Good day, everyone, and welcome to Pfizer's Analyst and Investor Call to Review Full Year 2025 Financial Guidance. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.

Good morning, and welcome to Pfizer's 2025 financial guidance call. I'm Francesca DeMartino, 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 2025 financial guidance 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. 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 today. We said that 2024 would be a year of execution for Pfizer, and I'm very proud for our colleagues for how they have delivered. I'm pleased with our year-to-date performance and our positive impact for millions of patients around the world. Today, we are reaffirming our full year 2024 guidance and David will provide our guidance for full year 2025. Before I turn it over to David to do that, I want to make some brief comments about why we are confident in our future, including our ability to continue delivering on our financial commitments. We believe our company is in a strong position, and as we have shown so far this year, we are relentlessly focused on execution of our 5-point plan to drive sustained long term value and impact. One year ago, we met with you to discuss the completion of our acquisition of Seagen, the formation of Pfizer Oncology and the change in our commercial model with the creation of two more focused commercial divisions, the Pfizer US Commercial and the Pfizer International Commercial. Each of these actions strengthened our company and they have been key contributors to the success we have achieved in 2024, as we executed against our five strategic priorities. We will review our performance in greater detail early next year when we report our full year 2024 results. For now, I will mention a few highlights that illustrate progress across our company. First, the integration of Seagen has gone extremely well. We have been successful in retaining the vast majority of Seagen's talented colleagues and together we have created one of the most experienced and capable oncology teams in the industry. Our growth year-to-date is demonstrating the power of our commercial capabilities and the combined Pfizer-Seagen oncology portfolio. Second, I am also proud of the strong year of progress with our pipeline. The oncology R&D team has continued to excel across the portfolio, delivering five Phase 3 study starts including our next-generation CDK4 inhibitor, the ADC sigvotatug vedotin and our EZH2 inhibitor mevrometostat. Several of these medicines could potentially be mega-blockbusters. At ASCO, we shared long-term follow-up data for Lorbrena leading to rapid adoption of next-generation ALK inhibitor globally as a first-line treatment of choice. Finally, highlighting our continued commitment to developing novel current cancer medicines, the team this year has initiated eight first-in-patient studies to date in oncology, including studies of two new ADCs with our next-generation TOPO1 payloads and also our panKRAS inhibitor. For the rest of our portfolio, we are also moving forward with our programs for cancer cachexia, obesity, next-generation oral COVID treatment and potential vaccines for flu/COVID and C. difficile as well as our fifth-generation pneumococcal vaccine candidate with more than 30 serotypes. Recently, we announced that starting in January, Dr. Chris Boshoff will begin serving as our Chief Scientific Officer and President of R&D. We conducted a comprehensive selection process and Chris rose to the top with his scientific expertise and his focus on execution, his proven leadership and his vision for advancing our pipeline of potential new medicines and vaccines. Chris will bring discipline and strategic focus to leverage his strong track record in oncology and drive progress across our key therapeutic areas. Chris also will partner with Andrew Baum, our new Chief Strategy and Innovation Officer, to ensure that we focus our R&D investments on the most impactful opportunities. We will look forward to talking more about this with you in the coming months. Third, our commercial teams both in the US and internationally have delivered strong results so far this year across our diversified portfolio. In the US, our new commercial model is yielding benefits as our specialized teams are more effectively targeting key opportunities to serve patient needs. Internationally, our commercial organization is capitalizing on the global reach and local expertise to expand patient access to medicines and vaccines. Fourth, we have also demonstrated good progress with financial discipline in 2024. We are working to realign our cost base in support of potential expanded margins. We achieved our goal of $4 billion in net cost savings by the end of this year and we expect an additional $500 million in net cost savings in 2025 with our previously announced cost realignment program. We also are already making progress with our plan designed to reduce manufacturing costs by $1.5 billion by the end of 2027. And finally, we are also moving forward with our fifth key priority by strategically allocating our capital to enhance shareholder value. We have an unwavering commitment to our dividend and remain focused on delivering while also reinvesting in our company's future. We remain confident that our previously deployed capital toward business development will produce significant long-term shareholder value and some deals such as Seagen and the BioNtech deal, have been transformational for Pfizer. Overall, our 2024 performance through the third quarter demonstrates the underlying strength of our business. It shows why we are confident that we remain well positioned in 2025 and are on the best path forward to enhance shareholder value. With that, I will turn it to my partner, Dave.

