Life Science News

Biktarvy Sales Increased 18% Year-Over-Year to $2.2 billion

Oncology Sales Increased 60% Year-Over-Year to $420 million

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter of 2022.

"Gilead's performance in the first quarter reflects the strength and diversity of our business with both our HIV and oncology therapies contributing to year-over-year growth," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "Biktarvy delivered strong 18% year-over-year revenue growth, and oncology sales increased by 60% year-over-year, driven by increased demand for Trodelvy and our cell therapy products. As we continue to advance our broad oncology portfolio, we look forward to providing more new options for people living with cancer."

First Quarter 2022 Financial Results

  • First quarter 2022 revenue increased 3% to $6.6 billion compared to the same period in 2021, primarily due to increased demand for Biktarvy ® (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) and Veklury ® (remdesivir 100mg for injection), partially offset by the impact of the loss of exclusivity for Truvada ® (FTC/tenofovir disoproxil fumarate 300mg ("TDF")) in the United States and unfavorable pricing dynamics for hepatitis C virus ("HCV") products.
  • Diluted Earnings Per Share ("EPS") decreased to $0.02 for the first quarter of 2022 compared to $1.37 for the same period in 2021. The decrease was primarily the result of a $2.7 billion in-process research and development ("IPR&D") impairment related to assets acquired by Gilead from Immunomedics in 2020.
  • Non-GAAP diluted EPS increased 4% to $2.12 for the first quarter of 2022 compared to $2.04 (1) for the same period in 2021, primarily reflecting higher product sales.
  • As of March 31, 2022, Gilead had $6.8 billion of cash, cash equivalents and marketable debt securities compared to $7.8 billion as of December 31, 2021.
  • During the first quarter of 2022, Gilead generated $1.8 billion in operating cash flow, which includes the cash outflow related to the $1.25 billion legal settlement.
  • During the first quarter of 2022, Gilead made a $725 million collaboration opt-in payment to Arcus Biosciences, Inc., repaid $500 million of debt, paid dividends of $945 million and repurchased $352 million of common stock.

________________________________

(1)

Non-GAAP diluted EPS has been recast due to an update to our non-GAAP policy in the first quarter 2022, resulting in a $0.04 reduction of previously-reported non-GAAP diluted EPS for the first quarter of 2021. Refer to Non-GAAP Financial Information section below for further information.

Product Sales Performance

First quarter 2022 product sales increased 3% to $6.5 billion compared to the same period in 2021. Total product sales, excluding Veklury, increased 2% to $5.0 billion in the first quarter of 2022 compared to the same period in 2021, primarily reflecting higher demand for Biktarvy, our cell therapy products and Trodelvy ® (sacituzumab govitecan-hziy), partially offset by unfavorable pricing dynamics in HCV.

HIV product sales increased 2% to $3.7 billion in the first quarter of 2022 compared to the same period in 2021, primarily reflecting higher demand for Biktarvy and favorable pricing dynamics partially offset, as expected, by the loss of exclusivity of Truvada in the United States.

  • Biktarvy sales increased 18% year-over-year in the first quarter of 2022, primarily due to higher demand.
  • Descovy ® (FTC 200mg/TAF 25mg) sales increased 4% year-over-year in the first quarter of 2022, primarily driven by increased demand and favorable pricing, partially offset by unfavorable channel inventory dynamics.
  • Truvada sales decreased 72% year-over-year in the first quarter 2022, as expected, primarily due to the loss of exclusivity in the United States in October 2020.

HCV product sales decreased 22% to $399 million in the first quarter of 2022 compared to the same period in 2021, primarily driven by lower net price and fewer patient starts.

Hepatitis B virus ("HBV") and hepatitis delta virus ("HDV") product sales increased 7% to $235 million in the first quarter of 2022 compared to the same period in 2021. Vemlidy ® (TAF 25mg) sales increased 10% in the first quarter of 2022 compared to the same period in 2021, primarily driven by higher demand in geographies outside the United States. Hepcludex ® (bulevirtide) contributed $11 million in the first quarter of 2022, as launch activities continued across Europe.

