Pfizer, Inc.

Good day, everyone, and welcome to Pfizer's first 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 Investment Relations Officer and Senior Vice President. Please go ahead, ma'am.

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 first quarter of 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, and Dave Denton, our CFO. Albert and Dave have some prepared remarks, and we will then open the call for questions. Members of our leadership team will also be available for the Q&A sessions. 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.

Thank you, Francesca. Good morning, everyone. Thank you for joining our call. We are very pleased with our performance in the first quarter as we continue to execute with focus and discipline on our strategic priorities. We are strengthening our R&D organization in our efforts to advance our pipeline and productivity. We are maximizing the value of key products in our commercial portfolio. And we are improving operating margins with our continued progress in making our company more efficient. In the current volatile external environment, the underlying strength of our business and strong relationships with government leaders across the world help us navigate with agility. While we continue to engage and plan for contingencies, we are focusing day to day on what we can do to move our business forward. I want to emphasize our continued confidence that we are well positioned to enhance shareholder value. Now I will turn to our top strategic priority in 2025, improving R&D productivity as we advance our pipeline with sharpened focus. We are intensifying our rigorous commercial assessment and portfolio prioritization from early clinical development. This means we will be disciplined in managing our portfolio, directing investment and attention to potential blockbuster or mega blockbuster, and scrutinizing the total number of assets under development. Our Daniel Glipper announcement earlier this month demonstrates our commitment to this approach. This continued the development of Daniel Glipper, one of our candidates in our business portfolio, although difficult was the right decision for the company. Going forward, We are committed to building our cardiometabolic pipeline, including obesity, by advancing internal programs such as our GIPR antagonist and pursuing external opportunities that could include partnerships or acquisitions. We will continue to be disciplined as we move through key decision points for our pipeline or our business development targets. We believe we have the potential to address significant patient needs with differentiated approaches that focus on supporting optimal weight management and related conditions. We will work on potential medicines and combination regimens that could be more accessible, better tolerated, easier to dose, and more effective in supporting the right effects on body composition and muscle mass. In addition to sharpening our focus in internal medicine, Since expanding his role in January as our chief scientific officer, Chris Bossoff has moved both thoughtfully and quickly in reshaping our R&D organization to also center on oncology, vaccines, and inflammation immunology in addition to paramedics. Chris has enhanced his leadership team with some terrific additions who are recognized as leaders in their field. Patricia Cavazzoni is our new chief medical officer. Jeff Legos is our new chief oncology officer. And Jim List is our new chief internal medicine officer. These leaders each bring many years of experience, deep expertise, and proven track record in guiding the discovery, development, and approval of practice-changing therapies. And they are an excellent addition to our already strong cast of leaders in R&D. We are on track for a strong year of anticipated pipeline catalyst in 2025. We are making progress towards anticipated multiple key milestones, including at least four regulatory decisions, up to nine phase three readouts, and significant series of pivotal program starts. With one of our key oncology programs, we are aimed to bring forward what could represent the first potential treatment advancement in more than 30 years for patients with BCG-naive, high-risk, non-muscle-invasive bladder cancer. We are encouraged by a positive readout of the Pivotal Phase III CREST trial of Sasalnima in combination with BCG, a current standard of care. We presented the full data from this study this past weekend at the annual meeting of the American Urological Association. Non-muscle invasive bladder cancer is a condition predominantly treated by urologists in multiple market research and focus group studies. Urologists stated a significant preference for a subcutaneous PD-L1 because it can be used in their practices and eliminates the need to refer their patients to infusion centers. We also anticipate meaningful redoubts this year for Patsy and Elrexfil. Patsy already is a core therapy in our oncology portfolios. PATSF plus pembrolizumab is the most prescribed first-line treatment for locally advanced metastatic urothelial cancer in the U.S. We are working toward more than doubling the total addressable patient population in the U.S. for PATSF with potentially registrational interim data we expect this year from ongoing pivotal studies in muscle-invasive bladder cancer. We are also working to reach a significantly expanded population of patients with multiple myeloma. We are anticipating a phased readout this year for Rexfuel in a study for double-class exposed relapsed refractory multiple myeloma. If successful