Biotech

First Quarter 2021 Product Sales Increased 16% Year-Over-Year Primarily Driven by Veklury

Returned $1.2 Billion of Cash to Shareholders in First Quarter 2021 Through Dividends and Share Repurchases

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

"We have made strong progress in this first quarter, with our new partnership with Merck in long-acting HIV therapies, two newly approved indications in the U.S. for Trodelvy in metastatic triple-negative breast cancer and metastatic urothelial cancer, and the addition of Hepcludex to our portfolio," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "2021 is a pivotal year for Gilead, with key milestones across our virology and oncology portfolios. We're looking forward to advancing our pipeline of promising therapies in the coming months."

First Quarter 2021 Financial Results

  • Total first quarter 2021 revenue of $6.4 billion increased 16% compared to the same period in 2020, primarily due to Veklury ® (remdesivir) sales, Cell Therapy growth with Yescarta ® (axicabtagene ciloleucel) and the U.S. launch of Tecartus ® (brexucabtagene autoleucel) in the third quarter 2020, the first full quarter recognition of Trodelvy ® (sacituzumab govitecan-hziy 180 mg) sales, and Hepatitis B virus ("HBV") growth with Vemlidy ® (tenofovir alafenamide 25 mg).
  • Diluted Earnings Per Share ("EPS") increased 12% to $1.37 for the first quarter 2021 compared to the same period in 2020, primarily driven by revenue growth, partially offset by fair value loss adjustments related to Gilead's equity investment in Galapagos NV ("Galapagos") and lower interest income.
  • Non-GAAP diluted EPS increased 24% to $2.08 for the first quarter 2021 compared to the same period in 2020, primarily due to higher operating income and lower effective tax rate, offset by lower interest income.
  • As of March 31, 2021, Gilead had $6.2 billion of cash, cash equivalents and marketable debt securities compared to $7.9 billion as of December 31, 2020.
  • During the first quarter 2021, Gilead generated $2.6 billion in operating cash flow.
  • During the first quarter 2021, Gilead repaid $1.3 billion of debt, utilized $1.3 billion on acquisitions, net of cash acquired (including in-process research and development ("IPR&D")), paid cash dividends of $917 million and utilized $309 million on repurchases of common stock.

Product Sales Performance

Total first quarter 2021 product sales increased 16% to $6.3 billion compared to the same period in 2020. Total product sales excluding Veklury decreased 11% to $4.9 billion for the first quarter 2021 compared to the same period in 2020, with contributions from new product launches such as Tecartus and Trodelvy offset, as expected, by loss of exclusivity of Truvada ® (emtricitabine 200 mg ("FTC") and tenofovir disoproxil fumarate 300 mg ("TDF")) and Atripla ® (efavirenz 600 mg/FTC/TDF) in the United States and COVID-19 pandemic-related impacts in both HIV and hepatitis C virus ("HCV").

HIV product sales decreased 12% to $3.7 billion for the first quarter 2021 compared to the same period in 2020, reflecting the expected loss of exclusivity of Truvada and Atripla in the United States, in addition to channel inventory dynamics including COVID-19 pandemic-related stocking in the first quarter 2020.

  • Biktarvy ® (bictegravir 50 mg/FTC/tenofovir alafenamide 25 mg ("TAF")) sales increased 8% year-over-year in the first quarter 2021, reflecting robust market share gains across core markets and partially offset by channel inventory dynamics.
  • Descovy ® (FTC/TAF) sales decreased 22% year-over-year in the first quarter 2021, driven by lower average net selling price and channel inventory dynamics including COVID-19 pandemic-related stocking in the first quarter 2020, in addition to the ongoing COVID-19 pandemic-related effects on the pre-exposure prophylaxis ("PrEP") market.
  • Truvada and Atripla sales decreased 67% year-over-year to $135 million and $31 million, respectively, in the first quarter 2021, following loss of exclusivity in the United States in October 2020.

HCV product sales decreased 30% to $510 million for the first quarter 2021 compared to the same period in 2020. Sales volumes were impacted by lower patient starts in the United States and Europe associated with the COVID-19 pandemic.