Cell therapy product sales increased 43% to $274 million in the first quarter of 2022 compared to the same period in 2021.

  • Yescarta ® (axicabtagene ciloleucel) sales increased to $211 million in the first quarter of 2022, primarily driven by demand for relapsed or refractory large B-cell lymphoma ("LBCL") in the United States and Europe and follicular lymphoma in the United States.
  • Tecartus ® (brexucabtagene autoleucel) sales were $63 million in the first quarter of 2022, primarily driven by growing adoption in Europe for mantle cell lymphoma and for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in the United States.

Trodelvy sales increased 103% to $146 million in the first quarter of 2022 compared to the same period in 2021, primarily reflecting uptake in the second line setting for the treatment of metastatic triple-negative breast cancer in the United States and Europe as well as metastatic urothelial cancer in the United States.

Veklury sales increased by 5% to $1.5 billion for the first quarter of 2022 compared to the same period in 2021. Veklury revenue generally reflects COVID-19 related rates of infections, hospitalizations and vaccinations, as well as the availability, uptake and effectiveness of alternative treatments for COVID-19.

First Quarter 2022 Product Gross Margin, Operating Expenses and Effective Tax Rate

  • Product gross margin was 78.2% for the first quarter of 2022 compared to 78.5% for the same period in 2021, primarily driven by a change in product mix and restructuring costs for the closing of a New Jersey manufacturing site in 2022, partially offset by lower inventory reserve adjustments. Non-GAAP product gross margin was 87.4% for the first quarter of 2022 compared to 86.5% in the same period in 2021, primarily driven by lower inventory reserve adjustments.
  • Research and development ("R&D") expenses for the first quarter of 2022 were $1.2 billion compared to $1.1 billion in the same period in 2021. Non-GAAP R&D expenses for the first quarter of 2022 were $1.2 billion compared to $1.0 billion in the same period in 2021. The increase in R&D and non-GAAP R&D expenses primarily reflect increased clinical activities for Trodelvy.
  • Selling, general and administrative ("SG&A") expenses were $1.1 billion for the first quarter of 2022 and for the same period in 2021. Non-GAAP SG&A expenses for the first quarter of 2022 were $1.1 billion compared to $1.0 billion in the same period in 2021.
  • The effective tax rate ("ETR") for the first quarter of 2022 was 107.9% compared to 23.9% for the same period in 2021, primarily driven by the $2.7 billion IPR&D impairment. Non-GAAP ETR for both the first quarter 2022 and the same period last year was 18.4%.

Guidance and Outlook

For the full-year, we have updated our EPS guidance to primarily reflect the $2.7 billion IPR&D impairment. We now expect EPS between $3.00 and $3.50, compared to $4.70 and $5.20 previously. There is no change to other guidance shared on February 1, 2022:

  • Total product sales between $23.8 billion and $24.3 billion.
  • Total product sales, excluding Veklury, between $21.8 billion and $22.3 billion.
  • Total Veklury sales of approximately $2.0 billion.
  • Non-GAAP earnings per share between $6.20 and $6.70.

This financial guidance excludes the impact of any expenses related to potential acquisitions or business development transactions that have not been executed, fair value adjustments of equity securities and discrete tax charges or benefits associated with changes in tax related laws and guidelines as Gilead is unable to project such amounts. A reconciliation between GAAP and non-GAAP financial information for the 2022 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.

Key Updates Since Our Last Quarterly Release

Viral Diseases

  • Received a Complete Response Letter from FDA related to vial compatibility issues for the New Drug Application of investigational lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced ("HTE") people with multi-drug resistant HIV-1 infection.
  • Presented one-year data from studies of investigational lenacapavir at the 29th Conference on Retroviruses and Opportunistic Infections ("CROI") with results from each of the Phase 2/3 CAPELLA trial in HTE people living with multi-drug resistant HIV and Phase 2 CALIBRATE trial in treatment-naive people living with HIV demonstrating high rates of virologic suppression at one-year.
  • Presented five-year results from two Phase 3 studies of Biktarvy at CROI which reinforced Biktarvy's sustained efficacy and durable viral suppression with zero cases of treatment failure due to emergent resistance observed.
  • Announced data demonstrating in vitro activity of Veklury against ten SARS-CoV-2 variants, including Omicron. Additionally, interim results from the Phase 2/3 CARAVAN trial of Veklury in pediatric patients aged 28 days to less than 18 years hospitalized with COVID-19 were presented at CROI.

