Pfizer Q4 2024 Earnings Call Transcript

Skip to Participants
Operator

Good day, everyone, and welcome to Pfizer's Fourth Quarter twenty twenty four Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DiMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.

Francesca DeMartino
Francesca DeMartino
Chief Investor Relations Officer at Pfizer

Good morning, and welcome to Pfizer's earnings call. I'm Francesca DiMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at fizer.com. Earlier this morning, we released our results for the and full year 2024 via a press release that is available on our website at pfizer.com.

Francesca DeMartino
Francesca DeMartino
Chief Investor Relations Officer at Pfizer

I'm joined today by doctor Albert Borla, our Chairman and CEO, and Dave Denton, our CFO. Albert and Dave have some prepared remarks, and we will then open the call for questions. Members of our leadership team will be available for the Q and A session. Before we get started, I want to remind you that we will be making forward looking statements and discussing certain non GAAP financial measures. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning and the disclosures in our SEC filings, which are all available on the IR website at visor.com.

Francesca DeMartino
Francesca DeMartino
Chief Investor Relations Officer at Pfizer

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.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you very much, Francesca. Good morning, everyone. Thank you for joining us today. 2024 was a strong year of execution and performance for Pfizer. We were guided by clear strategic priorities and we met or exceeded our goals for each one, while also delivering on our financial commitments.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

I'm pleased with the progress we made in executing transformative changes that strengthened our company. First, we successfully integrated the Seidgen business, one of the largest investments we have made in the past decade, creating one of the best oncology companies in the industry. At the start of 2024, we split our commercial operations into two divisions, U. S. And international, and appointed two senior commercial leaders to increase focus in both.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Amir Malik and Alexandre Tessegaume have done a tremendous job to upgrade our commercial capabilities. They consolidated our external agencies, Tau, to one powerhouse, global advertising company and leverage the power of AI to transform our marketing and selling engine. New data driven deployment of our commercial and medical field resources, precision market retargeting in social media and elevation of the Pfizer brand and commercial communications are some of the strategies that have significantly increased our commercial and medical effectiveness and returns on investment. We are seeing the impact of these actions in our strong financial performance and in the recognition of our market leaders. We earned the top position in the 2024 ranking report and improved our ranking to claim number one or two spot in 70% of the specialties in which we focus.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

I'm also proud of our strong year of pipeline progress in 2024, including more than a dozen approvals, seven pivotal study starts and eight key Phase III redoubts. I'm very excited with the changes in our R and D engine under its new leaders. Priscis Bosef moved fast to create four end to end R and D units focused on oncology vaccines, internal medicine and inflammation and immunology. This structure fully empowers research units that can operate with the focus and agility of a biotech company while tapping into our differentiated enterprise wide capabilities such as AI powered drug discovery and development. Our focus on financial discipline also has yielded good results.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

We ended the year with expanded margins after a series of actions to realign our cost base. And we strategically deployed capital to enhance shareholder value, investing nearly $11,000,000,000 in support of internal R and D programs, delivering by $780,000,000,0.0 and returning $950,000,000,0.0 directly to shareholders through our dividends. Finally, we also reinforced our commitment to strong governance. Our two new board members bring deep expertise in financial markets and shareholder value creation. All these changes have created a strong foundation and allow us to start the new year from a position of strength.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

So now let me speak about our 2025 priorities. Last year, we had a significant emphasis on improving our commercial effectiveness. In 2025, the emphasis will move to improving R and D productivity while maintaining focus on margin expansion, commercial excellence and shareholder lending capital allocation. Let me start with R and D. Across our pipeline, we believe we have a strong year of catalyst ahead of us and expect our new R and D organization to achieve multiple key milestones, including the possibility of at least four regulatory decisions, up to nine potential Phase III readouts and 13 potential pivotal program starts.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

For example, with at tirmusiklub, our next generation highly selective CDK4 inhibitor candidate, yesterday, we dosed our first patient in a Phase III study in first line metastatic breast cancer. We also anticipate starting an additional first line study in combination with the Dengestran, the ER degrader, we are co developing with Arvivas. Our ADC, sigglotatab, vedotin, continues its Phase III study in second line non small cell lung cancer. And this year, we expect to start a Phase III study in first line non small cell lung cancer. Our PD L1VADC candidate, a potential first in class PD L1 targeting adcoc, is expected to begin two Phase III studies this year: One in first line metastatic head and neck squamous cell carcinoma and one in second line plus non small cell lung cancer where the unmet need is significant.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

We have a robust clinical development program aimed in expanding eurexial indications in multiple myeloma. And this year, we anticipate the readout of a Phase III study in double class exposed relapsed refractory multiple myeloma that if successful and approved, will triple the addressable population versus the currently approved indication. In vaccines, we expect to start the Phase III study this year for our PCV25 candidate, covering 25 serotypes. This is important foundational work that could help us bridge to and accelerate progress with our fifth generation PCV candidate covering more than 30 serotypes. This year, we also expect to start a Phase III study for our CIDDET vaccine candidate.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

In internal medicines, we remain on track to provide an upgrade of our dose optimization studies of dalguilper in the For parcegroma, we expect to start a pivotal study this year in cancer CACXI. And Ibusatrelvir, our second generation COVID-nineteen oral antiviral candidate continues its Phase III study. Within IAI, we continue to progress a portfolio of medicines that include two potential first in class tri specific antibodies currently in Phase II. Now let's discuss our commercial strategy. 2024 was a strong year of commercial execution, and we are pleased with our progress in improving performance of our newly launched products and gaining and maintaining market share for several of our core brands.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

I would start by highlighting the strength and impact of our oncology portfolio. PADCEB plus pembrolizumab is an important growth driver as it has already become the number one prescribed first line treatment for locally advanced metastatic urothelial cancer in The U. S. We are expecting potential registrational interim data this year from ongoing pivotal studies in muscle invasive bladder counts, which if successful and approved, would nearly triple the total addressable patients in The U. S.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

BRAFTOVI, MEKTOVI achieved a 27% year over year worldwide operational growth and expanded its leadership position in multiple BRAFT tumors, which are some of the hardest to treat cancers. Yesterday, we announced that BRAFTOVI in combination with cetuximab and M4 FOX6 showed statistically significant and clinically meaningful improvement in progression free survival and overall survival in patients with metastatic colorectal cancer with BRAF V600E mutation. We are very excited with the robust improvement in PFS and OS and are looking forward to presenting this data in a scientific conference. LORBRAVENA, a treatment for adults with ALKi ALK positive metastatic non small cell lung cancer achieved thirty seven percent worldwide year over year operational growth and is emerging as a potential standard of care in the first line setting. Following unprecedented CROWN trial data showing sixty percent of patients were alive without disease progression after five years, LORBRANA has seen a double digit share increase in the first line in both new patient starts and new prescribers.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

