The operator introduces the participants of the Pfizer earnings call and provides information on accessing the call and earnings materials. The Chief Investor Relations Officer reminds listeners of the forward-looking statements and encourages them to read the disclaimer. The CEO thanks everyone for joining and highlights Pfizer's impact on human health.

Pfizer has reached over 457 million patients with their medicines and vaccines in the first nine months of the year, with strong performance in oncology, cardiovascular disease, and anti-infectives. They saw significant contributions from new launches and growth in key brands. Their newly launched RSV vaccine, ABRYSVO, contributed $375 million in US revenues and is the only one approved for both older adults and infants via maternal immunization. Nurtec, Vydura, and Oxbryta, acquired in 2022, also contributed to global revenues. Nurtec has a high potential due to the high unmet need in the oral CGRP market for migraines.

The company believes that oral CGRPs can become the leading treatment for migraines and has potential for significant growth in the primary care market. There is also a high unmet need for sickle cell disease patients, with the company's Oxbryta product addressing this issue. The Vyndaqel family of products saw a 47% growth due to strong uptake for the transthyretin amyloid cardiomyopathy indication. The company estimates a large number of undiagnosed patients for this disease and is focused on educational efforts. The Prevnar family of products also saw a 15% increase in global revenue compared to the previous year.

The increase in revenue for Pfizer's non-COVID products in the third quarter was driven by strong demand for Prevnar 20 Adult in the US, the approval and launch of Prevnar 20 Pediatric, and growth in certain emerging markets for Prevenar 13 Pediatric. However, there was a decline in market share for Prevnar Pediatric due to competition. Pfizer has had several recent milestones, including multiple product approvals and launches, and is on track to execute an unprecedented number of new product launches. The only remaining potential launch is their mRNA flu candidate, which is expected after 2024.

The company is working on a next-generation mRNA flu/COVID combination candidate that is expected to be on the market by 2025. They are also excited about their proposed acquisition of Seagen and its potential impact on human health, as one in three people will be diagnosed with cancer in their lifetime. The company has received antitrust clearance and expects the transaction to close in late 2023 or early 2024. They have raised $31 billion in acquisition financing and anticipate significant revenue and cost efficiencies from the acquisition. The company's CFO, Dave Denton, addressed concerns about future revenue forecasts and cost realignment during the quarter's results review. The US government is expected to receive a volume-based credit of approximately $4.2 billion for future treatment courses in exchange for returning 7.9 million EUA-labeled treatment courses, and Pfizer will also provide an additional 1 million treatment courses to the US strategic national stockpile.

In the third quarter, Pfizer's revenue and earnings were significantly impacted by their COVID products. They expect to deliver 8.9 million treatment courses and record $4.2 billion in revenue from them starting in 2024, with no cash compensation. They also anticipate achieving $3.5 billion in cost savings by the end of 2024. Excluding their COVID products, their operational revenue growth was strong at 10%, driven by their newly approved RSV vaccine and other key products. However, their reported and adjusted diluted loss per share were negatively affected by the decline in sales of Paxlovid and Comirnaty and a non-cash inventory write-off related to COVID products.

The inventory write-off of $4.7 billion for Paxlovid and $900 million for Comirnaty had a negative impact on adjusted loss per share. Foreign exchange movements also had a small negative impact. The company updated its full-year revenue and EPS guidance on October 13th, with total revenues expected to be in the range of $58 billion to $61 billion. Non-COVID products are expected to see 6-8% operational revenue growth year-over-year. Adjusted cost of sales is expected to be 41-43% of revenue, and adjusted SI&A and R&D expenses are expected to be lower than originally forecasted. The company now expects adjusted diluted earnings per share to be in the range of $1.45 to $1.65. The company's capital strategy includes reinvesting in the business and growing dividends over time.

The company has three main strategies for creating value for shareholders: investing in internal R&D, returning money to shareholders through dividends, and allocating funds for acquisitions. They have recently completed a large debt offering and plan to use remaining funds to complete an acquisition. The company is focused on launching new products and indications, and has a strong portfolio of respiratory vaccines built on three different platforms. They have achieved FDA approvals for vaccines from each platform and are working on developing more.

The company has achieved positive results in their Phase 3 flu trial for their first-gen mRNA flu vaccine in the 18-64 age group, demonstrating non-inferiority and superiority to a licensed flu vaccine. The vaccine also showed robust antibody responses against influenza A and encouraging T cell data in the 65 and older cohort. To address lower responses against influenza B, next-generation reformulations were incorporated into their flu-COVID combination vaccine candidates.