and approved, this would more than double the addressable population versus the currently approved indications. In addition to the increased addressable population, moving to earlier lines of therapy is expected to increase the duration of treatment and potentially create an inflection point in erectious growth. We expect to begin pivotal studies for our investigation of PD-L1 vedotin AEDC later this year. This will be for first-line metastatic head and neck squamous cell carcinoma and second-line non-small cell lung cancer. We also anticipate a first-line pivotal study start for SV, sigvotata vedotin. This is a novel integrin beta-6 targeting vedotin ADC that, if successful and approved, has the opportunity to change the standard of care globally for IBC-expressing tumors. Both these ADCs, PD-L1V and SV, are potential first-in-class ADCs using a vedodine payload that elicits immunogenic cell death and, in combination with an immune checkpoint inhibitor, demonstrates significant results. Early data for PD-L1V and SV in combination with pembrolizumab are highly encouraged. With both ADCs, we are targeting non-small cell lung cancer, the most frequently diagnosed cancer globally, and the leading cause of cancer-related deaths. Lung cancer represents a substantial area of patient need and a growing market with the highest projected CAGR in oncology through 2030. In vaccines, another of our priority therapeutic areas, we see opportunities to enhance and augment our strong positions in the market. We are also planning a potential registrational study in adults later this year with our fourth generation PCV candidate. With our fourth and fifth generation PCV candidates, we believe we can build on our leadership in the industry. Our fourth generation candidate covers 25 serotypes, including potentially improved immunogenicity for serotype 3, which is one of the largest remaining contributors of disease. We are also working to accelerate progress with our fifth generation candidate, which is in preclinical development and covers over 30 serotypes. As we continue to scrutinize the number of programs who are actively advancing, we will have opportunities to accelerate or add others to help address significant patient needs. One example is the recent accelerated start of a pivotal study for nurting, for menstrually related migraine, which is estimated to impact more than half of women who experience migraine. We look forward to providing future updates about our pipeline progress as we continue to sharpen our focus on our most meaningful programs in prioritized therapeutic areas. Commercial excellence in our key categories is another 2025 strategic priority. More than a year ago, we decided to separate the US and international operations. Under the leadership of Amir Malik, our chief US commercial officer, and Alexandre Desermet, our chief international commercial officer, we refined our commercial model to bring heightened focus, helping us strategically prioritize our most impactful products and regions. It is working well. In the U.S., our team demonstrated focus, the strength of our key products, and continuous improvement in execution. In international, we are back to operational growth. in the first quarter across all parts of the division. This was the result of prioritization and discipline focus on key growth drivers to maximize return and accelerate new product penetration there. Our performance was strong both in the U.S. and international markets across several key products, including the Vintakel family, Nurtek, Patzef, and Lorbren. Our Vintakel family of products had robust growth in the quarter though we are seeing the impact of competition with a new market entrant, and we anticipate this will continue through the year. We will work towards maintaining our market-leading position that has come from six years of establishing credibility expertise with the cardiology community. Our team remains committed to addressing high unmet patient need by helping to improve diagnosis and ensuring appropriate patients with ATTR cardiomyopathy receive treatment. Demand continues to strengthen for Nurfang, with revenue growing 40% operationally in the quarter. Our commercial teams effectively engage with healthcare professionals, And we were pleased with strong outperformance of our newly launched consumer campaigns. We are pleased with the continued strength also of our oncology portfolio. Paxif, for example, grew 25% operationally driven by increased market share in first-line metastatic urothelial cancer. Well, Brennan grew 39% operationally. as we continue to see strong adoption with its emerging as a potential first-line standard of care for patients with all positive metastatic non-small cell lung cancer. INI is another key commercial category for Pfizer, and we are drawing on our extensive experience in launching medicines in this therapeutic area. Familiarity among healthcare professionals continue to improve for Sibingo, which grew 42 operational in the quarter. Our commercial team is continuing to work towards increased patient access for this JAK inhibitor for patients age 12 and up with moderate to severe atopic dermatitis. With Litfulo, we are encouraged by the growth we have seen today. We will seek to further unlock access to this advanced systemic treatment for patients with severe alopecia areata. This highlights how we are positioned to further expand and sustain our performance trajectory among our key brands. And with that, now I will turn it to Dave to speak about the other two strategic priorities.