Full Year 2022 Product Gross Margin, Working Bills and Tax

• Product gross margin was 79.0% for the total 12 months 2022 in comparison with 75.6% in 2021. Non-GAAP product gross margin was 86.6% for the total 12 months 2022 in comparison with 83.2% in 2021. Increased product gross margin is primarily pushed by a cost associated to a authorized settlement within the fourth quarter 2021 that didn’t repeat, barely offset by different year-over-year modifications.
• R&D bills for the total 12 months 2022 have been $5.0 billion in comparison with $4.6 billion⁽¹⁾ in 2021. Non-GAAP R&D bills for the total 12 months 2022 have been $5.0 billion in comparison with $4.5 billion⁽¹⁾ in 2021. Increased R&D bills primarily mirror elevated medical actions, primarily in Oncology, in addition to inflationary will increase.
• Acquired IPR&D bills for the total 12 months 2022 have been $944 million in comparison with $939 million⁽¹⁾ in the identical interval in 2021.
• SG&A bills for the total 12 months 2022 have been $5.7 billion in comparison with $5.2 billion in 2021. Non-GAAP SG&A bills for full 12 months 2022 have been $5.6 billion in comparison with $5.0 billion in 2021. SG&A bills elevated primarily as a result of cost of $406 million related to the termination of the Trodelvy collaboration with Everest, elevated promotional and advertising and marketing funding, largely in Trodelvy and Cell Remedy, in addition to increased company actions and inflationary will increase. GAAP SG&A bills have been barely offset by a lower in donations to the Gilead Basis in 2022 as in comparison with prior 12 months.
• The ETR and non-GAAP ETR for the total 12 months 2022 have been 21.5% and 19.3%, respectively, in comparison with 25.1% and 20.4%, respectively, in 2021. Decrease ETR is primarily as a result of a useful change in jurisdictional mixture of revenue and decrease state taxes in 2022.

Steering and Outlook

Gilead is offering full-year 2023 steering beneath:

• Complete product gross sales between $26.0 billion and $26.5 billion.
• Complete product gross sales, excluding Veklury, between $24.0 billion and $24.5 billion.
• Complete Veklury gross sales of roughly $2.0 billion are anticipated to be extremely variable, relying on the frequency and severity of surges, and our steering will proceed to be up to date on a quarterly foundation as needed.
• Earnings per share between $5.30 and $5.70.
• Non-GAAP earnings per share between $6.60 and $7.00.

A reconciliation between GAAP and non-GAAP monetary info for the 2023 steering is offered within the accompanying tables. Additionally see the Ahead-Trying Statements described beneath. The monetary steering is topic to plenty of dangers and uncertainties, together with uncertainty across the period and magnitude of the COVID-19 pandemic.

Key Updates Since Our Final Quarterly Launch

Virology

• Introduced FDA approval of Sunlenca (lenacapavir), together with different antiretroviral(s), for the therapy of HIV-1 an infection in closely treatment-experienced adults with multi-drug resistant HIV-1 an infection.
• Introduced the European Fee (“EC”) licensed an prolonged indication and line extension for a low-dosage pill type of Biktarvy (bictegravir 30mg/FTC 120mg/TAF 15mg) for the therapy of HIV in virologically suppressed kids who’re not less than 2 years of age and weigh not less than 14 kg.
• Introduced FDA approval of Vemlidy for the therapy of power HBV an infection in pediatric sufferers 12 years and older with compensated liver illness.

