Pfizer Inc. (PFE.US) Q3 Earnings Call: Doubling Down on Oncology and Obesity Pipelines; Once-Monthly Weight-Loss Shot Targets 2028 Approval
Non-COVID business growth, ramp-up of new products, and cost improvements are supporting current profitability, while management also focused on explaining how the company will bridge the revenue pressure from drugs losing exclusivity and translate recent acquisitions and R&D investments into the next wave of growth.
Title context: Pfizer Inc. (PFE.US) Q3 Earnings Call: Doubling Down on Oncology and Obesity Pipelines; Once-Monthly Weight-Loss Shot Targets 2028 Approval
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The core message from U.S. pharmaceutical giant Pfizer Inc.'s (PFE.US) Q3 2026 earnings call was unmistakable: non-COVID business growth, ramping new products, and cost improvement are supporting current earnings, while management worked to explain how the company will bridge the revenue pressure from loss of exclusivity and convert recent acquisitions and R&D investment into the next wave of growth.
Pfizer Inc.'s reported financial data showed Q3 revenue of $16.6 billion, with non-COVID product revenue up 7% operationally; revenue from newly launched and acquired products was $3.8 billion, up 32%. Adjusted diluted EPS was $0.87, including a $0.10 per share charge related to the Innovent transaction. The company raised full-year revenue guidance to $62 billion$64 billion, lifting the midpoint by a significant $1.5 billion; adjusted diluted EPS guidance was raised and narrowed to $2.95$3.05, with the midpoint still up about $0.10 even while absorbing transaction costs.
On why cost savings have not yet produced more visible expense declines, and how dividends, R&D, and M&A will be balanced, management explained that part of the savings is being reinvested in R&D to support oncology and obesity programs advancing into late-stage clinical trials. The existing cost-improvement program is expected to deliver nearly all of the $7.2 billion in net savings by the end of 2026, with an additional $2.5 billion in net savings in 20272029. Operating cash flow for the first nine months was $8.8 billion, dividends paid were $7.3 billion, and leverage at quarter-end was 2.6x. Capital allocation remains centered on supporting growth, maintaining and gradually increasing the dividend, and preserving a strong balance sheet, with future transactions leaning more toward bolt-on acquisitions; share buybacks are expected to become an option again after the loss-of-exclusivity transition period. Formal 2027 guidance is expected in mid-December and will incorporate the impact of loss of exclusivity, most-favored-nation pricing, and the Inflation Reduction Act.
On R&D progress, Pfizer Inc. management said the obesity business is accelerating around once-monthly berobenatide, with the 2026 plan covering 10 ongoing or planned Phase III studies and a first potential approval targeted for 2028. The SOLIS-1 study of the amylin combination has completed enrollment, with efficacy results expected in the second half of 2027; the update at the end of this year from the Phase I/IIa study mainly involves safety and pharmacokinetics. In oncology, ELREXFIO is moving into earlier lines of treatment, while the highly selective CDK4 inhibitor atirmociclib and the PD-1/VEGF bispecific antibody tivunatamig continue to build clinical evidence; the prostate cancer program MEVPRO-1 is expected to read out in Q1 2027, and the timing for MEVPRO-2 was explicitly corrected in the Q&A to Q4 2027. In inflammation and immunology, tilrekimig, the next-generation pneumococcal vaccine, and the Lyme disease vaccine also constitute important upcoming catalysts.
The core disagreement between management and Wall Street is over long-term growth forecasts. Pfizer Inc. reiterated its target of a risk-adjusted high-single-digit revenue CAGR from the end of 2028 to the end of 2033, and argued that the market underestimates not only some pipeline programs but also the growth runway of existing products. Pfizer Inc.'s CEO said NURTEC's current annualized revenue on an operational basis is already close to $2 billion, but Wall Street forecasts only about $2.5 billion by 2030, implying limited growth room, so management believes the market underestimates the product's growth potential; the CEO believes Wall Street's long-term growth forecast for NURTEC is conservative: the product's current annualized revenue is already close to $2 billion, but the market's forecast for full-year 2030 revenue is only about $2.5 billion, meaning an outlook of only about $500 million in incremental revenue over the next few years looks too conservative.
