Product Sales Excluding Veklury Increased 6%
Year-Over-Year to $6.7 billion
Biktarvy Sales Increased 8% Year-Over-Year to
$3.2 billion
Oncology Sales Increased 15% Year-Over-Year to
$841 million
Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second
quarter 2024 results of operations.
“Gilead has had another strong quarter with 6% year-over-year
growth in our base business. This was driven by sales of our
therapies for HIV, Oncology and Liver Disease, including 8% growth
for Biktarvy,” said Daniel O’Day, Gilead’s Chairman and Chief
Executive Officer. “One of the key highlights of the quarter was
interim data from the Phase 3 PURPOSE 1 trial showing 100% efficacy
for lenacapavir in HIV prevention for cisgender women. We look
forward to additional clinical readouts in the coming months, and
to potentially launching seladelpar for primary biliary cholangitis
in the United States.”
Second Quarter 2024 Financial
Results
- Total second quarter 2024 revenue increased 5% to $7.0 billion,
compared to the same period in 2023, primarily due to higher
product sales in HIV, Liver Disease and Oncology.
- Diluted earnings per share (“EPS”) was $1.29 in the second
quarter 2024, compared to $0.83 in the same period in 2023. The
increase was primarily driven by lower operating expenses,
including a 2023 expense of $525 million for settlements with
certain plaintiffs in HIV antitrust litigation which did not repeat
in 2024, as well as higher revenues and lower income tax expense,
partially offset by higher net unrealized losses on equity
securities.
- Non-GAAP diluted EPS was $2.01 in the second quarter 2024,
compared to $1.34 in the same period in 2023. The increase was
primarily driven by lower operating expenses and higher
revenues.
- As of June 30, 2024, Gilead had $2.8 billion of cash, cash
equivalents and marketable debt securities, compared to $8.4
billion as of December 31, 2023. The decrease primarily reflects
the $3.9 billion acquisition of CymaBay Therapeutics, Inc. and a
$1.75 billion repayment of senior notes.
- During the second quarter 2024, Gilead generated $1.3 billion
in operating cash flow, net of a $1.2 billion transition tax
payment associated with the Tax Cuts and Jobs Act of 2017.
- During the second quarter 2024, Gilead paid dividends of $972
million and repurchased $100 million of common stock.
Second Quarter 2024 Product Sales
Total second quarter 2024 product sales increased 5% to $6.9
billion, compared to the same period in 2023. Total product sales,
excluding Veklury, increased 6% to $6.7 billion in the second
quarter 2024, compared to the same period in 2023, primarily due to
higher product sales in HIV, Liver Disease and Oncology.
HIV product sales increased 3% to $4.7 billion in the second
quarter 2024, compared to the same period in 2023, primarily driven
by higher demand across treatment and prevention, partially offset
by lower average realized price due to channel mix.
- Biktarvy® (bictegravir 50mg/emtricitabine 200mg
(“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 8% to
$3.2 billion in the second quarter 2024, compared to the same
period in 2023, primarily driven by higher demand.
- Descovy® (FTC 200mg/TAF 25mg) sales decreased 6% to $485
million in the second quarter 2024, compared to the same period in
2023, primarily driven by lower average realized price due to
channel mix, partially offset by higher demand.
The Liver Disease portfolio sales increased 17% to $832
million in the second quarter 2024, compared to the same period in
2023. This was primarily driven by higher average realized price
due to channel mix in the United States, as well as higher demand
in products for chronic hepatitis C virus (“HCV”), chronic
hepatitis B virus (“HBV”) and, in Europe, chronic hepatitis D virus
(“HDV”).
Veklury sales decreased 16% to $214 million in the second
quarter 2024, compared to the same period in 2023, primarily driven
by lower rates of COVID-19 related hospitalizations.
Cell Therapy product sales increased 11% to $521 million in the
second quarter 2024, compared to the same period in 2023.
- Yescarta® (axicabtagene ciloleucel) sales increased 9%
to $414 million in the second quarter 2024, compared to the same
period in 2023, primarily driven by higher demand in relapsed or
refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the
United States.
- Tecartus® (brexucabtagene autoleucel) sales increased
21% to $107 million in the second quarter 2024, compared to the
same period in 2023, driven by higher demand in R/R mantle cell
lymphoma and R/R adult acute lymphoblastic leukemia (“ALL”).
Trodelvy® (sacituzumab govitecan-hziy) sales increased
23% to $320 million in the second quarter 2024, compared to the
same period in 2023, primarily driven by higher demand in
second-line metastatic triple negative breast cancer and
pre-treated HR+/HER2- metastatic breast cancer.
Second Quarter 2024 Product Gross Margin, Operating Expenses
and Effective Tax Rate
- Product gross margin was 77.7% in the second quarter 2024,
compared to 78.0% in the same period in 2023. Non-GAAP product
gross margin was 86.0% in the second quarter 2024, compared to
86.9% in the same period in 2023.
- Research & development (“R&D”) expenses were $1.4
billion in the second quarter 2024 and in the same period in 2023.
Non-GAAP R&D expenses were $1.3 billion in the second quarter
2024, compared to $1.4 billion in the same period in 2023. The
changes were primarily driven by timing of clinical activities,
including wind-down of studies.
