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Date
Tuesday, Nov. 4, 2025 at 10 a.m. ET
Call participants
Chairman & Chief Executive Officer — Albert Bourla
Chief Financial Officer & Executive Vice President — David M. Denton
Chief Commercial Officer — Amir Malik
Chief Scientific Officer — Christopher Thomas Schott
Global Head, Business Development — Andrew Simon Baum
Senior Vice President, Investor Relations — Francesca DeMartino
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Risks
Paxlovid and Comirnaty revenues declined due to lower COVID-19 infection rates and reduced government stockpiling in Q3 2025, resulting in a 7% global operational revenue decrease versus the same period last year.
The planned MedCera acquisition is expected to be dilutive to adjusted EPS (non-GAAP) through 2030, with an estimated $0.16 per share dilution to adjusted EPS in 2026.
Gross leverage is projected to rise above the 2× target following the MedCera deal, as stated by management in Q3 2025. Management stated a need to delever over time to restore balance between reinvestment and capital return.
Gross-to-net dynamics, including IRA manufacturer rebates and payer contracting, will continue to impact Vyndamax net sales in Q4 2025, despite ongoing volume growth.
Takeaways
Revenue -- $16.7 billion, down 7% operationally versus the same period last year, mainly due to a decline in COVID-19 product demand, including Paxlovid, and the absence of government stockpiling recorded in 2024.
Non-COVID Product Growth -- 4% operational increase in non-COVID product revenues versus the same period last year, highlighting core portfolio resilience.
Adjusted Diluted EPS -- $0.87, ahead of internal expectations, driven by strong gross margin and cost management.
Adjusted Gross Margin -- Adjusted gross margin was approximately 76%, attributed to product mix and manufacturing cost discipline.
Adjusted Operating Expense -- $7 billion adjusted operating expense, reflecting a 21% operational increase due to the $1.4 billion acquired in-process R&D for 3S Bio, with other core SINA and R&D expenses each down 3% operationally.
Cash Flow -- $6.4 billion in operating cash flow for the first nine months of 2025, including a $1.35 billion upfront for 3S Bio.
MedCera Acquisition -- $4.9 billion transaction cleared early by the FTC, with additional contingent payments tied to pipeline milestones; stated as dilutive through 2030.
Cost Savings -- Realized $1.5 billion to date through manufacturing optimization, progressing toward $7.7 billion targeted by 2027, with approximately $500 million to be reinvested in R&D by 2026.
Dividend and Capital Return -- $7.3 billion returned to shareholders via dividends in the first nine months of 2025; share repurchase deprioritized until leverage returns to target.
Full-Year Guidance Raised -- Adjusted diluted EPS range increased to $3.00–$3.15 for the full year 2025; Full-year 2025 revenue guidance reiterated at $61 billion to $64 billion.
Agreement with US Government -- Three-year grace period from selected US tariffs; prescription drug price alignment achieved; management indicates the new pricing agreement does not impact 2025 guidance.
Pipeline Highlights -- 45+ abstracts disclosed at major meetings; key data include PADCEV (phase 3, halved recurrence and death risk in muscle-invasive bladder cancer) and FAROS trial (47.6-month median OS in BRAF V600E metastatic NSCLC).
BRAFTOVI/MEKTOVI Growth -- New patient starts increased 30% since October 2023 launch, strengthening the lung cancer portfolio.
Vyndaqel Family -- 7% global operational growth and continued US double-digit demand increase; market share leadership maintained, but net sales affected by payer and rebate dynamics.
Prevnar Pediatric -- Delayed US government bulk order timing cited as a factor in quarterly growth slowdown, with 60% of US Prevnar revenue linked to pediatric business.
ABRYSVO -- 75% year-over-year international operational growth, led by expanded market access.
Summary
Pfizer (PFE 1.46%) achieved a 4% operational revenue increase for non-COVID products, counterbalancing a headline 7% operational revenue decline versus the same period last year, driven by decreased demand for COVID-19 therapies. Management raised adjusted diluted EPS guidance to $3.00–$3.15 for the full year 2025, attributing outperformance to effective cost management and product mix, while reiterating FY revenue targets. Strong international performance for ABRYSVO and Vyndaqel offset domestic timing headwinds in Prevnar pediatrics, and robust pipeline disclosures highlighted strategic focus on oncology and cardiometabolic therapies. The MedCera acquisition advanced with unprecedented early FTC clearance and will be funded by cash and debt, projected to be dilutive through 2030 as R&D investments ramp.
