Pfizer Inc. (PFE) Earnings Call Transcript & Summary

Good day, everyone, and welcome to Pfizer's Third Quarter 2026 Earnings Conference Call. 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 earnings 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 results for the third quarter 2026 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 Cecile Guegan, our CFO; and Chris Boshoff, our scientific -- our Chief Scientific Officer. After their prepared remarks, we will open the call for questions. Members of our leadership team will be available for the Q&A session. Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning and the disclosures in our SEC filings, which are all available on the IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainty 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. I'm pleased with another strong quarter for Pfizer, our excellent commercial execution including 32% operational revenue growth in the quarter for our [ loans ] and acquired products shows the underlying strength of our business. Financial discipline and ongoing productivity improvement are driving efficiency and contributing favorably toward our margins. And with continued progress of our high-value R&D programs, we believe that we are on a pathway to the next stage of meaningful growth. Before going further, I want to welcome Cecile Guegan as our Chief Financial Officer. Cecile brings more than 25 years of finance leadership and the proven ability to deliver new sources of growth. She stood out in our global [ search ] for her expertise, her deep knowledge of Pfizer and our industry and the strategic vision that I believe will help Pfizer unlock sustained long-term value for patients and shareholders. I'm looking forward to Cecile's partnership, and I'm confident he will help us execute with a discipline and ambition this next chapter [indiscernible]. Now let me cover several highlights of our progress in this quarter. As you know, over the last few years, we have invested close to $80 billion in transactions that have equipped us with key products contributing to current commercial momentum and platforms with transformative potential. About 80% of this investment was for Seagen, Metsera and Biohaven, and we are making good progress in maximizing the value of each one. We are pleased with the overall performance of our acquired products, which grew 37% operationally in this quarter. Our legacy Seagen portfolio grew 39% year-over-year in the U.S. in the quarter, driven by the strong performance of Padcev, bringing Seagen's medicines together with the strengthened reach of our commercial organization has deepened our presence in the oncology community. We now offer physicians and care teams a broader set of options and more expertise, helping patients and driving growth for Pfizer. Seagen did more than strengthen our commercial position. It also expanded our ability to discover oncology breakthroughs, doubling the size of our early-stage pipeline at the time we closed the acquisition. In our late-stage development programs, we are advancing potential antibody drug conjugates that could bring meaningful improvements for patients with cans. I'm pleased with the pace of progress over the past year, with our expansive clinical development program across our obesity portfolio. We plan to advance 10 active and planned Phase III trials in 2026 and including one evaluating a [ switch ] from approved weekly therapies to our investigational monthly GLP-1 peptide, berobenatide. We have made significant progress with enrollment across our pivotal berobenatide program, as well as our amylin combination program, where our Phase IIb study is now fully enrolled. We are working towards the first in a series of potential approvals for berobenatide in 2028, with planning of our go-to-market strategy well underway. Biohaven also has been a strategically important addition for Pfizer. In the quarter, Nurtec grew by 33% operationally, driven by underlying demand and excellent commercial execution. We see a real opportunity to help patients with migraine and for the oral CGRP class to be a key growth driver, even as we manage market dynamics in a competitive field. We are leading the oral CGRP class in the U.S. and are working to extend that position internationally. We are seeing international growth as more patients can now get this treatment in key countries, including the U.K., Italy and Japan. We are also encouraged by strong adoption when we are able to expand access. 2026 execution in R&D has been strong. and we continue to prioritize the highest value opportunities for patients and future growth across our four therapeutic focus areas. Our excellent progress showcases our momentum in advancing our strategy. In recent months, we achieved two key regulatory decisions, one key pivotal readout and eight key pivotal study starts, alongside strong data we presented at several recent medical congresses. We are excited by the pipeline opportunities in areas of strategic focus and commercial strength. This includes late-stage programs across tumor types in oncology, including multiple myeloma, breast cancer and lung cancer, within inflammation and immunology and of course, in [ neococal ] vaccines. Chris will share more detail about our recent advancement in various end months. Our pipeline strategy is grounded in disciplined prioritization and accelerated execution. And we are confident that we are advancing our most significant opportunities for future patient impact and growth. Today, we are raising our guidance for full year 2026 revenue and adjusted earnings per share. This reflects our strong performance through the third quarter and confidence in our ability to execute our strategy, along with our financial discipline and the progress we continue to make with our R&D pipeline, we believe Pfizer is well positioned to drive growth towards the end of the decade and create sustained value for patients and shareholders over the long term. We have deployed AI in our business with the goal of improving efficiency in manufacturing and serving how we engage physicians and patients. In R&D, we are working to accelerate innovation with faster target validation and better molecule and biomarker select. The recent launch of GENESIS, a new pharmacovigilance platform shows our commitment to harnessing advanced AI and intelligent automation for a global safety monitoring. This typically involves a lengthy manual process for more than 600 products in over 120 countries. GENESIS takes on the administrative burden of our safety scientists can spend their time where it matters most, assessing causality, detecting safety signals and protecting patients. With that, I will turn it over to Cecile.