- Acquired IPR&D expenses were $38 million in the second
quarter 2024.
- Selling, general and administrative (“SG&A”) expenses and
non-GAAP SG&A expenses were $1.4 billion in the second quarter
2024, compared to $1.8 billion in the same period in 2023. The
decreases in GAAP and non-GAAP SG&A expenses were primarily
driven by the 2023 legal settlement expense referenced earlier
which did not repeat in 2024.
- The effective tax rate (“ETR”) was 21.4% in the second quarter
2024, compared to 34.6% in the same period in 2023. The decrease in
ETR primarily reflects a remeasurement of certain deferred tax
liabilities in the prior year and a settlement with a tax authority
in the second quarter 2024. Non-GAAP ETR was 17.8% in the second
quarter 2024, compared to 21.0% in the same period in 2023. The
decrease in non-GAAP ETR primarily reflects a settlement with a tax
authority.
Guidance and Outlook
For the full-year 2024, Gilead expects:
(in millions, except per share
amounts)
August 8, 2024
Guidance
Low End
High End
Comparison to April 25, 2024
Guidance
Product sales
$
27,100
$
27,500
Unchanged
Product sales, excluding Veklury
$
25,800
$
26,200
Unchanged
Veklury
$
1,300
$
1,300
Unchanged
Diluted EPS
$
0.00
$
0.30
Previously $0.10 to $0.50
Non-GAAP diluted EPS
$
3.60
$
3.90
Previously $3.45 to $3.85
Additional information and a reconciliation between GAAP and
non-GAAP financial information for the 2024 guidance is provided in
the accompanying tables. The financial guidance is subject to a
number of risks and uncertainties. See the Forward-Looking
Statements section below.
Key Updates Since Our Last Quarterly
Release
Virology
- Presented data from the Phase 3 PURPOSE 1 trial evaluating
twice-yearly subcutaneous lenacapavir for HIV prevention in
cisgender women at the International AIDS Conference (“AIDS 2024”).
At the interim analysis, lenacapavir demonstrated 100% efficacy
with zero HIV infections and superiority to both background HIV
incidence and once-daily oral Truvada® (FTC 200mg and tenofovir
disoproxil fumarate 300mg (“TDF”)). Lenacapavir was generally
well-tolerated and no new safety concerns were identified. The use
of lenacapavir for PrEP is investigational.
- Highlighted long-term, five-year data for Biktarvy at AIDS
2024, demonstrating virologic suppression in Hispanic/Latine people
with HIV, as well as older adults with comorbidities. Additionally,
presented results from Gilead’s investigational treatment pipeline,
including 48-week data from the Phase 2 portion of the Phase 2/3
ARTISTRY study of once-daily oral bictegravir plus lenacapavir,
once-weekly oral agents GS-1720 and GS-4182, as well as
twice-yearly lenacapavir in combination with two broadly
neutralizing antibodies, teropavimab and zinlirvimab.
- Announced U.S. Food and Drug Administration (“FDA”) approval of
an updated label for Biktarvy to include additional data for the
treatment of pregnant adults with HIV-1 with suppressed viral
loads.
- Presented Phase 2b MYR201 data demonstrating potential for the
investigational combination of bulevirtide 10 mg with pegylated
interferon alfa-2a as finite therapy for people with chronic HDV at
the European Association for the Study of the Liver (“EASL”)
meeting. These data were simultaneously published in the New
England Journal of Medicine.
- Presented 144-week follow-up data from the Phase 3 MYR301 study
at EASL that reinforced bulevirtide as an efficacious and generally
well-tolerated long-term treatment option as monotherapy in adults
with chronic HDV. Bulevirtide 2 mg remains the only approved
treatment for HDV in the EU and is not approved in the U.S.
Bulevirtide 10 mg is an investigational product and is not approved
anywhere globally.
Oncology
- Announced Trodelvy did not meet the primary endpoint of
improvement in overall survival (“OS”) in the intention-to-treat
(“ITT”) population of the confirmatory Phase 3 TROPiCS-04 study in
locally advanced or metastatic urothelial cancer. A numerical
improvement in OS favoring Trodelvy was observed, in addition to
trends in improvement for select pre-specified non-alpha controlled
subgroups analyses and secondary endpoints of progression-free
survival and overall response rate. In the ITT population, there
was a higher number of deaths due to adverse events with Trodelvy
compared to single-agent chemotherapy, which were primarily
observed early in treatment and related to neutropenic
complications, including infection.
- Presented detailed results from the Phase 3 EVOKE-01 study
evaluating Trodelvy in patients with metastatic or advanced
non-small cell lung cancer (“NSCLC”) that had progressed on or
after platinum-based chemotherapy and anti-PD(L)1 therapy at the
American Society of Clinical Oncology (“ASCO”) meeting. These data
were simultaneously published in the Journal of Clinical Oncology.
As announced in January 2024, EVOKE-01 did not meet its primary
endpoint of overall survival. The use of Trodelvy for lung cancer
is investigational.
