Pfizer, Inc.

Good day, everyone, and welcome to Pfizer's third 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.

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 third 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 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.

Thank you, Francesca. Good morning, everyone, and thank you for joining our call. The past few months have been pivotal for Pfizer. We are really excited about our future and confident that we are in a strong position to continue delivering value for patients and our shareholders. Our third quarter performance shows how we continued to execute with discipline and focus, even while taking on major strategic efforts. I will discuss highlights, including our agreement with the U.S. government, which has provided greater clarity of our strategic investment in future innovation and growth. Additionally, with our proposed acquisition of Metcera and the progress we have made since closing our licensing agreement with 3S Bio and key upcoming catalysts, the strength of our R&D pipeline continues to grow. Our landmark agreement with the U.S. government was an important milestone because it removed uncertainty on two critical policy fronts. We successfully addressed the administration's call to lower prescription drug costs and align prices with those in other developed countries. And we will have a three-year grace period from certain U.S. tariffs with our commitment to further invest in manufacturing in the U.S. Now, I want to address our proposed acquisition of Metzera. We believe that Novo Nordisk offer is illusory. and cannot constitute a superior proposal under the terms of our merger agreement with Metzera, because it violates antitrust law and there is a high risk it will never be consummated. We are encouraged by the US Federal Trade Commission's decision to grant early termination of the HSR waiting period, which is unprecedented during a government shutdown, and clears the path to completing this transaction following the Metzeler-Sarholder vote on November 13th. With a pending legal action we have taken to enforce and preserve Pfizer's rights under the merger agreement, you understand that we will be limited in the details we can address further during today's call. What I can say is that our belief in the promise of the Pfizer and Metzera combination is strong and unwavering. We are confident it will create substantial value for shareholders and advance innovation to bring important medicines to patients in the high-growth therapeutic area of obesity. Plus, we believe Pfizer will have distinct advantages in developing and delivering new potential treatments because of our proven scientific and commercial strengths. Our R&D infrastructure has global reach and extensive experience running clinical trials in large populations. Our commercial teams have well-established capabilities in bringing primary care therapies to patients. We have proven we can drive leading clinical, commercial, and strategic momentum with key cardiovascular brands such as Eliquis, Lipitor, Norvasc, and the Vintaker family, and we plan to execute in a similar way with Metzera as we reinvigorate Pfizer's cardiometabolic presence. The licensing agreement with 3S Bio is another way we have strategically enhanced our pipelines. Encouraging phase 2 first-line metastatic colorectal cancer efficacy and safety data for SSGJ707, the PD-1 VGF by specific, was shared last month at the European Society for Medical Oncology meeting. Looking ahead, we are excited to present additional clinical data at the upcoming Society for Immunotherapy of Cancer meeting. We are also encouraged by our discussions with regulators about our plans to unlock the potential of 707 with a robust clinical development program. As we look forward to executing with 707, Pfizer has distinct advantages. We have deep experience in the development of multi-specific antibody therapeutics and the ability to leverage unique combination regimens that make this promising cancer immunotherapy candidate a strong complement to our oncology portfolio. We've also made progress in advancing other key programs in our late-stage R&D pipeline. This was reinforced by our presence at ESMO last month with over 45 abstracts, five late-breaking presentations, and recognition in presidential symposium. Starting with a presidential symposium, new phase 3 data demonstrated that PADSE, in combination with Pembrolizumab, reduced the risk of recurrence and death by at least half for patients with cis-Latin ineligible muscle invasive cancer when given before and after surgery. This is the first and only regimen to improve survival when used before and after standard of care in this patient population. With this unprecedented data in hand, we see the potential to substantially increase the US addressable population with approximately 18,000 patients under the current label in metastatic urothelial cancer. And if there are further positive data, it's approved up to approximately 22,500 additional patients across both cis-eligible and cis-ineligible muscle-invasive bladder cancers. We also presented follow-up results from the PHAROS single-arm phase 2 clinical trial supporting BRAFTOVI and MECTOVI as a standard of care for patients with metastatic non-small cell lung cancer harboring a BRAF V600E mutation. This updated analysis showed a substantial median overall survival benefit of 47.6 months in treatment naive patients with metastatic non-small cell lung cancer with a BRAF V600 e-mutation. We are pleased with the continuous strong year-over-year growth of BRAFTOVI and MECTOVI with a 30 percentage points increase in new patient starts since the October 23 launch. We believe the results from the FAROS trial could establish a new benchmark with targeted combination therapies for its population of patients. These results fortify the strength of our growing lung cancer portfolio, but includes small molecules, ADCs, and our 707 