Q4 & FY21 Financial Results: February 1, 2022
Q4 & FY21 Financial Results: February 1, 2022
February 1, 2022
2
Contents
Appendix 30-36
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 grew $1.4B (19% YoY) to $8.6B for FY21
• Effectively managed $1.3B Truvada and Atripla LOE impact
• Dosed first patient in Phase 1 oral COVID nucleoside for treatment of COVID-19 in Jan 2022
Active Pipeline • 2+ long-acting candidates moving into clinical development for HIV treatment
Expansion • Opted into 4 Arcus assets in Q421, adding 6 clinical stage programs with 3+ more planned
Continuing in 2022 • Collaborations with Merck exploring Trodelvy and Keytruda combinations
• Over 20 planned initiations, including 15 Trodelvy trials, 7 of which are Phase 3
4 Note: aALL – adult acute lymphocytic leukemia. BLA – biologics license application. LBCL - large B cell Confidential
lymphoma. LOE– Internal Use
– loss of Only
exclusivity. MAA - marketing authorization application. mTNBC – metastatic triple-negative breast cancer.
sBLA – supplemental biologics license application.
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 Phase 3 FPI
Trodelvy
ASCENT-03 1L mTNBC PD-L1- Phase 3 FPI Magrolimab ENHANCE-3 1L Unfit AML Phase 3 FPI1
ASCENT-04 1L mTNBC PD-L1+ Phase 3 FPI Yescarta ZUMA-7 2L LBCL MAA decision
Lenacapavir CAPELLA HIV Tx in HTE NDA decision Domvanalimab ARC-7 1L NSCLC Phase 2 PFS data
Completed On Track
Note: aALL – adult acute lymphocytic leukemia. AML – acute myeloid leukemia. BLA – biologics license application. CRPC – castrate-resistant prostate cancer. FL – follicular lymphoma. FPI – first patient in. HDV – hepatitis D virus. HIV -
human immunodeficiency virus. HR+/HER2- mBC - hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. HTE – heavily treatment-experienced. LBCL - large B cell lymphoma. MAA -
5 marketing authorization application. mTNBC – metastatic triple-negative breast cancer. NDA – new drug application.
Confidential NSCLC – Use
– Internal non-small
Only cell lung cancer. PDAC - pancreatic ductal adenocarcinoma. PFS – progression free survival. R/R –
relapsed/refractory. sBLA – supplemental biologics license application. Tx – treatment. 1 Subject to shifts in timeline pending resolution of FDA partial clinical holds.
Commercial
Highlights
& Market
Dynamics
Confidential – Confidential
Internal Use Only
– Internal Use Only
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 Note: HBV – hepatitis B virus. HCV – hepatitis C virus. HDV – hepatitis D virus. HIV - human immunodeficiency
Confidential
virus. – Internal Use Only
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
1 Source: IntegriChain 852 & 867 and HHS | Latest Data Date: 01/14/2022
2 Source: Healthverity Data and PINC AI™ Healthcare Data White Paper: Data that informs and performs, September 14, 2021. PINC AI™ Applied Sciences, Premier Inc. https://offers.premierinc.com/rs/381-NBB-
8 525/images/Premier-Healthcare-Database-Whitepaper-Final.pdf Confidential – Internal Use Only
3 Patients treated and utilization estimates are based on global Veklury, global remdesivir, and generic remdesivir volume donated and shipped for distribution. Within the US, assumed average treatment course is 5.5 vials/patient
$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
$2,786
Q420 Q121 Q221 Q321 Q421 COVID-19 INSIGHT: Year-over-year improvement in HIV treatment market,
U.S. Europe Other Int'l but screening and diagnoses rates remain below pre-pandemic levels.
9 Note: Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg) tablets. Descovy (emtricitabine
Confidential 200 mg,
– Internal Usetenofovir
Only alafenamide 25 mg) tablets.