Thank you, Albert, and good morning everyone. At the start of this year, we outlined our five strategic priorities emphasizing focus and execution across the company. We have successfully fulfilled our financial commitments by achieving three consecutive quarters of solid performance, including maximizing the growth of our newly launched products, establishing oncology leadership and advancing our pipeline. In addition, we have also delivered on our $4 billion cost realignment program goal and strategically deployed our capital. So with that backdrop, let me begin this morning by reaffirming the company's 2024 financial guidance. We expect our full year '24 revenues will be in the range of $61 billion to $64 billion. Additionally, when excluding revenues contributed by both Comirnaty and Paxlovid, we expect our operational revenue growth to be in the range of 9% to 11% compared to 2023. Furthermore, we expect adjusted diluted earnings per share to be in the range of $2.75 to $2.95 for 2024. Please note that our '24 guidance incorporates approximately $1.2 billion in one-time Paxlovid revenues and roughly $0.30 in adjusted diluted earnings per share from all non-recurring items. After excluding these items, the baseline midpoint for 2024, which is used for comparison to our 2025 guidance, is $61.3 billion in revenues and $2.55 in adjusted diluted earnings per share. Now, looking ahead to 2025, we have confidence in the strength of our business and our ability to deliver on our commitments, creating long-term value for our shareholders. We want to emphasize that our approach to establishing our guidance and our outlook for 2025 will follow a more standard and typical process as the COVID-related variability in our business is mostly in the past and the revenue outlook for our overall business is stabilizing. Looking forward into next year, we are both very comfortable with our outlook and have a good line of sight to delivering on our financial commitments. On a total company basis, we anticipate 2025 revenues to be in the range of $61 billion to $64 billion with adjusted diluted earnings per share in the range of $2.80 to $3.00 a share. When comparing the 2025 guidance to the midpoint of the '24 baseline, we anticipate a year-over-year operational revenue growth rate ranging from approximately flat to up 5%. Now what truly highlights our performance, however, is the growth rate of our adjusted diluted earnings per share which is expected to grow operationally by approximately 10% to 18%. This implies an operating margin expansion of over 250 basis points versus 2024. This meaningful growth is a testament to our expansion in operating leverage and the disciplined approach we take to drive sustainable growth. Now before moving on to our other P&L line items, let me touch on a few highlights in our revenue outlook for next year. First, the impact of the IRA Medicare Part D redesign is expected to be a net headwind to the company's revenue of approximately $1 billion across our product portfolio, dampening growth by approximately 1.6% versus '24. We expect our share of the catastrophic coverage to exceed the potential volume benefit from the reduction of the patient out-of-pocket cap. As a reminder, the IRA is felt more acutely in higher-priced medicines like Vyndaqel, Ibrance, Xeljanz which reach catastrophic coverage much earlier in the year. Our assumption for our entire vaccines portfolio is that there will be no material US policy changes in 2025. Next year, our COVID-19 products are expected to contribute to stable revenue baseline -- stable revenue base in line with our 2024 guidance after adjusting for the $1.2 billion in one-time Paxlovid revenues. We expect that both Comirnaty and Paxlovid will maintain their market shares with stable pricing due to their commercialization in both the US as well as international markets. For Comirnaty, we expect materially stable US vaccine rates on par with 2024 levels. We continue to expect revenue primarily concentrated in the back half of the year. The distribution between Q3 and Q4 will depend upon the timing of the strain selection and approvals by regulatory agencies. Now, outside the US, we have a material portion of revenues from advanced purchase agreements, mostly in the European Union. Now Paxlovid utilization is expected to follow infection rates and revenues may fluctuate based on the timing, duration and severity of COVID-19 cases. It is important to note that in the US, we expect certain Medicaid and Medicare patients to transition out of the patient assistance program in the first quarter '25. This transition will allow us to recognize additional revenues on a cash basis benefiting operating cash flow. Our non-COVID vaccine products are expected to remain a key contributor to our business. We expect Abrysvo to benefit from international market expansion in both adult and maternal indications despite competition and a narrowing US market opportunity in the near term given the