bispecific. We are confident in our potential to deliver treatments across the lung cancer spectrum, a large and growing market expected to reach approximately 70 billion by year 2030. We also presented final overall survival results from the Phase III EMBARQ trial, evaluating Xtandi in combination with Luprolide and eczemanotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. As the first and only ARI-based regimen to demonstrate overall survival benefit in this population, These results highlight the potential benefit of Xtandi in this earlier line treatment setting. This strengthens our position for the product but is experiencing strong demand growth in hormone-sensitive prostate cancer and rapid uptake in the approximate 16,000 US patient population with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. I want to mention Another update about our program in sickle cell disease. We are very pleased that last month the FDA concluded that Pfizer may resume enrollment of Ociveloto studies outside of sub-Saharan Africa and in individuals who have not relocated from sub-Saharan Africa. We are still engaging with regulatory authorities to determine possible next steps for Oxbride. We look forward to sharing more details in the months ahead about our key pipeline catalysts for 2026 in the coming years. With disciplined execution and our continued focus on key products, both in the US and key international markets, we continue to build on our leadership position within our commercial portfolio. Our vertical family of products achieved 7% year-over-year global operational growth in the quarter, Strong demand reinforced that this is the foundation of treatment for patients with a heart condition of ATTR cardiomyopathy, helping them live longer and avoid hospitalization. We are encouraged by our continuous strong market leadership In international, we achieved 40% growth in the quarter in total patients on treatment. In the U.S., our continued double-digit demand growth reflects strong diagnostic efforts, broad access, and favorable affordability dynamics. Nurtek continues to lead the oral CGRP class in primary care penetration in the U.S. In international, we achieved growth with continuous strong uptake in key markets. Globally, we achieved 22% year-over-year operational growth in the quarter. We are pleased that our new consumer campaigns continue to perform well, and our team has been effective in sharing new compelling clinical data with healthcare professionals. Patsy, another market leader in our portfolio, achieved 13% year-over-year global operational growth in the quarter. PADSEV, in combination with PEMBRO, continues to expand utilization and has been established as a standard of care first-line treatment for patients with locally advanced metastatic urothelial cancer. Our vaccine portfolio is a key area of focus in international markets. We are pleased with the strong performance of the Prevram family, driven by CERN gains and launches in several key markets. We achieved 17% year-over-year international operational growth in the quarter. Pfizer is the pediatric pneumococcal vaccination leader, with public funding secured in about 140 national immunization programs around the world. After launching in the majority of key international markets, Prevner Adult is the established leader among adult pneumococcal conjugate vaccines. In the U.S., where we did experience a year-over-year decline in the quarter, we are pleased with the overall performance of Prevenor to end. For adults, Prevenor held a market-leading position and grew with the expanded recommendation for adults over 50. In the pediatric market, accounting for about 60% of Prevenor revenues in the U.S., we experienced a delayed timing of government bulk order, which we have seen from time to time. So it's a question of time. I want to provide an update about the next generation PCV programs. While we previously guided with phase three start of our adult 25 program in 2025, we are planning to start the study next year if the FDA aligns with our approach. For our pediatric program, we expect fourth-dose data from our ongoing Phase 1-2 study early next year, and pending positive data and regulatory feedback, we have the potential to start both Phase 3 programs in 2026, streamlining our development approach and aligning with our strategy to provide a single vaccine across age groups. We are committed to maintaining leadership in the PCV space. And as a reminder, our 25-valent vaccine candidate has the potential for improved immunogenicity for serotype 3, which is one of the largest remaining contributors of pneumococcal disease. Serotype 3 alone is estimated to cause approximately 20% of invasive disease in the 65-plus population in the US and EU. Abrisvo also achieved significant international momentum with 75% year-over-year operational growth in the quarter due to expanded access in key markets. In the U.S., we are experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV. Still, we are continuing to strengthen our position with a 59% market share in the U.S. in SIP dose volume in this quarter. From the significant strategic milestones we have achieved in recent months to our solid financial performance during this quarter, we are demonstrating how we are building for long-term value with near-term execution of our 2025 strategic priorities. By committing to focus simplification and leveraging technology across our business, we are accelerating progress and improving productivity. In the quarter, we achieved another strong gross margin performance. Additionally, we were able to deliver adjusted diluted EPS that was ahead of expectations significantly, even with lower infection rates contributing to a revenue decline in our COVID-19 portfolio. Our business is performing well. and we are raising the range of our adjusted diluted EPS guidance for full year 2025, while also remaining committed to our dividend. And with that, I'll turn it over to Dave.

