Pfizer Inc (PFE)

“I want once and for all to make that clear to everyone: the dividend will be maintained and, eventually after the LOE period, we will start growing it again.”

“We feel extremely confident that even in the most stretched scenarios we are running, we will be able to maintain our dividend.”

“We have made meaningful progress on our productivity enhancement initiative and remain on track to deliver most of the anticipated $7.2 billion in total net cost savings by the end of 2026.”

“I believe Pfizer is well positioned to return to growth from 2029 onward and create meaningful value for shareholders.”

“The results of this quarter show how well our company is executing and why we are confident in the strategy for returning to growth post 2028.”

“And we remain committed to maintaining and over time, growing our dividend.”

“Today, we are raising the midpoint of our revenue guidance for full year 2026 and reaffirming guidance for adjusted diluted earnings per share.”

“We also have clear line of sight to our aim of delivering a risk-adjusted high single-digit revenue CAGR from year-end 2028 through year-end 2033.”

“We believe these investments will drive high single-digit growth after the loss of exclusivity period in 2028.”

“We should release later this year the clinical trial design for the adjuvant study that should start by the end of 2026.”

“The pace of that growth, of course, is going to moderate from here as we reach the majority of eligible patients and prescribers in la/mUC, but we'll continue to drive that opportunity.”

“Here, we provide visibility into the steady cadence of milestones expected over the next 12 months, including 5 regulatory decisions, 8 key readouts and 19 pivotal study starts.”

“We plan to advance 10 Phase III studies in 2026, including one evaluating participants switching from approved weekly therapies to monthly berobenatide.”

“We expect data from SOLIS-1 in 2027, providing us with the first robust efficacy data from our amylin monotherapy and combination programs.”

“We expect to report data from Phase I/IIa studies of 3945 monotherapy and berobenatide combination this year.”

“Each of these studies is event-driven with the first readout expected for MEVPRO-1 in the fourth quarter based on the current event rate.”

“Over the next several years, we will continue to position Pfizer for high single-digit revenue growth towards the end of the decade.”

“Our plan also assumes that the majority of COMIRNATY sales will occur toward year-end, consistent with the vaccination season.”

“This outlook reflects year-to-date performance, confidence in our business, progress with ongoing cost improvement initiatives, our expectation of adjusted gross margin in the mid-70s range and continued investment to support growth by the end of the decade.”

“We are reaffirming all other components of guidance, including adjusted diluted EPS guidance of $2.80 to $3.”

“Our updated revenue guidance reflects strong non-COVID product performance and revised revenue expectation of approximately $4 billion, down from $5 billion for COVID-19 revenues.”

“Based on our performance to date and continued execution, we are raising our full year 2026 guidance by $500 million at the midpoint to a range of $60.5 billion to $62.5 billion from $59.5 billion to $60.5 billion.”

“Given the LOE impact over the next few years, we expect leverage to remain around current level or modestly higher through this transition period.”

“In summary, we now expect approximately $9.7 billion in total net savings from these programs through 2029.”

“We now expect total net cost savings from this program of approximately $3 billion through 2029.”

“Separately, the next phase of our multiyear manufacturing optimization program is designed to reduce cost of goods sold and deliver approximately $1.5 billion in additional net cost savings, and we expect to begin realizing a portion of this saving in 2027.”

“Building on that momentum, today, we announced the expansion of our ongoing cost improvement programs, which are expected to generate approximately $2.5 billion in additional net cost savings from 2027 through 2029.”

“So far, Seagen revenue performance has exceeded our initial expectation, and we aim to continue delivering above initial expectation in the long term.”

“We continue to expect $700 million in savings from Phase 1 of our manufacturing optimization program this year with $175 million realized in Q2.”

“We also expect post-2028 cash flow to benefit from the previously announced Vyndamax patent settlement.”

“We are also reaffirming adjusted diluted EPS guidance, which absorbs an approximately $0.10 impact related to the Innovent Biologics transaction that closed in the third quarter of 2026.”

“We are raising the midpoint of our revenue guidance range despite lower-than-expected COVID revenues.”

“With the continued growth of our launched and acquired products, we are laying the groundwork for high single-digit revenue growth towards the end of the decade.”

“And with additional savings, we now expect total net cost savings of approximately $3 billion from this program through 2029.”

“Net cost savings from these programs are now expected to total $6.7 billion through 2029.”

“We now expect an additional $1 billion in savings from our ongoing cost realignment program, powered in part by rapid advancement of technology.”

“We also expect a pivotal trial start this year investigating NURTEC's use as a treatment for chronic migraine.”

“And this year alone, we expect to advance an extensive Phase III program that includes 10 studies for chronic weight management and obesity-related conditions.”

“We are targeting a first approval in 2028.”

“Low COVID-19 incidence could continue to limit Paxlovid utilization.”

“So that study should read out midyear.”

“And I'm also very confident that we navigate the LOEs, as you saw right now, very well starting already this year, the LOEs.”

“Following the Vyndamax settlement, we now have a clear line of sight to a high single-digit 5-year revenue CAGR post-2028.”

“This gives us greater confidence that starting in 2029, we will enter a 5-year period of high single-digit revenue CAGR.”

“So you'll see us the capital allocation share repurchase level will come back into greater consideration going forward.”

“And that should read out middle or second half of this year.”

“We expect 24 weeks monotherapy and 28 weeks combination with the amylin and GLP-1 that will be shared in the second half of this year.”

“And additionally, our plan assumes that the majority of Comirnaty sales will occur towards the end of the year and consistent with the vaccination season.”