ACIP recommendations. Now, the PCV market has been a topic of many recent conversations. It is important to note that approximately two-thirds of Prevnar revenues are derived from the pediatric market which is anticipated to remain consistent with a stable market share through the end of the decade. However, the adult indication, which accounts for roughly one-third of the revenues, is expected to face competition with limited catch-up opportunities in the over-65 population in the US. Nevertheless, there are potential growth opportunities in the 50 to 64 age group in the US as well as in international markets through the continued rollout of PCV20 for both indications. Given all these market considerations, we expect Prevnar's overall revenue to moderately decline in 2025. Oncology is expected to significantly contribute to our growth in the later part of the decade. Padcev is expected to benefit from continued uptake in first-line treatment in locally advanced metastatic urethral cancer. Lorbrena is expected to continue strong growth through share expansion into first-line treatment and long duration of therapy. However, Ibrance is expected to be impacted by continued competitive pressures across markets as well as generic entry in select markets as well as the IRA. Overall, it's important to note that in 2025 our oncology growth rate will be mathematically dampened due to the overlapping effect of the Seagen acquisition. We anticipate Vyndaqel's growth will be tempered primarily due to the unfavorable impact of the IRA and new competition in the US. Internationally, increases in diagnosis and treatment rates is expected to drive continued expansion. And Eliquis, while over 10 years in the market, is expected to continue to grow through market and share expansion supported by strong data. We expect Nurtec to continue to benefit from commercial execution as well as ongoing HCP and patient engagement and education and to a lesser extent by uptake outside the US. And lastly, Xeljanz is expected to continue experiencing competitive and pricing pressures as it approaches patent expiry in the US and Japan towards the end of 2025 as well as the impact from the IRA. With that, now moving further down the P&L, total adjusted SI&A and R&D expenses are expected to be in the range of $24 billion to $26 billion and reflect the $4 billion in savings achieved from our cost realignment program. We anticipate an additional $500 million of savings from the program in '25 as we continue to aggressively control our costs. Specifically, the company expects adjusted SI&A expenses will be in the range of between $13.3 billion to $14.3 billion, a reduction of $500 million versus our 2024 guidance as we continue to focus on driving operational efficiencies. Adjusted R&D expenses are expected in the range of $10.7 billion to $11.7 billion, reflecting continued focus and prioritization in key therapeutic areas. As we enter next year, we will be focused on driving efficiency in our R&D organization with any resulting operational savings expected to be strategically reinvested in research to further fuel innovation and our long-term product development. The effective tax rate on adjusted income is expected to be approximately 15%, largely reflecting the impact of Pillar 2 and jurisdictional mix of our income. And while not part of our official guidance, adjusted gross margin is expected to be in the mid-70s which takes into consideration our expected product mix, the net impact of IRA Medicare Part D and the anticipated initial savings from Phase 1 of our manufacturing optimization program expected in the latter part of 2025. Now, as we cycle into 2025, we anticipate modest revenue growth of approximately flat to up 5%, but our unwavering dedication to driving operational efficiency will play a pivotal role in achieving an expected meaningful 10% to 18% growth rate and adjusted diluted earnings per share. We maintain our strong commitment to both maintaining and growing our dividend as well as meeting our de-levering targets by the end of 2025. We plan to continue to monetize our stake in Haleon over time, given consideration to our cash flow requirements as well as future market conditions. In closing, I'd like to emphasize several key aspects of our business. First, we believe we are entering a phase of revenue stability as the uncertainty caused by COVID are mostly resolved. Additionally, our cost-improvement programs have laid the groundwork for ongoing margin expansion. We will continue our focus and execution to maximize the commercial value of our product portfolio. Our new R&D leadership is dedicated to raising the bar for future innovation and strengthening our pipeline. And lastly, we have a clear line of sight to reloading our balance sheet, enabling us to effectively deploy capital and pursue additional opportunities to both strengthen our business and create value for our shareholders. And with that, I'll turn it back over to Albert and for Q&A.