ELEXVIO had a strong performance in 2024 with more than $130,000,000 in full year revenues and increasing overall share within a class of BCMA directed biospecific antibodies for patients with triple class exposed relapse or refractory multiple myeloma in The United States. I also want to comment about our COVID-nineteen portfolio. We continue to see stabilizing patterns in the disease burden with a strong correlation between the COVID-nineteen burden of disease and Paxlovid utilization. We see the same stabilizing patterns in U. S.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Vaccination rates at relatively low levels. Our assumptions for 2025 are on par with these 2023 and 2024 patterns. And with the multiyear contracts we have secured in international markets, we are confident that our COVID-nineteen portfolio will continue to be a predictable and durable contributor to our business. In another key category, our Vintracal family of products achieved continuing momentum with 90% year over year growth in The U. S.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And 32% operational growth in international markets. We drove progress in diagnosing more patients and improving access to this treatment from for transthyretin amyloid cardiomyopathy. Eliquis is a core brand for Pfizer with 10% worldwide year over year operational growth. It is prescribed to millions of patients and we continue to strengthen its leadership position in a growing oral and coagulant market. We are also pleased with the ongoing positive momentum for Nurtec with 36% worldwide year over year operational growth, driven by strong commercial execution.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Dorte is a leader in the oral CGRP class used for treating and preventing migraine with about 49% market share, and we see opportunities for continued growth. Our respiratory vaccines, Abrasivore and PREVNA20 also are key products in our commercial portfolio. We have achieved a market leadership position for the season in sick dose for Abrasivore with an approximately 13 percentage points increase in market share and remain confident in our ability to retain our position through strong commercial execution even as we see a decrease in the total adult RSV market volume driven by a reduction in vaccination rates in The U. S. For the older adult indication.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

We have seen positive momentum in key regions such as Europe and Latin America and are also seeing a strong demand for our maternal indication. A business season today cumulative maternal vaccination rate nearly tripled compared to last season. With Prevnar, we are confident that we are well positioned for strong sustained leadership with over 87% market share in The U. S. Across indications.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Globally, the pediatric market accounts for approximately two thirds of our Prevnar revenues, and we also continue to make progress for the adult indication in key international markets. We are encouraged by opportunities to maintain our leadership in the PCV space with our next generation PCV25 candidate mentioned earlier. In Phase I, we demonstrated potentially improving immunogenicity for serotype three, one of the largest contributors of disease, at approximately twenty percent of infectious disease in adults aged 65 and older in The United States and Europe. Across our commercial portfolio, in 2025, we are confident that we are in a strong position to build in our 2024 success and achieve commercial excellence in our key categories of oncology, cardiovascular, migraine, vaccines and INR. With that, I will turn it over to David.

Dave Denton
Dave Denton
CFO at Pfizer

Thank you, Albert, and good morning, everyone. I'll build on Albert's comments by reinforcing that we are very pleased with the financial results for both the as well as the full year of 2024. These results demonstrate that our focus and execution against our strategic priorities are driving both positive patient outcomes as well as financial and operational strength. In addition to our strong top line performance, our cost reduction programs are creating a more efficient organization driving operating margin improvement. And as we move into 2025, these efforts will continue to lay the groundwork for potential increased capital returns and reinforce our commitment to maintaining and growing our dividend while enhancing long term shareholder value.

Dave Denton
Dave Denton
CFO at Pfizer

With that said, let me start with our full year and results, then I'll touch on our capital allocation priorities. I'll finish up with a few comments on our 2025 guidance, which we are reaffirming today and our near term expectations that will continue to drive our growth potential in the latter half of the decade. For the full year of 2024, we recorded revenues of $6,360,000,000,0.0 versus $5,960,000,000,0.0 last year. Importantly, our operational revenue growth when excluding contributions from our COVID products was 12% exceeding our expectations of 9% to 11%. Full year 2024 adjusted gross margins expanded to 74% as we continue to drive cost improvements across our manufacturing network.

Dave Denton
Dave Denton
CFO at Pfizer

On the bottom line, we reported full year 2024 diluted EPS of $1,.41 versus 0.37 last year and adjusted diluted earnings per share of $3,.11 versus $1,.84 last year, significantly ahead of expectations due to our overall strong P and L performance. Now turning to the performance versus the same period of LY, let me walk down the P and L. Total company revenues were $1,780,000,000,0.0 versus $1,460,000,000,0.0 in the Once again, our non COVID-nineteen products exhibited robust performance with revenues of $1,370,000,000,0.0 reflecting 11% operational year over year growth. This performance continues to show that a refined commercial approach is working. We continue to focus on key products and geographies.

Dave Denton
Dave Denton
CFO at Pfizer

We've refined how we allocate our commercial field resources globally and we further optimizing our marketing resources into key priority areas. We saw strong contributions across our product portfolio, primarily driven by the Vindicel family, PADCEV, Aliquis and Nurtec, partially offset by declines in Brisvo and Xeljanz. Adjusted gross margin in the was approximately 68%, primarily the result of a net unfavorable mix related to our COVID-nineteen products, primarily due to the Comirnaty profit split with BioNTech and applicable royalty expenses. This was partially offset by an ongoing focus on cost management across our manufacturing network as I previously mentioned. And as we previously communicated, long term improvements in gross margin will remain a key focus for the company over the next few years.

Dave Denton
Dave Denton
CFO at Pfizer

We expect to begin to achieve initial savings from phase one of our manufacturing optimization program in the latter part and continue to expect approximately $150,000,000,0.0 in savings from this first phase by the We continue to evaluate other strategies to improve our network structure and as well as our product portfolio and we plan to share more information on those components of the program once it becomes available. Total adjusted operating expenses are essentially flat operationally at 7300000000.0 in the And I will note that this amount includes spending acquired via our CGen transaction. Looking at the component specifically, adjusted SI and A expenses decreased 4% operationally driven primarily by a decrease in marketing and promotional spend for various products including both Comirnaty and Paxlovid partially offset by an increase in spending for certain oncology and recently launched and acquired products. Adjusted R and D expenses increased 8% operationally, driven primarily by a net increase in spending mainly to develop certain product candidates acquired from Seagen, partially offset by lower spending on certain ongoing vaccine programs and certainly as a result of our cost realignment program. We continue to be disciplined with our operational expense management and delivered on our goal of at least $4,000,000,000 in net cost savings from our cost realignment program.