“This outlook reflects our expectation of strong contributions across our product portfolio, adjusted gross margins in the mid-70s range, disciplined cost management and continued investments to support growth by the end of this decade.”

“We continue to expect total company revenues in the range of $59.5 billion to $62.5 billion and adjusted diluted earnings per share in the range of $2.80 to $3 a share.”

“As just a reminder, given the LOE headwinds over the next few years, we expect leverage to remain around the current levels or even slightly higher through the transition period.”

“We have already made meaningful progress on our productivity initiatives and remain on track to deliver the majority of the anticipated $7.2 billion in total net cost savings by the end of '26.”

“We continue to expect approximately $700 million in savings from our Phase I of our manufacturing optimization program this year with approximately $175 million realized in this quarter.”

“We intend to maintain and over time, grow our dividend as we continue to delever and build long-term value.”

“We believe this gives us the strongest opportunity to maintain our current market leadership in the adult market over the long term, and we expect to enter clinical development this year.”

“We are targeting approximately 20 pivotal study starts, 8 key data readouts and 4 regulatory decisions this year.”

“We intend to advance 10 Phase III studies this year, and we are targeting a first approval in 2028 from a portfolio that includes ultra-long-acting peptides with the potential, if successful, developed and approved for competitive efficacy and tolerability with a differentiated monthly maintenance dosing schedule.”

“If you -- without saying that that's the guidance, but if you multiply by 4 just to give you [indiscernible], we are talking about over $12 billion this year and growing.”

“As a reminder, sustained low disease levels of COVID will likely continue to weigh on Paxlovid utilization over the next several months.”

“This could be a first-in-class vaccine for Lyme disease, the phase three VALOR trial... The study, we expect to read out first half of this year.”

“We should update you on the study results in the coming months. First half of this year.”

“we should in the next couple of months get additional PKPD data from that molecule, which will be our potential opportunity to go to three-monthly.”

“As a reminder, our leverage is expected to end 2025 at near our 2.7x target following the close of the Metcera transaction.”

“we hope to update later data later this year. Start the phase two study this year, and then next year, the phase three study for the combination.”

“We remain committed to achieving the expected $5.7 billion total net savings from our cost realignment program by 2026, at which time we will have met our savings commitment under the program.”

“We are on track to deliver the majority of the anticipated $7.2 billion in total net cost savings from our productivity programs by 2026.”

“We are primed to execute across an expansive phase three program of 3944 targeting potential approval starting in 2028.”

“as we accelerate the program, as you've seen, started phase three programs already for colorectal cancer, and earlier this year, we'll also start with first-line phase three with non-small cell lung cancer and then endometrial cancer and bladder cancer, including combinations with our ADC portfolio.”

“We are planning an additional phase three study for PADCEP. It'll start later this year.”

“This year, as Albert pointed out, we plan to start approximately 20 phase three programs driving the portfolio.”

“We should share later this year, including at ADA, updated data on the amylin, and potential early data for the combination of the amylin plus 3944.”

“Right now, we are assuming that the patent will be lost in 2028.”

“Revenues at the midpoint, excluding COVID and LOE products, are expected to grow approximately 4% operationally year over year.”

“We continue to expect stable revenue contribution from our non-COVID product portfolio, which incorporates an expectation of approximately $1.5 billion in revenue compression due to products impacted by anticipated generic entry in 2026.”

“Our COVID products are expected to trend lower again in 2026 with revenues of approximately $5 billion.”

“mid-seventies adjusted gross margin”

“full year 2026 adjusted diluted earnings per share to be in the range of $2.80 to $3 a share”

“We expect total company full year 2026 revenues to be in the range of $59.5 billion to $62.5 billion and full year 2026 adjusted diluted earnings per share to be in the range of $2.80 to $3 a share, which reflects our expectations of strong contributions across our product portfolio, mid-seventies adjusted gross margin, continued focus on strong cost management, all while prioritizing investments in our business to drive growth by the end of this decade.”

“However, given the next few years of LOE headwinds, we expect the leverage to remain at this current level or slightly higher through the LOE period.”

“As previously communicated, the R&D savings achieved in 2025 under the cost realignment program are expected to be reinvested in 2026 and are reflected in our 2026 R&D guidance range.”

“We expect additional savings of $700 million in 2026 and $200 million in 2027 from phase one of the manufacturing program for a total of $1.5 billion in savings by 2027.”

“We achieved approximately $600 million in savings from phase one of our manufacturing optimization program through 2025, with additional savings expected in 2026 and 2027.”

“We plan to continue to invest behind these two product groups to drive their future performance to enable the company to partially offset our LOEs over the next several years.”

“We will continue to drive cost improvements going forward across our manufacturing network.”

“We plan to show updated combination data later this year.”

“We are targeting the first of a series of potential approvals in 2028.”

“This year, we plan to advance 20 plus obesity trials, including 10 phase three studies of 3944 that span chronic weight management, obesity-associated comorbidities, and opportunities to increase patient optionality and access.”

“Projecting continued weight loss is expected as the study continues through week sixty-four.”

“These data are an important advancement in our obesity portfolio because they increase significantly our confidence in the phase three monthly dosing study that we expect to start later this year.”

“To meet the growing AI demand, over the next two years, we are expanding to more than 1,200 GPUs, largely driven by R&D application of AI.”

“We are encouraged by the opportunity to build on this with an expected regulatory decision for patients with cisplatin-eligible MIBC.”

“Among eight expected key readouts, we anticipate one for SV, our novel potential first-in-class integrating beta-six targeting the DOT in ADC.”

