Pfizer Q4 2021 Earnings Call Transcript

Quartr
Provided by Quartr
February 8, 2022

Key Takeaways

  • Record 2021 performance: Pfizer delivered $81.3 billion in revenues (+92% operationally), doubled adjusted EPS to $4.42, treated an estimated 1.4 billion patients and rose to 2nd place in the PatientView Global Biopharma Survey.
  • Ambitious 2022 guidance: The company forecasts $98–102 billion in total revenues (+24% operationally at midpoint), including $32 billion from Comirnaty and $22 billion from PAXLOVID, with adjusted EPS of $6.35–6.55.
  • COVID-19 remains central as an endemic disease, with Pfizer planning up to 120 million PAXLOVID treatment courses in 2022, ongoing Omicron- and bivalent vaccine candidate trials, and “lightspeed” R&D approaches applied across its pipeline.
  • Pfizer will pursue disciplined capital allocation and business development in mRNA, oncology, rare diseases and vaccines, aiming to add at least $25 billion of risk-adjusted revenues by 2030 while maintaining dividends and scientific rigor.
  • Enhanced ESG commitments include publishing clinical-trial diversity baselines (U.S. participation near census levels), delivering 1 billion vaccine doses to low- and middle-income countries, and linking executive compensation to ESG metrics.
AI Generated. May Contain Errors.
Earnings Conference Call
Pfizer Q4 2021
00:00 / 00:00

There are 18 speakers on the call.

Operator

Good day, everyone, and welcome to Pfizer's 4th Quarter 2021 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stilo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

Speaker 1

Thank you, Sylvia. Good morning, everyone. Welcome to Pfizer's 4th quarter earnings call. I'm joined today by Doctor. Albert Bourla, our Chairman and CEO Frank D'Amelio, our CFO Michael Dolsten, President of Worldwide Research and Development and Medical Angela Huang, Group President, Pfizer Biopharmaceuticals Group Amir Malik, our Chief Business and Innovation Officer and Doug Lankler, our General Counsel.

Speaker 1

We expect this call to last 90 minutes. The materials for this call and other earnings related materials are on the Investor Relations section of fizer.com. Please see our forward looking statements disclaimer on Slide 3 and additional information regarding these statements and our non GAAP financial measures is available on our earnings release and in our SEC Forms 10 ks and 10 Q under Risk Factors. Forward looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. With that, I will turn the call over to Albert.

Speaker 2

Thank you, Chris. Hello, everyone. 2021 was a watershed year for Fife, a year in which we set All time highs in all major areas of focus for Pfizer. We reached an estimated 1,400,000,000 patients with our medicines and vaccines. That's more than one out of every 6 people on earth.

Speaker 2

Never before has Pfizer's patient impact been so wide reaching. We improved our ranking from 4th to 2nd among large biopharma companies in the PatientView Global Survey. According to Morning Consult, 61 percent of Americans have a favorable view of Pfizer, which is up 33 points since January of 2020. Just last week, Fortune ranked us 4th on its Annual Awards Most Admired Companies list, the highest ranking we have ever achieved. 95% of our colleagues said in an internal survey that they are proud to work for Pfizer, which ranks among the best in Corporate America.

Speaker 2

We increased our investments in research and development from $8,900,000,000 in 2020 to $10,500,000,000 in 2021 And we initiated 13 pivotal clinical studies, the highest number ever for Pfizer. Last but not least, we grew revenues by 92% operationally to $81,300,000,000 and adjusted diluted EPS by 92% operationally to 4.42 Our success in leading the fight against COVID-nineteen have not only made a positive difference in the world, I believe that have fundamentally Change our company and our culture forever. Colleagues across Pfizer are inspired By what we have achieved and most the more determined than ever to be part of the next potentially game changing breakthrough. To that end, We are applying the light speed principles developed for our COVID-nineteen work to Our other therapeutic areas to make sure we continue to move at the speed of science for the benefits of all patients. As a result, we believe we can do even better with each of these metrics in 2022.

Speaker 2

It's one of them. Our full year 2022 financial guidance, for example, includes for the first time ever A forecasted revenue midpoint, but it is triple digit, dollars 100,000,000,000 and adjusted diluted EPS midpoint of 6.45. While Comirnat is having a significant positive impact on Pfizer's financial performance, It is a tremendous impact that COVID-nineteen vaccines have had on society, but it is most important. In the U. S.

Speaker 2

Alone, the COVID-nineteen vaccination program is estimated to have saved more than 1,000,000 lives And prevented more than 10,000,000 hospitalizations according to a December 2021 Commonwealth Fund report. The economic impact is equally astonishing astounding. According to a December 2021 Heartland Forward Report. The rapid deployment and wide availability of COVID-nineteen vaccines in the U. S.

Speaker 2

Created an estimated economic savings of $438,000,000,000 in 2021 alone, which amounted to U. S. GDP being 2.3% higher than it otherwise would have been, 2.3 points. I'm proud to say that Pfizer contributed significantly to these benefits given that approximately 6 out of 10 doses administered in the U. S.

Speaker 2

As of February 6, 2022, we are committed. This is the value of our science, What our culture has enabled and what drives our people. Now I would like to speak to 3 factors that will help drive our growth going forward. The first is the long term outlook for COVID-nineteen and why we believe we are well positioned to continue to lead the battle against this disease. 2nd, our thoughtful capital allocation strategy and why you believe it can help drive our growth in the 2nd part of the decade.

Speaker 2

And third, how our commitment to ESG principles is designed to create sustainable growth for Pfizer to deliver meaningful value to patients and society. Let me start with the COVID-nineteen pandemic. Our scientists continue to monitor the SARS CoV-two virus and believe it is unlikely that it will be fully eradicated in the foreseeable future. They believe this for several reasons. The global distribution of the virus makes it difficult to contain.

Speaker 2

The virus has shown an ability to mutate often, making it difficult to stay ahead of it. And the data appear to show that natural infections do not lead to the type of durable protection needed to prevent all transmissions and viral mutations. As a result, people can become reinfected by the same or different strains over time. That said, we now have the tools in the form of vaccines and treatments But we believe will help enable us to not only better manage the pandemic, but also help countries move into an endemic phase. In other words, we believe these tools will help allow us to go back to normality And spend time with family and friends, travel, attend indoor dining and concerts and enjoy many other activities, while All of us at Pfizer are extremely proud of the role we have continued to play in bringing these tools to the world.

Speaker 2

Throughout 2021, we continued our efforts to bring our COVID-nineteen vaccine to more populations and to further ramp up our manufacturing and distribution capabilities. As a result, The market share of our Comirnativ vaccine has continued to grow, representing 70% of all doses We expect to produce 6,000,000 treatment courses during the Q1 of 2022. Overall, We expect to produce 30,000,000 courses in the first half of twenty twenty two and 120,000,000 courses for the full year, Of course, depending on the global need. Having recently received a conditional marketing authorization from the European Medicines Agency, PAXCLOVID has now received emergency or conditional authorization for use with certain populations in approximately 40 countries so far. We are in discussions with governments around the world and expect that As the number of authorizations increase, so will the number of contracts for this treatment, which could truly be a game changer.

