Biktarvy Gross sales Elevated 28% 12 months-Over-12 months to $2.6 billion

Oncology Gross sales Elevated 71% 12 months-Over-12 months to $527 million

FOSTER CITY, Calif., August 02, 2022–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) introduced as we speak its outcomes of operations for the second quarter of 2022.

“This was a really sturdy quarter for Gilead, with strong industrial and scientific execution,” mentioned Daniel O’Day, Chairman and Chief Government Officer, Gilead Sciences. “Excluding Veklury, product gross sales grew 7% year-over-year. There was continued sturdy demand for our HIV portfolio with additional share development for Biktarvy, and oncology revenues reached an all-time excessive, pushed by cell remedy and Trodelvy.”

Second Quarter 2022 Monetary Outcomes

• Complete second quarter 2022 income elevated 1% to $6.Three billion in comparison with the identical interval in 2021, primarily because of elevated gross sales in HIV and oncology merchandise, offset partially by decreased gross sales of Veklury® (remdesivir) and hepatitis C virus (“HCV”) merchandise.

• Diluted Earnings Per Share (“EPS”) decreased to $0.91 for the second quarter of 2022 in comparison with $1.21 for a similar interval in 2021. The lower was primarily because of greater acquired in-process analysis & improvement (“IPR&D”) bills from an upfront cost of $300 million, or $0.18 on a post-tax per share foundation, associated to the Dragonfly Therapeutics, Inc. (“Dragonfly”) collaboration and better internet unrealized losses from our strategic fairness investments.

• Non-GAAP diluted EPS decreased 13% to $1.58 for the second quarter of 2022 in comparison with $1.81⁽¹⁾ for a similar interval in 2021, primarily reflecting the Dragonfly upfront cost and Biktarvy® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”))-related royalty expense that started within the first quarter of 2022, offset partially by greater revenues.

• As of June 30, 2022, Gilead had $7.Zero billion of money, money equivalents and marketable debt securities down from $7.Eight billion as of December 31, 2021 primarily because of cost related to the settlement of the bictegravir-related litigation, paid dividends, acquired IPR&D funds associated to collaborations, debt repayments, inventory repurchases and capital expenditures, partially offset by internet money offered by operations.

• Throughout the second quarter of 2022, Gilead generated $1.Eight billion in working money circulation.

• Throughout the second quarter of 2022, Gilead made a $300 million collaboration upfront cost to Dragonfly, paid dividends of $920 million and repurchased $72 million of frequent inventory.

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Product Gross sales Efficiency

Complete second quarter 2022 product gross sales have been $6.1 billion, flat in comparison with the identical interval in 2021. Complete product gross sales, excluding Veklury, elevated 7% to $5.7 billion within the second quarter of 2022 in comparison with the identical interval in 2021, primarily because of development within the HIV, Cell Remedy and Trodelvy® (sacituzumab govitecan-hziy) companies, offset partially by declining income in HCV.

HIV product gross sales elevated 7% to $4.2 billion within the second quarter of 2022 in comparison with the identical interval in 2021, primarily reflecting modifications in channel combine resulting in greater common realized worth in addition to greater demand for therapy and pre-exposure prophylaxis (“PrEP”) medicines.

• Biktarvy gross sales elevated 28% year-over-year within the second quarter of 2022, primarily because of greater demand and channel combine.

• Descovy® (FTC 200mg/TAF 25mg) gross sales elevated 6% year-over-year within the second quarter of 2022, primarily pushed by channel combine and elevated demand, partially offset by stock dynamics.

HCV product gross sales decreased 18% to $448 million within the second quarter of 2022 in comparison with the identical interval in 2021, primarily pushed by channel combine resulting in decrease common realized worth and fewer affected person begins.

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product gross sales decreased 1% to $234 million within the second quarter of 2022 in comparison with the identical interval in 2021. Vemlidy® (TAF 25mg) gross sales decreased 3% within the second quarter of 2022 in comparison with the identical interval in 2021, primarily pushed by China Quantity Primarily based Procurement replace, offset partly by quantity development in all different areas.

Cell remedy product gross sales elevated 68% to $368 million within the second quarter of 2022 in comparison with the identical interval in 2021.

