Gilead Sciences Announces Second Quarter 2021 Financial Results

Second Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury

Biktarvy Sales Increased 24% Year-Over-Year

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2021.

“We maintained our positive momentum in the second quarter, with both a solid financial performance and strong progress across our increasingly diverse portfolio. Our flagship HIV therapy, Biktarvy, saw continued growth and gains in market share, despite the ongoing impact of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma. In virology, recent results from our lenacapavir study reinforce its potential as a long-acting therapy for people living with HIV, and positive interim results from our Hepcludex studies in HDV moved us closer to a U.S. filing.”

Second Quarter 2021 Financial Results

  • Total second quarter 2021 revenue of $6.2 billion increased 21% compared to the same period in 2020, primarily due to Veklury® (remdesivir), higher demand for Biktarvy (bictegravir 50 mg/FTC/tenofovir alafenamide 25 mg (“TAF”)) and our hepatitis C virus (“HCV”) products, as well as continued uptake in the United States of Trodelvy® (sacituzumab govitecan-hziy) and Tecartus® (brexucabtagene autoleucel).
  • Diluted Earnings Per Share (“EPS”) increased to $1.21 for the second quarter 2021 compared to net loss per share of $2.66 for the same period in 2020. This was primarily driven by the impact of higher in-process research and development (“IPR&D”) expenses in the second quarter 2020 related to the Forty Seven, Inc. acquisition and revenue growth in the second quarter 2021, offset by fair value loss adjustments on Gilead’s equity investment in Galapagos NV.
  • Non-GAAP diluted EPS increased 68% to $1.87 for the second quarter 2021 compared to the same period in 2020, primarily due to higher operating income partially offset by lower interest income.
  • As of June 30, 2021, Gilead had $7.4 billion of cash, cash equivalents and marketable debt securities compared to $7.9 billion as of December 31, 2020.
  • During the second quarter 2021, Gilead generated $2.3 billion in operating cash flow.
  • During the second quarter 2021, Gilead paid cash dividends of $894 million and utilized $43 million to repurchase common stock.

Product Sales Performance

Total second quarter 2021 product sales increased 21% to $6.2 billion compared to the same period in 2020. Total product sales excluding Veklury increased 5% to $5.3 billion for the second quarter 2021 compared to the same period in 2020, reflecting continued uptake of Trodelvy and Tecartus in the United States as well as improving trends in HIV and HCV, offset, as expected, by loss of exclusivity of Truvada® (emtricitabine 200mg (“FTC”)/tenofovir disoproxil fumarate 300mg (“TDF”)) and Atripla® (efavirenz 600mg/FTC/TDF) in the United States.

HIV product sales decreased 2% to $3.9 billion for the second quarter 2021 compared to the same period in 2020, reflecting the expected loss of exclusivity of Truvada and Atripla in the United States, offset in part by increased demand.

  • Biktarvy® sales increased 24% year-over-year in the second quarter 2021, reflecting higher demand in all geographies.
  • Descovy® (FTC/TAF) sales increased 4% year-over-year in the second quarter 2021, driven by increased pre-exposure prophylaxis (“PrEP”) demand in the United States and the impact in the same period last year of the COVID-related channel inventory drawdown, offset by lower average net selling price.
  • Truvada and Atripla sales decreased 72% year-over-year to $108 million and 42% year-over-year to $60 million, respectively, in the second quarter 2021 due to generic entrants in the United States following loss of exclusivity in late 2020.

HCV product sales increased 23% to $549 million for the second quarter 2021 compared to the same period in 2020, driven primarily by improved market starts in the United States and Europe as well as an unfavorable change in estimate of government rebates in the second quarter 2020.

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Vemlidy® (tenofovir alafenamide 25 mg) sales increased 32% in the second quarter 2021 compared to the same period in 2020 driven by increased demand primarily in geographies outside the United States and Europe. Hepcludex® (bulevirtide) contributed $7 million in the second quarter 2021 reflecting the first full quarter of sales for Gilead.

Cell Therapy product sales increased 39% to $219 million for the second quarter 2021 compared to the same period in 2020.

  • Yescarta® (axicabtagene ciloleucel) sales increased to $178 million in the second quarter 2021, reflecting continued uptake in relapsed or refractory indolent follicular lymphoma (“FL”) in the United States following its approval by the U.S. Food and Drug Administration (“FDA”) in the first quarter 2021 and expansion in Europe.
  • Tecartus sales were $41 million for the second quarter 2021, driven by the launch in mantle cell lymphoma in the United States and Europe.

Trodelvy sales for the second quarter 2021 were $89 million. Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer.

Veklury sales were $829 million for the second quarter 2021. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations.

Other product sales increased 20% to $291 million for the second quarter 2021 compared to the same period in 2020.

  • AmBisome® (amphotericin B) sales increased in the second quarter 2021 compared to the same period in 2020 driven by an increase in shipments outside the United States, primarily in India and Europe.

Second Quarter 2021 Product Gross Margin, Operating Expenses and Tax

  • Product gross margin was 77.4% for the second quarter 2021 compared to 79.0% in the same period in 2020, reflecting additional amortization of intangibles acquired from Immunomedics, Inc. and MYR GmbH. Non-GAAP product gross margin was 86.4% for the second quarter 2021 compared to 84.3% in the same period in 2020, driven by lower royalty expense.
  • Research and Development (“R&D”) expenses for the second quarter 2021 were $1.1 billion compared to $1.3 billion in the same period in 2020. Non-GAAP R&D expenses for the second quarter 2021 were $1.1 billion compared to $1.2 billion in the same period in 2020. Lower R&D expenses reflect completion or wind-down of remdesivir-related programs, partly offset by increases in Trodelvy and magrolimab clinical activities.
  • Sales, General and Administrative (“SG&A”) expenses for the second quarter 2021 were $1.4 billion compared to $1.2 billion in the same period in 2020. The increase in SG&A expenses was driven primarily by a significant donation of equity securities to the Gilead Foundation. Non-GAAP SG&A expenses for the second quarter 2021 were $1.1 billion compared to $1.2 billion in the same period in 2020. The decrease in non-GAAP SG&A expenses was driven by lower legal expenses primarily due to a prior year settlement associated with a Department of Justice investigation, offset by increases in promotional and commercialization activities in geographies outside the United States.
  • The GAAP effective tax rate (“ETR”) and non-GAAP ETR for the second quarter 2021 were 16.5% and 19.6%, respectively, compared to (12.5)% and 22.8%, respectively, for the same periods in 2020.