Speaker 2

At Pfizer, we are keenly aware of our That's why we continue to develop and test different versions of our vaccine to potentially address variants of concern as they emerge and why we are currently working on a new Omicron based vaccine candidate and on a bivalent COVID-nineteen vaccine candidate. It is also why just 2 months after receiving emergency use authorization from the U. S. Food and Drug Administration for PAXLOVID, We are already working on a potential next generation oral COVID-nineteen trip. Going forward, We are confident in our ability to maintain this leadership position because of our significant investments in R and D, Combined with our ability to move at the speed of science without compromising quality or safety, The strong credibility we have earned with governments, healthcare providers and consumers combined with our extensive global field presence and our unparalleled capabilities for high quality manufacturing at scale.

Speaker 2

Now the second thing I wanted to touch on is how we think about our capital allocation and to repeat once more our strategy. We feel that the entirety of our business continues to demonstrate a robust top line growth trajectory through 2025. Consensus estimates are beginning to slowly recognize this momentum. However, Consensus estimates currently show our top line shrinking from 2025 to 20,230. I want to repeat that this is inconsistent with our own plans.

Speaker 2

Our goal is to continue to be a growth company from 2025 to 2030 despite the impact of LOEs expected during that period. Our confidence in our ability to achieve that is underpinned by the momentum of our business, The durability of our COVID-nineteen offerings, which as I just described, the underestimated strength of our internal pipeline And of course, by our ability to deploy capital into growth focused business development to access To advance our business strategies and objectives, the strength of our balance sheet and cash flows allow us to pursue new business development opportunities going forward that could add at least $25,000,000,000 of risk adjusted revenues to our 2,030 top line expectations. We expect to do this while still maintaining our growing dividend as well as flexibility for other uses of our cash. The focus of our business development efforts will continue to be on compelling external science in the form of both later stage assets as well as earlier medical innovations that have the potential to be breakthroughs for patients. Our focus will largely be in the therapeutic areas and platforms where we have the scientific skills and acumen to add substantial value and select the most successful targets.

Speaker 2

In addition, We feel that we have distinctive attributes such as world class excellence in clinical development and surpassed manufacturing and commercial capabilities at scale that makes us a very attractive partner across a variety of deal arrangements. We believe the opportunities to deliver on this approach exist and I will be personally focusing on this execution. I want to emphasize that despite our significant capital flexibility, We will never lower the scientific and financial standards we apply in our business development. As we pursue these opportunities, we will continue to be highly disciplined in our evaluation and prioritization processes. Since 2019, we have already invested almost $25,000,000,000 in business development transactions, Adding more than $13,000,000,000 in consensus, I repeat in consensus 2,030 revenue.

Speaker 2

I would point out that the $13,000,000,000 of consensus currently includes nothing for the Trillium assets, The Bioheaven collaboration or the recently announced mRNA deals, all of which have substantial potential. I see the space of business development accelerating going forward, and I'm confident it will be an important driver One highly visible example of our approach to business development is the recent investments we are making in mRNA technology and collaborations. MRNA has emerged as a versatile technology with potential application across many infectious diseases, cancer, Rare genetic disorders and even autoimmune diseases. Although mRNA is not the Holy Grail, We believe that technology has the potential to have a game changing impact on global health, which is why we have developed A robust mRNA strategy and are aggressively building our platform. While the pandemic has demonstrated that it is not that Easy to deliver mRNA vaccines at scale, Pfizer has emerged as a leader in this space.

Speaker 2

With decades Of experience on our side, we have developed what is arguably the most efficient clinical development and vaccine manufacturing capabilities that world has ever seen. We also have rapidly scaled and built our new out new capabilities in record time by hiring nearly 2,400 new colleagues in these functions in a 9 month timeframe. Going forward, we plan to continue to invest to capitalize on the leadership we have built in terms of both MR and A, R and D and Manufacturing. In addition, of course, to these internal investments and improvements, We are also making external investments to build out our capabilities in this space. For example, Pfizer recently has entered into 4 important business development deals to help advance our mRNA strategy.

Speaker 2

We are expanding our collaboration with BioNTech to use the existing platform to co develop an mRNA vaccine candidate for herpes zoster virus to protect against singlet. Our agreement with Beam Therapeutics expands our mRNA efforts to another core therapeutic area for Pfizer, A rare disease with a 4 year research collaboration for 3 targets for rare genetic diseases of the liver, muscle and central nervous system. We believe this will give us the potential to use mRNA to treat diseases, Not just PREVENT, TRITA. Our agreement with Acuitas gives us the ability to collaborate with and licensed their proprietary lipid nanoparticle technology for up to 10 targets for mRNA vaccines and therapy. We believe this will give us greater independence in this space.

Speaker 2

And we have signed a Strategic collaboration and licensing agreement with Codex DNA, a leader in the development of automated solutions For on demand synthesis of genes and mRNA, potentially allowing enzymatic assembly of DNA at the front end of the mRNA production process. This could possibly reduce the time to produce a new vaccine from 3 months down to 2 months. If successful, this would be an important differentiator when developing a vaccine for the flu, For example, as it would allow us to select the strain much closer to the start of any flu season. These deals represent only 4 pieces of a much bigger strategic puzzle. As we continue executing on our mRNA strategy, you should expect to see more targeted activity in this area.

Speaker 2

Of course, our business development activity in the last quarter went beyond executing on our mRNA strategy. This is an update of the slide I showed you last quarter, and I would like to highlight a few of the other recent deals. You can see them with the indication new. The acquisition of Trillium builds on our strong track record of leadership in oncology, Enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our strategic collaboration Bioheaven leverages our leading commercial capabilities in pain and women's health with Bioheaven's groundbreaking oral CGRP receptor antagonist, the only one approved in the U.

Speaker 2

S. For both acute and preventative treatment of migraine, so that we can potentially bring a valuable new treatment option to patients living with this debilitating neurological disease outside The U. S. And through our proposed acquisition of Arena, we plan to leverage Pfizer's leading research and global development capabilities to accelerate the clinical development of etrasimod for patients with immuno inflammatory diseases. Now I would like to share some details about Pfizer's enhanced ESD strategy.

Speaker 2

The strategy is focused on 6 areas where we see opportunities to create a meaningful and measurable impact over the next decade: Product Innovation, Equitable Access and Pricing, Product Quality and Safety, Diversity, Equity and Inclusion, Climate Change and Business Ethics. Each quarter going forward, I will provide Examples of how we are embedding ESG into all core areas of our business. This quarter, I would highlight our efforts To improve clinical trial diversity to improve diversity within our colleagues base and help ensure equitable access Last year Pfizer published an industry first retrospective analysis Of demographic data of U. S. Participants, 213 of our interventional clinical trials that initiated enrollment from 2011 through 2020.

Speaker 2

The analysis demonstrated that Overall trial participation of Black or African American individuals was at the U. S. Census level, 14.3 versus 13.4. Participation of Hispanic or Latino individuals was below U. S.

Speaker 2

Census 15.9 versus 18.5 and female participation was at U. S. Census 51.1 versus 50.8. We published this analysis to be transparent and for it to serve as the baseline As we measure progress in this area, we believe that diversity in trials is a matter of equity and good science and are taking decisive steps designed to improve diversity in our trials. Our goal is to achieve racially and ethnically diverse The second item I want to highlight is the significant progress we are making in diversifying our colleague base, particularly at more senior level positions.