• Yescarta® (axicabtagene ciloleucel) gross sales elevated 66% to $295 million within the second quarter of 2022, primarily pushed by demand for relapsed or refractory (“R/R”) massive B-cell lymphoma (“LBCL”) in america and Europe and R/R follicular lymphoma (“FL”) in america.

• Tecartus® (brexucabtagene autoleucel) gross sales elevated 78% to $73 million within the second quarter of 2022, primarily pushed by demand for R/R mantle cell lymphoma (“MCL”) in america and Europe and for grownup sufferers with R/R B-cell precursor acute lymphoblastic leukemia (“ALL”) in america.

Trodelvy gross sales elevated by 79% to $159 million within the second quarter of 2022 in comparison with the identical interval in 2021, primarily reflecting adoption in each the second- and third-line settings for the therapy of metastatic triple-negative breast most cancers (“TNBC”) in america and Europe in addition to for metastatic urothelial most cancers in america.

Veklury gross sales decreased by 46% to $445 million for the second quarter of 2022 in comparison with the identical interval in 2021. Veklury income typically displays COVID-19 associated charges and severity of infections and hospitalizations, in addition to the provision, uptake and effectiveness of vaccinations and various therapies for COVID-19.

Second Quarter 2022 Product Gross Margin, Working Bills and Efficient Tax Price

• Product gross margin was 76.5% for the second quarter of 2022 in comparison with 77.4% for a similar interval in 2021. Non-GAAP product gross margin was 85.6% for the second quarter of 2022 in comparison with 86.4% in the identical interval in 2021. The decreases have been primarily pushed by Biktarvy-related royalty expense that started within the first quarter of 2022.

• Analysis and improvement (“R&D”) bills for the second quarter of 2022 have been $1.1 billion, comparatively flat with the identical interval in 2021. Non-GAAP R&D bills for the second quarter of 2022 have been $1.1 billion in comparison with $1.Zero billion⁽²⁾ in the identical interval in 2021. GAAP and Non-GAAP R&D bills primarily mirror elevated funding in improvement actions and timing of scientific trial actions, primarily for oncology. GAAP R&D bills have been offset by decrease restructuring bills as in comparison with the prior 12 months.

• Acquired IPR&D bills for the second quarter of 2022 have been $330 million in comparison with $138 million⁽²⁾ in the identical interval in 2021. The rise primarily displays an upfront cost associated to the Dragonfly collaboration.

• Promoting, normal and administrative (“SG&A”) bills for the second quarter of 2022 have been $1.Four billion, comparatively flat with the identical interval in 2021. Non-GAAP SG&A bills for the second quarter of 2022 have been $1.Three billion in comparison with $1.1 billion in the identical interval in 2021. GAAP and Non-GAAP SG&A bills primarily mirror elevated promotional and advertising funding, together with for Trodelvy, in addition to greater company actions, together with data know-how tasks and grants. GAAP SG&A bills have been offset by decrease donations to Gilead Basis as in comparison with the prior 12 months.

• The efficient tax charge (“ETR”) for the second quarter of 2022 was 24.5% in comparison with 16.5% for a similar interval in 2021, primarily because of a discrete tax profit associated to an intra-entity switch of intangible property within the three months ended June 30, 2021, and better internet unrealized losses from fairness investments which might be non-deductible for revenue tax functions. Non-GAAP ETR for the second quarter of 2022 was 19.3% in comparison with 19.5% for a similar interval in 2021.

Steering and Outlook

For the full-year, Gilead has up to date its steerage and now expects:

• Complete product gross sales between $24.5 billion and $25.Zero billion, in comparison with $23.Eight billion and $24.Three billion beforehand.

• Complete product gross sales, excluding Veklury, between $22.Zero billion to $22.5 billion, in comparison with $21.Eight billion and $22.Three billion beforehand.

• Complete Veklury gross sales of roughly $2.5 billion, in comparison with roughly $2.Zero billion beforehand.

• Non-GAAP earnings per share between $6.35 and $6.75, in comparison with $6.20 and $6.70 beforehand.

• Earnings per share between $2.90 and $3.30, in comparison with $3.00 and $3.50 beforehand.

