Gilead Sciences Announces Third Quarter 2024 Financial Results

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Nov 06, 2024

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 millionin 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®, KITETM, 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.

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