Gilead Sciences Announces Second Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 11% Year-Over-Year to $6.3 billion

Biktarvy Sales Increased 17% Year-Over-Year to $3.0 billion

Oncology Sales Increased 38% Year-Over-Year to $728 million

Net Income Reflects $525 million Legal Settlement Accrual ($0.32 per share)

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter of 2023.

“It was another strong quarter for Gilead, with continued commercial and clinical momentum,” said Daniel O’Day, Gilead's Chairman and Chief Executive Officer. “11% year-over-year growth across our base business was driven by our diverse portfolio of therapies for HIV, Oncology, and Liver Disease. We received positive regulatory updates for six of our therapies and presented a large body of data on our pipeline, reinforcing our growing potential to help more patients and communities worldwide.”

Second Quarter 2023 Financial Results

  • Total second quarter 2023 revenue increased 5% to $6.6 billion compared to the same period in 2022, primarily driven by increased sales in HIV and Oncology, partially offset by lower Veklury® (remdesivir) sales.
  • Diluted Earnings Per Share (“EPS”) decreased to $0.83 for the second quarter of 2023 compared to $0.91 for the same period in 2022, mainly driven by a $525 million litigation accrual for settlements with certain plaintiffs in the HIV antitrust litigation, representing an unfavorable $0.32 impact to diluted EPS, as well as other higher operating costs and tax expense, partially offset by higher product revenues and unrealized gains on equity investments compared to unrealized losses in 2022.
  • Non-GAAP diluted EPS decreased to $1.34 for the second quarter of 2023 compared to $1.58 for the same period in 2022, primarily driven by the litigation accrual referenced earlier, representing an unfavorable $0.32 impact to non-GAAP diluted EPS, as well as other higher operating costs, partially offset by higher product revenues.
  • As of June 30, 2023, Gilead had $8.0 billion of cash, cash equivalents and marketable debt securities, up from $7.6 billion as of December 31, 2022.
  • During the second quarter of 2023, Gilead generated $2.3 billion in operating cash flow.
  • During the second quarter of 2023, Gilead paid dividends of $944 million and repurchased $150 million of common stock.

Product Sales Performance

Total second quarter 2023 product sales increased 7% to $6.6 billion compared to the same period in 2022. Total product sales, excluding Veklury, increased 11% to $6.3 billion in the second quarter of 2023 compared to the same period in 2022, primarily due to increased sales related to HIV, Cell Therapy and Trodelvy® (sacituzumab govitecan-hziy).

HIV product sales increased 9% to $4.6 billion in the second quarter of 2023 compared to the same period in 2022, primarily driven by favorable pricing dynamics and higher demand, partially offset by lower channel inventory.

  • Biktarvy® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 17% year-over-year in the second quarter of 2023, primarily driven by higher demand and favorable pricing dynamics, partially offset by lower channel inventory.
  • Descovy® (FTC 200mg/TAF 25mg) sales increased 12% year-over-year in the second quarter of 2023, primarily driven by favorable pricing dynamics and higher demand, partially offset by lower channel inventory.

The Liver Disease portfolio sales, which includes chronic hepatitis C virus (“HCV”), chronic hepatitis B virus (“HBV”), and chronic hepatitis delta virus (“HDV”), increased 4% to $711 million in the second quarter of 2023 compared to the same period in 2022. The increase was primarily driven by higher demand, partially offset by unfavorable pricing dynamics.

Cell Therapy product sales increased 27% to $469 million in the second quarter of 2023 compared to the same period in 2022.

  • Yescarta® (axicabtagene ciloleucel) sales increased 29% year-over-year to $380 million in the second quarter of 2023, primarily driven by strong demand in the second- and third-line settings for relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”).
  • Tecartus® (brexucabtagene autoleucel) sales increased 21% year-over-year to $88 million in the second quarter of 2023, primarily driven by increased demand in R/R adult acute lymphoblastic leukemia (“ALL”) and R/R mantle cell lymphoma (“MCL”).

Trodelvy sales increased by 63% to $260 million in the second quarter of 2023 compared to the same period in 2022, primarily driven by growing adoption in pre-treated HR+/HER2- metastatic breast cancer (“mBC”) in the United States.

Veklury sales decreased by 43% to $256 million for the second quarter of 2023 compared to the same period in 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19.

Second Quarter 2023 Product Gross Margin, Operating Expenses and Effective Tax Rate

  • Product gross margin was 78.0% for the second quarter of 2023 compared to 76.5% for the same period in 2022. Non-GAAP product gross margin was 86.9% for the second quarter of 2023 compared to 85.6% in the same period in 2022.
  • Research and development (“R&D”) expenses and non-GAAP R&D expenses for the second quarter of 2023 were $1.4 billion compared to $1.1 billion in the same period in 2022. The increases in GAAP and non-GAAP R&D expenses were primarily driven by higher clinical activities.
  • Acquired in-process R&D (“IPR&D”) expenses for the second quarter of 2023 were $236 million, primarily driven by the acquisition of XinThera, Inc. (“XinThera”) and the expanded collaboration with Arcus Biosciences, Inc. (“Arcus”).
  • Selling, general and administrative (“SG&A”) expenses for the second quarter of 2023 were $1.8 billion compared to $1.4 billion in the same period in 2022. Non-GAAP SG&A expenses for the second quarter of 2023 were $1.8 billion compared to $1.3 billion in the same period in 2022. The increases in GAAP and non-GAAP SG&A expenses were primarily driven by the litigation accrual referenced earlier, as well as increased commercial activities in Oncology and HIV, partially offset by lower corporate expenses.
  • The effective tax rate (“ETR”) for the second quarter of 2023 was 34.6% compared to 24.5% for the same period in 2022, primarily driven by a remeasurement of certain deferred tax liabilities. Non-GAAP ETR for the second quarter of 2023 was 21.0% compared to 19.3% for the same period in 2022.

