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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)

FOSTER CITY, Calif.–(BUSINESS WIRE)–#Earnings–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

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.

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.

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

Guidance and Outlook

For the full-year, Gilead expects:

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

Oncology

Inflammation

Corporate

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

%

 

Contacts

Investors:
Jacquie Ross, CFA

investor_relations@gilead.com

Media:
Ashleigh Koss

public_affairs@gilead.com

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