HBV and hepatitis delta virus ("HDV") product sales increased 18% to $220 million for the first quarter 2021 compared to the same period in 2020. Vemlidy sales increased 33% in the first quarter 2021 compared to the same period in 2020. Hepcludex ® (bulevirtide) contributed $6 million in sales subsequent to Gilead's acquisition of MYR GmbH ("MYR"), representing a partial quarter of sales.

Cell Therapy product sales increased 36% to $191 million for the first quarter 2021 compared to the same period in 2020.

  • Yescarta sales increased to $160 million in the first quarter 2021, reflecting increased uptake and geographic expansion in Europe.
  • Tecartus sales were $31 million for the first quarter 2021 as launch activities continue to ramp up in the United States.

Trodelvy sales for the first quarter 2021 were $72 million, representing the first full quarter of sales for Gilead.

Veklury sales were $1.5 billion for the first quarter 2021. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations.

Other product sales decreased 13% to $241 million for the first quarter 2021 compared to the same period in 2020.

  • Letairis ® (ambrisentan 5 mg and 10 mg) and Ranexa ® (ranolazine 500 mg and 1000 mg) sales decreased in the first quarter 2021, as expected, as generic competition continues to gain share following loss of exclusivity in 2019.

First Quarter 2021 Product Gross Margin, Operating Expenses and Tax

  • Product gross margin was 78.5% for the first quarter 2021 compared to 82.3% in the same period in 2020. Non-GAAP product gross margin was 86.5% for the first quarter 2021 compared to 87.1% in the same period in 2020, reflecting a less favorable product mix and an inventory charge, partially offset by favorable royalty adjustments.
  • Research and Development ("R&D") expenses for the first quarter 2021 were $1,055 million compared to $1,004 million in the same period in 2020. Non-GAAP R&D expenses for the first quarter 2021 were $1,049 million compared to $1,004 million in the same period in 2020. The higher R&D expenses included ramp-up of magrolimab and Trodelvy clinical activities, partially offset by study completions and discontinuations.
  • Sales, General and Administrative ("SG&A") expenses for the first quarter 2021 were $1,055 million compared to $1,076 million in the same period in 2020. Non-GAAP SG&A expenses for the first quarter 2021 were $1,033 million compared to $1,076 million in the same period in 2020. The lower SG&A expenses reflect lower promotional spend in HIV and HCV and timing of grants, partially offset by increased commercialization investments for Veklury, Trodelvy, Cell Therapy, and HBV and HIV in China.
  • The GAAP effective tax rate ("ETR") and non-GAAP ETR for the first quarter 2021 were 23.9% and 18.4%, respectively, compared to 23.2% and 19.7% for the same period in 2020, respectively.

Key Updates Since Our Last Quarterly Release

Viral Diseases

  • Gilead announced a collaboration with Merck Sharp & Dohme Corp ("Merck"), a subsidiary of Merck & Co., Inc., to develop and commercialize long-acting, investigational treatment combinations of Gilead's lenacapavir and Merck's islatravir in HIV. The first clinical studies of the oral combination are expected to begin in the second half of 2021.
  • At the Conference on Retroviruses and Opportunistic Infections ("CROI"), Gilead presented additional results from lenacapavir's Phase 2/3 CAPELLA trial. The interim efficacy results showed lenacapavir maintained high rates of virologic suppression through 26 weeks among heavily treatment-experienced people with multi-drug resistant HIV; 73% of participants who reached Week 26 since the first dose of subcutaneous lenacapavir with an optimized background regimen achieved undetectable viral load.
  • At CROI, Gilead presented data from an open label-extension of two Phase 3 studies of Biktarvy, demonstrating sustained safety and efficacy with greater than 98% of treatment-naïve participants achieving and maintaining undetectable viral load through four years of follow-up.

Oncology

  • The New England Journal of Medicine published primary results from the randomized confirmatory Phase 3 ASCENT study of Trodelvy in metastatic triple-negative breast cancer ("mTNBC"). The publication demonstrated that Trodelvy significantly extended both progression-free survival and overall survival for patients compared to standard single-agent chemotherapy.
  • U.S. Food and Drug Administration ("FDA") granted accelerated approval of Trodelvy for adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
  • FDA granted full approval of Trodelvy for adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
  • European Medicines Agency ("EMA") validated the Marketing Authorization Application and granted accelerated review for Trodelvy for the treatment of mTNBC.
  • FDA approved Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Yescarta is the first CAR T therapy approved for indolent follicular lymphoma.
  • Gilead and Kite announced new analysis from the ZUMA-1 trial of Yescarta in a cohort of adult patients with relapsed or refractory large B-cell lymphoma. Findings suggest use of corticosteroids prior to Yescarta infusion has potential to impact the benefit/risk profile.