Pfizer Inc. management said the revenue forecast gap between ELREXFIO and a competing product also warrants reassessment, though the relevant efficacy and tolerability advantages still need further confirmation. Meanwhile, artificial intelligence has been deployed in target validation, molecule and biomarker screening, physician and patient engagement, and the pharmacovigilance platform GENESIS, which covers more than 600 products in over 120 countries. Management emphasized that the operating significance of AI applications lies mainly in improving R&D and operational efficiency, allowing more resources to be directed toward clinical advancement and commercial conversion, and enabling drug safety scientists to spend more time on causality assessment, safety signal identification, and patient protection.
Below is the full transcript of Pfizer Inc.'s earnings call (translated with the assistance of AI tools):
Full Transcript Pfizer Inc. Q3 2026 Earnings Call:
Operator: Hello everyone, and welcome to Pfizer Inc.'s Q3 2026 earnings call. This call is being recorded. I will now turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President. Ma'am, please go ahead.
Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President, Pfizer Inc.: Good morning everyone, and welcome to Pfizer Inc.'s earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer Inc. team, thank you for joining us. This call is being webcast live at pfizer.com. Earlier this morning, we released our Q3 2026 results via press release, which is available on our website at pfizer.com. Joining me today are Dr. Albert Bourla, Chairman and Chief Executive Officer; Ccile Guegan, Chief Financial Officer; and Chris Boshoff, Chief Scientific Officer. Following their prepared remarks, we will open the call for Q&A. Members of the leadership team will also be joining for Q&A. Before we begin, I want to remind everyone that we will be making forward-looking statements and discussing certain non-GAAP financial measures.
Please review the disclaimer in the presentation, the press release we issued this morning, and the disclosures in our filings with the U.S. Securities and Exchange Commission. All of these are available on the Investor Relations site at pfizer.com. Forward-looking statements on this call are subject to significant risks and uncertainties and reflect only the views as of the original date of this call; we undertake no obligation to update or revise any such statements. I will now turn the call over to Albert.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you, Francesca. Good morning everyone, and thank you for joining our call. I'm pleased with another strong quarter for Pfizer Inc. Our excellent commercial execution, including 32% operational growth in revenue from newly launched and acquired products this quarter, demonstrates the underlying strength of the business. Disciplined financial management and continuous productivity improvements are increasing efficiency and having a positive impact on our margins. With continued progress across high-value R&D programs, we believe the company is moving toward its next phase of significant growth. Before going further, I want to welcome Ccile Guegan as Chief Financial Officer. Ccile has more than 25 years of financial leadership experience and has proven her ability to create new sources of growth.
In a global search, she stood out for her expertise, deep knowledge of Pfizer Inc. and our industry, and strategic vision. I believe these qualities will help Pfizer Inc. unlock sustainable long-term value for patients and shareholders. I look forward to working with Ccile and am confident she will help us execute with the rigor and ambition required for the company's next chapter. Next, let me highlight a few developments this quarter. As you know, over the past few years we have invested nearly $80 billion in transactions, giving us key products that are contributing to our current commercial momentum as well as platforms with transformative potential. About 80% of these investments went to Seagen, Metsera, and Biohaven, and we are making good progress in maximizing the value of each. We are pleased with the overall performance of acquired products, which grew 37% operationally this quarter.
Driven by strong PADCEV performance, the former Seagen portfolio grew 39% year over year in the U.S. this quarter. Combining Seagen's medicines with the strength and reach of our commercial organization has enhanced our oncology presence. We can now offer physicians and care teams a broader range of options and richer specialist support, helping patients and driving Pfizer Inc.'s growth. Seagen not only strengthened our commercial position but also expanded our ability to discover breakthrough oncology assets; at the time of the acquisition, our early-stage pipeline doubled in size. Among late-stage programs, we are advancing antibody-drug conjugate candidates that could deliver meaningful improvements for cancer patients. I am pleased with the pace of progress across the broad clinical development plan in the obesity portfolio over the past year.