Guidance and Outlook

For the full-year, Gilead expects:

  • Total product sales between $26.3 billion and $26.7 billion, compared to $26.0 billion and $26.5 billion previously.
  • Total product sales, excluding Veklury, between $24.6 billion and $25.0 billion, compared to $24.0 billion and $24.5 billion previously.
  • Total Veklury sales of approximately $1.7 billion, compared to approximately $2.0 billion previously.
  • Diluted earnings per share between $4.50 and $4.85, compared to $4.75 and $5.15 previously.
  • Non-GAAP diluted earnings per share between $6.45 and $6.80, compared to $6.60 and $7.00 previously.

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2023 guidance is provided in the accompanying tables. Also see the Forward-Looking Statements described below. The financial guidance is subject to a number of risks and uncertainties, including uncertainty around the duration and magnitude of the COVID-19 pandemic.

Key Updates Since Our Last Quarterly Release

Virology

  • Received U.S. Food and Drug Administration (“FDA”) and European Commission (“EC”) approval to extend the use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis.
  • Presented data on Biktarvy at the International AIDS Society Conference that further demonstrate the safety and efficacy profile in different subgroups of people with HIV, such as virologically suppressed pregnant women. Also presented patient-reported outcomes from the Phase 2/3 CAPELLA study of lenacapavir in heavily treatment-experienced people with HIV as well as data from use of oral lenacapavir as a bridging regimen. Note that the use of lenacapavir for oral bridging is not approved by any regulatory authority.
  • Presented new long-term data at the European Association for the Study of the Liver Congress 2023 from the MYR301 Phase 3 trial evaluating bulevirtide for HDV, showing improved response rates at Week 96 compared to Week 48. Additionally, abstracts across viral hepatitis and liver fibrosis were highlighted.
  • Received full marketing authorization from the EC for Hepcludex® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease. Hepcludex was initially granted conditional marketing authorization in July 2020. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S.
  • Announced partnerships with the Clinton Health Access Initiative and Penta to improve treatment and adherence rates among children with HIV in low and middle income countries.

Oncology

  • Received EC approval for Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic HR+/HER2- mBC who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
  • Presented longer-term overall survival (“OS”) data from the Phase 3 TROPiCS-02 study evaluating Trodelvy in pre-treated HR+/HER2- mBC at the 2023 American Society of Clinical Oncology (“ASCO”) meeting, demonstrating durable and clinically meaningful improvement in median OS versus comparator chemotherapy. Data were also presented from a Phase 2 trial evaluating Trodelvy as a potential therapy in advanced endometrial cancer.
  • Presented OS data at ASCO from the Phase 3 ZUMA-7 trial of Yescarta in second-line R/R LBCL, which demonstrated significantly longer OS versus standard of care. Additionally, real-world evidence data for Tecartus in MCL were reported, which showed consistently high complete response and overall response rates, regardless of the type of prior treatment received.
  • Presented data at the European Hematology Association Annual Congress evaluating Yescarta, Tecartus, and magrolimab in a number of hematologic malignancies.
  • Received a recommendation from the National Institute for Health and Care Excellence in the United Kingdom for use of Yescarta in the second-line setting for diffuse LBCL and high-grade B-cell lymphoma, and Tecartus in R/R B-cell precursor ALL in England’s National Health Service.
  • Announced, through Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., the approval of axicabtagene ciloleucel (under the trade name Yikaida®) by the China National Medical Products Administration for the treatment of adult patients with R/R LBCL who failed first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy.
  • Completed the transfer of Yescarta’s marketing authorization in Japan from Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) to Gilead Sciences K.K.
  • Announced data from an interim analysis at ASCO from the Phase 2 ARC-7 study of domvanalimab, zimberelimab and etrumadenant in first-line, metastatic PD-L1-high non-small cell lung cancer, demonstrating consistent improvement in progression-free survival and a clinically meaningful reduction in the risk of progression or death in the domvanalimab-containing arms, as compared to the zimberelimab monotherapy arm.
  • Announced the Phase 3 ENHANCE trial of magrolimab in combination with azacitidine in higher-risk myelodysplastic syndromes was discontinued due to futility based on a planned analysis. Data from the trial will be presented at an upcoming medical meeting.
  • Announced the acquisition of XinThera, adding additional pipeline assets including rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology as well as MK2 for inflammatory diseases.

Inflammation

  • Announced expansion of the Arcus collaboration to include research programs in inflammatory diseases.

Corporate

  • Appointed Cindy Perettie as Executive Vice President of Kite, who joins with more than 20 years of scientific and commercial leadership experience in global biopharmaceutical organizations.
  • The company’s Board of Directors declared a quarterly dividend of $0.75 per share of common stock for the third quarter of 2023. The dividend is payable on September 28, 2023, to stockholders of record at the close of business on September 15, 2023. 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 2:00 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 inventory step-up charges, 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, coronavirus disease 2019 (“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: the impact of the COVID-19 pandemic on Gilead’s business, financial condition and results of operations; the development, manufacturing and distribution of Veklury as a treatment for COVID-19, including the uncertainty of the amount and timing of Veklury sales and Gilead’s ability to effectively manage the global supply and distribution of Veklury; Gilead’s ability to achieve its anticipated full year 2023 financial results; Gilead’s ability to make progress on any of its long-term ambitions or strategic 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 XinThera 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 Hepcludex, Tecartus, Trodelvy, Yescarta, domvanalimab, etrumadenant, magrolimab, and zimberelimab, 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 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; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products, including the risk that Kite may be unable to increase its manufacturing capacity, timely manufacture and deliver its products or produce an amount of supply sufficient to satisfy demand for such 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 these products over other therapies and may therefore be reluctant to prescribe the products, including Hepcludex, Tecartus, Trodelvy, Veklury and Yescarta; 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, 2023 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™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. This report may also refer to trademarks, service marks and trade names of other companies.