Inflammatory Diseases

  • Gilead and Novo Nordisk A/S ("Novo Nordisk") expanded their clinical collaboration in non-alcoholic steatohepatitis ("NASH") with plans to launch a new Phase 2b for a triple combination regimen in NASH patients with cirrhosis.
  • Gilead and Galapagos discontinued ISABELA Phase 3 trials in idiopathic pulmonary fibrosis.

Corporate

  • In response to the rapid increase in COVID-19 in India, Gilead announced that it would provide voluntary licensees with technical assistance to expand local production capacity, support for the addition of new manufacturing facilities and a donation of active pharmaceutical ingredient. Gilead will also donate at least 450,000 vials of Veklury to the government of India.
  • Gilead welcomed Flavius Martin, MD, as Executive Vice President, Research, following the retirement of William A. Lee, PhD. Dr. Martin brings decades of experience in early drug discovery research.
  • Gilead completed the acquisition of MYR for up to approximately €1.3 billion (or $1.6 billion) in aggregate consideration. The acquisition provides Gilead with Hepcludex, which is conditionally approved by EMA for the treatment of chronic HDV in adults with compensated liver disease.
  • Kite appointed Frank Neumann, MD, PhD, as Worldwide Head of Clinical Development. Dr. Neumann has a record of proven leadership in cell therapy and oncology clinical development.

Guidance and Outlook

The COVID-19 pandemic is expected to continue to impact our business and broader market dynamics, such as HCV treatment initiations and HIV new starts and switches. We now expect a more gradual recovery in the COVID-19 related dynamics starting in the second quarter 2021, and the rate and degree of recovery may vary by geography. Sales of Veklury will continue to be subject to significant volatility and uncertainty. As a result, Gilead believes providing full year 2021 revenue guidance excluding Veklury is useful for investors, when considered in conjunction with its GAAP financial information.

Except for GAAP earnings per diluted share, there is no change to the guidance shared on February 4, 2021, including: full year product sales excluding Veklury between $21.7 billion and $22.1 billion; full year Veklury sales between $2 billion and $3 billion; total product sales for 2021 between $23.7 billion and $25.1 billion; and non-GAAP earnings per share for 2021 between $6.75 and $7.45. GAAP earnings per diluted share for 2021 is now expected to be between $4.75 and $5.45, updated primarily for actual changes in fair value of equity investments in the first quarter 2021. A reconciliation between GAAP and non-GAAP financial information for the 2021 guidance is provided in the table on page 12.

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 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 tables on pages 10 - 11.

Conference Call

At 4:30 p.m. Eastern Time today, Gilead will host a conference call to discuss Gilead's results. The live webcast can be accessed through the Gilead website at http://investors.gilead.com . Alternatively, individuals can access the call by dialing 877-359-9508 (U.S.) or 224-357-2393 (international) with conference ID 5069935. A replay of the conference call will be posted on the Gilead website after the event and will be available 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 Merck, MYR and Novo Nordisk; 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; the risk that safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including 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; Gilead's ability to receive regulatory approvals in a timely manner or at all, including EMA approval of Trodelvy for treatment of TNBC and EMA approval of Hepcludex for treatment of chronic HDV, 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 March 31, 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.