Thank you, Albert, and good morning, everyone. To begin this morning, I'd like to highlight that our solid financial performance directly reflects our continued disciplined execution of our key strategic priorities. We continue to prioritize enhanced patient outcomes as well as the achievement of our financial objectives. Furthermore, our recent agreement with the U.S. government demonstrates our ability to navigate in a complex external environment. Our cost improvement measures have driven greater operational efficiency and streamlined decision-making, which is evident in the solid operating margins for this quarter. Year-to-date margins expanded despite the unfavorable impact of the acquired in-process R&D from the 3S BIO transaction. Going forward, we expect to improve our cash flow and increase flexibility across our three capital allocation pillars. Our focus remains on creating long-term shareholder value. We will continue to invest in our business for the long term, evidenced by our recent business development activity, while prudently returning capital to our shareholders. Now with that, let me start with our third quarter results. Then I'll touch on our cost improvement initiatives as well as our capital allocation priorities. I'll finish with a few comments on our 2025 guidance, which continues to improve as we move throughout this year. For the third quarter of 2025, we recorded revenues of $16.7 billion, a decrease of 7% operationally versus the same period of last year. That's largely driven by a decline in our COVID products. The decline was primarily due to Paxlovid, which experienced reduced demand from lower levels of disease incidence, as well as last year's one-time Paxlovid government stockpiling recorded in Q3 of 24, and to a lesser extent, Comirnaty. With that said, our non-COVID product's performance was solid, growing 4% operationally versus the same period of LY. On the bottom line, third quarter 2025 reported diluted earnings per share was $0.62, and adjusted diluted earnings per share was $0.87, ahead of our expectations due to our overall gross margin and cost management performance. I'll point out that this profit performance includes a headwind of approximately $0.20 of acquired in-process R&D from the 3S BIO transactions. Our results demonstrate the effectiveness of a refined commercial strategy. We remain committed to prioritizing key products and markets, optimizing the global allocation of our commercial field resources, and concentrating our market efforts on high-priority areas. We saw solid contributions across our product portfolios, primarily driven by Eloquus, the Vindickel family, and Nertec, but it was more than offset by declines in Paxlovid and Comirnaty. Through the first nine months of 25, Pfizer's recently launched and acquired products delivered $7.3 billion in revenue while growing approximately 9% operationally versus last year. This lower growth rate in the third quarter as compared to Q2 was primarily driven by the timing of pediatric CDC shipments of Prevnar and a one-time favorable impact in Q2 for Cigen products transitioning to a wholesale distribution model in the U.S., We plan to continue to invest behind these two product groups to drive your future performance and help enable the company to largely offset our LOEs over the next several years. Adjusted gross margin for the third quarter was approximately 76%, primarily reflecting the product mix in the quarter and continued strong cost management within our manufacturing footprint. As a reminder, over the past two years, our adjusted gross margins have generally remained in the mid to upper 70s, excluding Comirvy, which has a 50-50 profit split with our partner BioNTech. We expect $1.5 billion in savings from phase one of the manufacturing optimization program by the end of 27 to support our long-term operating margin expansion goal. Going forward, cost management across our manufacturing network remains a top priority. Total adjusted operating expense were $7 billion for the third quarter of 25, an increase of 21% operationally versus LY, driven in large part by the acquired in-process R&D expense for 3S Bio. Excluding the 3S Bio deal, adjusted operating expense is contracted by approximately $150 million versus last year. And looking at the components, adjusted SINA expenses decreased 3% operationally, primarily driven by focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products. Adjusted R&D expense decreased 3% operationally as well, driven by a net decrease in spending due to pipeline focus and optimization, including the expansion of our digital capabilities. And finally, acquired in-process R&D expenses increased $1.4 billion, largely resulting from the 3S Bio deal. As our adjusted S&A and R&D expenses demonstrate, we continue to be disciplined with our operational expense management. Q3 reported diluted earnings per share was 87 cents, which benefited from our efficient operating structure. Additionally, EPS was aided by our effective tax rate, primarily driven by favorable changes in jurisdictional mix of earnings and tax benefits related to global income tax resolutions in multiple jurisdictions spanning multiple years, partially offset by the aforementioned 3S Bio acquired in-process R&D charge. We continue to be disciplined with expense management, progressing multiple cost improvement programs