Slide 1: H1 & Q2 2020 Earnings Results
H1 & Q2 2020 Earnings Results July 30, 2020
Slide 2: Forward-Looking Statements
Forward-Looking Statements The projected financial results presented in the following slides represent management’s estimates of Gilead’s future financial results. Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Pri
Slide 3: Contents
Contents H1 & Q2 2020 Overview 4-8 Commercial Performance 9-18 Research & Development 19-26 Financial Performance 27-34 Updated 2020 Guidance 35-38 Appendix 39-44 3
Slide 4: H1 & Q2 2020 Overview
H1 & Q2 2020 Overview 4
Slide 5: H1 & Q2 Earnings Call Highlights
H1 & Q2 Strong financial • Total product sales of $5.1 billion in Q2 and $10.5 billion in H1 - Q2 sales declined -7% QoQ and H1 sales declined -3% YoY due to COVID pandemic 2020 performance - Pandemic primarily impacted HCV and PrEP in Q2; seeing early signs of recovery in certain markets driven by
Slide 6: Ensuring Rapid and Broad Access to Remdesivir
Ensuring Rapid and Broad Access to Remdesivir Donation Commercial Model • Donated entire supply of • To ensure access, Veklury (remdesivir) priced responsibly and well below value to healthcare system 1.5 M vials early in pandemic − $390/vial for governments in all developed countries where approved
Slide 7: Remdesivir Manufacturing Projections
Remdesivir Manufacturing Projections Cumulative treatment courses >2,000,000 Expect enough 288,000 supply to meet global 190,000 real-time need by 30,000 beginning of October 5,000 Jan 2020 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 + Existing API, additional Contract Manufacturing Existing su
Slide 8: Progress Across Three Pillars of Gilead's Next Chapter
Progress Across Three Pillars of Gilead’s Next Chapter Durable Core Existing Pipeline Strategy to Drive Business + Opportunities + Additional Growth Biktarvy #1 across markets Remdesivir for COVID-19 11 tailored transactions Year to Date Progress Descovy for PrEP launch success Tecartus ap
Slide 9: Commercial Performance
Commercial Performance 9
Slide 10: Commercial Revenue Highlights: H1 & Q2 2020
Commercial Revenue Highlights: H1 & Q2 2020 in millions, except percentages H1 2019 H1 2020 YoY Change Q1 2020 Q2 2020 QoQ Change HIV1 7,659 8,134 6% 4,134 4,000 (3%) HCV 1,632 1,177 (28%) 729 448 (39%) Yescarta 216 296 37% 140 156 11% Ranexa and Letairis 575 172 (70%) 91 81 (11%) Other Products2 72
Slide 11: HIV Franchise: Long-Term Robust Growth and Durability
HIV Franchise Long-Term Robust Growth and Durability 12% HIV franchise CAGR growth since 2011 1 Highly effective HIV treatment • Best HIV launch in history2,3 90-95% Gilead patients expected on single tablet • Expect to be preferred option through 20334 F/TAF-based regimens by Q4’205 regimen HIV pre
Slide 12: HIV Franchise Product Sales
HIV Franchise Product Sales in millions H1 '20 up 6% from H1 '19 $8,134 $4,577 $7,659 $195 • Increase driven by the continued U.S. treatment and $492 $4,202 $4,134 $4,041 $4,000 PrEP demand growth and Biktarvy uptake, partially $406 $210 $562 offset by COVID $187 $242 $250 $1,151 $558 $1,192 $623 $6
Slide 13: Continued Descovy (F/TAF)-Based Regimen Uptake
HIV Treatment Continued Descovy(F/TAF)-Based Regimen Uptake 90% #1 prescribed of Gilead’s U.S. HIV treatment Biktarvy is #1 regimen prescribed prescription volume comprised of regimen in U.S. and EU5 Descovy (FTC/TAF)-Based Regimens 100% TDF-based Regimens Descovy (FTC/TAF)-based Regimens 0% Q4’15 Q
Slide 14: Continued Uptake of Descovy for PrEP
HIV Prevention Continued Uptake of Descovy for PrEP Opportunity to reach more of the ~1.1m Continued uptake with ~43% individuals individuals who could benefit from PrEP in U.S. on PrEP now taking Descovy for PrEP 100% 243,000 Individuals ~43% on PrEP in Q2 20 0% Q4’19 Q2’20 COVID-19 Insight: COVID
Slide 15: HCV Franchise Product Sales
HCV Franchise Product Sales in millions $842 $1,632 H1 '20 down 28% from H1 '19 $729 $210 • Decrease driven by lower patients starts across major $404 $674 markets due to COVID, lower average net selling price $630 $183 and favorable adjustments for statutory rebates $1,177 recorded in Europe in Q2'
Slide 16: HCV Patient Initiations
HCV Franchise HCV Patient Initiations in thousands 45 45 42 41 15 15 Q2 '20 U.S. market share at ~60% 15 18 • Q1 '20 up 16 percentage points from Jan 2019 in the 25 U.S.1 7 COVID-19 Insight: COVID impacted HCV market starts QoQ by -42% in U.S. and -58% in EU5, due to fewer HCP visits and screenings.