“This year, we anticipate progress with approximately 20 recently initiated and planned key pivotal studies with 10 of them in the Metsera portfolio and four with our anti-PD-1 VEGF bispecific.”

“Applying the same model to project the potential efficacy of the planned phase three high dose regimen of 9.6 milligrams monthly, we predict placebo-adjusted weight loss of nearly 16% at week twenty-eight.”

“If successful, we will substantially expand the US addressable population with approximately 22,500 additional patients across both cis-eligible and cis-ineligible muscle-invasive bladder cancer, up from about 19,000 patients in metastatic urothelial cancer.”

“Now given our strong performance to date and our fourth quarter outlook, including our more efficient cost structure, we are raising and narrowing our full year 2025 adjusted diluted earnings per share guidance by approximately $0.08 at the midpoint to $3 a share to $3.15 a share.”

“We remain on track to deliver on our goal of at least $4.5 billion in cumulative net cost savings from our ongoing cost realignment program by the end of this year.”

“Our business is performing well, and we are raising the range of our adjusted diluted EPS guidance for full year 2025, while also remaining committed to our dividend.”

“Share repurchases is an important lever for us. In the near term, it's not a tool that we're going to use.”

“I would say that to the low end of our guidance range from a revenue perspective would assume that the COVID franchise continues a very modest uptake for the balance of this year, particularly in the U.S.”

“So as we cycle into Q4, we expect the whole Seagen portfolio, including Padcev to return to growth.”

“As we kind of look forward on Vynda, we'll see some of these dynamics continue into Q4 as well, where we expect continued volume growth, but the 2 GTN drivers that I described will certainly impact our net sales, but Vynda is performing in the way that we expected.”

“I'd like to just close by noting that it is our expectation that we'll provide guidance for 2026, most likely by the end of this year.”

“Furthermore, we now expect adjusted R&D to be in the range of $10 billion to $11 billion and our effective tax rate to be approximately 11%.”

“We continue to expect full year 2025 revenues to be in the range of $61 billion to $64 billion.”

“That said, upon the close of the Metsera transaction, our leverage is expected to be above the 2.7x target.”

“For our pediatric program, we expect fourth dose data from our ongoing Phase I/II study early next year.”

“Those investments carry over into '26 and beyond with either Metsera or 3SBio to bring these innovative medicines to market. Those will have a slightly dilutive effect to our operating performance next year.”

“The agreement has no impact on our 2025 guidance, but we expect a dilutive impact to our 2026 financial outlook.”

“Additionally, we expect another $0.05 of dilution in '26 from the 3SBio deal, which closed in the third quarter.”

“Specifically, we currently expect the Metsera transaction to be approximately $0.16 dilutive to 2026 adjusted EPS.”

“We expect the deal to be dilutive through 2030 as we continue to invest to enable further promising late-stage pipeline assets.”

“Of these savings, approximately $500 million identified in R&D will be reinvested in the pipeline, which we expect by the end of 2026.”

“As a reminder, in total for these programs, we expect approximately $7.7 billion in savings by the end of '27 to drive operational efficiencies, strengthening our business with the potential of contributing significantly to our bottom line over this period.”

“We continue to be disciplined with expense management, progressing multiple cost improvement programs as we remained focused on driving operating margin expansion over the coming years.”

“We expect $1.5 billion in savings from Phase 1 of the manufacturing optimization program by the end of '27 to support our long-term operating margin expansion goal.”

“We plan to continue to invest behind these 2 product groups to drive the future performance and help enable the company to largely offset our LOEs over the next several years.”

“Going forward, we expect to improve our cash flow and increase flexibility across our 3 capital allocation pillars.”

“We're currently further optimizing dose and formulation and hope to update you on that program in 2026.”

“And pending positive data and regulatory feedback, we have the potential to start both Phase III programs in 2026, streamlining our development approach and aligning with our strategy to provide a single vaccine across age groups.”

“and we'll later this year announce a Phase III program for 707.”

“We're not going to wait for readout from these studies, and we'll start earlier with Phase I/II combinations this year.”

“I just -- I would just say that the underlying strength of our business is allowing us to raise our guidance in the back half of the year. And with -- to Albert's point, with the work that's going on across the industry, we're able to come up with a range of scenarios, and we believe that those range of scenarios associated with potential timing of all this would allow us to absorb any impact this year based again on the underlying strength of our business today and performance today.”

“As a result, our revised full year '25 adjusted diluted earnings per share range is now $2.90 to $3.10 a share.”

“As part of our goal to return to pre-pandemic operating margin, we remain on track to deliver on our goal of at least $4.5 billion in cumulative net cost savings from our ongoing cost realignment program by the end of this year.”

“With our strong year-to-date performance, we are raising our adjusted diluted EPS guidance for full year 2025 and remain committed to our dividend.”

“We're accelerating that into a Phase III program for head and neck cancer”

“In the short term, Padcev and the readouts for the muscle invasive bladder cancer studies... we expect those readouts in the next 6 months.”

“Moving forward, we think we're going to continue to grow on this product for three reasons.”

“So we do expect those dynamics to impact our sequential growth in the back half of this year.”

“Now we do expect continued TRx volume growth, but there will be GTM pressure on U.S. performance, and that's a function of both the Medicare Part D design, but also a result of contracting to maintain access for Vynda, both in Medicare and commercial, where we've maintained 90% access for the brand.”

“We also don't anticipate any major changes in coverage by payers for this season. So this could have a modest effect on our vaccination rates, but we anticipate having a very strong season.”

“That said, the company's guidance absorbs the impact of the currently imposed tariffs from China, Canada and Mexico as well as potential price changes this year based on the letter received on July 31 from President Trump.”