This monetary steerage excludes the influence of any bills associated to potential acquisitions or enterprise improvement transactions that haven’t been executed, honest worth changes of fairness securities and discrete tax prices or advantages related to modifications in tax associated legal guidelines and tips as Gilead is unable to challenge such quantities. A reconciliation between GAAP and non-GAAP monetary data for the 2022 steerage is offered within the accompanying tables. Additionally see the Ahead-Wanting Statements described beneath. The monetary steerage is topic to a lot of dangers and uncertainties, together with uncertainty across the length and magnitude of the COVID-19 pandemic. Whereas the pandemic might be anticipated to proceed to influence Gilead’s enterprise and broader market dynamics, the speed and diploma of those impacts in addition to the corresponding restoration from the pandemic could fluctuate throughout Gilead’s enterprise.

Key Updates Since Our Final Quarterly Launch

Virology

• Introduced FDA lifted the scientific maintain positioned on the Investigational New Drug Utility to guage injectable lenacapavir for HIV therapy and pre-exposure prophylaxis following the company’s evaluate of the storage and compatibility knowledge of lenacapavir injection with an alternate vial produced from aluminosilicate glass.

• Introduced FDA accepted for evaluate the New Drug Utility resubmission for investigational lenacapavir for the therapy of HIV-1 an infection in closely treatment-experienced individuals with multi-drug resistant HIV-1 an infection. FDA has assigned a Prescription Drug Consumer Payment Act date of December 27, 2022.

• Acquired a constructive opinion from the European Medicines Company’s (“EMA”) Committee for Medicinal Merchandise for Human Use (“CHMP”) for investigational lenacapavir for the therapy of HIV-1 an infection, together with different antiretroviral(s), in adults with multi-drug resistant HIV-1 an infection for whom it’s in any other case not doable to assemble a suppressive anti-viral routine.

• Introduced knowledge on the Worldwide AIDS Convention, which included Week 48 knowledge from the Section Three ALLIANCE trial evaluating Biktarvy in adults with HIV/HBV coinfection. Outcomes from ALLIANCE confirmed that Biktarvy had superior HBV DNA suppression over the comparator dolutegravir/FTC/TDF, with each antiretroviral regimens equally attaining excessive charges of HIV suppression. Moreover, five-year knowledge from two Section Three trials of Biktarvy as first-line remedy in individuals residing with HIV additional demonstrated Biktarvy’s sustained efficacy, security profile and excessive barrier to resistance.

• Introduced Week 48 outcomes for the pivotal Section Three MYR301 trial of bulevirtide for the therapy of power HDV on the Worldwide Liver Congress 2022. The research met its main endpoint, attaining statistically important mixed response charges (virologic and biochemical responses) with bulevirtide. Responses elevated from Week 24 to Week 48, highlighting an improved response with extended therapy. The protection profile is in keeping with prior studies.

• Introduced a brand new Joint Procurement Settlement for Veklury for taking part member states throughout the European Union and the European Financial Space.

• Acquired a constructive opinion from EMA’s CHMP for Veklury to be granted full advertising authorization for the therapy of COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen and adults who don’t require supplemental oxygen and are at elevated danger of growing extreme COVID-19.

Oncology

• Introduced outcomes from the first evaluation of the Section Three TROPiCS-02 research of Trodelvy versus physicians’ selection of chemotherapy (“TPC”) in closely pre-treated sufferers with HR+/HER2- metastatic breast most cancers on the American Society of Medical Oncology (“ASCO”) Annual Assembly.

• Introduced remaining knowledge from the Section Three ASCENT trial of Trodelvy in second-line and later metastatic TNBC at ASCO, reinforcing Trodelvy’s survival profit over TPC on this affected person inhabitants.

• Acquired up to date NCCN suggestions for sacituzumab govitecan-hziy to a class 1 most well-liked advice in second-line and later metastatic TNBC and was added as a class 2A most well-liked advice within the investigational indication of HR+/HER2- superior breast most cancers by the NCCN Tips® for Breast Most cancers. Class 1 is the very best advice by NCCN, indicating that primarily based upon high-level proof, there’s uniform NCCN consensus that the intervention is acceptable. The usage of Trodelvy in sufferers with HR+/HER2- breast most cancers is investigational, and Trodelvy has not been authorised by FDA for this use.

• Highlighted Yescarta and Tecartus knowledge at ASCO that included findings from a subanalysis of ZUMA-7, real-world outcomes and long-term follow-ups. Actual-world knowledge for Yescarta confirmed constant survival and security knowledge no matter race and ethnicity, and in a ZUMA-7 subanalysis, demonstrated an over eight-fold better median event-free survival and clinically significant enhancements in high quality of life as in comparison with normal of care. For Tecartus, long-term knowledge instructed sturdy responses have been induced in sufferers with R/R MCL and in grownup sufferers with R/R ALL.