Management confirmed the cost alignment agreement with the US government provides near-term regulatory clarity, with future guidance to incorporate potential incrementally dilutive effects from pricing concessions.
Gross leverage rose to 2.7× following the 3S Bio acquisition, and is expected to exceed 2× when MedCera closes, temporarily curtailing share buybacks in favor of balance sheet repair.
Recent product launches and acquired assets generated $7.3 billion in revenue, with approximately 9% operational growth for the first nine months of 2025, signaling sustained demand for new portfolio entrants despite lower growth in Q3 2025 relative to Q2 2025 due to shipment timing.
R&D pipeline highlights include a phase 3 PADCEV regimen achieving the first survival benefit for muscle-invasive bladder cancer, and an EZH2 inhibitor positioned for imminent phase 3 prostate cancer readout.
CEO Bourla stated, "we believe Pfizer Inc. will have distinct advantages in developing and delivering new potential treatments, because of our proven scientific and commercial strengths," emphasizing confidence in both the MedCera transaction and future cardio-metabolic leadership.
Industry glossary
Gross-to-Net (GTN): The adjustment from gross sales to net revenue, incorporating discounts, rebates, and other deductions.
Adjusted Diluted EPS: Earnings per share metric excluding specified items to reflect core operating results.
PADCEV: Brand name for enfortumab vedotin, an antibody-drug conjugate for urothelial cancer.
BRAFTOVI/MEKTOVI: Targeted therapies used in combination for cancers with BRAF mutations.
ABRYSVO: Pfizer's vaccine for respiratory syncytial virus (RSV).
Comirnaty: COVID-19 mRNA vaccine marketed by Pfizer and BioNTech.
Paxlovid: Pfizer’s antiviral treatment for COVID-19.
ATTR Cardiomyopathy: A rare heart condition caused by misfolded transthyretin protein deposits.
SINA (SI&A): Selling, information, and administrative expenses.
LOEs: Loss of exclusivity periods leading to generic competition for branded drugs.
Full Conference Call Transcript
Albert Bourla: The past few months have been pivotal for Pfizer Inc. 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 US government, which has provided greater clarity of our strategic investment future innovation and growth. Additionally, with our proposed acquisition of MedCera, 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 US 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 US tariffs with our commitment to further invest in manufacturing in the US. Now I want to address our proposed acquisition of MedCera. We believe that Novo Nordisk's offer is illusory and cannot constitute a superior proposal under the terms of our merger agreement with MedCera. 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 MedCera shareholder vote on November 13. With a pending legal action we have taken to enforce and preserve Pfizer Inc.'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 Inc. and MedCera 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 Inc. 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 Vyndaqel family, and we plan to execute in a similar way with MedCera, as we reinvigorate Pfizer Inc.'s cardiometabolic presence. The licensing agreement with 3S Bio is another way we have strategically enhanced our pipeline. Encouraging phase two first-line metastatic colorectal cancer efficacy and safety data for SS SSZJ-707 the PD-one VEGF bispecific, 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, executing with 707, Pfizer Inc. 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 the presidential symposium.
Starting with the presidential symposium, new phase three data demonstrate the PADCE in combination with pembro reduced the risk of recurrence and death by at least half for patients with cisplatin-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, with approximately eighteen thousand patients under the current label e metastatic urothelial cancer and if there are further positive data that is approved, up to approximately twenty-two thousand five hundred additional patients across both muscle-invasive bladder cancer.
We also presented follow-up results from the FAROS single-arm phase two clinical trial supporting BRAFTOVI and MEKTOVI 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 forty-seven point six months in treatment-naive patients with metastatic non-small cell lung cancer with a BRAF V600E mutation. We are pleased with the continued strong year-over-year growth of BRAFTOVI and MEKTOVI, with a thirty percentage points increase in new patient starts since the October twenty-three launch. We believe the results from the FAROS trial could establish a new benchmark with targeted therapies for its population of patients.