Thank you, Albert, and good morning. I am proud to speak to you today as Pfizer's CFO. I'm looking forward to continuing to work alongside the executive leadership team and lead a world-class finance organization. I am genuinely excited about what we can achieve together, and I will approach this role with financial discipline and a focus on translating Pfizer scientific and commercial progress into durable shareholder value. I am confident in our strategy and that as a team, we can deliver durable long-term value for our shareholders with rigorous capital allocation and disciplined execution. Now I am pleased to share our third quarter results, which demonstrate continuous commercial execution and financial discipline. The revenues from our non-COVID product delivered solid growth, while product mix, productivity and cost management supported margin expansion and enable continuous investments across our robust pipeline. This year's performance gives us the confidence to raise our full year 2026 revenue guidance as well as raise and narrow our adjusted diluted EPS guidance. Now on to the results. Third quarter 2026 revenue of $16.6 billion came in ahead of our expectations. We strong 7% operational revenue growth of our non-COVID products, driven by key brands in the U.S. and select international markets, offset by lower revenues from our COVID-19 products. On the bottom line, third quarter 2026 reported diluted EPS was $0.56. In addition, adjusted diluted EPS of $0.87 exceeded our expectation and includes the $0.10 charge related to the Innovent transaction. This outperformance reflects cost discipline, and improve productivity across the organization even as we increase investment towards future growth drivers and advanced several Phase III study stocks. We saw solid revenue contributions in the quarter from adequate [indiscernible], [ Venecal family ], Nurtec and our brand, while our COVID-19 products and the Prevnar family declined in the quarter. Our launched and acquired product contributed $3.8 billion in revenues and grew 32% operationally in the quarter, primarily driven by Padcev, up $265 million, Nurtec up $135 million and [indiscernible] $114 million. We continue to invest behind this group of products to mitigate LOE headwinds over the next several years. In addition, this quarter's performance demonstrates clear progress against our objective of returning to growth towards the end of the decade. Cost discipline and continued optimization across the company including our manufacturing footprint remain priorities. We are making meaningful progress with our productivity initiatives and remain on track to deliver nearly all of the anticipated $7.2 billion of net savings by the end of 2026 for ongoing cost improvement programs. As we announced last quarter, we are initiating the next phase of these programs to deliver an anticipated additional $2.5 billion of net cost savings from 2027 through 2029. These savings support increased operating efficiency and contribute favorably to our margins. At the same time, we continue to prioritize investment in pipeline programs that we believe have the greatest potential to deliver meaningful breakthroughs for patients and create long-term value for our shareholders. Adjusted gross margin for the third quarter was 77%, primarily reflecting favorable product mix and continued cost management. When we look at the components of adjusted operating expenses of $6.8 billion, adjusted SI&A expenses increased 2% operationally, reflecting in part an increase due to a lower favorable adjustment of U.S. health care reform fees year-over-year, offset partially by lower and targeted marketing and promotional investments towards growth drivers and ongoing cost productivity improvements. Adjusted R&D expenses increased 18% operationally, which includes planned investment in priority, oncology and obesity programs, including several Phase III study starts. An acquired in-progress R&D decreased 52% operationally, primarily reflecting a $650 million charge related to the Innovent transaction this quarter, compared to $1.35 billion charge in the prior year quarter related to the 3SBio transaction. Third quarter 2026 adjusted operating margin was 36%, reflecting effective cost management, strong non-COVID revenue performance higher investments in the business, and I will note, was tempered by the AIPR&D charge related to the Innovent transaction. And as I mentioned earlier, third quarter adjusted diluted EPS was $0.87. Based on our year-to-date performance, including continued growth across our non-COVID product and disciplined execution, we are raising our full year 2026 revenue guidance by $1.5 billion at the midpoint to a range of $62 million to $64 million. We are reaffirming our expectation of approximately $4 billion for the COVID products with the majority of the [ ComeaNatio ] revenues expected in the fourth quarter, consistent with the vaccination season. Accolade utilization will continue to be in trend by infection rates and treatment demand. In addition, we now expect full year 2026 R&D expense to be in the range of $10.8 billion to $11.8 billion. We are raising and narrowing our full year 2026 adjusted diluted EPS guidance to a range of $2.95 to $3.05. This represents an increase of $0.10 at the midpoint while absorbing the $0.10 per share impact of the Innovent transaction. We are reaffirming all other components of our financial guidance. Our updated outlook reflects our confidence in a non-COVID product progress across our cost improvement initiative, an expectation of full year adjusted gross margin in the mid-70s percent range and continued investments in our priority pipeline programs. Turning to capital allocation. Our capital allocation priorities remain unchanged. We invest in the business at appropriate returns maintain another time, grow our dividend and deliver shareholder returns while preserving flexibility for future value-enhancing actions, including share repurchases. Following the Innovent transaction, which closed in the third quarter, our current BB capacity is approximately $6 billion. In the first month -- 9 months of 2026, we invested $9.2 billion in internal and external R&D and returned $7.3 billion to shareholders through our quarterly dividend. Our third quarter year-to-date 2026 operating cash flow was $8.8 billion, and leverage ended the quarter at 2.6x, slightly below our 2026 target of 2.7x. Given the impact of upcoming we expect leverage to remain around current levels or modestly higher due to the -- during the LOE transition period. We remain focused on maintaining our strong financial position while continuing to invest in innovation and support shareholder returns. In conclusion, I want to leave you with two key takeaways: First, operational excellence. The non-COVID product continued to perform well, growing 7% operationally and our launched and acquired product with 32% operationally, providing further evidence of our strength capabilities and consistent execution. Second, financial discipline. We are improving operating efficiency while enabling increased pipeline investment in program waiver offers a greatest potential for patients and shareholders. Together, this performance demonstrates that we are executing our strategy, managing the upcoming LOE transition and strengthen the foundation for a return to growth towards the end of the digital. With that, I'll turn it over to Chris.