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 also refers 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

March 31,

(in millions, except per share amounts)

2021

2020

Revenues:

Product sales

$

6,340

$

5,467

Royalty, contract and other revenues

83

81

Total revenues

6,423

5,548

Costs and expenses:

Cost of goods sold

1,361

969

Research and development expenses

1,055

1,004

Acquired in-process research and development expenses

62

97

Selling, general and administrative expenses

1,055

1,076

Total costs and expenses

3,533

3,146

Income from operations

2,890

2,402

Interest expense

(257

)

(241

)

Other income (expense), net

(369

)

(158

)

Income before income taxes

2,264

2,003

Income tax expense

542

465

Net income

1,722

1,538

Net loss attributable to noncontrolling interest

(7

)

(13

)

Net income attributable to Gilead

$

1,729

$

1,551

Net income per share attributable to Gilead common stockholders - basic

$

1.38

$

1.23

Shares used in per share calculation - basic

1,256

1,262

Net income per share attributable to Gilead common stockholders - diluted

$

1.37

$

1.22

Shares used in per share calculation - diluted

1,262

1,270

Cash dividends declared per share

$

0.71

$

0.68

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

Three Months Ended

March 31,

(In millions, except percentages)

2021

2020

Change

Product sales:

HIV

$

3,650

$

4,134

(12)%

HCV

510

729

(30)%

HBV/HDV (1)

220

186

18%

Cell Therapy

191

140

36%

Trodelvy

72

NM

Other

241

278

(13)%

Total product sales excluding Veklury

4,884

5,467

(11)%

Veklury

1,456

NM

Total product sales

6,340

5,467

16%

Royalty, contract and other revenues

83

81

2%

Total revenues

$

6,423

$

5,548

16%

________________________________

NM - Not Meaningful

(1)

First quarter 2021 includes $6 million of Hepcludex sales recorded subsequent to Gilead's acquisition of MYR. First quarter 2021 Hepcludex sales, including the period prior to the completion of Gilead's acquisition of MYR, were $13 million.

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION (1)

(unaudited)

Three Months Ended

March 31,

(In millions, except percentages)

2021

2020

Change

Non-GAAP:

Cost of goods sold

$

855

$

703

22%

Product gross margin

86.5

%

87.1

%

-60 bps

Research and development expenses

$

1,049

$

1,004

4%

Selling, general and administrative expenses

$

1,033

$

1,076

(4)%

Other income (expense), net

$

(18)

$

125

NM

Diluted EPS

$

2.08

$

1.68

24%

Effective tax rate

18.4

%

19.7

%

(1.3)%

________________________________

NM - Not Meaningful

(1)

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

March 31,

(in millions, except percentages and per share amounts)

2021

2020

Cost of goods sold reconciliation:

GAAP cost of goods sold

$

1,361

$

969

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

(506

)

(266

)

Non-GAAP cost of goods sold

$

855

$

703

Product gross margin reconciliation:

GAAP product gross margin

78.5

%

82.3

%

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

8.0

%

4.9

%

Non-GAAP product gross margin (4)

86.5

%

87.1

%

Research and development expenses reconciliation:

GAAP research and development expenses (1)

$

1,055

$

1,004

Acquisition-related – other costs (3)

(6

)

Non-GAAP research and development expenses

$

1,049

$

1,004

Acquired IPR&D expenses reconciliation (1) :

GAAP acquired IPR&D expenses

$

62

$

97

Acquired IPR&D expenses (1)

(62

)

(97

)

Non-GAAP acquired IPR&D expenses

$

$

Selling, general and administrative expenses reconciliation:

GAAP selling, general and administrative expenses

$

1,055

$

1,076

Acquisition-related – other costs (3)

(22

)

Non-GAAP selling, general and administrative expenses

$

1,033

$

1,076

Operating income reconciliation:

GAAP operating income

$

2,890

$

2,402

Acquired IPR&D expenses (1)

62

97

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

506

266

Acquisition-related – other costs (3)

28

Non-GAAP operating income

$

3,486

$

2,765

Operating margin reconciliation:

GAAP operating margin

45.0

%

43.3

%

Acquired IPR&D expenses (1)

1.0

%

1.7

%

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

7.9

%

4.8

%

Acquisition-related – other costs (3)

0.4

%

%

Non-GAAP operating margin (4)

54.3

%

49.8

%

Other income (expense), net reconciliation:

GAAP other income (expense), net

$

(369

)

$

(158

)

Losses from equity securities, net

351

283

Non-GAAP other income (expense), net

$

(18

)

$

125

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)

(unaudited)

Three Months Ended

March 31,

(in millions, except percentages and per share amounts)

2021

2020

Effective tax rate reconciliation:

GAAP effective tax rate

23.9

%

23.2

%

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

(5.5

)%

(3.5

)%

Non-GAAP effective tax rate (4)