Key Updates Since Our Last Quarterly Release

Viral Diseases

  • Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science. Phase 2 data from CALIBRATE, an ongoing, open-label, active-controlled trial in treatment-naïve people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide (“F/TAF”) led to high rates of viral suppression by Week 28. These results support the ongoing evaluation and further development of lenacapavir in combination with other long-acting partner agents for the treatment of HIV-1 infection and will support Gilead’s long-acting oral and injectable development program.
  • Gilead also announced at IAS 2021 new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrate that lenacapavir administered subcutaneously every six months in combination with other antiretrovirals achieved high rates of virologic suppression at Week 26.
  • Gilead filed a New Drug Application to FDA seeking approval of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant infection.
  • Gilead announced interim results from the Phase 3 study (MYR301) of bulevirtide for the treatment of HDV at the International Liver Congress (“ILC”) 2021 annual meeting. After 24 weeks, 36.7% of patients receiving a 2mg dose of bulevirtide and 28% of patients receiving a 10mg dose of bulevirtide showed a combined virological and biological response compared to 0% in the no treatment group.
  • Gilead also announced at ILC 2021 the interim results from the Phase 2b study (MYR204) of bulevirtide for the treatment of HDV. At week 24, results showed that bulevirtide alone or in combination with peginterferon alfa-2a, is associated with a significant HDV RNA decline and improvements in biochemical disease activity.
  • Gilead received FDA approval for a new formulation of Epclusa, expanding the pediatric indication for the treatment of HCV to now include children as young as 3 years of age.

Oncology

  • Kite announced top-line results from the primary analysis of ZUMA-7 trial of Yescarta in second-line relapsed or refractory large B-cell lymphoma (“LBCL”). At a median follow-up of two years, Yescarta improved event free survival by 60% over the standard of care chemotherapy plus stem cell transplant. The study also met the key secondary endpoint of objective response rate. Full data will be presented later this year and discussions are underway with global regulatory authorities.
  • Kite announced that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., received approval from the China National Medical Products Administration for axicabtagene ciloleucel (FKC876) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy. Yescarta is the first and only commercially available chimeric antigen receptor (“CAR”) T-cell therapy approved in China.
  • Kite announced a partnership with Shoreline Biosciences, Inc. to develop allogeneic candidates for a range of hematologic malignancies. The collaboration will focus initially on CAR NK targets, with Kite having an option to expand the collaboration to include an induced pluripotent stem cell CAR Macrophage program.
  • Kite announced follow-up results from the pivotal ZUMA-5 trial of Yescarta in relapsed or refractory FL at the American Society of Clinical Oncology (“ASCO”) 2021 annual meeting. At a minimum follow-up of 18 months, 94% of patients had achieved a response, and secondary endpoints of median progression-free survival and overall survival were not yet reached.
  • Kite announced at ASCO 2021, with a publication in The Lancet, primary analysis of ZUMA-3 evaluating Tecartus in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. In the pivotal Phase 2 portion of the trial, 71 patients with relapsed or refractory disease were enrolled and Kite observed a response rate of 71%. Importantly, the majority of these responses were associated with undetectable minimal residual disease. The findings have been designated for Priority Review by FDA with a Prescription Drug User Fee Act (“PDUFA”) date of October 1, 2021.
  • Gilead announced analyses from Phase 3 ASCENT study at ASCO 2021 in patients with relapsed or refractory mTNBC. Treatment with Trodelvy demonstrated significantly greater survival benefit over chemotherapy in patients treated in the second-line setting and in patients greater than 65 years old.

Corporate

  • Kite announced a purchase agreement with BioNTech SE to acquire Kite’s solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, Maryland.
  • Gilead welcomed William Grossman, MD, PhD, as Senior Vice President, Oncology Clinical Research. Dr. Grossman brings extensive experience as a clinician and a veteran biopharmaceutical executive.
  • Gilead announced that the company’s Board of Directors has declared a quarterly dividend of $0.71 per share of common stock for the third quarter of 2021. The dividend is payable on September 29, 2021, to stockholders of record at the close of business on September 15, 2021. Future dividends will be subject to Board approval.

Guidance and Outlook

Gilead has updated its full-year guidance, and now expects:

  • Total product sales between $24.4 billion and $25.0 billion, compared to $23.7 billion and $25.1 billion previously, reflecting solid results in the first half of the year and our updated expectations for the second half of 2021.
  • Total product sales, excluding Veklury, between $21.7 billion and $21.9 billion, compared to $21.7 billion to $22.1 billion previously, primarily reflecting the longer than expected pandemic impact on our HIV business, including the latest increase in COVID-19 cases.
  • Total Veklury sales between $2.7 billion and $3.1 billion, compared to $2.0 billion to $3.0 billion previously, reflecting the ongoing role of Veklury in the pandemic, in addition to the continued uncertainties around the path of the pandemic since Veklury revenue tends to track hospitalization rates.
  • GAAP earnings per share between $4.70 and $5.05, compared to $4.75 to $5.45 previously.
  • Non-GAAP earnings per share between $6.90 and $7.25, compared to $6.75 to $7.45 previously.

A reconciliation between GAAP and non-GAAP financial information for the 2021 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. While the pandemic can be expected to continue to impact Gilead’s business and broader market dynamics, the rate and degree of these impacts as well as the corresponding recovery from the pandemic may vary across Gilead’s business.

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 excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges in cost of goods sold, acquired IPR&D expenses, 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. Acquired IPR&D expenses reflect IPR&D impairments as well as the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and other payments related to various collaborations and the initial costs of rights to IPR&D projects. 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.

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.

