Life Science News

Biktarvy Sales Increased Year-Over-Year by 19% for Full Year 2021 & 22% for Fourth Quarter 2021

EPS Results Reflect $1.25 Billion Charge for a Legal Settlement & $625 Million Arcus Opt-In Charge

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

"Gilead is at an important point in its transformation journey, having built considerable momentum in the expansion of our commercial and clinical portfolios in both virology and oncology in 2021," said Daniel O'Day, Gilead's Chairman and Chief Executive Officer. "We are planning to further increase the number of clinical development studies across our novel oncology portfolio in 2022. We also look forward to advancing our long-acting programs for HIV. Today our cancer therapies, Trodelvy, Yescarta and Tecartus are reaching increasing numbers of cancer patients, Veklury is playing a critical role in the pandemic and Biktarvy remains the most prescribed HIV treatment in the US. We have all the elements in place for a strong year and a strong decade."

Fourth Quarter 2021 Financial Results

  • Total fourth quarter 2021 revenue of $7.2 billion decreased 2% compared to the same period in 2020, due to decreased demand for Veklury ® (remdesivir 100 mg for injection), partially offset by favorable pricing dynamics in HIV.
  • Diluted Earnings Per Share ("EPS") decreased to $0.30 for the fourth quarter 2021 compared to $1.23 for the same period in 2020. The decrease was primarily driven by a $1.25 billion charge related to a legal settlement and a charge of $625 million related to the Arcus Biosciences, Inc. ("Arcus") collaboration opt-in, representing an unfavorable $0.80 and $0.38 impact to diluted EPS, respectively. This was partially offset by favorable changes in the fair value of Gilead's equity investments.
  • Non-GAAP diluted EPS decreased to $0.69 for the fourth quarter 2021 compared to $2.19 for the same period in 2020, primarily due to the impact of the aforementioned $1.25 billion charge related to a legal settlement and a charge of $625 million related to the Arcus collaboration opt-in, representing an unfavorable $0.80 and $0.38 impact to non-GAAP diluted EPS, respectively.
  • As of December 31, 2021, Gilead had $7.8 billion of cash, cash equivalents and marketable debt securities compared to $7.9 billion as of December 31, 2020.
  • During the fourth quarter 2021, Gilead generated $3.2 billion in operating cash flow.
  • During the fourth quarter 2021, Gilead repaid $1.0 billion in debt, paid cash dividends of $894 million and utilized $49 million to repurchase common stock.

Product Sales Performance for the Fourth Quarter 2021

Total fourth quarter 2021 product sales decreased 2% to $7.2 billion compared to the same period in 2020. Total product sales excluding Veklury increased 8% to $5.8 billion for the fourth quarter 2021 compared to the same period in 2020, primarily reflecting higher demand for Biktarvy ® (bictegravir 50 mg/emtricitabine ("FTC") 200 mg/tenofovir alafenamide ("TAF") 25mg) and favorable pricing dynamics in HIV as well as contributions from Trodelvy ® (sacituzumab govitecan-hziy) and Cell Therapy.

HIV product sales increased 7% to $4.5 billion for the fourth quarter 2021 compared to the same period in 2020, reflecting higher Biktarvy demand and favorable pricing dynamics in HIV, partially offset, as expected, by the loss of exclusivity of Truvada ® (FTC 200mg/tenofovir disoproxil fumarate ("TDF") 300mg) and Atripla ® (efavirenz 600mg/FTC 200mg/TDF 300mg) in the United States.

  • Biktarvy sales increased 22% year-over-year in the fourth quarter 2021, primarily reflecting higher demand and favorable pricing dynamics.
  • Truvada and Atripla sales decreased 58% and 29% year-over-year, respectively, in the fourth quarter 2021, as expected, due to the loss of exclusivity in the United States in late 2020.

Hepatitis C virus ("HCV") product sales decreased 7% to $393 million for the fourth quarter 2021 compared to the same period in 2020, primarily driven by unfavorable changes in payer mix and fewer patient starts.

Hepatitis B virus ("HBV") and hepatitis delta virus ("HDV") product sales increased 9% to $265 million for the fourth quarter 2021 compared to the same period in 2020. Vemlidy ® (TAF 25 mg) sales increased 17% in the fourth quarter 2021 compared to the same period in 2020, driven primarily by uptake in all geographies. Hepcludex ® (bulevirtide) contributed $12 million in the fourth quarter 2021 as launch activities continued across Europe.

Cell Therapy product sales increased 47% to $239 million for the fourth quarter 2021 compared to the same period in 2020.