Biktarvy: Leading and Growing in Market Share
U.S. Treatment TRx Share1
U.S. HIV Treatment Market
45%
30%
5% Share Gain in 2021
TRx Share
25%
20%
15%
10%
#1 prescribed regimen in the U.S. 2
5%
6% New
Entrants
0%
1 Source: IQVIA NPA Weekly; Descovy, Truvada and gF/TDF PrEP Volume excluded. New entrants include 2 new branded HIV treatments launched in the past 36 months. Based on the mixed reimbursement model, injectable
products will flow through both retail and non-retail channels and could cause underrepresentation in retail data due to buy and bill option. Note: This information is an estimate derived from the use of information under license
from the following IQVIA information service: NPA and LAAD. IQVIA expressly reserves all rights, including rights of copying, distribution and republication.
10 2 Source: Weekly IQVIA NPA MD Q421. Biktarvy #1 prescribed HIV regimen in the U.S. in Q421. Confidential – Internal Use Only
3 Source: Naïve U.S. Share based on longitudinal patient claims from IQVIA LAAD.
HCV: Market Share Growth Starts
Product Sales1 ($M)
$549
$510
$129
$423 $117 $429
$393
$229
$258 • Maintaining 50-60% share across core markets
$224 $209
1 HCV includes Epclusa, the authorized generic version of Epclusa, Harvoni, the authorized generic version of Harvoni, Sovaldi and Vosevi.
11 Confidential – Internal Use Only
US Sources: IQVIA, Integrichain, New Patient Starts excludes PAP. EU Source: Country Q4 EU5 and December LE (non-EU5) submissions. Base is DAA Market.
HBV / HDV: Leveraging Commercial Footprint
Product Sales1 ($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
$24
$23
$113 $104
$122 Q421 sales of $12M, flat QoQ
$81 $90
• 2022 plans to secure reimbursement for commercial
launches in several major European countries
Q420 Q121 Q221 Q321 Q421
U.S. Europe Other Int'l
1HBV includes Hepsera, Vemlidy and Viread. HDV Hepcludex sales of $6M reflect amount in Gilead books in Q1 after MYR acquisition closed.
12 Note: Hepcludex (bulevirtide) is conditionally authorized by the European Commission for treatment ofConfidential
chronic HDV.– Internal Use
Its safety Only
and efficacy have not been established in the United States or in other regions where it has not received
regulatory approval.
Trodelvy: Strong Momentum Heading into 2022
Product Sales1 ($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 testing and
Q420 Q121 Q221 Q321 Q421 diagnosis remain behind pre-COVID levels.
U.S. Europe
1 The acquisition of Immunomedics closed in Q420, and Gilead recognized $49M of the full $64M Trodelvy sales in Q420. The remaining $15M of sales were previously recognized by Immunomedics prior to the acquisition.
13 Confidential – Internal Use Only
2 YoY Growth reflects the full Q420 revenues of $64M compared to Q421 revenues of $118M.
Cell Therapy: Strong Q4 Momentum with 47% YoY Growth
Product Sales ($M)
$239
$222
$219
$191
$57 Sales grew 41% YoY; Up 4% QoQ
$41 $47
Note: ACE – Australia, Canada, and Europe. ALL - acute lymphocytic leukemia. FL – follicular lymphoma. LBCL – large B-cell lymphoma. MCL – mantle cell lymphoma. sBLA – supplemental biologics license application.
14 Confidential – Internal Use Only
1 Tecartus for the treatment of relapsed / refractory MCL has been granted accelerated approval by the FDA and conditional approval by the EMA.
CMO
Updates
Confidential – Confidential
Internal Use Only
– Internal Use Only
Expanding Indications for COVID-19 Treatment
Adults and adolescents requiring hospitalization (U.S.) or • GS-5245, a novel antiviral oral
supplemental oxygen (EU) COVID nucleoside
Note: FPI – first patient in. 1 In December 2021, the European Commission (EC) approved a variation to the Conditional Marketing Authorization to include adults who do not require supplemental oxygen and are at an increased risk of
progressing to severe COVID-19. The EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use
16 Confidential – Internal Use Only
for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. 2 In January 2022, the FDA granted accelerated approval of a supplemental new drug application (sNDA) for Veklury for the treatment of
non-hospitalized patients who are at high risk of progression to severe COVID-19, including hospitalization or death. Results from Phase 3 PINETREE study in non-hospitalized patients at high risk of disease progression.