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 INCOME

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions, except per share amounts)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Revenues:

 

 

 

 

 

 

 

 

Product sales

 

$

6,564

 

 

$

6,138

 

 

$

12,870

 

 

$

12,672

 

Royalty, contract and other revenues

 

 

35

 

 

 

122

 

 

 

81

 

 

 

178

 

Total revenues

 

 

6,599

 

 

 

6,260

 

 

 

12,951

 

 

 

12,850

 

Costs and expenses:

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

1,442

 

 

 

1,442

 

 

 

2,843

 

 

 

2,866

 

Research and development expenses

 

 

1,407

 

 

 

1,102

 

 

 

2,854

 

 

 

2,280

 

Acquired in-process research and development expenses

 

 

236

 

 

 

330

 

 

 

717

 

 

 

338

 

In-process research and development impairment

 

 

 

 

 

 

 

 

 

 

 

2,700

 

Selling, general and administrative expenses

 

 

1,849

 

 

 

1,357

 

 

 

3,168

 

 

 

2,440

 

Total costs and expenses

 

 

4,934

 

 

 

4,231

 

 

 

9,581

 

 

 

10,624

 

Operating income

 

 

1,665

 

 

 

2,029

 

 

 

3,370

 

 

 

2,226

 

Interest expense

 

 

(230

)

 

 

(242

)

 

 

(459

)

 

 

(480

)

Other income (expense), net

 

 

152

 

 

 

(284

)

 

 

(22

)

 

 

(395

)

Income before income taxes

 

 

1,588

 

 

 

1,503

 

 

 

2,888

 

 

 

1,351

 

Income tax expense

 

 

(549

)

 

 

(368

)

 

 

(865

)

 

 

(204

)

Net income

 

 

1,039

 

 

 

1,135

 

 

 

2,024

 

 

 

1,147

 

Net loss attributable to noncontrolling interest

 

 

6

 

 

 

9

 

 

 

32

 

 

 

16

 

Net income attributable to Gilead

 

$

1,045

 

 

$

1,144

 

 

$

2,055

 

 

$

1,163

 

Basic earnings per share attributable to Gilead

 

$

0.84

 

 

$

0.91

 

 

$

1.65

 

 

$

0.93

 

Shares used in basic earnings per share attributable to Gilead calculation

 

 

1,249

 

 

 

1,256

 

 

 

1,249

 

 

 

1,255

 

Diluted earnings per share attributable to Gilead

 

$

0.83

 

 

$

0.91

 

 

$

1.63

 

 

$

0.92

 

Shares used in diluted earnings per share attributable to Gilead calculation

 

 

1,258

 

 

 

1,260

 

 

 

1,260

 

 

 

1,261

 

Cash dividends declared per share

 

$

0.75

 

 

$

0.73

 

 

$

1.50

 

 

$

1.46

 

 

 

 

 

 

 

 

 

 

Research and development expenses as a % of revenues

 

 

21.3

%

 

 

17.6

%

 

 

22.0

%

 

 

17.7

%

Selling, general and administrative expenses as a % of revenues

 

 

28.0

%

 

 

21.7

%

 

 

24.5

%

 

 

19.0

%

 

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

(in millions, except percentages)

 

 

2023

 

 

 

2022

 

 

Change

 

 

2023

 

 

 

2022

 

 

Change

Product sales:

 

 

 

 

 

 

 

 

 

 

 

 

HIV

 

$

4,626

 

$

4,228

 

9

%

 

$

8,816

 

$

7,935

 

11

%

Oncology

 

 

728

 

 

 

527

 

 

38

%

 

 

1,398

 

 

 

947

 

 

48

%

Liver Disease

 

 

711

 

 

 

682

 

 

4

%

 

 

1,386

 

 

 

1,317

 

 

5

%

Other

 

 

243

 

 

 

256

 

 

(5

)%

 

 

442

 

 

 

493

 

 

(10

)%

Total product sales excluding Veklury

 

 

6,308

 

 

 

5,693

 

 

11

%

 

 

12,041

 

 

 

10,692

 

 

13

%

Veklury

 

 

256

 

 

 

445

 

 

(43

)%

 

 

829

 

 

 

1,980

 

 

(58

)%

Total product sales

 

 

6,564

 

 

 

6,138

 

 

7

%

 

 

12,870

 

 

 

12,672

 

 

2

%

Royalty, contract and other revenues

 

 

35

 

 

 

122

 

 

(71

)%

 

 

81

 

 

 

178

 

 

(54

)%

Total revenues

 

$

6,599

 

 

$

6,260

 

 

5

%

 

$

12,951

 

 

$

12,850

 

 

1

%

 

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION(1)

(unaudited)

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

(in millions, except percentages)

 

 

2023

 

 

 

2022

 

 

Change

 

 

2023

 

 

 

2022

 

 

Change

Non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

$

861

 

 

$

886

 

 

(3

)%

 

$

1,732

 

 

$

1,711

 

 

1

%

Research and development expenses

 

$

1,377

 

 

$

1,102

 

 

25

%

 

$

2,816

 

 

$

2,251

 

 

25

%

Acquired IPR&D expenses

 

$

236

 

 

$

330

 

 

(29

)%

 

$

717

 

 

$

338

 

 

NM

 

Selling, general and administrative expenses

 

$

1,848

 

 

$

1,272

 

 

45

%

 

$

3,166

 

 

$

2,355

 

 

34

%

Other income (expense), net

 

$

83

 

