FOSTER CITY, Calif.--(
BUSINESS WIRE
)--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2024 results of operations.
“Gilead’s third quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this very strong topline growth and disciplined operating expense management, we are increasing our full year revenue, operating income, and earnings per share guidance,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We are excited to further increase our impact for patients and communities in the months ahead. This includes building on the momentum from the U.S. launch of Livdelzi for primary biliary cholangitis and preparing for the potential launch of the first twice-yearly option for HIV prevention option, lenacapavir.”
Third Quarter 2024 Financial Results
Total third quarter 2024 revenue increased 7% to $7.5 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Veklury
®
(remdesivir), Oncology and Liver Disease.
Diluted earnings per share (“EPS”) was $1.00 in the third quarter 2024 compared to $1.73 in the same period in 2023. The decrease was primarily driven by a pre-tax in-process research and development (“IPR&D”) impairment of $1.75 billion, or $1.04 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, as well as higher acquired IPR&D expense. This was partially offset by higher product sales and higher net unrealized gains on equity securities.
Non-GAAP diluted EPS was $2.02 in the third quarter 2024 compared to $2.29 in the same period in 2023. The decrease was primarily driven by higher acquired IPR&D and tax expense, partially offset by higher product sales.
As of September 30, 2024, Gilead had $5.0 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.
During the third quarter 2024 Gilead generated $4.3 billion in operating cash flow.
During the third quarter 2024 Gilead paid dividends of $983 million and repurchased $300 million of common stock.
Third Quarter 2024 Product Sales
Total third quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total third quarter 2024 product sales, excluding Veklury, increased 7% to $6.8 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Oncology and Liver Disease.
HIV
product sales increased 9% to $5.1 billion in the third quarter 2024 compared to the same period in 2023, driven by higher average realized price, primarily due to shifts in channel mix, and higher demand, partially offset by inventory dynamics.
Biktarvy
®
(bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 13% to $3.5 billion in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
Descovy
®
(FTC 200mg/TAF 25mg) sales increased 15% to $586 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
The
Liver Disease
portfolio sales increased 4% to $733 million in the third quarter 2024 compared to the same period in 2023. This was primarily driven by higher demand in viral hepatitis medicines, partially offset by unfavorable pricing dynamics.
Veklury
sales increased 9% to $692 million
in the third quarter 2024 compared to the same period in 2023, primarily driven by increased rates of COVID-19 related hospitalizations, particularly in the United States.
Cell Therapy
product sales of $485 million in the third quarter 2024 were relatively flat compared to the same period in 2023.
Yescarta
®
(axicabtagene ciloleucel) sales decreased 1% to $387 million in the third quarter 2024 compared to the same period in 2023, reflecting increased in- and out-of-class competition in the United States, partially offset by increased demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) in other regions.
Tecartus
®
(brexucabtagene autoleucel) sales increased 2% to $98 million in the third quarter 2024 compared to the same period in 2023, driven by increased demand in adult acute lymphoblastic leukemia (“ALL”).
Trodelvy
®
(sacituzumab govitecan-hziy) sales increased 17% to $332 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand across all regions.
Third Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate
Product gross margin was 79.1% in the third quarter 2024 compared to 77.6% in the same period in 2023. Non-GAAP product gross margin was 86.8% in the third quarter 2024 compared to 85.9% in the same period in 2023. The increases in GAAP and non-GAAP were primarily driven by product mix.
Research & development (“R&D”) expenses and non-GAAP R&D expenses were $1.4 billion in the third quarter 2024 compared to $1.5 billion in the same period in 2023. The decreases were primarily driven by the timing of clinical activities, including the wind-down of the magrolimab and obeldesivir COVID programs.
Acquired IPR&D expenses were $505 million in the third quarter 2024, primarily driven by a $320 million charge related to the buy-out of global Livdelzi
®
(seladelpar) royalties from Janssen Pharmaceutica NV, as well as payments related to ongoing collaborations.
IPR&D impairment was $1.75 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023.
Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses were $1.4 billion in the third quarter 2024 compared to $1.3 billion in the same period in 2023. The increases reflect the timing of commercial activities, including the launch of Livdelzi in the United States, and other corporate activities.