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 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 future Veklury sales, Gilead’s ability to recoup the expenses incurred to date and future expenses related to the development and production of Veklury, and Gilead’s ability to effectively manage the global supply and distribution of Veklury; Gilead’s ability to achieve its anticipated full year 2021 financial results, including as a result of potential adverse revenue impacts from COVID-19, increases in R&D expenses and potential revenues from Veklury; 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 antiviral and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including those involving Shoreline Biosciences, Inc.; 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 (bulevirtide), Tecartus, Trodelvy and Yescarta; the risk that safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates, including those involving lenacapavir, or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates in the currently anticipated timelines, including those involving Hepcludex (bulevirtide) for treatment of HDV, Tecartus for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia and Yescarta for treatment of second-line relapsed or refractory LBCL; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA approval of lenacapavir for treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant infection, and the risk that any such approvals 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; 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; 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, 2021 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®, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX® (BULEVIRTIDE), HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, 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 OPERATIONS

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions, except per share amounts)

 

2021

 

2020

 

 

2021

 

2020

Revenues:

 

 

 

 

 

 

 

 

Product sales

 

$

6,152

 

 

 

$

5,067

 

 

 

$

12,492

 

 

 

$

10,534

 

 

Royalty, contract and other revenues

 

65

 

 

 

76

 

 

 

148

 

 

 

157

 

 

Total revenues

 

6,217

 

 

 

5,143

 

 

 

12,640

 

 

 

10,691

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

Cost of goods sold

 

1,390

 

 

 

1,064

 

 

 

2,751

 

 

 

2,033

 

 

Research and development expenses

 

1,134

 

 

 

1,299

 

 

 

2,189

 

 

 

2,303

 

 

Acquired in-process research and development expenses

 

96

 

 

 

4,524

 

 

 

158

 

 

 

4,621

 

 

Selling, general and administrative expenses

 

1,351

 

 

 

1,239

 

 

 

2,406

 

 

 

2,315

 

 

Total costs and expenses

 

3,971

 

 

 

8,126

 

 

 

7,504

 

 

 

11,272

 

 

Income (loss) from operations

 

2,246

 

 

 

(2,983

)

 

 

5,136

 

 

 

(581

)

 

Interest expense

 

(256

)

 

 

(240

)

 

 

(513

)

 

 

(481

)

 

Other income (expense), net

 

(173

)

 

 

250

 

 

 

(542

)

 

 

92

 

 

Income (loss) before income taxes

 

1,817

 

 

 

(2,973

)

 

 

4,081

 

 

 

(970

)

 

Income tax expense

 

(300

)

 

 

(373

)

 

 

(842

)

 

 

(838

)

 

Net income (loss)

 

1,517

 

 

 

(3,346

)

 

 

3,239

 

 

 

(1,808

)

 

Net loss attributable to noncontrolling interest

 

5

 

 

 

7

 

 

 

12

 

 

 

20

 

 

Net income (loss) attributable to Gilead

 

$

1,522

 

 

 

$

(3,339

)

 

 

$

3,251

 

 

 

$

(1,788

)

 

Net income (loss) per share attributable to Gilead common stockholders - basic

 

$

1.21

 

 

 

$

(2.66

)

 

 

$

2.59

 

 

 

$

(1.42

)

 

Shares used in per share calculation - basic

 

1,255

 

 

 

1,255

 

 

 

1,256

 

 

 

1,258

 

 

Net income (loss) per share attributable to Gilead common stockholders - diluted

 

$

1.21

 

 

 

$

(2.66

)

 

 

$

2.58

 

 

 

$

(1.42

)

 

Shares used in per share calculation - diluted

 

1,260

 

 

 

1,255

 

 

 

1,261

 

 

 

1,258

 

 

Cash dividends declared per share

 

$

0.71

 

 

 

$

0.68

 

 

 

$

1.42

 

 

 

$

1.36

 

 

 

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

(In millions, except percentages)

 

2021

 

2020

 

Change

 

2021

 

2020

 

Change

Product sales:

 

 

 

 

 

 

 

 

 

 

 

 

HIV

 

$

3,938

 

 

$

4,000

 

 

(2

)%

 

$

7,588

 

 

$

8,134

 

 

(7

)%

HCV

 

549

 

 

448

 

 

23

%

 

1,059

 

 

1,177

 

 

(10

)%

HBV/HDV(1)

 

237

 

 

219

 

 

8

%

 

457

 

 

405

 

 

13

%

Cell Therapy

 

219

 

 

157

 

 

39

%

 

410

 

 

297

 

 

38

%

Trodelvy

 

89

 

 

 

 

NM

 

 

161

 

 

 

 

NM

 

Other

 

291

 

 

243

 

 

20

%

 

532

 

 

521

 

 

2

%

Total product sales excluding Veklury

 

5,323

 

 

5,067

 

 

5

%

 

10,207

 

 

10,534

 

 

(3

)%

Veklury

 

829

 

 

 

 

NM

 

 

2,285

 

 

 

 

NM

 

Total product sales

 

6,152

 

 

5,067

 

 

21

%

 

12,492

 

 

10,534

 

 

19

%

Royalty, contract and other revenues

 

65

 

 

76

 

 

(14

)%

 

148

 

 

157

 

 

(6

)%

Total revenues

 

$

6,217

 

 

$

5,143

 

 

21

%

 

$

12,640

 

 

$

10,691

 

 

18

%

 

NM - Not Meaningful

(1)

The six months ended June 30, 2021 includes $13 million of Hepcludex sales recorded subsequent to Gilead’s acquisition of MYR GmbH (“MYR”). The six months ended June 30, 2021 of Hepcludex sales, including the period prior to the completion of Gilead’s acquisition of MYR, were $20 million.