Speaker 2

In the last 3 years, for example, we have increased the percentage of women at the Vice President level and above globally From 32% to 42%. Over the same time frame, we have increased the percentage of minorities The 3rd item I wanted to highlight is the progress we are making to help ensure our COVID-nineteen vaccine and oral treatment are accessible by everyone everywhere. I'm thrilled to say that we remain on track to meet or exceed our global or our goal of delivering at least 2,000,000,000 doses of our vaccine to low and middle income countries by the end of 2022, having just met our goal of delivering the first $1,000,000,000 by the end of 2021. I also want to highlight 2 data points about our 2,000,000,000 dose commitment. 1,000,000,000 of these doses are being provided to the poorest countries completely free of charge.

Speaker 2

Thanks to our agreement with the U. S. Government, Pfizer is providing these doses to the U. S. Government at a not for profit price and the government Is then providing them to the poorest countries for free.

Speaker 2

Also, the 1,000,000,000 doses we delivered in 2021 represented 37% of all doses we delivered this last year. In terms of our oral COVID-nineteen treatment, We have signed a voluntary license agreement with the Medicines Patent Pool, which we hope will lead to expanded access pending country regulatory authorization for approval in 95 low and middle income countries that account for approximately 53% of the world's population. Lastly, I'm pleased to announce that the compensation committee of our Board of Directors Has been reviewing methods to linking executive compensation with ESG performance, which we expect to begin this year. For details regarding the impact of our ESG strategy had on our business in 2021, please keep an eye out for Pfizer's 2021 ESG report, which will be published online in mid March. In summary, 2021 was an outstanding year for Pfizer and we look forward to continuing to apply the lessons learned from COVID-nineteen to deliver breakthroughs for patients across all our therapeutic areas.

Speaker 2

We remain focused on being nimble, investing in our R and D organization and exploring dynamic partnerships that will enable us to fully realize the power of our science. None of this is possible without the contributions of our amazingly purpose driven colleagues who continue to rise to the challenge of addressing the world's most Devastating diseases. In 2021, our colleagues exceeded expectations. Therefore, we will once again Use part of the bonus pool that the Board approved for bonus eligible colleagues and executives To provide a one time special COVID-nineteen circumstances bonus to our non bonus eligible colleagues across the board to reward them for their hard work and to help them cover personal, family and living expenses incurred because of the COVID-nineteen pandemic. With that, I will turn it over to Michael to update you on our R and D efforts.

Speaker 2

After Michael, Frank will provide financial details on the Q4 and our outlook for 2022. So, Mikael?

Speaker 3

Thank you, Albert. I'm delighted to share updates from this quarter as we continue to deliver 1st in class science. Today, I will share updates from our COVID-nineteen programs and select other assets in our pipeline. Let's start with PAXLOVID. As the COVID-nineteen pandemic continues to burden public health, we have advanced the science on our novel oral antiviral therapeutics.

Speaker 3

Importantly, we see consistent potent antiviral activity in vitro against all current variants of concern, including both Delta and Omicron. This would be expected from how the compound was designed. On the left, you can see a crystal structure showing how tightly near matrilvir binds to the active site of the Omicron variant. History has told us from the HIV process field that the closer the therapeutic is designed to mimic the substrate, the harder it is for That combined with essential nature of the protest, the short duration of treatment And the co dosing with ritonavir to drug exposures that over 5 to 6 times the amount of compound needed to kill the virus in an immediate assay suggests this reduced risk for resistance. External data support our findings.

Speaker 3

In this slide, the lower values, the stronger potency illustrated by Nymatravir Being on the lower end of the y axis on the left, having the most potent activity. Nematril Beer Maintains in vitro potency in the low nonamolar range. As you can see in these graphs that include other authorized or approved On the left is in vitro data from a study done with the Aiken School of Medicine at Mont Sainte Marie and Pfizer. Nematravir demonstrated potent antiviral activity as measured by SC50, a measure of drug efficacy Indicating the concentration needed to inhibit infection behalf. This is consistent with findings from the Riga Institute, the KU Leuven 2 respectively and a study start in children 6 to 18 years old in the Q1 of 2022.

Speaker 3

In the standard risk study, We're expanding enrollment by 750 non hospitalized patients with symptomatic COVID-nineteen and vaccinated standard risk patients may also be eligible, Provided our loss SARS CoV-two vaccine dose was received at least 12 months prior to screening. This expansion will allow us to further evaluate the in the treated compared to placebo. We also are advancing work on our potential next generation SARS CoV antiviral With the aim of achieving similar high clinical efficacy in pan coronavirus design properties that maintain activity With a favorable safety profile and counter potential viral resistance, but without the need for ritonavir boosting, The first in human study is expected in the second half of twenty twenty two. Now we also continue to advance vaccine development and have achieved emergency use authorization for using children as young as age 5. Effectiveness data for 3 doses Including Omicron suggests that people vaccinated with 3 doses coming off the way may have a higher degree of Protection against both symptomatic and severe outcome compared to 2 primary doses.

Speaker 3

Informed by these data, In addition to the immuno bridging data, we are evaluating a third 3 microgram dose in our study of children 6 months through 4 years of age, We do believe that the 3rd dose may be optimal for this age group. However, as pediatric cases and hospitalization are at an all time high, FDA urged us to start the rolling EUA authorization submission with a 2 dose efficacy immunoicity and safety data we have While we continue to collect data including on 3rd dose administration, We plan to submit 3rd dose data once available. In the meantime, FDA has scheduled an advisory committee meeting for February 15 to consider the 2 dose pediatric data collected today. If emergency use of station of 2 doses is granted And the CDC recommends usage, parents will have the opportunity to begin a COVID-nineteen vaccination series for the children between 6 months And 4 years of age, while awaiting potential authorization of a third dose. Turning to the adult population.

Speaker 3

In the wake of surging Omicron cases, in January, we completed a lab analysis of the effect of a third dose boost of Cominati on live virus Encouragingly, there was a more than 25 fold increase in Omicron live virus methylation titers observed between day of dose 3 and 1 month post dose 3. We observed a moderate 4 months post twothree antibody decay for wild type and the Omicron variant. Between 1 month and 4 months post twothree, Neutralizing cases were 1.6 and 2 for lower for wild type and the Omicron variant, respectively. We're now starting to see effects of a 3rd dose boost in maintaining a high level of protection against Omicron in the real world. These data from Kaiser Permanente Southern California show Omicron related emergency departed visits without hospitalization on top and hospitalization on the bottom.

Speaker 3

3 doses of Cominati provided better vaccine effectiveness against Omicron than 2 doses. And it was high vaccine effectiveness of 3 doses against Omicron related hospitalization, Similar to Delta related hospitalization, we did see some waning of effectiveness against emergency departure admissions Due to Omicron 3 months or more of the 3rd dose, which suggests the potential need for another boost of the current vaccine or an Omicron based We have started an Omnicom based vaccine candidate trial in adults 18 to 55 years of age. This study will evaluate more than 1400 participants across 3 cohorts. Those who have Already received 2 doses of the current vaccine 90 to 180 days prior to enrollment will receive 1 or 2 doses of the Omicron based Those who have already received 3 doses of the current vaccine, 90 to 180 days prior to enrollment, We'll receive one dose of the current vaccine or the Omicron based vaccine. And those who are vaccine naive will receive 3 doses of the Omicron based vaccine.