The effective tax rate (“ETR”) was (31.1)% in the third quarter 2024 compared to 6.3% in the same period in 2023. The decrease in ETR primarily reflects the impact of a legal entity restructuring and the aforementioned Immunomedics IPR&D impairment expense, partially offset by a prior year decrease in tax reserves that did not repeat. Non-GAAP ETR was 17.5% in the third quarter 2024 compared to 7.0% in the same period in 2023, primarily reflecting the impact of the prior year decrease in tax reserves.
Guidance and Outlook
For the full-year 2024, Gilead expects:
(in millions, except per share amounts)
November 6, 2024 Guidance
Low End
High End
Comparison to August 8, 2024 Guidance
Product sales
$
27,800
$
28,100
Previously $27,100 to $27,500
Product sales, excluding Veklury
$
26,000
$
26,300
Previously $25,800 to $26,200
Veklury
$
1,800
$
1,800
Previously $1,300
Diluted EPS
$
0.05
$
0.25
Previously $0.00 to $0.30
Non-GAAP diluted EPS
$
4.25
$
4.45
Previously $3.60 to $3.90
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
Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with 2 incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada
®
(FTC 200mg and tenofovir disoproxil fumarate 300mg; 89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. Gilead expects to file for U.S. Food and Drug Administration (“FDA”) approval before the end of the year, with global filings to follow. The use of lenacapavir for the prevention of HIV is investigational.
Presented HIV treatment data at the Infection Disease Week (“IDWeek”) meeting, including Week 48 data from the Phase 2 study evaluating the investigational oral once-weekly combination regimen of lenacapavir with Merck’s, known as MSD outside of the United States and Canada (“Merck”), islatravir. In addition, Phase 1a data of the investigational once-weekly GS-1720 and 3-year follow up from the Phase 2/3 CAPELLA trial of twice-yearly lenacapavir in people with multi-drug resistant HIV were also highlighted.
Signed royalty-free voluntary licensing agreements with six manufacturers to make and sell generic lenacapavir for HIV prevention and for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV in 120 high-incidence, resource-limited countries, subject to regulatory approval of lenacapavir in those markets.
Presented data at IDWeek from the Phase 3 BIRCH and OAKTREE trials of investigational obeldesivir in non-hospitalized participants at high-risk or standard-risk for severe COVID-19, respectively. Previously, Gilead announced the early termination of the BIRCH trial and top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint, obeldesivir was found to have a generally well tolerated safety profile. The detailed data presented add to the breadth of safety data on obeldesivir.
Donated approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in response to the Marburg Virus Disease (“MVD”) outbreak for emergency use. Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known.
Oncology
Announced abstracts for the American Society of Hematology 2024 Annual Meeting (“ASH”), including preliminary data from the registrational Phase 2 iMMagine-1 trial evaluating the Arcellx, Inc. (“Arcellx”) partnered investigational CAR T anito-cel (anitocabtagene autoleucel) in R/R multiple myeloma, as well as updated results from the Phase 1 trial. Additionally, the first patient has been dosed in the Phase 3 iMMagine-3 trial in 2L+ R/R multiple myeloma.
Announced ASH abstracts for long-term follow-up of Yescarta in R/R indolent non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Tecartus in B-cell precursor ALL.
Presented Trodelvy data at the International Association for the Study of Lung Cancer World Conference on Lung Cancer across first- and second-line advanced or metastatic non-small cell lung cancer, as well as in extensive-stage small cell lung cancer. The use of Trodelvy for lung cancer is investigational.
Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024.
Received FDA Regenerative Medicine Advanced Therapy Designation for the evaluation of Yescarta as first-line treatment for adult patients with newly diagnosed, high-risk LBCL, an investigational use.
Inflammation
Received FDA accelerated approval for Livdelzi for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
Corporate
Announced a strategic collaboration with Genesis Therapeutics, Inc. (“Genesis”) to discover and develop novel small molecule therapies across multiple targets using Genesis’ GEMS AI platform.