Oncology

  • Announced results from the Phase 3 TROPiCS-02 study of Trodelvy in patients with HR+/HER2- metastatic breast cancer who had been heavily pre-treated. The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival compared to physician's choice of chemotherapy. Additionally, at the first interim analysis, a trend in improvement for overall survival ("OS") was observed, a key secondary endpoint. No new safety concerns were noted. The company will discuss the study data with regulators and the study will continue to follow patients for OS and detailed results will be presented at an upcoming medical conference. Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer, and its safety and efficacy have not been established for this indication.
  • Received FDA approval for Yescarta for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapse within 12 months of first-line chemoimmunotherapy. Additionally, the National Comprehensive Cancer Network updated its Clinical Practice Guidelines for B-cell Lymphomas to include Yescarta as a Category 1 recommendation for "Relapsed disease
  • Announced that FDA has lifted the partial clinical hold on studies evaluating investigational magrolimab in combination with azacitidine for the treatment of myelodyspastic syndrome and acute myeloid leukemia.

Corporate

  • Announced that the company's Board of Directors declared a quarterly dividend of $0.73 per share of common stock for the second quarter of 2022. The dividend is payable on June 29, 2022, to stockholders of record at the close of business on June 15, 2022. Future dividends will be subject to Board approval.
  • Announced $24 million in grants to support 116 organizations in 41 countries as part of Gilead's Zeroing In™: Ending the HIV Epidemic program. Grantee organizations will focus on advancing comprehensive HIV innovation programs, digital health innovations, and/or community outreach and education.
  • Received FDA approval for commercial production at Kite's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
  • Purchased approximately 27 acres of additional land in Oceanside, California to potentially support further manufacturing operations.

Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

Non-GAAP Financial Information

The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead's GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead's operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, and other items that are considered unusual or not representative of underlying trends of Gilead's business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission ("SEC"), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. Acquired IPR&D expenses reflect 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. Prior period non-GAAP financial measures are revised to conform to the new presentation.

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 and Gilead's ability to effectively manage the global supply and distribution of Veklury; Gilead's ability to achieve its anticipated full year 2022 financial results, including as a result of potential adverse revenue impacts from COVID-19 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 virology, oncology and other programs; Gilead's ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements; Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the risk that FDA may not remove clinical holds currently in place on any clinical trials, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy, Trodelvy, Veklury, Yescarta, lenacapavir and magrolimab, and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead's product candidates or the product candidates of Gilead's strategic partners; Gilead's ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead's ability to provide the requested documentation and address the comments in a Complete Response Letter to the satisfaction of the FDA; Gilead's ability to receive regulatory approvals in a timely manner or at all, including FDA approval of Trodelvy for treatment of HR+/HER2- metastatic breast cancer and other indications and 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, including the risk that Kite may be unable to increase its manufacturing capacity, timely manufacture and deliver its products or produce an amount of supply sufficient to satisfy demand for such products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products, including Yescarta; and other risks identified from time to time in Gilead's reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended March 31, 2022 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 INCOME

(unaudited)

Three Months Ended

March 31,

(in millions, except per share amounts)

2022

2021

Revenues:

Product sales

$

6,534

$

6,340

Royalty, contract and other revenues

56

83

Total revenues

6,590

6,423

Costs and expenses:

Cost of goods sold

1,424

1,361

Research and development expenses

1,186

1,055

In-process research and development impairment

2,700

Acquired in-process research and development expenses

62

Selling, general and administrative expenses

1,083

1,055

Total costs and expenses

6,393

3,533

Income from operations

197

2,890

Interest expense

(238

)