18.4

%

19.7

%

Net income attributable to Gilead reconciliation:

GAAP net income attributable to Gilead

$

1,729

$

1,551

Acquired IPR&D expenses (1)

50

75

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

409

224

Acquisition-related – other costs (3)

22

Losses from equity securities, net

364

256

Discrete and related tax charges (2)

54

33

Non-GAAP net income attributable to Gilead

$

2,628

$

2,139

Diluted EPS reconciliation:

GAAP diluted EPS

$

1.37

$

1.22

Acquired IPR&D expenses (1)

0.04

0.06

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

0.32

0.18

Acquisition-related – other costs (3)

0.02

Losses from equity securities, net

0.29

0.20

Discrete and related tax charges (2)

0.04

0.03

Non-GAAP diluted EPS (4)

$

2.08

$

1.68

Non-GAAP adjustment summary:

Cost of goods sold adjustments

$

506

$

266

Research and development expenses adjustments

6

Acquired IPR&D expenses adjustments (1)

62

97

Selling, general and administrative expenses adjustments

22

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

596

363

Other income (expense), net, adjustments

351

283

Total non-GAAP adjustments before tax

947

646

Income tax effect

(102)

(91)

Discrete and related tax charges (2)

54

33

Total non-GAAP adjustments after tax

$

899

$

588

________________________________

(1)

Beginning in the second quarter 2020, Acquired IPR&D expenses are presented separately from R&D expenses in Gilead's GAAP Condensed Consolidated Statements of Income. The amounts for prior periods have been reclassified to conform to the current period presentation. Acquired IPR&D expenses have been historically excluded from Gilead's non-GAAP financial information.

(2)

Amounts represent the reversal of the deferred tax assets established in the fourth quarter 2019. The reversal arose from the amortization of the intangible assets that were transferred from a foreign subsidiary to Ireland and the United States. The discrete tax benefit from the original transaction was excluded from Gilead's non-GAAP financial information.

(3)

Includes primarily employee-related and other expenses associated with Gilead's acquisitions of Immunomedics and MYR.

(4)

Amounts may not sum due to rounding differences.

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

Projected product sales GAAP to non-GAAP reconciliation:

GAAP projected product sales

$23,700 - $25,100

Unchanged

Less: Veklury sales

2,000 - 3,000

Non-GAAP projected product sales excluding Veklury sales

$21,700 - $22,100

Projected product gross margin GAAP to non-GAAP reconciliation:

GAAP projected product gross margin

78% - 79%

Unchanged

Acquisition-related expenses

9%

Non-GAAP projected product gross margin

87% - 88%

Projected operating income GAAP to non-GAAP reconciliation:

GAAP projected operating income

$9,300 - $10,700

$9,000 - $10,400

Acquisition-related, acquired IPR&D and other expenses

2,200

2,500

Non-GAAP projected operating income

$11,500 - $12,900

$11,500 - $12,900

Projected effective tax rate GAAP to non-GAAP reconciliation:

GAAP projected effective tax rate

~ 23%

Unchanged

Less: Amortization of deferred tax assets and tax rate effects of adjustments noted above

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

Acquisition-related, acquired IPR&D and other expenses, amortization of deferred tax assets and historical fair value adjustments of equity securities

1.50

2.00

Non-GAAP projected diluted EPS

$6.75 - $7.45

$6.75 - $7.45

________________________________

(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)

March 31,

December 31,

(in millions)

2021

2020

Assets

Cash, cash equivalents and marketable securities

$

6,245

$

7,910

Accounts receivable, net

3,925

4,892

Inventories

2,996

3,014

Property, plant and equipment, net

4,990

4,967

Intangible assets, net

34,781

33,126

Goodwill

8,334

8,108

Other assets

6,221

6,390

Total assets

$

67,492

$

68,407

Liabilities and Stockholders' Equity

Current liabilities

$

9,705

$

11,397

Long-term liabilities

38,823

38,789

Stockholders' equity (1)

18,964

18,221

Total liabilities and stockholders' equity

$

67,492

$

68,407

________________________________

(1)

As of March 31, 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

March 31,

(in millions)

2021

2020

Net cash provided by operating activities

$

2,610

$

1,436

Net cash used in investing activities

(2,042

)

(344

)