as we remain focused on driving operating margin expansion over the coming years. Phase one of the manufacturing optimization program contributed savings in the third quarter. In addition, we remain on track to deliver on our goal of at least $4.5 billion in cumulative net cost savings from our ongoing cost realignment program by the end of this year. As a reminder, in total for these programs, we expect approximately $7.7 billion in savings by the end of 27 to drive operational efficiencies, strengthening our business with the potential of contributing significantly to our bottom line over this period. Of these savings, approximately $500 million identified in R&D will be reinvested in the pipeline, which we expect by the end of 2026. With that, now let me quickly touch upon our capital allocation, which is designed to enhance long-term shareholder value. Our strategy consists of maintaining and growing our dividend over time, reinvesting in our business at the appropriate level of financial returns, and making value-enhancing share repurchases. In the first nine months of this year, we returned $7.3 billion to shareholders via our quarterly dividend, invested $7.2 billion in internal R&D, and invested approximately $1.6 billion in business development transactions, primarily reflecting the 3S Bio licensing deal. As a reminder, our business development capacity after the 3S Bio deal is approximately $13 billion. In the third quarter, we announced a planned acquisition of MetSara for approximately $4.9 billion with additional contingent value rights tied to successful pipeline progression. The transaction is expected to be funded through a mix of available cash as well as debt. We expect the deal to be dilutive through 2030 as we continue to invest to enable further promising late-stage pipeline assets. Specifically, we currently expect the Metcera transaction to be approximately $0.16 dilutive to 2026 adjusted EPS. Additionally, we expect another $0.05 of dilution in 2026 from the 3S bio deal, which closed in the third quarter. With that said, we believe the two deals set up a strong potential revenue growth trajectory in 2030 and beyond. And lastly, through the first nine months of 25, operating cash flow was approximately $6.4 billion, which includes the $1.35 billion upfront payment for the 3S Bio transaction. Our gross leverage at the end of the third quarter was approximately 2.7 times. That said, upon the close of the MetSara transaction, our leverage is suspected to be above the 2.7 times target. We expect to bring our leverage back down to the target levels over time to continue to support a balanced allocation of capital between reinvestments and direct return to shareholders. Now let me turn to our full year 2025 guidance. As Albert noted in September, we reached a new voluntary agreement with the US government that will help ensure US patients pay lower prices prescription medication while providing the clarity we need to focus on our business and our investments in future innovation. The agreement has no impact on our 2025 guidance, but we expect a dilutive impact to our 2020 financial outlook. We continue to expect full-year 2025 revenues to be in the range of $61 to $64 billion. Non-COVID products continue to perform very well operationally and ahead of our plan. However, we note there is softness in our COVID products due to lower vaccination rates and COVID infection rates. In addition, our guidance assumes a favorable impact to revenues from foreign exchange rates. Furthermore, we now expect adjusted R&D to be the range of $10 billion to $11 billion, and our effective tax rate to be approximately 11%. Additionally, adjusted S&A remains unchanged, Now, given our strong performance today and our fourth quarter outlook, including our more efficient cost structure, we are raising and narrowing our full year 2025 adjusted diluted earnings per share guidance by approximately $0.08 at the midpoint to $3 a share to $3.15 a share. I'd like to emphasize our adjusted diluted earnings per share guidance substantially de-risked the current lower than anticipated COVID trends. In closing, we remain committed to enhancing the value of our product portfolio and advancing innovation to further strengthen our pipeline. With a stronger balance sheet, we plan to continue deploying capital effectively. We aim to boost R&D productivity with digital tools, including AI, prioritize investments in key R&D programs, and deliver new growth through business development. Furthermore, our performance continues to exceed expectations and deliver strong results, even as the incidence of COVID remains low. This consistent performance highlights our resilience and commitment to excellence. Regardless of the challenging external environment, our efforts to enhance cost efficiency and generate improvements in operating margins by driving productivity and optimizing processes. Lastly, with the recent agreement with the U.S. government, we can now focus on executing our strategy and our strategic priorities across our business to deliver new medicines for patients and enhance long-term shareholder value. I'd like to just close by noting that it is our expectation that we'll provide guidance for 2026, most likely by the end of this year. So with that, I'll turn it back over to Albert, and we'll begin our question and answer sessions.