 

$

20

 

 

NM

 

 

$

165

 

 

$

5

 

 

NM

 

Diluted EPS

 

$

1.34

 

 

$

1.58

 

 

(15

)%

 

$

2.71

 

 

$

3.70

 

 

(27

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

Product gross margin

 

 

86.9

%

 

 

85.6

%

 

131 bps

 

 

86.5

%

 

 

86.5

%

 

4 bps

Research and development expenses as a % of revenues

 

 

20.9

%

 

 

17.6

%

 

326 bps

 

 

21.7

%

 

 

17.5

%

 

422 bps

Selling, general and administrative expenses as a % of revenues

 

 

28.0

%

 

 

20.3

%

 

768 bps

 

 

24.4

%

 

 

18.3

%

 

612 bps

Operating margin

 

 

34.5

%

 

 

42.7

%

 

-815 bps

 

 

34.9

%

 

 

48.2

%

 

-1331 bps

Effective tax rate

 

 

21.0

%

 

 

19.3

%

 

173 bps

 

 

20.0

%

 

 

18.8

%

 

118 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 on pages 10 - 11.

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)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Cost of goods sold reconciliation:

 

 

 

 

 

 

 

 

GAAP cost of goods sold

 

$

1,442

 

 

$

1,442

 

 

$

2,843

 

 

$

2,866

 

Acquisition-related – amortization(1)

 

 

(581

)

 

 

(556

)

 

 

(1,110

)

 

 

(1,113

)

Other(2)

 

 

 

 

 

 

 

 

 

 

 

(42

)

Non-GAAP cost of goods sold

 

$

861

 

 

$

886

 

 

$

1,732

 

 

$

1,711

 

 

 

 

 

 

 

 

 

 

Product gross margin reconciliation:

 

 

 

 

 

 

 

 

GAAP product gross margin

 

 

78.0

%

 

 

76.5

%

 

 

77.9

%

 

 

77.4

%

Acquisition-related – amortization(1)

 

 

8.8

%

 

 

9.1

%

 

 

8.6

%

 

 

8.8

%

Other(2)

 

 

%

 

 

%

 

 

%

 

 

0.3

%

Non-GAAP product gross margin

 

 

86.9

%

 

 

85.6

%

 

 

86.5

%

 

 

86.5

%

 

 

 

 

 

 

 

 

 

Research and development expenses reconciliation:

 

 

 

 

 

 

 

 

GAAP research and development expenses

 

$

1,407

 

 

$

1,102

 

 

$

2,854

 

 

$

2,280

 

Acquisition-related – other costs(3)

 

 

(30

)

 

 

 

 

 

(38

)

 

 

(11

)

Other(2)

 

 

 

 

 

 

 

 

 

 

 

(18

)

Non-GAAP research and development expenses

 

$

1,377

 

 

$

1,102

 

 

$

2,816

 

 

$

2,251

 

 

 

 

 

 

 

 

 

 

IPR&D impairment reconciliation:

 

 

 

 

 

 

 

 

GAAP IPR&D impairment

 

$

 

 

$

 

 

$

 

 

$

2,700

 

IPR&D impairment

 

 

 

 

 

 

 

 

 

 

 

(2,700

)

Non-GAAP IPR&D impairment

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses reconciliation:

 

 

 

 

 

 

 

 

GAAP selling, general and administrative expenses

 

$

1,849

 

 

$

1,357

 

 

$

3,168

 

 

$

2,440

 

Acquisition-related – other costs(3)

 

 

(1

)

 

 

 

 

 

(2

)

 

 

 

Other(2)

 

 

 

 

 

(85

)

 

 

 

 

 

(85

)

Non-GAAP selling, general and administrative expenses

 

$

1,848

 

 

$

1,272

 

 

$

3,166

 

 

$

2,355

 

 

 

 

 

 

 

 

 

 

Operating income reconciliation:

 

 

 

 

 

 

 

 

GAAP operating income

 

$

1,665

 

 

$

2,029

 

 

$

3,370

 

 

$

2,226

 

Acquisition-related – amortization(1)

 

 

581

 

 

 

556

 

 

 

1,110

 

 

 

1,113

 

Acquisition-related – other costs(3)

 

 

31

 

 

 

 

 

 

40

 

 

 

11

 

IPR&D impairment

 

 

 

 

 

 

 

 

 

 

 

2,700

 

Other(2)

 

 

 

 

 

85

 

 

 

 

 

 

145

 

Non-GAAP operating income

 

$

2,277

 

 

$

2,670

 

 

$

4,521

 

 

$

6,195

 

 

 

 

 

 

 

 

 

 

Operating margin reconciliation:

 

 

 

 

 

 

 

 

GAAP operating margin

 

 

25.2

%

 

 

32.4

%

 

 

26.0

%

 

 

17.3

%

Acquisition-related – amortization(1)

 

 

8.8

%

 

 

8.9

%

 

 

8.6

%

 

 

8.7

%

Acquisition-related – other costs(3)

 

 

0.5

%

 

 

%

 

 

0.3

%

 

 

0.1

%

IPR&D impairment

 

 

%

 

 

%

 

 

%

 

 

21.0

%

Other(2)

 

 

%

 

 

1.4

%

 

 

%

 

 

1.1

%

Non-GAAP operating margin

 

 

34.5

%

 

 

42.7

%

 

 

34.9

%

 

 

48.2

%

 

 

 

 

 

 

 

 

 

Other income (expense), net reconciliation:

 

 

 

 

 

 

 

 

GAAP other income (expense), net

 

$

152

 

 

$

(284

)

 

$

(22

)

 

$

(395

)

(Gain) loss from equity securities, net

 

 

(69

)

 

 

303

 

 

 

187

 

 

 

399

 