- Provided a longer-term update on Cohort A of the Phase 2
EVOKE-02 study of Trodelvy in combination with pembrolizumab in
first-line advanced or metastatic squamous or non-squamous
PD-L1-high NSCLC at the ASCO meeting.
- Announced new data from a pilot study in collaboration with
Dana-Farber Cancer Institute that evaluated the safety of Yescarta
in patients living with R/R primary or secondary central nervous
system lymphoma, an investigational use. This data was presented at
the ASCO meeting.
- Presented updated, four-year OS data from the pivotal Phase 2
ZUMA-3 study evaluating Tecartus in adult patients with R/R B-cell
ALL at the ASCO meeting.
- Presented updated analysis at the ASCO meeting from Arm A1 of
the Phase 2 EDGE-Gastric study evaluating domvanalimab,
zimberelimab (“zim”) and FOLFOX as a potential first-line treatment
for upper gastrointestinal cancers, in partnership with Arcus
Biosciences, Inc. (“Arcus”). Additionally, presented Phase 1b/2
ARC-9 Cohort B data with our partner Arcus, which is evaluating
etrumadenant plus zim, FOLFOX and bevacizumab in third-line
metastatic colorectal cancer. These products and uses are
investigational.
- Announced preliminary findings at the European Hematology
Association (“EHA”) meeting from the Phase 2 ZUMA-24 study
suggesting outpatient administration of Yescarta is feasible.
Additionally, presented real-world manufacturing experience
analysis demonstrating a statistically significant higher number of
R/R large B-cell lymphoma patients that received second-line
treatment with Yescarta achieved first-pass manufacturing success
compared to patients that received treatment with Yescarta in
third-line and beyond.
- Announced key operational updates, together with Arcellx, Inc.
(“Arcellx”), for the anitocabtagene autoleucel multiple myeloma
development program, including the design of the Phase 3 iMMagine-3
trial as a second- to fourth-line treatment for multiple myeloma,
as well as the completion of the technical transfer to Kite.
Inflammation
- Presented two-year interim results from the ongoing long-term
Phase 3 ASSURE study evaluating seladelpar in people living with
primary biliary cholangitis (“PBC”) who participated in any prior
seladelpar clinical study at the Digestive Diseases Week and EASL
meetings. The data demonstrated a sustained and consistent
long-term efficacy and safety profile for seladelpar in PBC.
Seladelpar is an investigational product and is currently under
review by FDA, with a PDUFA date of August 14, 2024.
- Entered into an amended license agreement featuring the buy-out
of global seladelpar royalties from Janssen Pharmaceutica NV for
$320 million. This transaction will be reflected in Gilead’s third
quarter results.
Corporate
- Announced Gilead reached a settlement agreement in principle in
the federal TDF litigation in the U.S. District Court for the
Northern District of California. The agreement, which is subject to
certain conditions, provides that Gilead will make a one-time
payment of up to $40 million and is expected to resolve the claims
of the overwhelming majority of plaintiffs in the federal TDF
litigation.
- Announced Chief Medical Officer Merdad Parsey, MD, PhD, will
leave the company in the first quarter of 2025. A search is
underway for his successor.
- The Board declared a quarterly dividend of $0.77 per share of
common stock for the third quarter of 2024. The dividend is payable
on September 27, 2024, to stock holders of record at the close of
business on September 13, 2024. Future dividends will be subject to
Board approval.
Certain amounts and percentages in this press release may not
sum or recalculate due to rounding.
Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference
call to discuss Gilead’s results. A live webcast will be available
on http://investors.gilead.com and will be archived on
www.gilead.com for one year.
Non-GAAP Financial
Information
The information presented in this document has been prepared in
accordance with U.S. generally accepted accounting principles
(“GAAP”), unless otherwise noted as non-GAAP. Management believes
non-GAAP information is useful for investors, when considered in
conjunction with Gilead’s GAAP financial information, because
management uses such information internally for its operating,
budgeting and financial planning purposes. Non-GAAP information is
not prepared under a comprehensive set of accounting rules and
should only be used to supplement an understanding of Gilead’s
operating results as reported under GAAP. Non-GAAP financial
information generally excludes acquisition-related expenses
including amortization of acquired intangible assets 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.