Thank you, Dave. So, operator, please assemble the queue.

At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. Our first question comes from Vommel Devan with Guggenheim Securities. Please go ahead.

Hi, great. Thanks for taking my question. I'm going to have to defer them at Sarah's question to other analysts, but curious to hear what you say there. I'll just ask a couple more on the commercial side. So one, Vindimax, obviously facing more competition there. Surprised to see the performance there was a little bit of a decline. So maybe you can just comment on the pricing and sort of market share dynamics you're seeing in that space, obviously, with the new competitors. And then similar question on PADSEV, obviously great data that you shared at ESMO. The commercial uptake for the quarter, at least, was a little bit less than we thought. So maybe just how you expect the muscle invasive indication, assuming you get that here soon. to impact uptake of that program and kind of drive upside to where the numbers are right now. Thank you.

Thank you. Thank you, Vamil. Amir? Sure. Vamil, thanks for the question. So let me start with your question on Vinda. And I want to level set a couple of things about Vinda, and then I'll talk about the performance in the quarter. So there's obviously new competition in the category, and it's important to note that Vinda is still the only ATTR-CM product that has statistically significant reductions in both mortality and CV-related hospitalizations, together and as a standalone. And it's also the only product where there is a once-daily capsule, placebo-like safety, and near-complete PTR stabilizations. We've got 90% access for Vindamax across the U.S. Now, with regards to the quarter, there are a couple of different dynamics that are happening. First of all, we saw very strong demand growth, and that's reinforced by our continued market share leadership, both on a TRX basis, clearly, but also in terms of first-line share. Now, that volume growth was offset by two gross-to-net headwinds. One is the IRA manufacturer rebates, which we've talked about before. And the second is what we alluded to last quarter, which is payer contracting that took place in the third quarter. So Vindamax is performing exactly where we thought it would and consistent with what we guided. And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics, and that's going to continue to grow our volume. We are seeing competition. Atruvi is taking some first-line share from treatment-naive patients, and Ambucha has driven minimal switching to date. And as we kind of look forward on Vinda, we'll see some of these dynamics continue into Q4 as well, where we expect continued volume growth. But the two GTN drivers that I described will certainly impact our net sales. But Vinda is performing in the way that we expected. On your question with regards to PATSEF, You know, we're, again, very encouraged by how PatSeth is doing. You know, for us, we look at this through two lenses. First is the LAMUC population, where we currently have about 55% share among cisplatin ineligible patients and 45 to 50% share among cisplatin eligible patients. So there is headroom for us to continue to focus on that segment of the market. I think your question with regards to how PATSA performed on consensus is related to the comment that Dave made, which is as part of integrating the CGEN products into the Pfizer portfolio. In Q2, we moved from a dropship model to a wholesaler model. So that resulted in a one-time growth in our Q2 sales. So you have to grow products off of that adjusted for two to three weeks of inventory. So as we cycle into Q4, we expect the whole Cgen portfolio, including PADSEP to return to growth. And then finally, on MIBC, we're excited about the possibility as a result of both the 303 and also 304 trials that are ongoing, and that'll open up a patient population of close to 22,000 patients to help with the next horizon of PADSEP growth.

Thank you, Amir. Next call, please. Next question, please.

We'll go next to Dave Reisinger with Learing Partners.

Yes, thanks very much for taking my question and congrats on the performance in the quarter. So my question is on MetSERA. Could you just comment on the legal process ahead? I know that Pfizer is arguing that Novo's acquisition of MetSERA would be anti-competitive. and even if the FTC doesn't allow it, it could be anti-competitive. So, could you just talk us through the clock and the process for courts to hear Pfizer's arguments? Thanks very much.

Thank you, Dave. As I said in my opening comments, it is very difficult for us, to start commending when we have all these legal issues pending, right, as we speak. But I will repeat what I did say, which is kind of an answer to your question, not on the timing, but we don't see how Novo's deal can be superior. It is an illegal attempt by a foreign company to do an end run around antitrust laws, taking advantage of the government shutdown. What they want to achieve. not to get the products, to destroy them. What they want is to catch and kill an emerging competitor, which is a significant and distrust concern, given Novo's dominant market position. So all I can say is that we are continuing to pursue all legal resources. Thank you. Next question, please.

We'll go next to Assad Hader with Goldman Sachs.

Great, thanks for taking the question. I guess just for Albert and Dave, just quick high level question on BD. What's the plan if that Sarah doesn't work out for some reason and then second on 2026? Any early framing on guidance pushes and pulls specifically on how we should think about Apex with and without the Sarah? And then any additional color on how to think about the dilution you mentioned from your recent MSN deal with the administration. Thank you.

I will send the question today because there are a lot of financial elements. And then if Andrew wants to add something on the BD.

Yeah, so maybe we'll start with business development. Obviously, the company has still significant resources to understand and how to deploy successfully BD. transactions to bring science in-house, and we will continue to work aggressively to do so across all of our four therapeutic areas. And we continue to work across the globe to identify potential candidates for acquisition to help bring new and innovative medicines to patients. So that's still a very ongoing focused activity for the company. I think it's probably a little early to talk exactly about 2026. You heard me give a little color in the sense that clearly we're making investments today, and those investments carry over into 2026 and beyond with either MedCera or 3S Bio to bring these innovative medicines to market. Those will have a slightly dilutive effect to our operating performance next year. We will then wrap all that together with the puts and takes of 26 when we give guidance by the end of this year.

Thank you. Anything to add on BD, Andrew? Yeah, I mean, I'd echo what Dave said. We are very active in all geographies, especially in China. You saw the 3S bio, which adds a foundational asset to become the backbone across multiple indications. And the same is true in China and beyond across all the main therapeutic areas. We've increased the size of our team in China in particular, and we have very active efforts and we have something to inform you. You'll certainly be the first to know.

Thank you. Next question, please.

We'll go next to Jeff Meacham with Citibank.

Good morning, guys. Thanks so much for the question. I guess one for Albert or Dave. When you look at the manufacturing investments, you know, you're making as part of the MFN agreement, relative to the operational cost efficiencies, you know, how would you rank those as priorities? I guess both seem to have three-year timeframes. I'm just trying to get a sense of the incremental dollar and the strategy there. Thank you.

Yeah, clearly there are important elements of our strategy. We're going to clearly invest in the U.S. from a production perspective. We're working now to work through our plans with the new agreement with the U.S. government on how to effectively deploy our capacity here in the U.S. and further build it out. So more to come. We will also provide some color to that when we give guidance for 2026. But we will be able to improve our operating, manufacturing operating infrastructure and at the same time invest in manufacturing here at the U.S. And those two are not necessarily completely in conflict with one another. We'll be able to do both. Thank you. Next question, please.

We'll go next to Courtney Breen with Bernstein.