Dave Denton
Dave Denton
CFO at Pfizer

Reported diluted earnings per share was $0,.07 and our adjusted diluted earnings per share was $0,.63 benefiting from our top line performance as well as our efficient operating structure, partially offset by a higher effective tax rate driven primarily by jurisdictional mix. In support of our goal to enhance R and D productivity and to focus on high impact medicines, our GAAP results reflect strategic decisions in our development plans and updated long range revenue forecasts for several medicines. And as a result, we recorded approximately $290,000,000,0.0 in non cash intangible asset impairments related to several medicines in development as well as several in line products. These decisions reinforce our focus on future growth as well as innovation. Now let me quickly touch upon our capital allocation strategy which is designed to enhance long term shareholder value.

Dave Denton
Dave Denton
CFO at Pfizer

Our strategy consists of maintaining and growing our dividend over time, reinvesting in our business at an appropriate level of financial return, and finally making value enhancing share repurchases after delivering our balance sheet. In 2024, we returned $950,000,000,0.0 to shareholders via our quarterly dividend, invested $1,080,000,000,0.0 in internal R and D, and as expected completed business development activity was minimal. Our commitment to delivering our capital structure to a gross leverage target of 3.25 times by the remains a key priority. In support of that goal in 2024, we delivered by approximately $780,000,000,0.0 paying down approximately $230,000,000,0.0 in maturing debt and approximately $550,000,000,0.0 in commercial paper. And in we monetized another tranche of our Halion shares, which for reporting purposes is a event.

Dave Denton
Dave Denton
CFO at Pfizer

We received approximately $3,000,000,000 in net cash proceeds and now our ownership in Halion was reduced from approximately 15% to approximately 7%. We intend to monetize our remaining Halion investment in a prudent fashion during 2025. Overall in we generated robust operating cash flows, which combined with the most recent Halion net sales proceeds of approximately $3,000,000,000 resulted in significant free cash flow generation as we enter 2025. Our objective remains to deliver and return to a more balanced allocation of capital between reinvestments and direct return to shareholders over time. Given we issued our full year 2025 financial guidance on let me just hit a few highlights.

Dave Denton
Dave Denton
CFO at Pfizer

We expect total company full year '25 revenues to be in the range of $61,000,000,000 to $64,000,000,000 and full year '25 adjusted diluted earnings per share to be in the range of $2.8 to $3 a share, which reflects our expectation of strong contributions across our product portfolio as well as our focus on disciplined cost management. Importantly, we believe the steps taken to right size our cost base will put us on a strong footing towards increased operational efficiency and support our goal to return to pre pandemic operating margins. In further support of this initiative, we now expect to deliver overall net savings of $450,000,000,0.0 from our ongoing cost relying programs by the while continuing to advance programs that will improve cost of goods sold in the years to come. As a reminder, the impact of the IRA Medicare Part D redesign is expected to be a net headwind to the company's revenue of approximately $1,000,000,000 across our product portfolio, dampening growth by approximately 1.6% versus 2024. The impact of catastrophic coverage is expected to exceed the potential volume benefit from the reduction of a patient out of pocket cap, leading to a negative impact beginning in early in the year, while the positive impact of lower patient out of pocket costs is expected to build throughout this year.

Dave Denton
Dave Denton
CFO at Pfizer

As the IRA is felt more acutely in higher priced medicines, we expect Vindical, Ibrance, Xandy, and Xeljanz to reach catastrophic coverage much earlier in the year. And due to these changes, we expect a higher gross to net impact on our revenues for all drugs in the that is expected to moderate throughout the remainder of the year when compared to 2024. And lastly, I will mention that we continue to monitor currency fluctuation as the year progresses. So in closing, let me just emphasize several key aspects of our business. We believe our financial targets for 2025 are both reasonable and achievable reinforcing our commitment to operational excellence.

Dave Denton
Dave Denton
CFO at Pfizer

We also believe our revenue volatility is largely in the past as covid related uncertainties have diminished. Additionally, our cost improvement programs have set the stage for ongoing margin expansion. We will continue our focus and execution to maximize the commercial value of our product portfolio and our new R and D leadership is committed to driving value creating innovation and strengthening our pipeline. And lastly, we have a clear path to reloading our balance sheet, enabling enhanced capital deployment and pursuit of additional opportunities to strengthen our business and create value for our shareholders. We are dedicated to maintaining and growing our dividend and meeting our delivering targets by the providing for a more balanced capital allocation.

Dave Denton
Dave Denton
CFO at Pfizer

And with that, I'll turn it back to Albert to start the Q and A session.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Yeah. Thank you, David. But before we turn to the questions, I would like to close the year with one comment. Pfizer knows how to execute well when we set our focus on something. We saw what we could do in 2020 when we rapidly developed and prepared to manufacture billions of doses of the COVID-nineteen vaccine, in 'twenty one when we repeated the same with Paxlovid and in 'twenty two when with successful commercialization we exceeded 100,000,000,000 in full year.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

In 2023, despite the difficulties with the rebase COVID-nineteen expectations, we invested in our future with a big bet in oncology with the acquisition of Seatsheet. And last year, we exceeded expectations repeated with four consecutive quarters of strong financial performance from our disciplined commercial execution. Now as we are directing similar focus and our proven ability to execute on our R and D pipeline, we are confident that we are well positioned to drive meaningfully improved productivity. And with that, operator, please assemble

Operator

We'll go first to Steve Scala with TD Cowen. Please go ahead.

Steve Scala
Pharmaceutical Analyst at TD Cowen

Thank you so much. I have two questions. First, on the Danaglupron dose optimization data, it's apparently still on track for the first quarter of this year. What is the range of possible outcomes and is dropping this version of the compound a possibility and what would be the next step? Second question is Chris Boshoff.

Steve Scala
Pharmaceutical Analyst at TD Cowen

I assume he's on the line. Under the heading of nothing's perfect, can you share with us two or three things in the Pfizer R and D portfolio or system that you think need to be fixed? New leaders usually say they want to move quicker, but sometimes they also thoroughly go through the portfolio and shed many projects. Is that also a possibility? Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Chris?