“In addition, we now expect adjusted SI&A to be in the range of $13.1 billion to $14.1 billion, adjusted R&D to be in the range of $10.4 billion to $11.4 billion and our adjusted effective tax rate of approximately 13%.”

“We continue to expect full year '25 revenues to be in the range of $61 billion to $64 billion.”

“We expect to begin realizing initial savings from the Phase 1 manufacturing optimization program in the latter part of this year.”

“We expect to see improved cash flows in the back half of this year.”

“Going forward, we expect to improve our cash flow, reduce our debt leverage over time and increased flexibility across our three capital allocation pillars.”

“LORBRENA seen 48% year-over-year operational growth in the quarter, and we expect continued strength through 2025.”

“We intend to serve detail later this year for our plans for a Phase III program.”

“Based on these newly announced Phase II data, we are preparing for a Phase III start before the end of this year.”

“I would expect going forward with the new tax regs globally that we would be largely closer to the 15% level from a global tax perspective in the long-term.”

“If we were to do a BD transaction, we might tick back up over that 2.7x, but our objectives to still get down and continue to delever the balance sheet in the long-term.”

“Of these savings, approximately $500 million identified in R&D will be reinvested in the pipeline, which we expect by the end of '26.”

“As a reminder, in total, we expect approximately $7.7 billion in savings by the end of '27 to drive operating efficiencies, strengthening our business with the potential of contributing significantly to our bottom line over the period.”

“We continue to be disciplined with our operational expense management, progressing multiple improvement programs as we remain focused on driving operating margin expansion over the coming years.”

“Adjusted R&D expenses decreased 9% operationally, driven primarily by a decline in spending due to pipeline optimization expected to be reinvested later this year and into next year.”

“In addition, we believe the expected $1.5 billion savings from our Phase I of our manufacturing optimization program by the end of '27 will help bolster gross margins as we transition through the LOE period.”

“Also, I'd like to highlight a significant trend within our portfolio that we expect to fuel the company's top line for the next several years.”

“In another one of our phased programs, we finished dosing the last patient in our study of a vaccine candidate for Lyme disease. If successful, we expect to submit for approval next year.”

“So that will kind of flow into our business and welcome you to sustain significant growth with the year.”

“Our team is executing well, and we have confidence in we will grow for the balance of the year.”

“We continue to again, trend through the top end of our guidance range even with those costs to be incurred this year.”

“We're comfortable with the $10 to $15 billion budget that Dave effectively forecasted or gave beginning of this year.”

“Now as we move into Q2 and Q3, we will start actually shipping our vaccine into a thousand hemisphere countries where vaccination campaigns are gonna start and in particular in Brazil where we won the two-year contract for adults, which is a very important vaccination country.”

“Additionally, our cost improvement programs are set to deliver operating margin expansion.”

“We remain on track to deliver on our goal of at least $4.5 billion in cumulative net cost savings from our ongoing cost realignment program by the end of this year.”

“We are on track for a strong year of anticipated pipeline catalysts in 2025.”

“The PCD is listed on clinicaltrials.gov for the end of 2025, so expect beginning 2026 potential data.”

“We anticipate those tariffs to be approximately $150 million for 2025.”

“That dampening will lessen in the back half of the year as we continue to offset that a bit with incremental prescriptions.”

“I think from an R&D perspective, the $500 million that we're saving in improving productivity in R&D, largely, that will happen this year.”

“But we're continuing to focus on improving our gross margin over time and improving our operating margin over time, which I think is even a more critical component for us.”

“full-year 2025 adjusted diluted earnings per share to be in the range of $2.80 to $3.00 a share, which reflects our expectation of strong contributions across our product portfolio and our focused discipline on cost management.”

“We expect total company full-year 2025 revenues to be in the range of $61 to $64 billion”

“Going forward, we expect to improve our cash flows, reduce our debt leverage, and have more flexibility for three capital allocation pillars.”

“Our Vintechl family of products had robust growth in the quarter, though we are seeing the impact of competition with a new market entrant, and we anticipate this will continue through the year.”

“We also anticipate a first-line pivotal study start for SV Sigmata top with doctor.”

“We expect to begin pivotal studies for our ADC later this year.”

“We are anticipating a phase two readout this year for LRxview in a study for double-class exposed relapsed refractory multiple myeloma.”

“We also anticipate meaningful readouts this year for POTS and LRx.”

“We are making progress towards anticipated multiple key milestones, including at least four regulatory decisions, up to nine phase three readouts, and a significant series of people thought program starts.”

“We know that we can hit it and the spoke about $7 billion by year 2027 while maintaining the R&D at the current levels of investment.”

“Clearly, you've also heard us reiterate very specifically our focus on maintaining and growing our dividend over time, and we would continue to do that.”

“The additional $1.2 billion that we've identified. Probably modest delivery of that in 2025, most of that in 2026 and 2027, but maybe a little bit.”

“We expect to become an EPS growth story.”

“We expect that those growing assets will offset the LOEs in 2026, 2027, 2028 more or less.”

“Now in total, we expect approximately $7.7 billion in savings by the end of 2027 to drive operational efficiency, strengthening our business with the potential of contributing significantly to our bottom line over this period.”

“We expect approximately $500 million in savings associated with these efforts to be realized by the end of 2026, with the savings reinvested within our R&D program.”

“The savings are expected to be fully realized by the end of 2027.”

“And today, we've announced our expectation that this program will deliver an additional $1.2 billion in net savings, primarily in SIA and in part by leveraging digital tools, including automation and AI, as well as simplification of our business processes.”