Thank you so much for answering our question today. I really wanted to understand, and perhaps another question on them at CRO, but from a different angle. I wanted to understand, in your mind, what factors supported Pfizer in garnering that unprecedented early termination of the waiting period from the U.S. Federal Trade Commission? That would be really helpful. Thank you so much.

I'm not sure I understood the question.

The FTC clearance.

Why the FTC clearance?

If there are any factors that drove the early.

If there are any factors. No, I think the FTC made their own decision. Of course, they were aware of this question, so I don't want to speak for them. But they decided that it is appropriate in the middle of a foreign attempt to supervise just release our deal, which is now clear. So that's all.

I think it does further demonstrate the strength of our deal and the pathway to clearance and the pathway for us to be able to further develop these products and take them to the marketplace in a very rapid fashion. This is helpful to patients long-term, is helpful to prices long-term under our management and our direction with these assets.

And you should not be surprised, right? Because we all understand that's the epitome of antitrust conflict. The entire pipeline of Metzera, it is the entire pipeline of Novo, plus they have a dominant position with the current products that they have. Of course, FTC would worry about that. I don't want to speak for themselves, but it is something that everybody understands. All right, next question, please.

We'll go next to Terrence Flynn with Morgan Stanley.

Hi. Thanks for taking the question. Maybe two for me. You've previously talked about LRExVO being a key driver for you over the long term. We noticed that Magnetism 5 trial was pushed out data into 2026. We know J&J had a similar trial in a similar patient population that just read out. So maybe to just remind us of any potential differences here in terms of your trial versus their trial and why there might be a difference in timing given they started around the same time. And the second question is just a clarification on Paxlovid dynamics for the quarter. It looks like, by our math, price per script went up over last quarter. So just wondering if there's any one-time items that we need to think about here as we think about the trends into fourth quarter. Thank you.

All right. Chris? Yeah, thanks for the question. So Magnetism 5, as you know, is double-class exposed. Possibly later this year, beginning next year, it's an event-driven study. So timing could shift due to events not happening, which we cannot speculate. But as you can imagine, that's often positive if events are not happening in this study. So we'll just continue to follow the events and hopefully... and report early next year.

Yeah, and on the Paxlovid question, I don't think there's any material change in price. We have, maybe there's different channels mix and things of that nature, but nothing significant from that standpoint.

Thank you. Thank you for clarifying that. Let's go to the next question.

We'll go next to Akash Tiwari with Jefferies.

Hey, thanks so much. I had a question on your upcoming Phase 3 EZH2 readout in CRPC. I'm surprised This study isn't more prominently flagged given the potential to extend the Xtandi franchise. What drives your confidence that you're getting adequate target exposure after examining some of your food effect studies? And also, what's your expectations around overall survival? Could we see a 20% to 30% benefit here? Thanks so much.

Chris, that's for you. Thank you very much for the question. This is another first-in-class internally discovered program, EZH2 program. We've previously shared randomized data. We showed significant PFS benefit in all comers and late-line metastatic restoration-resistant prostate cancer. And we now have... three phase three studies ongoing. The first one will read out, to your point, is post-adiraterone metastatic hormone-resistant prostate cancer, and that we expect in the coming months. We recently also presented data at ASCO, randomized data on the food effect to your question, which was 875 milligrams twice a day with food, and showed that the data are compatible with the dose we now use in phase three with reduced GIAE. So we are confident in the dose that was selected.

Thank you. Next question, please.

We'll go next to Kerry Holford with Barenberg.

Thank you for taking my question. Just on the guidance, please, for this year, you've clearly reiterated the total revenue range of 61 to 64. But when you first set that guidance, you spoke of total COVID-19 sales of around $9 billion for the year. Seeing that you booked only around just over four year to date, just interested in your comments around whether that nine is achievable for the full year. And if not, what other assets would you call out as likely to fill that gap and give you confidence to reiterate the total sales guidance?

Thank you. Dave, please. Yes, you're absolutely right, Kerry, as you pointed out. I would say that to the low end of our guidance range from a revenue perspective would assume that the COVID franchise continues a very modest uptake for the balance of this year, particularly in the U.S., However, as you know, the COVID franchise is subject to peaks and valleys. If there happens to be a wave of COVID in the next several months, you can see utilization spike up. So that's why the range is so large. I'll just point out that what we have done with an earnings per share guidance range is we've de-risked the COVID franchise with the guidance that we provided. given that if the trends continue, we'll be closer to the low end of that range, and we will still be able to deliver on our earnings commitment.

Thank you. Very clear, Dave. Let's move to the next question, please.

We'll go next to Mohit Bansal with Wells Fargo.

Great. Thank you very much for taking my question. Just wanting to understand the thought process around the pricing of these GLP-1 and this class of medicines, given that, I mean, even today there's a news article out there suggesting the price could be $150 or so. So it seems like the price is only going in one direction. In that case, I mean, how do you justify the price that you're paying to Medcera and, in general, the obesity landscape how do you think about that with this pricing decline for the class? Thank you.