Although Gilead consistently excludes the amortization of acquired
intangible assets from the non-GAAP financial information,
management believes that it is important for investors to
understand that such intangible assets were recorded as part of
acquisitions and contribute to ongoing revenue generation. Non-GAAP
measures may be defined and calculated differently by other
companies in the same industry. Reconciliations of the non-GAAP
financial measures to the most directly comparable GAAP financial
measures are provided in the accompanying tables.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19 and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
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 uncertainties that could cause actual results
to differ materially. These risks and uncertainties include those
relating to: Gilead’s ability to achieve its anticipated full year
2024 financial results, including as a result of the uncertainty of
the amount and timing of Veklury revenues; Gilead’s ability to make
progress on any of its long-term ambitions or priorities laid out
in its corporate strategy; Gilead’s ability to accelerate or
sustain revenues for its virology, oncology and other programs;
Gilead’s ability to realize the potential benefits of acquisitions,
collaborations or licensing arrangements, including the
arrangements with Arcellx and Arcus; patent protection and
estimated loss of exclusivity for our products and product
candidates; Gilead’s ability to initiate, progress or complete
clinical trials within currently anticipated timeframes or at all,
the possibility of unfavorable results from ongoing and additional
clinical trials, including those involving Biktarvy, Trodelvy,
Truvada, Yescarta, bevacizumab, bictegravir, bulevirtide,
anitocabtagene autoleucel, domvanalimab, etrumadenant, GS-1720,
GS-4182, lenacapavir, teropavimab, seladelpar, zimberelimab, and
zinlirvimab (such as the ARTISTRY-1, ASSURE, EDGE-Gastric,
EVOKE-01, EVOKE-02, iMMagine-3, MYR201, MYR301, PURPOSE-1,
TROPiCS-04, ZUMA-3 and ZUMA-24 studies) , and the risk that safety
and efficacy data from clinical trials may not warrant further
development of Gilead’s product candidates or the product
candidates of Gilead’s strategic partners; Gilead’s ability to
submit new drug applications for new product candidates or expanded
indications in the currently anticipated timelines; Gilead’s
ability to receive or maintain regulatory approvals in a timely
manner or at all, including FDA approval of the New Drug
Application for seladelpar, and the risk that any such approvals,
if granted, may be subject to significant limitations on use and
may be subject to withdrawal or other adverse actions by the
applicable regulatory authority (such as the risk that the FDA may
not grant full approval or may withdraw its accelerated approval
for Trodelvy for the treatment of locally advanced or metastatic
urothelial cancer); Gilead’s ability to successfully commercialize
its products; the risk of potential disruptions to the
manufacturing and supply chain of Gilead’s products; pricing and
reimbursement pressures from government agencies and other third
parties, including required rebates and other discounts; a larger
than anticipated shift in payer mix to more highly discounted payer
segments; market share and price erosion caused by the introduction
of generic versions of Gilead products; the risk that physicians
and patients may not see advantages of Gilead’s products over other
therapies and may therefore be reluctant to prescribe the products,
including Biktarvy; and other risks identified from time to time in
Gilead’s reports filed with the SEC, including annual reports on
Form 10-K, quarterly reports on Form 10-Q and current reports on
Form 8-K. In addition, Gilead makes estimates and judgments that
affect the reported amounts of assets, liabilities, revenues and
expenses and related disclosures. Gilead bases its estimates on
historical experience and on various other market specific and
other relevant assumptions that it believes to be reasonable under
the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. There may be other
factors of which Gilead is not currently aware that may affect
matters discussed in the forward-looking statements and may also
cause actual results to differ significantly from these estimates.
Further, results for the quarter ended June 30, 2024 are not
necessarily indicative of operating results for any future periods.
Gilead directs readers to its press releases, annual reports on
Form 10-K, quarterly reports on Form 10-Q and other subsequent
disclosure documents filed with the SEC. Gilead claims the
protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements.
The reader is cautioned that forward-looking statements are not
guarantees of future performance and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead and Gilead assumes no obligation to update or
supplement any such forward-looking statements other than as
required by law. Any forward-looking statements speak only as of
the date hereof or as of the dates indicated in the statements.
Gilead owns or has rights to various
trademarks, copyrights and trade names used in its business,
including the following: GILEAD®, GILEAD SCIENCES®, KITETM,
AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®,
DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®,
HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®,
SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®,
TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®,
YESCARTA® and ZYDELIG®. KEYTRUDA® is a registered trademark of
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, United States. Other trademarks are the property of
their respective owners.
For more information on Gilead Sciences, Inc.,
please visit www.gilead.com or call the Gilead Public Affairs
Department at 1-800-GILEAD-5 (1-800-445-3235).
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions, except per share
amounts)
2024
2023
2024
2023
Revenues:
Product sales
$
6,912
$
6,564
$
13,559
$
12,870
Royalty, contract and other revenues
41
35
81
81
Total revenues
6,954
6,599
13,640
12,951
Costs and expenses:
Cost of goods sold
1,544
1,442
3,096
2,843
Research and development expenses
1,351
1,407
2,871
2,854
Acquired in-process research and
development expenses
38
236
4,169
717
In-process research and development
impairment
—
—
2,430
—
Selling, general and administrative
expenses
1,377
1,849
2,752
3,168
Total costs and expenses
4,309
4,934
15,317
9,581
Operating income (loss)
2,644
1,665
(1,678
)
3,370
Interest expense
237
230
491
459
Other (income) expense, net
355
(152
)
265
22
Income (loss) before income taxes
2,053
1,588
(2,433
)
2,888
Income tax expense
438
549
123
865
Net income (loss)
1,614
1,039
(2,556
)
2,024
Net loss attributable to noncontrolling
interest
—
(6
)
—
(32
)
Net income (loss) attributable to
Gilead
$
1,614
$
1,045
$
(2,556
)
$
2,055
Basic earnings (loss) per share
attributable to Gilead
$
1.29
$
0.84
$
(2.05
)
$
1.65
Shares used in basic earnings (loss) per
share attributable to Gilead calculation
1,247
1,249
1,247
1,249
Diluted earnings (loss) per share
attributable to Gilead
$
1.29
$
0.83
$
(2.05
)
$
1.63
Shares used in diluted earnings (loss) per
share attributable to Gilead calculation
1,251
1,258
1,247
1,260
Supplemental Information:
Cash dividends declared per share
$
0.77
$
0.75
$
1.54
$
1.50
Product gross margin
77.7
%
78.0
%
77.2
%
77.9
%
Research and development expenses as a %
of revenues
19.4
%
21.3
%
21.0
%
22.0
%
Selling, general and administrative
expenses as a % of revenues
19.8
%
28.0
%
20.2
%
24.5
%
Operating margin
38.0
%
25.2
%
(12.3
)%
26.0
%
Effective tax rate
21.4
%
34.6
%
(5.1
)%
29.9
%
GILEAD SCIENCES, INC.