  • Yescarta ® (axicabtagene ciloleucel) sales increased to $182 million in the fourth quarter 2021, reflecting continued demand in relapsed or refractory large B-cell lymphoma ("LBCL") in the United States and Europe and follicular lymphoma ("FL") in the United States.
  • Tecartus ® (brexucabtagene autoleucel) sales increased to $57 million in the fourth quarter 2021, driven by continued adoption in mantle cell lymphoma ("MCL") and launch in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Trodelvy sales for the fourth quarter 2021 were $118 million, reflecting continued uptake in the second-line setting for treatment of metastatic triple-negative breast cancer ("TNBC") in the United States and Europe as well as second-line metastatic urothelial cancer ("UC") in the United States.

Veklury sales decreased 30% to $1.4 billion for the fourth quarter 2021 compared to the same period in 2020. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations as well as the availability, uptake and effectiveness of alternative treatments for COVID-19.

Fourth Quarter 2021 Product Gross Margin, Operating Expenses and Tax

  • Product gross margin was 63.3% for the fourth quarter 2021 compared to 80.9% in the same period in 2020. Non-GAAP product gross margin was 70.5% for the fourth quarter 2021 compared to 87.5% in the same period in 2020. The lower product gross margin reflects the impact of the $1.25 billion charge related to the aforementioned legal settlement.
  • Research and Development ("R&D") expenses for the fourth quarter 2021 were $2.0 billion compared to $1.6 billion in the same period in 2020. Non-GAAP R&D expenses for the fourth quarter 2021 were $2.0 billion compared to $1.5 billion in the same period in 2020. Higher R&D expenses primarily reflect a charge related to the Arcus collaboration opt-in and increased Trodelvy and magrolimab clinical activities, partially offset by the impact of higher 2020 expenses in connection with an amended agreement with Galapagos NV in the prior year that did not repeat.
  • Selling, General and Administrative ("SG&A") expenses for the fourth quarter 2021 were $1.7 billion compared to $1.7 billion in the same period in 2020. Non-GAAP SG&A expenses for the fourth quarter 2021 were $1.6 billion compared to $1.5 billion in the same period in 2020. Higher non-GAAP SG&A expenses reflect increased promotional and marketing activities, primarily due to Trodelvy.
  • The effective tax rate ("ETR") and non-GAAP ETR for the fourth quarter 2021 were 50.5% and 32.2%, respectively, compared to 14.9% and 15.8%, respectively, for the same period in 2020. The higher ETR reflects tax expense related to uncertain tax positions, an increase in valuation allowance as well as the impact of discrete tax benefits related to settlements with tax authorities in 2020 that did not recur in 2021.

Full Year 2021 Financial Results

  • Total full year 2021 revenue of $27.3 billion increased 11% compared to 2020, due to increased demand for Veklury.
  • Diluted EPS increased to $4.93 for the full year 2021 compared to $0.10 in 2020. Non-GAAP diluted EPS increased 3% to $7.28 for the full year 2021 compared to $7.09 in 2020. The increase in EPS and non-GAAP diluted EPS was primarily due to higher product sales partially offset by the impact from the aforementioned legal settlement, representing an unfavorable $0.80 impact, and higher operating expenses, including a charge related to the Arcus collaboration opt-in, representing an unfavorable $0.38 impact. EPS in 2020 reflects higher acquired in-process R&D ("IPR&D") charges and higher unrealized losses on our equity investments.

Product Sales Performance for the Full Year 2021

Total full year 2021 product sales increased 11% to $27.0 billion compared to the same period in 2020. Total product sales excluding Veklury decreased 0.5% to $21.4 billion for the full year 2021 compared to 2020 primarily driven by, as expected, the loss of exclusivity of Truvada, Atripla and Letairis ® (ambrisentan 5 mg and 10 mg) in the United States, partially offset by Biktarvy demand and contributions from Cell Therapy and Trodelvy.

HIV product sales decreased 4% to $16.3 billion for the full year 2021 compared to 2020, reflecting, as expected, the loss of exclusivity of Truvada and Atripla in the United States, partially offset by improved treatment and PrEP medication demand.

  • Truvada and Atripla sales decreased 74% and 58% year-over-year, respectively, in the full year 2021, as expected, due to the loss of exclusivity in the United States in late 2020.
  • Biktarvy sales increased 19% year-over-year in the full year 2021, reflecting higher demand.
  • Descovy sales decreased 9% year-over-year in the full year 2021, primarily driven by lower net price, partially offset by higher PrEP medication demand.

HCV product sales decreased 9% to $1.9 billion for the full year 2021 compared to 2020, primarily due to fewer patient starts.

HBV and HDV product sales increased 13% to $969 million for the full year 2021 compared to 2020, driven primarily by higher demand for Vemlidy in all geographies as well as ongoing launch activities with Hepcludex in Europe.

Cell Therapy product sales increased 43% to $871 million for the full year 2021 compared to 2020, primarily due to launches of Tecartus in MCL and Yescarta in FL.

Trodelvy sales for the full year 2021 were $380 million, reflecting continued uptake and launch activities in second-line metastatic TNBC in the United States and Europe as well as second-line metastatic UC in the United States.