“We continue to expect initial savings from phase one of our manufacturing optimization program in the latter part of this year, with approximately $1.5 billion in savings from phase one that's expected by the end of 2027.”

“Adjusted R&D expenses also decreased 12% operationally, driven primarily by a decline in spending due to our pipeline optimization efforts expected to be reinvested later this year and into next year.”

“Our baseline assumption is that we will have those waves this year as well.”

“We are also planning a potential registrational study in adults later this year with our fourth-generation PCB candidate.”

“If successful and approved, this would more than double the addressable population versus the currently approved indication.”

“we're confident in the growth of Vynda, obviously at a different rate than it grew in '24.”

“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.”

“we're now targeting first quarter to have data from the ongoing dose optimization and formulation study, the PK study, and we're on track to deliver that in Q1.”

“We believe our financial targets for 2025 are both reasonable and achievable, reinforcing our commitment to operational excellence.”

“Our commitment to delevering our capital structure to a gross leverage target of 3.25x by the end of 2025 remains a key priority.”

“there will continue to be favorable affordability conditions. But we do expect that there will be some headwinds... impact that remains to be seen both on switching patients as well as new patient starts.”

“we expect this to be a much more stable market. We plan to retain that kind of leadership share, and we expect volumes to be more stable here.”

“we also think there is growth opportunity in the 50 to 64 age group that brings about 30 million adults into the eligible population.”

“on the adult side, here, again, we've seen a very strong growth in 2024 that we continue to expect significant growth just because we are expanding access in more mature markets with our Prevnar 20 adults.”

“we expect to continue this leadership position in 2025.”

“in 2025, we are expecting to get an additional 18 markets and four additional of our top 15 markets will launch this year.”

“over the course of this year, we expect it to grow rapidly, driven primarily by increased demand in our top 100 accounts as well as increased adoption in the community setting, which I think positions ELREXFIO very, very well for the future as we expand indications into earlier lines of therapy in '26 and beyond.”

“the cancer cachexia study should start later this year in a Phase III experience.”

“we're expecting to get a full German population access in Q1 2025.”

“we expect a higher gross to net impact on our revenues for all drugs in the beginning of 2025 that is expected to moderate throughout the remainder of the year when compared to 2024.”

“we expect Vyndaqel, Ibrance, Xtandi and Xeljanz to reach catastrophic coverage much earlier in the year.”

“The impact of catastrophic coverage is expected to exceed the potential volume benefit from the reduction of the 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.”

“the impact of the IRA Medicare Part D redesign is expected to be a net headwind to the company's revenue of approximately $1 billion across our product portfolio, dampening growth by approximately 1.6% versus 2024.”

“Our assumptions for 2025 are on par with this 2023 and 2024 patterns.”

“We are expecting potential registrational interim data this year from ongoing pivotal studies in muscle invasive bladder cancer, which if successful and approved, would nearly triple the total addressable patients in the U.S.”

“For ponsegromab, we expect to start a pivotal study this year in cancer caked”

“we remain on track to provide an upgrade of our dose optimization studies of danuglipron in the first quarter of this year.”

“This year, we also expect to start a Phase 3 study for our C. diff vaccine candy.”

“Our PDL1 ADC candida, a potential first-in-class PD-L1 targeting vedotin ADC, is expected to begin 2 Phase 3 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.”

“We also anticipate starting an additional first-line study in combination with vepdegestrant, the ER degrader we are codeveloping with Arvinas.”

“In 2025, the emphasis will move to improving R&D productivity, while maintaining focus on margin expansion, commercial excellence and shareholder lending capital allocation.”

“We had -- very clear about so far, we have acquired $20 billion of [indiscernible] revenues. We are very confident that we will hit this number, very confident.”

“We expect to begin to achieve initial savings from Phase 1 of our manufacturing optimization program in the latter part of 2025 and continue to expect approximately $1.5 billion in savings from this first phase by the end of 2027.”

“long-term improvements in gross margin will remain a key focus for the company over the next few years.”

“we hope to provide additional data later this year.”

“I think what our performance to date as well as the quarter, which show us is that these are both entering into a category where we understand what the volumes are likely to be. And we believe these are going to be durable businesses going forward.”

“We remain on track with our dose optimization studies for danuglipron, our oral GLP-1 receptor agonist candidate and look forward to discussing more about this in early 2025.”

“We believe our cost-saving programs will drive enhanced operating leverage over time that will enable us to consistently deliver on our financial commitments to our shareholders.”

“We continue to be disciplined with our operational expense management and remain on track to deliver at least $4 billion in net cost savings from our cost realignment program by year-end.”

“We also are working toward our immunobridging study in 2025 in China, so that we can do an NDA filing, which is also an important market for us.”

“But we do think that the volume growth will be at meaningfully lower levels than what we've seen year-to-date.”

“But having said that, we continue to make investments in our business such that we're more productive, top to bottom, therefore, expanding our operating margin profile of the company.”

“We expect to see vaccinations continue in October through December.”

“When you look over the next 18 months and including Oncology and non-Oncology, we will have up to 40 different opportunities to fill the left side that I hear you are eager to see progress on and the right hand.”

“In the coming months, we expect potential Phase III readouts for breakwater, which is a very importation for us in BRAF mutated colorectal cancer.”

“In the coming months, we'll also start additional Phase III studies, as I mentioned, CDK4 in first line [indiscernible] breast cancer [indiscernible] in combination with pembrolizumab in PD-L1 high first-line non-small cell lung cancer and CAT 6 with positive breast cancer.”