(257

)

Other income (expense), net

(111

)

(369

)

Income (loss) before income taxes

(152

)

2,264

Income tax benefit (expense)

164

(542

)

Net income

12

1,722

Net loss attributable to noncontrolling interest

7

7

Net income attributable to Gilead

$

19

$

1,729

Net income per share attributable to Gilead common stockholders - basic

$

0.02

$

1.38

Shares used in per share calculation - basic

1,255

1,256

Net income per share attributable to Gilead common stockholders - diluted

$

0.02

$

1.37

Shares used in per share calculation - diluted

1,262

1,262

Cash dividends declared per share

$

0.73

$

0.71

Research and development expenses as a % of revenues

18.0

%

16.4

%

Selling, general and administrative expenses as a % of revenues

16.4

%

16.4

%

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

Three Months Ended

March 31,

(in millions, except percentages)

2022

2021

Change

Product sales:

HIV

$

3,707

$

3,650

2%

HCV

399

510

(22)%

HBV/HDV

235

220

7%

Cell therapy

274

191

43%

Trodelvy

146

72

103%

Other

236

241

(2)%

Total product sales excluding Veklury

4,998

4,884

2%

Veklury

1,535

1,456

5%

Total product sales

6,534

6,340

3%

Royalty, contract and other revenues

56

83

(33)%

Total revenues

$

6,590

$

6,423

3%

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION (1)

(unaudited)

Three Months Ended

March 31,

(in millions, except percentages)

2022

2021

Change

Non-GAAP:

Cost of goods sold

$

825

$

855

(4)%

Research and development expenses

$

1,158

$

1,049

10%

Acquired IPR&D expenses

$

$

62

NM

Selling, general and administrative expenses

$

1,083

$

1,033

5%

Other income (expense), net

$

(15

)

$

(18

)

(17)%

Diluted EPS

$

2.12

$

2.04

4%

Product gross margin

87.4

%

86.5

%

90 bps

Research and development expenses as a % of revenues

17.6

%

16.3

%

130 bps

Selling, general and administrative expenses as a % of revenues

16.4

%

16.1

%

30 bps

Operating margin

53.5

%

53.3

%

20 bps

Effective tax rate

18.4

%

18.4

%

0 bps

________________________________

NM - Not Meaningful

(1)

Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 10 - 11. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission, the Company no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. Acquired IPR&D expenses reflect 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. Prior period non-GAAP financial measures are revised to conform to the new presentation.

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)

2022

2021

Cost of goods sold reconciliation:

GAAP cost of goods sold

$

1,424

$

1,361

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

(557

)

(506

)

Other (1)

(42

)

Non-GAAP cost of goods sold

$

825

$

855

Product gross margin reconciliation:

GAAP product gross margin

78.2

%

78.5

%

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

8.5

%

8.0

%

Other (1)

0.6

%

%

Non-GAAP product gross margin

87.4

%

86.5

%

Research and development expenses reconciliation:

GAAP research and development expenses

$

1,186

$

1,055

Acquisition-related – other costs (2)

(10

)

(6

)

Other (1)

(18

)

Non-GAAP research and development expenses

$

1,158

$

1,049

IPR&D impairment reconciliation:

GAAP IPR&D impairment

$

2,700

$

IPR&D impairment

(2,700

)

Non-GAAP IPR&D impairment

$

$

Selling, general and administrative expenses reconciliation:

GAAP selling, general and administrative expenses

$

1,083

$

1,055

Acquisition-related – other costs (2)

(22

)

Non-GAAP selling, general and administrative expenses

$

1,083

$

1,033

Income from operations reconciliation:

GAAP income from operations

$

197

$

2,890

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

557

506

Acquisition-related – other costs (2)

10

28

IPR&D impairment

2,700

Other (1)

60

Non-GAAP income from operations

$

3,524

$

3,424

Operating margin reconciliation:

