Gilead Sciences, Inc. · NASDAQ:GILD

Gilead Sciences — Q4 2020 Earnings Presentation

51 slides from Gilead Sciences's earnings presentation, Feb 4, 2021

  1. Slide 1: Q4 and Full Year 2020 Financial Results

    Q4 and Full Year 2020 Financial Results February 4, 2021

  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 Business Update 4-8 Financial Performance 9-20 Commercial Performance 21-31 Research & Development Update 32-42 Appendix 43-50 3

  4. Slide 4: Business Update

    Business Update 4

  5. Slide 5: Earnings Call Highlights

    Earnings • Total product sales of $7.3B in Q4 and $24.4B in FY 2020 Call - Q4 sales increased 26% YoY primarily due to $1.9B of Veklury sales Highlights Overall Financial Performance Exceeded - FY product sales excluding Veklury declined 3% YoY primarily due to Atripla and Truvada LOEs and impact of

  6. Slide 6: 2020: Building for Growth

    2020: Building for Growth 2020 Strategy Execution Highlights Completed Increased pipeline Re-prioritized Five new product Recruited key talent significant BD size by 50% overall1 programs and created approvals2, including (research, clinical activity to enhance with notable opt-in new governance for

  7. Slide 7: Clear Path to Near and Long-Term Growth

    Clear Path to Near and Long-Term Growth Excluding Veklury (remdesivir) Deliver on Opportunities in New Therapeutic Areas Illustrative Growth (Excluding Veklury) New Therapeutic Areas Diverse and Continue Leadership (Oncology + Inflammation) Sustainable in Antivirals Portfolio Existing Antiviral Base

  8. Slide 8: Key Areas of Focus for Gilead in 2021

    Key Areas of Focus for Gilead in 2021 Antiviral Leadership Oncology Expansion Enterprise Focus Continue growth of Biktarvy and maintain Establish Trodelvy as a key growth driver and Recruit and develop key talent and further leadership as #1 treatment for HIV pursue broad potential as cornerstone th

  9. Slide 9: Financial Performance

    Financial Performance 9

  10. Slide 10: Q4 & FY 2020 Highlights

    • Robust product sales growth driven by Biktarvy and Veklury ‒ Q4 sequential growth of 13% and full year growth of 10% ‒ Q4 revenue excluding Veklury decreased 4% sequentially primarily due to the Atripla and Truvada LOEs ‒ Full year HIV revenue grew 3% driven by strong Biktarvy and Descovy uptake d

  11. Slide 11: Financial Highlights: Q4 2020

    Financial Highlights: Q4 2020 in millions, except percentages and per share amounts Q4 2019 Q3 2020 Q4 2020 YoY Change QoQ Change HIV1 4,577 4,547 4,257 (7%) (6%) Other Products2 1,219 1,073 1,133 (7%) 6% Product Sales excluding Veklury $5,796 $5,620 $5,390 (7%) (4%) Veklury - 873 1,938 NM 122% Prod

  12. Slide 12: Financial Highlights: Full Year

    Financial Highlights: Full Year in millions, except percentages and per share amounts 2019 2020 YoY Change HIV1 $16,438 $16,938 3% Other Products2 5,681 4,606 (19%) Product Sales excluding Veklury $22,119 $21,544 (3%) Veklury - 2,811 NM Product Sales $22,119 $24,355 10% COGS 3,587 3,294 (8%) Product

  13. Slide 13: Net Product Sales

    Net Product Sales in millions $7,328 $6,493 Q4’20 up 13% from Q3’20 Veklury $1,938 $5,796 • Growth driven by higher Veklury sales $5,467 $5,067 • Excluding Veklury, revenue declined 4% driven by the loss of exclusivity on Atripla and Truvada in the U.S., partially offset by strong Biktarvy performan

  14. Slide 14: Non-GAAP R&D Expenses

    Non-GAAP R&D Expenses in millions $1,512 Q4’20 up 31% from Q3’20 $1,186 $1,155 $1,103 • Increase driven by the Galapagos amendment of $190 million and Pionyr collaboration milestones of $1,004 ~$70 million as well as pipeline investments in magrolimab and Trodelvy Q4’20 up 37% from Q4’19 • Increase

  15. Slide 15: Non-GAAP SG&A Expenses

    Non-GAAP SG&A Expenses in millions $1,499 $1,204 $1,164 Q4’20 up 37% from Q3’20 $1,076 $1,095 • Primarily driven by increased corporate grants to support racial equity and help our non-profit grantees weather the pandemic, investments in Veklury, Trodelvy, and cell therapy, and higher marketing prog