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

So we start with Daniel. So for Daniel, just to be clear, we as we stated previously, we're now targeting to update from the ongoing dose optimization and formulation study, the PK study and we're on track to deliver that in And we haven't seen the data yet, but obviously that data will then determine decisions for the future of Danagloprone. On your second question, as we've recently announced, we already focused our portfolio further. We've now established four end to end therapeutic areas, oncology, vaccines, internal medicine and INI. And part of that will be to focus on those opportunities that could provide the biggest value both for patients but also for Pfizer.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

So you will see during the coming months that we further focus and execute and accelerate those medicines we believe could be potential future blockbusters.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you, Chris. And Steve, you're right that usually new leaders are taking their time to assess. But the good news with Chris is that he knew really the Pfizer organization and I'm very impressed with the speed and faultfulness that he's deploying his changes. Already he announced the new organizations that selected a lot of leaders and refocused our pipeline in collaboration with Andrew Bog. So next question, please.

Operator

We'll go next to Jeff Meacham with Citibank. Please go ahead.

Geoff Meacham
Geoff Meacham
Managing Director at Citi

Good morning everyone. Thanks for the question. Just had a couple of quick ones. So for the COVID franchise, you guys talked about stabilizing revenue for this year. Maybe just give us some level of conviction and your level of investments in this business kind of going forward?

Geoff Meacham
Geoff Meacham
Managing Director at Citi

I think most investors kind of would like for to kind of be viewed as just maybe upside to the story. And then from a capital allocation perspective, when you guys think about the appetite for potential BD as you reprioritize or look at the pipeline and evaluate a lot of the assets and say early to mid development. Just want to get a sense from you guys for the appetite for growing out the number of TAs, if you had more optimization to do that can be achieved through BD. Thank you very much.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Amit.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

So, Jeff, on COVID, maybe I'll start with PAXLOVID. You saw Albert describe, we have multiple years now of reference where Paxlovid utilization tracks directly to the level of disease outbreak. And the year 2024 was was no different. So we know that to be the case and we've also put in place a very effective commercial model in PAXLOVID that allows us to deliver on that and continue to improve.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

In fact, if you look at 2024, we had higher physician treatment rates, than '23, and we also had gains in market share versus, versus '23. So we know we have a model that works. And with regards to resource allocation, we have targeted our resource modeling for PAXLOVID so that we are investing the places where it's relevant when it's relevant. So we have a very, very tailored model. And I think you see that in the results.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

We had a very big summer and early fall wave of COVID in '24, and then we had a milder and shorter winter wave. And you see that reflected in Paxlovid utilization. And we've also ensured that we have the right pricing model in place and put in place a new agreement with the US government on our Paxlovid contract that defines the eligibility for the USG path going forward. So there's clarity on that for Jan. 0, Feb.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

0, and going into March 0. And as with regards to vaccinations on, on Comirnaty, again, we saw a pattern in, '24 that very closely mirrored '23. So rep vaccination rates were quite stable. Again, here, we also saw saw an improvement in our market share position for Comirnaty. And we are confident that our commercial execution both with regards to the retail setting and the non retail setting will continue to put us in good stead as we move forward.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. And of course, in international, to save time here, we have contracts with our multi year contracts that they are covering not only this year, but the year after. So all of that makes us feel that this is a very stable and predictable revenue stream. Why don't we go to capital allocation and then Dave, maybe also Andrew, you can comment on the BTD?

Dave Denton
Dave Denton
CFO at Pfizer

So just Albert, I'll be real quick. From a capital allocation perspective, I'm very pleased with the company's cash flow generation throughout 2024 as we've continued to enhance our cash flow yield, number one. Number two, continue to aggressively delever. And now as we enter 2025, we'll be in a position from a cash and a delevering perspective to have a more balanced capital allocation strategy, allowing us to do slightly bigger business development programs if so desired in 2025. And with that, maybe I'll pass it over to Andrew to give some context around how we're thinking about that.

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

Yes. So to recap what Chris says, we've narrowed our current therapy of scarriers to the fourth. So oncology, vaccines, INI and internal medicine. Now it's fair to say that those are fairly broad areas. They're big buckets that you can put lots of therapeutic indications in.

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

If we were to explore adjacencies or indeed therapeutic areas where historically Pfizer hasn't been active. I think firstly, we'll be looking for truly breakthrough science that's tractable with a drug. Second, an unmet medical need that we feel that can be monetized. And thirdly and most importantly, we have to have the talent with it in order to develop those assets if we go into a therapeutic area that is one that is unfamiliar to us or we don't have historically that backbone of talent.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you very much, Andrew. And Dave, next question, please.

Operator

We'll go next to Chris Schott with JPMorgan. Please go ahead.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Great. Thanks so much. Just two questions for me. Just coming back to capital deployment. Dave, just to build on those comments, you talked about slightly larger BD transactions.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Can you just help size the range of what Pfizer is able to look at from here and how you think about balancing business development versus share repo, which I know I think you talked about as you started to delever would be part of the story. The second is on the RSV market. Just talk a little bit about the thinking and the size of the opportunity from here and the potential for growth given some of the 2024 results, both The U. S. As well as globally.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Thank you.

Dave Denton
Dave Denton
CFO at Pfizer

Great. Yes. So as far as capital deployment goes, Chris, I think the good news is the company has a very robust cash flow generation capabilities. And over time, we'll be able to do both dividends as well as BD as well as value enhancing share repurchases. Specifically, as we come into 2025, given the strength of the company from a cash flow perspective, we have the capacity in the $10,000,000,000 to $15,000,000,000 zip code from a business development perspective, within 2025 if we chose to focus in that area.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you, Amir. And Alexander of ERSV.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

So very quickly in The U. S, firstly, the market did decrease in 2024 and that's something that we have been signaling for quite some time. This was because of shifts in ACIP as well as, the early adopters of the vaccine in 2023. The important thing for us, the things that we can control, the strength of our commercial execution led us to the leading market share of the doses shipped the doses shipped to end customers at 50% for 2024 and an improvement in the shots in arms market share by 18 percentage points versus last year. And our maternal indication also performed very well tripling, the uptake from from last season.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

Now as we look forward, in the absence of any major policy or ACIP change in '25, the RSV market without that is likely not to grow, but there are a lot of catalysts for midterm growth. One is any policy updates to year round vaccination. Second, age expansion for 18 50 nine year olds at at risk where we have great data as well as potential revaccination recommendations as data becomes more available. So those are midterm growth catalysts. And in the meantime, we remain confident in our ability to execute as that evolves.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