These results fortify the strength of our growing lung cancer portfolio, that 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 twenty-third. We also presented final overall survival results from the phase three EMBARK trial evaluating Xtandi in combination with leuprolide and as the monotherapy 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 a product that is experiencing strong demand growth in hormone-sensitive prostate cancer and rapid uptake in the approximate sixteen thousand U.S. 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 Inc. may resume enrollment relocated from Sub-Saharan Africa. We are still engaging with regulatory authorities for 2026 in the coming years. With disciplined execution and our continued focus on key products, markets, we continue to build on our leadership position within our commercial portfolio. Our 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 continued strong market leadership In international, we achieved 40% growth in the quarter. In total patients on treatment. In the US, our continued double-digit demand growth reflects strong diagnostic efforts broad access, and favorable affordability dynamic. Nurtec continues to lead with the oral to lead the oral CGRP class in primary care penetration, in the US In international, we achieved growth with continued 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. Patzen, another market leader in our portfolio, Patsy, 13% year-over-year global operational growth in the quarter. PATCEV in combination with Pembroke 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 vaccines portfolio is a key area of focus in international markets. We are pleased with the strong performance of the Pregnant family. Driven by churn gains and launches in several key markets.
We achieved 17% year-over-year international operational growth in the quarter, Pfizer Inc. 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, Prevnar Adult is the established leader among adult pneumococcal conjugate vaccines. In the US, where we did experience a year-over-year decline in the quarter, we are pleased with the overall performance of Prevnar twenty. For adults, Prevnar held a market-leading position and grew with the expanded recommendation for adults 50.
In the pediatric market, accounting for about 60% of Prevnar revenue in the US, 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 to a phase three start of our adult 25 valent 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 one-two study early next year, and finding positive data and regulatory feedback have the potential to start both phase three 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 PCA space, And as a reminder, our 25 valent vaccine candidate has the potential for improved immunogenicity for serotype three. Which is one of the largest remaining contributors of pneumococcal disease. Serotype three alone is estimated to cause approximately twenty percent of invasive disease, the 65 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 US, we are experiencing the headwind of a more difficult to activate population, Still, we are continuing to strengthen our position with a in SiP dose volume in this quarter. From the significant strategic 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 twenty-five strategic priorities. By committing 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-nineteen 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.
David M. Denton: 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 US 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 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 product. The decline was primarily due to Paxlovid, experienced reduced demand from lower leveled levels of disease incidents as well as last year's one-time tax loaded government stockpiling recorded in '24 and, to a lesser extent, commodity. With that said, our non-COVID products performance was solid. Growing 4% operationally versus the same period of LY. On the bottom line, third quarter twenty-five reported diluted earnings per share was 62¢, and adjusted diluted earnings per share was 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 20¢ of acquired in-process R&D from the 3S Bio transaction. 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 contribution across our product portfolios, primarily driven by Eliquis, the Vyndaqel family, and Nurtec, but it was more than offset by declines in Paxlovid and Commerity. Through the first nine months of twenty-five, Pfizer Inc.'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 siegen product transitioning to a wholesale distribution model in the US. We plan to continue to invest behind these two product groups to drive the 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 seventies, Excluding Commerity, which has a fifty-fifty profit split with our partner, BioNTech. We expect $1.5 billion in savings from phase one of the manufacturing optimization program by the '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 '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 expenses contracted by approximately $150 million versus last year, And looking at the components, adjusted SI and A 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 SNA and RD expenses demonstrate, we continue to be disciplined with our operational expense management.
Q3 reported diluted earnings per share was 62¢, and our adjusted diluted earnings per share was 87¢, which benefited from our efficient operating structure Additionally, EPS was aided by our effective tax rate primarily driven by favorable changes in general jurisdictional mix of earnings and tax benefits related to global income tax resolutions in multiple spanning multiple years. Partially offset by the aforementioned 3S Bio acquired in-process R&D charge. We continue to be disciplined with all 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 court 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 '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 2026.
With that, now let me quickly touch upon our capital allocation which is designed to enhance long-term shorter value. Our strategy consists of maintaining and growing our dividend over time, reinvesting in our business at the appropriate level of financial returns, 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 transactionally primarily reflecting the 3S Bio licensing deal. As a reminder, our business development capacity after the 3S Bio deal is a $13 million.