 

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION(1)

(unaudited)

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

(In millions, except percentages)

 

2021

 

2020

 

Change

 

2021

 

2020

 

Change

Non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

$

836

 

 

$

798

 

 

5

%

 

$

1,691

 

 

 

$

1,501

 

 

13

%

Research and development expenses

 

$

1,084

 

 

$

1,186

 

 

(9

)%

 

$

2,133

 

 

 

$

2,190

 

 

(3

)%

Selling, general and administrative expenses

 

$

1,121

 

 

$

1,164

 

 

(4

)%

 

$

2,154

 

 

 

$

2,240

 

 

(4

)%

Other income (expense), net

 

$

1

 

 

$

49

 

 

(98

)%

 

$

(17

)

 

 

$

174

 

 

(110

)%

Diluted EPS

 

$

1.87

 

 

$

1.11

 

 

68

%

 

$

3.95

 

 

 

$

2.80

 

 

41

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Product gross margin

 

86.4

%

 

84.3

%

 

210 bps

 

86.5

%

 

85.8

%

 

70 bps

Research and development expenses as a % of revenues

 

17.4

%

 

23.1

%

 

(6

)%

 

16.9

%

 

20.5

%

 

(4

)%

Selling, general and administrative expenses as a % of revenues

 

18.0

%

 

22.6

%

 

(5

)%

 

17.0

%

 

21.0

%

 

(4

)%

Operating expenses as a % of revenues

 

35.5

%

 

45.7

%

 

(10

)%

 

33.9

%

 

41.4

%

 

(8

)%

Operating margin

 

51.1

%

 

38.8

%

 

1230 bps

 

52.7

%

 

44.5

%

 

820 bps

Effective tax rate

 

19.6

%

 

22.8

%

 

(3

)%

 

19.0

%

 

21.0

%

 

(2

)%

 

NM - Not Meaningful

(1)

A reconciliation between GAAP and non-GAAP financial information is provided in the accompanying tables.

 

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)

 

2021

 

2020

 

2021

 

2020

Cost of goods sold reconciliation:

 

 

 

 

 

 

 

 

GAAP cost of goods sold

 

$

1,390

 

 

 

$

1,064

 

 

 

$

2,751

 

 

 

$

2,033

 

 

Acquisition-related – amortization of acquired intangibles and inventory step-up charges

 

(554

)

 

 

(266

)

 

 

(1,060

)

 

 

(532

)

 

Non-GAAP cost of goods sold

 

$

836

 

 

 

$

798

 

 

 

$

1,691

 

 

 

$

1,501

 

 

 

 

 

 

 

 

 

 

 

Product gross margin reconciliation:

 

 

 

 

 

 

 

 

GAAP product gross margin

 

77.4

 

%

 

79.0

 

%

 

78.0

 

%

 

80.7

 

%

Acquisition-related – amortization of acquired intangibles and inventory step-up charges

 

9.0

 

%

 

5.2

 

%

 

8.5

 

%

 

5.1

 

%

Non-GAAP product gross margin(1)

 

86.4

 

%

 

84.3

 

%

 

86.5

 

%

 

85.8

 

%

 

 

 

 

 

 

 

 

 

Research and development expenses reconciliation:

 

 

 

 

 

 

 

 

GAAP research and development expenses

 

$

1,134

 

 

 

$

1,299

 

 

 

$

2,189

 

 

 

$

2,303

 

 

Acquisition-related – other costs(2)

 

(6

)

 

 

(113

)

 

 

(12

)

 

 

(113

)

 

Other

 

(44

)

 

 

 

 

 

(44

)

 

 

 

 

Non-GAAP research and development expenses

 

$

1,084

 

 

 

$

1,186

 

 

 

$

2,133

 

 

 

$

2,190

 

 

 

 

 

 

 

 

 

 

 

Acquired IPR&D expenses reconciliation:

 

 

 

 

 

 

 

 

GAAP acquired IPR&D expenses

 

$

96

 

 

 

$

4,524

 

 

 

$

158

 

 

 

$

4,621

 

 

Acquired IPR&D expenses

 

(96

)

 

 

(4,524

)

 

 

(158

)

 

 

(4,621

)

 

Non-GAAP acquired IPR&D expenses

 

$

 

 

 

$

 

 

 

$

 

 

 

$

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses reconciliation:

 

 

 

 

 

 

 

 

GAAP selling, general and administrative expenses

 

$

1,351

 

 

 

$

1,239

 

 

 

$

2,406

 

 

 

$

2,315

 

 

Acquisition-related – other costs(2)

 

(10

)

 

 

(77

)

 

 

(32

)

 

 

(77

)

 

Other(3)

 

(220

)

 

 

2

 

 

 

(220

)

 

 

2

 

 

Non-GAAP selling, general and administrative expenses

 

$

1,121

 

 

 

$

1,164

 

 

 

$

2,154

 

 

 

$

2,240

 

 

 

 

 

 

 

 

 

 

 

Operating income reconciliation:

 

 

 

 

 

 

 

 

GAAP operating income (loss)

 

$

2,246

 

 

 

$

(2,983

)

 

 

$

5,136

 

 

 

$

(581

)

 

Acquired IPR&D expenses

 

96

 

 

 

4,524

 

 

 

158

 

 

 

4,621

 

 

Acquisition-related – amortization of acquired intangibles and inventory step-up charges

 

554

 

 

 

266

 

 

 

1,060

 

 

 

532

 

 

Acquisition-related – other costs(2)

 

16

 

 

 

190

 

 

 

44

 

 

 

190

 

 

Other(3)

 

264

 

 

 

(2

)

 

 

264

 

 

 

(2

)

 

Non-GAAP operating income

 

$

3,176

 

 

 

$

1,995

 

 

 

$

6,662

 

 

 

$

4,760

 

 

 

 

 

 

 

 

 

 

 

Operating margin reconciliation:

 

 

 

 

 

 

 

 

GAAP operating margin

 

36.1

 

%

 

(58.0

)

%

 

40.6

 

%

 

(5.4

)

%

Acquired IPR&D expenses

 

1.5

 

%

 

88.0

 

%

 

1.2

 

%

 

43.2

 

%

Acquisition-related – amortization of acquired intangibles and inventory step-up charges

 

8.9

 

%

 

5.2

 

%

 

8.4

 

%

 

5.0

 

%

Acquisition-related – other costs(2)

 