  16. Slide 16: Non-GAAP Diluted EPS

    Non-GAAP Diluted EPS $2.19 $2.11 Q4’20 increased from Q3’20 $1.68 • Increase due to higher Biktarvy and Veklury sales • Partially offset by the impact of LOEs and increased operating expenses including Galapagos amendment, Pionyr collaboration milestones, and $1.10 $1.11 corporate grants Q4’20 incre

  17. Slide 17: 2020 Shareholder Return

    2020 Shareholder Return Total Dividend Dollar Repurchase Dividend Average Shareholder Amount Dollar Amount1 Shares per Share Purchase Price Return (in millions) (in millions) (in millions) Q1 '20 $875 $0.68 $1,328 18,749,098 $70.82 $2,203 Q2 '20 $855 $0.68 $53 700,100 $76.39 $908 Q3 '20 $861 $0.68 $

  18. Slide 18: Full Year 2021 Guidance

    Full Year 2021 Guidance in millions, except percentages and Provided on February 4, 2021 Comments per share amounts Product Sales x-Veklury $21,700 – $22,100 1-3% growth despite Atripla and Truvada LOEs in the U.S. Veklury Sales $2,000 – 3,000 Wide range driven by uncertainty related to the pandemic

  19. Slide 19: 2021 Product Sales Guidance excluding Veklury

    2021 Product Sales Guidance excluding Veklury $1.9B - $2.1B $21.7 - $22.1B $21.5B ($1.7B) – ($1.5B) YoY: +1% to +3% Base Growth US LOEs YoY: +9% to +10% YoY: -7% to -8% ↓ Truvada ↑ Biktarvy ↓ Atripla ↑ Trodelvy ↓ Letairis ↑ Vemlidy ↑ Cell Therapy 2020 Actual 2021 Guidance Range 19 Note: The financia

  20. Slide 20: 2021 Capital Allocation Priorities

    2021 Capital Allocation Priorities Continue to invest in our business and R&D pipeline while managing expenses Grow our dividend and pay down at least $4B of debt Repurchase shares to offset dilution and opportunistically reduce share count 20

  21. Slide 21: Commercial Performance

    Commercial Performance 21

  22. Slide 22: Commercial Revenue Highlights: Q4 2020

    Commercial Revenue Highlights: Q4 2020 in millions, except percentages Q1 2020 Q2 2020 Q3 2020 Q4 2020 QoQ Change HIV1 $4,134 $4,000 $4,547 $4,257 (6%) HCV 729 448 464 423 (9%) HBV2 186 219 211 244 16% Cell Therapy3 140 157 147 163 11% Trodelvy - - - 49* NM Veklury - - 873 1,938 122% Other Products4

  23. Slide 23: HIV Franchise Product Sales

    HIV Franchise Product Sales in millions Q4’20 down 6% from Q3’20 $4,577 $4,547 • Decrease primarily driven by lower sales volume of $195 $256 $4,257 Atripla and Truvada in connection with the U.S. loss of $4,134 $4,000 $252 exclusivity in Q4’20 $562 $242 $569 $250 $567 Q4’20 down 7% from Q4’19 $639

  24. Slide 24: Biktarvy is the Standard of Care in HIV

    HIV Franchise Biktarvy is the Standard of Care in HIV Total US HIV Treatment Regimen Volume1 200K 180K #1 53% 160K Prescribed Regimen in YoY Revenue Growth 140K US and Other Regions2 2020 vs. 2019 120K TRx/Month 100K 80K 60K 40K ~1 in 2 US Market Exclusivity Through 20K 0K U.S. patients initiating o

  25. Slide 25: Trodelvy Launch Progressing Well

    Oncology Trodelvy Launch Progressing Well Trodelvy US Product Sales • Total Q4’20 Net Revenue of $64M and FY20 Net Revenue of $137M $70 ‒ Gilead Q4’20 Net Revenue: $49M (portion of sales post-deal close on Oct 23rd) • Trodelvy established as #1 therapy in 3L mTNBC within 8 months of launch2 $60 $50

  26. Slide 26: Trodelvy Has Broad Expansion Opportunities Across Multiple Tumor Types

    Oncology Trodelvy Has Broad Expansion Opportunities Across Multiple Tumor Types Later Lines Earlier Lines 2025 of Therapy of Therapy Market Size1 Triple-negative Broad Applicability Breast Cancer $40B+ Trodelvy targets Trop-2 Breast Cancer HR+/HER2- which is expressed in Breast Cancer Total multiple

  27. Slide 27: HCV Franchise Product Sales

    HCV Franchise Product Sales in millions $729 $630 Q4’20 down 9% from Q3’20 $183 • Decrease primarily driven by the timing of purchases in $142 other international markets $464 $448 $148 $423 Q4’20 down 33% from Q4’19 $151 $125 $96 • Decrease primarily driven by lower patient starts in the $158 U.S.

