Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q3 2021 Earnings Presentation

34 slides from Gilead Sciences's earnings presentation, Oct 28, 2021

  1. Slide 1: Q321 Financial Results

    Q321 Financial Results October 28, 2021 Confidential – Internal Use Only

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements Statements included in this press release 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 u

  3. Slide 3: Contents

    Contents Q321 Highlights 4-5 Commercial Highlights 6-14 CMO Updates 15-22 Financial Performance 23-26 Appendix 28-34 3

  4. Slide 4: Gilead Q321 Key Takeaways

    Gilead Q321 Key Takeaways • Veklury up 132% QoQ to $1.9B with Q3 hospitalization surge Financial Results • HIV grew 6% QoQ to $4.2B with record Biktarvy revenue1 & continued pandemic recovery • Increased 2021 full year revenue & EPS guidance • Initiated Phase 2 lenacapavir and islatravir long-acting

  5. Slide 5: Select 2021 Oncology and Virology Milestones

    Select 2021 Oncology and Virology Milestones Program Trial Anticipated Milestone 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 LBCL (potential submissions in 2H21) DOMVANALIMAB1 ARC-7 Phase 2 NSCLC interi

  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 Q321

    Commercial Revenue Highlights Q321 Veklury® $7.4B Total Product Sales Up 13% YoY, up 20% QoQ $1,923 120% YoY $5.4B Trodelvy $101 HIV Total Product Sales excluding Veklury $4,189 NM YoY HCV -8% YoY Down 3% YoY, up 2% QoQ Cell Therapy $429 -8% YoY $222 51% YoY HBV/HDV $4.2B HIV Product Sales $247 17%

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

    Veklury: Continues to Play Key Role in Pandemic U.S. COVID-19 Hospitalizations 87K 86K 85K 82K 79K 74K 64K 64K $1,923M 55K Q321 Sales 50K 48K 33K >60% ~9M Patients hospitalized Patients globally 23K in the U.S. treated treated with 17K 14K with Veklury1 remdesivir1 COVID-19 INSIGHT: Increase in Vekl

  9. Slide 9: HIV: Biktarvy Hits Record Quarterly Sales of $2.3B

    HIV: Biktarvy Hits Record Quarterly Sales of $2.3B Product Sales ($M) ~3 in 4 are on a Gilead therapy 1 $4,547 $256 $4,257 $4,189 $252 $3,938 $569 $285 $3,650 $567 $298 $602 $286 20% YoY sales growth 14% QoQ sales growth $596 2 $578 $3,722 $3,438 $3,302 $3,044 $2,786 Down 15% YoY, reflecting Continu

  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% 41% BVY • Modest recovery with overall Tx market up 3% 40% QoQ and up 1.5% YoY 35% 30% TRx Share 25% 20% 15% 10% #1 prescribed regimen in US and other regions 2 5% 5% New Entrants 0% >1 in 2 start o

  11. Slide 11: HCV: Pandemic Headwinds Impacting Starts

    HCV: Pandemic Headwinds Impacting Starts Product Sales1 ($M) $549 $510 $464 $129 $423 $117 $429 $125 $96 $93 $111 $135 $98 $98 $94 Declined 8% YoY; down 22% QoQ • Gilead market share remains steady with 50-60% share across core markets $327 $241 $258 $229 $224 COVID-19 INSIGHT: Sequential declines i

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

    HBV / HDV: Leveraging Commercial Footprint Product Sales1 ($M) >$1B in HBV / HDV franchise annual sales by 2022 $244 $247 $237 $220 $211 $115 $114 Grew 18% YoY; up 4% QoQ $123 $91 $116 • Driven by demand in international markets $16 $29 $18 $24 $23 $102 $113 $104 $90 $81 Q321 revenue of $12M • Seque