We plan to advance 10 ongoing or planned Phase III trials in 2026, one of which will evaluate switching from an approved weekly therapy to our investigational once-monthly GLP-1 peptide berobenatide. Our berobenatide pivotal development program has made significant enrollment progress, as has the amylin combination program, whose Phase IIb study has now completed full enrollment. We are working toward the first in a series of potential approvals for berobenatide in 2028, and planning for its launch strategy is already well under way. Biohaven is also a strategically important addition for Pfizer Inc. This quarter, NURTEC grew 33% operationally, driven by underlying demand and excellent commercial execution. While we need to navigate market dynamics in a highly competitive area, we see real opportunities to help migraine patients and the potential for oral CGRP medicines to become a key growth driver.
We lead the U.S. oral CGRP market and are working to extend that position internationally. We are seeing international growth as more patients in key countries such as the UK, Italy, and Japan can now access this treatment. We are encouraged by the strong momentum in patient use of this therapy when we can expand access. R&D execution in 2026 has been strong, and we continue to prioritize the opportunities across our four focus therapeutic areas that can create the most value for patients and drive future growth. The excellent progress we have made reflects the momentum of our strategy. In recent months, we have achieved two key regulatory decisions, important data results from a pivotal study, and initiated eight pivotal studies, while presenting strong data at several recent medical congresses. We are excited about pipeline opportunities in our strategic focus areas and areas of commercial strength.
These include late-stage oncology programs across multiple tumor types, such as multiple myeloma, breast cancer, and lung cancer, as well as programs in inflammation and immunology and, of course, the pneumococcal vaccine program. Chris will provide more detail on progress in recent months. Our pipeline strategy is grounded in rigorous prioritization and accelerated execution, and we believe we are advancing the opportunities that matter most for patients and growth in the future. Today, we are raising full-year 2026 revenue and adjusted EPS guidance. This reflects our strong performance through Q3 and our confidence in our ability to execute our strategy. Combined with disciplined financial management and continued pipeline progress, we believe Pfizer Inc. is well positioned to drive growth as the decade comes to a close and to create sustainable value for patients and shareholders over the long term.
We have deployed artificial intelligence across the business with the goal of increasing productivity and improving how we engage with physicians and patients. In R&D, we are accelerating innovation through faster target validation and better molecule and biomarker screening. The new pharmacovigilance platform GENESIS, recently launched, reflects our commitment to global safety monitoring using advanced AI and intelligent automation. This work covers more than 600 products in over 120 countries and typically involves lengthy manual processes. GENESIS absorbs the transactional workload, allowing our safety scientists to devote time to what matters most: assessing causality, identifying safety signals, and protecting patients. I will now turn the call over to Ccile.
Ccile Guegan, Chief Financial Officer, Pfizer Inc.: Thank you, Albert, and good morning everyone. It is a great privilege to speak with you today as Pfizer Inc.'s Chief Financial Officer. I look forward to continuing to work alongside the executive leadership team and to leading our world-class finance organization. I am genuinely excited about what we can achieve together. I will carry out this role with disciplined financial management, focused on translating Pfizer Inc.'s scientific and commercial progress into durable shareholder value. I am confident in our strategy and in the team's ability to create lasting long-term value for shareholders through rigorous capital allocation and disciplined execution. Now, I am pleased to walk you through our Q3 results, which reflect continued commercial execution and disciplined financial management. Our non-COVID product revenue delivered solid growth, while portfolio, productivity, and cost management supported margin expansion and enabled continued investment in our rich pipeline.
This year's performance gives us confidence to raise full-year 2026 revenue guidance while raising and narrowing adjusted diluted EPS guidance. Turning to the results. Q3 2026 revenue was $16.6 billion, ahead of our expectations. Non-COVID product revenue grew a strong 7% operationally, driven by key brands in the U.S. and select international markets, partially offset by lower COVID product revenue. On the bottom line, Q3 2026 reported diluted EPS was $0.56. In addition, adjusted diluted EPS was $0.87, ahead of our expectations, including a $0.10 per share charge related to the Innovent transaction. Despite increased investment in future growth drivers and advancement of multiple Phase III study starts, disciplined cost management and productivity gains across the organization drove the beat.