Thanks, Cecile. Across our four therapeutic areas, we made strong progress last quarter. I'll provide color on recent developments of some of these programs. starting with Elrexfio, our internally discovered BCMA bispecific, which has now delivered two positive Phase III readouts in double-class exposed multiple myeloma. Most recently, in MM32, Elrexfio monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus investigators choice of three established standard of care regimens. This is important because the choice of three standard of care regimens provides a robust representation of how CD38 refractory multiple myeloma is treated today in a patient population that is growing as anti-CD38 therapy moves in the first-line setting. And the results themselves were strong. At the time of the interim analysis, more than 75% of patients receiving Elrexfio had not experienced disease progression or death from any course and the estimated 18-month progression-free survival rate was approximately 68%. Safety in MM32 was consistent with our Elrexfio's known profile and also potentially differentiated with infection prophylaxis measures incorporated from the start of MM32, rates of grade three or higher infections were lower than those observed in MM5, Elrexfio's first positive pivotal trial in double [ plastic posed ] multiple myeloma. For context, such infection prophylaxis measures were not in place at the start of MM5. These were instituted following early deaths due to infections that were concentrated in China and two other countries during the COVID wave impacting the overall hazard ratio of MM5. MM5 data expected at a medical meeting before year-end and will provide further information on efficacy and safety. Taken together, these positive Phase III results from MM32 and MM5 strengthen our confidence in moving Elrexfio into earlier lines of treatment. We are building a compelling case of fixed-dose Elrexfio monotherapy from first relapse regardless of prior CD38 exposure. And with additional pivotal studies in newly diagnosed myeloma underway, Elrexfio's eligible patient population could grow approximately 5-fold, pending clinical and regulatory success. Moving next to atirmociclib, our potential first-in-class, highly selective CDK4 inhibitor, building on the leadership we established with IBRANCE, we are advancing atirmociclib as a potential next-generation backbone for first-line and early HR-positive breast cancer. Our KAT6 inhibitor, prifetrastat, is being developed in later-line settings. Atirmociclib was designed in-house to improve upon CDK4/6 inhibitors, the current standard of care backbone for HR-positive breast cancer. A key limitation of this class is safety and tolerability with CDK6 inhibition being a key contributor to adverse events. We designed atirmociclib to maximize efficacy through greater CDK4 inhibition while improving tolerability by minimizing CDK6 engagement. Atirmociclib is 33x more selective for CDK4 versus CDK6 comparing favorably versus the standard of care. Year 2 data sets fueling enthusiasm for atirmociclib, on the left, our data presented at ESMO from the Phase II FOURLIGHT-1 study of atermaciclib plus fulvestrant in patients with HR-positive HER2-negative breast cancer. All participants had previously received a CDK4/6 inhibitor. And notably, 92% of atirmociclib participants were randomized within 3 months of discontinuing a CDK4/6 inhibitor. The atirmociclib regimen reduced the risk of disease progression or death by 40% compared to investigators' choice of fulvestrant or everolimus plus exemestane. These results in a population with highly refractory or resistant disease, increase our confidence in our ongoing Phase III trial of atirmociclib versus investigators choice of CDK4/6 inhibitor in the first-line setting. On the right, our data for atirmociclib Phase II study in early breast cancer. With the combination of atirmociclib plus [ letrozole ], 88% of participants tumors demonstrated complete cell cycle arrest compared to only 18% versus [ letrozole ] alone. These results support our plan to combine atirmociclib with a selective estrogen receptor degrader giredestrant in a Phase III early breast cancer trial expected to initiate within the next few months. This study design has been aligned with the regulators building on the expected approval for giredestrant in this setting. This slide shows for light on safety and tolerability data alongside results from pivotal studies of the three approved CDK4/6 inhibitors plus fulvestrant. These are cross-trial comparisons. Therefore, definitive conclusions cannot be drawn. These data further address that high state selectivity drives improved safety and tolerability enabling continuous dosing excellent adherence and potentially greater efficacy. [ Great through ] or higher neutropenia was numerically low