Non-GAAP other income (expense), net

 

$

83

 

 

$

20

 

 

$

165

 

 

$

5

 

 

 

 

 

 

 

 

 

 

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)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Effective tax rate reconciliation:

 

 

 

 

 

 

 

 

GAAP effective tax rate

 

 

34.6

%

 

 

24.5

%

 

 

29.9

%

 

 

15.1

%

Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(4)

 

 

(13.5

)%

 

 

(5.2

)%

 

 

(10.0

)%

 

 

3.7

%

Non-GAAP effective tax rate

 

 

21.0

%

 

 

19.3

%

 

 

20.0

%

 

 

18.8

%

 

 

 

 

 

 

 

 

 

Net income attributable to Gilead reconciliation:

 

 

 

 

 

 

 

 

GAAP net income attributable to Gilead

 

$

1,045

 

 

$

1,144

 

 

$

2,055

 

 

$

1,163

 

Acquisition-related – amortization(1)

 

 

461

 

 

 

442

 

 

 

884

 

 

 

885

 

Acquisition-related – other costs(3)

 

 

26

 

 

 

 

 

 

32

 

 

 

11

 

IPR&D impairment

 

 

 

 

 

 

 

 

 

 

 

2,057

 

Loss (gain) from equity securities, net

 

 

(70

)

 

 

308

 

 

 

187

 

 

 

372

 

Discrete and related tax charges(4)

 

 

227

 

 

 

31

 

 

 

256

 

 

 

68

 

Other(2)

 

 

 

 

 

59

 

 

 

 

 

 

104

 

Non-GAAP net income attributable to Gilead

 

$

1,688

 

 

$

1,985

 

 

$

3,414

 

 

$

4,661

 

 

 

 

 

 

 

 

 

 

Diluted earnings per share reconciliation:

 

 

 

 

 

 

 

 

GAAP diluted earnings per share

 

$

0.83

 

 

$

0.91

 

 

$

1.63

 

 

$

0.92

 

Acquisition-related – amortization(1)

 

 

0.37

 

 

 

0.35

 

 

 

0.70

 

 

 

0.70

 

Acquisition-related – other costs(3)

 

 

0.02

 

 

 

 

 

 

0.03

 

 

 

0.01

 

IPR&D impairment

 

 

 

 

 

 

 

 

 

 

 

1.63

 

Loss (gain) from equity securities, net

 

 

(0.06

)

 

 

0.24

 

 

 

0.15

 

 

 

0.30

 

Discrete and related tax charges(4)

 

 

0.18

 

 

 

0.02

 

 

 

0.20

 

 

 

0.05

 

Other(2)

 

 

 

 

 

0.05

 

 

 

 

 

 

0.08

 

Non-GAAP diluted earnings per share

 

$

1.34

 

 

$

1.58

 

 

$

2.71

 

 

$

3.70

 

 

 

 

 

 

 

 

 

 

Non-GAAP adjustment summary:

 

 

 

 

 

 

 

 

Cost of goods sold adjustments

 

$

581

 

 

$

556

 

 

$

1,110

 

 

$

1,155

 

Research and development expenses adjustments

 

 

30

 

 

 

 

 

 

38

 

 

 

29

 

IPR&D impairment adjustments

 

 

 

 

 

 

 

 

 

 

 

2,700

 

Selling, general and administrative expenses adjustments

 

 

1

 

 

 

85

 

 

 

2

 

 

 

85

 

Total non-GAAP adjustments to costs and expenses

 

 

612

 

 

 

641

 

 

 

1,150

 

 

 

3,968

 

Other income (expense), net, adjustments

 

 

(69

)

 

 

303

 

 

 

187

 

 

 

399

 

Total non-GAAP adjustments before income taxes

 

 

543

 

 

 

945

 

 

 

1,338

 

 

 

4,368

 

Income tax effect of non-GAAP adjustments above

 

 

(126

)

 

 

(135

)

 

 

(235

)

 

 

(938

)

Discrete and related tax charges(4)

 

 

227

 

 

 

31

 

 

 

256

 

 

 

68

 

Total non-GAAP adjustments after tax

 

$

644

 

 

$

841

 

 

$

1,358

 

 

$

3,498

 

 

(1)

 

Relates to amortization of acquired intangibles and inventory step-up charges.

(2)

 

Adjustments to Cost of goods sold and Research and development expenses primarily include various restructuring expenses during the first quarter of 2022. Adjustments to Selling, general and administrative expenses include donations to the Gilead Foundation, a California nonprofit organization, during the second quarter of 2022.

(3)

 

Adjustments include employee-related expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc. and XinThera, Inc.

(4)

 

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 2023 FULL-YEAR GUIDANCE(1)

(unaudited)

 

 

 

 

 

 

 

 

(in millions, except percentages and per share amounts)

 

Provided

February 2, 2023

 

Updated

April 27, 2023

 

Updated

August 3, 2023

Projected product gross margin GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected product gross margin

 

79.0%

 

77.0%

 

77.0%

Acquisition-related expenses

 

~ 7%

 

~ 9%

 

~ 9%

Non-GAAP projected product gross margin

 

86.0%

 

86.0%

 

86.0%

 

 

 

 

 

 

 

Projected operating income GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected operating income

 

$9,200 - $9,800

 

$8,600 - $9,200

 

$8,000 - $8,500

Acquisition-related expenses

 

~ 1,800

 

~ 2,400

 

~ 2,400

Non-GAAP projected operating income

 

$11,000 - $11,600

 

$11,000 - $11,600

 

$10,400 - $10,900

 

 

 

 

 

 

 

Projected effective tax rate GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected effective tax rate

 

~ 22%

 

~ 22%

 