So on the international front, Chris, the, what we see in this quarter is the beginning of financial impact of the work we've done in approving and getting through the VTC and the payers for Abrasbo. And in the countries where we received positive VTC and got reimbursement, we start to see great execution working hand in hand with the authority and HCP. Let me give you two example in maternal immunization. So in The UK, after winning the exclusive tender, ASCO professional vaccinated with a BRIBO over sixty percent of the eligible pregnant women in just one quarter in In France, in a competitive setting, a Briscoe was administered to over forty percent of the eligible pregnant woman in alone. So clearly, we see a potential as we move into 2025 in the MI, a great opportunity to expand usage and to expand the vaccination.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

And of course, that is not just in the developed market, but also in emerging market. And for instance, as you know, Abreizvo was listed at the Pan America Health Organization. And so starting this year, we can have Latin American country to start contracting Abreizvo. Now in the OA, we start also to to see some traction and, the vaccination campaign in The UK already reached forty four percent of the eligible population and regional vaccination was granted in about half of the German population. And we're expecting to get the full German population access in So again, on both maternal immunization and older adults, plenty of opportunity to grow.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And your next question, please.

Operator

We'll go next to Vamil Divan with Guggenheim Securities.

Vamil Divan
Managing Director & Senior Research Analyst at Guggenheim Securities, LLC

So maybe a couple I could on the pipeline. So Prevnar, the '25 valent, you mentioned starting Phase three in adults this year. Just curious if you can comment on what you've seen so far, it gives you comfort in moving up for when we might see the data publicly and also any updates on the pediatric population and when you where things stand there? Then the second one is on ponzekromab. And just you have the obviously cancer KAKXI, which you're starting Phase III.

Vamil Divan
Managing Director & Senior Research Analyst at Guggenheim Securities, LLC

We also noticed in the Phase II heart failure program, you increased the patient enrollment significantly there. Just curious if you can provide any perspective on what drove that change and just maybe your broader views on the heart failure opportunity for that product? Thanks.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And Chris?

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

So first for PCV25, as Albert mentioned, this is an ongoing Phase two study with potential best in class vaccine. The phase two study is ongoing in both adults and in pediatrics. As we've mentioned earlier, serotype three is very important and is emerging as a very important serotype with up to twenty to thirty percent of the population actually developed serotype three. So we're very pleased that we're now seeing what looks like best in class immunogenicity against serotype three.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

On the pediatric fund, as you mentioned, the study is ongoing so we hope to provide additional data later this year but everything we've seen so far suggests to us that we've got improved immunogenicity of PCV25 versus our current vaccine. Just a reminder as well, we do have a first generation vaccine 30 plus that's also now preclinical development that we hope to launch in phase one later this year. On ponsonlebac, very quickly, we're excited about the data for cancer catexia. And the cancer catexia study should start later this year in a Phase three experience. We stopped the development of the cardiovascular study.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. And I want also to emphasize that the development strategy on PCV30 plus involves the development of PCV25. So we define the strategy, which is development and regulatory that will allow us to accelerate the 30 plus by investing now in '25, which will come earlier, of course, to the market. And I think there was a question also on the penetration of PCA. But right now, both pediatric and adult, we have very, very high market share.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

We reported actually 87% market share. Next question please.

Operator

We'll go next to Courtney Green with Bernstein. Please go ahead.

Courtney Breen
Senior Research Analyst at Bernstein

Hi, everyone. Thanks for taking my call today. And thanks for the details on kind of how you're thinking about the R and D organization. Just a clarifier and perhaps you can help us understand the strategy a little bit more here. It sounds like you're shifting into four R and D organizations.

Courtney Breen
Senior Research Analyst at Bernstein

I also heard reference though to end to end areas. So can you talk about whether these are similar or different to how oncology was set up earlier this year earlier last year? And then additionally, can you talk a little bit about how you're allocating investment across R and D across those four separate engines? How are you making sure that the bar is high in all of those different therapeutic areas and ensuring you've got the right prioritization given the independence of these units?

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. That's a great question. So Chris, start and then Andre can sign it.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

Yes. So thank you very much for the question. So for oncology, as you stated, since the beginning we had an end to end organization covering discovery, early stage development, late stage development, as well as medical. And we already had that in vaccines since 02/9 and now we build the same structure for INI and internal medicine. So essentially, all four of those will be end to end organizations for quicker decision making and quicker handover between discovery phase one and then from early development into late phase development.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

Andrew, regarding the Yes, Courtney, you hit upon that critical question. So historically, when

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

you look back, there's no shortage of first in class breakthrough molecules that we've successfully shepherded through development. However, some of those really have not delivered in terms of financial revenues and therefore to shareholders. And the key issue is really ensuring that we have successful portfolio prioritization, bringing that commercial lens to much earlier during the process and having estimates that are derived in an unbiased way and a dynamic subject to continued revision. So as in my role as Chair of the PNT since I joined Pfizer, partnering with Chris, we have been working through that pipeline starting with the late stage assets, but then moving earlier to make sure the decisions we make drug by drug, indication by indication are ones that are going to deliver value for shareholders as well as to patients.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you for the question, Kartna. And I want also to chime in and say that PRD organization that we have right now, I think has very, very, very strong capabilities and is proven with the number of approvals. But we have 13, right, last year and even same number in '23, no one even had even close to this number. If you see our success rates are at 17 compared to ten, eleven of the industry, very few that have these success rates. And in time to the market, we are having approximately five point six years when most of the industry is in seven, eight years after improvements.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

However, looking back, I don't think that we necessarily we could have done way better in choosing the right products to focus our R and D capabilities, which is I think what now Chris and Andrew with the commercial assessments will try to do. The good news is that if it was a question of capabilities to improve our R and D productivity, that would be a multiyear undertake. When it is a question of refocusing your investments, that's way more quick. And I'm very optimistic that the results will come out very, very quickly. With that, let's go to the next question.

Operator

We'll go next to Evan Sigerman with BMO Capital Markets. Please go ahead.

Evan Seigerman
Evan Seigerman
MD & Senior Research Analyst at BMO Capital Markets

Hi guys. Thank you so much for taking my question. Congrats on all the progress. So given RFK Jr. Approval by the Senate Finance Committee this morning, can you walk me through how you plan on working with him as a likely head of HHS, especially with his views on vaccine and general skepticism of the pharma industry?