Targeting HIV Lifecycle With Long-Acting Portfolio
GS-2872 + GS-5423 bNAb
1 Class: bNAb Class: bNAb
Phase: 1b Phase: Exploratory
LA Bictegravir GS-6212
Class: INSTI Class: INSTI
CYTOPLASM Phase: 1 Phase: Pre-IND
6 4
3 Nuclear Entry Maturation
GS-1720 INSTI
& Capsid Class: INSTI Class: INSTI
Disassembly Phase: Pre-IND Phase: Discovery
GS-1156
5 6 Class: PI
Phase: Discovery
Assembly &
1 Merck’s investigational islatravir. Note: bNAb - broadly neutralizing antibody. CAI - capsid assembly inhibitor. IND -
Budding investigational newOnly
drug. INSTI - integrase strand transfer inhibitor. LA - long-acting. NDA - new drug application; NRTI -
NUCLEUS 4 Integration Confidential – Internal Use
nucleoside reverse transcriptase inhibitor. NNRTI - non-nucleoside reverse transcriptase inhibitor. PI - protease inhibitor.
17
Long-Acting Pipeline Positioned To Be Best-in-Disease
Treatment Prevention
Dosing Every Foundation Partner Dosing Every Foundation
1 Week
Lenacapavir Islatravir1 Potential Approval in 2025
Phase 2
LA Bictegravir
1-3 Months Lenacapavir2 Phase 1 “With 6-month dosing, if
approved, lenacapavir would
Islatravir
3 Months Lenacapavir2 IND TBD have the potential to be a true
game changer.”
2 bNAbs
6 Months Lenacapavir2 Phase 1b POC
- Monica Gandhi, MD, MPH; Professor of Medicine, Division of HIV, Infectious Disease and
Global Medicine, UCSF; Director: UCSF Center for AIDS Research
Note: Lenacapavir is an investigational agent and is not approved by any regulatory authority for any use; its safety and efficacy are not established. Merck’s islatravir is an investigational agent and is not approved by any regulatory authority for any use;
its safety and efficacy are not established. 1 FDA has placed a partial clinical hold on the Phase 2 long-acting oral trial of Merck’s islatravir and lenacapavir. 2 FDA has placed a clinical hold on trials with injectable lenacapavir due to vial compatibility.
18
18 Presented strong lenacapavir 6-month efficacy data for HTE population; NDA submitted.
Confidential – Internal Use Only
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
Breast 1L NSCLC
Note: FPI – first patient in. HR+/HER2-mBC - hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. mTNBC – metastatic triple-negative breast cancer. mUC – metastatic urothelial
19 Confidential – Internal Use Only
cancer. NSCLC – non-small cell lung cancer. OS – overall survival. PFS – progression free survival. SOC – standard of care.
Exploring Magrolimab’s Potential Across Indications
Solid tumor
1L HR MDS Ph 3 Partial clinical hold1 (mNSCLC, Ph 1b/2 FPI completed in Q421
mSCLC, mUC)
Note: AML – acute myeloid leukemia. FPI – first patient in. HR MDS – higher risk myelodysplastic syndrome. mNSCLC – metastatic non-small cell lung cancer. mSCLC – metastatic small cell lung cancer. mTNBC – metastatic triple-negative
20 breast cancer. mUC – metastatic urothelial cancer. 1 FDA placed partial clinical holds on trials evaluating
Confidential
magrolimab
– Internal
in combination
Use Onlywith azacitidine as well as the fully enrolled DLBCL and multiple myeloma study. 2 Subject to shifts in
timeline pending resolution of FDA partial clinical holds.
Cell Therapy: Reinforcing Best-in-Class LBCL Data
ZUMA-1: 3L LBCL ZUMA-7: 2L Relapsed/Refractory LBCL ZUMA-12: 1L High-Risk LBCL
Note: EFS – event free survival. LBCL - large B cell lymphoma. OS – overall survival. ORR – objective response rate.