The Board declared a quarterly dividend of $0.77 per share of common stock for the fourth quarter of 2024. The dividend is payable on December 30, 2024, to stockholders of record at the close of business on December 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 such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. 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, Genesis and Merck; 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 Trodelvy, anito-cel, GS-1720, lenacapavir, and obeldesivir (such as the BIRCH, CAPELLA, iMMagine-1, iMMagine-3, OAKTREE, and PURPOSE-2 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, including for lenacapavir for HIV PrEP; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, 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; 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 Livdelzi; 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 September 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
®
, KITE
TM
, AMBISOME
®
, ATRIPLA
®
, BIKTARVY
®
, CAYSTON
®
, COMPLERA
®
, DESCOVY
®
, DESCOVY FOR PREP
®
, EMTRIVA
®
, EPCLUSA
®
, EVIPLERA
®
, GENVOYA
®
, HARVONI
®
, HEPCLUDEX
®
, HEPSERA
®
, JYSELECA
®
, LIVDELZI
®
, LETAIRIS
®
, ODEFSEY
®
, SOVALDI
®
, STRIBILD
®
, SUNLENCA
®
, TECARTUS
®
, TRODELVY
®
, TRUVADA
®
, TRUVADA FOR PREP
®
, TYBOST
®
, VEKLURY
®
, VEMLIDY
®
, VIREAD
®
, VOSEVI
®
, YESCARTA
®
and ZYDELIG
®
.
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
Nine Months Ended
September 30,
September 30,
(in millions, except per share amounts)
2024
2023
2024
2023
Revenues:
Product sales
$
7,515
$
6,994
$
21,074
$
19,864
Royalty, contract and other revenues
30
56
111
138
Total revenues
7,545
7,051
21,185
20,002
Costs and expenses:
Cost of goods sold
1,574
1,565
4,670
4,408
Research and development expenses
1,395
1,457
4,266
4,310
Acquired in-process research and development expenses
505
91
4,674
808
In-process research and development impairment
1,750
—
4,180
—
Selling, general and administrative expenses
1,433
1,315
4,184
4,482
Total costs and expenses
6,657
4,428
21,975
14,009
Operating income (loss)
888
2,623
(790
)
5,993
Interest expense
238
232
728
692
Other (income) expense, net
(306
)
72
(41
)
95
Income (loss) before income taxes
956
2,318
(1,477
)
5,206
Income tax (benefit) expense
(297
)
146
(174
)
1,010
Net income (loss)
1,253
2,172
(1,303
)
4,196
Net loss attributable to noncontrolling interest
—
(8
)
—
(40
)
Net income (loss) attributable to Gilead
$
1,253
$
2,180
$
(1,303
)
$
4,236
Basic earnings (loss) per share attributable to Gilead
$
1.00
$
1.75
$
(1.04
)
$
3.39
Shares used in basic earnings (loss) per share attributable to Gilead calculation
1,247
1,248
1,247
1,249
Diluted earnings (loss) per share attributable to Gilead
$
1.00
$
1.73
$
(1.04
)
$
3.37
Shares used in diluted earnings (loss) per share attributable to Gilead calculation
1,254
1,257
1,247
1,259
Supplemental Information:
Cash dividends declared per share
$
0.77
$
0.75
$
2.31
$
2.25
Product gross margin
79.1
%
77.6
%
77.8
%
77.8
%
Research and development expenses as a % of revenues
18.5
%
20.7
%
20.1
%
21.5
%
Selling, general and administrative expenses as a % of revenues
19.0
%
18.6
%
19.8
%
22.4
%
Operating margin
11.8
%
37.2
%
(3.7
)%
30.0
%
Effective tax rate
(31.1
)%
6.3
%
11.8
%
19.4
%
GILEAD SCIENCES, INC.
TOTAL REVENUE SUMMARY
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in millions, except percentages)
2024
2023
Change
2024
2023
Change
Product sales:
HIV
$
5,073
$
4,667
9%
$
14,160
$
13,482
5%
Liver Disease
733
706
4%
2,302
2,093
10%
Oncology
816
769
6%
2,446
2,167
13%
Other
201
216
(7)%
705
658
7%
Total product sales excluding Veklury
6,823
6,358
7%
19,613
18,400
7%
Veklury
692
636
9%
1,461
1,465
—%
Total product sales
7,515
6,994
7%
21,074
19,864
6%
Royalty, contract and other revenues
30
56
(46)%
111
138
(19)%
Total revenues
$
7,545
$
7,051
7%
$
21,185
$
20,002
6%
GILEAD SCIENCES, INC.