The company has announced positive Phase 1/2 data for their lead flu candidate, which has shown improved immunogenicity against influenza B and meets all criteria for advancement to Phase 3. They plan to initiate a Phase 3 study in the coming months and are also working on developing a broad seasonal vaccine franchise. In addition, they have an FDA indication for pneumonia in adults with their PCV business and are supported by a successful trial.

The company's innovative study on pneumococcal vaccines has solidified their leading position in the market. They are committed to continued innovation and are developing a fourth-generation PCV candidate with improved immunogenicity and increased valency. This candidate is expected to enter a first-in-human trial in the fourth quarter of 2023. The company has recently received multiple regulatory approvals and launched several new products. The Q&A session will begin shortly.

During a conference call, a question was asked about the impact of COVID vaccine fatigue on Pfizer's new launches, particularly the RSV and pneumococcal vaccines. CEO Albert Bourla responded by emphasizing the benefits of combination products and the company's efforts to develop them. Another question was asked about the flu vaccine and the need for data against high dose vaccines, as well as an update on the danu vaccine.

Pfizer CEO Albert Bourla confirms that the low dose of the flu comparator is being used on younger populations, but they are also conducting studies with a higher dose on older populations. He also mentions that they are waiting for data on their danu GLP-1 program before making any decisions. The company has also moved a new molecule, 522, into Phase 1 for obesity treatment. When asked about the potential for revaccination in 2024 for their RSV launch, the company did not provide any specific information.

During a recent discussion, Pfizer's CEO and other executives commented on the recent failures in DMD studies and the company's own DMD gene therapy program. They expressed concern for patients and discussed the potential for an interim data analysis by year-end. The CEO also mentioned that their gene therapy program has shown consistent and promising results, unlike a competitor's program. The executives also discussed the recommendation for their RSV treatment and the need for further data.

The speaker confirms that there will be additional data on vaccine effectiveness, safety, and immunogenicity in the next year. They also mention that there will be second season efficacy data and that this will all be taken into consideration when determining recommendations and vaccination schedules. The primary completion of the danu data was a while ago, but the speaker has not seen any of it yet. They clarify that the "totality of data" refers to multiple factors, such as the release formulation and waiting to see how things develop.

In this paragraph, Albert Bourla and Mikael Dolsten discuss their excitement for the upcoming data on danuglipron, a potential treatment for obesity and Type 2 diabetes. They mention that they are not focused on historical data and are instead eagerly awaiting the efficacy and safety results from the ongoing study. They also mention that they have other new molecules and mechanisms in development for these indications. Additionally, they briefly mention the availability of ABRYSVO at pharmacies and OBGYN offices, and Monadelphous addresses a question about the additional serotype coverage of the fourth generation PCV.

The company expects to see an increase in uptake in the next few months, especially during the winter. They have developed new technology for their fourth generation PCV vaccine that can provide higher immune responses and broader coverage. The company is also excited about the potential of danuglipron, their once-daily QD molecule, and will have final data on the best formulation option early next year. The Phase 2b results for danuglipron are expected soon and will be shared publicly through a press release. The company is looking forward to seeing the obesity data for danuglipron later this year.

The company has made progress in accelerating the QD danu and is waiting for more clinical data next year. They may decide to start a pivotal study with an once a day molecule. The speaker then answers two questions about the company's expectations for Nurtec and their 2024 earnings, stating that the risk of COVID is behind them and they will have more clarity on utilization trends as the year progresses.

The company plans to provide more guidance on their non-COVID products and the potential for their COVID franchise in the new year. They are seeing strong performance from their Nurtec product, with a 28% increase in TRx and a 6% increase in NRxs. The number of prescribers and new to brand starts for Nurtec is also higher than their competitors. The company is focusing on promoting their larger pill pack size for Nurtec, which has helped them achieve a leading market share in terms of total pill volume.

The speaker discusses the positive indicators for the company's expansion into primary care and the potential for growth in the market for oral CGRPs. They also mention the impact of rebates on pricing and the focus on providing access to patients. The speaker then addresses a question about the label for their S1P etrasimod, stating that it has a robust label with a simple dosing and no need for prior cardiac exams. However, all S1P drugs require eye exams for monitoring.