  13. Slide 13: Trodelvy: Continued Opportunity Ahead

    Trodelvy: Continued Opportunity Ahead Product Sales1 ($M) $101 $89 Now Preferred Regimen for 2L mTNBC in NCCN Breast Guideline and ESMO Clinical $72 Practice Guidelines $64 $53 $101M 13% Product Sales in Q321 QoQ Growth COVID-19 INSIGHT: Oncology patient visits for testing and diagnosis Q320 Q420 Q1

  14. Slide 14: Cell Therapy: Delivering 51% YoY Growth

    Cell Therapy: Delivering 51% YoY Growth Product Sales ($M) $222 $219 $191 $41 $47 Grew 27% YoY; down 2% QoQ $163 $31 $178 • Growing Yescarta demand in Europe $175 $147 $160 • Continued strong uptake for 3L+ follicular lymphoma1 $9 $34 $138 • Submitted sBLA to FDA for R/R LBCL in 2L setting $129 Up 1

  15. Slide 15: CMO Updates

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

  16. Slide 16: Continued Efforts to Advance HIV Portfolio

    Continued Efforts to Advance HIV Portfolio Prevention Treatment Initiated PURPOSE 1 Received FDA Priority Review Initiated lenacapavir and evaluating lenacapavir as for lenacapavir’s NDAs in islatravir1 Phase 2 long- subQ Q6M in adolescent individuals with multi-drug acting oral combination girls an

  17. Slide 17: Veklury Efficacy Demonstrated in Outpatient Setting

    Veklury Efficacy Demonstrated in Outpatient Setting Primary Endpoint Analysis Key Findings Composite of COVID-19 Hospitalization or All-cause Death by Day 28 20 RDV Placebo • 87% reduction in risk of n=279 n=283 COVID-19-related COVID-19 hospitalization or death by Day 2 (0.7) 15 (5.3) hospitalizati

  18. Slide 18: Building a Diverse Pipeline with Trodelvy

    Building a Diverse Pipeline with Trodelvy Breast Cancer Approved in 2L mTNBC1 HR+/HER2- TROPiCS-02 Readout in Q1222 Initiating Phase 3 1L mTNBC in 1H223 Other Solid Tumors NSCLC Phase 3 Initiating in 2H21 HNSCC as part of TROPiCS-03 Endometrial as part of TROPiCS-03 Urothelial Cancer Accelerated app

  19. Slide 19: Investing in Magrolimab: Front Line Potential

    Investing in Magrolimab: Front Line Potential Hematological Studies: Solid Tumor Studies: Indication Stage Update Indication Stage Update 1L Higher Risk MDS Ph 1b Readout now expected in Q122 1L Head and Neck Ph 2 First patient dosed in Q321 1L Higher Risk MDS Ph 3 Enrollment on track Solid tumor (m

  20. Slide 20: Select 2021 Oncology and Virology Milestones

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

  21. Slide 21: Robust, Diverse Pipeline through Partnerships

    Robust, Diverse Pipeline through Partnerships SELECT PROGRAMS: • HLA-G checkpoint inhibitor SELECT PROGRAMS: • Anti-TIGIT • Adenosine receptor inhibitor • CD73 inhibitor SELECT PROGRAMS: • TREM2 • TREM1 SELECT PROGRAMS: • CCR8 inhibitor1 SELECT PROGRAMS: • CD137 agonist 21 Confidential Note: Select

  22. Slide 22: Robust Pipeline with Upcoming Catalysts

    Robust Pipeline with Upcoming Catalysts PHASE 1 PHASE 2 PHASE 3, FILED, or APPROVED Sacituzumab govitecan-hziy Basket study (incl. NSCLC) Magrolimab anti-CD47 Solid Tumors Sacituzumab govitecan-hziy HR+/HER2-mBC Magrolimab anti-CD47 1L AML Trodelvy® 2L mUC 45 Magrolimab anti-CD47 Magrolimab anti-CD4