Oncology

• Introduced that the European Medicines Company has validated a Kind II variation of the Advertising and marketing Authorization Utility for Trodelvy for the therapy of grownup sufferers with pre-treated HR+/HER2- metastatic breast most cancers (“mBC”).
• Introduced post-hoc evaluation from the Part 3 TROPiCS-02 research of Trodelvy in HR+/HER2- mBC on the 2022 San Antonio Breast Most cancers Symposium. Within the evaluation Trodelvy demonstrated constant efficacy throughout Trop-2 expression ranges in sufferers with pre-treated HR+/HER2- mBC with enchancment throughout progression-free survival (“PFS”), total survival and goal response charge as in comparison with customary chemotherapy. The protection profile for Trodelvy was in step with prior research, with no new security indicators recognized on this inhabitants.
• Introduced the switch of the Advertising and marketing Authorization for Yescarta in Japan from Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) to Gilead Okay.Okay. in 2023.
• Obtained approval from the Ministry of Well being, Labour and Welfare in Japan for Yescarta for the preliminary therapy of R/R LBCL.
• Entered right into a strategic collaboration between Kite, a Gilead firm, and Arcellx, Inc. (“Arcellx”) to co-develop and co-commercialize CART-ddBMCA, a late-stage medical asset in improvement for the therapy of a number of myeloma.
• Entered into an settlement to amass Tmunity Therapeutics Inc. (“Tmunity”), a medical stage personal biotech firm, which can present Kite with preclinical and medical applications, together with an “armored” CAR T expertise platform that has the potential to be utilized to a wide range of CAR Ts to reinforce anti-tumor exercise, in addition to fast manufacturing processes. The transaction is anticipated to shut within the first quarter of 2023.
• Introduced long-term information and real-world evaluation of Yescarta and Tecartus on the American Society of Hematology 2022 assembly. Results confirmed that in a real-world evaluation, shorter vein-to-vein occasions have been related to improved outcomes for sufferers handled with Yescarta for R/R LBCL. Moreover, in a three-year follow-up evaluation of ZUMA-5 in R/R indolent non-Hodgkin lymphoma confirmed continued response in 52% of sufferers and extended period of PFS. Three follow-up analyses have been introduced on Tecartus, together with a two-year follow-up of ZUMA-3 in comparison with SCHOLAR-3 in R/R B-cell acute lymphoblastic leukemia and up to date three-year outcomes from ZUMA-2 research in R/R mantle cell lymphoma.
• Introduced optimistic information, alongside Arcus, from the fourth interim evaluation of the Part 2 ARC-7 research on the American Society of Medical Oncology Month-to-month Plenary Session. The research is evaluating the combos of domvanalimab plus zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant (triplet), versus zimberelimab monotherapy in sufferers with first-line, metastatic PD-L1-high NSCLC. Within the research, each the doublet and triplet combos demonstrated clinically significant enhancements in median PFS in comparison with zimberelimab monotherapy, with a forty five% discount in threat of illness development or demise for the doublet and 35% for the triplet.
• Acquired the remaining rights to GS-1811, an anti-CCR8 antibody, developed by Jounce for the therapy of stable tumors.

Irritation

• Introduced a collaboration and licensing settlement with EVOQ Therapeutics, Inc. (“EVOQ”) to advance EVOQ’s proprietary NanoDisc expertise for the therapy of rheumatoid arthritis and lupus.

Company

• Acknowledged as one of the sustainable pharmaceutical firms in accordance with the Dow Jones Sustainability World Index, reflecting Gilead’s ongoing dedication to company accountability.
• Introduced the U.S. Supreme Courtroom denied Juno Therapeutics, Inc.’s enchantment within the Juno v. Kite case, successfully ending this patent dispute.

Sure quantities and percentages on this press launch might not sum or recalculate as a result of rounding.

Convention Name

At 1:30 p.m. Pacific Time at the moment, Gilead will host a convention name to debate Gilead’s outcomes. A stay webcast will likely be accessible on http://traders.gilead.com and will likely be archived on www.gilead.com for one 12 months.

Non-GAAP Financial Data

The knowledge introduced on this doc has been ready in accordance with U.S. typically accepted accounting rules (“GAAP”), until in any other case famous as non-GAAP. Administration believes non-GAAP info is helpful for traders, when thought-about at the side of Gilead’s GAAP monetary info, as a result of administration makes use of such info internally for its working, budgeting and monetary planning functions. Non-GAAP info isn’t ready beneath a complete set of accounting guidelines and will solely be used to complement an understanding of Gilead’s working outcomes as reported beneath GAAP. Non-GAAP monetary info typically excludes acquisition-related bills together with amortization of acquired intangible belongings and stock step-up expenses, and different objects which can be thought-about uncommon or not consultant of underlying traits of Gilead’s enterprise, truthful worth changes of fairness securities and discrete and associated tax expenses or advantages related to modifications in tax associated legal guidelines and pointers. Though Gilead constantly excludes the amortization of acquired intangible belongings from the non-GAAP monetary info, administration believes that it’s important for traders to grasp that such intangible belongings 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 firms in the identical trade. Reconciliations of the non-GAAP monetary measures to essentially the most instantly comparable GAAP monetary measures are offered within the accompanying tables.