Veklury sales increased 98% to $5.6 billion for the full year 2021 compared to 2020. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations as well as the availability, uptake and effectiveness of alternative treatments for COVID-19.

Full Year 2021 Product Gross Margin, Operating Expenses and Tax

  • Product gross margin was 75.6% for the full year 2021 compared to 81.2% in 2020. Non-GAAP product gross margin was 83.2% for the full year 2021 compared to 86.5% in 2020. Lower product gross margin primarily reflects the aforementioned legal settlement, partially offset by product mix and lower royalty expense.
  • R&D expenses for the full year 2021 were $5.4 billion compared to $5.0 billion in 2020. Non-GAAP R&D expenses for the full year 2021 were $5.2 billion compared to $4.9 billion in 2020. Higher R&D expenses primarily reflect a charge related to the Arcus collaboration opt-in in the fourth quarter 2021 and timing of clinical activities related to Trodelvy and magrolimab, partially offset by lower remdesivir and inflammation related expenses.
  • SG&A expenses for the full year 2021 were $5.2 billion compared to $5.2 billion in 2020. Non-GAAP SG&A expenses for full year 2021 were $5.0 billion compared to $4.8 billion in 2020. Higher SG&A expenses primarily reflect increased commercial activities.
  • The ETR and non-GAAP ETR for the full year 2021 were 25.1% and 20.4%, respectively, compared to 94.7% and 18.6%, respectively, in 2020. The lower ETR is primarily due to certain acquired IPR&D charges in 2020 that were non-deductible for income tax purposes. The higher non-GAAP ETR primarily reflects the impact of discrete tax benefits related to settlements with tax authorities in 2020 that did not recur in 2021.

Key Updates Since Our Last Quarterly Release

Viral Diseases

  • Announced updates to the lenacapavir clinical development program for the treatment and prevention of HIV. Dosing in the Phase 2 trial evaluating an investigational once-weekly oral combination treatment regimen of lenacapavir plus islatravir for the treatment of HIV was paused following clinical hold by FDA due to recent safety findings associated with Merck & Co., Inc.'s ("Merck") islatravir.
  • Announced a pause in clinical trials evaluating injectable lenacapavir following a clinical hold placed by FDA related to the compatibility of vials made with borosilicate glass with that of the lenacapavir solution. The dosing of oral formulations of lenacapavir continues.
  • Announced that Gilead had conducted genetic analysis of more than 15,000 genetic sequences of the Omicron variant isolates and found no additional prevalent mutations in the viral RNA polymerase compared to prior SARS-CoV-2 variants, suggesting Veklury remains active against the Omicron variant.
  • Received approval from the European Commission ("EC") to expand the indication for Veklury for use in the earlier stages of the disease in adult patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
  • Received FDA approval in January 2022 to expand the Veklury indication to include the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The pediatric Emergency Use Authorization was also expanded to include use of Veklury in non-hospitalized pediatric patients weighing at least 3.5 kg who are younger than 12 years of age or weigh less than 40 kg and who are at high risk of disease progression.
  • Published results from the Phase 3 PINETREE study of Veklury in non-hospitalized patients in the New England Journal of Medicine . Participants receiving a three-day course of Veklury intravenously achieved an 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28; there were no deaths in either arm of the study through the primary endpoint.
  • Announced the submission of a Biologics License Application ("BLA") to FDA for investigational bulevirtide (labeled as Hepcludex in the EU) for treatment of chronic HDV infection in adults with compensated liver disease.