Net cash used in financing activities

(2,477

)

(2,611

)

Effect of exchange rate changes on cash and cash equivalents

(23

)

(61

)

Net change in cash and cash equivalents

(1,932

)

(1,580

)

Cash and cash equivalents at beginning of period

5,997

11,631

Cash and cash equivalents at end of period

$

4,065

$

10,051

Three Months Ended

March 31,

(in millions)

2021

2020

Net cash provided by operating activities

$

2,610

$

1,436

Capital expenditures

(165

)

(171

)

Free cash flow

$

2,445

$

1,265

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

Three Months Ended

March 31,

(in millions)

2021

2020

HIV Products

Descovy (FTC/TAF) Based Products

Biktarvy – U.S.

$

1,465

$

1,412

Biktarvy – Europe

216

181

Biktarvy – Other International

143

100

1,824

1,693

Descovy – U.S.

282

363

Descovy – Europe

42

61

Descovy – Other International

35

34

359

458

Genvoya – U.S.

506

612

Genvoya – Europe

106

151

Genvoya – Other International

61

61

673

824

Odefsey – U.S.

240

269

Odefsey – Europe

113

127

Odefsey – Other International

14

13

367

409

Revenue share – Symtuza (1) – U.S.

89

72

Revenue share – Symtuza (1) – Europe

44

38

Revenue share – Symtuza (1) – Other International

2

2

135

112

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

2,582

2,728

Total Descovy (FTC/TAF) Based Products – Europe

521

558

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

255

210

3,358

3,496

Truvada (FTC/TDF) Based Products

Atripla – U.S.

23

81

Atripla – Europe

4

7

Atripla – Other International

4

7

31

95

Complera / Eviplera – U.S.

25

24

Complera / Eviplera – Europe

34

47

Complera / Eviplera – Other International

4

5

63

76

Stribild – U.S.

31

34

Stribild – Europe

11

17

Stribild – Other International

4

2

46

53

Truvada – U.S.

119

383

Truvada – Europe

7

8

Truvada – Other International

9

15

135

406

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

198

522

Total Truvada (FTC/TDF) Based Products – Europe

56

79

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

21

29

275

630

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

March 31,

2021

2020

Other HIV (2) – U.S.

6

3

Other HIV (2) – Europe

1

2

Other HIV (2) – Other International

10

3

17

8

Total HIV – U.S.

2,786

3,253

Total HIV – Europe

578

639

Total HIV – Other International

286

242

3,650

4,134

HCV Products

Ledipasvir / Sofosbuvir (3) – U.S.

19

53

Ledipasvir / Sofosbuvir (3) – Europe

16

11

Ledipasvir / Sofosbuvir (3) – Other International

21

48

56

112

Sofosbuvir / Velpatasvir (4) – U.S.

214

311

Sofosbuvir / Velpatasvir (4) – Europe

75

122

Sofosbuvir / Velpatasvir (4) – Other International

92

131

381

564

Other HCV (5) – U.S.

25

34

Other HCV (5) – Europe

44

15

Other HCV (5) – Other International

4

4

73

53

Total HCV – U.S.

258

398

Total HCV – Europe

135

148

Total HCV – Other International

117

183

510

729

HBV/HDV Products

Vemlidy – U.S.

77

73

Vemlidy – Europe

8

7

Vemlidy – Other International

96

56

181

136

Viread – U.S.

4

4

Viread – Europe

7

11

Viread – Other International

20

25

31

40

Other HBV/HDV (6) – U.S.

8

Other HBV/HDV (6) – Europe

8

2

Other HBV/HDV (6) – Other International

8

10

Total HBV/HDV – U.S.

81

85

Total HBV/HDV – Europe

23

20

Total HBV/HDV – Other International

116

81

220

186

Veklury

Veklury – U.S.

820

Veklury – Europe

388

Veklury – Other International

248

1,456

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

March 31,

2021

2020

Cell Therapy Products

Tecartus – U.S.

27

Tecartus – Europe

4

Tecartus – Other International

31

Yescarta – U.S.

92

103

Yescarta – Europe

61

37

Yescarta – Other International

7

160

140

Total Cell Therapy – U.S.

119

103

Total Cell Therapy – Europe

65

37

Total Cell Therapy – Other International

7

191

140

Trodelvy - U.S .