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Yes. I was also informed that the Senate Committee voted in favor of him. So I think his confirmation is pretty much secure right now. Of course, we will see what the full Senate will do. Look, I mean, we have with the Trump administration as a pharma industry, in particular, I will speak as Pfizer, a very good relations.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Personally, myself, I have very long lasting relationship with the president, but was cemented during the operational worst week when we developed the vaccine for COVID. And I know that the president is very proud of what he was able to accomplish and he has made public statements on that. We met with Mr. Ken and the actually the President introduced me to him and to have dinner all three together and we try to understand his reduce. I focus more not on the things that we clearly disagree like the vaccines, but on the things that we can agree and we can do things together.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And those are things in chronic diseases, in cardiovascular diseases, and more importantly, cancer, which is something that is very, very high in the mind of the president. And it is also very high in the mind of mister Kennedy. I met him few times also after that, and we expect that we will have a collaboration. It's not my do I expect that we will agree on everything on vaccines? I don't know, but I think probably as I hear all the statements that have been done by him and by the administration, he will have a way more tempered view on how to interact in the vaccines.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

But I don't want to speak about him. I think there are a lot of opportunities that probably outweigh the risks that we have with the radical change that we will see from the Trump administration, actually that we are seeing now with the Trump administration. So I'm cautiously optimistic. Now let's move to the next question.

Operator

We'll go next to Kripa Devarakhanda with Truist Securities. Please go ahead.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Equity Research at Truist Securities

Hey guys, thank you so much for taking my question and congratulations on all the progress. I have a question on your breast cancer franchise. You recently announced a a strategy for developing your CDK4 in frontline first line breast cancer as monotherapy and also in combination with the BebDAG, the ER PROTAC. As the landscape evolves with other CDK4six six inhibitors, different combinations, how do you see Pfizer's portfolio in breast cancer evolve over the next few years? Do you see this as the strategy as getting a piece of the broader pie or are there areas with your CDK4 and with WebTAG where you think you could establish a niche?

Kripa Devarakonda
Kripa Devarakonda
Vice President - Equity Research at Truist Securities

And also with the Phase three data from WebTAG expected any time in What needs to happen with these data for it to be considered competitive? Thank you.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

Bruce, thank you very much. Thank you for the question. We are very fortunate because we've got a lot of optionality now in breast cancer. I'll start with CDK4, we believe this is a best in class CDK inhibitor and what we've seen for compliance and the rate of IE, specifically treatment related AEs as well as discontinuations. We are very optimistic that CDK4 could not only replace Ibrance but all CDK4six inhibitors early line breast cancer including first line as well as potentially in the future also and the adjuvant setting.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

As Albert has mentioned, we are pleased that the first line study is now ongoing that CDK4 ateblacyte in combination with letrozole. To your point, we also expect the readout for VepTek in the second line setting with a derisk study that includes ESR1 population as well as OCCOMA population. And that medicine potentially could become a replacement for backbone endocrine treatment. We are planning a study in the first line setting combining Vebtech plus CDK4 in first line ER positive breast cancer. I also just quickly wanna mention CDK and CAT6 because CAT6 is a differentiated epigenetic molecule.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

This is a first in category medicine. You've seen the data, very exciting, very encouraging data in later line disease and we're celebrating that also into a registration study with an ongoing Phase III trial in second line plus ER positive breast count. Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. Was there a question also for Daniel? No, it was not. Okay, good. Let's go now to the next question, please.

Operator

We'll go next with Terence Flynn with Morgan Stanley. Please go ahead.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Great. Thanks so much for taking the question. Maybe two for me on the pipeline. On LREXVIO first, just on the commercial side, can you talk about what you're seeing in terms of uptake at the academic versus community centers? Are you seeing any broadening out into the community setting?

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Or is that really going to be contingent on getting some of the earlier line data that you're expecting later this year from the Phase three trial? And then on danequiliparone on the dose optimization study, can you just kind of clarify how much data you're going to share, later this quarter? Will we get weight loss data? Will we get tolerability data? How much data will be in the initial press release?

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. Amir?

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

Yeah. We're very excited about the momentum on LrexBio. We continue to see, increase in share and new patient starts quarter over quarter in the class. And the uptick also does include community receptivity and awareness and new account adoption. And obviously with the whole slew of trials, assuming they're successful to follow, I think there's a lot of momentum behind LrexVIO.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

And over the course of this year, we expect it to grow rapidly, driven primarily by increased demand in our top hundred accounts as well as increased adoption in, in the community setting, which I think positions Lrexvio very, very well for the future as we expand indications into earlier lines of therapy in '26 and beyond.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. And myself, I was quite impressed with the community oncologist uptake of this product as quickly as it happened in The U. S. But also, we have very good news for ARRXCL in the international market, Alexander.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

Yes, you did. Oraxio was commercially launched in already six markets in 2024 out of our top 15 markets, quite fast penetration. And of course, in 2025, we're expecting to get an additional 18 markets and four additional of our top 15 markets will launch this year. But the combination of the expand access plus the performance of the brands where we already have introduced the product gives us great confidence for accelerated growth. And to give you a sense, Japan is the second largest market outside of The U.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

S. And we had a significant and very rapid demand in Japan where Erector was introduced first to market BCMAB specific and that's we've seen an immediate acceleration of utilization actually deep into the community in Japan. And where we've launched with other product, BCMAB specific, like in The UK, in Spain, in Italy, are markets where we have demonstrated that REx euro leadership and we expect to continue this leadership position in 2025. So the combination of increased access and where we already introduced growth expansions, there are two reasons why we believe the product has greater platform.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

In general, Rexio, we do think that it is a mega blockbuster that will become, you need to understand that already in the first year, we've had more than $130,000,000 of sales. And this is in a very niche indication. This is triple refractory, which means patients that they have short duration of treatment and they are really failed after everything else that was tried. As we move to we have four Phase III studies, right? One could read this year.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And that not only triples the population, so we go to bigger population, but also expands significant deterioration of treatment. And that it is true as we go to the next line and to the first line eventually. So we think that in The U. S. And international, this product will become a very big oncology product for Pfizer.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And with that, let's Daniel, please, Chris.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

Yeah. Just what we said it earlier. So in we expect the PK data, we are target for that. Remember, this is looking at different formulations and will determine the dose selection for once a day tablet, for once a day approach for a potential taking forward into a registration strategy. Although you mentioned weight loss, weight loss is a secondary endpoint on the study.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

This is a smaller study. It's an in unit study. So it may not be that reliable for weight loss from a small number of patients.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. Next question.

