2/3/2026

speaker
Operator

Good day, everyone, and welcome to Pfizer's fourth quarter 2025 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DiMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.

speaker
Francesca DiMartino
Chief Investor Relations Officer and Senior Vice President

Good morning, and welcome to Pfizer's earnings call. I'm Francesca DiMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at Pfizer.com. Earlier this morning, we released our results for the fourth quarter and full year 2025 via a press release that is available on our website at Pfizer.com. I'm joined today by Dr. Albert Bourla, our chairman and CEO, Dr. Chris Boshoff, our scientific officer, chief scientific officer, and Dave Denton, our CFO. Albert, Chris, and Dave have some prepared remarks, and we will then open the call for questions. Members of our leadership team will be available for the Q&A session. Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR website on Pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements. With that, I will turn the call over to Albert.

speaker
Dr. Albert Bourla
Chairman and Chief Executive Officer

Thank you, Francesca. So, 2025 was a very good year for Pfizer. I'm very pleased with strong execution to deliver and, frankly, over-deliver on our financial commitments. We exceeded expectations for revenues and adjusted diluted EPS, while also returning $9.8 billion to shareholders via quarterly dividend. We grew overall operational revenue for full year 2025 when excluding COVID-19 products, achieved solid double-digit growth in recently launched and acquired products, and expanded adjusted gross margins. Strategic actions in 2025 helped us resolve significant uncertainty, including achieving greater clarity on pricing and tariffs, and demonstrating the underlying resilience of our business to deliver EPS despite the lowest ever COVID-19 season. We achieved four key approvals, eight critical readouts, and initiated 11 pivotal studies. And our Metzera, Yaufarm, and 3S Bio deals help strengthen our robust pipeline. Overall, 2025 reinforced how well Pfizer can execute. We strengthened a foundation positioning us for growth towards the end of the decade, continued impact for patient and long-term shareholder value. We have once again defined strategic priorities for the year ahead, which we presented at J.P. Morgan. 2026 is an important year in a pivotal investment period as we strive for industry-leading growth after several key products lose patent or regulatory exclusivity in the next few years. Cigen, Metcera, and Bioheaven are the most significant strategic acquisitions in recent years. They have transformative potential for Pfizer, and we are focused on maximizing the value of in-line product portfolios and accelerating pipeline development. We made continued progress last year, integrating legacy seeds and products into our commercial portfolio. I'm also pleased with notable advances in our development programs, including recent FDA approval for PADSEV in combination with PEMBRO for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. We are encouraged by the opportunity to build on this with an expected regulatory decision for patients with cis Latin eligible MIBC. If successful, we will substantially expand the US addressable population with up to approximately 22,500 additional patients across both cis eligible and cis ineligible. muscle invasive bladder cancer, up from about 19,000 patients in metastatic urothelial cancer. We have a clear strategy aiming for Pfizer leadership in the next generation of therapies for chronic weight management with a highly differentiated Metcera pipeline portfolio, our Yao Pharma exclusive global collaboration and licensing agreement, and other Pfizer programs such as our oral GIPR antagonist candidate. Since closing our BioHeaven acquisition a few years ago, we have globally scaled a leading migraine portfolio. It strengthened our product mix to drive significant impact both for patients and our commercial performance. Nurtek has a strong market leadership position in the oral CGRP class in 2025. In Q4, we captured 83% of new CGRP writer volume, and remain the leader in new patient starts. I expect 2026 to be also a very rich year for key catalysts and to intend to deliver on our critical R&D milestones. This year we anticipate progress with approximately 20 recently initiated and planned key pivotal studies with 10 of them in the Metcera portfolio and four with our anti-PD-1 VGF, by specific. Among eight expected key readouts, we anticipate one for SV, our novel potential first-in-class, integrating beta-6 targeting the dot in ADC. The readout will be in second line plus non-squamous metastatic, non-small cell lung cancer, which affects about 50,000 patients in the U.S. and more than 200,000 patients globally. We are also expecting key phase three readouts for L-rexfio in double-class exposed relapse refractory multiple myeloma and for our Lyme disease vaccine candidate. The foundation of our strategy in obesity and adjacent condition is targeting breakthrough medicines in what could be 150 billion mark. Earlier today, we announced encouraging results from our VESPR-3 study, which previously was known as Metera-097i, the ultra-long-acting, investigational, next-generation injectable GLP-1 receptor agonist. In a few moments, Chris Bossoff, our chief scientific officer, will walk through additional details and our plans for advancing our obesity portfolio this year. Oncology is another source of strength, and I'm excited by opportunities for significant progress in 2026, that would build on our established presence in breast, in genituitary, in thoracic, and gastrointestinal cancer, and of course, blood cancer. In addition to promising programs such as the SV, our oncology team is moving quickly with a robust program for 4404, the bispecific antibody licensed last year from 3S Bio. We have seven near term plan or recently started trials for 4404, including two large global phase three studies, anchoring our efforts to establish this investigational medicine as a potential backbone therapy across multiple tumor types. We're also pleased that the FDA has granted Kimbanzi breakthrough therapy designation for investigation in younger pediatric patients aged 6 to 11 in hemophilia B, with or without inhibitor. That's an important innovative medicine today, and we are investigating the full potential of Himbavzi to support more patients living with hemophilia. Our third strategic priority is investing to maximize post-2028 growth. We are committed to fully supporting a robust and accelerated approach to R&D, the successful commercial launch of new products and bolt-on business development while maintaining our robust dividend. And finally, we are scaling artificial intelligence across R&D, manufacturing, commercial and patient engagement to improve productivity and accelerate innovation. We have been setting the foundation with AI-ready data, agentic workflows, and compute capacity. To meet the growing AI demand over the next two years, we are expanding to more than 1,200 GPUs, largely driven by R&D application of AI. In R&D, we are embedding AI across discovery, development, regulatory, and medical to increase productivity and accelerate the pipeline and timelines. AI is optimizing supply planning and manufacturing, contributing to our manufacturing optimization program goals. In commercial, AI is helping to accelerate new product launches, delivering insights for dynamic targeting and supporting personalized messaging and real-time marketing content. So with that, and after I describe the four priorities, which describe the full picture of what we plan to do in 2026, I will turn it over to Chris to discuss for the news of the day, which are the Metera long-acting announcement of VESPR3.

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