In the third quarter, we announced a planned acquisition of MetCera 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. 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 $20.26 adjusted EPS. Additionally, we expect another 5¢ of dilution in '26 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 MetCera transaction, our leverage is expected to be above the two-point 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 will help ensure US patients pay lower prices prescription medications 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 $20.20 cents financial outlook. We continue to expect full year 2025 revenues to be in the range of $61 billion 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 in the range of $10 billion to $11 billion and our effective tax rate to be approximately 11%. Additionally, adjusted SINA remains unchanged, Now given our strong performance to date 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 $0.8 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 derisk 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 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 US government, we can now focus on executing our strategy and our strategic priorities across our business to deliver new medicines for patients enhance long-term shareholder value. I would like to just close by noting that it is our expectation that we will 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 session.
Albert Bourla: Thank you, Dave. So, operator, please assemble the queue.
Operator: At this time, if you would like to ask a question, 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 Vamil Divan with Guggenheim Securities. Please go ahead. Hi, great. Thanks for taking my question. I'm gonna have to defer the MetSeric question to other analysts, but I'm curious to hear what you say there. I'll just ask a couple more on the commercial side. So one, Vimdemex, obviously, facing more competition there. Surprised to see the performance. There was a little bit sequential 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. Similar question on PADCEV. Obviously great data that you shared at ESMO. The commercial uptake for the quarter, least, a little bit less than we thought. So just how you expect muscle invasive indication, assuming you get that here soon. To impact uptake of that program and drive upside to where the numbers are right now. Thank you.
Albert Bourla: Thank you. Thank you, Vamil. Amir? Sure. Vamil, for the question. So let me start with your question on Vinda, and I'll just, I wanna level set a couple of things about Vinda, and then I'll talk about 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 Centimeters product that has statistically significant reductions in both mortality and CV related hospitalizations together and as a stand alone, And it's also the only product where there is a once daily capsule placebo like safety, and near complete TTR stabilization. We've got 90% access, for Vindamax across The US.
Now with regards to the quarter, there are a couple of different dynamics that are happening. First of all, we saw a very strong demand growth, and that's reinforced by 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, with what we guided.
And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics, and that's gonna continue to grow our volume We are seeing competition. Attribute 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, 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 PATCEF is doing.
You know, for us, we look at this through two lenses. First is the LAM UC population, where we currently have about 55% share among cisplatin ineligible patients, and forty five to fifty percent share among cisplatin eligible So there is headroom for us to continue to focus on that segment of the market. I think your question with regards to how paths have performed on consensus, is related to the comment that Dave made, which is as part of integrating the c gen products into the Pfizer Inc. portfolio in Q2, we moved from a drop ship model to a wholesaler model. So that resulted in a onetime growth in our Q2 sales.
So you have to grow products off of that, adjusted for two to three weeks of inventory as we cycle into Q4, we expect the whole c gen portfolio, including PADCEP, to return to growth. And then finally, on MIDC, we're excited, about, about the possibility as a result of both the three zero three and also three zero four trials that are ongoing, and that'll open up a patient population of close to 22,000 patients. To help with an exorizin of PADCEP growth.
Albert Bourla: Thank you, Amir. Next call, please. Next question, please.
Operator: We'll go next to David Reed Risinger with Leerink Partners.
David Reed Risinger: Yes. Thanks very much for taking my question and congrats on the performance in the quarter. So my question is on METZERA. Could you just comment on the legal process ahead? I know that Pfizer Inc. is arguing that Novo's acquisition of Metcera would be anticompetitive. And even if, you know, the FTC doesn't allow it, it could be anticompetitive So could you just talk us through the clock and the process for courts to hear Pfizer Inc.'s arguments. Thanks very much.
Albert Bourla: Thank you, Dave. As I said in my opening comments, it is very difficult for us to start commenting 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 Novos deal 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 What they want is to cut 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 will are continuing to pursue all legal resources. Thank you. Next question, please.
Operator: We'll go next to Asad Haider with Goldman Sachs.