NON-GAAP FINANCIAL INFORMATION
(1)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in millions, except percentages)
2024
2023
Change
2024
2023
Change
Non-GAAP:
Cost of goods sold
$
995
$
985
1%
$
2,933
$
2,717
8%
Research and development expenses
$
1,382
$
1,453
(5)%
$
4,120
$
4,268
(3)%
Acquired IPR&D expenses
(2)
$
505
$
91
NM
$
4,674
$
808
NM
Selling, general and administrative expenses
$
1,405
$
1,298
8%
$
4,051
$
4,464
(9)%
Other (income) expense, net
$
(48
)
$
(96
)
(50)%
$
(189
)
$
(261
)
(28)%
Diluted earnings per share attributable to Gilead
$
2.02
$
2.29
(12)%
$
2.72
$
5.00
(46)%
Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation
1,254
1,257
—%
1,254
1,259
—%
Product gross margin
86.8
%
85.9
%
84 bps
86.1
%
86.3
%
-24 bps
Research and development expenses as a % of revenues
18.3
%
20.6
%
-229 bps
19.4
%
21.3
%
-189 bps
Selling, general and administrative expenses as a % of revenues
18.6
%
18.4
%
21 bps
19.1
%
22.3
%
-320 bps
Operating margin
43.2
%
45.7
%
-255 bps
25.5
%
38.7
%
-1320 bps
Effective tax rate
17.5
%
7.0
%
1052 bps
30.0
%
14.5
%
1552 bps
________________________________
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
Nine Months Ended
September 30,
September 30,
(in millions, except percentages and per share amounts)
2024
2023
2024
2023
Cost of goods sold reconciliation:
GAAP cost of goods sold
$
1,574
$
1,565
$
4,670
$
4,408
Acquisition-related – amortization
(1)
(579
)
(581
)
(1,737
)
(1,691
)
Restructuring
—
—
1
—
Non-GAAP cost of goods sold
$
995
$
985
$
2,933
$
2,717
Product gross margin reconciliation:
GAAP product gross margin
79.1
%
77.6
%
77.8
%
77.8
%
Acquisition-related – amortization
(1)
7.7
%
8.3
%
8.2
%
8.5
%
Restructuring
—
%
—
%
(—
)%
—
%
Non-GAAP product gross margin
86.8
%
85.9
%
86.1
%
86.3
%
Research and development expenses reconciliation:
GAAP research and development expenses
$
1,395
$
1,457
$
4,266
$
4,310
Acquisition-related – other costs
(2)
(9
)
1
(78
)
(37
)
Restructuring
(5
)
(5
)
(68
)
(5
)
Non-GAAP research and development expenses
$
1,382
$
1,453
$
4,120
$
4,268
IPR&D impairment reconciliation:
GAAP IPR&D impairment
$
1,750
$
—
$
4,180
$
—
IPR&D impairment
(1,750
)
—
(4,180
)
—
Non-GAAP IPR&D impairment
$
—
$
—
$
—
$
—
Selling, general and administrative expenses reconciliation:
GAAP selling, general and administrative expenses
$
1,433
$
1,315
$
4,184
$
4,482
Acquisition-related – other costs
(2)
(5
)
—
(88
)
(2
)
Restructuring
(23
)
(17
)
(45
)
(17
)
Non-GAAP selling, general and administrative expenses
$
1,405
$
1,298
$
4,051
$
4,464
Operating income (loss) reconciliation:
GAAP operating income (loss)
$
888
$
2,623
$
(790
)
$
5,993
Acquisition-related – amortization
(1)
579
581
1,737
1,691
Acquisition-related – other costs
(2)
13
(1
)
167
39
Restructuring
28
22
112
22
IPR&D impairment
1,750
—
4,180
—
Non-GAAP operating income
$
3,258
$
3,224
$
5,406
$
7,745
Operating margin reconciliation:
GAAP operating margin
11.8
%
37.2
%
(3.7
)%
30.0
%
Acquisition-related – amortization
(1)
7.7
%
8.2
%
8.2
%
8.5
%
Acquisition-related – other costs
(2)
0.2
%
—
%
0.8
%
0.2
%
Restructuring
0.4
%
0.3
%
0.5
%
0.1
%
IPR&D impairment
23.2
%
—
%
19.7
%
—
%
Non-GAAP operating margin
43.2
%
45.7
%
25.5
%
38.7
%
Other (income) expense, net reconciliation:
GAAP other (income) expense, net
$
(306
)