This quarter, ELIQUIS, PAXLOVID, the VYNDAQEL family, NURTEC, and LORBRENA contributed solid revenue, while COVID products and the PREVNAR family declined. Newly launched and acquired products contributed $3.8 billion in revenue this quarter, up 32% operationally, driven primarily by PADCEV, NURTEC, and LORBRENA, which increased revenue by $255 million, $175 million, and $114 million, respectively. We continue to invest behind this group of products to help mitigate the impact of loss of exclusivity in the coming years. In addition, this quarter's performance demonstrates clear progress toward our goal of returning to growth as the decade comes to a close. Disciplined cost management and continued optimization across the company, including manufacturing footprint optimization, remain priorities.
Our productivity initiatives are making tangible progress, and the current cost-improvement program remains on track to deliver nearly all of the expected $7.2 billion in net savings by the end of 2026. As we announced last quarter, we are launching the next phase of these programs, expected to deliver an additional $2.5 billion in net cost savings from 2027 to 2029. These savings support operating efficiency and have a positive impact on margins. At the same time, we continue to prioritize investment in the pipeline programs we believe have the greatest potential to deliver major breakthroughs for patients and long-term value for shareholders. Q3 adjusted gross margin was 77%, mainly reflecting favorable product mix and continued cost management.
Within the $6.8 billion of adjusted operating expenses, adjusted selling, informational and administrative (SI&A) expenses grew 2% operationally. This partly reflects higher expenses due to a smaller favorable adjustment related to U.S. healthcare reform costs versus the prior-year period, while marketing and promotional investment decreased and was more targeted toward growth drivers, with continued cost efficiencies and improvements partially offsetting the increase. Adjusted R&D expenses grew 18% operationally, including planned investment in key oncology and obesity programs and the initiation of multiple Phase III studies. Charges related to acquired in-process R&D decreased 52% operationally, mainly reflecting a $650 million charge this quarter related to the Innovent transaction versus a $1.35 billion charge related to the 3SBio transaction in the prior-year period.
Q3 2026 adjusted operating margin was 36%, reflecting effective cost management, strong non-COVID product revenue performance, and higher investment in the business; I would also note that acquired in-process R&D (AIPR&D) charges related to the Innovent transaction were a drag on margin. As I said earlier, Q3 adjusted diluted EPS was $0.87. Based on year-to-date performance, including continued strong execution on non-COVID products, we are raising full-year 2026 revenue guidance to $62 billion$64 billion, lifting the midpoint by $1.5 billion. We reiterate that full-year COVID product revenue is expected to be about $4 billion, with the majority of COMIRNATY revenue expected in Q4, consistent with the vaccination season. PAXLOVID usage will continue to be affected by infection rates and treatment demand.
In addition, we now expect full-year 2026 R&D expenses of $10.8 billion$11.8 billion. We are raising and narrowing full-year 2026 adjusted diluted EPS guidance to $2.95$3.05. This means the midpoint of the guidance range is still up $0.10 while absorbing the $0.10 per share impact of the Innovent transaction. We reiterate all other components of our financial guidance. The updated outlook reflects our confidence in non-COVID products and progress on cost-improvement initiatives, with full-year adjusted gross margin expected in the mid-70s percent range while continuing to invest in key pipeline programs. Turning to capital allocation. Our capital allocation priorities remain unchanged. We invest in the business against appropriate returns, maintain the dividend, and increase the dividend over time.
At the same time, we create shareholder returns and retain flexibility for future value-enhancing actions, including share buybacks. Following completion of the Innovent transaction in Q3, we currently have about $6 billion of business development capacity. In the first nine months of 2026, we invested $9.2 billion in internal and external R&D and returned $7.3 billion to shareholders through quarterly dividends. Operating cash flow for the first three quarters of 2026 was $8.8 billion, and leverage at quarter-end was 2.6x, slightly below our 2026 target of 2.7x. Given the upcoming loss of exclusivity, we expect leverage to remain near current levels or rise slightly during this transition period. We will continue to focus on maintaining a strong financial position while continuing to invest in innovation and support shareholder returns. Finally, I want to leave you with two key takeaways. First, operational excellence.