21 Confidential – Internal Use Only
Source: ZUMA-1 Neelapu SS, et al. N Engl J Med. 2017;377:2531-2544. ZUMA-7 ASH Presentation by Locke et al., 2021. ZUMA-12 ASH Presentation by Neelapu et al., 2021
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 Phase 3 FPI
Trodelvy
ASCENT-03 1L mTNBC PD-L1- Phase 3 FPI Magrolimab ENHANCE-3 1L Unfit AML Phase 3 FPI1
ASCENT-04 1L mTNBC PD-L1+ Phase 3 FPI Yescarta ZUMA-7 2L LBCL MAA decision
Lenacapavir CAPELLA HIV Tx in HTE NDA decision Domvanalimab ARC-7 1L NSCLC Phase 2 PFS data
Completed On Track
Note: aALL – adult acute lymphocytic leukemia. AML – acute myeloid leukemia. BLA – biologics license application. CRPC – castrate-resistant prostate cancer. FL – follicular lymphoma. FPI – first patient in. HDV – hepatitis D virus. HIV -
human immunodeficiency virus. HR+/HER2- mBC - hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. HTE – heavily treatment-experienced. LBCL - large B cell lymphoma. MAA -
22 marketing authorization application. mTNBC – metastatic triple-negative breast cancer. NDA – new drug application.
Confidential NSCLC – Use
– Internal non-small
Only cell lung cancer. PDAC - pancreatic ductal adenocarcinoma. PFS – progression free survival. R/R –
relapsed/refractory. sBLA – supplemental biologics license application. Tx – treatment. 1 Subject to shifts in timeline pending resolution of FDA partial clinical holds.
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 Magrolimab anti-CD47 Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Trodelvy®
Solid Tumors HNSCC 1L mTNBC (PD-L1-) 2-3L NSCLC 2L mTNBC Clinical stage
Etruma combinations (ARC-9) Magrolimab anti-CD475 Sacituzumab govitecan-hziy Magrolimab anti-CD475 Tecartus® (brexu-cel) programs1
Oncology
Etruma combinations (ARC-6)2 Magrolimab anti-CD47 Magrolimab anti-CD476 Magrolimab anti-CD475 Yescarta® (axi-cel)
mCRPC TNBC 1L Unfit AML 1L AML R/R FL
Yescarta® (axi-cel)
Brexu-cel
Pediatric ALL
Durva ± dom (PACIFIC-8)
Stage 3 NSCLC
Dom + zim vs. zim vs. chemo
(ARC-10) 1L NSCLC
Yescarta® (axi-cel)
2L LBCL
11
1L LBCL
Potential clinical
Lenacapavir/islatravir oral Vesatolimod TLR-7 agonist Lenacapavir capsid inhibitor Hepcludex® (bulevirtide)3 Veklury® (remdesivir)
combination HIV LA VS HIV Cure HIV PrEP HDV COVID-19 Outpatient stage opt-in
Viral Disease
Lenacapavir capsid inhibitor Lefitolimod TLR-9 agonist Lenacapavir capsid inhibitor assets
HIV LA VS HIV Cure HIV LA HTE
7
HIV Cure HDV
Selgantolimod TLR-8
agonist HBV Cure
Selonsertib ASK1 inhibitor Cilofexor/ firsocostat/ semaglutide Cilofexor FXR agonist Filgotinib JAK-1 inhibitor Filgotinib JAK-1 inhibitor
Inflammatory
approvals or AA
Galapagos
Gilead Program Kite Program Publicly Announced Planned Program Optionable Partner Program
in 20217
7 clinical stage programs4
Note: FDA placed clinical holds on all injectable lenacapavir programs due to vial quality concerns. FDA approved medicines shown: Trodelvy® for 2L mTNBC, Trodelvy® for 2L mUC (accelerated approval), Yescarta® for 3L LBCL, Yescarta® R/R FL (accelerated
approval), Tecartus® for R/R adult ALL and MCL (accelerated approval), Veklury® for COVID-19. 1. Program count does not include potential partner opt-in programs or publicly announced planned programs. 2. Phase 1b/2 trials. 3. Conditionally authorized by the
European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. 4. Includes six Phase 1 clinical stage programs and one Phase 2 clinical stage program. 5. FDA placed partial clinical holds on trials
evaluating magrolimab in combination with azacitidine as well as the fully enrolled DLBCL and MM study. 6. Subject to shifts in timeline pending resolution of FDA partial clinical holds. 7. Approval count does not include MAA approval for filgotinib for ulcerative
colitis in Q4’21. AA – accelerated approval. ALL - acute lymphocytic leukemia. AML - acute myeloid leukemia. axi-cel - axicabtagene ciloleucel. bNAb - broadly neutralizing antibody. brexu-cel - brexucabtagene autoleucel. DKD – diabetic kidney disease. DLBCL -