0.3

 

%

 

3.7

 

%

 

0.3

 

%

 

1.8

 

%

Other(3)

 

4.2

 

%

 

 

%

 

2.1

 

%

 

 

%

Non-GAAP operating margin(1)

 

51.1

 

%

 

38.8

 

%

 

52.7

 

%

 

44.5

 

%

 

 

 

 

 

 

 

 

 

Other income (expense), net reconciliation:

 

 

 

 

 

 

 

 

GAAP other income (expense), net

 

$

(173

)

 

 

$

250

 

 

 

$

(542

)

 

 

$

92

 

 

Losses (gains) from equity securities, net

 

174

 

 

 

(201

)

 

 

525

 

 

 

82

 

 

Non-GAAP other income (expense), net

 

$

1

 

 

 

$

49

 

 

 

$

(17

)

 

 

$

174

 

 

 

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)

 

2021

 

2020

 

2021

 

2020

Effective tax rate reconciliation:

 

 

 

 

 

 

 

 

GAAP effective tax rate

 

16.5

 

%

 

(12.5

)

%

 

20.6

 

%

 

(86.4

)

%

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

 

3.1

 

%

 

35.3

 

%

 

(1.6

)

%

 

107.4

 

%

Non-GAAP effective tax rate(1)

 

19.6

 

%

 

22.8

 

%

 

19.0

 

%

 

21.0

 

%

 

 

 

 

 

 

 

 

 

Net income attributable to Gilead reconciliation:

 

 

 

 

 

 

 

 

GAAP net income (loss) attributable to Gilead

 

$

1,522

 

 

 

$

(3,339

)

 

 

$

3,251

 

 

 

$

(1,788

)

 

Acquired IPR&D expenses (after tax)

 

75

 

 

 

4,514

 

 

 

125

 

 

 

4,589

 

 

Acquisition-related – amortization of acquired intangibles and inventory step-up charges (after tax)

 

446

 

 

 

224

 

 

 

855

 

 

 

448

 

 

Acquisition-related – other costs (after tax)(2)

 

15

 

 

 

148

 

 

 

37

 

 

 

148

 

 

Losses (gains) from equity securities, net (after tax)

 

169

 

 

 

(149

)

 

 

533

 

 

 

107

 

 

Discrete and related tax charges (benefits)(4)

 

(40

)

 

 

4

 

 

 

14

 

 

 

37

 

 

Other (after tax)(3)

 

166

 

 

 

(2

)

 

 

166

 

 

 

(2

)

 

Non-GAAP net income attributable to Gilead

 

$

2,353

 

 

 

$

1,400

 

 

 

$

4,981

 

 

 

$

3,539

 

 

 

 

 

 

 

 

 

 

 

Diluted EPS reconciliation:

 

 

 

 

 

 

 

 

GAAP diluted earnings (loss) per share

 

$

1.21

 

 

 

$

(2.66

)

 

 

$

2.58

 

 

 

$

(1.42

)

 

Acquired IPR&D expenses

 

0.06

 

 

 

3.58

 

 

 

0.10

 

 

 

3.62

 

 

Acquisition-related – amortization of acquired intangibles and inventory step-up charges

 

0.35

 

 

 

0.18

 

 

 

0.68

 

 

 

0.35

 

 

Acquisition-related – other costs(2)

 

0.01

 

 

 

0.12

 

 

 

0.03

 

 

 

0.12

 

 

Losses (gains) from equity securities, net

 

0.13

 

 

 

(0.12

)

 

 

0.42

 

 

 

0.08

 

 

Discrete and related tax charges (benefits)(4)

 

(0.03

)

 

 

 

 

 

0.01

 

 

 

0.03

 

 

Other(3)

 

0.13

 

 

 

 

 

 

0.13

 

 

 

 

 

Non-GAAP diluted EPS(1)

 

$

1.87

 

 

 

$

1.11

 

 

 

$

3.95

 

 

 

$

2.80

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP adjustment summary:

 

 

 

 

 

 

 

 

Cost of goods sold adjustments

 

$

554

 

 

 

$

266

 

 

 

$

1,060

 

 

 

$

532

 

 

Research and development expenses adjustments

 

50

 

 

 

113

 

 

 

56

 

 

 

113

 

 

Acquired IPR&D expenses adjustments

 

96

 

 

 

4,524

 

 

 

158

 

 

 

4,621

 

 

Selling, general and administrative expenses adjustments

 

230

 

 

 

75

 

 

 

252

 

 

 

75

 

 

Total non-GAAP adjustments before other income (expense), net, and income taxes

 

930

 

 

 

4,978

 

 

 

1,526

 

 

 

5,341

 

 

Other income (expense), net, adjustments

 

174

 

 

 

(201

)

 

 

525

 

 

 

82

 

 

Total non-GAAP adjustments before income taxes

 

1,104

 

 

 

4,777

 

 

 

2,051

 

 

 

5,423

 

 

Income tax effect of non-GAAP adjustments above

 

(233

)

 

 

(42

)

 

 

(335

)

 

 

(133

)

 

Discrete and related tax charges (benefits)(4)

 

(40

)

 

 

4

 

 

 

14

 

 

 

37

 

 

Total non-GAAP adjustments after tax

 

$

831

 

 

 

$

4,739

 

 

 

$

1,730

 

 

 

$

5,327

 

 

 

(1)

Amounts may not sum due to rounding.

(2)

Includes primarily employee-related expenses and contingent consideration, as well as other expenses associated with Gilead’s acquisitions of Immunomedics, Inc., Forty Seven, Inc. and MYR GmbH.

(3)

Includes primarily a significant donation of equity securities to the Gilead Foundation, a California nonprofit public benefit corporation.

(4)

Primarily represents discrete and related deferred tax charges or benefits associated with a transfer of intangible assets from a foreign subsidiary to Ireland and the United States.