TOTAL REVENUE SUMMARY
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions, except
percentages)
2024
2023
Change
2024
2023
Change
Product sales:
HIV
$
4,745
$
4,626
3
%
$
9,088
$
8,816
3
%
Liver Disease
832
711
17
%
1,569
1,386
13
%
Oncology
841
728
15
%
1,629
1,398
17
%
Other
280
243
15
%
504
442
14
%
Total product sales excluding Veklury
6,698
6,308
6
%
12,790
12,041
6
%
Veklury
214
256
(16
)%
769
829
(7
)%
Total product sales
6,912
6,564
5
%
13,559
12,870
5
%
Royalty, contract and other revenues
41
35
18
%
81
81
(1
)%
Total revenues
$
6,954
$
6,599
5
%
$
13,640
$
12,951
5
%
GILEAD SCIENCES, INC.
NON-GAAP FINANCIAL
INFORMATION(1)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions, except
percentages)
2024
2023
Change
2024
2023
Change
Non-GAAP:
Cost of goods sold
$
965
$
861
12%
$
1,939
$
1,732
12%
Research and development expenses
$
1,335
$
1,377
(3)%
$
2,738
$
2,816
(3)%
Acquired IPR&D expenses(2)
$
38
$
236
(84)%
$
4,169
$
717
NM
Selling, general and administrative
expenses
$
1,351
$
1,848
(27)%
$
2,646
$
3,166
(16)%
Other (income) expense, net
$
(37
)
$
(83
)
(56)%
$
(141
)
$
(165
)
(15)%
Diluted earnings per share attributable to
Gilead
$
2.01
$
1.34
50%
$
0.70
$
2.71
(74)%
Shares used in non-GAAP diluted earnings
per share attributable to Gilead calculation
1,251
1,258
(1)%
1,254
1,260
—%
Product gross margin
86.0
%
86.9
%
-84 bps
85.7
%
86.5
%
-84 bps
Research and development expenses as a %
of revenues
19.2
%
20.9
%
-167 bps
20.1
%
21.7
%
-167 bps
Selling, general and administrative
expenses as a % of revenues
19.4
%
28.0
%
-857 bps
19.4
%
24.4
%
-504 bps
Operating margin
47.0
%
34.5
%
NM
15.7
%
34.9
%
NM
Effective tax rate
17.8
%
21.0
%
-322 bps
51.4
%
20.0
%
NM
________________________________
NM - Not Meaningful
(1)
Refer to Non-GAAP Financial Information
section above for further disclosures on non-GAAP financial
measures. A reconciliation between GAAP and non-GAAP financial
information is provided in the tables below.
(2)
Equal to GAAP financial information.
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO
NON-GAAP FINANCIAL INFORMATION
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions, except percentages and
per share amounts)
2024
2023
2024
2023
Cost of goods sold
reconciliation:
GAAP cost of goods sold
$
1,544
$
1,442
$
3,096
$
2,843
Acquisition-related – amortization(1)
(579
)
(581
)
(1,158
)
(1,110
)
Restructuring
—
—
1
—
Non-GAAP cost of goods sold
$
965
$
861
$
1,939
$
1,732
Product gross margin
reconciliation:
GAAP product gross margin
77.7
%
78.0
%
77.2
%
77.9
%
Acquisition-related – amortization(1)
8.4
%
8.8
%
8.5
%
8.6
%
Restructuring
(—
)%
—
%
(—
)%
—
%
Non-GAAP product gross margin
86.0
%
86.9
%
85.7
%
86.5
%
Research and development expenses
reconciliation:
GAAP research and development expenses
$
1,351
$
1,407
$
2,871
$
2,854
Acquisition-related – other costs(2)
(3
)
(30
)
(70
)
(38
)
Restructuring
(13
)
—
(63
)
—
Non-GAAP research and development
expenses
$
1,335
$
1,377
$
2,738
$
2,816
IPR&D impairment
reconciliation:
GAAP IPR&D impairment
$
—
$
—
$
2,430
$
—
IPR&D impairment
—
—
(2,430
)
—
Non-GAAP IPR&D impairment
$
—
$
—
$
—
$
—
Selling, general and administrative
expenses reconciliation:
GAAP selling, general and administrative
expenses
$
1,377
$
1,849
$
2,752
$
3,168
Acquisition-related – other costs(2)
(17
)
(1
)
(84
)
(2
)
Restructuring
(8
)
—
(22
)
—
Non-GAAP selling, general and
administrative expenses
$
1,351
$
1,848
$
2,646
$
3,166
Operating income (loss)
reconciliation:
GAAP operating income (loss)
$
2,644
$
1,665
$
(1,678
)
$
3,370
Acquisition-related – amortization(1)
579
581
1,158
1,110
Acquisition-related – other costs(2)
21
31
153
40
Restructuring
21
—
84
—