with the atirmociclib than with any of the approved agents with no grade four pipe neutropenia reported. Any great diarrhea was lower than with atirmociclib and comparable to [ palbociclib and ribociclib ]. Dose reductions due to adverse events were 14% with atirmociclib compared to 32% to 43% with the improved age. Turning to tivunatamig. We are advancing an extensive program for this potentially best-in-class PD-1 VGF bispecific antibody with over 1,200 patients treated globally and a consistent safety profile. This includes two ongoing Phase III trials with two additional Phase III trials expected to begin this year. Updated results at ESMO strengthen our confidence as we expand tivunatamig's development. Since [ SITC 25 ] confirmed response rate for the pivotal dose of tivunatamig plus doublet chemotherapy from the ongoing Phase II study have risen by roughly 20 percentage points in non-squamous and squamous first-line non-small cell lung cancer. They now stand at approximately 80%, exceeding those of tislelizumab plus chemotherapy in this study. Median progressive-free survival was nearly 14 months for both histologies, an improvement of roughly 4 to 5 months versus the comparators. Notably, tislelizumab's efficacy was consistent with historical Phase III results for the leading PD-1 antibody [ pembrolizumab ] which supports the relevance of the control arms. We are also encouraged by how tivunatamig efficacy and safety results compared with Phase III data for the PD-1 VGF bispecific antibody [ ivonescimab ], while recognizing the limitations of cross-trial comparisons. Now for I&I, tilrekimig, a potential first-in-class trispecific antibody, tilrekimig was designed in-house to simultaneously target multiple complementary drivers of type 2 inflammation, IL-4, IL-13 and TSLP. Phase II results in atopic dermatitis provide compelling proof of concept. At the top monthly doses, tilrekimig treatment led to placebo-adjusted response rate of about 50% for [ EASI 75], defined as 75% or greater improvement in the Eczema Area and Severity Index. While cross-trial comparisons have limitations, these Phase II data suggests the potential for superiority over [ dupilumab ], the current standard of care biologic. Key secondary endpoints in our ongoing Phase III program are powered to test this hypothesis in a head-to-head setting. For safety, tilrekimig demonstrated a favorable profile at subcutaneous doses up to 400 milligrams once every 4 weeks, the observed frequency of conjunctivitis and injection site reactions were lower than rates supported with [ dupilumab ] and comparable to placebo. Beyond atopic dermatitis, tilrekimig a pipeline and a product opportunity, targeting pathways that are validated by approved therapies across nine different diseases, late-stage studies underway in severe asthma moderate-to-severe COPD. Moving to our potential best-in-class pneumococcal conjugate vaccine program, building on Prevnar's 25-plus year legacy of effectiveness and safety. We're advancing next-generation candidates designed for leading serotype and invasive disease coverage. In pediatrics, [ BCB 25 ] delivered strong Phase II results, all 20 serotypes shared with Prevnar 20, [ meth-olose-4 IgG ] criterion historically used to establish noninferiority. Since the pediatric licensure of Prevnar 20 in 2023, the [ FK ] established an updated more stringent 1.5-fold noninferiority criterion that is incorporated into our Phase III design. Given the Phase II results and tighter confidence intervals expected with a much larger sample size in Phase III, modeling predicts this criteria and will be met with least 22 of 25 serotypes in our pivotal study, taken together with sero response data, functional OP test and the totality of evidence approach to licensure. These results provide confidence as we aim to deliver a best-in-class pediatric pneumococcal vaccine protecting against serotypes that collectively caused an estimated 84% of invasive disease cases in U.S. children under 5. This would represent an incremental increase of approximately 25 percentage points versus Prevnar 20. Our Phase III program is well underway with the Phase III lot-to-lot consistency study already fully enrolled. In adults, PCB 35 extends the enhanced serotype three technology we validated with PCB 25 to other key serotypes with a Phase I start expected this year. Looking ahead, we expect a strong cadence of regulatory decisions, data readouts and pivotal study starts over the next 12 months. These include a readout from MEVPRO-1 on which based on the current event rate is now expected in the first quarter of 2027. If successful, MEVPRO-1 could support approval for mevrometostat, our in-house discovered with potential first-in-class EZH2 inhibitor for prostate cancer, expanding our franchise. With that, I'll hand it back to Albert.