The executives of the company are discussing the potential of their new ulcerative colitis drug and how it compares to competitors in terms of efficacy and safety. They also mention their focus on patient support and their confidence in launching the product as planned. They then address questions about the impact of the Seagen acquisition on their pipeline and the potential opportunities for their new metabolic drug, danu.

Seagen has a strong track record with ADCs and small molecule drugs. They have recently started two Phase 3 trials, one for bladder cancer and one for non-small cell lung cancer. Mikael Dolsten discusses the potential for an oral GLP in obesity, citing the preference for oral agents and the potential for long-term use. He also mentions the potential for cardiac and renal protection with this drug class.

The speaker discusses the benefits of oral agents in building drug combinations for certain populations, such as using drug 52 to protect the heart. The next speaker asks about a QTc signal in early data for danuglipron and whether it will persist in later data. The speaker also asks about the tolerability of mRNA flu vaccines compared to licensed vaccines. The response is that danuglipron is a safe drug and the tolerability of mRNA flu vaccines is similar to other available vaccines. The next question is about the cost savings program and the plan for 2024.

The speaker is asking the company to explain the difference in cost reductions between research and development (R&D) and selling, general, and administrative (SI&A) expenses in the recently reported quarter. They also inquire about the success of the company's product ABRYSVO, asking about sales, demand, and market share. The company responds by stating that the cost reduction programs are still ongoing and they will provide more information in the future. They also mention that ABRYSVO has exceeded their expectations and attribute its success to both stocking and high vaccination rates.

The success of ABRYSVO is largely due to vaccinations, with Pfizer having a leading preference in non-retail settings. The company expects this trend to continue, as there is still a lot of potential for uptake in older adults and with the recent approval for maternal use. When the Phase 2 data for oral danu is released, there will likely be plans for a Phase 3 trial, but the timeline for this is uncertain. The recent data from ESMO on the EV-302 trial reaffirms Pfizer's expectations for the deal.

The company is expecting important data by the end of the year and will publicly announce their plans for Phase 3 trials once they have the data. The data is expected to show significant progress in bladder and urothelial cancer treatment. There is interest and anticipation for the data, but the company is being cautious and will not make any claims without first seeing the data. The company is also considering a bridging study for a QD formulation of danuglipron. The trial for danu was completed in October, but the company is waiting for top line data and may continue the program if there are no significant issues found during the four week titration cohort.

Mikael Dolsten discusses the success of the reformulated danu and the potential of incorporating more sophisticated technology in the future. GSK has filed a lawsuit against Pfizer for patent infringement related to RSV, but it is too early to determine the outcome. The recent ACIP recommendation for PENBRAYA may impact its sales ramp and peak potential, but GSK remains confident in its success.

The speaker is pleased with the outcome of the TL1A program and explains that the decision to create Televant was a strategic one. They held on to a 25% stake and will receive a significant amount of cash from Roche's proposed acquisition of Televant. They also retain other rights and are looking forward to having Roche as a partner.

The speaker is excited about the potential investments in advancing clinical stage programs for TL1A. There is potential synergy in combining Seagen's MMAE auristatin-based payloads with a PD-1. Seagen also has topo 1 based payloads that will enter the clinic, but it is uncertain if they will have the same immunogenicity as the MMAE auristatin-based ones. The goal for danuglipron is to review the data and potentially develop a fixed dose combination with other anti-diabetes drugs. The company will keep it simple and clear when making decisions about the potential use of danuglipron in obesity and diabetes. The company's long term revenue guidance may be updated based on clinical or regulatory successes or failures.

In the paragraph, CEO Albert Bourla and CFO Dave Denton discuss Pfizer's revenue projections for 2030. They clarify that the $25 billion in revenue is expected to be acquired by 2030, with $20 billion already acquired pending the Seagen acquisition. They mention that while analysts' expectations for the acquisitions are similar to their own, there is a gap between their projections and analysts' for their internal pipeline launches. They also mention that their core business is performing well and they have rebaselined their COVID franchises. They plan to reassess their revenue projections for 2024 and beyond in the future. Overall, they believe Pfizer's future remains bright.

Pfizer has updated their expectations for COVID revenues and believes they will remain stable going forward. They have also seen strong performance in their non-COVID products, with 10% growth this quarter, positioning them for future growth. The call has now ended.

This summary was generated with AI and may contain some inaccuracies.