Oncology

  • Announced a partial clinical hold for global studies evaluating magrolimab in combination with azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo.
  • Granted Priority Review by FDA for a supplemental BLA seeking approval of Yescarta for second-line LBCL with a PDUFA date of April 1, 2022. Regulatory submissions were also announced for the European Medicines Agency ("EMA").
  • Presented results from long-term and earlier-line studies of Yescarta at the American Society of Hematology 2021 meeting. Results from the landmark ZUMA-7 trial of Yescarta in second-line LBCL were highlighted in a plenary session, where data included 60% improvement in event-free survival as compared to standard of care after a median follow-up of 24.9 months. Additional presentations included five-year follow-up data from ZUMA-1 that demonstrated overall survival of 42.6% and updated two-year results from ZUMA-5 data in adult patients with relapsed or refractory indolent non-Hodgkin lymphoma after at least two prior lines of therapy. Results from ZUMA-12 were also reported in patients with high-risk LBCL receiving Yescarta in the front-line setting.
  • Received approval from FDA for a label update for Yescarta to include the use of prophylactic corticosteroids across all approved indications. Yescarta is now the first and only chimeric antigen receptor T-cell therapy with information in the label to help physicians prophylactically manage, and potentially prevent, treatment side effects with corticosteroids.
  • Announced the availability of Yescarta to patients with relapsed or refractory LBCL in Japan following authorization of the first CAR T-cell therapy treatment site by Daiichi Sankyo Co., Ltd. ("Daiichi Sankyo").
  • Announced Gilead's decision to exercise options to opt-in to three clinical-stage Arcus programs, which includes both anti-TIGIT molecules (domvanalimab and AB308) as well as etrumadenant and quemliclustat. The transaction was closed in December for total option fee of $725 million paid in January 2022. As part of the agreement, the $100 million option continuation payment previously due to Arcus in the third quarter of 2022 was waived, resulting in a $625 million charge recorded in the fourth quarter of 2021.
  • Received marketing authorization from the EC for Trodelvy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.
  • Announced a clinical trial collaboration with Merck to evaluate Trodelvy in combination with Keytruda in the first-line setting in patients with metastatic TNBC and, in the first quarter 2022, in patients with non-small cell lung cancer.
  • Announced with Everest Medicines that the Phase 2b EVER-132-001 study evaluating sacituzumab govitecan (labeled as Trodelvy in the U.S.) for patients with metastatic TNBC in China reached the primary overall response rate endpoint.
  • Presented a new subgroup analysis of the ASCENT study at the 2021 San Antonio Breast Cancer Symposium which demonstrated that the clinical benefit of Trodelvy in Black patients was consistent with the full metastatic TNBC population in the study.

Corporate

  • Announced that a Virology Deep-Dive event will be held on February 17, 2022 and Oncology Deep-Dive event will be held on April 14, 2022.

Guidance and Outlook

Gilead is providing full-year 2022 guidance below:

  • 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, primarily reflecting the recent surge in COVID-19 related hospitalizations and our expectations for a step-down in hospitalization rates over the remainder of 2022.
  • Earnings per share between $4.70 and $5.20.
  • Non-GAAP earnings per share between $6.20 and $6.70.

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.

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, acquired IPR&D expenses, and other items that are considered unusual or not representative of underlying trends of Gilead's business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Acquired IPR&D expenses reflect IPR&D impairments as well as the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and other payments related to various collaborations and the initial costs of rights to IPR&D projects. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Conference Call

At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead's results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operations; the development, manufacturing and distribution of Veklury as a treatment for COVID-19, including the uncertainty of the amount and timing of future Veklury sales 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, 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 virology, oncology and other programs; Gilead's ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including those involving Arcus, Daiichi Sankyo, Everest Medicines and Merck; 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 Trodelvy, Veklury, Yescarta and lenacapavir, 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, including Trodelvy and Yescarta, in the currently anticipated timelines; Gilead's ability to receive regulatory approvals in a timely manner or at all, including FDA approval of bulevirtide for treatment of chronic HDV infection in adults with compensated liver disease or FDA or EMA approval of Yescarta for second-line LBCL, 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, including Trodelvy, Veklury and Yescarta; and other risks identified from time to time in Gilead's reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended December 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.

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.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions, except per share amounts)

2021

2020

2021

2020

Revenues:

Product sales

$

7,160

$

7,328

$

27,008

$

24,355

Royalty, contract and other revenues

84

93

297

334

Total revenues

7,244

7,421

27,305

24,689

Costs and expenses:

Cost of goods sold

2,627

1,398

6,601

4,572

Research and development expenses

2,027

1,578

5,363

5,039

Acquired in-process research and development expenses

64

177

5,856

Selling, general and administrative expenses

1,650

1,730

5,246

5,151

Total costs and expenses

6,304

4,770

17,387

20,618

Income from operations

940

2,651

9,918

4,071

Interest expense

(238

)

(267

)

(1,001

)

(984

)

Other income (expense), net

57

(570

)

(639

)

(1,418

)

Income before income taxes

759

1,814

8,278

1,669

Income tax expense

(383

)

(270

)

(2,077

)

(1,580

)

Net income

376

1,544

6,201

89

Net loss attributable to noncontrolling interest

6

7

24

34

Net income attributable to Gilead

$

382

$

1,551

$

6,225

$

123

Net income per share attributable to Gilead common stockholders - basic

$

0.30

$

1.24

$

4.96

$

0.10

Shares used in per share calculation - basic

1,256

1,255

1,256

1,257

Net income per share attributable to Gilead common stockholders - diluted

$

0.30

$

1.23

$

4.93

$

0.10

Shares used in per share calculation - diluted

1,262

1,259

1,262

1,263

Cash dividends declared per share

$

0.71

$

0.68

$

2.84

$

2.72

Research and development expenses as a % of revenues

28.0

%

21.3

%

19.6

%

20.4

%

Selling, general and administrative expenses as a % of revenues

22.8

%

23.3

%

19.2

%

20.9

%

Operating expenses as a % of revenues

50.8

%

45.4

%

39.5

%

65.0

%

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(In millions, except percentages)