 

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP 2021 FULL YEAR GUIDANCE(1)

(unaudited)

 

(in millions, except percentages and per share amounts)

 

Provided

February 4, 2021

 

Updated

April 29, 2021

 

Updated

July 29, 2021

Projected product sales GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected product sales

 

$23,700 - $25,100

 

Unchanged

 

$24,400 - $25,000

Less: Veklury sales

 

2,000 - 3,000

 

 

2,700 - 3,100

Non-GAAP projected product sales excluding Veklury sales

 

$21,700 - $22,100

 

 

$21,700 - $21,900

 

 

 

 

 

 

 

Projected product gross margin GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected product gross margin

 

78% - 79%

 

Unchanged

 

77% - 78%

Acquisition-related expenses

 

9%

 

 

9%

Non-GAAP projected product gross margin

 

87% - 88%

 

 

86% - 87%

 

 

 

 

 

 

 

Projected operating income GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected operating income

 

$9,300 - $10,700

 

$9,000 - $10,400

 

$9,200 - $9,900

Acquisition-related, acquired IPR&D and other expenses

 

2,200

 

2,500

 

2,700

Non-GAAP projected operating income

 

$11,500 - $12,900

 

$11,500 - $12,900

 

$11,900 - $12,600

 

 

 

 

 

 

 

Projected effective tax rate GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected effective tax rate

 

~ 23%

 

Unchanged

 

Unchanged

Less: Income tax effect of non-GAAP adjustments and discrete and related tax adjustments

 

2%

 

 

Non-GAAP projected effective tax rate

 

~ 21%

 

 

 

 

 

 

 

 

 

Projected diluted EPS GAAP to non-GAAP reconciliation:

 

 

 

 

 

 

GAAP projected diluted EPS

 

$5.25 - $5.95

 

$4.75 - $5.45

 

$4.70 - $5.05

Acquisition-related, acquired IPR&D and other expenses, historical fair value adjustments of equity securities, related tax effects as well as discrete and related tax adjustments

 

1.50

 

2.00

 

2.20

Non-GAAP projected diluted EPS

 

$6.75 - $7.45

 

$6.75 - $7.45

 

$6.90 - $7.25

 

 

 

 

 

 

 

(1)

The 2021 guidance non-GAAP financial information excludes the impact of any potential future acquisition-related, acquired IPR&D and other expenses, fair value adjustments of equity securities and discrete tax and related charges or benefits associated with changes in tax related laws and guidelines as Gilead is unable to project such amounts.

 

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

 

 

 

June 30,

 

December 31,

(in millions)

 

2021

 

2020

Assets

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

7,361

 

 

$

7,910

 

Accounts receivable, net

 

4,149

 

 

4,892

 

Inventories

 

2,988

 

 

3,014

 

Property, plant and equipment, net

 

4,996

 

 

4,967

 

Intangible assets, net

 

34,341

 

 

33,126

 

Goodwill

 

8,334

 

 

8,108

 

Other assets

 

5,815

 

 

6,390

 

Total assets

 

$

67,984

 

 

$

68,407

 

Liabilities and Stockholders’ Equity

 

 

 

 

Current liabilities

 

$

10,214

 

 

$

11,397

 

Long-term liabilities

 

38,060

 

 

38,789

 

Stockholders’ equity(1)

 

19,710

 

 

18,221

 

Total liabilities and stockholders’ equity

 

$

67,984

 

 

$

68,407

 

 

(1)

As of June 30, 2021 and December 31, 2020, there were 1,254 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)

 

2021

 

2020

 

2021

 

2020

Net cash provided by operating activities

 

$

2,316

 

 

 

$

2,566

 

 

 

$

4,926

 

 

 

$

4,002

 

 

Net cash used in investing activities

 

(577

)

 

 

(5,023

)

 

 

(2,619

)

 

 

(5,367

)

 

Net cash used in financing activities

 

(931

)

 

 

(874

)

 

 

(3,408

)

 

 

(3,485

)

 

Effect of exchange rate changes on cash and cash equivalents

 

20

 

 

 

26

 

 

 

(3

)

 

 

(35

)

 

Net change in cash and cash equivalents

 

828

 

 

 

(3,305

)

 

 

(1,104

)

 

 

(4,885

)

 

Cash and cash equivalents at beginning of period

 

4,065

 

 

 

10,051

 

 

 

5,997

 

 

 

11,631

 

 

Cash and cash equivalents at end of period

 

$

4,893

 

 

 

$

6,746

 

 

 

$

4,893

 

 

 

$

6,746

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

2021

 

2020

 

2021

 

2020

Net cash provided by operating activities

 

$

2,316

 

 

 

$

2,566

 

 

 

$

4,926

 

 

 

$

4,002

 

 

Capital expenditures

 

(119

)

 

 

(143

)

 

 

(284

)

 

 

(314

)

 

Free cash flow

 

$

2,197

 

 

 

$

2,423

 

 

 

$

4,642

 

 

 

$

3,688

 

 

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

2021

 

2020

 

2021

 

2020

 

 

 

 

 

 

 

 

 

HIV Products

 

 

 

 

 

 

 

 

Descovy (FTC/TAF) Based Products

 

 

 

 

 

 

 

 

Biktarvy – U.S.

 

$

1,586

 

 

$

1,350

 

 

$

3,051

 

 

$

2,762

 

Biktarvy – Europe

 

237

 

 

153

 

 

453

 

 

334

 

Biktarvy – Other International

 

171

 

 

101

 

 

314

 

 

201

 

 

 

1,994

 

 

1,604

 

 

3,818

 

 

3,297

 

 

 

 

 

 

 

 

 

 

Descovy – U.S.

 

357

 

 

337

 

 

639

 

 

700

 

Descovy – Europe

 

44

 

 

46

 

 

86

 

 

107

 

Descovy – Other International

 

34

 

 

34

 

 

69

 

 

68

 

 

 

435

 

 

417

 

 

794

 

 

875

 

 

 

 

 

 

 

 

 

 

Genvoya – U.S.

 

551

 

 

646

 

 

1,057

 

 

1,258

 

Genvoya – Europe

 

100

 

 

109

 

 

206

 

 

260

 

Genvoya – Other International

 

55

 

 

61

 

 

116

 

 

122

 

 

 

706

 

 

816

 

 

1,379

 

 

1,640

 

 

 

 

 

 

 

 

 

 

Odefsey – U.S.