GAAP operating margin

3.0

%

45.0

%

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

8.5

%

7.9

%

Acquisition-related – other costs (2)

0.2

%

0.4

%

IPR&D impairment

41.0

%

%

Other (1)

0.9

%

%

Non-GAAP operating margin

53.5

%

53.3

%

Other income (expense), net reconciliation:

GAAP other income (expense), net

$

(111

)

$

(369

)

Loss from equity securities, net

96

351

Non-GAAP other income (expense), net

$

(15

)

$

(18

)

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)

2022

2021

Effective tax rate reconciliation:

GAAP effective tax rate

107.9

%

23.9

%

Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments (3)

(89.5

)%

(5.6

)%

Non-GAAP effective tax rate

18.4

%

18.4

%

Net income attributable to Gilead reconciliation:

GAAP net income attributable to Gilead

$

19

$

1,729

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

443

409

Acquisition-related – other costs (2)

10

22

IPR&D impairment

2,057

Other (1)

45

Loss from equity securities, net

64

364

Discrete and related tax charges (3)

38

54

Non-GAAP net income attributable to Gilead

$

2,676

$

2,578

Diluted EPS reconciliation:

GAAP diluted EPS

$

0.02

$

1.37

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

0.35

0.32

Acquisition-related – other costs (2)

0.01

0.02

IPR&D impairment

1.63

Other (1)

0.04

Loss from equity securities, net

0.05

0.29

Discrete and related tax charges (3)

0.03

0.04

Non-GAAP diluted EPS

$

2.12

$

2.04

Non-GAAP adjustment summary:

Cost of goods sold adjustments

$

599

$

506

Research and development expenses adjustments

28

6

IPR&D impairment adjustments

2,700

Selling, general and administrative expenses adjustments

22

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

3,327

534

Other income (expense), net, adjustments

96

351

Total non-GAAP adjustments before income taxes

3,423

885

Income tax effect of non-GAAP adjustments above

(803

)

(90

)

Discrete and related tax charges (3)

38

54

Total non-GAAP adjustments after tax

$

2,657

$

849

______________________________

(1)

Includes restructuring expenses associated with the closing of a manufacturing site in New Jersey.

(2)

Primarily includes employee-related expenses, contingent consideration fair value adjustments and other expenses associated with Gilead's acquisitions of Immunomedics, Inc. and MYR GmbH.

(3)

Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States.

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP 2022 FULL-YEAR GUIDANCE (1)

(unaudited)

(in millions, except percentages and per share amounts)

Provided
February 1, 2022

Updated
April 28, 2022

Projected product gross margin GAAP to non-GAAP reconciliation:

GAAP projected product gross margin

76% - 77%

76% - 77%

Acquisition-related and other

~ 9%

~ 9%

Non-GAAP projected product gross margin

85% - 86%

85% - 86%

Projected income from operations GAAP to non-GAAP reconciliation:

GAAP projected income from operations

$8,600 - $9,400

$5,800 - $6,600

Acquisition-related, IPR&D impairment and other

~ 2,100

~ 4,900

Non-GAAP projected income from operations

$10,700 - $11,500

$10,700 - $11,500

Projected effective tax rate GAAP to non-GAAP reconciliation:

GAAP projected effective tax rate

~ 22%

~ 20%

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

~ 2%

—%

Non-GAAP projected effective tax rate

~ 20%

~ 20%

Projected diluted EPS GAAP to non-GAAP reconciliation:

GAAP projected diluted EPS

$4.70 - $5.20

$3.00- $3.50

Acquisition-related, IPR&D impairment, fair value adjustments of equity securities, other and discrete and related tax adjustments

~ 1.50

~ 3.20

Non-GAAP projected diluted EPS

$6.20 - $6.70

$6.20 - $6.70

________________________________

(1)

The non-GAAP 2022 full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

March 31,

December 31,

(in millions)

2022

2021

Assets

Cash, cash equivalents and marketable securities

$

6,752

$

7,829

Accounts receivable, net

3,787

4,493

Inventories

2,675

2,734

Property, plant and equipment, net

5,253

5,121

Intangible assets, net

30,331

33,455

Goodwill

8,314

8,332

Other assets

5,968

5,988

Total assets

$

63,080

$

67,952

Liabilities and Stockholders' Equity

Current liabilities

$

8,558

$

11,610

Long-term liabilities

34,607

35,278

Stockholders' equity (1)

19,915

21,064

Total liabilities and stockholders' equity

$

63,080

$

67,952

________________________________

(1)

As of March 31, 2022 and December 31, 2021, there were 1,255 and 1,254 shares of common stock issued and outstanding, respectively.