“We're also planning to start the combination of sicotatactedotin pembrolizumab in the first-line setting of non-small cell lung cans and recently discussed and aligned with the FDA on trial design and on the dosing.”

“Regarding 2025, it's really topical because we're in the middle, as you can imagine, building our 2025 financial plan here across all of our business lines. It is our expectation that we will provide guidance for 2025, most likely by the end of this year.”

“Based on these positive results, we expect to advance to a registration-enabling study next year.”

“We expect to start a Phase III study in the coming months.”

“And we expect the first Phase III data in the coming months for vepdegestrant, an Eastern receptor [indiscernible] that we are codeveloping right now with [indiscernible].”

“Atirmociclib, our potential first-in-class CDK4 inhibitor is enrolling a second line Phase III trial, and we expect to start a first line Phase III study by early 2025.”

“All in, these items are expected to have a favorable impact on full year 2024 adjusted diluted earnings per share of approximately $0.30.”

“Given our ownership of Helion is now below 20%, we will no longer record equity income from that investment in our adjusted earnings beginning in 2025.”

“As a reminder, our EPS guidance includes an anticipated $0.40 of earnings dilution from the Seagen acquisition, largely due to financing costs.”

“We expect adjusted diluted earnings per share of $2.75 to $2.95, primarily reflecting the top line increase and absorbing the Oxbryta impact.”

“COVID-19 product revenues are now expected to be $10.5 billion, $5 billion for COMIRNATY and $5.5 billion for PAXLOVID.”

“We now expect revenues in the range of $61 billion to $64 billion and operational revenue growth, excluding COVID-19 products is unchanged at 9% to 11% and takes into consideration reduction of sales associated with Oxbryta.”

“We continue to expect gross margins to be in the mid-70s for the full year.”

“Obviously, mid- to high 30s is very much within the realm of our business model. We're very focused against that. We continue to march and make progress against that over time.”

“We expect to achieve savings from Phase I of our manufacturing optimization program beginning in 2025 and deliver approximately $1.5 billion in savings for the first phase by the end of 2027.”

“Obviously, the IRA and that [indiscernible] has pluses and pull -- pushes and pulls to us as we cycle into next year. When we provide guidance by the end of this year, we will give you a view on the net impact of that as we think about our business.”

“If Daniel moves fast based on what we know right now, we should be the second oral into the market, provided that the first one will be successful and the other ones will not come before us.”

“It may not be at the level that we saw in the first half of the year because of the Q1 bolus of patients, but the combination of what we're doing in terms of physician expansion, investment in driving diagnosis, and tailwinds from IRA reform do give us conviction around short term VYNDAQEL growth.”

“In closing, we remain on track to deliver at least $4 billion of net savings from our cost-realignment program by the end of this year.”

“We remain confident in our full-year performance as we believe we are well positioned to help address the expected rising need later in the year among older adults at increased risk for RSV.”

“As Dave will discuss in more detail, we are raising our full-year 2024 guidance ranges for revenue and adjusted diluted earnings per share.”

“Hey, Evan. So, a bit as I mentioned earlier, yes, we do expect to see continued growth momentum for VYNDA in the back half of this year and going forward for the reasons I described earlier.”

“But we do expect continued growth with VYNDAQEL.”

“So we do think that the opportunity set expands.”

“And in terms of timing, right now with everything we know we are the only one with 2b data on an oral GLP-1 after, of course, Lilly. So right now for everything we know, we should be the second after Lilly if DANUBE progressed into registration enabling studies.”

“We therefore plan to initiate a Phase 3 program over the next six months, and you'll learn more about that.”

“We see that we will have similar trends in other major markets in Europe.”

“Moving forward, we see significant growth behind Nurtec.”

“So as we look forward, we continue to see strength in Nurtec demand.”

“early next year or during 2025, you'll see the readouts for the bigger opportunities, which is MagnetisMM-5 in the double-class exposed population and then later in the year, potentially MagnetisMM-32, which is post-CD38.”

“As we think about margin expansion, just given the guidance that I provided for the balance of this year, it would imply that margin – gross margin rates would actually improve versus the low-70s color that we've given previously to probably mid-70s at this point in time.”

“We are, as Albert said in the oral remarks, doing the dose optimization for PK and formulation to select potential doses for pending data progression to Phase 3 and we expect to share that first quarter.”

“This improvement in our cost base alongside our new initiatives focused on manufacturing is expected to put us on strong footing towards margin expansion and improved financial returns.”

“Our guidance for adjusted SI&A and adjusted R&D remains unchanged while our effective tax rate on adjusted income is now expected to be approximately 13%”

“COVID product revenues are now expected to be $8.5 billion for the year; $5 billion for Comirnaty and $3.5 billion for Paxlovid.”

“We expect heavily weighting of revenues to the fourth quarter as our business has become more seasonal in nature with the potential that a high level of cash collections may carry over into Q1 of 2025.”

“As we've previously stated previously, we expect operating cash flow to be significantly below typical levels this year and particularly during the first half of 2024, due to the timing of certain payments and one-time expenses.”

“With strong growth through the second quarter, we believe there is additional opportunity to identify more patients who could benefit from our Vyndaqel products because of high unmet need.”

“We expect to see the impact of this in 2025 and now we're working to build on this with additional payers.”

“Approximately one out of every two new patients on advanced systemic therapies is receiving a Litfulo prescription, a position we expect to grow as we continue focusing on execution.”

“We see additional opportunities for expanding share in both acute and prevention usage, as well as growth opportunities in international markets where we are making progress with our launches.”