 

258

 

 

273

 

 

498

 

 

542

 

Odefsey – Europe

 

111

 

 

98

 

 

224

 

 

225

 

Odefsey – Other International

 

13

 

 

11

 

 

27

 

 

24

 

 

 

382

 

 

382

 

 

749

 

 

791

 

 

 

 

 

 

 

 

 

 

Revenue share – Symtuza(1) – U.S.

 

86

 

 

90

 

 

175

 

 

162

 

Revenue share – Symtuza(1) – Europe

 

40

 

 

40

 

 

84

 

 

78

 

Revenue share – Symtuza(1) – Other International

 

3

 

 

2

 

 

5

 

 

4

 

 

 

129

 

 

132

 

 

264

 

 

244

 

 

 

 

 

 

 

 

 

 

Total Descovy (FTC/TAF) Based Products – U.S.

 

2,838

 

 

2,696

 

 

5,420

 

 

5,424

 

Total Descovy (FTC/TAF) Based Products – Europe

 

532

 

 

446

 

 

1,053

 

 

1,004

 

Total Descovy (FTC/TAF) Based Products – Other International

 

276

 

 

209

 

 

531

 

 

419

 

 

 

3,646

 

 

3,351

 

 

7,004

 

 

6,847

 

 

 

 

 

 

 

 

 

 

Truvada (FTC/TDF) Based Products

 

 

 

 

 

 

 

 

Atripla – U.S.

 

52

 

 

95

 

 

75

 

 

176

 

Atripla – Europe

 

4

 

 

5

 

 

8

 

 

12

 

Atripla – Other International

 

4

 

 

3

 

 

8

 

 

10

 

 

 

60

 

 

103

 

 

91

 

 

198

 

 

 

 

 

 

 

 

 

 

Complera / Eviplera – U.S.

 

20

 

 

27

 

 

45

 

 

51

 

Complera / Eviplera – Europe

 

39

 

 

42

 

 

73

 

 

89

 

Complera / Eviplera – Other International

 

3

 

 

3

 

 

7

 

 

8

 

 

 

62

 

 

72

 

 

125

 

 

148

 

 

 

 

 

 

 

 

 

 

Stribild – U.S.

 

35

 

 

39

 

 

66

 

 

73

 

Stribild – Europe

 

11

 

 

12

 

 

22

 

 

29

 

Stribild – Other International

 

5

 

 

8

 

 

9

 

 

10

 

 

 

51

 

 

59

 

 

97

 

 

112

 

 

 

 

 

 

 

 

 

 

Truvada – U.S.

 

94

 

 

370

 

 

213

 

 

753

 

Truvada – Europe

 

6

 

 

6

 

 

13

 

 

14

 

Truvada – Other International

 

8

 

 

11

 

 

17

 

 

26

 

 

 

108

 

 

387

 

 

243

 

 

793

 

 

 

 

 

 

 

 

 

 

Total Truvada (FTC/TDF) Based Products – U.S.

 

201

 

 

531

 

 

399

 

 

1,053

 

Total Truvada (FTC/TDF) Based Products – Europe

 

60

 

 

65

 

 

116

 

 

144

 

Total Truvada (FTC/TDF) Based Products – Other International

 

20

 

 

25

 

 

41

 

 

54

 

 

 

281

 

 

621

 

 

556

 

 

1,251

 

 

 

 

 

 

 

 

 

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

2021

 

2020

 

2021

 

2020

 

 

 

 

 

 

 

 

 

Other HIV(2) – U.S.

 

5

 

 

11

 

 

11

 

 

14

 

Other HIV(2) – Europe

 

4

 

 

1

 

 

5

 

 

3

 

Other HIV(2) – Other International

 

2

 

 

16

 

 

12

 

 

19

 

 

 

11

 

 

28

 

 

28

 

 

36

 

 

 

 

 

 

 

 

 

 

Total HIV – U.S.

 

3,044

 

 

3,238

 

 

5,830

 

 

6,491

 

Total HIV – Europe

 

596

 

 

512

 

 

1,174

 

 

1,151

 

Total HIV – Other International

 

298

 

 

250

 

 

584

 

 

492

 

 

 

3,938

 

 

4,000

 

 

7,588

 

 

8,134

 

 

 

 

 

 

 

 

 

 

HCV Products

 

 

 

 

 

 

 

 

Ledipasvir / Sofosbuvir(3) – U.S.

 

30

 

 

24

 

 

49

 

 

77

 

Ledipasvir / Sofosbuvir(3) – Europe

 

3

 

 

4

 

 

19

 

 

15

 

Ledipasvir / Sofosbuvir(3) – Other International

 

29

 

 

39

 

 

50

 

 

87

 

 

 

62

 

 

67

 

 

118

 

 

179

 

 

 

 

 

 

 

 

 

 

Sofosbuvir / Velpatasvir(4) – U.S.

 

262

 

 

165

 

 

476

 

 

476

 

Sofosbuvir / Velpatasvir(4) – Europe

 

82

 

 

57

 

 

157

 

 

179

 

Sofosbuvir / Velpatasvir(4) – Other International

 

98

 

 

113

 

 

190

 

 

244

 

 

 

442

 

 

335

 

 

823

 

 

899

 

 

 

 

 

 

 

 

 

 

Other HCV(5) – U.S.

 

35

 

 

31

 

 

60

 

 

65

 

Other HCV(5) – Europe

 

8

 

 

9

 

 

52

 

 

24

 

Other HCV(5) – Other International

 

2

 

 

6

 

 

6

 

 

10

 

 

 

45

 

 

46

 

 

118

 

 

99

 

 

 

 

 

 

 

 

 

 

Total HCV – U.S.

 

327

 

 

220

 

 

585

 

 

618

 

Total HCV – Europe

 

93

 

 

70

 

 

228

 

 

218

 

Total HCV – Other International

 

129

 

 

158

 

 

246

 

 

341

 

 

 

549

 

 

448

 

 

1,059

 

 

1,177

 

 

 

 

 

 

 

 

 

 

HBV/HDV Products

 

 

 

 

 

 

 

 

Vemlidy – U.S.