~ 21%

Discrete and related tax adjustments, and income tax effect of adjustments above and fair value adjustments of equity securities

 

(~ 2%)

 

(~ 2%)

 

(~ 4%)

Non-GAAP projected effective tax rate

 

~ 20%

 

~ 20%

 

~ 17%

 

 

 

 

 

 

 

Projected diluted EPS GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected diluted EPS

 

$5.30 - $5.70

 

$4.75 - $5.15

 

$4.50 - $4.85

Acquisition-related expenses, fair value adjustments of equity securities and discrete and related tax adjustments

 

~ 1.30

 

~ 1.85

 

~ 1.95

Non-GAAP projected diluted EPS

 

$6.60 - $7.00

 

$6.60 - $7.00

 

$6.45 - $6.80

 

(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)

 

 

2023

 

 

 

2022

 

Assets

 

 

 

 

Cash, cash equivalents and marketable debt securities

 

$

8,001

 

$

7,630

Accounts receivable, net

 

 

4,229

 

 

 

4,777

 

Inventories

 

 

3,181

 

 

 

2,820

 

Property, plant and equipment, net

 

 

5,540

 

 

 

5,475

 

Intangible assets, net

 

 

27,750

 

 

 

28,894

 

Goodwill

 

 

8,314

 

 

 

8,314

 

Other assets

 

 

5,322

 

 

 

5,262

 

Total assets

 

$

62,337

 

 

$

63,171

 

Liabilities and Stockholders’ Equity

 

 

 

 

Current liabilities

 

$

13,964

 

 

$

11,237

 

Long-term liabilities

 

 

27,279

 

 

 

30,725

 

Stockholders’ equity(1)

 

 

21,094

 

 

 

21,209

 

Total liabilities and stockholders’ equity

 

$

62,337

 

 

$

63,171

 

 

(1)

 

As of June 30, 2023 and December 31, 2022, there were 1,247 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)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Net cash provided by operating activities

 

$

2,337

 

 

$

1,802

 

 

$

4,082

 

 

$

3,642

 

Net cash used in investing activities

 

 

(483

)

 

 

(308

)

 

 

(1,309

)

 

 

(1,378

)

Net cash used in financing activities

 

 

(1,101

)

 

 

(1,003

)

 

 

(2,507

)

 

 

(2,797

)

Effect of exchange rate changes on cash and cash equivalents

 

 

14

 

 

 

(48

)

 

 

26

 

 

 

(66

)

Net change in cash and cash equivalents

 

 

768

 

 

 

443

 

 

 

292

 

 

 

(599

)

Cash and cash equivalents at beginning of period

 

 

4,936

 

 

 

4,296

 

 

 

5,412

 

 

 

5,338

 

Cash and cash equivalents at end of period

 

$

5,704

 

 

$

4,739

 

 

$

5,704

 

 

$

4,739

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Net cash provided by operating activities

 

$

2,337

 

 

$

1,802

 

 

$

4,082

 

 

$

3,642

 

Capital expenditures

 

 

(139

)

 

 

(143

)

 

 

(248

)

 

 

(390

)

Free cash flow(1)

 

$

2,199

 

 

$

1,659

 

 

$

3,834

 

 

$

3,252

 

 

(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)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

HIV

 

 

 

 

 

 

 

 

Biktarvy – U.S.

 

$

2,439

 

$

2,095

 

$

4,600

 

$

3,801

Biktarvy – Europe

 

 

302

 

 

 

268

 

 

 

606

 

 

 

529

 

Biktarvy – Other International

 

 

237

 

 

 

193

 

 

 

449

 

 

 

376

 

 

 

 

2,979

 

 

 

2,556

 

 

 

5,656

 

 

 

4,707

 

 

 

 

 

 

 

 

 

 

Complera / Eviplera – U.S.

 

 

13

 

 

 

20

 

 

 

27

 

 

 

37

 

Complera / Eviplera – Europe

 

 

16

 

 

 

31

 

 

 

37

 

 

 

55

 

Complera / Eviplera – Other International

 

 

3

 

 

 

3

 

 

 

6

 

 

 

7

 

 

 

 

32

 

 

 

54

 

 

 

70

 

 

 

99

 

 

 

 

 

 

 

 

 

 

Descovy – U.S.

 

 

460

 

 

 

397

 

 

 

855

 

 

 

708

 

Descovy – Europe

 

 

25

 

 

 

32

 

 

 

50

 

 

 

64

 

Descovy – Other International

 

 

31

 

 

 

32

 

 

 

60

 

 

 

63

 

 

 

 

516

 

 

 

460

 

 

 

965

 

 

 

834

 

 

 

 

 

 

 

 

 

 

Genvoya – U.S.

 

 

455

 

 

 

482

 

 

 

872

 

 

 

939

 

Genvoya – Europe

 

 

56

 

 

 

72

 

 

 

111

 

 

 

149

 

Genvoya – Other International

 

 

29

 

 

 

29

 

 

 

58

 

 

 

76

 

 

 

 

540

 

 

 

582

 

 

 

1,041

 

 

 

1,164

 

 

 

 

 

 

 

 

 

 

Odefsey – U.S.

 

 

267

 

 

 

255

 

 

 

497

 

 

 

487

 

Odefsey – Europe

 

 

74

 

 

 

97

 

 

 

149

 

 

 

193

 

Odefsey – Other International

 

 

11

 

 

 

12

 

 

 

22

 

 

 

23

 

 

 

 

351

 

 

 

364

 

 

 

668

 

 

 

703

 

 

 

 

 

 

 

 

 

 

Stribild – U.S.