Asad Haider: 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 Netsera doesn't work out for some reason? And then second, on 2026, any early framing on guidance pushes and pulls, specific on how we should think about OpEx within without Nissera? And then any additional color on how to think about the dilution you mentioned from your recent, NFN deal with the administration? Thank you.
Albert Bourla: I will send the question today because there are a lot of financial also And then if Andrew wants to add something on the BD, thanks for it. Yeah. So maybe we'll start with business development. Obviously, the company has still significant resource to understand and how to deploy successfully 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. That still a very ongoing focused activity for the company. I think it is probably a little early to talk 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 '26 and beyond with either MedCerra or 3S Bio. To bring these innovative medicines to market. Those will have a slightly a 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.
Andrew Simon Baum: Thank you. Anything to add on BT, Andrew? I mean, I'd echo what Dave said. We are very active in all geographies, in China. You saw this 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 when we have something to inform you, you'll certainly be the first to know.
Albert Bourla: Thank you. Next question, please.
Operator: We'll go next to Geoff Meacham with Citibank.
Geoff Meacham: 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 MSN agreement, relative to the operational cost efficiencies, you know, how would you rank those as priorities? I guess both seem to have three-year time frames. I'm just trying to get a sense of the of the incremental dollar and the strategy there. Thank you.
David M. Denton: Okay. Yeah. We're yeah. Clearly, there are important elements of our strategy. We're gonna clearly invest in The US from a production perspective. We're working now to work through our plans with the new agreement with US government on how to effectively deploy our capacity here in The US and further build it out. So more to come. We will also provide some color to that when we get 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 US, and those two are not necessarily completely in conflict with one another. We'll be able to do both.
Albert Bourla: Thank you. Next question, please.
Operator: We'll go next to Courtney Breen with Bernstein.
Courtney Breen: Thank you so much for answering our question today. I really wanted to understand and perhaps another question the MET zero but from a different angle. I want to understand in your mind, what factors supported Pfizer Inc. in garnering that unprecedented early termination of the waiting period from the US Federal Trade Commission. That would be really helpful. Thank you so much.
Albert Bourla: I'm not sure I understood the question.
Francesca DeMartino: The FTC clearance Why the FTC clearance?
Albert Bourla: If there are any fact no. I think the FTC made their own decision Of course, they were aware of, of, these questions, so I don't want to speak for them. But, they decided that it is appropriate in the middle of a foreign attempt to supervene it to just release our deal, which is now clear. So that's 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 path fashion.
This is helpful to patients long term as helping to helpful to prices long term under our management and our direction with these assets. Yeah. And people should not be surprised. Right? Because we all understand that's the epitome of antitrust conflict. The entire pipeline of it's the entire pipeline of NovoPlus. They have a dominant position with the current products that they have. Of course, FTC would worry about that. I want to speak for themselves, but it is something that it is everybody understands. Alright. Next question, please.
Operator: We'll go next to Terence C. Flynn with Morgan Stanley.
Terence C. Flynn: 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 five trial was pushed out, data into 2026. We know J and J had a similar trial, in a similar patient population that just read out. So maybe you could 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, you know, price per script went up over last quarter. Just wondering if there's any onetime items that we need to think about here as we think about the trends in the fourth quarter? Thank you.
Christopher Thomas Schott: Alright. Chris? Yeah. Thanks for the question. So Macron is in five, 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, it's that often positive. If events are not happening in the study. So we'll just continue to follow the events and hopefully report early next year.
David M. Denton: Yeah. On 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.
Albert Bourla: Thank you. Thank you for clarifying that. Let's go to the next question.
Operator: We'll go next to Akash Tewari with Jefferies.
Akash Tewari: Hey, thanks so much. I had a question on your upcoming Phase III EZH2 readout in CRPC. I'm surprised this study is in 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 effects studies? And also, what's your expectations around overall survival? Could we see a 20% to 30% benefit here? Thanks so much.
Albert Bourla: Chris, that's for you.
Christopher Thomas Schott: Thank you very much for the question. This is another first in class internally discovered program, our EZH2 program. We've previously shared randomized data, which we showed significant PFS benefit in all comers and late line, metastatic castration-resistant prostate cancer. And we now have three phase three studies ongoing. The first one we'll 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 eight hundred seventy-five milligrams twice a day with food. And show that the data compatible with the dose we now use in phase three with reduced GIAE.