  28. Slide 28: Progress in Viral Hepatitis Further Strengthens Core Antiviral Business

    Viral Hepatitis Progress in Viral Hepatitis Further Strengthens Core Antiviral Business Expected HBV Sales of $1B+ by 20221 Novel HDV Therapy HEPCLUDEX is a first-in-class and potentially $1B+ best-in-class treatment for HDV2 Hepcludex + TDF $860M 54% TDF 43% 7% 4% % Patients with % Patients with No

  29. Slide 29: Delta Virus Overview

    Viral Hepatitis Delta Virus Overview HDV Prevalence HDV Increases Risk of Poor Outcomes1 (Compared to HBV mono-infected patients) 3.9x increased risk of cirrhosis High Intermediate 2.0x increased risk of HCC 2.1x increased risk for death Low Very low No data >12M ~230K <20% HDV occurs as a co-infect

  30. Slide 30: Tecartus Launch Renewing Growth to Cell Therapy Franchise

    Cell Therapy Franchise Tecartus Launch Renewing Growth to Cell Therapy Franchise Cell Therapy Product Sales Total Cell Therapy Product Sales: Q4’20: $163M, FY20: $607M $180 Yescarta: $160 • Net Sales: Q4’20: $129M (+6% YoY), FY20: $563M (+23% YoY) $140 - H2’20 US revenues impacted by COVID-19 pandem

  31. Slide 31: Veklury Progresses in Highly Unpredictable Environment

    COVID-19 Therapy Veklury Progresses in Highly Unpredictable Environment Only FDA approved antiviral for COVID-193 ~1 in 2 Multiple dynamic factors impacting uptake Patients hospitalized in the Hospital shipments of Veklury increased in Q4’20 driven US treated with Veklury1 by surge in COVID-19 cases

  32. Slide 32: Research & Development Update

    Research & Development Update 32

  33. Slide 33: Overview of Clinical Pipeline Today

    Phase 1 Phase 2 Phase 3 Filed Overview Phase 2/3 of Clinical Viral Diseases Pipeline Today MAA Filed Inflammatory Diseases 52 Clinical stage programs1, 2 18 through BD since Jan '19 MAA and BLA Approved sBLA Filed sBLA NDA/BLA/MAA filings, 17 sBLA for AA P3 and Registrational P2 trials Pivotal Pivot

  34. Slide 34: Accelerating Oncology Portfolio and Expertise Buildout

    Oncology Accelerating Oncology Portfolio and Expertise Buildout Magrolimab (CD47) Zimberelimab (PD-1), Domvanalimab (TIGIT) Anti SIRP-a Etrumadenant (A2a/A2bR), AB680 (CD73) Anti c-KIT + others JTX-1811 (CCR8) PY314 (TREM2) TTX-080 (HLA-G) Protein Degradation PY159 (TREM1) Discovery Collaboration Fi

  35. Slide 35: Trodelvy Brings Transformational Benefit to 3L+ mTNBC

    Oncology Trodelvy Brings Transformational Benefit to 3L+ mTNBC; Filed for Accelerated Approval in 3L mUC 100 ASCENT (Ph3): Results in 3L+ mTNBC1 • is a foundational therapy offering transformational benefits in 3L+ 80 Increased median Overall mTNBC Survival to 12.1 from 6.7 months (p<0.0001) Probabi

  36. Slide 36: Trodelvy Studies Demonstrate Expansion Opportunity

    Oncology Trodelvy Studies Demonstrate Expansion Opportunity Trial Indication Phase 1 Phase 2 Phase 3 Filed Approved IMMU-132-01 mTNBC (3L+) ASCENT mTNBC (3L) sBLA filed for full approval TROPHY U-01 Urothelial (3L+) sBLA filed for accelerated approval TROPiCS-02 HR+/HER2- mBC (3L+) Basket (mNSCLC /

  37. Slide 37: Magrolimab Update

    Oncology Magrolimab Update Updated magrolimab + azacitidine data in frontline AML patients1 presented at ASH 2020 • Demonstrated continued robust efficacy in both all-comers and TP53 mutant patients • ORR of 63% with 42% CR rate in all-comer AML patients and similar responses in TP53 mutant Phase 1b

  38. Slide 38: An Important New Pillar of Growth

    Oncology An Important New Pillar of Growth Key Oncology Portfolio Features PHASE 1 PHASE 2 PHASE 3 MARKETED Trodelvy Trodelvy (+ CPI) Trodelvy Trodelvy Trodelvy‡ Basket study 3L+ HR+/ 3L mTNBC • Multiple new, high-quality programs mTNBC 1L, mUC, mTNBC, mUC, Ovarian (+ PARPi) (incl. NSCLC) mNSCLC HER