Thank you, Chris. And in closing, operational excellence is driving a commercial momentum across our key growth brands. And I would say importantly, with our launch and acquired products. . Our capital allocation strategy, on the other hand, is designed to create long-term shareholder value. And our late-stage pipeline progress with a significant number of pivotal readouts expected near term, is strengthening our opportunity to extend our leadership in key areas and make a difference for patients. I'm confident Pfizer is well positioned for growth towards the end of this decade. And for long-term shareholder value creation. We have line of sight to our aim of delivering a risk-adjusted high single-digit revenue CAGR and from year-end 2008 through year-end 2033. Now we will move to Q&A. And operator, please assemble the queue.

[Operator Instructions] Our first question today will come from Chris Schott with JPMorgan.

I just had two pipeline ones. Maybe first on the trispecific tilrekimig. How are you thinking about the positioning of this one in atopic derm as you consider I guess, first-line versus second-line usage maybe just think about the very strong data you presented versus a very well-entrenched standard of care? And maybe just a second part of that, can you just talk about the time lines for the indications beyond AD that you're pursuing? The second question was then just pivoting over to the upcoming Phase I/IIa amylin and combo data that we're going to see here, can you just help set some expectations about how you're thinking about that data and then the type of titration schedule that's being used to that study just to help us kind of frame out what we're going to see with that readout.

No. Thank you. Chris, would you like to cover the time lines of trispecific and, of course, the amylin and berobenatide questions. And then maybe Alexandre, you can speak a little bit about the commercial positioning.

Thank you very much for the question. So as you know, we've now started the Phase III program for recommend in atopic dermatitis II studies. One of those studies include a head-to-head against [ dupilumab ], and we also started the Phase II/III study, a continuous design for COPD and Phase III studies for severe asthma with expected readouts in 2028 and 2029. Regarding amylin GLP-1, as you with the [ SOLIS ] study has now completely recruited, that is the robustly designed Phase IIb study called amylin single agent and amylin plus and berobenatide in different doses and different titrations. We expect the readout for that study for efficacy the second half of 2027. The ongoing Phase I -- Phase IIa study, we'll give an update at the end of this year, recognizing that study was designed for safety and [ PK ] clinical pharmacology, not for efficacy.