Non-COVID products continue to perform well, growing 7% operationally, while newly launched and acquired products grew 32% operationally, further demonstrating our strong capabilities and consistent execution. Second, disciplined financial management. We are improving operating efficiency while increasing investment in pipeline programs that we believe have the greatest potential to create value for patients and shareholders. Together, these demonstrate that we are executing our strategy, navigating the upcoming loss-of-exclusivity transition, and strengthening our foundation to return to growth as the decade comes to a close. I will now turn the call over to Chris.
Chris Boshoff, Chief Scientific Officer, Pfizer Inc.: Thank you, Ccile. Last quarter, we made strong progress across all four therapeutic areas. I will provide more detail on recent progress for some of these programs, starting with ELREXFIO, our internally discovered BCMA bispecific antibody, which has now delivered two positive Phase III study results in multiple myeloma previously treated with two classes of medicines. Recently, in the MagnetisMM-32 study, ELREXFIO monotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival compared with investigator's choice of three established standard-of-care regimens. This matters because the three standard-of-care options represent current practice well in anti-CD38-refractory multiple myeloma. As anti-CD38 therapies move into frontline treatment, this patient population is expanding. The results themselves are also strong.
At the interim analysis, more than 75% of patients treated with ELREXFIO had not experienced disease progression or death from any cause; the estimated 18-month progression-free survival rate was about 68%. The safety profile in MagnetisMM-32 was consistent with ELREXFIO's known safety profile and also showed potential differentiation. MagnetisMM-32 implemented infection prophylaxis from the start of the study, and the rate of Grade 3 or higher infections was lower than in MagnetisMM-5. The latter was the first pivotal trial of ELREXFIO to produce positive results in multiple myeloma previously treated with two classes of medicines. As background, MagnetisMM-5 did not implement such infection prophylaxis at the start. Subsequently, a wave of early deaths from infections occurred during a COVID period, concentrated in China and two other countries, affecting the overall hazard ratio in MagnetisMM-5, after which these measures were implemented. Data from MagnetisMM-5 are expected to be presented at a medical conference before the end of the year, when more efficacy and safety information will be available.
Taken together, the positive Phase III results from MagnetisMM-32 and MagnetisMM-5 strengthen our confidence in moving ELREXFIO into earlier lines of treatment. We are building compelling evidence to support patients receiving fixed-duration ELREXFIO monotherapy from first relapse, regardless of prior anti-CD38 treatment. With more pivotal studies ongoing in newly diagnosed multiple myeloma, if clinical studies and regulatory approvals are successful, the eligible patient population for ELREXFIO could expand to about five times the current level. Next, atirmociclib, our highly selective CDK4 inhibitor with first-in-class potential. Building on the leadership position established through IBRANCE, we are advancing atirmociclib as a potential next-generation backbone for first-line and early-stage treatment of HR-positive breast cancer. Our CDK6 inhibitor prifetrastat is being developed in later-line settings. Atirmociclib was designed internally to improve on CDK4/6 inhibitors, which are the backbone of current standard of care in HR-positive breast cancer. A key limitation of this class is safety and tolerability, and CDK6 inhibition is an important contributor to adverse events.
We designed atirmociclib to maximize efficacy through stronger CDK4 inhibition while minimizing CDK6 activity to improve tolerability. Atirmociclib is 33 times more selective for CDK4 than CDK6, an advantage versus standard of care. There are two data sets that give us confidence in atirmociclib. On the left are Phase II FOURLIGHT-1 data presented at the European Society for Medical Oncology (ESMO) Congress. The study evaluated atirmociclib plus fulvestrant in patients with HR-positive, HER2-negative breast cancer. All subjects had previously received a CDK4/6 inhibitor; notably, 92% of subjects in the atirmociclib arm were randomized within three months of stopping the CDK4/6 inhibitor. Compared with investigator's choice of fulvestrant or everolimus plus exemestane, the atirmociclib regimen reduced the risk of disease progression or death by 40%. Results in this heavily pretreated or resistant patient population strengthen our confidence in the ongoing Phase III trial. That trial compares atirmociclib with investigator's choice of CDK4/6 inhibitor in the first-line setting.