• Introduced approval of Yescarta by the European Fee for the therapy of R/R FL.

• Acquired a constructive opinion from EMA’s CHMP for Tecartus for the therapy of grownup sufferers 26 years of age and above with R/R B-cell precursor ALL.

• Introduced FDA lifted the remaining partial scientific maintain on research evaluating magrolimab as a possible therapy for lymphoma and a number of myeloma.

• Entered right into a strategic analysis collaboration with Dragonfly to advance a lot of novel pure killer (“NK”) cell engager-based immunotherapies for oncology and irritation indications. Beneath the settlement, Gilead will obtain an unique worldwide license to investigational DF7001 and have choices to license a number of extra NK cell engager packages.

Company

• Introduced that the corporate’s Board of Administrators declared a quarterly dividend of $0.73 per share of frequent inventory for the third quarter of 2022. The dividend is payable on September 29, 2022, to stockholders of document on the shut of enterprise on September 15, 2022. Future dividends can be topic to Board approval.

• Appointed Stacey Ma, PhD as Government Vice President, Pharmaceutical Growth and Manufacturing efficient July 2022.

• Appointed Deborah Telman as Government Vice President, Company Affairs and Normal Counsel efficient August 2022.

• Introduced an $85 million contribution to the Gilead Basis.

Sure quantities and percentages on this press launch could not sum or recalculate because of rounding.

Convention Name

At 1:30 p.m. Pacific Time as we speak, Gilead will host a convention name to debate Gilead’s outcomes. A dwell webcast can be accessible on http://buyers.gilead.com and can be archived on www.gilead.com for one 12 months.

Non-GAAP Monetary Data

The knowledge introduced on this doc has been ready in accordance with U.S. typically accepted accounting rules (“GAAP”), except in any other case famous as non-GAAP. Administration believes non-GAAP data is helpful for buyers, when thought of along with Gilead’s GAAP monetary data, as a result of administration makes use of such data internally for its working, budgeting and monetary planning functions. Non-GAAP data will not be ready below a complete set of accounting guidelines and may solely be used to complement an understanding of Gilead’s working outcomes as reported below GAAP. Non-GAAP monetary data typically excludes acquisition-related bills together with amortization of acquired intangible property and stock step-up prices, and different gadgets which might be thought of uncommon or not consultant of underlying tendencies of Gilead’s enterprise, honest worth changes of fairness securities and discrete and associated tax prices or advantages related to modifications in tax associated legal guidelines and tips. Though Gilead constantly excludes the amortization of acquired intangible property from the non-GAAP monetary data, administration believes that it will be significant for buyers to know that such intangible property have been recorded as a part of acquisitions and contribute to ongoing income technology. Non-GAAP measures could also be outlined and calculated otherwise by different corporations in the identical business. Reconciliations of the non-GAAP monetary measures to probably the most instantly comparable GAAP monetary measures are offered within the accompanying tables.

Starting within the first quarter of 2022, in keeping with current business communications from the U.S. Securities and Change Fee (“SEC”), Gilead not excludes the preliminary prices of acquired IPR&D tasks from its non-GAAP monetary measures. Prior interval non-GAAP monetary measures are revised to evolve to the brand new presentation.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical firm that has pursued and achieved breakthroughs in drugs for greater than three a long time, with the aim of making a more healthy world for all individuals. The corporate is dedicated to advancing revolutionary medicines to forestall and deal with life-threatening illnesses, together with HIV, viral hepatitis and most cancers. Gilead operates in additional than 35 international locations worldwide, with headquarters in Foster Metropolis, California.