Operator

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

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

Hey, thank you very much for taking my question. Maybe if you can talk a little bit about Pavanar. How are you seeing Pavanar share? I mean, you did talk about the market share here, but in terms of peeps versus others, how are you seeing the market share evolving? Now that also vaccumuance has an expansion in next year, there is also a lower adult eligibility in terms of age.

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

So can you talk a little bit about these dynamics and how do you see market evolving here?

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Alright. Let's start with international and we go to The US for a change.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

Okay. Alright. So on on Pravda, as you know, in international, two third of the business come from the pediatric education. And this that kind of macro view with our Prennopococcal vaccine, we have maintained exclusivity in an IP of in about 140 markets around the world. So that gives you the sense of the breadth of our Novococcal vaccine.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

And as we move over the times, our intention is, of course, to replace our PREMDA13 to our PREMDA20. So now, of course, they are now if you go into the details, in emerging market, we have a very large cohort of babies every year, so around 76000000 new baby. And of course, alongside our great collaboration with the Gaffney organization, we have our commercial organizations where we have demonstrated this year a double digit growth of our partner franchise. So a great execution in emerging markets. Now in the developed markets, following the EMA and the Japan approval, remember, in we've started to gain VTC approval and funding.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

And where we start to see that, we see that we are recapturing very quickly some of the business that went to competition. So give you an example. In Japan, PREMDA20, as I said, was approved in March 0. We got the VTC recommendation in Oct. 0.

Alexandre de Germay
Alexandre de Germay
Executive VP & Chief International Commercial Officer at Pfizer

And our market share in first dose went from 3% in Sept. 0 to 86% in Dec. 0. So we see that when the PREMET20 gets approved, we really have an opportunity to regain that business. And on the outlook side, here again, we've seen a very strong growth in 2024 that we'll continue to expect significant growth just because we are expanding access in more mature markets with our 20 adults.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And Amir, in The US?

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

In The US, let me start with the adult market. We have right now a very strong position in the adult market. Now we are going to face competitive pressure over the course of 2025 from capacity. But we are confident that we will continue to maintain meaningful market share. A lot of that has to do with our commercial execution as well as the fact that many accounts, particularly non retail accounts, prefer to stock a single vaccine.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

So we'll see that evolve over the course of the year. And while we don't think that there's much catch up opportunity in the 65, we also think there is growth opportunity in the fifty to sixty four age group that brings about 30000000 adults into the eligible population. So those will be the dynamics in, in adult. Now in peds, there again, we have very significant market share and on the theme of improved market share across all of our vaccines, we saw 12 percentage point improvement from August '23 to December '24 in our pediatric market share. And here, we expect this to be a much more stable market.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

We plan to retain that kind of leadership share and we expect volumes to be more stable here.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Okay. Thank you very much. Next question.

Operator

We'll go next to Dave Reisinger with Leerink Partners. Please go ahead.

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Yes. Thanks very much and thanks for all the updates. So, my question is just going back to RFK Jr. So assuming he is confirmed as HHS Secretary and given his history of suing manufacturers and his commentary on lawsuits in the hearings last week. Could you just help us understand his ability as HHS secretary to remove U.

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

S. Vaccine liability protections that manufacturers currently benefit from and allow manufacturers the freedom to develop and sell vaccines that save lives? Thank

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Yes. Look, I don't want to comment because these are the reasons, but I believe that the liability is through Senate, through Congress approval. So I don't think anyone can change that without, let's say, Senate approval. I know that that creates a turbulent into the market today and with RK, it was almost certain that he will get confirmed.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And we have engaged with him early enough so that we can mitigate all these issues. If he does the things that he has said in the past, because during the hearings, he, of course, clearly tempered his statements on vaccines. But if he tries to do some of the things that he said in the past, I think that he won't find in front of him the industry. You won't find in front of him the total medical community and the total scientific community and payers, but they don't want to see a reduction in vaccination because that's a very cost effective way of controlling health care costs. And more than important, this is not what the Trump administration would like to see another health price.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

So I would say that I feel cautiously optimistic that they will be very, very prudent with everything they try to do. Let's go to the next question.

Operator

We'll go next to Trung Huynh with UBS. Please go ahead.

Trung Huynh
Trung Huynh
Analyst at UBS Group

Hi, guys. Thanks for the questions. Just two from me. So firstly, going back to Abhryso, I think Amir noted potential policy changes in RSV. So do you have any insight if there's going to be a discussion from ACIP on revaccination or cohort expansion this year?

Trung Huynh
Trung Huynh
Analyst at UBS Group

I guess that could be a positive for your guide. And then two, on PADSEV's potential registrational muscle invasive bladder cancer trial, in general, I think cystectomy is used to cure patients in this setting. So just wondering how you're going to position this and how quick could you penetrate this population if approved? Thanks very much.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. Very quickly, Amir on the Brisbane, then we go.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

Yes. What I

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

described during where the catalyst that could could result in market expansion for Abrisbo. Obviously, it's too early and not our place to comment on what exactly Asep's gonna take on and when.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And and Chris on Patson?

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

So thank you for the question. Reminded that this is events event driven studies. So we hope by the end of this year, but if event doesn't happen, we'll move a little bit on. Muscle invasive, about twenty eight thousand population in The US alone. So it could more than double, as we mentioned, triple the population currently eligible.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

Currently, there's no standard of care treatment other than surgery, cystectomy for patients considered cisplatin ineligible. So there's two studies, one for cisplatin eligible and one for cisplatin ineligible. For the cisplatin eligible, the current currently is dominated by new adjuvant chemotherapy. So there's a real need for both adjuvant and new adjuvant treatment and to replace chemotherapy in the setting of cisplatin eligible disease. And of course for cisplatin ineligible disease, it will completely change the future treatment paradigm.

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

So we're very excited that these studies are positive and what we've seen. We've got confidence in these data from earlier studies. So, yeah. Thank you. Next question, please.

Operator

We'll go next to Akash Tewari with Jefferies. Please go ahead.

Akash Tewari
Akash Tewari
Managing Director at Jefferies

Hey, thanks so much. Just on tibi denigrut front, it looks like you're using a bilayer immediate release and matrix technology here, but you don't actually test your bilayer formulation until the second half of your weight loss trial. Is that what your team is waiting on before you make a formal update? Or is it perhaps the Lilly orthogliplopron data that's also going to factor into this decision? Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

I don't think we can disclose the technology. I know that there were speculations into the marketplace, but we haven't disclosed the technology. So I'm not sure we can say much. But Chris, you want to add anything?