  23. Slide 23: Financial Performance

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

  24. Slide 24: Strong Third Quarter Results

    Strong Third Quarter Results YoY Product Sales Up 13% YoY Q320 Q321 Non-GAAP1; in millions, except percentages and per share amounts Change • Growth driven by higher sales of Veklury Product Sales $6,493 $7,356 13% Veklury 873 1,923 NM • Excluding Veklury, sales were down 3% due to Truvada and Atrip

  25. Slide 25: Solid Results Year-to-Date

    Solid Results Year-to-Date YoY 9M20 9M21 Non-GAAP1; in millions, except percentages and per share amounts Change Product Sales: Up 17% YoY Product Sales $17,027 $19,848 17% • Growth driven by higher sales of Veklury Veklury 873 4,208 NM Product Sales excluding Veklury $16,154 $15,640 -3% • Excluding

  26. Slide 26: Updating 2021 Outlook

    Updating 2021 Outlook Provided on Updated on Updated on Updated on Revenue Guidance Updates in millions, except percentages and per share amounts February 4, 2021 April 29, 2021 July 29, 2021 October 28, 2021 • Total Product Sales updated to Total Product Sales $23,700 – $25,100 Unchanged $24,400 -

  27. Slide 27: Confidential – Internal Use Only

    27 Confidential – Internal Use Only

  28. Slide 28: Appendix

    Appendix Confidential – Internal Use Only

  29. Slide 29: 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, 2020 Dec 31, 2020 Mar 31, 2021 Jun 30, 2021 Sep 30, 2021 Total Debt, net $29.29 $31.40 $30.17 $30.18 $27.69 Debt Discounts, Premiums and Issuance Costs 0.21 0.20 0.20 0.19 0.19 Liabi

  30. Slide 30: Select 2021 Milestones

    Select 2021 Milestones Lenacapavir capsid inhibitor (GS-6207) Phase 2 readout in virologically suppressed population2 Lenacapavir capsid inhibitor (GS-6207) Lenacapavir/islatravir combination NDA filed for heavily treatment experienced population Phase 2 initiation in long-acting oral treatment3 Len

  31. Slide 31: Oncology Pipeline

    Oncology Pipeline Phase 2 Phase 3 Filed Updates since Q2’21 Trodelvy® (sacituzumab govitecan-hziy) 2L mTNBC sBLA Approved; MAA Filed Trodelvy® (sacituzumab govitecan-hziy) 2L mUC sBLA Approved Magrolimab anti-CD47 (GS-4721)1,2 1L HR MDS P Magrolimab anti-CD47 (GS-4721)2 1L AML Gilead Oncology Sacitu

  32. Slide 32: Oncology Cell Therapy Pipeline

    Oncology Cell Therapy Pipeline Phase 2 Phase 3 Filed Updates since Q2’21 Yescarta® (axi-cel) R/R FL sBLA Approved; Type II Filed EMA Type II variation filed Tecartus® (brexu-cel) Adult ALL sBLA Approved; Type II Filed FDA approval granted 01Oct21 Cell Therapy Yescarta® (axi-cel) 2L LBCL sBLA Filed s

  33. Slide 33: Viral Diseases Pipeline

    Viral Diseases Pipeline Phase 2 Phase 3 Filed Updates since Q2’21 Veklury® (remdesivir) COVID-19 outpatient sNDA filed 21Oct21 EV sNDA filed Lenacapavir capsid inhibitor (GS-6207) HIV LA HTE NDA and MAA Filed MAA filed Lenacapavir capsid inhibitor (GS-6207)1 HIV PrEP Lenacapavir capsid inhibitor (GS

  34. Slide 34: Inflammatory Diseases Pipeline

    Inflammatory Diseases Pipeline Phase 2 Phase 3 Filed Updates since Q2’21 Inflamm- Filgotinib JAK-1 inhibitor (GS-6034) Ulcerative colitis Disease MAA Filed atory Filgotinib JAK-1 inhibitor (GS-6034) Crohn's Disease Cilofexor FXR agonist (GS-9674) PSC Fibrotic Disease Cilofexor/firsocostat/semaglutid

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