 

 

19

 

 

 

24

 

 

 

39

 

 

 

46

 

Stribild – Europe

 

 

5

 

 

 

8

 

 

 

11

 

 

 

16

 

Stribild – Other International

 

 

2

 

 

 

2

 

 

 

4

 

 

 

5

 

 

 

 

26

 

 

 

33

 

 

 

55

 

 

 

66

 

 

 

 

 

 

 

 

 

 

Truvada – U.S.

 

 

32

 

 

 

24

 

 

 

55

 

 

 

52

 

Truvada – Europe

 

 

3

 

 

 

5

 

 

 

7

 

 

 

9

 

Truvada – Other International

 

 

7

 

 

 

5

 

 

 

12

 

 

 

11

 

 

 

 

42

 

 

 

34

 

 

 

74

 

 

 

72

 

 

 

 

 

 

 

 

 

 

Revenue share – Symtuza(1) – U.S.

 

 

84

 

 

 

80

 

 

 

182

 

 

 

166

 

Revenue share – Symtuza(1) – Europe

 

 

33

 

 

 

42

 

 

 

70

 

 

 

86

 

Revenue share – Symtuza(1) – Other International

 

 

3

 

 

 

4

 

 

 

7

 

 

 

6

 

 

 

 

120

 

 

 

126

 

 

 

259

 

 

 

258

 

 

 

 

 

 

 

 

 

 

Other HIV(2) – U.S.

 

 

10

 

 

 

5

 

 

 

15

 

 

 

10

 

Other HIV(2) – Europe

 

 

7

 

 

 

9

 

 

 

8

 

 

 

13

 

Other HIV(2) – Other International

 

 

3

 

 

 

4

 

 

 

6

 

 

 

9

 

 

 

 

20

 

 

 

18

 

 

 

29

 

 

 

33

 

 

 

 

 

 

 

 

 

 

Total HIV – U.S.

 

 

3,778

 

 

 

3,383

 

 

 

7,142

 

 

 

6,245

 

Total HIV – Europe

 

 

521

 

 

 

562

 

 

 

1,049

 

 

 

1,112

 

Total HIV – Other International

 

 

326

 

 

 

282

 

 

 

624

 

 

 

577

 

 

 

 

4,626

 

 

 

4,228

 

 

 

8,816

 

 

 

7,935

 

 

 

 

 

 

 

 

 

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Oncology

 

 

 

 

 

 

 

 

Cell Therapy

 

 

 

 

 

 

 

 

Tecartus – U.S.

 

56

 

53

 

114

 

100

Tecartus – Europe

 

 

29

 

 

 

20

 

 

 

56

 

 

 

35

 

Tecartus – Other International

 

 

4

 

 

 

 

 

 

6

 

 

 

1

 

 

 

 

88

 

 

 

73

 

 

 

177

 

 

 

136

 

 

 

 

 

 

 

 

 

 

Yescarta – U.S.

 

 

217

 

 

 

193

 

 

 

427

 

 

 

318

 

Yescarta – Europe

 

 

133

 

 

 

85

 

 

 

254

 

 

 

162

 

Yescarta – Other International

 

 

30

 

 

 

17

 

 

 

58

 

 

 

26

 

 

 

 

380

 

 

 

295

 

 

 

739

 

 

 

506

 

 

 

 

 

 

 

 

 

 

Total Cell Therapy – U.S.

 

 

272

 

 

 

246

 

 

 

542

 

 

 

418

 

Total Cell Therapy – Europe

 

 

162

 

 

 

105

 

 

 

310

 

 

 

197

 

Total Cell Therapy – Other International

 

 

34

 

 

 

17

 

 

 

65

 

 

 

27

 

 

 

 

469

 

 

 

368

 

 

 

916

 

 

 

642

 

 

 

 

 

 

 

 

 

 

Trodelvy

 

 

 

 

 

 

 

 

Trodelvy – U.S.

 

 

189

 

 

 

120

 

 

 

351

 

 

 

240

 

Trodelvy – Europe

 

 

53

 

 

 

35

 

 

 

107

 

 

 

61

 

Trodelvy – Other International

 

 

17

 

 

 

3

 

 

 

23

 

 

 

5

 

 

 

 

260

 

 

 

159

 

 

 

482

 

 

 

305

 

 

 

 

 

 

 

 

 

 

Total Oncology – U.S.

 

 

462

 

 

 

366

 

 

 

893

 

 

 

658

 

Total Oncology – Europe

 

 

215

 

 

 

141

 

 

 

417

 

 

 

258

 

Total Oncology – Other International

 

 

51

 

 

 

21

 

 

 

88

 

 

 

32

 

 

 

 

728

 

 

 

527

 

 

 

1,398

 

 

 

947

 

Liver Disease

 

 

 

 

 

 

 

 

HCV

 

 

 

 

 

 

 

 

Ledipasvir / Sofosbuvir(3) – U.S.

 

 

8

 

 

 

6

 

 

 

12

 

 

 

19

 

Ledipasvir / Sofosbuvir(3) – Europe

 

 

2

 

 

 

4

 

 

 

9

 

 

 

8

 

Ledipasvir / Sofosbuvir(3) – Other International

 

 

5

 

 

 

13

 

 

 

10

 

 

 

31

 

 

 

 

15

 

 

 

23

 

 

 

30

 

 

 

58

 

 

 

 

 

 

 

 

 

 

Sofosbuvir / Velpatasvir(4) – U.S.

 

 

223

 

 

 

227

 

 

 

427

 

 

 

389

 

Sofosbuvir / Velpatasvir(4) – Europe

 

 

84

 

 

 

75

 

 

 

174

 

 

 

157

 

Sofosbuvir / Velpatasvir(4) – Other International

 

 

90

 

 

 

74

 

 

 

181

 

 

 

159

 

 

 

 

397

 

 

 

376

 

 

 

782

 

 

 

706

 

 

 

 

 

 

 

 

 

 

Other HCV(5) – U.S.