diffuse large B cell lymphoma. dom - domvanalimab. durva - durvalumab. etruma - etrumadenant. EV – emerging viruses. FL - follicular lymphoma. HNSCC – head and neck squamous cell carcinoma. HR MDS – higher risk myelodysplastic syndrome. HR+/HER2-mBC -
23 hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. HTE – heavily Confidential – Internal UseLAOnly
treatment-experienced. – long acting. LBCL - large B cell lymphoma. mCRC – metastatic colorectal cancer. mCRPC – metastatic castrate-
resistant prostate cancer. MM – multiple myeloma. mTNBC – metastatic triple-negative breast cancer. mUC - metastatic urothelial carcinoma. NASH – nonalcoholic steatohepatitis. NSCLC – non small cell lung cancer. PrEP - pre-exposure prophylaxis. PSC – primary
sclerosing cholangitis. quemli – quemliclustat. R/R - relapsed / refractory. TLR - toll-like receptor. VS – virologically suppressed. zim – zimberelimab.
Financial
Performance
Confidential – Confidential
Internal Use Only
– Internal Use Only
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 expenses, and other items that are
considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines.
25 Please refer to the accompanying press release for GAAP to non-GAAP reconciliations. 2 Guidance midpoints represents
Confidential the midpoints
– Internal Use Onlyof our FY21 non-GAAP EPS guidance shared on October 28, 2021. Q4 midpoint is calculated using the FY
guidance less the three quarters reported year to date on October 28, 2021.
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 8% driven
Product Sales excluding Veklury $5,390 $5,803 8% by growth in Biktarvy and contributions
COGS 918 2,111 130% from Cell Therapy and Trodelvy
Product Gross Margin 88% 71%
Gross Margin Down 1,700 bps YoY
R&D 1,512 1,984 31%
• Impacted by a $1.25B legal settlement
Acquired IPR&D - -
charge
SG&A 1,499 1,642 10%
Operating Expenses Up 20% YoY
Non-GAAP Costs and Expenses $3,929 $5,737 46%
Non-GAAP Operating Income $3,492 $1,507 -57% • Primarily driven by Arcus opt-in net
expense of $625M, increased clinical
Operating Margin 47% 21%
activities for Trodelvy and magrolimab,
Effective Tax Rate 16% 32% and increased commercial investment
Non-GAAP Net Income $2,762 $866 -69%
• Partially offset by a prior year expense
Non-GAAP Diluted EPS $2.19 $0.69 -69%
related to an amended agreement with
Shares used in per share calculation-diluted 1,259 1,262 0% Galapagos
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 expenses, and other items that are
26 considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity– securities
Confidential andOnly
Internal Use discrete and related tax charges or benefits associated with changes in tax related laws and guidelines.
Please refer to the accompanying press release for GAAP to non-GAAP reconciliations.
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 excluding Veklury $21,544 $21,443 0%
generally flat primarily due to LOEs in the
COGS 3,294 4,538 38% U.S., offset by growth in Biktarvy and
Product Gross Margin 87% 83% contributions from Cell Therapy and
Trodelvy
R&D 4,857 5,226 8%
Acquired IPR&D - 19 NM
SG&A 4,834 4,974 3% Operating Expenses: Up 5% YoY
Non-GAAP Costs and Expenses $12,985 $14,757 14% • Primarily driven by the Arcus opt-in net
Non-GAAP Operating Income $11,704 $12,548 7%
expense of $625M, timing of clinical
activities for Trodelvy and magrolimab and
Operating Margin 47% 46% increased commercial investment
Effective Tax Rate 19% 20%
Non-GAAP Net Income $8,958 $9,190 3%
• Partially offset by lower Veklury and prior
year expense related to an amended
Non-GAAP Diluted EPS $7.09 $7.28 3% agreement with Galapagos
Shares used in per share calculation-diluted 1,263 1,262 0%
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 expenses, and other items that are
27 Confidential
considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity– securities
Internal Use
andOnly
discrete and related tax charges or benefits associated with changes in tax related laws and guidelines.