Speaker 3

This study is part of our science based approach to develop a variant based vaccine That we hope achieve a similar level of protection against Omicron as the current vaccine has with both wild type and earlier variant, But with potentially longer duration of protection. Now let's turn to our next generation CDK inhibitors for cancer. Most patients with advanced or metastatic breast cancer eventually develop resistance to both endocrine and CD4K6 inhibitor therapy Despite our transformative efficacy, inhibition of CDK2 delivered with a CDK selective active drug or a triple active CDK246 agent may prevent, delay or reverse resistance and prolong survival. These are data from a subset in the CDK-two forty six inhibitor Phase 1 dose escalation and antitumor activity study of heavily pretreated patients With hormone receptor positive metastatic breast cancer, the most improvement in terms of tumor size reduction was seen in patients treated with monotherapy or in combination with colvestrant. We observed 3 confirmed partial responses and 3 patients with stable disease For more than 12 months, one patient has been receiving ongoing treatment for more than 28 months.

Speaker 3

There's been an acceptable safety profile at the recommended Phase 2 dose, which is 25 milligrams twice daily. We plan to conduct the Phase 1 dose expansion and expect to complete it in the Q4 of this year. Selective CDK2 inhibition with a CDK2 only inhibitor may allow dose titration And has the potential to be used in combination with approved CDK inhibitors such as palbociclib or other next There were 2 confirmed partial responses in the Phase 1 study of our select CDK2 inhibitor in patients with advanced hematopoietic hormone receptor HER2 negative breast cancer who had received progress On prior CDK4six inhibition and endocrine therapy, one patient had a maximum tumor shrinkage of 54% Following CDK2 inhibitor treatment for approximately 8 months and the second 100% shrinkage of all target Lesions following treatment per cochlelet demand 9 months. We are showing scans of the 1st patient at baseline and 8 weeks. There was an acceptable safety profile as a monotherapy and we're currently exploring combination.

Speaker 3

We expect the Phase III Now let's turn to our 6 valent Lyme disease vaccine candidate, which we are developing in partnership with Valneva. We have received further positive data from our Phase 2 proof of concept study and expect to start Phase 3 in the Q3 of this year with a dosing regimen of 0, 2 6 months to prime, followed by routine boosters before the start of a Lyme disease. Our Phase 2 studies continue and includes a pediatric population 85 to 17 years. Since Lyme disease is seasonal, our goal is to establish a regimen that We saw substantial boost antibody response in Phase 2 to all sick serotypes present in North America and Europe Follow the 3 dose primary serious vaccination schedule, with a 14 to 31 fold rise in season 1 And the 51 to 69 fold rise in Season 2, the vaccine candidate was generally well tolerated at all those levels tested and we are We told you that we saw robust dystrophin expression out to 1 year in our Duchenne muscular dystrophy Yin Therapy Phase 1b study. I will show you encouraging functional multidata in a moment.

Speaker 3

We recently shared some very sad news that the DMD patients with advanced disease In the non ambulatory cohort of the Phase Ib trial, passed away after presenting with hypovolemia and cardiogenic shock. The patients were 16 years old and the 1st in the non ambulatory cohort treated with Rapimmune along with Steroids as part of the immunosuppressive regimen. Rapamun is not used in the Phase III ambulatory study. Like most non ambulatory DMD patients, he had more advanced disease with underlying cardiac dysfunction. There is evidence of an active viral infection and we're investigating how this may have contributed to the outcome.

Speaker 3

Additional assessment We'll be required to define next steps to restart the Phase 1b study in non ambulatory patients who have more progressed in the disease. I will now share data from this study. The ambulatory cohort sorry, I had one more sentence to say here. 19 patients were enrolled in this study, 16 of whom received the dose Selective our Phase 3 program and 3 of whom received a previously studied lower dose. At 1 year post treatment, there was a 5.6 point improvement in ambulatory function as measured by NorthStar Ambulatory Assessment compared to an external control match for age and baseline function.

Speaker 3

This is particularly encouraging given that patients at this age and stage of disease typically experience a considerable decline in ambulatory function as illustrated by the external control. On the right, we show timing study with 6 participants nearing or more than 3 years in treatment. The ambulatory cohort in Phase Ib is similar, but slightly older on average to the population in the Phase III CEFR trial. Considering the favorable benefit to risk profile in this study and observed in the ambulatory patient population And in consultation with the Data Monitoring Committee, we believe the safety profile of our D and D gene therapy is manageable in this patient group. Additional mitigation are being added to our study in consultation with DMC and other medical experts.

Speaker 3

Pending regulatory feedback, anticipate Phase 3 study sites to begin reopen in the next few months with a potential to report top line results And sebexo clinical trial success submit the delay by the end of 2023. Turning now to Tintana Medicine And poincigramab, our candidate for cachexia due to cancer, it targets GD15. EDI-fifteen is frequently elevated in cancer patients, drives reduction of appetite and body weight loss and is associated with poor outcomes. There may also be a potential to treat cachexia associated with other chronic diseases such as heart failure and COPD. We have encoded Phase Ib data, which I will show next.

Speaker 3

Ponsecromab was evaluated in 10 cancer patients We are undergoing anti tumor treatment and had more than 5% body weight loss in the last 6 months More than 2% body weight loss with a body mass index of less than 20 kilogram per meter squared or diagnosed sarcopenia. Ponseguimab administration was found to suppress circulating TDR-fifteen levels in cancer catexta patients below the level observed in healthy SABYAG. Preliminary data from the Phase Ib trial show poincigramab treatment resulted in significant body weight gain Compared to historical placebo, you can see the nice trend in body weight increase remained even after the dosing was stopped at week 12. The gray dotted line indicates historical cutoff associated with improved survival. We are co developing a 2 study in cancer kick assays in the Q4 of this year.

Speaker 3

Injectable GLP-one receptor agonist offer potent lowering of glucose and weight in diabetic and obese patients with proven cardiovascular benefit, But this drug class is underutilized due to its injectable administration route. Our small molecule Oral GLP-one receptor agonist, dinogluperone could potentially offer a convenient oral alternative Tunektivol and is being evaluated for the treatment of Type 2, 2 diabetes, obesity and NASH. It has been developed in our internal medicine research group with a vision to expand the use of this potent easily administered Lip BuenBraglabs to a primary care setting. Here are data from the Phase 2 study in Type 2 diabetes. We recorded strong dose dependent reduction in both HbA1c, a measure of long term blood sugar levels and body weight compared to the marginal effect noted with placebo.

Speaker 3

After 12 weeks of treatment with a 200 milligram twice daily dose, HbA1c decreased by almost 1.6% and body weight decreased by 5.4 kilograms. The safety and tolerability profile is consistent with the GLP-one class and the most frequent adverse events rates were GI related. We expect to start the Phase 2b titration optimization study mid-twenty 2 with doses up to 200 milligram twice a day and complete the Phase 2b study in nondiabetic subjects with obesity in the Q1 of next year. Finally, here are select recent upcoming milestones from across the pipeline. The solid blue dots represent milestones achieved And the open blue dots represent anticipated milestones.