Slide 17: Cell Therapy Franchise Business Update
Cell Therapy Franchise Business Update Expanding leadership in hematological malignancies with the 1st cell therapy franchise Enhanced access for patients with a global 96% manufacturing success rate and rapid 17- Launch of Amsterdam manufacturing site for authorized site footprint of 180+ ATCs day
Slide 18: Emerging Growth Opportunities
Emerging Growth Opportunities Accelerating Lenacapavir efforts to build Filgotinib as foundation of IO portfolio and receives positive next wave of expertise Yescarta and European HIV products Accelerating Tecartus in cell CHMP opinion HBV to therapy for RA Continued $1 billion+ by Growth in 20222 C
Slide 19: Research & Development
Research & Development 19
Slide 20: Overview of Clinical Pipeline Today
Overview Phase 1 Phase 2 Phase 3 NDA/BLA/MAA of Clinical Viral Diseases Pipeline Today Inflammatory Diseases 42 Clinical stage programs1 8 through BD since Jan '19 12 NDA/BLA/MAA, P3 and Registrational P2 trials Oncology Clinical stage NMEs via 17 in-licensing, and acquisitions 3 Breakthrough Therap
Slide 21: Conference Data Readouts
Conference Data Readouts HIV Oncology • Magrolimab + azacitidine show durable activity in • Phase 1 data supporting 6 month dosing for lenacapavir previously-untreated MDS and AML in phase 1b trial • Phase 1 data supporting dose-dependent immune responses with vesatolimod, TLR-7 agonist for HIV cure
Slide 22: Long-Acting Programs Reinforce Commitment to HIV
HIV Franchise Long-Acting Programs Reinforce Commitment to HIV Lenacapavir Capsid Inhibitor as the Foundation Current Clinical Programs • Weekly oral and subcutaneous options administered as HTE P2/3 infrequently as every 6 months with self-admin potential Virologically suppressed2 P2 • Breakthrough
Slide 23: Remdesivir Data Highlights
COVID-19 Therapy Remdesivir Data Highlights Shortens 5 day treatment Real-world Generally recovery time effective for mortality well-tolerated most patients analysis Remdesivir shortened 5 day dosing was effective Remdesivir demonstrated Safety database from recovery time by average of in patients w
Slide 24: Ongoing Remdesivir Clinical Development Program
COVID-19 Therapy Ongoing Remdesivir Clinical Development Program • Plans to initiate a study of injectable remdesivir in outpatient populations who are at high risk for severe COVID-19 complications in Sep '20 Reaching additional patient • Initiated phase 1a study of an inhaled remdesivir solution i
Slide 25: Accelerating Efforts to Build IO Portfolio and Expertise
Immuno-Oncology Accelerating Efforts to Build IO Portfolio and Expertise Acquisition Research collaboration Select Internal Assets Equity purchase with Equity purchase with Clinical stage IO portfolio, Co-develop/commercialize IO exclusive right to acquire exclusive right to acquire including potent
Slide 26: Upcoming Milestones
Upcoming Milestones COVID-19 Insight: Clinical trials are Veklury (remdesivir for injection)1 Lenacapavir selectively being impacted by the Expected NDA submission for full COVID-19 approval P3 primary endpoint for HIV LA HTE pandemic, which may result in delays in Remdesivir for injection Lenacapav
Slide 27: Financial Performance
Financial Performance 27
Slide 28: Financial Highlights: Six Months Ended June 30
Financial Highlights: Six Months Ended June 30 in millions, except percentages and per share amounts H1 2019 H1 2020 YoY Change HIV1 7,659 8,134 6% HCV 1,632 1,177 (28%) Yescarta 216 296 37% Ranexa and Letairis 575 172 (70%) Other Products2 725 755 4% Product Sales $10,807 $10,534 (3%) COGS 1,401 1,
Slide 29: Financial Highlights: Q2 2020
Financial Highlights: Q2 2020 in millions, except percentages and per share amounts Q2 2019 Q1 2020 Q2 2020 YoY Change QoQ Change HIV1 4,041 4,134 4,000 (1%) (3%) HCV 842 729 448 (47%) (39%) Yescarta 120 140 156 30% 11% Ranexa and Letairis 223 91 81 (64%) (11%) Other Products2 381 373 382 0% 2% Prod
Slide 30: Total Revenue