2021

2020

Change

2021

2020

Change

Product sales:

HIV

$

4,538

$

4,257

7%

$

16,315

$

16,938

(4)%

HCV

393

423

(7)%

1,881

2,064

(9)%

HBV/HDV

265

244

9%

969

860

13%

Cell Therapy

239

163

47%

871

607

43%

Trodelvy

118

49

NM

380

49

NM

Other

250

254

(2)%

1,027

1,026

—%

Total product sales excluding Veklury

5,803

5,390

8%

21,443

21,544

—%

Veklury

1,357

1,938

(30)%

5,565

2,811

98%

Total product sales

7,160

7,328

(2)%

27,008

24,355

11%

Royalty, contract and other revenues

84

93

(10)%

297

334

(11)%

Total revenues

$

7,244

$

7,421

(2)%

$

27,305

$

24,689

11%

_______________________________

NM - Not Meaningful

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION (1)

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(In millions, except percentages)

2021

2020

Change

2021

2020

Change

Non-GAAP:

Cost of goods sold

$

2,111

$

918

130%

$

4,538

$

3,294

38%

Research and development expenses

$

1,984

$

1,512

31%

$

5,226

$

4,857

8%

Acquired in-process research and development expenses

$

$

NM

$

19

$

NM

Selling, general and administrative expenses

$

1,642

$

1,499

10%

$

4,974

$

4,834

3%

Other income (expense), net

$

$

46

NM

$

(29

)

$

249

NM

Diluted EPS

$

0.69

$

2.19

(68)%

$

7.28

$

7.09

3%

Product gross margin

70.5

%

87.5

%

NM

83.2

%

86.5

%

-330 bps

Research and development expenses as a % of revenues

27.4

%

20.4

%

700 bps

19.1

%

19.7

%

-60 bps

Selling, general and administrative expenses as a % of revenues

22.7

%

20.2

%

250 bps

18.2

%

19.6

%

-140 bps

Operating expenses as a % of revenues

50.1

%

40.6

%

950 bps

37.4

%

39.3

%

-190 bps

Operating margin

20.8

%

47.1

%

NM

46.0

%

47.4

%

-140 bps

Effective tax rate

32.2

%

15.8

%

NM

20.4

%

18.6

%

180 bps

________________________________
NM - Not Meaningful

(1)

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

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions, except percentages and per share amounts)

2021

2020

2021

2020

Cost of goods sold reconciliation:

GAAP cost of goods sold

$

2,627

$

1,398

$

6,601

$

4,572

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

(516

)

(417

)

(2,063

)

(1,215

)

Acquisition-related and other costs (1)

(63

)

(63

)

Non-GAAP cost of goods sold

$

2,111

$

918

$

4,538

$

3,294

Product gross margin reconciliation:

GAAP product gross margin

63.3

%

80.9

%

75.6

%

81.2

%

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

7.2

%

5.7

%

7.6

%

5.0

%

Acquisition-related and other costs (1)

%

0.9

%

%

0.3

%

Non-GAAP product gross margin (2)

70.5

%

87.5

%

83.2

%

86.5

%

Research and development expenses reconciliation:

GAAP research and development expenses

$

2,027

$

1,578

$

5,363

$

5,039

Acquisition-related – amortization of inventory step-up charges

(42

)

(109

)

Acquisition-related and other costs (1)

(1

)

(66

)

(28

)

(182

)

Non-GAAP research and development expenses

$

1,984

$

1,512

$

5,226

$

4,857

Acquired IPR&D expenses reconciliation:

GAAP acquired IPR&D expenses

$

$

64

$

177

$

5,856

Acquired IPR&D expenses

(64

)

(158

)

(5,856

)

Non-GAAP acquired IPR&D expenses

$

$

$

19

$

Selling, general and administrative expenses reconciliation:

GAAP selling, general and administrative expenses

$

1,650

$

1,730

$

5,246

$

5,151

Acquisition-related and other costs (1)(3)

(8

)

(231

)

(272

)

(317

)

Non-GAAP selling, general and administrative expenses

$

1,642

$

1,499

$

4,974

$

4,834

Operating income reconciliation:

GAAP operating income

$

940

$

2,651

$

9,918

$

4,071

Acquired IPR&D expenses

64

158

5,856

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

558

417

2,172

1,215

Acquisition-related and other costs (1)(3)

9

360

300

562

Non-GAAP operating income

$

1,507

$

3,492

$

12,548

$

11,704

Operating margin reconciliation:

GAAP operating margin

13.0

%

35.7

%

36.3

%

16.5

%

Acquired IPR&D expenses

%

0.9

%

0.6

%

23.7

%

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

7.7

%

5.6

%

8.0

%

4.9

%

Acquisition-related and other costs (1)(3)

0.1

%

4.8

%

1.1

%

2.3

%

Non-GAAP operating margin (2)

20.8

%

47.1

%

46.0

%

47.4

%

Other income (expense), net reconciliation:

GAAP other income (expense), net

$

57

$

(570

)

$

(639

)

$

(1,418

)

(Gain) loss from equity securities, net

(57

)

616

610

1,667

Non-GAAP other income (expense), net

$

$

46

$

(29

)

$

249

GILEAD SCIENCES, INC.