Thank you, Dave, and a very good summary at the end. Now, operator, please assemble the queue.

[Operator Instructions] And we will take our first question from Chris Schott with JPMorgan. Please go ahead.

Great. Thanks so much for the question here. I guess my question was really centered around gross margins. You're targeting mid-70s this year, but as we look past 2025, how much additional opportunity is there for improvement as we consider maybe not just Phase 1 of the restructuring, but some potential future opportunities you've highlighted as well? I guess I'm trying to get a sense of like are upper 70s are realistic target for longer-term gross margins. And if I can slip in a second quick question just on capital allocation, I know de-levering has been a priority. Do we think about 2025 as a year we should think about maybe potential for acceleration of BD and capital return or is that more 2026 and beyond? Thank you.

Chris, this is Dave. I'll take the question. Clearly, upper 70s from a gross margin perspective is a target for us and it is attainable. Let me just frame up a bit about our manufacturing optimization program. The team has worked really hard to identify and execute against our savings plan. Realistically, those savings get realized as we produce products into inventory and those savings get -- become realized through the P&L once we sell the inventory as we cycle through 2025. So there is a delay in the P&L of seeing the savings through the financial statements versus what's actually happening at the moment. So you're seeing a partial benefit in '25. You'll see more benefits as we wrap into '26 and '27. Secondly, on the capital allocation perspective, yes, our dedication is supporting our dividend, investing in our business as well as de-levering. You would expect that we -- you would not see us do large BD in 2025. That's largely a '26 and beyond focus for us. Having said that, as I've always stated, we always have a little flexibility to do BD in the near term as we see appropriate assets that would enhance our value long term.

Thank you very much, Dave. Let's go to the next question, please.

Thank you. And we will take our next question from Geoff Meacham with Citibank. Please go ahead.

Morning, guys. Thanks for the question. Dave had another one on capital priorities. I know you guys are committed to the dividend. I did note that you said raising it is also a priority. But would you say de-levering is by far the main focus for 2025? And I know there's been a lot of market chatter on potential spin-off of your hospital business. Wanted to get maybe any comments on that with respect to strategy and potential use of proceeds. Thank you.

Yeah, Geoff, the good news actually both supporting our dividend and growing our dividend as well as de-levering are both very high in our priority list and fortunate for us as our business is able to generate enough cash flow to be able to do both in 2025. So I put them on par from that perspective. And then secondly, while I won't on any market rumors, I would say that we are constantly looking at our business, understanding the assets that we have within our business that might perform or look differently outside. So we're constantly doing that evaluation to make sure what is the best value-creating opportunity for Pfizer in the long term. And we will continue to be resilient on that with all the businesses within Pfizer at this point.

Thank you, Geoff, for the question and thank you for the very clear answer, Dave. Let's go to the next question.

Thank you. And we will take our next question from Steve Scala with TD Securities. Please go ahead.

Thank you so much. Dave, you used the term revenue stability. Does that mean flat revenue through the end of the decade or a consistent revenue growth rate? And if the latter, then is Pfizer considering reinstating the 6% longer-term revenue aspiration that was pulled a year ago? And if not, what are your reservations? So that's the first question. And second, if Pfizer were planning to co-develop danuglipron with an established obesity company, would any financial implications of that be in the 2025 guidance? And would you need to call that out? Thank you.

Yeah. So, maybe I'll take the last one first is from a danuglipron, we do not have a co-development program baked into our expectations for 2025. So that would be different and new and unique. So we would come back to the market if that were to happen. So, number one. And then secondly, my revenue stability comment was not reflective of us having flat revenues through that time period. It was actually -- the revenue stability was a comment saying that largely the COVID variability is in the past for Pfizer. Keep in mind, let's cycle back a couple years. COVID was roughly $55 billion in revenue. This year is just around $10 billion in revenue. The air -- the size of the air bars around our expectations as we look forward for COVID revenues is much smaller. So therefore there's some stability now as we think about projecting out our revenues for '25, '26 and beyond. So that is the meaning of the statement. We have not given long-term expectations to the end of the decade at this point.

Okay. Thank you very much. Let's go to the next question, please.