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

No, I

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

don't think we need to add right now. Yeah. Yeah.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Let's go to the next question.

Operator

We'll go next to Chris Shibutani with Goldman Sachs. Please go ahead.

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

Great. Thank you. Quick one on the pipeline and another on business development strategy. On the pipeline, I noticed in Phase two, you've advanced the GIP antagonist. Is that something that you'll be continuing to share data on, particularly the monotherapy?

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

And do you have any efforts on going to do a combination? In terms of business development strategy, I think the vocabulary you used included a capacity of perhaps in the $10,000,000,000 to $15,000,000,000 zip code. And I'm curious to know what you are solving for. And I ask this in part because historically there had been a view of using cash to acquire $25,000,000,000 in revenue by the end of the decade. But now when we think about where we are in this decade and what you could be solving for structurally, there seem to be approaches sourcing assets from China, for instance.

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

Many of your competitors are doing this. Are you solving for near term revenues or are you looking to use other methods, including perhaps partnerships over M and A? That would be helpful. Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Yes. Let me start a little bit on the PD and as well you can sign it. We had very clear that so far we have acquired $20,000,000,000 of twenty, thirty revenues. We are very confident that we will hit this number, very confident. So that's so far so good about that, right?

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Looking forward, of course, we are looking more strategic opportunities right now, which will enhance pipeline in areas that we would like to play rather than near term revenues on BT. I would ask Andrew to comment and then if you can speak, Chris, about the deep antagonist.

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

Sure. So hi, Chris. Nice to hear your voice. So on the side, Albert said the key word, which is strategic. So everything we do will be through a strategic lens of building around our core competencies or building competencies in the areas that maybe we have not been in previously if that's what we decide to do.

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

On your point regarding China, it has not escaped our attention. Of course, the innovation from China across multiple therapeutic areas and indeed was most evident with oncology some years ago, but now it's expanding to most therapeutic areas. They're mostly fast followers, but I expect that will change as well. It's an area that we are very, very active in. We continue to have very fruitful discussions And let's just see where we get, so I'll have interest.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

We have a very strong footprint in China. And that includes not on commercial, but we have very strong R and D footprint that they are looking at Chinese innovation because they are progressing very fast and to identify novelties. Chris?

Chris Boshoff
Chris Boshoff
Chief Scientific Officer and President, Research & Development at Pfizer

On the Guipa antagonist, this is potentially a first in class oral small molecule Guipa antagonist. It's currently in an ongoing phase two placebo controlled study evaluating the GIPR antagonist in adults with obesity on the background of GLP-one receptor agonists. If the data from the phase two study are positive, we may potentially be able to develop also fixed dose combinations including with GLP-one, including potentially danelepron in the future.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you. Next question, please.

Operator

We'll go next to Alex Hammett with Wolfe Research. Please go ahead.

Alexandria Hammond
Director, Head of Therapeutics at Wolfe Research LLC

Thanks for squeezing me in. On VindoPal, with new competitors on the market and on the way,

Alexandria Hammond
Director, Head of Therapeutics at Wolfe Research LLC

can you walk us through how

Alexandria Hammond
Director, Head of Therapeutics at Wolfe Research LLC

we should think about the near term commercial dynamics? Where could we see the largest share impact, newly prescribed patients or switches? Thank you.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you, Alex. Amit?

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

Yes. Stinda obviously had very significant momentum in 2024. You saw the growth rates and that was due in large part to the commercial efforts and the attention and investment we put behind it. We saw improvement in diagnosis rate as well as new patient starts and we also did benefit from what was a one time bolus of annual enrollment patients in the due to favorable affordability. So as we look into '25, there's there's both headwinds and tailwinds, and we're confident in the growth of VINDA, obviously, at a different rate than it grew in, in '24.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

We do see increased diagnosis education, growth in the prescriber base, and there will continue to be favorable affordability conditions. But we do expect that there will be some headwinds. Obviously, you referred to two new market entrants. That will have some impact that remains to be seen both on switching patients as well as new patient starts. I think it's also important to remember that there will be impact of IRA on VINDA and the effect that it has on the calendarization of our GTN with more of the GTN impact coming earlier in the year as we reach the catastrophic phase.

Aamir Malik
Aamir Malik
Executive VP & Chief U.S. Commercial Officer at Pfizer

Now with all of that said, I think we remain really confident and excited. With Vinda, we've got a robust clinical profile that has data both from the clinical trial and the long term extension. We've got five year real world data on VAWS. We've got strong access and we are confident in our position as a standard of care.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

And let's move to the last question now.

Operator

Our last question comes from Tim Anderson with Bank of America. Please go ahead.

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

Thank you. I have a question on just obesity strategy. So to me late entering companies with one lead asset might struggle unless they have real clinical differentiation. It could be in a better position if they have a collection of assets. There's naturally turnkey solutions out there in terms of companies that any larger company could either partner with or acquire outright.

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

How is Pfizer looking at its key efforts in this regard, either partnership or acquisition that could bring you one or more assets that aren't par away from being in Phase III?

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Andrew?

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

Yes. Hi, Tim. So I agree with your assertion that obesity is heterogeneous and likely require a set of tools encompassing both different modalities and different delivery devices in order to manage what is a lifelong condition. These assets do exist.

Andrew Baum
Andrew Baum
Chief Strategy & Innovation Officer, Executive VP at Pfizer

Some are scattered, some have portfolios. But you could imagine that, of course, we are looking at all the opportunities and trying to understand what delivers most value to patients and obviously to Pfizer shareholders.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you very much. And I think that concludes our call. Thank you all for your interest. 2024 was a strong year of performance and our 2025 strategic priorities are very clear. We are planning to execute as well on them as we execute it in 2024.

Albert Bourla
Albert Bourla
Chairman & CEO at Pfizer

Thank you very much and have a nice day.

Operator

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

Remove Ads
Executives
    • Francesca DeMartino
      Francesca DeMartino
      Chief Investor Relations Officer
    • Albert Bourla
      Albert Bourla
      Chairman & CEO
    • Dave Denton
      Dave Denton
      CFO
Analysts
Earnings Conference Call
PJT Partners Q4 2024
00:00 / 00:00

Transcript Sections

Remove Ads