Yeah, thank you. This is also competition that brings prices down. And of course, they try now to restrict competition. But anyway, yes, in our calculations, we have taken into consideration that the prices of GLP-1s probably will start going down. So I don't know what will be announced now. But in our calculations, we took already that into consideration. Thank you, Mohit. Let's go to the next question, please.

We'll go next to Alex Hammond with Wolff Research.

Thanks for taking the question. Can you elaborate more on the reason for the delay to the initiation of the pivotal trial for the adult 25-valent pneumococcal program? You'd mentioned the caveat of if the FDA aligns with your approach. So does the tenor of the dialogue change with the FDA? Is there a chance that surrogate endpoints may no longer be approvable?

Thank you very much. Boris?

Yeah, thank you for the question. Across all our vaccine programs, we're obviously working very closely with the FDA and other regulators on the designs of the study and also the endpoint. PCV25, pending positive data and FDA feedback, We, as mentioned, we intend to start that study as well as the pediatric 25 valent program next year. So it means we will align the pediatric and the adult study. We expect the fourth dose data from the pediatric study early next year. So that helps us to coordinate the two studies. So we'll just make it easier. The 25 vaccine candidate covers 25 serotypes, particularly to point out serotype three, which we did before. because the vaccine is designed with significantly enhanced immunogenicity against serotype 3, which currently constitutes up to 20% of infections in the US and the EU. And to continue our leadership, we also continue to study our fifth generation with 30 plus serotypes, which we'll update you on more in 2026. Thank you.

Thank you, Chris. Operator, the next question, please.

We'll go next to Chris Schock with JP Morgan.

Great. Thanks very much. Just maybe two MFN questions. First one's kind of bigger picture. As you think about MFN on new launches over time, what do you think about this suggesting for international revenues? Is this, I guess, I could read this as a net positive that you could get higher price. I could read it as net negative because reimbursement hurdle is going to be tougher at these higher prices. It could be neutral. It's just about how you kind of envisioned what plays out with international as you signed that deal. And the second one is just trying to get a little bit more color on the MFN impact for 2026. I think you mentioned some dilution there, but just any more quantitative metrics you could provide of just like how much of a headwind is that for next year? Thanks so much.

Yes. I'm sure if I ask Dave to tell you, he will tell you, he will provide guidance at the end of the year, and that will incorporate everything, including that and the other things that he has spoken. So I don't think you will get more words out of our mouth, no matter how much you torture us. But on the new launches in international, of course, we are waiting to see how things may play. The price differential is not sustainable. We are speaking about the smaller basket of countries in international that are affected by that. And with these countries, we are hoping that they will understand that they need to change the way that they price their products going forward. Of course, a little bit help from the U.S. government and USTR through trade negotiations also can make that happen. And my assessment is that Howard Latnick and the U.S. trade representatives are highly, highly important. committed to make this go away. So we will see how that plays. But in theoretical, if the prices over there are, we are not agreeing a decent way of pricing our products, clearly we will not get reimbursement there. And we will price them to the price that will not affect the U.S. price. Thank you.

And now let's go to the next question, please.

We'll go next to Umar Rafat with Evercore ISI.

Morning, guys. First, on Metcera, I realize this is perhaps in the hands of your M&A lawyers and antitrust lawyers, but from an R&D perspective, can we make sure you'll be evaluating all the new data that's imminent? For example, the monthly transition and how the GI tolerability holds, as well as, even more importantly, the Amlin plus GLIP early combo data. And then separately, I was very intrigued by a phase 2B trial you guys initiated on an oral drug in atopic derm. Could you confirm if it's a stat set to gauge the magnitude of stat 6 inhibition phase 1? Thank you.

Thank you. Look, on the matter, it's easy if they provide us data or if they publicize data. Of course, we are eager to see that. And we believe it will be positive. On the second question, I will ask Chris to comment.

Thank you, Umar, to ask a question regarding our INI portfolio. I just want to check, are you referring to PF9820?

I don't think you can come back to that.

Okay. So you are correct. That is a stat inhibitor. I want to point out that we currently have a very differentiated INI portfolio with at least five molecules in-house discovered and developed. Most of these at a significantly accelerated speed, including obviously P40-TL1A, which is being co-developed with Roche, which covers IL-12 and IL-23 via P40. Our two tri-specifics covering IL-4, IL-13, TSNL-PO, IL-33, both of those now entering phase 2 for atopic dermatitis and for other Th2-related diseases. Litfulo with the ongoing phase 3 trial in non-segmental vitiligo, which is a JAK3 tech inhibitor, also differentiated in-house. And then the STAT6. early, just entering phase two, could be potentially first-in-class oral. We're currently further optimizing dose and formulation and hope to update you on that program in 2026. Thank you.

Thank you very much. Next question, please.

We'll go next to Steve Scala with TD Cowan.