Speaker 3

Programs involved are major anticipated events. Some of the programs on the right have already been designated as light speed, meaning they have accelerated development timelines or are being considered for light speed designation. Finally, I would like to take a moment to thank Morrie Wienbaum, our outgoing Chief Scientific Officer of the Internal Medicine Research Union for his immense contribution over the last 7 years. And welcome Bill Sessa, who joins us on Yale School of Medicine Following a decades long career in academia, including service as Vice Chair of Pharmacology, Professor of Medicine and Director of the Vascular Volodin and Therapeutics Program at Yale. Bill is an eminent lead in the field, a groundbreaking scientist and a celebrated innovator, And I know he will bring his tremendous vision and insights to our investigation of cardiovascular metabolic diseases.

Speaker 3

Thank you for your attention. I look forward to your questions. Now let me turn it over to Frank.

Speaker 4

Thanks, Michael. I know you've seen our release, so let me provide a few highlights regarding the financials. The COVID-nineteen vaccine once again had a positive impact on our quarterly results and Albert and Michael have already addressed key points on the COVID-nineteen landscape. Turning to the income statement, revenue increased 106% operationally in the Q4 of 2021, driven by COVID-nineteen vaccines, vaccine sales and strong performance from a number of our other key growth drivers. Looking at the revenue excluding the COVID-nineteen vaccine direct sales and Alliance revenues and PAX Lovid contribution, 4th quarter was slower In the 1st 9 months of the year declining by 2% operationally.

Speaker 4

So we discussed during our Q3 call, there was a 4% negative impact or approximately $500,000,000 from fewer selling days in the U. S. And international. Excluding that impact, operational growth would have been 2%, which is still lower than the mid to high single digit growth we had experienced during the rest of the year. This was factored into our forecast for the year, but let me briefly walk you through this.

Speaker 4

In our biopharma business, you will remember that the Q4 of 'twenty one faced a tough comp from the Q4 of 2020 for Prevnar As pneumococcal vaccinations were strong and have COVID-nineteen vaccine availability, excluding vaccines from the current and comparable period will add 5 percentage points to the growth. Adjusting for the unusual comp period differences related to vaccines and selling days, Our revenue growth would have been approximately 7%, which is similar to what we've been delivering lately. For the year, 2021 operational revenue growth was 6%. This is consistent with our projected revenue CAGR of at least 6% from 2020 through the end of 2025. Of course, there will be some variability in quarterly and annual growth rates due to a variety of factors, but we continue to expect at least 6% CAGR through 2025.

Speaker 4

The adjusted cost of sales increase shown here reduced this quarter's gross margin by approximately 16 percentage points compared to the Q4 of 2020, which is almost entirely driven by the impact of the COVID-nineteen vaccine. Adjusted SI and A expenses in the 4th quarter increased primarily due to increased product level spending, including Cominarty and higher healthcare reform Sales based fees. The increase in adjusted R and D expense this quarter was primarily driven by increased investments in late stage pipeline projects, including additional spending related to our oral COVID-nineteen treatment. So we've again provided total company guidance, which includes the business with the COVID-nineteen vaccine. We will continue to provide insight into our expected revenues for Cominar And now for the first time, we'll also provide some color on our expected revenues for PAXLOVID.

Speaker 4

However, note that we'll no longer be providing EPS guidance for the business excluding co minority. Similarly, we won't provide EPS guidance for PAXLOVID. Our revenue guidance represents a record for Pfizer and we expect total company revenue to be in a range of $98,000,000,000 to 102,000,000,000 representing an operational growth rate of 24% at the midpoint. Please consider that this revenue range reflects $1,100,000,000 of anticipated negative impact from changes in foreign currencies and also the impact of the loss of MRIdian sales of approximately $300,000,000 both of which your models may not take into account. Regarding our COVID related revenues, we now expect the COVID-nineteen vaccine revenue for the year to be approximately $32,000,000,000 an increase of approximately $1,000,000,000 compared to our prior guidance provided on December 17.

Speaker 4

For PAXLOVID, we expect sales of approximately $22,000,000,000 This means that excluding the COVID related revenues, We expect sales to be $46,000,000,000 at the midpoint, representing operational growth of 5%. While this is slightly below the 6% CAGR Let me give you some detail on our cost and expense guidance. For adjusted cost of sales, we are expecting a range of 32.2% 34.2 percent. Given that we are now more than 12 months past the launch of Combinati, we expect its negative impact on our cost of sales margins to be less than it was in 2021, assuming a similar level of revenues. Further, Paxlovid is expected to have a very positive impact on cost of sales as a percentage of revenues in 2022.

Speaker 4

On adjusted SI and A, we expect $12,500,000,000 to $13,500,000,000 increase of $900,000,000 at the midpoint. We expect our adjusted R and D guidance range to be $10,500,000,000 to $11,500,000,000 at the midpoint that is about $500,000,000 higher than last year. We expect an adjusted effective tax rate for the year somewhat higher than 2021 at approximately 16%. These assumptions yield an adjusted diluted EPS range of $6.35 to $6.55 or 47 percent operational growth at the midpoint compared to 2021, excluding and expected $0.06 negative impact from foreign exchange. I'd like to point out some additional information which may be helpful for your models.

Speaker 4

You will note that our guidance assumes a weighted average share count of approximately 5,800,000,000 which represents an increase of approximately 100,000,000 shares over 2021. This accounts for the number of shares that we normally issue for employee compensation annually. The increase of 100,000,000 shares over 2021 decreases our EPS by about $0.10 at the midpoint. I noticed that most of your models instead assume a flat share count for 2022 as compared to 2021. From the Q1 of 2022 and going forward, We've made a decision to modify our adjusted financial treatment of amortization of intangibles.

Speaker 4

Previously, we only excluded Amortization related to large mergers and acquisitions, I'll exclude all intangible asset amortization expense. This is anticipated to contribute $0.06 to our 2022 adjusted diluted earnings per share helps improve comparability with our peers. 2022 guidance once again assumes no share repurchases. We will note that Pfizer did not repurchase shares in either 2020 or 2021. And we continue while we continue to have outstanding unused authorization to repurchase another $5,300,000,000 of stock, it can be opportunistic.

Speaker 4

Given the potentially value enhancing business development opportunities, which are available to us, we do not expect to repurchase shares Our word on our 32% stake in the consumer joint venture with GSK. You know, GSK has announced its intention to engage in a demerger transaction for at least 80% of its 68% stake in the JV in the summer of 2022. We talked about our stake as a non core asset whose value we will seek to realize over time. While we have determined neither the manner nor timing of how we will do so, There are a number of possible alternatives and we will attempt to monetize this asset in the manner which will create the most value for our shareholders. We received approximately $600,000,000 in pre tax income from the JV annually and this will not change as a result of the merger transaction And our guidance assumes that this will continue throughout 2022 with no change to our 32% stake.

Speaker 4

Let me quickly remind you of some assumptions and context on the projected COVID-nineteen vaccine contribution and our collaboration agreement. The Pfizer BioNTech COVID-nineteen vaccine collaboration construct is a fifty-fifty gross profit split. Pfizer books the vast majority of the global collaboration revenue, except for Germany and Turkey, where we receive a profit share for BioNTech and we do not participate in the China region. We continue to expect that we can manufacture 4,000,000,000 doses in total by the end of 2022. The 1,000,000,000 increase in COVID vaccine revenues to approximately $32,000,000,000 in 2022 primarily represents the impact of contracts signed since mid December, which they cut off for our prior guidance.