IPR&D impairment
—
—
2,430
—
Non-GAAP operating income
$
3,265
$
2,277
$
2,148
$
4,521
Operating margin
reconciliation:
GAAP operating margin
38.0
%
25.2
%
(12.3
)%
26.0
%
Acquisition-related – amortization(1)
8.3
%
8.8
%
8.5
%
8.6
%
Acquisition-related – other costs(2)
0.3
%
0.5
%
1.1
%
0.3
%
Restructuring
0.3
%
—
%
0.6
%
—
%
IPR&D impairment
—
%
—
%
17.8
%
—
%
Non-GAAP operating margin
47.0
%
34.5
%
15.7
%
34.9
%
Other (income) expense, net
reconciliation:
GAAP other (income) expense, net
$
355
$
(152
)
$
265
$
22
(Loss) gain from equity securities,
net
(392
)
69
(405
)
(187
)
Non-GAAP other (income) expense, net
$
(37
)
$
(83
)
$
(141
)
$
(165
)
Income (loss) before income taxes
reconciliation:
GAAP income (loss) before income taxes
$
2,053
$
1,588
$
(2,433
)
$
2,888
Acquisition-related – amortization(1)
579
581
1,158
1,110
Acquisition-related – other costs(2)
21
31
153
40
Restructuring
21
—
84
—
IPR&D impairment
—
—
2,430
—
Loss (gain) from equity securities,
net
392
(69
)
405
187
Non-GAAP income before income taxes
$
3,065
$
2,131
$
1,798
$
4,226
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO
NON-GAAP FINANCIAL INFORMATION - (Continued)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions, except percentages and
per share amounts)
2024
2023
2024
2023
Income tax expense
reconciliation:
GAAP income tax expense
$
438
$
549
$
123
$
865
Income tax effect of non-GAAP
adjustments:
Acquisition-related – amortization(1)
121
120
242
227
Acquisition-related – other costs(2)
7
5
37
8
Restructuring
7
—
16
—
IPR&D impairment
—
—
611
—
Loss (gain) from equity securities,
net
33
1
(6
)
1
Discrete and related tax charges(3)
(60
)
(227
)
(100
)
(256
)
Non-GAAP income tax expense
$
546
$
448
$
923
$
844
Effective tax rate
reconciliation:
GAAP effective tax rate
21.4
%
34.6
%
(5.1
)%
29.9
%
Income tax effect of above non-GAAP
adjustments and discrete and related tax adjustments(3)
(3.5
)%
(13.5
)%
56.4
%
(10.0
)%
Non-GAAP effective tax rate
17.8
%
21.0
%
51.4
%
20.0
%
Net income (loss) attributable to
Gilead reconciliation:
GAAP net income (loss) attributable to
Gilead
$
1,614
$
1,045
$
(2,556
)
$
2,055
Acquisition-related – amortization(1)
458
461
916
884
Acquisition-related – other costs(2)
14
26
117
32
Restructuring
14
—
68
—
IPR&D impairment
—
—
1,819
—
Loss (gain) from equity securities,
net
359
(70
)
412
187
Discrete and related tax charges(3)
60
227
100
256
Non-GAAP net income attributable to
Gilead
$
2,519
$
1,688
$
874
$
3,414
Diluted earnings (loss) per share
reconciliation:
GAAP diluted earnings (loss) per share
$
1.29
$
0.83
$
(2.05
)
$
1.63
Acquisition-related – amortization(1)
0.37
0.37
0.73
0.70
Acquisition-related – other costs(2)
0.01
0.02
0.09
0.03
Restructuring
0.01
—
0.05
—
IPR&D impairment
—
—
1.46
—
Loss (gain) from equity securities,
net
0.29
(0.06
)
0.33
0.15
Discrete and related tax charges(3)
0.05
0.18
0.08
0.20
Non-GAAP diluted earnings per share
$
2.01
$
1.34
$
0.70
$
2.71
Non-GAAP adjustment summary:
Cost of goods sold adjustments
$
579
$
581
$
1,157
$
1,110
Research and development expenses
adjustments
16
30
133
38
IPR&D impairment adjustments
—
—
2,430
—
Selling, general and administrative
expenses adjustments
26
1
106
2
Total non-GAAP adjustments to costs and
expenses
620
612
3,826
1,150
Other (income) expense, net
adjustments
392
(69
)
405
187
Total non-GAAP adjustments before income
taxes
1,012
543
4,231
1,338
Income tax effect of non-GAAP adjustments
above
(168
)
(126
)
(900
)
(235
)
Discrete and related tax charges(3)
60
227
100
256
Total non-GAAP adjustments to net income
attributable to Gilead
$
905
$
644
$
3,431
$
1,358
______________________________
(1)
Relates to amortization of acquired
intangibles.