GILEAD SCIENCES, INC.

SELECTED CASH FLOW INFORMATION

(unaudited)

Three Months Ended

March 31,

(in millions)

2022

2021

Net cash provided by operating activities

$

1,840

$

2,610

Net cash used in investing activities

(1,070

)

(2,042

)

Net cash used in financing activities

(1,794

)

(2,477

)

Effect of exchange rate changes on cash and cash equivalents

(18

)

(23

)

Net change in cash and cash equivalents

(1,042

)

(1,932

)

Cash and cash equivalents at beginning of period

5,338

5,997

Cash and cash equivalents at end of period

$

4,296

$

4,065

Three Months Ended

March 31,

(in millions)

2022

2021

Net cash provided by operating activities

$

1,840

$

2,610

Capital expenditures

(247

)

(165

)

Free cash flow (1)

$

1,593

$

2,445

________________________________

(1)

Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above.

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

Three Months Ended

March 31,

(in millions)

2022

2021

HIV

Biktarvy – U.S.

$

1,706

$

1,465

Biktarvy – Europe

261

216

Biktarvy – Other International

184

143

2,151

1,824

Descovy – U.S.

311

282

Descovy – Europe

32

42

Descovy – Other International

31

35

374

359

Genvoya – U.S.

457

506

Genvoya – Europe

77

106

Genvoya – Other International

48

61

582

673

Odefsey – U.S.

232

240

Odefsey – Europe

96

113

Odefsey – Other International

11

14

339

367

Revenue share – Symtuza (1) – U.S.

86

89

Revenue share – Symtuza (1) – Europe

44

44

Revenue share – Symtuza (1) – Other International

3

2

132

135

Complera / Eviplera – U.S.

17

25

Complera / Eviplera – Europe

24

34

Complera / Eviplera – Other International

4

4

44

63

Stribild – U.S.

22

31

Stribild – Europe

8

11

Stribild – Other International

3

4

32

46

Truvada – U.S.

28

119

Truvada – Europe

4

7

Truvada – Other International

6

9

38

135

Other HIV (2) – U.S.

5

29

Other HIV (2) – Europe

4

5

Other HIV (2) – Other International

5

14

14

48

Total HIV – U.S.

2,862

2,786

Total HIV – Europe

550

578

Total HIV – Other International

295

286

3,707

3,650

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

March 31,

(in millions)

2022

2021

HCV

Ledipasvir / Sofosbuvir (3) – U.S.

13

19

Ledipasvir / Sofosbuvir (3) – Europe

4

16

Ledipasvir / Sofosbuvir (3) – Other International

18

21

35

56

Sofosbuvir / Velpatasvir (4) – U.S.

162

214

Sofosbuvir / Velpatasvir (4) – Europe

83

75

Sofosbuvir / Velpatasvir (4) – Other International

85

92

330

381

Other HCV (5) – U.S.

24

25

Other HCV (5) – Europe

8

44

Other HCV (5) – Other International

2

4

34

73

Total HCV – U.S.

199

258

Total HCV – Europe

95

135

Total HCV – Other International

105

117

399

510

HBV/HDV

Vemlidy – U.S.

80

77

Vemlidy – Europe

9

8

Vemlidy – Other International

111

96

200

181

Viread – U.S.

4

Viread – Europe

6

7

Viread – Other International

17

20

23

31

Other HBV/HDV (6) – Europe

13

8

Total HBV/HDV – U.S.