Speaker 4

While we cannot predict what may be needed due to Omicron or the variance, I'd also caution you that there is less potential upside to this guidance to the year compared to the situation we faced in 2021 when the vaccine was newly available, Few people have received any doses of the vaccine. As you will remember, our cost of sales for the COVID-nineteen vaccine revenue includes manufacturing Distribution costs, applicable royalty expenses and payment to Viantech representing 50% gross profit We expect that the adjusted income before tax margin for the COVID-nineteen vaccine contribution to be slightly higher In the high 20s as a percentage of revenue that we had in 2021. Unlike the situation for Comenity, Demand for PAXLOVATE should have upside from these levels depending on the outcomes of discussions with certain governments and potential purchases for stockpiling against future coronavirus pandemics. If we remove the projected COVID-nineteen vaccine and PAXLOVID contribution from both periods, You will see that we expect the 2022 revenue range to be $45,000,000,000 to $47,000,000,000 representing approximately 5% operational revenue growth at the midpoint. Please remember our guidance excludes the former revenue contribution of approximately $300,000,000 from MRIdian All 21 quarters have been recast to exclude Meridian's discontinued operations accounting for its divestiture.

Speaker 4

Going forward, we will not give earnings guidance Excluding the estimated income from our commodity direct sales and Alliance revenues and PAXLOVID. However, to help you with your forecasting a couple of minutes ago, I gave you my view on 2022 Cominarney pretax margins. For PAXLOVID, I would think about its margins as being typical For small molecule drug and unlike commonality, it is expected not to be dilutive to pretax earnings. To help you further, Several years ago before COVID-nineteen existed, I spoke about our business being on a path to a 40% plus pretax margin We continue to be prudent in our capital allocation activities with the opportunities for deployment show here on this slide. In summary, exceptionally strong quarter in year Based on continued strong performance for our growth drivers, during the year we raised guidance and for the year we met or exceeded our guidance in all key metrics.

Speaker 4

Our pipeline continues to advance. We have invested record amounts to support that advance. Last week, Arena shareholders voted to approve Pfizer's acquisition of the We look forward to a targeted closing of the Arena acquisition soon as the first half of twenty twenty two subject to dissatisfaction of With that, let me turn it over to Chris to start the Q and A session.

Speaker 1

Thank you, Frank. Apologies everyone for those technical difficulties. Just want to remind you, we do have the And given the technical difficulties, we're going to try to let the Q and A session run a little longer to answer people's questions. Sophia, first question please.

Operator

Thank you. Your first question comes from the line of Geoff Meacham from Bank of America Securities.

Speaker 5

Hey, guys. Thanks for taking the question. Just to add 2, the first one on Paxlovid guidance. I know you guys are factoring in only Signed agreements, but could you give us a general sense as to agreements or doses perhaps that are under discussion? And is that dependent on supply ramping?

Speaker 5

The second question, on external VD, Albert, I understand the strategy. I think the uncertainty It's really the ability to scale some of the products that you brought in. So if COVID is less of a long term contributor than you assume, what's the appetite To do higher impact larger deals, you clearly have the capacity. Thank you.

Speaker 2

Thank you. Angela, you want to take a little bit the paxlovid?

Speaker 6

Sure. So currently, we are in active discussions with over 100 countries and governments around the world. So I'd say that The discussions are going really well. In terms of where we are with the contracting, as you say, we've included Every day and contracts are being secured and distribution agreements being secured literally on a day to day basis. So I think that this is a number to watch And we do continue to expect movement.

Speaker 6

I think that there is a tremendous amount of interest for our product. And certainly as the clinical program continues to develop and emerge, as you know, we only have the high risk study right now. We still have the standard risk and the prophylaxis That's coming up. And I think that the full clinical program will also be another point of impetus for contracting and ordering. So I think it's going just really well and more to come on this front.

Speaker 2

Thank you. Amir, maybe some comments on the BD.

Speaker 7

Sure. Thanks for the question, Jeff. I think in terms of the top line, we're going to be incredibly flexible. We have said We are most interested in compounds that have potential to be real breakthroughs. And this can take the form of later stage Clinical development as well as earlier stage medical innovation.

Speaker 7

We're going to bias to the TAs, oncology, INI, rare, vaccines, internal medicine Hospital where we've got the scientific chops to make good choices and add real value, and we're going to be flexible on the deal types. Acquisitions are obviously very much in the cards, but strategic partnerships and alliances are well. And in fact, some of our best successes have come from some capital light collaborations. If we see a larger opportunity that's strategic and creates value and meets the criteria that I just described, we've obviously got the balance to do that. So we certainly will look at those, but we're going to talk about and focus on the priorities that I described more so than synergy driven deals per se.

Speaker 2

Thank you, Amira. And Jeff, just to add to both points because I'm sure that both will be asked a lot. On rupaxlovid, clearly, Numbers could become way bigger than what we have right now, but this is not something that we have done in the past and we don't plan to do Right now, to give based on what could be the potential as a guidance. We are giving guidance based on what it is more or less Secure, either signed deals or already agreed but not signed yet, deals but agreed prices and volumes. So Clearly, if you remember, when we started with the vaccine, in the beginning, we had a guidance of, I think, 1,000,000,000 in the Q1, something like that, eventually made 36,000,000.

Speaker 2

Here, we started even stronger in our first projections with paxlovid. So and that's why we manufacture and to move ahead with our plans and already we are at 120,000,000 treatments And we have the ability to go higher if the discussions that we are having materialize all. In terms of also the business development, I just want to emphasize that because I'm getting a lot this question on the size. We are agnostic precise. Where we are biased, it is deals that in order to justify The premium, we will have to do significant cost synergies.

Speaker 2

This is not these are could be very profitable deals For other, let's say, periods of the history of the company, not now. Right now, the company is Having a manufacturing machine, but it is performing at its best an R and D machine, but it's performing at its best A commercial machine that keeps being the leader in the industry in terms of their ability to execute and deliver. So the last thing I want to do it is to do a deal, but in order to justify the premium to the shareholders of the other company, we will have shutdown manufacturing sites and to consolidate research sites and consolidate field forces so that we can justify So we can generate the core synergies. This is not the time to disrupt the momentum of the company. This is the time to bring into this Manufacturing machine, the research machine, the commercial machine, more substrate in addition to what we produce Organically ourselves and this is why the business development is aiming in these areas.

Speaker 2

So let's go to the next one.

Operator

Your next question comes from Mohit Bansal from Wells Fargo.

Speaker 8

Great. Thanks. Thanks for taking my question. Maybe one on PAXLOVATE. So there have been some news reports talking about logistical and access issues of PAXLOVATE.

Speaker 8

And I understand that supply is tight for now. I would love to get your thoughts on how you're working on improving the logistics and the supply is no longer an issue, especially in a world where Home testing would become a norm and one needs to take this drug within 5 days of diagnostic.

Speaker 3

Thank you.

Speaker 2

I wouldn't say that we have logistical issues of supply, but Angela, would you like to take that please?

Speaker 6

Sure. So first of all, again, our deliveries and our Allocations for the doses have gone extremely well here in the U. S. Just to give you some context, 265,000 doses have been allocated by the U. S.

Speaker 6

Government since the EUA was approved. And of that 265, 85% of all the doses have been ordered. So, and we see a range of ordering patterns from the states. Some But I would say for the most part, the weekly orders are going up and increasing week by week and there is a very strong placement of orders. So I would say that the drawdown Right, of the doses and the utilization is going really well.