Thank you. And we will take our next question from Tim Anderson with Bank of America. Please go ahead.

Well, thank you. Albert, I think you met with Donald Trump recently. Has Pfizer met with others from his administration, including RFK Jr.? And any color you're willing to provide on how any of those discussions have been going? I think there's obviously uncertainty on the vaccine front what the downside risk could be to COVID if they directly target COVID vaccines and maybe on that latter point, what would be a realistic downside scenario to COVID revenues in the US in 2025?

Thank you for the question. As it was written in the press and this -- actually the President confirmed in few interviews, including yesterday, we did have dinner with him and as the President said, he invited also Mr. Kennedy to that dinner. We had, and me personally, a very long-lasting relationship with President Trump that during his first term was cemented, particularly during the Operation Warp Speed period that the President is extremely proud and of course we are extremely proud. That basically delivered a vaccine through this landmark golden standard program, the Operation Warp Speed, actually not one, but two vaccines, that they saved millions of lives. And I know that the President is very proud of it. I don't want to speak about the details of what we discussed during that dinner because I want to respect the privacy. But we developed a good relation with Mr. Kennedy and he's now going through the confirmation. If he's confirmed, we will work with him to make sure that we advance the right policies. We are not interested in politics, we are interested in policies. And whoever is in the health, whoever has -- is in the leading position, we will work with them to accomplish. Really, I can't speak about what Mr. Kennedy's beliefs are and will be. But I can say that on the vaccines particularly that the President is very proud of the work that was done with the vaccine and because he and his program contributed significantly. Thank you for the question. Next question, please.

Thank you. And we will take our next question from Chris Shibutani with Goldman Sachs. Please go ahead.

Thank you very much. If I could just ask you, Albert, to follow on and potentially address the topic of drug pricing, particularly in the US with IRA implementation, but also internationally, I think there's been some talking points that have been out there in the media and amongst investors about most favored nation, whether or not there's potential to perhaps potentially increase pricing outside the US. Any commentary that you can share, perhaps stemming from the discussion that you had with the President-elect would be helpful. Thank you.

It's very -- I don't want to go into details because as I said, I want to respect the privacy of these discussions. However, I can make some comments based on what the President chose to release in his interview. He spoke particularly yesterday and -- but also in previous interview that he gave over the previous weekend. He did speak that, that was -- he did reveal, but that was a topic that was discussed. And the President has very strong views, as he articulated recently and before from his very first term for the middlemen, the PBMs, that he wants transparency. It's very clear. He wants that the savings even more importantly will pass to the patients which they will see dramatic reduction in the cost they are experiencing with their medicines if that happens. And it seems to me that he is very committed to make this happen. Internationally, I think that the other countries should step up and pay their fair price for innovation and we are really focusing on doing that. Thank you. Next question, please.

Thank you. And we will take our next question from Trung Huynh with UBS. Please go ahead.

Hi, guys. Two questions, please. Just firstly, can you outline some of the Part D impact per drug? Your commentary was super useful here. So, you said that there's a volume uplift, but you're also going to have an impact for the higher-priced products. Just quantify that impact for the key products. We're not surprised through the year. And are there going to be any winners from Part D? And then you mentioned the current OpEx guide that includes the additional $500 million saving in '25. Can you contemplate the spend associated with a broad Phase 3 program in obesity? And could this guide change based on the QD danuglipron data that reads out at the start of next year? Thank you.

Yeah. Well, maybe I'll start with the danuglipron question. Just to clarify, if we move danuglipron into Phase 3 and we'll have more data here in Q1, we have -- that is contemplated within our 2025 budget for R&D. So that is -- that would be -- there'd be no change to our expectation or guidance if we move to Phase 3, number one. Secondly, from a Medicare Part D perspective, I probably can't get you a byproduct, but maybe I'll step back and give a little clarity just kind of how this works. Once you reach the catastrophic phase within Part D, the -- our commitment or our responsibility is 20% of the price. So think about it the fact that basically in those catastrophic phases, we are contributing a 20% discount to the price of our product at that point in time. So you can imagine a product like Vyndaqel that gets into the catastrophic coverage pretty quickly because of its current price point, we dampen our growth rate by 20% from a price perspective despite the fact that utilization is going up, number one. Secondly, if you just step back and look at the puts and takes across our business, it's a $1 billion net negative to us or 1.6% dampening of our growth rate. But if you think about it, there's probably about $500 million of uptake, higher utilization because of the lower out-of-pocket offset by $1.5 billion of headwinds from the catastrophic phase, netting us down to $1 billion in 2025. And then finally, for your question around the additional $500 million, we continue to work that expectation into our plan. We have really good line of sight to that. The incremental cost of that has been factored into our one-time expectations for the program. So, nothing incremental from that perspective at this point.