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

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions, except percentages and per share amounts)

2021

2020

2021

2020

Effective tax rate reconciliation:

GAAP effective tax rate

50.5

%

14.9

%

25.1

%

94.7

%

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

(18.3

)%

0.9

%

(4.7

)%

(76.1

)%

Non-GAAP effective tax rate (2)

32.2

%

15.8

%

20.4

%

18.6

%

Net income attributable to Gilead reconciliation (after tax):

GAAP net income attributable to Gilead

$

382

$

1,551

$

6,225

$

123

Acquired IPR&D expenses

50

125

5,672

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

449

329

1,750

1,002

Acquisition-related and other costs (1)(3)

3

286

192

443

(Gain) loss from equity securities, net

(56

)

628

631

1,718

Discrete and related tax charges (4)

88

(82

)

267

Non-GAAP net income attributable to Gilead

$

866

$

2,762

$

9,190

$

8,958

Diluted EPS reconciliation:

GAAP diluted earnings per share

$

0.30

$

1.23

$

4.93

$

0.10

Acquired IPR&D expenses

0.04

0.10

4.49

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

0.36

0.26

1.39

0.79

Acquisition-related and other costs (1)(3)

0.23

0.15

0.35

(Gain) loss from equity securities, net

(0.04

)

0.50

0.50

1.36

Discrete and related tax charges (4)

0.07

(0.07

)

0.21

Non-GAAP diluted EPS (2)

$

0.69

$

2.19

$

7.28

$

7.09

Non-GAAP adjustment summary:

Cost of goods sold adjustments

$

516

$

480

$

2,063

$

1,278

Research and development expenses adjustments

43

66

137

182

Acquired IPR&D expenses adjustments

64

158

5,856

Selling, general and administrative expenses adjustments

8

231

272

317

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

567

841

2,630

7,633

Other income (expense), net, adjustments

(57

)

616

610

1,667

Total non-GAAP adjustments before income taxes

510

1,457

3,240

9,300

Income tax effect of non-GAAP adjustments above

(114

)

(164

)

(542

)

(465

)

Discrete and related tax charges (4)

88

(82

)

267

Total non-GAAP adjustments after tax

$

484

$

1,211

$

2,965

$

8,835

______________________________

(1)

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

(2)

Amounts may not sum due to rounding.

(3)

Includes a donation of equity securities to the Gilead Foundation, a California nonprofit organization, during the second quarter of 2021.

(4)

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

GILEAD SCIENCES, INC.

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

(unaudited)

(in millions, except percentages and per share amounts)

Provided

February 1, 2022

Projected product gross margin GAAP to non-GAAP reconciliation:

GAAP projected product gross margin

76% - 77%

Acquisition-related expenses

~ 9%

Non-GAAP projected product gross margin

85% - 86%

Projected operating income GAAP to non-GAAP reconciliation:

GAAP projected operating income

$8,600 - $9,400

Acquisition-related expenses

~ 2,100

Non-GAAP projected operating income

$10,700 - $11,500

Projected effective tax rate GAAP to non-GAAP reconciliation:

GAAP projected effective tax rate

~ 22%

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

~ 2%

Non-GAAP projected effective tax rate

~ 20%

Projected diluted EPS GAAP to non-GAAP reconciliation:

GAAP projected diluted EPS

$4.70 - $5.20

Acquisition-related expenses, related tax effects and amortization of deferred tax assets

~ 1.50

Non-GAAP projected diluted EPS

$6.20 - $6.70

________________________________

(1)

The 2022 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 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)

December 31,

(in millions)

2021

2020

Assets

Cash, cash equivalents and marketable securities

$

7,829

$

7,910

Accounts receivable, net

4,493

4,892

Inventories

2,734

3,014

Property, plant and equipment, net

5,121

4,967

Intangible assets, net

33,455

33,126

Goodwill

8,332

8,108

Other assets

5,988

6,390

Total assets

$

67,952

$

68,407

Liabilities and Stockholders' Equity

Current liabilities

$

11,610

$

11,397

Long-term liabilities

35,278

38,789

Stockholders' equity (1)

21,064

18,221

Total liabilities and stockholders' equity

$

67,952

$

68,407

________________________________

(1)

As of December 31, 2021 and December 31, 2020, there were 1,254 shares of common stock issued and outstanding, respectively.

GILEAD SCIENCES, INC.