(2)
Adjustments include integration expenses,
contingent consideration fair value adjustments and other expenses
associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd.,
Tmunity Therapeutics, Inc., XinThera, Inc. and CymaBay
Therapeutics, Inc.
(3)
Represents discrete and related deferred
tax charges or benefits primarily associated with acquired
intangible assets and transfers of intangible assets from a foreign
subsidiary to Ireland and the United States.
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO
NON-GAAP 2024 FULL-YEAR GUIDANCE(1)
(unaudited)
(in millions, except percentages and
per share amounts)
Provided
February 6, 2024
Updated
April 25, 2024
Updated
August 8, 2024
Projected product gross margin GAAP to
non-GAAP reconciliation:
GAAP projected product gross margin
76.0% - 77.0%
76.0% - 77.0%
76.0% - 77.0%
Acquisition-related expenses and
restructuring expenses
~ 9.0%
~ 9.0%
~ 9.0%
Non-GAAP projected product gross
margin
85.0% - 86.0%
85.0% - 86.0%
85.0% - 86.0%
Projected operating income GAAP to
non-GAAP reconciliation:
GAAP projected operating income
$8,700 - $9,200
$1,900 - $2,400
$2,100 - $2,500
IPR&D impairment, acquisition-related
and restructuring expenses
~ 2,500
~ 5,100
~ 5,100
Non-GAAP projected operating income
$11,200 - $11,700
$7,000 - $7,500
$7,200 - $7,600
Projected effective tax rate GAAP to
non-GAAP reconciliation:
GAAP projected effective tax rate
~ 21%
~ 65%
~ 87%
Income tax effect of above non-GAAP
adjustments and fair value adjustments of equity securities, and
discrete and related tax adjustments
(~ 2%)
(~ 35%)
(~ 57%)
Non-GAAP projected effective tax rate
~ 19%
~ 30%
~ 30%
Projected diluted EPS GAAP to non-GAAP
reconciliation:
GAAP projected diluted EPS
$5.15 - $5.55
$0.10 - $0.50
$0.00 - $0.30
IPR&D impairment, acquisition-related
and restructuring expenses, fair value adjustments of equity
securities and discrete and related tax adjustments
~ 1.70
~ 3.35
~ 3.60
Non-GAAP projected diluted EPS
$6.85 - $7.25
$3.45 - $3.85
$3.60 - $3.90
________________________________
(1)
Our full-year guidance excludes the
potential impact of any (i) acquisitions or business development
transactions that have not been executed, (ii) future fair value
adjustments of equity securities and (iii) discrete tax charges or
benefits associated with changes in tax related laws and guidelines
that have not been enacted, as Gilead is unable to project such
amounts. The non-GAAP full-year guidance includes non-GAAP
adjustments to actual current period results as well as adjustments
for the known future impact associated with events that have
already occurred, such as future amortization of our intangible
assets and the future impact of discrete and related deferred tax
charges or benefits primarily associated with acquired intangible
assets and transfers of intangible assets from a foreign subsidiary
to Ireland and the United States.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited)
June 30,
December 31,
(in millions)
2024
2023
Assets
Cash, cash equivalents and marketable debt
securities
$
2,772
$
8,428
Accounts receivable, net
4,663
4,660
Inventories
3,388
3,366
Property, plant and equipment, net
5,346
5,317
Intangible assets, net
22,832
26,454
Goodwill
8,314
8,314
Other assets
6,265
5,586
Total assets
$
53,579
$
62,125
Liabilities and Stockholders’
Equity
Current liabilities
$
10,781
$
11,280
Long-term liabilities
24,602
28,096
Stockholders’ equity(1)
18,197
22,749
Total liabilities and stockholders’
equity
$
53,579
$
62,125
________________________________
(1)
As of June 30, 2024 and December 31, 2023,
there were 1,246 shares of common stock issued and outstanding.
GILEAD SCIENCES, INC.
SELECTED CASH FLOW
INFORMATION
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions)
2024
2023
2024
2023
Net cash provided by operating
activities
$
1,325
$
2,337
$
3,544
$
4,082
Net cash used in investing activities
(307
)
(483
)
(2,514
)
(1,309
)
Net cash used in financing activities
(2,953
)
(1,101
)
(4,314
)
(2,507
)
Effect of exchange rate changes on cash
and cash equivalents
(11
)
14
(29
)
26
Net change in cash and cash
equivalents
(1,947
)
768
(3,313
)
292
Cash and cash equivalents at beginning of
period
4,718
4,936
6,085
5,412
Cash and cash equivalents at end of
period
$
2,772
$
5,704
$
2,772
$
5,704
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions)
2024
2023
2024
2023
Net cash provided by operating
activities
$
1,325
$
2,337
$
3,544
$
4,082
Capital expenditures
(130
)
(139
)
(235
)
(248
)
Free cash flow(1)
$
1,195
$
2,199
$
3,309
$
3,834
________________________________
(1)
Free cash flow is a non-GAAP liquidity
measure. Please refer to our disclosures in the Non-GAAP Financial
Information section above.