Thank you. And clearly, utilization of technology and also, let's say, optimization of our operations is part of our plans to achieve those $500 million. And I'm happy that you clarified the danu question, Dave, before you spoke about co-development and indeed we don't have plans to co-develop it which will be less development cost, but the cost of a Phase 3 is incorporated in case. But we'll start. Let's go to the next question.

Thank you. And we will take our next question from Vamil Divan with Guggenheim. Please go ahead.

Great. Thanks for taking my questions. I have two if I could. One is a follow-up on Comirnaty and I know you commented that your guidance assumes no major policy changes around vaccines. I'm curious how you just thought about maybe just the rhetoric around vaccines and if there's more discussion about the vaccine, maybe more anti-vaccine or anti-COVID vaccine sentiment, how that could impact use of the product even if there is no actual policy changes. And then my second question, maybe just as we're thinking about 2025, I'm curious maybe I guess for Albert, just while you point to sort of the key data events that we should be focused on, obviously a lot of attention on danu in the first quarter, but just other sort of key pipeline events that you think you maybe are underappreciated right now that investors should be focused on. Thank you.

Yes. Thank you, Vamil. On Comirnaty in general, which is first of all, Dave made very clear that our expectations and this is where we build our forecast is we will not have any major changes in the US policy in 2025. And I believe that will be the case. But of course, we are very alerted and that's why we had these very productive discussions with the incoming Trump administration to ensure that the health and safety of the people that are using our products is there. In general, on the COVID and Paxlovid stability, it's very, very clear now that it is -- they are following identical patterns over -- year after year. The uncertainties and the things that could skew sales year-over-year were more related with the switch to commercialization or one-time events like the Paxlovid with the US Government building stock and then releasing the stock and all of that which are all behind us. Now we have commercial models and -- but they utilize -- and stable price. But the utilization is following identical patterns year after year after year. And I'm just watching in front of me right now, I'm staring the CDC charts of the of the wastewater COVID over the last three, four years. And every year, we have two waves and this year we have it in -- last year, we said the COVID wave in Q2 and Q4. This year, we had the COVID waves in Q3 and we are just experiencing an uptick that is very predictive with very high accuracy. I can say that we are expecting now a new wave of COVID as we are exiting '24 and we are entering 2025. So that means that both utilization of Paxlovid will be very stable at the levels that we had with very stable pricing with the only caveat that prices will increase for some patients that will go out of the path in Medicare. And in vaccines, again, we are trending very, very close to what was the vaccination rates of last year. And with a new wave, I think the vaccination rates will increase. Those are my comments on the vaccines. Was there another question? Yes, a very important question that what you should focus next year. Let me start with some readouts that I think are important because next year is very rich in some of these catalysts. Clearly, we are expecting the protein inhibitor the second-line metastatic ER-positive breast cancer to come next year. In Braftovi, the breakwater, it is for Braftovi in colorectal cancer. We are expecting also that readout to happen next year. The Sasanlimab which is our subcutaneous PD-L1 for non-muscle invasive bladder is coming next year. We have Elrexfio plus daratumumab in double class exposed multiple myeloma that is coming next year. We have the hemophilia A and B with inhibitors coming next year. Those are some of the important readouts. But there is a tremendous activity in Phase 3 starts for next year. Let me start with the next-generation COVID which actually we were expecting to start with next year, but I have -- I can tell you now that the study started already recently. Of course, danu, we expect to see the final results that we can start a Phase 3. Nurtec, we plan to start in menstrual migraine. Of course, ponsegromab with cancer cachexia, we plan to start. And CDI, with the vaccine against C. difficile that we are also looking forward to starting the Phase 3. In oncology, which is even more richer the pipeline, we have the CDK4 start that we expect in the first-line HER -- HR+ metastatic breast cancer, I repeat first-line. We have basically four Phase 3 studies with SV which is a new ADC from Seagen. We have one with TPS-high non-small lung -- cell lung cancer. We had one with head and neck squamous cell carcinoma. We will have also an all-comers squamous non-small cell lung cancer and all-comers squamous, not small cell lung cancer. Those are four new studies that we expect with -- I spoke about CDK4 of course, KAT6 plus endocrine therapy in second-line metastatic breast cancer and a very important product that we have high hopes because of the early data. It is our PDL1V ADC which is a very novel concept and we expect to start again Phase 3 next year. So, as you will see, it's very, very rich in terms of expectations next year. So with that, I think we have time for one more question. Operator, can you please take the last question?