So we are confident in the dose that was selected.
Albert Bourla: Thank you. Next question, please.
Operator: We'll go next to Kerry Ann Holford with Berenberg.
Kerry Ann Holford: Thank you for taking the question. Just on the guidance, please, for this year, you've clearly reiterated the total rep range of sixty-one to sixty-four. And when you first set that guidance, you spoke of total COVID nineteen 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 reach rates the total sales guidance.
Albert Bourla: Thank you. Dave, please. Yes. On the you're 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 US. However, as you know, the COVID franchise is subject to big 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 derisk the COVID franchise with the guidance that we provided given that if the trends continue, will be closer to the low end of that range and we will still be able to deliver on our earnings commitment.
Albert Bourla: Thank you. Very clear, Dave. Let's move to the next question, please.
Operator: We'll go next to Mohit Bansal with Wells Fargo.
Mohit Bansal: Great. Thank you very much for taking my question. Just wanted to understand the thought process around the pricing of the GLP one 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 being you're paying to MedCera? And in general, the obesity landscape over time, how do you think about that for this pricing decline for the class? Thank you.
Albert Bourla: Yeah. Thank you. And this is also competition. Brings prices down. And, of course, they try now to restrict competition. But anyway, the yes. We in our calculations, we have taken into consideration. That the prices of GLP ones probably will start going down. So I know. What will be announced now, But in our calculations, we took already that into consideration. Thank you, Mohil. Let's go to the next question, please.
Operator: We'll go next to Alexandria Janet Hammond with Wolfe Research.
Alexandria Janet Hammond: Thanks for taking the Can you elaborate more on the reason for the delay to the initiation of the pivotal trial for the adult twenty-five valent pneumococcal program. You'd mentioned the caveat of if the FDA aligns with your approach. So is the tenor of the dialogue change with the FDA? Is there a chance that surrogate endpoints may no longer be approvable?
Albert Bourla: Thank you very much. Chris?
Christopher Thomas Schott: 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. PCV twenty-five pending positive data and FDA feedback we, as mentioned, we intend to start that study as well as the pediatric twenty-five valent program next year. So it means we will align the pediatric and the adult study We expect the full dose data from the pediatric study early next year, so that helps us to coordinate the two the two studies. It will just make it easier.
The twenty-five vaccine candidate covers twenty-five serotypes, particularly, and you point out serotype three, which we did before because the vaccine is designed with significantly enhanced immunogenicity against stereotype three, which currently constitutes up to 2020% of it. 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.
Albert Bourla: Thank you. Thank you, Chris. Operator, the next question, please.
Operator: We'll go next to Christopher Thomas Schott with JPMorgan.
Christopher Thomas Schott: Great. Thanks very much. Just maybe two MFN questions. First one is kind of bigger picture. As you think about MFN on new launches over time, what are you thinking about this suggesting for international revenues? Is this, I guess, I could read this as a net positive that you could get higher price? Read as net negative because reimbursement hurdle is gonna be tougher at these higher prices. It could be neutral. It's just it's about how you kind of envisioned what plays out with international as you signed that deal. And then 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 Thanks so much.
Albert Bourla: Yes. I'm sorry if I asked Dave to tell you, but she would tell you. He will provide guidance at the end of the year, and that will incorporate everything that and the other things that he have us talking. So I don't think you will get more words out of our mouth. No much how much you torture us. But on the on the new launches in international, 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 US government and USTR trade negotiations. Also, can make that happen. And my, assessment is that Howard Latnick and The US trade representatives are finally, finally committed to make this go away. So we will see how that plays, but in theoretical, if the prices over there are they are not we are not agreeing 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 US price. Let's thank you.
And now let's go to the next question, please.
Operator: Go next to Umer Raffat with Evercore ISI.
Umer Raffat: Morning, guys. First, on Metaira, I realize this is perhaps in the hands of your M and A lawyers antitrust lawyers. But from an r and 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 Amlan plus GLP early combo data. I was very intrigued by a phase two b trial you guys initiated on an oral drug in atopic derm. Could you confirm if it's a stat six inhibitor? And were you able to gauge the magnitude of STAT6 inhibition phase one? Thank you.