$
72
$
(41
)
$
95
Gain (loss) from equity securities, net
258
(168
)
(148
)
(356
)
Non-GAAP other (income) expense, net
$
(48
)
$
(96
)
$
(189
)
$
(261
)
Income (loss) before income taxes reconciliation:
GAAP income (loss) before income taxes
$
956
$
2,318
$
(1,477
)
$
5,206
Acquisition-related – amortization
(1)
579
581
1,737
1,691
Acquisition-related – other costs
(2)
13
(1
)
167
39
Restructuring
28
22
112
22
IPR&D impairment
1,750
—
4,180
—
(Gain) loss from equity securities, net
(258
)
168
148
356
Non-GAAP income before income taxes
$
3,068
$
3,088
$
4,866
$
7,314
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in millions, except percentages and per share amounts)
2024
2023
2024
2023
Income tax (benefit) expense reconciliation:
GAAP income tax (benefit) expense
$
(297
)
$
146
$
(174
)
$
1,010
Income tax effect of non-GAAP adjustments:
Acquisition-related – amortization
(1)
121
120
363
347
Acquisition-related – other costs
(2)
2
—
39
8
Restructuring
4
5
21
5
IPR&D impairment
440
—
1,051
—
(Gain) loss from equity securities, net
(46
)
4
(52
)
5
Discrete and related tax charges
(3)
314
(58
)
214
(314
)
Non-GAAP income tax expense
$
538
$
216
$
1,461
$
1,061
Effective tax rate reconciliation:
GAAP effective tax rate
(31.1
)%
6.3
%
11.8
%
19.4
%
Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments
(3)
48.6
%
0.7
%
18.2
%
(4.9
)%
Non-GAAP effective tax rate
17.5
%
7.0
%
30.0
%
14.5
%
Net income (loss) attributable to Gilead reconciliation:
GAAP net income (loss) attributable to Gilead
$
1,253
$
2,180
$
(1,303
)
$
4,236
Acquisition-related – amortization
(1)
458
461
1,374
1,345
Acquisition-related – other costs
(2)
11
(1
)
128
31
Restructuring
24
17
92
17
IPR&D impairment
1,310
—
3,129
—
(Gain) loss from equity securities, net
(212
)
164
200
351
Discrete and related tax charges
(3)
(314
)
58
(214
)
314
Non-GAAP net income attributable to Gilead
$
2,531
$
2,879
$
3,405
$
6,293
Diluted earnings (loss) per share reconciliation:
GAAP diluted earnings (loss) per share
$
1.00
$
1.73
$
(1.04
)
$
3.37
Acquisition-related – amortization
(1)
0.37
0.37
1.10
1.07
Acquisition-related – other costs
(2)
0.01
—
0.10
0.02
Restructuring
0.02
0.01
0.07
0.01
IPR&D impairment
1.04
—
2.51
—
(Gain) loss from equity securities, net
(0.17
)
0.13
0.16
0.28
Discrete and related tax charges
(3)
(0.25
)
0.05
(0.17
)
0.25
Difference in shares used for GAAP vs. Non-GAAP
—
—
(0.01
)
—
Non-GAAP diluted earnings per share
$
2.02
$
2.29
$
2.72
$
5.00
Non-GAAP adjustment summary:
Cost of goods sold adjustments
$
579
$
581
$
1,736
$
1,691
Research and development expenses adjustments
13
4
146
42
IPR&D impairment adjustments
1,750
—
4,180
—
Selling, general and administrative expenses adjustments
28
17
133
19
Total non-GAAP adjustments to costs and expenses
2,370
602
6,196
1,752
Other (income) expense, net adjustments
(258
)
168
148
356
Total non-GAAP adjustments before income taxes
2,113
770
6,343
2,108
Income tax effect of non-GAAP adjustments above
(521
)
(129
)
(1,421
)
(364
)
Discrete and related tax charges
(3)
(314
)
58
(214
)
314
Total non-GAAP adjustments to net income attributable to Gilead
$
1,278
$
699
$
4,708
$
2,057
________________________________
(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 in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings.