“additional milestones include expected updates later this year about our COVID/flu combination vaccine, marstacimab, for hemophilia A and B, and ponsegromab, for Cachexia, a wasting disorder associated with chronic disease.”

“We plan to conduct dose optimization studies in the second half of the year that are intended to inform our registration enabling studies.”

“So let me just anchor us on a few facts here. First, the cost reduction effort that we currently have initiated is Phase 1 of a multiple-phase program. So this $1.5 billion savings is only a part of – or a piece of the story.”

“We do expect that all these investments, both our cost realignment program and our investments from a manufacturing optimization program are all designed to improve operating margins to get us back to pre-pandemic levels in the near future.”

“This first phase is expected to deliver approximately $1.5 billion in savings by the end of 2027, some of which is anticipated to be realized beginning in 2025.”

“Improvements in our gross margin rate will continue to be a focus for the company over the next few years as we execute on our recently announced Manufacturing Optimization Program.”

“We expect PADCEV to continue to do well. There's significant enthusiasm from health care providers, from patients, from patient advocacy groups because of the groundbreaking data, double the overall survival. So we are confident that we'll continue to see PADCEV growth.”

“Lastly, we remain on track to deliver at least $4 billion of net savings from our cost realignment program by the end of the year.”

“This disciplined cost control puts us squarely on track to delivering on our $4 billion net savings commitment by the end of the year.”

“So we do think that we will sustain this momentum, probably not at the same rate that we saw in Q1 but we will continue to perform well with VYNDA.”

“Now for our overall franchise, we continue to expect growth.”

“As it relates to bolt-on acquisitions, in the near term, you would not expect us to do much there. We are -- that is a lower priority in the near term until we get ourselves.”

“I would say that it's unlikely for our gross margin rate to fall below 70% in any given quarter.”

“Keep in mind that the cost changes that we've made in the U.S. are largely complete. Obviously, in ex U.S., some of those changes lag, but you will see changes in the cost structure ex U.S. for the balance of the year.”

“In addition, even though COMIRNATY revenues continue to perform consistent with our plan, it is important to remember that we expect approximately 90% of our sales to occur in the second half of the year, mostly in Q4, given the seasonal nature of these products.”

“We continue to expect revenues in the range of $58.5 billion to $61.5 billion.”

“Looking ahead to the next couple of quarters, I'd like to point out that we expect operating cash flow to be significantly below typical levels, largely due to the timing of certain payments.”

“We are committed to delivering our capital structure with a gross leverage target of 3.25x, which we expect to achieve over time.”

“To that end, we expect our COVID products will continue to have an outsized effect on both our top line and our bottom line throughout this year.”

“We expect an FDA decision before year end for marstacimab, which has the potential to become the first once-weekly subcutaneous treatment for the hemophilia B market, and the first treatment delivered as a flat dose for both hemophilia A and hemophilia B.”

“With the power of our deep expertise, broad and diverse portfolio and global scale, we are confident we are well on our way toward our 2030 goals of doubling the number of patients treated with our innovative cancer medicines; increasing the number of blockbuster medicines in our portfolio from 5 today to 8 or more; and driving an anticipated tenfold increase in the proportion of revenue from biologics.”

“I would just say that the focus that we have around improving our cost of goods sold is a multiyear journey. And these costs that we are working to improve take time to adjust and to further implement ways to be more effective and efficient in this infrastructure.”

“However, I do want to point out that we expect our COVID products will continue to be contributors to revenues and cash flows for the foreseeable future.”

“We think this will follow a seasonal trend. And we think we're very well positioned for the fall season for several reasons.”

“We have high confidence on the number that we gave.”

“Hopefully, as we said, mid-year is where we expect to have more information on that.”

“So the immediate readouts for this year, second half 2024 will be the [indiscernible] in second-line hormone receptor positive metastatic breast cancer, the VERITAC-2 study, also second half 2024.”

“We continue to accumulate important RSV data and expansion of how the -- this important vaccine can be used. So you should expect this first half of the year, likely Q2, that we share more from our clinical trials, including full second season but also expansion in traditional age groups.”

“Clearly, the higher those revenue targets and achievements happen, the better improvement from a margin perspective you should expect from us.”

“And then from a progression standpoint, yes, you can think about this as a gradual steady improvement story over the next several periods.”

“That will ultimately improve gross margin rate as we cycle into later years.”

“That in sourcing requires time before we get up to peak yield and performance so that in the short-term, dampens gross margin rate, but has a trajectory to improve gross margin rate over time.”

“But our strategy, it is that you will not see anything major in business development in terms of dollars.”

“So you saw you have a very strong Q4, like you expect in flu vaccination type of markets. And that’s what we see also to be expected in 2024.”

“And that’s what we see also to be expected in 2024.”

“International, both, we expect to see growth because the products have just been launched, and then the recommendations are following.”

“So we expect that business to continue to face that smaller patient population going forward.”

“We believe all these components support our growth potential through 2024 and drive growth potential into 2025.”

“So also over there, I think what we announced, we feel now we're more confident but we should be able to achieve and hopefully exceed.”

“And actually, we feel very good about the $10 billion.”

“But clearly, we have given expectations about Seagen, and we say that we expect it to be at $10 billion by year 2030 from $3.1 billion we gave guidance in 2024.”

“No, I think you're absolutely correct. Mid- to high 30s is a reasonable target for us, with a slight caveat in the sense that the vaccine program, Comirnaty, has a shared, as you know, gross margin level with our partner.”

“So on etrasimod, keep in mind that this product, we still anticipate to be over $1 billion in peak sales.”

“And when we have that in place, we see upside momentum from the launch.”