Total Revenue in millions H1 '20 down 3% from H1 '19 • Decrease driven by lower HCV patient starts due to $10,966 $10,691 $5,879 COVID, expected declines in sales of Ranexa and Letairis $5,685 $5,604 $5,548 following generic entries and favorable adjustments for statutory rebates recorded in Europe
Slide 31: Non-GAAP R&D Expenses
Non-GAAP R&D Expenses in millions $1,186 $1,103 $1,028 $996 $1,004 Q2 '20 up 19% from Q2 '19 • Increase driven by higher clinical trial and manufacturing ramp-up expenses related to remdesivir • Partially offset by lower clinical trial expenses as a result of Gilead’s pause or postponement of other
Slide 32: Non-GAAP SG&A Expenses
Non-GAAP SG&A Expenses in millions $1,204 $1,164 $1,096 $1,076 $1,045 Q2 '20 up 6% from Q2 '19 • Increase primarily due to a $97 million accrual related to a previously disclosed DOJ investigation • Partially offset by lower spend related to COVID Q2 '20 up 8% from Q1 '20 • Increase primarily due to
Slide 33: Non-GAAP Operating Income & Margin
Non-GAAP Operating Income & Margin in millions $2,866 $2,762 $2,765 Q2 '20 down 30% from Q2 '19 $2,155 $1,995 • Decrease driven by lower revenues due to COVID, higher operating expenses due to investments in remdesivir and a $97 million accrual related to a previously disclosed DOJ investigation Q2
Slide 34: Non-GAAP Diluted EPS
Non-GAAP Diluted EPS in millions 1 $1.72 $1.68 $1.64 Q2 '20 decrease from Q2 '19 • Decrease due to lower operating income, higher Other Income & Expenses, and higher tax rate $1.11 $1.10 Q2 '20 decrease from Q1 '20 • Decrease due to lower operating income, higher Other Income & Expenses, and higher
Slide 35: Updated 2020 Guidance
Updated 2020 Guidance 35
Slide 36: Revised COVID-19 Macroeconomic Scenarios
Revised COVID-19 Macroeconomic Scenarios WORST CASE BASE CASE BEST CASE Outbreak continues through mid to Epidemiologists forecast continued peaks and valleys with some geographies containing the virus and others less so Rapid decline in COVID late 2021 and recovery blends into a Likely intensificat
Slide 37: Full Year 2020 Guidance
Full Year 2020 Guidance Starting in 2020, Gilead no longer regularly excludes stock-based compensation expense from its non-GAAP financial information in millions, except percentages and per share amounts Provided on February 4, 2020 Updated on July 30, 2020 Product Sales $21,800 - $22,200 $23,000 -
Slide 38: GAAP to Non-GAAP Reconciliation of Full Year 2020 Guidance
GAAP to Non-GAAP Reconciliation of Full Year 2020 Guidance1 Starting in 2020, Gilead no longer regularly excludes stock-based compensation expense from its non-GAAP financial information in millions, except percentages and per share amounts Provided on February 4, 2020 Updated on July 30, 2020 Proje
Slide 39: Appendix
Appendix 39
Slide 40: Viral Disease Pipeline
Viral Disease Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 NDA/MAA Updates since Q1’20 1 Veklury (remdesivir) injectable form COVID-19 P3 NDA * Remdesivir inhaled form COVID-19 New Lenacapavir capsid inhibitor (GS-6207) HIV LA HTE P2/3 Registrational for HTE 2 Lenacapavir capsid inhibitor (GS-620
Slide 41: Inflammatory Disease Pipeline
Inflammatory Disease Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 NDA/MAA Updates since Q1’20 Filgotinib JAK-1 inhibitor (GS-6034) Rheumatoid arthritis Filgotinib JAK-1 inhibitor (GS-6034) Ulcerative colitis Filgotinib JAK-1 inhibitor (GS-6034) Crohn’s disease Filgotinib JAK-1 inhibitor (GS-6034) P
Slide 42: Oncology Pipeline (1 of 2)
Oncology Pipeline (1 of 2) Pre-Clinical Phase 1 Phase 2 Phase 3 BLA/MAA Updates since Q1’20 Axi-cel 2L DLBCL Axi-cel iNHL Pivotal Axi-cel 1L DLBCL Axi-cel 3L DLBCL (+rituximab) Brexu-cel Adult ALL Pivotal Brexu-cel Pediatric ALL Pivotal Cell Therapy Axi-cel 3L DLBCL (+mavrilimumab) New Axi-cel 3L DL
Slide 43: Oncology Pipeline (2 of 2)
Oncology Pipeline (2 of 2) Pre-Clinical Phase 1 Phase 2 Phase 3 BLA/MAA Updates since Q1’20 Arcus – TIGIT1 ONC New Arcus – Adenosine Antagonist1 ONC New Arcus – PD12 ONC New Magrolimab (GS-4721) MDS P1b P3 initiation H2 2020 P3 P1b3 Magrolimab (GS-4721) AML P1b P3 initiation H1 2021 P2 P1b3 Magr
Slide 44: Thank You
THANK YOU CONTACT US investor_relations@gilead.com investors.gilead.com