Please refer to the accompanying press release for GAAP to non-GAAP reconciliations. NM - Not Meaningful.
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
significantly than prior years as a result of
Product Gross Margin 85% - 86% favorable gross-to-net adjustments in Q421
This financial guidance reflects the impact of recent corporate development transactions as well as funding for ordinary course partnering activities in 2021 but excludes the effects of any potential future extraordinary acquisitions,
collaborations and investments, the exercise of significant opt-ins or options related to collaboration programs where Gilead has such rights with its collaboration partners, and any other transactions or items that have not yet been
28 identified or quantified. Total interest expense and amortization from all issued debt is expected to beConfidential – Internal
approximately Use Only
$900 million for full year 2022. This guidance is subject to a number of risks and uncertainties. See Forward-Looking
Statements on page 2. Please refer to the accompanying press release and for GAAP to non-GAAP reconciliations.
29 Confidential – Internal Use Only
Appendix
Dec 31, 2020 Mar 31, 2021 Jun 30, 2021 Sep 30, 2021 Dec 31, 2021
Net Income attributable to Gilead $0.12 $0.30 $5.16 $7.39 $6.23
Add: Interest Expense2 & Other Income (expense), net 2.40 2.63 3.07 2.30 1.64
Add: Tax 1.58 1.66 1.58 1.96 2.08
Add: Depreciation 0.29 0.30 0.31 0.32 0.32
Add: Amortization3 1.28 1.52 1.80 2.03 2.12
Add: Acquired in-process research and development expenses4 5.86 5.82 1.39 0.24 0.18
Adjusted Debt to Adjusted EBITDA ratio6, 7 ~2.65x ~2.39x ~2.20x ~1.88x ~1.86x
1. Represents a funding agreement with RPI Finance Trust that was assumed as part of our acquisition of Immunomedics under which Immunomedics received cash in exchange for perpetual, tiered royalty payments on worldwide sales of Trodelvy. This funding
agreement is classified as debt. 2. Total interest expense and amortization from all issued debt is expected to be approximately $900 million for full year 2022. 3. Beginning in Q4 2020, includes acquisition-related amortization of inventory step-up charges. 4.
Beginning in Q3 2020, adjusted EBITDA excludes all acquired IPR&D expenses which comprise a separate line item on our Condensed Consolidated Statements of Operations. Prior to the change, adjusted EBITDA excluded some, but not all charges aggregated within
31 acquired IPR&D expenses. Prior periods have been recast to reflect the change. Acquired IPR&D expenses reflect IPR&D Confidential
impairments– as
Internal
well as Use Only costs of externally developed IPR&D projects, acquired directly in a transaction other than a business
the initial
combination, that do not have an alternative future use, including upfront payments related to various collaborations and the initial costs of rights to IPR&D projects. 5. Represents a charge related to a legal settlement. 6. Represents the last twelve months of
adjusted EBITDA. 7. Adjusted EBITDA and adjusted debt to adjusted EBITDA ratio are non-GAAP performance measures used by our investors and analysts to assess the overall operating performance in the context of financial leverage.