On the right are Phase II data for atirmociclib in early breast cancer. With atirmociclib plus letrozole, 88% of subjects achieved complete cell-cycle arrest in their tumors, versus only 18% in the letrozole monotherapy arm. These results support our plan to combine atirmociclib with the selective estrogen receptor degrader giredestrant in a Phase III early breast cancer trial expected to start in the coming months. The study design has been agreed with regulators, premised on the expected approval of giredestrant in this treatment setting. This slide shows safety and tolerability data from FOURLIGHT-1 alongside pivotal study results for three approved CDK4/6 inhibitors combined with fulvestrant. These are cross-trial comparisons, so no definitive conclusions can be drawn. These data further suggest that high CDK4 selectivity can improve safety and tolerability, supporting continuous dosing, excellent treatment adherence, and potentially greater efficacy.
Numerically, atirmociclib had a lower rate of Grade 3 or higher neutropenia than any approved agent, with no Grade 4 or 5 neutropenia reported. The rate of any-grade diarrhea was lower than abemaciclib and comparable to palbociclib and ribociclib. Atirmociclib dose reductions due to adverse events were 14%, versus 32%43% for approved agents. Next, tivunatamig. We are advancing a broad development program for this potential best-in-class PD-1/VEGF bispecific antibody, with more than 1,200 patients treated globally and a consistent safety profile. The program includes two ongoing Phase III trials, with two additional Phase III trials expected to start this year. Updated results presented at the ESMO Congress strengthened our confidence in expanding tivunatamig development.
Since the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, in the ongoing Phase II study, tivunatamig at the dose intended for pivotal trials combined with doublet chemotherapy improved confirmed response rates by about 20 percentage points in both first-line non-squamous and squamous non-small cell lung cancer. Both are now about 80%, higher than tislelizumab plus chemotherapy in this study. Median progression-free survival was close to 14 months in both histologies, an improvement of about four to five months versus the control regimen. Notably, tislelizumab's efficacy was consistent with prior Phase III results for the leading PD-1 antibody pembrolizumab, supporting the reference value of the control arm. We are also encouraged by how tivunatamig's efficacy and safety results compare with Phase III data for the PD-1/VEGF bispecific antibody ivonescimab, while recognizing the limitations of cross-trial comparisons. Next, tilrekimig in inflammation and immunology, a trispecific antibody with first-in-class potential.
Tilrekimig was designed internally to target multiple complementary drivers of type 2 inflammation simultaneously: IL-4, IL-13, and TSLP. Its Phase II results in atopic dermatitis provided compelling proof of concept. At the highest monthly dosing level, the placebo-adjusted EASI75 response rate for tilrekimig was about 50%. EASI75 refers to at least 75% improvement in the Eczema Area and Severity Index. Although cross-trial comparisons have limitations, these Phase II data suggest tilrekimig may be superior to the current standard biologic therapy dupilumab. These secondary endpoints in our ongoing Phase III program are adequately powered to test this hypothesis in a head-to-head comparison. On safety, tilrekimig showed a favorable profile. With subcutaneous dosing every four weeks at doses up to 400 mg, the observed rates of conjunctivitis and injection-site reactions were lower than those reported for dupilumab and comparable to placebo.
Beyond atopic dermatitis, tilrekimig offers both pipeline-level and product-level opportunities, with the pathways it targets validated by approved therapies across nine different diseases. Late-stage studies in severe asthma and moderate-to-severe chronic obstructive pulmonary disease are ongoing. Next, our potential best-in-class pneumococcal conjugate vaccine program. Building on more than 25 years of efficacy and safety experience with PREVNAR, we are advancing next-generation candidates aiming for leadership in serotype coverage and invasive disease coverage. In pediatrics, PCV25 delivered strong Phase II results. All 20 serotypes shared with PREVNAR 20 met the two-fold IgG threshold after the fourth dose, the standard historically used to establish non-inferiority. Since PREVNAR 20 received pediatric approval in 2023, the U.S. Food and Drug Administration (FDA) has established a newer, stricter 1.5-fold non-inferiority threshold, which we have incorporated into our Phase III study design.