“Seagen's in-line medicines are expected to immediately enhance Pfizer's top-line growth, and our combined portfolio provides the opportunity to lead genitourinary cancers and be a leader in breast cancer and deliver at least eight potential blockbuster products by 2030.”

“We continue to feel confident about the peak sales.”

“Obviously, we remain very confident that we will close Seagen towards the end of this year, beginning next year.”

“And we will have this available in 2024.”

“We are expecting the data to show up before the end of the year.”

“Finally, I think that, just from a momentum perspective, we expect things to continue. The vaccinations really are happening throughout this time now – October, November, December are big vaccination months.”

“But as Albert said, we're enthusiastic to look forward to the efficacy data later this year.”

“So, we'll be able to bring this totality of data together to determine whether the recommendations will change, but also what the vaccination schedule will be. So that's to come in 2024.”

“You are right, there is an opportunity for an interim analysis around year-end with final analysis second half of next year.”

“Following these positive immunogenicity data, we plan to initiate a Phase 3 study in the coming months.”

“We expect a readout from this age group later this year.”

“We expect that the cost realignment program will improve our operating margins, enhancing long-term shareholder value.”

“We expect to de-lever our capital structure following the completion of this transaction, and as we de-lever, we anticipate returning to a more balanced capital allocation strategy, inclusive of share repurchases.”

“Adjusted SI&A expenses are expected to be in the range of $13.3 billion to $14.3 billion, and adjusted R&D expenses to be within a range of $11.9 billion to $12.9 billion.”

“Adjusted cost of sales as a percentage of revenue is expected to be in the range of 41% to 43%, primarily the result of the $5.6 billion non-cash charge related to inventory write-offs for our COVID products.”

“Importantly, we continue to expect 6% to 8% full- year operational revenue growth for non-COVID products year-over-year.”

“We expect $1 billion of targeted savings in 2023 and expect an additional savings of at least $2.5 billion in 2024.”

“As a result of all that, Pfizer has an obligation to deliver an estimated 8.9 million treatment courses for which we will record approximately $4.2 billion of revenue beginning in 2024 as we deliver treatment courses.”

“We recently gained unconditional antitrust clearance from the EC, and we continue to expect the transaction to close in late 2023 or early 2024, subject to customary closing conditions, including clearance by the US FTC.”

“If successful, our next-generation mRNA flu/COVID combination candidate is expected to market in 2025.”

“Given our recent positive results from our next-generation mRNA flu/COVID combination candidate and pending results for our 65-and-older first-generation Phase 3 standalone mRNA flu study, timing for our standalone mRNA flu is now expected after 2024.”

“We have raised $31 billion in acquisition financing so far and continue to expect incremental 2030 risk-adjusted revenues in excess of $10 billion and expected cost efficiencies of $1 billion to be realized by the end of year three post-closing without impacting any R&D programs.”

“Now, we're waiting for some more clinical data early next year, but I think it's within our reach. If we decide to do, to start the pivotal study next year to do it with an once a day molecule.”

“And by the end of the year, we’ll have -- the uncertain will be removed almost largely.”

“So, yes, we're looking forward to share the data later this year for you.”

“So normally, we should have also in Q3, most of it in Q4.”

“And near term, we expect soon approval for etrasimod and another readout.”

“That should come later this year, and we’ll update you with the final analysis for the study then in 2024.”

“And we do have an interim analysis later this year for the CIFFREO trial.”

“Having said that, we will be informed in the back half of the year of our revenue performance, specifically as it relates to COVID. That will inform us the level of opportunity we have to expand our margins into ‘24 and ‘25 and beyond.”

“Yes. As I said in my prepared remarks, we expect data at the later part of this year.”

“So, over the next year or so, as we collect and finalize our data, that is really the anticipation of it.”

“Clearly, it is our expectation to get back to, at a minimum, pre-COVID levels with one caveat is that we -- as we go forward, we do have a different mix of products within our portfolio, particularly the vaccine related to COVID.”

“To that end, if our COVID-19 revenues are less than what we have assumed, we are prepared to launch an enterprise-wide cost improvement program aligned with the longer-term revenue projections for our business.”

“We remain committed to both defending and growing our overall level of profitability.”

“Our visibility into future COVID revenues and demands should improve through the remainder of 2023, as we gain clarity on a more typical annual revenue run-rate.”

“In the interest of public health and with the important fall season ahead of us, we are maintaining our COVID revenue outlook for the year while continuing to invest, largely on a variable expense basis, to support our COVID products in 2023.”

“These factors coupled with the impact of the damaged Rocky Mount manufacturing facility presents near-term revenue challenges. However, we expect positive revenue momentum as we exit 2023 and head into 2024.”

“From a launch timing standpoint, I’ll point out that the majority of our 2023 launches are anticipated to occur in the second half of 2023 and our commercialization schedule remains materially unchanged.”

“We are narrowing our expectations for revenues to between $67 billion to $70 billion and maintaining guidance for adjusted diluted earnings per share of $3.25 to $3.45 for the full year.”

“We expect these products to transition to a commercial market in the second half of this year.”

“As we de-lever it is our expectation to return to a more balanced capital allocation strategy inclusive of share repurchases.”

“On a full year run rate basis, the annual financing cost associated with the acquisition is expected to be nearly $2 billion.”

“If you see, we will have basically July, August, September in the third quarter. So the vaccinations with the new will start in September, hopefully.”

“We are continuing with the study because we just wanted to have more events and particularly have additional flu B type of events, which were scarce in the U.S. part of the trial. And we look forward to update you, hopefully, be able to conclude the study later this year.”