Revenue Performance and Guidance - First-quarter 2024 revenues totaled 14.9billion,a2012.5 billion, driven by strong performance in non-COVID products[1][13] - Pfizer raised its 2024 Adjusted diluted EPS guidance to 2.15−2.35, while maintaining full-year revenue guidance of 58.5−61.5 billion[9][10] - The company expects 8billioninrevenuesfromComirnaty(5 billion) and Paxlovid (3billion)in2024,with9014.879 billion compared to 18.486billioninQ12023[35]−ProductrevenuesinQ12024declinedby2312.443 billion from 16.221billioninQ12023[35]−Royaltyrevenuesincreasedby29263 million in Q1 2024 compared to 204millioninQ12023[35]−Totalrevenuesfor2024were14,879 million, a 20% decrease from 2023's 18,486million[51]−GlobalBiopharmaceuticalsbusinessrevenuefor2024was14,604 million, down 20% from 2023's 18,173million[51]−PrimaryCarerevenuefor2024was7,211 million, a 38% decrease from 2023's 11,560million[51]−Eliquisrevenuefor2024was2,040 million, a 9% increase from 2023's 1,874million[51]−Prevnarfamilyrevenuefor2024was1,691 million, a 6% increase from 2023's 1,602million[51]−Comirnatyrevenuefor2024was354 million, an 88% decrease from 2023's 3,064million[51]−Vyndaqelfamilyrevenuefor2024was1,137 million, a 66% increase from 2023's 686million[51]−Oncologyrevenuefor2024was3,549 million, an 18% increase from 2023's 2,997million[51]−Ibrancerevenuefor2024was1,054 million, an 8% decrease from 2023's 1,144million[51]−TotalAlliancerevenuesfor2024were2,172 million, a 5% increase from 2023's 2,060million[51]COVID−19ProductPerformance−Comirnatyrevenuesdeclined88354 million, reflecting lower demand and the transition to commercial market sales[13] - Paxlovid revenues declined 50% operationally to 2.0billion,impactedbylowercontractualdeliveriesanddemandinkeymarkets[13]−DemandforPfizer′sCOVID−19products,includingComirnatyandPaxlovid,hasdeclinedduetothemarketbecomingmoreendemicandseasonal,leadingtoinventorywrite−offsandreducedrevenues[55]Non−COVIDProductPerformance−Vyndaqelfamilyrevenuesgrew662.5 billion in internal R&D and 100millioninbusinessdevelopmenttransactionsduringthefirstquarter[12]−PfizeranticipateseightormorepotentialblockbustersinOncologyby2030,focusingonsmallmolecules,ADCs,andbispecificantibodies[25]−PfizerandtheAmericanCancerSocietylauncheda15 million initiative to improve cancer care disparities in medically underrepresented communities[25] Cost Management and Savings - The company remains on track to deliver at least 4billioninnetcostsavingsbytheendof2024throughitscostrealignmentprogram[1][3]−Pfizertargets4 billion in net cost savings compared to the midpoint of its SI&A and R&D expense guidance provided on August 1, 2023[30] - Cost of sales decreased by 31% to 3.379billioninQ12024from4.886 billion in Q1 2023[35] Regulatory Approvals and Clinical Trials - Abrysvo demonstrated durable efficacy against RSV-associated LRTD with vaccine efficacy of ≥80% for both RSV-A and RSV-B subtypes after two seasons[21] - Beqvez eliminated bleeds in 60% of patients compared to 29% in the prophylaxis arm, with a median annualized bleeding rate (ABR) of zero after up to three years of follow-up[22] - The FDA granted full approval for Tivdak based on positive overall survival (OS) results from the Phase 3 innovaTV 301 study[22] - The European Commission granted marketing authorization for Emblaveo for treating complicated intra-abdominal infections, hospital-acquired pneumonia, and complicated urinary tract infections[22] - Prevnar 20 received EU marketing authorization for preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants and children[22] - Velsipity was granted EU marketing authorization for treating moderately to severely active ulcerative colitis in patients aged 16 and older[22] - The FDA granted Fast Track designation for vepdegestrant in treating ER+/HER2- locally advanced or metastatic breast cancer[24] Financial Metrics and Adjustments - Q1 2024 Adjusted diluted EPS favorably impacted by 0.11duetoa771 million final adjustment to the Paxlovid revenue reversal, reflecting 5.1 million treatment courses returned by the U.S. government versus the estimated 6.5 million[30] - Adjusted diluted EPS guidance for 2024 assumes diluted weighted-average shares outstanding of approximately 5.75 billion shares and no share repurchases[32] - Foreign exchange rates are expected to have an unfavorable impact of approximately 0.4billiononrevenuesandafavorableimpactof0.02 on Adjusted diluted EPS in 2024[32] - Restructuring charges and certain acquisition-related costs totaled 102millioninQ12024,comparedto9 million in Q1 2023[38] - Net interest expense increased in Q1 2024 due to 31billioninseniorunsecurednotesissuedinMay2023and8 billion in commercial paper issued in Q4 2023 for the Seagen acquisition[40] - The Seagen acquisition was completed in December 2023 for 43.4billion,leadingtolowerinvestmentbalancesanddecreasedinterestincome[40]−Q12024includeda150 million gain from the partial sale of the investment in Haleon plc and 61millionindividendincomefromViiVHealthcare[40]−EffectivetaxrateforQ12024was8.63.1 billion, with 1.9billionpaidintheU.S.[40]−AdjustedincomeforQ12024was4.674 billion, compared to 7.036billioninQ12023[46]−AdjusteddilutedEPSforQ12024was0.82, down from 1.23inQ12023[46]−Non−GAAPAdjustedOther(income)/deductions––netforQ12024was296 million, compared to (324)millioninQ12023[49]−NetinterestexpenseforQ12024was664 million, up from 143millioninQ12023[49]−Haleonequitymethod(income)/lossforQ12024was(158) million, compared to $(117) million in Q1 2023[49] Risks and Challenges - Pfizer's financial guidance is based on estimates and assumptions subject to significant uncertainties, with potential risks including unfavorable clinical trial results, regulatory delays, and market competition[54] - The company's December 2023 acquisition of Seagen is expected to face challenges in integration, revenue growth, and potential financial impacts such as increased leverage or credit rating downgrades[54] - Pfizer is exposed to risks related to manufacturing disruptions, supply chain issues, and legal or regulatory actions that could impact product availability and commercial potential[55] - The company faces uncertainties related to public health outbreaks, such as COVID-19, which could affect its business operations, financial condition, and clinical trials[55] - Pfizer is navigating challenges in pricing and reimbursement, including the impact of the Inflation Reduction Act of 2022 and government-mandated price reductions in international markets[56] - Risks related to intellectual property include potential patent disputes, challenges to patent validity, and regulatory actions that could limit the enforcement of IP rights for products like Comirnaty and Paxlovid[56] - The company is addressing climate change and ESG priorities, but uncertainties remain regarding the impact of natural disasters and the ability to achieve environmental sustainability goals[56] - Pfizer is exposed to cybersecurity risks, including potential disruptions to IT systems, data breaches, and threats from adversarial artificial intelligence techniques[56] - The company is managing risks related to tax litigation, investigations, and changes in tax laws, including the potential impact of the "Tax Relief for American Families and Workers Act of 2024"[56]
Pfizer(PFE)2024-05-01 12:11