Thank you. And we will take our last question from Evan Seigerman with BMO Capital Markets. Please go ahead.

Hi, guys. Thank you so much for taking my question and congrats on the really reasonable and clear guidance. So, a year into the Seagen acquisition closing and it's mostly being integrated now, how do you see the growth profile of the assets from this acquisition contributing to the broader plan revenue growth going forward? How significant of an accelerant are these assets beyond Padcev? And where do you see the greatest growth coming from the acquisition? Thank you, guys.

Thank you. We -- when we did the acquisition, we set a goal that by year 2030, we expect that the Seagen acquisition will deliver $10 billion of revenues. We stay with this projection, but I think that we are advancing way better in the first years than what we thought we would. Actually, we are advancing way better than what the state thought that the Seagen acquisition will do. I also spoke for so many Phase 3 studies that they just started. Those clearly are not part of the $10 billion of this acquisition. So a reasonable success in any of them, full success in all of them, I mean, it's going to blow up the number big time. But reasonable success in some of them will clearly deliver higher value. And even the most important of the Seagen is that this is a platform that first of all, it is not facing -- it's very difficult to have generic competition. Basically, there is no regulatory path for an ADC to develop a biosimilar. And actually, it's extremely challenging for anyone to develop an ADC and prove that it is biosimilar. So it's pretty much LOE-free right now with the current science asset. And the other one it is that the platform is delivering constantly new Phase 1, Phase 2, Phase 3 studies. So, this is why I believe that the Seagen acquisition has been transformational. I think that the trends in the world and very much most key opinion leaders agree that chemotherapy will be replaced in the next 10 years largely by targeted chemotherapy, which is the ADCs. And right now, chemotherapy, it is the vast majority of cancer treatment. So, with that, I think that I would say what excites me -- I think I will close by saying what excites me for next year. And the first one is this one, I just spoke about the pipeline expectations, but I would say that with the new Head of R&D, I'm very excited about our R&D refocus efforts. We have very good performance on oncology. We have very good performance in vaccines. And the other therapeutic areas, we have tremendous capabilities that with the right focus will deliver significant new assets. So our goal is to turn around internal medicine and INI and bring it to the levels of oncology and vaccines that we are having right now. Another thing that also excites me is that I believe in even the most skeptical investors. Finally, we realize that the COVID revenues are stable. Will be next year the fourth year of an identical pattern for the first three, I believe will be for the fourth year. And that will provide some stability, as Dave said, in the expectations for revenues and probably will assign the right demand. And thirdly, I'm very excited because with Dave's leadership, our capital allocation has become really, really strategic. And right now it is very -- it was investing in the business in '23, largely with very big acquisitions. Then going forward, maintain the growth in dividend, paying down the leverage that we took to invest in the business and start, let's say, using other forms of capital allocation that we will see next year, so -- and then of course 2026 and '27 further. So I think I'm very optimistic that '25 will be a year of continuous commercial execution and R&D turnaround.

With that, I want to wish everyone Happy Holidays. Merry Christmas, Happy Hanukkah for everyone out there and Happy Ramazan. And we are going to have another call in end of January at that time frame when we will announce the results of our last quarter. Thank you very much to all. Happy holidays.

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