 

86

 

 

76

 

 

163

 

 

149

 

Vemlidy – Europe

 

8

 

 

7

 

 

16

 

 

14

 

Vemlidy – Other International

 

106

 

 

68

 

 

202

 

 

124

 

 

 

200

 

 

151

 

 

381

 

 

287

 

 

 

 

 

 

 

 

 

 

Viread – U.S.

 

3

 

 

3

 

 

7

 

 

7

 

Viread – Europe

 

8

 

 

8

 

 

15

 

 

19

 

Viread – Other International

 

17

 

 

54

 

 

37

 

 

79

 

 

 

28

 

 

65

 

 

59

 

 

105

 

 

 

 

 

 

 

 

 

 

Other HBV/HDV(6) – U.S.

 

1

 

 

1

 

 

1

 

 

9

 

Other HBV/HDV(6) – Europe

 

8

 

 

2

 

 

16

 

 

4

 

 

 

9

 

 

3

 

 

17

 

 

13

 

 

 

 

 

 

 

 

 

 

Total HBV/HDV – U.S.

 

90

 

 

80

 

 

171

 

 

165

 

Total HBV/HDV – Europe

 

24

 

 

17

 

 

47

 

 

37

 

Total HBV/HDV – Other International

 

123

 

 

122

 

 

239

 

 

203

 

 

 

237

 

 

219

 

 

457

 

 

405

 

 

 

 

 

 

 

 

 

 

Veklury

 

 

 

 

 

 

 

 

Veklury – U.S.

 

416

 

 

 

 

1,236

 

 

 

Veklury – Europe

 

264

 

 

 

 

652

 

 

 

Veklury – Other International

 

149

 

 

 

 

397

 

 

 

 

 

829

 

 

 

 

2,285

 

 

 

 

 

 

 

 

 

 

 

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

(in millions)

 

2021

 

2020

 

2021

 

2020

 

 

 

 

 

 

 

 

 

Cell Therapy Products

 

 

 

 

 

 

 

 

Tecartus – U.S.

 

32

 

 

 

 

59

 

 

 

Tecartus – Europe

 

9

 

 

1

 

 

13

 

 

1

 

 

 

41

 

 

1

 

 

72

 

 

1

 

 

 

 

 

 

 

 

 

 

Yescarta – U.S.

 

108

 

 

95

 

 

200

 

 

198

 

Yescarta – Europe

 

61

 

 

56

 

 

122

 

 

93

 

Yescarta – Other International

 

9

 

 

5

 

 

16

 

 

5

 

 

 

178

 

 

156

 

 

338

 

 

296

 

 

 

 

 

 

 

 

 

 

Total Cell Therapy – U.S.

 

140

 

 

95

 

 

259

 

 

198

 

Total Cell Therapy – Europe

 

70

 

 

57

 

 

135

 

 

94

 

Total Cell Therapy – Other International

 

9

 

 

5

 

 

16

 

 

5

 

 

 

219

 

 

157

 

 

410

 

 

297

 

 

 

 

 

 

 

 

 

 

Trodelvy - U.S.

 

89

 

 

 

 

161

 

 

 

 

 

 

 

 

 

 

 

 

Other Products

 

 

 

 

 

 

 

 

AmBisome – U.S.

 

13

 

 

10

 

 

25

 

 

28

 

AmBisome – Europe

 

69

 

 

49

 

 

135

 

 

108

 

AmBisome – Other International

 

74

 

 

36

 

 

117

 

 

78

 

 

 

156

 

 

95

 

 

277

 

 

214

 

 

 

 

 

 

 

 

 

 

Letairis – U.S.

 

57

 

 

80

 

 

111

 

 

163

 

 

 

 

 

 

 

 

 

 

Ranexa – U.S.

 

2

 

 

1

 

 

5

 

 

9

 

 

 

 

 

 

 

 

 

 

Zydelig – U.S.

 

8

 

 

8

 

 

16

 

 

16

 

Zydelig – Europe

 

13

 

 

9

 

 

20

 

 

21

 

Zydelig – Other International

 

1

 

 

1

 

 

1

 

 

1

 

 

 

22

 

 

18

 

 

37

 

 

38

 

 

 

 

 

 

 

 

 

 

Other(7) – U.S.

 

27

 

 

38

 

 

54

 

 

71

 

Other(7) – Europe

 

18

 

 

10

 

 

31

 

 

22

 

Other(7) – Other International

 

9

 

 

1

 

 

17

 

 

4

 

 

 

54

 

 

49

 

 

102

 

 

97

 

 

 

 

 

 

 

 

 

 

Total Other – U.S.

 

107

 

 

137

 

 

211

 

 

287

 

Total Other – Europe

 

100

 

 

68

 

 

186

 

 

151

 

Total Other – Other International

 

84

 

 

38

 

 

135

 

 

83

 

 

 

291

 

 

243

 

 

532

 

 

521

 

 

 

 

 

 

 

 

 

 

Total product sales – U.S.

 

4,213

 

 

3,770

 

 

8,453

 

 

7,759

 

Total product sales – Europe

 

1,147

 

 

724

 

 

2,422

 

 

1,651

 

Total product sales – Other International

 

792

 

 

573

 

 

1,617

 

 

1,124

 

 

 

$

6,152

 

 

$

5,067

 

 

$

12,492

 

 

$

10,534

 

 

(1)

 

Represents Gilead’s revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland UC.

(2)

 

Includes Emtriva 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)

 

The six months ended June 30, 2021 includes $13 million of Hepcludex sales recorded subsequent to Gilead’s acquisition of MYR. The six months ended June 30, 2021 of Hepcludex sales, including the period prior to the completion of Gilead’s acquisition of MYR, were $20 million.

(7)

 

Includes Cayston and Jyseleca.

 

Contacts

Investors:

Jacquie Ross, CFA

(650) 358-1054

Media:

Sonia Choi

(650) 425-5483

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