Speaker 6

And again, this is by state what the allocations are and how that's going. And then, as Albert said, I don't know that we have, logistical they are not logistical issues. I think initially, what was difficult was That, it was not clear where the doses were being located because every state had a different system for where to actually distribute PAX loaded from. But there are a number of tools now that have gone up online both At the state level as well as on Pfizer's website, we've taken the state government tool and also loaded it on our website So that both HCPs and patients can see where Paxlovid is being where it's available and where the orders as well as prescription can be placed. So I think in that regard, that's all been ironed out.

Speaker 6

I think looking forward into the future, I mean clearly having a seamless End to end from diagnosis, positive results to then being able to prescribe quickly and having the patient be able To acquire the drug quickly is our goal. And I think on all of those fronts, we're working with a number of partners, both from a testing and a diagnostics perspective, but also from a telemedicine perspective and from a pharmacy perspective to ensure that we have as fast and as efficient, I can say, a patient journey, right, from diagnosis right until treatment. So all of that is in place and you'll hear more you'll continue to hear more about that as the launch and as the utilization

Speaker 2

So again, to punctuate and give a little bit of context to what Angela said, the 85% That it has already been order from the quantities that we are making available to the government is a very, very high number. For example, the same number in the 1st month for vaccines, if you remember well, if you remember from that time, was dramatically lower than that because it takes time for the states to get their act together. And it is really variable state by state. So there are states right now, But once the quantities are made to them available, they are ordering immediately and there are states that take their time until they get their act together for the distribution. In general, Way, way, way more efficient than what used to be in the 1st month of the vaccine.

Speaker 2

Also what is extremely important, it is that every week There is constant replenishment, which although we do not have right now data for scripts because it's too early. What we do have it is that the quantities that the states are accumulating, they are disappearing and then immediately they are placing orders. So I would say We have, let's say, we are pretty happy with the way that the 1st month, the collaboration with the U. S. Government went in terms of allocating doses.

Speaker 2

And there is dramatically also improvement in the tools as Angela described, but the bigger improvement will come from the fact that the 2nd month We'll make available way more quantities in the 3rd month, way more quantities because the issues right now for people trying to find it, it is that it is in few places in the state Because you can expand the network of prices that it is available when you have smaller quantities. That will be very, very different this month and basically all over the place I think in the 3rd month where significant quantities will be delivered. Okay. I think, let's go to the next question.

Operator

Your next question is from Evan Seygerman from BMO Capital Markets.

Speaker 9

Hi, guys. Thank you so much for taking my question. I was wondering if you could provide an update on the SEC review process for the Arena deal. I'm not mistaken, there was a recent procedural move where you and Irina withdrew the withdrew and refiled the HSR Act filing essentially to allow the FTC an additional 30 days for review. Then I'd also love for you to walk me through your assumptions on how you forecast $13,000,000,000 in revenue from Vidi transactions.

Speaker 9

That would imply that you have specific

Speaker 2

On the last one, just to make sure, but this is not our assumption. Our assumption is way higher of the €13,000,000,000 What I just gave you, it is what is the consensus of the deals that we have signed so far. But on the FTC review, I would like to ask Doug, to provide much maybe a review on that. Doug Langer, our General Counsel.

Speaker 10

Yes. As you pointed out, we did get a request to refile, which is not unusual. Under it's the deal is, of course, subject to customary closing conditions Antitrust clearance and shareholder approval, which as you know, we've received, we don't expect a significant break In time from our proposed sense that the deal will close in the first half of this year. We still expect it to Closed in the first half of this

Speaker 2

year. Thank you. And Miro, I did explain that this is consensus numbers, not our numbers. You want to make any other comment on the $13,000,000,000 of 2,030 revenues that consensus forecasts for the deals that we have signed?

Speaker 7

Yes. The only thing I would add is we feel very good about the progression of all of the substrate in the deal since 2019 that Albert We've seen a significant number of approvals in EUAs in that group, submissions as well as quite a few Phase 3 starts. So we think that that substrate is progressing well and the $13,000,000,000 is a consensus number. Our expectations of what's there are materially higher And there are a number of transactions. We spoke to Trillium, Biohaven and even some of the recent things that we've done in mRNA that are not yet factored in the consensus forecast on those transactions.

Speaker 2

Thank you. Next question please.

Operator

Your next question comes from Umer Raffat from Evercore ISI.

Speaker 11

Hi, guys. Thanks so much for taking my questions. Perhaps 2 on vaccines today, if

Speaker 12

I may.

Speaker 11

First, On the flu vaccine, I know you've had a trial on going on your modRNA since September. And I noticed just initiated a new trial of a self amplifying mRNA for flu. And I wonder if the decision to progress a second mRNA program in flu was triggered by any emerging From your 1st gen flu Phase 1 that's been ongoing. And then secondly, on Omicron specific booster, perhaps in light of some of the emerging data on Immunogenicity differences or lack thereof versus regular COVID vaccine. I guess my question is, what's your confidence on ability to show superiority of an omicron specific booster versus regular?

Speaker 11

And what would be the regulatory criteria? Thank you.

Speaker 2

Thank you very much. I think Michael can On the flu vaccine, just to make sure that I clarify, the plan was always to initiate NSA mRNA for flu and to run the 2 programs in parallel. It's not that We saw data that forced us to do SMA. It was always the plan. We are advancing new forms of mRNA technology and SAA It is one of the most promising next generation of RNA technologies.

Speaker 2

But Michael, any comments on that and on the Omicron specific, Our confidence for some period.

Speaker 3

Thank you. Yes, we are accumulating, 1st of all, from our mod mRNA Data trial, data on various regimens and on multivalent construct. We remain of the view that we aspire to develop a flu vaccine. Currently, the most aggressive timelines are focused on the to develop something that have differentiation versus the current TretaVeyland standard of care. I know other companies have spoken about being similar, while at this moment, we still see opportunities to possibly differentiate With an mRNA based on mod mRNA, as Albert alluded to, we are actually filing the IND for the self amplified.

Speaker 3

I think the protocol may have gone up already on teamtrial.gov, but dosing is going to be within the next Couple of months or so. And it's entirely based on us aiming to develop that platform, which has particular relevance for Combinations vaccine, given that possibly we expect to have much lower mRNA burden and can over time build Vaccine combination of several different pathogens. We'll keep you updated on progress with the Moderna Flu, and we certainly see Data that suggests that this is a feasible path and we are working to refine our approach to aim for a differentiated Vaccine?

Speaker 2

What about Omicron? How confident we are about the superiority?

Speaker 3

Yes. The regulatory path is that we expect to have a if successful and Wild type vaccine and acceptable titers to the other previously available strains to provide preserve broad protection, but possibly with higher Omicron. I really think we should let the science play out here. We are talking about a number of weeks before we get data. And as alluded to, It has 3 different arms on top of 3 doses, omicron versus Wild type, that was on top of 3 previous doses, on top of 2 previous vaccine doses, 1 or 2 Omicron, that will be very interesting data set, and then Omicron or naive.