SELECTED CASH FLOW INFORMATION

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2021

2020

2021

2020

Net cash provided by operating activities

$

3,205

$

1,916

$

11,384

$

8,168

Net cash used in investing activities

(278

)

(8,977

)

(3,131

)

(14,615

)

Net cash provided by (used in) financing activities

(1,942

)

131

(8,877

)

770

Effect of exchange rate changes on cash and cash equivalents

(9

)

41

(35

)

43

Net change in cash and cash equivalents

976

(6,889

)

(659

)

(5,634

)

Cash and cash equivalents at beginning of period

4,362

12,886

5,997

11,631

Cash and cash equivalents at end of period

$

5,338

$

5,997

$

5,338

$

5,997

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2021

2020

2021

2020

Net cash provided by operating activities

$

3,205

$

1,916

$

11,384

$

8,168

Capital expenditures

(156

)

(181

)

(579

)

(650

)

Free cash flow

$

3,049

$

1,735

$

10,805

$

7,518

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2021

2020

2021

2020

HIV Products

Descovy (FTC/TAF) Based Products

Biktarvy – U.S.

$

2,123

$

1,749

$

7,049

$

6,095

Biktarvy – Europe

262

207

969

735

Biktarvy – Other International

145

115

606

429

2,530

2,071

8,624

7,259

Descovy – U.S.

403

402

1,397

1,526

Descovy – Europe

36

41

164

197

Descovy – Other International

34

35

139

138

473

478

1,700

1,861

Genvoya – U.S.

634

678

2,267

2,605

Genvoya – Europe

85

114

391

490

Genvoya – Other International

37

60

221

243

756

852

2,879

3,338

Odefsey – U.S.

303

321

1,076

1,172

Odefsey – Europe

104

109

440

450

Odefsey – Other International

13

14

52

50

420

444

1,568

1,672

Revenue share – Symtuza (1) – U.S.

94

87

355

331

Revenue share – Symtuza (1) – Europe

40

37

165

149

Revenue share – Symtuza (1) – Other International

3

2

11

8

137

126

531

488

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

3,557

3,237

12,144

11,729

Total Descovy (FTC/TAF) Based Products – Europe

527

508

2,129

2,021

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

232

226

1,029

868

4,316

3,971

15,302

14,618

Truvada (FTC/TDF) Based Products

Atripla – U.S.

25

32

121

307

Atripla – Europe

2

4

12

21

Atripla – Other International

2

12

21

27

38

145

349

Complera / Eviplera – U.S.

29

12

102

89

Complera / Eviplera – Europe

38

35

142

159

Complera / Eviplera – Other International

2

4

14

21

69

51

258

269

Stribild – U.S.

38

25

132

125

Stribild – Europe

10

12

43

54

Stribild – Other International

2

5

14

17

50

42

189

196

Truvada – U.S.

46

131

314

1,376

Truvada – Europe

4

7

22

27

Truvada – Other International

11

8

35

45

61

146

371

1,448

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

138

200

669

1,897

Total Truvada (FTC/TDF) Based Products – Europe

54

58

219

261

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

15

19

75

104

207

277

963

2,262

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2021

2020

2021

2020

Other HIV (2) – U.S.

1

1

15

25

Other HIV (2) – Europe

9

1

18

5

Other HIV (2) – Other International

5

7

17

28

15

9

50

58

Total HIV – U.S.

3,696

3,438

12,828

13,651

Total HIV – Europe

590

567

2,366

2,287

Total HIV – Other International

252

252

1,121

1,000

4,538

4,257

16,315

16,938

HCV Products

Ledipasvir / Sofosbuvir (3) – U.S.

21

(21

)

84

92

Ledipasvir / Sofosbuvir (3) – Europe

7

3

31

29

Ledipasvir / Sofosbuvir (3) – Other International

21

27

97

151

49

9

212

272

Sofosbuvir / Velpatasvir (4) – U.S.

166

218

815

864

Sofosbuvir / Velpatasvir (4) – Europe

82

84

316

337

Sofosbuvir / Velpatasvir (4) – Other International

59

68

331

398

307

370

1,462

1,599

Other HCV (5) – U.S.

22

32

119

132

Other HCV (5) – Europe

10

11

74

48

Other HCV (5) – Other International

5

1

14

13

37

44

207

193

Total HCV – U.S.

209

229

1,018

1,088

Total HCV – Europe

99

98

421

414

Total HCV – Other International

85

96

442

562

393

423

1,881

2,064

HBV/HDV Products

Vemlidy – U.S.

118

108

384

356

Vemlidy – Europe

9

7

34

29

Vemlidy – Other International

98

78

396

272

225

193

814

657

Viread – U.S.

3

4

11

14

Viread – Europe

6

7

28

34

Viread – Other International

17

37

72

137

26

48

111

185

Other HBV/HDV (6) – U.S.