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
Updated
November 6, 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%
78.0%
Acquisition-related expenses and restructuring expenses
~ 9.0%
~ 9.0%
~ 9.0%
~ 8.0%
Non-GAAP projected product gross margin
85.0% - 86.0%
85.0% - 86.0%
85.0% - 86.0%
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
$1,100 - $1,400
IPR&D impairment, acquisition-related and restructuring expenses
~ 2,500
~ 5,100
~ 5,100
~ 6,900
Non-GAAP projected operating income
$11,200 - $11,700
$7,000 - $7,500
$7,200 - $7,600
$8,000 - $8,300
Projected effective tax rate GAAP to non-GAAP reconciliation:
GAAP projected effective tax rate
~ 21%
~ 65%
~ 87%
~ 56%
Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments
(~ 2%)
(~ 35%)
(~ 57%)
(~ 29%)
Non-GAAP projected effective tax rate
~ 19%
~ 30%
~ 30%
~ 27%
Projected diluted EPS GAAP to non-GAAP reconciliation:
GAAP projected diluted EPS
$5.15 - $5.55
$0.10 - $0.50
$0.00 - $0.30
$0.05 - $0.25
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
~ 4.20
Non-GAAP projected diluted EPS
$6.85 - $7.25
$3.45 - $3.85
$3.60 - $3.90
$4.25 - $4.45
________________________________
(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 in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
September 30,
December 31,
(in millions)
2024
2023
Assets
Cash, cash equivalents and marketable debt securities
$
5,037
$
8,428
Accounts receivable, net
4,587
4,660
Inventories
3,435
3,366
Property, plant and equipment, net
5,391
5,317
Intangible assets, net
20,546
26,454
Goodwill
8,314
8,314
Other assets
7,215
5,586
Total assets
$
54,525
$
62,125
Liabilities and Stockholders’ Equity
Current liabilities
$
11,725
$
11,280
Long-term liabilities
24,409
28,096
Stockholders’ equity
(1)
18,390
22,749
Total liabilities and stockholders’ equity
$
54,525
$
62,125
________________________________
(1)
As of September 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
Nine Months Ended
September 30,
September 30,
(in millions)
2024
2023
2024
2023
Net cash provided by operating activities
$
4,309
$
1,756
$
7,853
$
5,837
Net cash used in investing activities
(710
)
(229
)
(3,224
)
(1,538
)
Net cash used in financing activities
(1,379
)
(1,518
)
(5,693
)
(4,026
)
Effect of exchange rate changes on cash and cash equivalents
44
(7
)
15
20
Net change in cash and cash equivalents
2,265
1
(1,049
)
293
Cash and cash equivalents at beginning of period
2,772
5,704
6,085
5,412
Cash and cash equivalents at end of period
$
5,037
$
5,705
$
5,037
$
5,705
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in millions)
2024
2023
2024
2023
Net cash provided by operating activities
$
4,309
$
1,756
$
7,853
$
5,837
Capital expenditures
(140
)
(122
)
(376
)
(370
)
Free cash flow
(1)
$
4,169
$
1,633
$
7,478
$
5,467
________________________________
(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
Nine Months Ended
September 30,
September 30,
(in millions)
2024
2023
2024
2023
HIV
Biktarvy – U.S.
$
2,826
$
2,504
$
7,726
$
7,104
Biktarvy – Europe
375
313
1,110
920
Biktarvy – Rest of World
272
268
814
717
3,472
3,085
9,649
8,741
Descovy – U.S.