And then what about the positioning of the trispecifics?

Chris, thanks for the questions. I think we all know that this is a very large category. What we have learned with our [ Sibinco ] and overall dermatology franchises, there is a lot of patient profile that requires different type of therapy. And we see that very much with the [indiscernible] this is the map and we see that there are some patients that actually move from one to the other, they drop off. There's a lot of circulation of those of those patients. We are building capabilities across U.S. and international, and we see that we are making good progress. So for instance, as you saw in this quarter, in international, we reached like $100 million combined between our two assets in dermatology for the quarter. So we start having a nice base and as I said, as we move into the result of the study, we will be able to actually capture some of those lapsed patients and naive patients with a very specific profile that we are defining. So first-in-class, strong efficacy and clearly unmet medical lead in the category.

Thank you very much. Next question, please.

Next question comes from Dave Risinger with Leerink Partners.

Yes. And I wanted to say congratulations to Cecile on your new role as CFO of Pfizer and look forward to working with you. My question is on U.S. net price in the third quarter and going forward. Could you comment on any gross to net benefits to net sales in the third quarter, including from any [ 340B ] scrubbing and discuss U.S. net price prospects looking forward in the near term?

Thanks very much. First, for your good wishes. So as it relates to the pricing in Q3, with the exception of, as we were expecting the impact on adequate, we started in Q3 of the January price decrease. I would say there is not really any very material change into our gross to net dynamics during the third quarter. So the performance that we are seeing is, for most part, driven by strong market performance and volume rather than dynamics around the growth unit. As we are looking into the future, obviously, not commenting today on 2027, but we will obviously reflect into our guidance for 2027, the various dynamics that we are seeing being [ IRI ] with two of our products entering in 2027 and any of the dynamics around the [ 340B ] impact and changes, including a credit rebate model implemented starting in January and also, obviously, some of the [ MFN ] impacts that we have following the agreement with we have this environment. But as a summary, the performance into Q3 is really a reflection of the strong execution rather than dynamics around gross to net that would not continue.

Very well. Thank you very much. next question, please.

Next question comes from Umer Raffat with Evercore ISI.

Albert, there's clearly been a lot of progress on SG&A improvements over the last couple of years. and I acknowledge that. It's not step function, but there's been improvement. But then I recall, Dave, before he moved on had mentioned that majority of the total net cost savings of $7.2 billion will be delivered by the end of '26. So when I look now back at the Pfizer P&L, I'm seeing [ SGN ] R&D was about $24.5 billion back in 2022. It's about the same in 2026 as well. And I acknowledge R&D has gone up a bit, SG&A has come back a bit. But the broader dynamics on OpEx are still broadly in that $24 billion to $25 billion camp. And I guess, how do you think about that heading into the dividend integrity, the cost lever heading into Padcev [ race ]?

Cecile, why don't you take this question?

Yes. So as I mentioned earlier, we are on track to delivering the $7.2 billion of savings that we had implemented as part of our first phase of the cost improvement programs. Those savings were in different places is one in our manufacturing footprint for cost, two in R&D, but reinvested and we are indeed increasing our R&D investment in order to support the pipeline products and programs that we have in addition to obviously the acquisition that we made. And then on the [ SINA ] side, mostly coming from the commercial and marketing expenses as well as SG&A. So what we are seeing today in our operating expenses. And I would then relate to just the third quarter, which had some onetime dynamics that drove [ SINA ] up. We are still expecting, based on guidance, we'll see a decline in [ SINA ] versus last year. So that's the first piece that I would say. Going forward, we have announced our second phase of the program with a $2.5 billion of savings both in SG&A and in our case manufacturing. Those will translate into savings. So we are expecting to see those translating and mitigating the margin erosion as part of the LOE transition in 2027 to 2029.

We'll go next to Akash Tewari with Jefferies.

Just a couple. I know in the spring, you had a kind of 45, 50 patient biomarker analysis on your stat sticks. And you were going to make a decision on whether to go from stage 1 to stage 2. Is there an update on that program? And really, how do you think about [ tork ] reduction and biomarker reduction to what we've seen with some of the degraders? And then on your GLP-1 amylin, I think your Phase I/II, you just updated on clinic trials to 201 patients, I think it was originally planned to be closer to 400, any color on what drove that decision with the amylin GLP-1 combo with Metsera?