Oh, thank you so much. Two questions. What does the drug pricing deal with Trump allow Pfizer to do that other companies will not be able to do other than, of course, AstraZeneca? And secondly, on Metzera, so the data looks more similar than different than competitors, and Metzera disclosures haven't been completely transparent, raising serious questions. Many other big cap pharmas have passed over Metzera when pursuing other products, validating the Me Too point. Nothing in all this justifies a bidding war or even a protracted legal battle. Is Pfizer's determination to persist underpinned by substantial confidentiality data, confidential data, or simply the desire to be a player in obesity? Or does Pfizer agree with the points that I just said? And could it just walk away? Thank you.

Thank you, Steve. On the first one, on the drug prices and what we have that other companies may not have, I can't answer because I don't know what the other companies are having. As you know, the discussions are between the administration and individual companies, which also ensures that there is no antitrust issues. And also, of course, they are confidential, because that's also what the administration and the agreements portray, that we should keep confidentiality of those. So I know what we are getting. Some of that has been public, and some of that is part of the overall very lengthy deal. But I don't know what others I will take. On the Metzera, look. We have seen the data, we did extensive due diligence, and we priced the asset into a price that we thought offers tremendous value. to the shareholders of Metzera and to the shareholders of Pfizer, because those assets that we like in our hands, of course, will provide significant competitive edge. What you see now, it is, I repeat, an effort to catch and kill this emerging competitor, which is Pfizer. And to do that by evading the antitrust scrutiny and virtually get control, de facto control of the company, as they will become the major shareholder and the major creditor without any regulatory scrutiny. So that's all I have to say. And I'm, you know, we will see how things go.

Let's move to our next question, please.

Our next question comes from Evan Sigerman with BMO. Hi, guys.

Thank you so much for taking my question. You know, assuming MetSERA closes, what near-term factors must you consider to continue growing the dividend and then delivering, Dave, as you had said? When do you think you may be able to also start to repurchase shares, or is that less of a priority, you know, with all this BD? Thank you so much.

Yeah, Evan, very good question. Obviously, you've seen us over the last year and a half or two years really lean into productivity across our platform. That productivity has allowed us to de-lever from roughly four times to 2.7 times. That's given us increased flexibility to do both business development as well as maintain and grow our dividend over time. That cycle of improvement and productivity is something that we've now embedded in the company. We will continue to do that. We will continue to do that across the enterprise. We will continue to prioritize ourselves from an R&D perspective. Clearly, we have several assets that we think are key to the growth of this company by the end of the decade. We are going to invest behind those assets from a pipeline perspective, and we're going to invest behind the categories of products that we've either acquired and or recently launched, because those will ultimately allow us to offset the LOEs over the next several years. So we'll be able to do all of that. Share repurchases is an important lever for us. in the in the near term it's not a tool that we're going to use we have to get the balance sheet back to where we need to be and we we again we have business priorities that come uh in the forefront of that at this point great question thank you okay so now i think uh let's get the last question our last question comes from rajesh kumar with hsbc good morning uh

Two questions, if I may. Appreciate you cannot say a lot about MetSERA at this junction. Just from a modeling perspective, if we are thinking of additional balance sheet capacity for deal-making, how much capacity would you assume, assuming that you are keeping some capacity away from MetSERA at the moment in 2026? on your own internal budgeting. That would be really helpful. And just on the 3S Bio, appreciate the deal has just closed and some of the trials have just started. When can we expect to see data news flow come out of that deal? Is it more a 2027 event or do we have any interim readouts or updates in 2026?

Thank you. I think Dane can answer, and Sarah Mogerlin.

Yeah, so as you think about BD capacity, as I said in my prepared remarks, we have approximately $13 billion of capacity as we enter here into the third quarter. So with that...

Chris, let's understand the 3SBI. Yeah, the data flows. So just a reminder, ASCO 2025, we shared phase 2 monotherapy, or shared by 3SBI, phase 2 monotherapy data. And first-line non-small cell lung cancer showing the overall response, objective response of 65%. At ESMO, phase 2 combo data plus chemotherapy, ZLOX, or modified FOLFOX6 was shown for first-line monotherapy. metastatic colorectal cancer, and that was showing a response rate of close to 60%. At CITSE, we provide additional data, combination data in lung cancer. You've just seen we posted two phase three programs starting now this year in first-line non-small cell lung cancer and in first-line colorectal cancer. And in the coming weeks, we'll also provide the full development plan to you at an event. And that will show the breadth and the depth of our clinical development program for 707.

Thank you, Chris. So thank you very much all for your attention. We have been successful in achieving a series of significant strategic milestones. We deliver the solid performance during the quarter, and we are confident in our business. And that's why you are raising the rates of our adjusted diluted EPS. And of course, we maintain our range of revenue despite the lowest COVID right now trends. So thank you for your interest in Pfizer, and I hope you have a wonderful week.

This does conclude today's program. Thank you for your participation. You may disconnect at any time.