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions)
2024
2023
2024
2023
HIV
Biktarvy – U.S.
$
2,585
$
2,439
$
4,900
$
4,600
Biktarvy – Europe
370
302
735
606
Biktarvy – Rest of World
277
237
542
449
3,232
2,979
6,177
5,656
Descovy – U.S.
434
460
805
855
Descovy – Europe
25
25
51
50
Descovy – Rest of World
26
31
55
60
485
516
911
965
Genvoya – U.S.
372
455
704
872
Genvoya – Europe
45
56
95
111
Genvoya – Rest of World
23
29
44
58
440
540
843
1,041
Odefsey – U.S.
233
267
457
497
Odefsey – Europe
72
74
148
149
Odefsey – Rest of World
10
11
21
22
315
351
626
668
Symtuza - Revenue share(1) – U.S.
131
84
236
182
Symtuza - Revenue share(1) – Europe
34
33
67
70
Symtuza - Revenue share(1) – Rest of
World
3
3
6
7
168
120
309
259
Other HIV(2) – U.S.
65
74
125
136
Other HIV(2) – Europe
25
31
70
63
Other HIV(2) – Rest of World
15
15
27
28
105
120
222
228
Total HIV – U.S.
3,821
3,778
7,226
7,142
Total HIV – Europe
571
521
1,167
1,049
Total HIV – Rest of World
353
326
695
624
4,745
4,626
9,088
8,816
Liver
Disease
Sofosbuvir / Velpatasvir(3) – U.S.
267
223
515
427
Sofosbuvir / Velpatasvir(3) – Europe
84
84
163
174
Sofosbuvir / Velpatasvir(3) – Rest of
World
126
90
203
181
476
397
881
782
Vemlidy – U.S.
117
96
212
183
Vemlidy – Europe
11
10
22
19
Vemlidy – Rest of World
115
113
233
216
243
219
467
418
Other Liver Disease(4) – U.S.
47
37
89
64
Other Liver Disease(4) – Europe
47
37
94
78
Other Liver Disease(4) – Rest of World
19
21
38
44
113
95
221
186
Total Liver Disease – U.S.
431
356
816
674
Total Liver Disease – Europe
142
131
279
271
Total Liver Disease – Rest of World
259
225
474
441
832
711
1,569
1,386
Veklury
Veklury – U.S.
76
97
391
349
Veklury – Europe
53
52
123
163
Veklury – Rest of World
85
107
255
317
214
256
769
829
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY -
(Continued)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in millions)
2024
2023
2024
2023
Oncology
Cell Therapy
Tecartus – U.S.
63
56
118
114
Tecartus – Europe
37
29
73
56
Tecartus – Rest of World
7
4
16
6
107
88
207
177
Yescarta – U.S.
186
217
357
427
Yescarta – Europe
169
133
327
254
Yescarta – Rest of World
58
30
110
58
414
380
794
739
Total Cell Therapy – U.S.
250
272
475
542
Total Cell Therapy – Europe
206
162
400
310
Total Cell Therapy – Rest of World
66
34
126
65
521
469
1,001
916
Trodelvy
Trodelvy – U.S.
224
189
429
351
Trodelvy – Europe
69
53
137
107
Trodelvy – Rest of World
26
17
62
23
320
260
628
482
Total Oncology – U.S.
474
462
904
893
Total Oncology – Europe
275
215
537
417
Total Oncology – Rest of World
92
51
188
88
841
728
1,629
1,398
Other
AmBisome – U.S.
17
20
31
27
AmBisome – Europe
69
69
139
129
AmBisome – Rest of World
65
61
124
111
151
151
294
267
Other(5) – U.S.
98
64
156
127
Other(5) – Europe
8
10
18
22
Other(5) – Rest of World
24
17
36
26
130
92
209
175
Total Other – U.S.
115
85
188
153
Total Other – Europe
77
80
156
152
Total Other – Rest of World
88
78
160
137
280
243
504
442
Total product sales – U.S.
4,916
4,777
9,525
9,211
Total product sales – Europe
1,118
999
2,262
2,052
Total product sales – Rest of World
878
788
1,772
1,607
$
6,912
$
6,564
$
13,559
$
12,870
______________________________
(1)
Represents Gilead’s revenue from
cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a
fixed dose combination product commercialized by Janssen Sciences
Ireland Unlimited Company.
(2)
Includes Atripla, Complera/Eviplera,
Emtriva, Sunlenca, Stribild, Truvada and Tybost.
(3)
Includes Epclusa and the authorized
generic version of Epclusa sold by Gilead’s separate subsidiary,
Asegua Therapeutics LLC (“Asegua”).
(4)
Includes ledipasvir/sofosbuvir (Harvoni
and the authorized generic version of Harvoni sold by Asegua),
Hepcludex, Hepsera, Sovaldi, Viread and Vosevi.
(5)
Includes Cayston, Jyseleca, Letairis,
Ranexa and Zydelig.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240807993584/en/
Investors: Jacquie Ross, CFA
investor_relations@gilead.com Media: Ashleigh Koss
public_affairs@gilead.com
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