534
460
1,339
1,314
Descovy – Europe
24
25
75
75
Descovy – Rest of World
28
26
82
86
586
511
1,496
1,475
Genvoya – U.S.
384
433
1,088
1,305
Genvoya – Europe
44
47
138
157
Genvoya – Rest of World
21
23
66
81
449
503
1,292
1,544
Odefsey – U.S.
248
257
705
754
Odefsey – Europe
69
74
217
223
Odefsey – Rest of World
9
11
30
33
326
343
952
1,011
Symtuza - Revenue share
(1)
– U.S.
103
96
338
278
Symtuza - Revenue share
(1)
– Europe
33
32
101
101
Symtuza - Revenue share
(1)
– Rest of World
3
3
9
10
139
131
448
390
Other HIV
(2)
– U.S.
65
56
190
192
Other HIV
(2)
– Europe
26
28
96
91
Other HIV
(2)
– Rest of World
9
9
36
38
100
94
322
321
Total HIV – U.S.
4,161
3,807
11,386
10,949
Total HIV – Europe
570
519
1,737
1,568
Total HIV – Rest of World
342
341
1,038
965
5,073
4,667
14,160
13,482
Liver Disease
Sofosbuvir / Velpatasvir
(3)
– U.S.
222
215
737
643
Sofosbuvir / Velpatasvir
(3)
– Europe
67
76
230
250
Sofosbuvir / Velpatasvir
(3)
– Rest of World
96
85
299
266
385
377
1,266
1,159
Vemlidy – U.S.
126
112
338
295
Vemlidy – Europe
11
9
33
28
Vemlidy – Rest of World
95
106
328
322
232
228
699
645
Other Liver Disease
(4)
– U.S.
45
49
134
113
Other Liver Disease
(4)
– Europe
54
33
148
112
Other Liver Disease
(4)
– Rest of World
17
20
55
64
116
102
337
289
Total Liver Disease – U.S.
393
376
1,210
1,051
Total Liver Disease – Europe
132
119
411
390
Total Liver Disease – Rest of World
207
211
682
652
733
706
2,302
2,093
Veklury
Veklury – U.S.
393
258
784
607
Veklury – Europe
81
65
204
227
Veklury – Rest of World
219
313
473
630
692
636
1,461
1,465
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY - (Continued)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in millions)
2024
2023
2024
2023
Oncology
Cell Therapy
Tecartus – U.S.
63
64
181
179
Tecartus – Europe
29
27
102
83
Tecartus – Rest of World
6
4
22
11
98
96
305
272
Yescarta – U.S.
145
197
502
624
Yescarta – Europe
182
154
509
408
Yescarta – Rest of World
60
40
170
99
387
391
1,181
1,130
Total Cell Therapy – U.S.
208
261
683
802
Total Cell Therapy – Europe
211
181
611
491
Total Cell Therapy – Rest of World
66
45
192
109
485
486
1,485
1,402
Trodelvy
Trodelvy – U.S.
226
201
655
551
Trodelvy – Europe
80
62
217
169
Trodelvy – Rest of World
26
21
88
44
332
283
960
764
Total Oncology – U.S.
433
462
1,338
1,354
Total Oncology – Europe
291
243
828
660
Total Oncology – Rest of World
92
65
280
153
816
769
2,446
2,167
Other
AmBisome – U.S.
6
12
37
39
AmBisome – Europe
71
63
210
192
AmBisome – Rest of World
52
39
176
150
130
115
424
381
Other
(5)
– U.S.
47
69
203
197
Other
(5)
– Europe
8
9
26
31
Other
(5)
– Rest of World
16
23
52
49
71
101
281
277
Total Other – U.S.
53
82
241
236
Total Other – Europe
80
72
236
224
Total Other – Rest of World
68
62
228
199
201
216
705
658
Total product sales – U.S.
5,433
4,985
14,958
14,196
Total product sales – Europe
1,154
1,017
3,416
3,069
Total product sales – Rest of World
928
992
2,700
2,599
$
7,515
$
6,994
$
21,074
$
19,864
________________________________
(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, Livdelzi, Sovaldi, Viread and Vosevi.
(5)
Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.