Based on the Phase II results and the narrower confidence intervals expected with the substantially larger Phase III sample size, modeling predicts that at least 22 of the 25 serotypes will meet this threshold in our pivotal studies. Combined with serum response data, functional opsonophagocytic activity (OPA) titers, and the way regulators assess the totality of evidence in approval, these results strengthen our confidence. Our goal is to deliver a best-in-class pediatric pneumococcal vaccine whose covered serotypes together are estimated to account for 84% of invasive disease cases in U.S. children under five. Compared with PREVNAR 20, that represents an additional increase of about 25 percentage points. Our Phase III development program is progressing well, with the Phase III lot-to-lot consistency study having completed full enrollment. In adults, PCV35 extends the serotype 3 enhancement technology validated in PCV25 to other key serotypes, with a Phase I study expected to start this year.
Looking ahead, we expect a dense cadence of regulatory decisions, data readouts, and pivotal study starts over the next 12 months. These include the MEVPRO-1 data readout; based on current event accrual rates, it is now expected in Q1 2027. If successful, MEVPRO-1 could support approval of mevrometostat, our internally discovered EZH2 inhibitor with first-in-class potential for prostate cancer, further expanding our product business in this area. I will now turn the call back over to Albert.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you, Chris. In closing, operational excellence is driving commercial momentum across our key growth brands; I would particularly note the standout performance of newly launched and acquired products. At the same time, our capital allocation strategy is designed to create long-term shareholder value. Continued progress in the late-stage pipeline, with a substantial number of pivotal study results expected in the near term, is strengthening our opportunity to extend leadership in key areas and improve patients' lives. I believe Pfizer Inc. is well positioned to deliver growth as the decade comes to a close and to create long-term value for shareholders. We see a clear path to our goal of a risk-adjusted high-single-digit revenue CAGR from the end of 2028 to the end of 2033. We will now open the call for Q&A, and the operator will queue questions.
Below is the Q&A session of the earnings call (AI-assisted summary and translation):
Operator: Thank you. If you would like to ask a question, please press star and 1 on your telephone keypad. To withdraw from the question queue at any time, please press star and 2. Again, please press star and 1 to ask a question. Our first question today comes from Chris Schott of JPMorgan. Your line is open.
Chris Schott, Analyst, JPMorgan: Great, thanks very much for the opportunity. I have two pipeline questions. First, on the trispecific antibody tilrekimig. Given the very strong data you've reported and the very entrenched position of the current standard of care, how are you thinking about positioning in atopic dermatitis, particularly first-line versus second-line? And a follow-up to that: could you talk about the timing of the additional indications beyond atopic dermatitis that you're pursuing? Second question shifts to the upcoming Phase I/IIa data for the amylin plus berobenatide combination. Can you help set expectations, walk us through how you're thinking about that data and what the dose-escalation scheme was in that study, so we can understand the upcoming results?
Thanks very much.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you. Chris, can you walk through the timing for the trispecific antibody and, of course, the question on amylin and berobenatide? And then, Alexandre, perhaps you can speak to the commercial positioning.
Chris Boshoff, Chief Scientific Officer, Pfizer Inc.: Thanks very much for your question. As you know, we have now initiated the Phase III program for tilrekimig in atopic dermatitis, which includes two studies. One study includes a head-to-head comparison with dupilumab. We have also started a Phase II/III study in chronic obstructive pulmonary disease (COPD) with a seamless design, as well as a Phase III study in severe asthma, with results expected in 2028 and 2029. On amylin and GLP-1, as you know, the SOLIS-1 study has now completed full enrollment. This is a rigorously designed Phase IIb study evaluating amylin monotherapy at different doses and with different dose-escalation schemes, as well as amylin combined with berobenatide. We expect efficacy results from this study in the second half of 2027. For the ongoing Phase I/IIa study, we will provide an update at the end of this year, but note that this study is designed to assess safety and pharmacokinetics (PK), that is, clinical pharmacology, not efficacy.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you. So, how about the positioning for the trispecific antibody? What do you think?