1

1

2

10

Other HBV/HDV (6) – Europe

13

2

42

8

14

3

44

18

Total HBV/HDV – U.S.

122

113

397

380

Total HBV/HDV – Europe

28

16

104

71

Total HBV/HDV – Other International

115

115

468

409

265

244

969

860

Veklury

Veklury – U.S.

877

1,241

3,640

2,026

Veklury – Europe

334

547

1,095

607

Veklury – Other International

146

150

830

178

1,357

1,938

5,565

2,811

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY - (Continued)

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2021

2020

2021

2020

Cell Therapy Products

Tecartus – U.S.

42

29

136

34

Tecartus – Europe

15

5

40

10

57

34

176

44

Yescarta – U.S.

106

79

406

362

Yescarta – Europe

65

47

253

191

Yescarta – Other International

11

3

36

10

182

129

695

563

Total Cell Therapy – U.S.

148

108

542

396

Total Cell Therapy – Europe

80

52

293

201

Total Cell Therapy – Other International

11

3

36

10

239

163

871

607

Trodelvy

Trodelvy – U.S.

109

49

370

49

Trodelvy – Europe

9

10

118

49

380

49

Other Products

AmBisome – U.S.

7

15

39

61

AmBisome – Europe

72

64

274

230

AmBisome – Other International

41

32

227

145

120

111

540

436

Letairis – U.S.

49

73

206

314

Ranexa – U.S.

5

10

9

Zydelig – U.S.

4

7

26

31

Zydelig – Europe

8

9

35

39

Zydelig – Other International

1

1

2

12

17

62

72

Other (7) – U.S.

18

33

100

136

Other (7) – Europe

39

13

80

45

Other (7) – Other International

7

7

29

14

64

53

209

195

Total Other – U.S.

83

128

381

551

Total Other – Europe

119

86

389

314

Total Other – Other International

48

40

257

161

250

254

1,027

1,026

Total product sales – U.S.

5,244

5,306

19,176

18,141

Total product sales – Europe

1,259

1,366

4,678

3,894

Total product sales – Other International

657

656

3,154

2,320

$

7,160

$

7,328

$

27,008

$

24,355

_______________________________

(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 Unlimited Company.

(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)

Includes Hepcludex and Hepsera.

(7)

Includes Cayston and Jyseleca.

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

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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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"investingnews.com"

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
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  • 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

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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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ROSEN, SKILLED INVESTOR COUNSEL, Encourages AbbVie Inc. Investors With Losses Over $100K to Secure Counsel Before Important Deadline in Securities Class Action - ABBV

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline .

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

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ROSEN, A LEADING LAW FIRM, Encourages Aurinia Pharmaceuticals Inc. Investors With Losses Exceeding $100K to Secure Counsel Before Important Deadline in Securities Class Action - AUPH

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) between May 7, 2021 and February 25, 2022, inclusive (the "Class Period"), of the important June 14, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Aurinia securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

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ROSEN, A TOP RANKED FIRM, Encourages AbbVie Inc. Investors With Losses Exceeding $100K to Secure Counsel Before Important Deadline in Securities Class Action - ABBV

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Rosen Law Firm, P.A. Logo

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31 , 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline .

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than June 6, 2022 . A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) safety concerns about Xeljanz and Xeljanz XR extended to Rinvoq and other Janus kinase (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 AbbVie's business, operations, and prospects lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm , on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/ .

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/rosen-a-top-ranked-firm-encourages-abbvie-inc-investors-with-losses-exceeding-100k-to-secure-counsel-before-important-deadline-in-securities-class-action--abbv-301547293.html

SOURCE Rosen Law Firm, P.A.

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ABBV DEADLINE: Kessler Topaz Meltzer & Check, LLP Reminds Investors of AbbVie, Inc. of Deadline in Securities Fraud Class Action Lawsuit 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").

KTMC Logo (PRNewsfoto/Kessler Topaz Meltzer & Check, LLP)

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

TO VIEW OUR 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?
AbbVie investors 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

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/abbv-deadline--kessler-topaz-meltzer--check-llp-reminds-investors-of-abbvie-inc-of-deadline-in-securities-fraud-class-action-lawsuit-and-encourages-investors-with-substantial-losses-to-contact-the-firm-301545076.html

SOURCE Kessler Topaz Meltzer & Check, LLP

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Aurinia, Stronghold, Lilium, and Li-Cycle and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH), Stronghold Digital Mining, Inc. (NASDAQ: SDIG), Lilium N.V. (NASDAQ: LILM), and Li-Cycle Holdings Corp. (NYSE: LICY). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH)

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Aurinia, Stronghold, Lilium, and Li-Cycle and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH), Stronghold Digital Mining, Inc. (NASDAQ: SDIG), Lilium N.V. (NASDAQ: LILM), and Li-Cycle Holdings Corp. (NYSE: LICY). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH)

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