 

 

28

 

 

 

30

 

 

 

51

 

 

 

54

 

Other HCV(5) – Europe

 

 

9

 

 

 

16

 

 

 

27

 

 

 

24

 

Other HCV(5) – Other International

 

 

3

 

 

 

3

 

 

 

6

 

 

 

5

 

 

 

 

40

 

 

 

49

 

 

 

85

 

 

 

83

 

 

 

 

 

 

 

 

 

 

Total HCV – U.S.

 

 

259

 

 

 

263

 

 

 

491

 

 

 

462

 

Total HCV – Europe

 

 

95

 

 

 

94

 

 

 

209

 

 

 

189

 

Total HCV – Other International

 

 

98

 

 

 

91

 

 

 

197

 

 

 

196

 

 

 

 

452

 

 

 

448

 

 

 

897

 

 

 

847

 

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

HBV/HDV

 

 

 

 

 

 

 

 

Vemlidy – U.S.

 

96

 

97

 

183

 

177

Vemlidy – Europe

 

 

10

 

 

 

9

 

 

 

19

 

 

 

18

 

Vemlidy – Other International

 

 

113

 

 

 

89

 

 

 

216

 

 

 

199

 

 

 

 

219

 

 

 

195

 

 

 

418

 

 

 

394

 

 

 

 

 

 

 

 

 

 

Viread – U.S.

 

 

1

 

 

 

3

 

 

 

1

 

 

 

3

 

Viread – Europe

 

 

6

 

 

 

6

 

 

 

12

 

 

 

12

 

Viread – Other International

 

 

14

 

 

 

15

 

 

 

28

 

 

 

32

 

 

 

 

21

 

 

 

24

 

 

 

40

 

 

 

47

 

 

 

 

 

 

 

 

 

 

Other HBV/HDV(6) – Europe

 

 

20

 

 

 

15

 

 

 

31

 

 

 

28

 

 

 

 

20

 

 

 

16

 

 

 

31

 

 

 

28

 

 

 

 

 

 

 

 

 

 

Total HBV/HDV – U.S.

 

 

97

 

 

 

100

 

 

 

183

 

 

 

180

 

Total HBV/HDV – Europe

 

 

35

 

 

 

30

 

 

 

62

 

 

 

57

 

Total HBV/HDV – Other International

 

 

127

 

 

 

104

 

 

 

244

 

 

 

232

 

 

 

 

259

 

 

 

234

 

 

 

489

 

 

 

470

 

 

 

 

 

 

 

 

 

 

Total Liver Disease – U.S.

 

 

356

 

 

 

363

 

 

 

674

 

 

 

642

 

Total Liver Disease – Europe

 

 

131

 

 

 

124

 

 

 

271

 

 

 

247

 

Total Liver Disease – Other International

 

 

225

 

 

 

195

 

 

 

441

 

 

 

427

 

 

 

 

711

 

 

 

682

 

 

 

1,386

 

 

 

1,317

 

Veklury

 

 

 

 

 

 

 

 

Veklury – U.S.

 

 

97

 

 

 

41

 

 

 

349

 

 

 

843

 

Veklury – Europe

 

 

52

 

 

 

126

 

 

 

163

 

 

 

430

 

Veklury – Other International

 

 

107

 

 

 

278

 

 

 

317

 

 

 

708

 

 

 

 

256

 

 

 

445

 

 

 

829

 

 

 

1,980

 

Other

 

 

 

 

 

 

 

 

AmBisome – U.S.

 

 

20

 

 

 

15

 

 

 

27

 

 

 

40

 

AmBisome – Europe

 

 

69

 

 

 

63

 

 

 

129

 

 

 

129

 

AmBisome – Other International

 

 

61

 

 

 

54

 

 

 

111

 

 

 

107

 

 

 

 

151

 

 

 

132

 

 

 

267

 

 

 

275

 

 

 

 

 

 

 

 

 

 

Letairis – U.S.

 

 

39

 

 

 

49

 

 

 

70

 

 

 

92

 

 

 

 

 

 

 

 

 

 

Other(7) – U.S.

 

 

26

 

 

 

37

 

 

 

56

 

 

 

63

 

Other(7) – Europe

 

 

10

 

 

 

26

 

 

 

22

 

 

 

41

 

Other(7) – Other International

 

 

17

 

 

 

13

 

 

 

26

 

 

 

22

 

 

 

 

53

 

 

 

76

 

 

 

105

 

 

 

125

 

 

 

 

 

 

 

 

 

 

Total Other – U.S.

 

 

85

 

 

 

101

 

 

 

153

 

 

 

195

 

Total Other – Europe

 

 

80

 

 

 

88

 

 

 

152

 

 

 

169

 

Total Other – Other International

 

 

78

 

 

 

67

 

 

 

137

 

 

 

129

 

 

 

 

243

 

 

 

256

 

 

 

442

 

 

 

493

 

 

 

 

 

 

 

 

 

 

Total product sales – U.S.

 

 

4,777

 

 

 

4,254

 

 

 

9,211

 

 

 

8,582

 

Total product sales – Europe

 

 

999

 

 

 

1,042

 

 

 

2,052

 

 

 

2,216

 

Total product sales – Other International

 

 

788

 

 

 

842

 

 

 

1,607

 

 

 

1,873

 

 

 

$

6,564

 

 

$

6,138

 

 

$

12,870

 

 

$

12,672

 

 

(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, Emtriva, Sunlenca and Tybost.

(3)

 

Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC.

(4)

 

Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC.

(5)

 

Includes Vosevi and Sovaldi.

(6)

 

Includes Hepcludex and Hepsera.

(7)

 

Includes Cayston, Jyseleca, Ranexa and Zydelig.

 

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