Alexandre, Commercial Business Leadership Team, Pfizer Inc.: Okay, Chris, thanks for your question. I think everyone knows this is a very large category. Through CIBINQO and the overall dermatology portfolio, we have learned that patients with different profiles need different types of treatment, particularly between JAK inhibitors and monoclonal antibodies. We also see that some patients actually switch from one treatment to another, and some discontinue. There is a lot of patient flow between treatments. We are building capabilities in the U.S. and internationally, and we see good progress. For example, as you saw this quarter, in international markets, combined quarterly sales of our two dermatology products reached $100 million. So we are starting to get to a good place.
As I said, as the data come out, we will be able to cover a portion of patients who have discontinued treatment, as well as patients with certain specific profiles who have not yet been treated; we are defining those profiles. So this will be a first-in-class product with strong efficacy, and there is clearly unmet medical need in this category.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you very much. Next question, please.
Operator: The next question comes from Dave Risinger of Leerink Partners. Please go ahead.
Dave Risinger, Analyst, Leerink Partners: Great, thanks very much. I want to congratulate Ccile Guegan on becoming Pfizer Inc.'s CFO and look forward to working with you. My question is about U.S. net pricing in Q3 and going forward. Can you talk about whether gross-to-net adjustments in Q3 had any favorable impact on net sales, including from the 340B verification cleanup, and discuss the near-term U.S. net pricing outlook? Thank you.
Ccile Guegan, Chief Financial Officer, Pfizer Inc.: First, thank you very much for your good wishes. On Q3 pricing, I think that, apart from the impact of the expected ELIQUIS price reduction in January beginning to show up in Q3, there were no very significant changes in gross-to-net adjustments in Q3. The performance we saw was driven largely by strong market performance and volume, rather than by changes in gross-to-net adjustments.
Looking ahead, obviously, I won't comment on 2027 today, but we will of course reflect in our 2027 guidance the various changes we see, including the Inflation Reduction Act (IRA) two of our products will begin to be subject to maximum fair price (MFP) in 2027 as well as various 340B impacts and changes, including the credit rebate model starting in January, and of course some of the most-favored-nation (MFN) pricing impact following our agreement with the government. But in summary, Q3 performance really reflected strong execution, not changes in gross-to-net adjustments; we did not see changes in the latter.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Great. Thank you very much. Next question, please.
Operator: The next question comes from Umer Raffat of Evercore ISI. Your line is open.
Umer Raffat, Analyst, Evercore ISI: Hi everyone. Thanks for taking my question. Albert, over the past few years, you've clearly made a lot of progress on improving selling, general and administrative (SG&A) expenses, and I acknowledge that. It's not a step change, but there has been improvement. I recall Dave mentioning before he left that most of the total $7.2 billion in net cost savings would be achieved by the end of 2026. Now looking back at Pfizer Inc.'s income statement, I see that SG&A and R&D combined were about $24.5 billion in 2022, and roughly the same in 2026. I acknowledge R&D is up and SG&A is down, but overall operating expenses remain broadly in the $24 billion to $25 billion range. I want to ask how you think about this when considering maintaining the dividend and the cost actions you can take when patents expire in the future. Thank you.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Ccile, please take that question.
Ccile Guegan, Chief Financial Officer, Pfizer Inc.: Okay. As I mentioned earlier, we are on track with the first phase of the cost-improvement program, working toward the $7.2 billion in cost savings. These savings come from different areas. First is our manufacturing footprint or production costs. Second is R&D, but the savings are reinvested. We are indeed increasing R&D investment to support existing pipeline products and programs, as well as, of course, the acquisitions we have completed. Then, in selling, informational and administrative (SI&A) expenses, savings come mainly from commercial and marketing expenses, as well as general and administrative expenses. As for the operating expenses seen so far, I'll speak only to Q3 here, when some one-time factors pushed SI&A higher. Based on our guidance, we still expect SI&A to decline versus last year.
That's my first point. Looking ahead, we have announced the second phase, which will deliver $2.5 billion in combined savings across SG&A and production costs. These actions will cost savings. We expect these savings to materialize and to mitigate margin pressure during the loss-of-exclusivity (LOE) transition from 2027 to 2029.
Dr. Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.: Thank you very, very much, Ccile. Next question.
Operator: Next is Akash Tewari of Jefferies. Your line is open.
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