Chris, both questions goes to you.

Okay. Thank you very much. So the first on STAT6, potentially first-in-class oral STAT6 program. Thanks for the question. This is an area very important for us or the I&I portfolio. As we previously stated, we've adapted the program to incorporate some additional DDI studies. So we should give you a readout for the STAT6 this year. Regarding the amylin and berobenatide. As I stated earlier, the [ SOLIS-1 ] study is fully recruited, that study [indiscernible] out end of next year. And Phase I/IIa study was adapted for the additional PK studies we are doing. But there's nothing really -- nothing material changes to the trial.

We'll go next to Vamil Divan with Guggenheim.

Again, maybe on the pipeline, One, we noticed that you posted a new Phase I trial for your [ PIK3CA ] inhibitor on [indiscernible] last week, I heard what you said around atirmociclib and your KAT6. Curious if you could maybe just talk about how you see that asset sort of fitting into your broader breast cancer strategy? And then the other question may be coming from ESMO, we saw the [ Volga ], the AstraZeneca release that could suggest maybe less need for they use a fewer cycles of Padcev in patients with bladder cancer. Curious if you have any reactions to that data center outline impact, do you think the use of pads may play out in the future?

Yes. So firstly, on the [ PLPK ], we started a Phase I study on an internally discovered [ PIK3CA ] inhibitor, the reminder that [ gedatolisib ] with salute is also prize discovered medicine. We have an ongoing clinical trial with relay with the [ PIK3CA ], [ alpha-pan, alpha-isoform ] selected inhibitor called, and the advanced also in combination with atirmociclib. The advantage of atirmociclib is we do not see DDIs, which has been experienced with all the other [ CDCs ] combining with the [ PIK3CA ]. So it's a potentially significant advantage to your point, up to 40% of breast cancer -- positive breast cancer, up to 20%, 25% of two positive breast cancer will harbor a [ PIK3CA ] mutation. So it's an important area for us. The second question was on the bulker data. Just I'll start briefly. Firstly, this reinforces the use of Padcev for massive invasive bladder cancer. It reinforces the use of Padcev in combination with the PD-1 for muscle-invasive bladder cancer. It also reinforces the confidence we have in the study, we've just started 309, which is blood is sparing Padcev [ pembrolizumab ] in a bladder sparing setting as well as the ongoing planned Phase III trial with Padcev plus tivunatamig, which should also start later this year. I just want to remind on the [ BARDA ] study, this was a no cisplatin eligible population pathological complete remission was lower than what we've seen with [ pembro ] plus Padcev, which is important, including slightly lower event-free survival. And most importantly, this is a curative in setting, so we're not clear yet which patients can be escalated. So that's important proposition. Who can you actually give less therapy?

We'll go next to Evan Seigerman with BMO Capital Markets.

As you inherit the capital allocation framework kind of established by our predecessor, how do you think about the marginal dollars that you can kind of invest from here between internal R&D, another bolt-on, you talked about BD capacity, deleveraging and eventually restarting buybacks, where do you currently see the highest perspective return for shareholders?

So our priorities are clear, and they are not changing versus what was in place. I think they are -- we have a solid plan to get us through [ loan ] poster. So our priorities impact for growth maintain or our dividend over time and then keep a strong balance. So through the LOE period, our operating cash flow, financial assets and access to capital market will give us the ability to continue to invest and maintain a dividend. As we go post LOE target, our operating cash flow grows with the levers, and we have other options to continue to increase shareholder value. And in that situation, share repurchases become again, one of the levers that we have in order to be able to continue to enhance the shareholder right.

Thank you very much, next question, please.

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

Two questions. Given the pushout of MEVPRO-1 were there any changes to MEVPRO-2 and -3 timelines? So that's the first question. Second question is for Cecile. So you started at Pfizer when Warner-Lambert was being consolidated have been through the acquisitions of [ Pharmacia ], [indiscernible] and Seagen and many BD deals, including that for [ Eliquis ]. I think it could be argued that Pfizer's most successful products that come through deals. And in each of those years, as it is now, Pfizer but its pipeline is very good. So given this history, why doesn't Pfizer make another big deal, its primary focus? Or would you say that the pipeline is significantly better now than at any time in the last 25 years?