72

Other Products

AmBisome – U.S.

12

18

AmBisome – Europe

66

59

AmBisome – Other International

43

42

121

119

Letairis – U.S.

54

83

Ranexa – U.S.

3

8

Zydelig – U.S.

8

8

Zydelig – Europe

7

12

Zydelig – Other International

15

20

Other (7) – U.S.

27

33

Other (7) – Europe

13

12

Other (7) – Other International

8

3

48

48

Total Other – U.S.

104

150

Total Other – Europe

86

83

Total Other – Other International

51

45

241

278

Total product sales – U.S.

4,240

3,989

Total product sales – Europe

1,275

927

Total product sales – Other International

825

551

$

6,340

$

5,467

_______________________________

(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)

First quarter 2021 includes $6 million of Hepcludex sales recorded subsequent to Gilead's acquisition of MYR. First quarter 2021 Hepcludex sales, including the period prior to the completion of Gilead's acquisition of MYR, were $13 million.

(7)

Includes Cayston and Jyseleca.

Investors:
Jacquie Ross, CFA
(650) 358-1054

Media:
Amy Flood
(650) 522-5643

News Provided by Business Wire via QuoteMedia

IBM, ABBV, & TWTR Class Actions: Bronstein, Gewirtz & Grossman, LLC, A Leading Class Action Firm Reminds Shareholders to Actively Participate

Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss, you can request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff

Bronstein, Gewirtz and Grossman, LLC, Monday, May 16, 2022, Press release picture

International Business Machines Corporation (NYSE:IBM)
Class Period: April 4, 2017 - October 20, 2021
Deadline: June 6, 2022
For more info: www.bgandg.com/ibm.

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

SHAREHOLDER ALERT: CELH AUPH MULN: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Celsius Holdings, Inc. (NASDAQ:CELH)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/celsius-holdings-inc-loss-submission-form?prid=27287&wire=1
Lead Plaintiff Deadline: May 16, 2022
Class Period: August 12, 2021 - March 1, 2022

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit against AbbVie, Inc. and Encourages Investors with Substantial Losses to Contact the Firm

The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE: ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THEFOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE:JUNE 6, 2022
CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:
James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/123953

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

  • A total of 27 abstracts reinforce AbbVie leadership in advancing research and the standards of care across multiple gastroenterological conditions, including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)
  • Presentations include further analyses of Phase 3 clinical study programs for RINVOQ ® (upadacitinib) in moderately to severely active ulcerative colitis and investigational use of risankizumab in moderately to severely active Crohn's disease

ABBVie (NYSE: ABBV) today announced that 27 abstracts across its gastroenterology portfolio will be presented at the Digestive Disease Week (DDW) Annual Meeting, May 21-24, 2022 in San Diego and virtually.

AbbVie's research to be presented at DDW 2022 addresses digestive and inflammatory bowel diseases, including ulcerative colitis (UC), Crohn's disease (CD), and irritable bowel syndrome with constipation (IBS-C) / chronic idiopathic constipation (CIC).

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AbbVie and Cugene Announce Collaboration in Autoimmune Diseases

- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology

- Cugene to complete a Phase 1a study in healthy volunteers and to conduct a Phase 1b study in patients with autoimmune/inflammatory disease during the option period

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Aurinia Pharmaceuticals Announces Presentations at the 2022 ERA Congress and the 2022 EULAR Congress

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced that data from multiple studies of LUPKYNIS™ (voclosporin) will be presented at the 59th European Renal Association (ERA) Congress and at the European Congress of Rheumatology, European Alliance of Associations for Rheumatology (EULAR) 2022. The 2022 ERA Congress will take place virtually and in Paris on May 19-22 and the EULAR 2022 Congress will take place virtually and in Denmark on June 1-4.

"Aurinia continues to expand its clinical evidence supporting LUPKYNIS as a reliable treatment option for people and HCPs working to protect their patients' kidneys from the devastating impact of lupus nephritis," said Neil Solomons, M.D., Chief Medical Officer at Aurinia. "We look forward to presenting new data for LUPKYNIS at the ERA and EULAR Congresses, including our results from the two-year AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS for the treatment of lupus nephritis."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×