Albert Bourla: Yeah. Thanks. Look. On the METARIS, easy if they provide us data or if they publicize data. Of course. Will we are eager to see them. And we believe it will be positive. On the second question, I will ask Chris to comment. And thank you, Uma.
Christopher Thomas Schott: To ask a question regard regarding our I and I portfolio. I just wanna check. Are you referring to p f nine eight two zero?
Albert Bourla: I don't think you can come back to me. Okay.
Christopher Thomas Schott: inhibitor. I wanna 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 in including, obviously, p 40 t l one a, which we codevelop or which is being codeveloped with Roche, which covers IL 12 and IL 23. now entering phase two for atopic dermatitis and for other t h two related diseases. Lipfullo with the ongoing phase three trial in potentially first in class oral. We currently further optimizing dose and formulation and hope to update you on program in 2026. Thank you.
Albert Bourla: Thank you very much. Next question, please.
Stephen Michael Scala: Oh, thank you so much. Two questions. What does the drug pricing deal with Trump allow Pfizer Inc. to do that other companies will not be able to do other than, of course, AstraZeneca? And secondly, on Metcira, so the data looks more similar than Many other big cap pharmas have passed over Metcera when pursuing other products, validating the me too point. protracted legal battle, is Pfizer Inc.'s determination to persist underpinned by substantial confidentiality data? Confidential data or simply the desire to be a player in obesity or does Pfizer Inc. agree with the points that I just said, and could it just walk away? Thank you.
Albert Bourla: Thank you, Steve. On the first, one on the drug prices and what we have that other companies may not have, As you know, the discussions are between the administration and individual companies. Which also ensures that there's no antitrust issues. And, also, of course, if there are confidential because, that's also what the administration, the agreements portray that we should keep confidentiality of those sets. So 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 Metaira, look. the asset into a price that we thought offers value to the shareholders of Meterra and to shareholders of Pfizer Inc., 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 cut and kill our this emerging competitor, which is Pfizer Inc., scrutiny 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 know, we will see. How things should go. Let's move to our next question, please.
Operator: Our next question comes from Evan David Seigerman with BMO.
Evan David Seigerman: Guys. Thank you so much for taking my question. Assuming Metsera closes, what near-term factors must you consider to continue growing the dividend and then delevering, 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? You so much.
David M. Denton: Evan, very good question. Obviously, you have 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 delever from roughly four times to 2.7 times That has 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. 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 will 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 gonna use.
We have to get the balance sheet back to where we need to be and we again, we have business priorities that come in the forefront of that at this point. Great question. Thank you.
Albert Bourla: Okay. So now I think let's get the last question.
Operator: Our last question comes from Rajesh Kumar with HSBC. Good morning.
Rajesh Kumar: Two questions, if I may. Appreciate you cannot say a lot about Metsera at this junction. Just from, you know, 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 Mitra at the moment, in 2026, on your own internal budgeting. That would be really helpful. And some of the trials have just started. When can we to see data news flow come out of that deal? Is it more a 2027 event or we have any interim readouts or updates in '26?
Albert Bourla: Thank you. I think Dave can answer the Metsera modeling.
David M. Denton: 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 first bite. Yeah. The data flows. So just a reminder, ASCO twenty-five, we shared phase two monotherapy or the shared by three by phase two monotherapy and data. And first-line non-small cell lung cancer showing the overall respond objective response at sixty-five percent. At ESMO, phase two combo data plus chemotherapy, zealoxa or modified four fox six was shown for first-line metastatic restoration. Sorry. Metastatic colorectal cancer, and that was showing a response rate of close to sixty percent.
At SITC, we provide additional data, combination data in lung cancer And you've just seen we posted two phase three programs starting now this year in first non-small cell lung cancer and in first non-colorectal cancer And in the coming weeks, we'll also provide the full development plan to you at nVent, and that will be show the broad the breadth and the depth of our clinical development program for 07/2007.
Albert Bourla: Thank you, Chris. So, thank you very much all for your attention. You have been successful achieving a series of significant strategic milestones We delivered 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 annual revenue despite the lowest COVID right now trends. So thank you for your interest in Pfizer Inc., and, I hope you have a wonderful week.
Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time.