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 Magrolimab anti-CD47 Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Trodelvy®
Solid Tumors HNSCC 1L mTNBC (PD-L1-) 2-3L NSCLC 2L mTNBC Clinical stage
Etruma combinations (ARC-9) Magrolimab anti-CD475 Sacituzumab govitecan-hziy Magrolimab anti-CD475 Tecartus® (brexu-cel) programs1
Oncology
Etruma combinations (ARC-6)2 Magrolimab anti-CD47 Magrolimab anti-CD476 Magrolimab anti-CD475 Yescarta® (axi-cel)
mCRPC TNBC 1L Unfit AML 1L AML R/R FL
Yescarta® (axi-cel)
Brexu-cel
Pediatric ALL
Durva ± dom (PACIFIC-8)
Stage 3 NSCLC
Dom + zim vs. zim vs. chemo
(ARC-10) 1L NSCLC
Yescarta® (axi-cel)
2L LBCL
11
1L LBCL
Potential clinical
Lenacapavir/islatravir oral Vesatolimod TLR-7 agonist Lenacapavir capsid inhibitor Hepcludex® (bulevirtide)3 Veklury® (remdesivir)
combination HIV LA VS HIV Cure HIV PrEP HDV COVID-19 Outpatient stage opt-in
Viral Disease
Lenacapavir capsid inhibitor Lefitolimod TLR-9 agonist Lenacapavir capsid inhibitor assets
HIV LA VS HIV Cure HIV LA HTE
7
HIV Cure HDV
Selgantolimod TLR-8
agonist HBV Cure
Selonsertib ASK1 inhibitor Cilofexor/ firsocostat/ semaglutide Cilofexor FXR agonist Filgotinib JAK-1 inhibitor Filgotinib JAK-1 inhibitor
Inflammatory
approvals or AA
Galapagos
Gilead Program Kite Program Publicly Announced Planned Program Optionable Partner Program
in 20217
7 clinical stage programs4
Note: FDA placed clinical holds on all injectable lenacapavir programs due to vial quality concerns. FDA approved medicines shown: Trodelvy® for 2L mTNBC, Trodelvy® for 2L mUC (accelerated approval), Yescarta® for 3L LBCL, Yescarta® R/R FL (accelerated
approval), Tecartus® for R/R adult ALL and MCL (accelerated approval), Veklury® for COVID-19. 1. Program count does not include potential partner opt-in programs or publicly announced planned programs. 2. Phase 1b/2 trials. 3. Conditionally authorized by the
European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. 4. Includes six Phase 1 clinical stage programs and one Phase 2 clinical stage program. 5. FDA placed partial clinical holds on trials
evaluating magrolimab in combination with azacitidine as well as the fully enrolled DLBCL and MM study. 6. Subject to shifts in timeline pending resolution of FDA partial clinical holds. 7. Approval count does not include MAA approval for filgotinib for ulcerative
colitis in Q4’21. AA – accelerated approval. ALL - acute lymphocytic leukemia. AML - acute myeloid leukemia. axi-cel - axicabtagene ciloleucel. bNAb - broadly neutralizing antibody. brexu-cel - brexucabtagene autoleucel. DKD – diabetic kidney disease. DLBCL -
diffuse large B cell lymphoma. dom - domvanalimab. durva - durvalumab. etruma - etrumadenant. EV – emerging viruses. FL - follicular lymphoma. HNSCC – head and neck squamous cell carcinoma. HR MDS – higher risk myelodysplastic syndrome. HR+/HER2-mBC -
32 hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. HTE – heavily Confidential – Internal UseLAOnly
treatment-experienced. – long acting. LBCL - large B cell lymphoma. mCRC – metastatic colorectal cancer. mCRPC – metastatic castrate-
resistant prostate cancer. MM – multiple myeloma. mTNBC – metastatic triple-negative breast cancer. mUC - metastatic urothelial carcinoma. NASH – nonalcoholic steatohepatitis. NSCLC – non small cell lung cancer. PrEP - pre-exposure prophylaxis. PSC – primary
sclerosing cholangitis. quemli – quemliclustat. R/R - relapsed / refractory. TLR - toll-like receptor. VS – virologically suppressed. zim – zimberelimab.
Oncology Pipeline
New listing since Q3’21 Change since Q3’21
Breakthrough Therapy Designation P PRIME Designation
Planned program
Yescarta® (axi-cel) 2L LBCL sBLA Filed, Type II Filed EMA Type II variation filed
Lenacapavir capsid inhibitor (GS-6207)1 HIV LA HTE NDA and MAA Filed
36 Confidential
1 In collaboration with Galapagos. 2 Screening/enrollment paused pending evaluation of preliminary preclinical – Internal
findings. Use Only
3 Clinical collaboration with Novo Nordisk.DKD – diabetic kidney disease. NASH – nonalcoholic steatohepatitis. PSC
– primary sclerosing cholangitis.