Ahead-Wanting Statements

Statements included on this press launch that aren’t historic in nature are forward-looking statements inside the which means of the Personal Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are topic to sure dangers and uncertainties that might trigger precise outcomes to vary materially. These dangers and uncertainties embrace these referring to: the influence of the COVID-19 pandemic on Gilead’s enterprise, monetary situation and outcomes of operations; the event, manufacturing and distribution of Veklury as a therapy for COVID-19, together with the uncertainty of the quantity and timing of future Veklury gross sales and Gilead’s skill to successfully handle the worldwide provide and distribution of Veklury; Gilead’s skill to attain its anticipated full 12 months 2022 monetary outcomes, together with on account of potential opposed income impacts from COVID-19 and potential revenues from Veklury; Gilead’s skill to make progress on any of its long-term ambitions or strategic priorities specified by its company technique; Gilead’s skill to speed up or maintain revenues for its virology, oncology and different packages; Gilead’s skill to comprehend the potential advantages of acquisitions, collaborations or licensing preparations, together with the association with Dragonfly; Gilead’s skill to provoke, progress or full scientific trials inside at the moment anticipated timeframes or in any respect, the opportunity of unfavorable outcomes from ongoing and extra scientific trials, together with these involving Trodelvy, Tecartus, Yescarta and bulevirtide, and the chance that security and efficacy knowledge from scientific trials could not warrant additional improvement of Gilead’s product candidates or the product candidates of Gilead’s strategic companions; Gilead’s skill to submit new drug functions for brand spanking new product candidates or expanded indications within the at the moment anticipated timelines; Gilead’s skill to obtain regulatory approvals in a well timed method or in any respect, together with FDA approval of lenacapavir for therapy of HIV-1 an infection in closely treatment-experienced individuals with multi-drug resistant HIV-1 an infection, EC approval of lenacapavir for therapy of HIV-1 an infection, together with different antiretroviral(s), in adults with multi-drug resistant HIV-1 an infection for whom it’s in any other case not doable to assemble a suppressive anti-viral routine, EC approval of Veklury for the therapy of COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen and EC approval for Tecartus for the therapy of grownup sufferers 26 years of age and above with R/R B-cell precursor ALL, and the chance that any such approvals, if granted, could also be topic to important limitations on use; Gilead’s skill to efficiently commercialize its merchandise; the chance of potential disruptions to the manufacturing and provide chain of Gilead’s merchandise, together with the chance that Kite could also be unable to extend its manufacturing capability, well timed manufacture and ship its merchandise or produce an quantity of provide enough to fulfill demand for such merchandise; pricing and reimbursement pressures from authorities businesses and different third events, together with required rebates and different reductions; a bigger than anticipated shift in payer combine to extra extremely discounted payer segments; market share and worth erosion attributable to the introduction of generic variations of Gilead merchandise; the chance that physicians and sufferers could not see benefits of those merchandise over different therapies and should due to this fact be reluctant to prescribe the merchandise, together with Yescarta; and different dangers recognized every so often in Gilead’s studies filed with the SEC, together with annual studies on Kind 10-Okay, quarterly studies on Kind 10-Q and present studies on Kind 8-Okay. As well as, Gilead makes estimates and judgments that have an effect on the reported quantities of property, liabilities, revenues and bills and associated disclosures. Gilead bases its estimates on historic expertise and on numerous different market particular and different related assumptions that it believes to be affordable below the circumstances, the outcomes of which type the premise for making judgments in regards to the carrying values of property and liabilities that aren’t readily obvious from different sources. There could also be different elements of which Gilead will not be at the moment conscious which will have an effect on issues mentioned within the forward-looking statements and may additionally trigger precise outcomes to vary considerably from these estimates. Additional, outcomes for the quarter ended June 30, 2022 usually are not essentially indicative of working outcomes for any future durations. Gilead directs readers to its press releases, annual studies on Kind 10-Okay, quarterly studies on Kind 10-Q and different subsequent disclosure paperwork filed with the SEC. Gilead claims the safety of the Protected Harbor contained within the Personal Securities Litigation Reform Act of 1995 for forward-looking statements.

The reader is cautioned that forward-looking statements usually are not ensures of future efficiency and is cautioned to not place undue reliance on these forward-looking statements. All forward-looking statements are primarily based on data at the moment accessible to Gilead and Gilead assumes no obligation to replace or complement any such forward-looking statements apart from as required by legislation. Any forward-looking statements converse solely as of the date hereof or as of the dates indicated within the statements.

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Gilead owns or has rights to numerous emblems, copyrights and commerce names utilized in its enterprise, together with the next: 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 additionally confer with emblems, service marks and commerce names of different corporations.

For extra data on Gilead Sciences, Inc., please go to www.gilead.com or name the Gilead Public Affairs Division at 1-800-GILEAD-5 (1-800-445-3235).