Robust Trodelvy Portfolio

    Growing Momentum: Robust Trodelvy Portfolio • Existing Trials • Phase 3 FPI completed in 2-3L NSCLC Ongoing Phase 3 TROPiCS-04 in mUC Planned Phase 3 Trial Initiations on Track • Phase 2 Solid Tumor Basket on-track 1L mTNBC • Accelerating Trodelvy programs Breast 1L mTNBC 7+ Planned across indicatio

  20. Slide 20: Exploring Magrolimab's Potential Across Indications

    Exploring Magrolimab’s Potential Across Indications Hematology Trials Solid Tumor Trials Indication Stage Update Magrolimab Indication Stage Update No longer pursuing 1L Head and 1L HR MDS Ph 1b Ph 2 FPI completed in Q321 Accelerated Approval1 Neck Solid tumor 1L HR MDS Ph 3 Partial clinical hold1 (

  21. Slide 21: Cell Therapy: Reinforcing Best-in-Class LBCL Data

    Cell Therapy: Reinforcing Best-in-Class LBCL Data ZUMA-1: 3L LBCL ZUMA-7: 2L Relapsed/Refractory LBCL ZUMA-12: 1L High-Risk LBCL 43% >4x 2.5x 89% 5-Year OS ORR Median EFS 2-year EFS • 92% of study patients • High rate of rapid and alive at 5 years durable responses needed no additional with 78% comp

  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 Potential sBLA/MAA TROPiCS-02 HR+/HER2- mBC Phase 3 topline readout TROPiCS-02 HR+/HER2- mBC submission Trodelvy EVOKE-02 1L NSCLC Phase 2 FPI EVOKE-03 1L NSCLC P

  23. Slide 23: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Magrolimab anti-CD472,5 DLBCL Sacituzumab govitecan-hziy Basket study (incl. NSCLC) Sacituzumab govitecan-hziy 1L mTNBC (PD-L1+) Sacituzumab govitecan-hziy HR+/HER2- mBC Trodelvy® 2L mUC 55 Magrolimab anti-CD47 Magro

  24. Slide 24: Financial Performance

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

  25. Slide 25: EPS Impacted by Legal Settlement and Arcus Opt-In

    EPS Impacted by Legal Settlement and Arcus Opt-In Q421 Non-GAAP1 EPS FY21 Non-GAAP1 EPS 2 2 1 Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges in cost of goods sold, acquired IPR&D expens

  26. Slide 26: Strong Fourth Quarter Results

    Strong Fourth Quarter Results YoY Product Sales Down 2% YoY Q420 Q421 Non-GAAP1; in millions, except percentages and per share amounts Change • Driven by lower Veklury sales, partially Product Sales $7,328 $7,160 -2% offset by growth in HIV Veklury 1,938 1,357 -30% • Excluding Veklury, sales were up

  27. Slide 27: Solid Financial Execution in FY21

    Solid Financial Execution in FY21 YoY FY20 FY21 Non-GAAP1; in millions, except percentages and per share amounts Change Product Sales: Up 11% YoY Product Sales $24,355 $27,008 11% • Driven by increased sales of Veklury Veklury 2,811 5,565 98% • Excluding Veklury, product sales were Product Sales exc

  28. Slide 28: 2022 Guidance

    2022 Guidance Feb 1, 2022 Revenue Guidance • Total Product Sales, excluding Veklury Total Product Sales $23.8B - $24.3B expected to grow 2-4% YoY Product Sales ex-Veklury $21.8B - $22.3B • Veklury sales weighted to Q122 Veklury Sales ~$2B • HIV Q122 sales expected to decline more Non-GAAP significan

  29. Slide 29: Confidential – Internal Use Only

    29 Confidential – Internal Use Only

  30. Slide 30: Appendix

    Appendix Confidential – Internal Use Only

  31. Slide 31: 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 Dec 31, 2020 Mar 31, 2021 Jun 30, 2021 Sep 30, 2021 Dec 31, 2021 Total Debt, net $31.40 $30.17 $30.18 $27.69 $26.70 Debt Discounts, Premiums and Issuance Costs 0.20 0.20 0.19 0.19 0.18 Liabi

  32. Slide 32: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Magrolimab anti-CD472,5 DLBCL Sacituzumab govitecan-hziy Basket study (incl. NSCLC) Sacituzumab govitecan-hziy 1L mTNBC (PD-L1+) Sacituzumab govitecan-hziy HR+/HER2- mBC Trodelvy® 2L mUC 55 Magrolimab anti-CD47 Magro

  33. Slide 33: Oncology Pipeline

    Oncology Pipeline New listing since Q3’21 Change since Q3’21 Breakthrough Therapy Designation P PRIME Designation Planned program Phase 1 Phase 2 Phase 3 Filed Updates since Q3’21 Trodelvy® (sacituzumab govitecan-hziy) 2L mTNBC sBLA Approved; MAA Approved MAA approved Trodelvy® (sacituzumab goviteca

  34. Slide 34: Oncology Cell Therapy Pipeline

    Oncology Cell Therapy Pipeline Phase 1 Phase 2 Phase 3 Filed Updates since Q3’21 Yescarta® (axi-cel) R/R FL sBLA Approved; Type II Filed Tecartus® (brexu-cel) R/R Adult ALL sBLA Approved; Type II Filed Cell Therapy Yescarta® (axi-cel) 2L LBCL sBLA Filed, Type II Filed EMA Type II variation filed Yes

  35. Slide 35: Viral Diseases Pipeline

    Viral Diseases Pipeline Phase 1 Phase 2 Phase 3 Filed Updates since Q3’21 Veklury® (remdesivir) COVID-19 Outpatient sNDA Approved FDA approval granted 21Jan22 EV Oral CoV prodrug (GS-5245) COVID-19 New Lenacapavir capsid inhibitor (GS-6207)1 HIV LA HTE NDA and MAA Filed Lenacapavir capsid inhibitor

  36. Slide 36: Inflammatory Diseases Pipeline

    Inflammatory Diseases Pipeline Phase 1 Phase 2 Phase 3 Filed Updates since Q3’21 Filgotinib JAK-1 inhibitor (GS-6034)1 Ulcerative Colitis MAA Approved MAA approved Inflammatory Disease Filgotinib JAK-1 inhibitor (GS-6034)1 Crohn’s Disease TPL2 inhibitor (GS-5290) Inflammatory Bowel Disease IRAK4 inh

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