80

81

Total HBV/HDV – Europe

28

23

Total HBV/HDV – Other International

128

116

235

220

Veklury

Veklury – U.S.

801

820

Veklury – Europe

304

388

Veklury – Other International

430

248

1,535

1,456

Cell therapy

Tecartus – U.S.

47

27

Tecartus – Europe

15

4

Tecartus – Other International

1

63

31

Yescarta – U.S.

125

92

Yescarta – Europe

77

61

Yescarta – Other International

9

7

211

160

Total cell therapy – U.S.

172

119

Total cell therapy – Europe

92

65

Total cell therapy – Other International

10

7

274

191

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

March 31,

(in millions)

2022

2021

Trodelvy

Trodelvy – U.S.

119

72

Trodelvy – Europe

25

Trodelvy – Other International

2

146

72

Other

AmBisome – U.S.

25

12

AmBisome – Europe

66

66

AmBisome – Other International

53

43

144

121

Letairis – U.S.

43

54

Other (7) – U.S.

26

38

Other (7) – Europe

15

20

Other (7) – Other International

9

8

50

66

Total other – U.S.

94

104

Total other – Europe

81

86

Total other – Other International

62

51

236

241

Total product sales – U.S.

4,329

4,240

Total product sales – Europe

1,174

1,275

Total product sales – Other International

1,031

825

$

6,534

$

6,340

_______________________________

(1)

Represents Gilead's revenue from cobicistat ("C"), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company.

(2)

Includes Atripla, Emtriva and Tybost.

(3)

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

(4)

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

(5)

Includes Vosevi and Sovaldi.

(6)

Includes Hepcludex and Hepsera.

(7)

Includes Cayston, Jyseleca, Ranexa and Zydelig.

Investors:
Jacquie Ross, CFA
investor_relations@gilead.com

Media:
Chris Ridley
Public_affairs@gilead.com

News Provided by Business Wire via QuoteMedia

GILD
abigail echo-hawk

CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

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Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

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HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

As quoted in the press release:

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Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors

Kite, a Gilead Company (Nasdaq: GILD), today announced results from an ongoing Phase 1 study conducted by the National Cancer Institute (NCI) showing that clinical responses were observed with investigational T cell receptor (TCR) cell therapy targeting human papillomavirus type 16 (HPV-16) E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).

As quoted in the press release:

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Gilead Sciences Announces Promotion in Oncology Division

Gilead Sciences (NASDAQ:GILD) shared the promotion of Dr. Alessandro Riva to executive vice president of Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs.
As quoted in the press release:

Dr. Riva will become a member of Gilead’s senior leadership team.
Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutic Area Head. He has been instrumental in expanding Gilead’s oncology program with the recent acquisition of Kite Pharma, establishing the company as a leader in the field of cellular therapy. He has also guided the strategy and development of Gilead’s broader oncology pipeline during his tenure.

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CLASS ACTION ALERT: Kessler Topaz Meltzer & Check, LLP Reminds AbbVie, Inc. Investors of Upcoming Lead Plaintiff Deadline

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 THE FOLLOWING 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

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, 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, LLPor 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

SOURCE: Kessler Topaz Meltzer & Check, LLP



View source version on accesswire.com:
https://www.accesswire.com/702143/CLASS-ACTION-ALERT-Kessler-Topaz-Meltzer-Check-LLP-Reminds-AbbVie-Inc-Investors-of-Upcoming-Lead-Plaintiff-Deadline

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SHAREHOLDER ALERT: ABBV NTRA 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

AbbVie Inc. (NYSE:ABBV)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/abbvie-inc-loss-submission-form-2?prid=27532&wire=1
Lead Plaintiff Deadline: June 6, 2022
Class Period: April 30, 2021 - August 31, 2021

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Use of LUPKYNIS was safe and well tolerated in patients for up to three years of treatment, with no new safety signals

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ABBVie Inc. (NYSE:ABBV)

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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)
Class Period: May 7, 2021 - February 25, 2022
Lead Plaintiff Deadline: June 14, 2022

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