  39. Slide 39: Lenacapavir Could Be A Long-Acting Game-Changer

    HIV Lenacapavir Could Be A Long-Acting Game-Changer Lenacapavir Profile Highlights 6-month Dosing Unlocks Significant Potential • Potential first-in-class HIV capsid inhibitor • Assuming equal safety, efficacy, and cost, more people prefer 6-month dosing option • Highly potent investigational agent,

  40. Slide 40: Accelerating Development of Lenacapavir in HIV Long-Acting Treatment and Prevention

    HIV Accelerating Development of Lenacapavir in HIV Long-Acting Treatment and Prevention Treatment Prevention • NDA submission in hTE population anticipated • Monotherapy may be sufficient in 2H 2021 • 6-month dosing could meet significant unmet • Phase 2 data in treatment naïve population to need, m

  41. Slide 41: Ongoing Remdesivir Clinical Development Program

    COVID-19 Therapy Ongoing Remdesivir Clinical Development Program • Initiated Phase 3 study of intravenous infusion of remdesivir in outpatient populations at high risk for severe COVID-19 complications in Sep ’20 • Completed Phase 1a study of an inhaled remdesivir solution in healthy volunteers and

  42. Slide 42: Select 2021 Anticipated Milestones

    Select 2021 Anticipated Milestones  Lenacapavir capsid inhibitor COVID-19 Impact: Some clinical trials continue to be impacted by the Phase 3 initiation for PrEP pandemic, which may result in delays in achieving milestones.  Hepcludex1 (Bulevirtide) Phase 3 data readout in HDV Regulatory approval

  43. Slide 43: Appendix

    Appendix 43

  44. Slide 44: Non-GAAP Operating Income & Margin

    Non-GAAP Operating Income & Margin in millions except percentages $3,452 $3,492 $2,765 $2,155 $1,995 Q4’20 operating income up 1% from Q3’20 • Increase due to higher operating income driven by Veklury • Partially offset by higher R&D investments and other operating expenses Q4’20 operating income up

  45. Slide 45: 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, 2019 Mar 31, 2020 Jun 30, 2020 Sep 30, 2020 Dec 31, 2020 Total Debt, net $24.59 $24.10 $24.10 $29.29 $31.40 Debt Discounts, Premiums and Issuance Costs 0.16 0.15 0.15 0.21 0.20 Liabi

  46. Slide 46: GAAP to Non-GAAP Reconciliation of Full Year 2021 Guidance

    GAAP to Non-GAAP Reconciliation of Full Year 2021 Guidance1 in millions, except percentages and per share amounts Provided on February 4, 2021 Projected product sales GAPP to non-GAAP reconciliation GAAP projected product sales $23,700 - $25,100 Less: Veklury sales $2,000 - $3,000 Non- GAAP projecte

  47. Slide 47: Viral Disease Pipeline

    Viral Disease Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 Veklury® (remdesivir for injection) Outpatient COVID-19 Expanded indication Remdesivir inhaled form (GS-5794) Outpatient COVID-19 EV Remdesivir sub cutaneous form (GS-5794) COVID-19 Lenacapavir capsid inhibitor (GS

  48. Slide 48: Inflammatory Disease Pipeline

    Inflammatory Disease Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 Filgotinib JAK-1 inhibitor (GS-6034) Ulcerative colitis MAA Filed MAA filed Filgotinib JAK-1 inhibitor (GS-6034) Crohn's Disease Filgotinib JAK-1 inhibitor (GS-6034) Psoriatic arthritis Removed from pipeline

  49. Slide 49: Oncology Cell Therapy Pipeline

    Oncology Cell Therapy Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 TecartusTM (Brexu-cel)1 MCL MAA and BLA Approved MAA approved Axi-cel iNHL sBLA Filed Yescarta® (Axi-cel) 2L DLBCL Yescarta® (Axi-cel) 1L DLBCL Brexu-cel Adult ALL Pivotal Brexu-cel Pediatric ALL Pivotal Ce

  50. Slide 50: Oncology Non-Cell Therapy Pipeline

    Oncology Non-Cell Therapy Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Updates since Q3’20 TrodelvyTM Sacituzumab govitecan-hziy1 mTNBC (3L) sBLA sBLA filed for full approval Sacituzumab govitecan-hziy (GS-0132) Urothelial (3L+) sBLA for AA sBLA filed for accelerated approval Magrolimab anti-

  51. Slide 51: Thank You

    THANK YOU CONTACT US investor_relations@gilead.com investors.gilead.com

Gilead Sciences — Q4 2020 Earnings Presentation on 6ix