Speaker 3

So I think it's Really interesting trial and we'll extract a lot of data and we report whether we can get that superiority. But in any case, I would just want to punctuate that our current vaccine is active after 3 doses and raise Relevant neutralizing antibodies and the T cell responses that we see are likely the one that contribute in real world evidence to provide effective Protection of the current vaccine against hospitalization and death. Omicron vaccine is an interesting opportunity that we'll learn more about, But our science is progressing against several dimensions on how to further improve over time immuno vaccine, Although there are pretty good ones, so you should expect Pfizer continue to be a leader in this field through multiple Approaches together with BioNTech.

Speaker 2

Thank you, Michael. Next question please.

Operator

Your next Question comes from Louise Chen from Cantor.

Speaker 13

Hi, thanks for taking my questions. So my first question for you is, what are the key pushes and pulls to your underlying business excluding COVID? And what gives you confidence that you can still meet that Top line sales guidance that you gave through 2025 despite some of the volatility that we're seeing right now. And then just wanted to ask you on your 1a antibody and where you are with development of that product and the reporting of data. Have you changed any of the timelines for when you report data?

Speaker 13

Thank you.

Speaker 2

Thank you very much. On the 6% what gives us confidence, it is that we are we keep meeting the goal. As I said that we set the goal in 2019 for a 6% all the way CAGR and then we had Year to date, we are at 6% right now. The year, particularly, it is at 5% for the underlying business. But there is a little bit of volatility, but always we knew that this will be a year, but we are losing some of the revenues of Chandex and compared to previous year, which affects quite significantly this deal, which then as we are launching new products are coming up.

Speaker 2

Maybe I will ask Angela to give a little bit more details on the inputs and how this It's progressing. And also, Michael, on the antibody question. Angela?

Speaker 6

Thank you, Louise. I think the 6% confidence is really driven by 2 things. First of all, the launches, right, that will take place between now 2025, which Continue to drive growth for us. But also importantly, in our in line portfolio, Louise, every single one of our products still have opportunities to grow. They can grow from a number of different ways, right?

Speaker 6

There's still under diagnosed patients. So from new diagnosis, you can continue CDK4six's, think about Xtandi, think about BRAF, MEKTOVI, these are all therapies that Still I think under utilized from a class perspective, so there's growth there. And then finally for all of them, there's the opportunity to grow In terms of market share, just given just the strong clinical profile and strong lifecycle support that we have for all of our products. So I think we see tremendous amount of growth still. We just have not tapped out of growth in our core inline brands.

Speaker 6

And then you add on top That the Launch Brands, this is where we're going to get our growth from.

Speaker 3

Thank you, Angela. On the Till 1a, as you remember at previous earnings call, we showed some really strong data in the range of 34% Endoscopic improvement and with a biomarker of 48% in patients way above expected standard of care. That file has enrolled very fast. It's fully enrolled. Full file readout will be Q4.

Speaker 3

We are obviously considering based on the encouraging data in the previous trial, opportunity for interim analysis that Pending data could allow us to accelerate development of the program towards potential pivotal studies. So all in, it's moving very well and very fast.

Speaker 2

Thank you. Next question please.

Operator

Your next question comes from Steve Scala from Cowen.

Speaker 14

Thank you very much. Just to be absolutely clear, I understand that Pfizer wants to be conservative on PAXLOVID, But it seems that Pfizer has merely scratched the surface on its 2022 potential and that scratching of the surface Is what's in 2022 paclovic guidance. So please just tell me if you disagree with that statement. Secondly, And just to be clear once again, do you not see growth for Pfizer overall in 25 through 30 without business development? And then lastly on Danugliplipron, Slide 39 shows some very good data.

Speaker 14

I'm curious What was the discontinuation rate in the study? Can the dose be increased further? And does Pfizer expect additional weight loss beyond 12 weeks? Thank you very

Speaker 12

much.

Speaker 2

Yes. So let me take the 2 first questions and then Michael can take the research one. Look, it's not that we are giving conservative guidance. What we do, we have principles that we follow because otherwise you can be lost. And the principle that we are following, it is that we are only giving guidance for contracts that have been signed or they are very close To be signed because we have agreed critical terms predominantly, right?

Speaker 2

So this is what you have heard about Paxlovid. Clearly, this is only a very small fraction of the $120,000,000 treatments that we are right now preparing to manufacture. And it is a small fraction of things that we are discussing right now around with different governments. But we are not taking, for example, an approach that we take all the discussions that we are having with the different governments. We risk adjust to them To see how many things can go part through and then we give a guidance.

Speaker 2

This is not what we do. We only give and this is the same with the vaccines, Things that have been signed or are really agreed by the time in a specific deadline. And I think Frank said it was Last week, I think this deadline. So clearly, there is a lot of potential, but it is not that we are putting a little bit of our own We are following a principle so that we can always be clear with what we say And why we say, so that's the thing. Then what about the study dose And the 12 weeks delay, Michael.

Speaker 3

On the DanubeLipron, I'm pleased that you were happy and impressed with our data. And indeed, I would say the glucose lowering through HbA1c and the body weight reduction are probably Among the best in such a short treatment period, tolerability and discontinuation rates proved versus previous study because we extended the dose titration from week to 2 weeks and overall safety adverse event, I think are very much in line with what you see Comparable titration approaches with injectable, given that we see that we can improve solubility and And the discontinuations with this medium titration rate, we have the next studies coming up will be a further Low dose saturation, maybe up to a month or so. And we think that may even bring Readouts of efficacy further above this. So we are very pleased with the profile, and I think the next study will Nailed down for us those regimen and will help us to move with a strong profile Into a potential pivotal study.

Speaker 2

All right. Next question please.

Operator

Your next question comes from Tim Anderson from Wolfe Research.

Speaker 9

Thank you. A few questions. The RSV vaccine data previously said early 2022, now you're saying first half twenty twenty two. Does that imply there's been some slippage? Because early to me, I always felt that mid January, February, something like that.

Speaker 9

MRNA flu, second question, what's a realistic timeframe for potential regulatory filing Of a product like that assuming you find success in your trials. And then last question, Ibrance, Salesoft, you say it's due to patient assistant programs. We haven't seen that impact other CDK4six's and I haven't generally heard about those programs impacting other brands either at Pfizer or other companies. So I'm wondering what else may be putting pressure on Ibrance or you're having to cut price to maintain access?

Speaker 2

Yes. What was your question on flutin?

Speaker 9

A realistic timeframe for filing for approval of mRNA flu vaccine.

Speaker 2

Yes. Thanks. So why don't we go Michael, what about RSV? You can speak about both. We have both now adult and maternal and then The mRNA and then Angela, if you speak about IFRS.

Speaker 3

Yes. On the RSV, we have enrolled very well Martyno and adult and are basically, I would say, fully enrolled. So it's entirely to ensure We have the number of events that we were looking for and we expect both trials to read out Whether it's somewhere between Q1, Q2 or at the Later part of Q2, we'll just see and as events accumulate, but it's going very well. So I feel very optimistic with RSV starting to conclude and looking forward to that data. MRNA flu, we are right now accumulating immunogenicity from several And if we are able to conclude With optimal dose regimen using the modern RNA, a potential Phase 2 Phase 3 study could certainly be initiated this year, but of course, it's a little bit early to speculate before you have identified the right 2, 3 dose regimen, if we would embark on such a study This year, we expect it can conclude very fast given our experience to run very large Trials in this sector and this population of adults.

Speaker 3

And So we're talking about possible conclusion then within next year. But it's, I would say one step at a time, we'll keep you informed. We are encouraged so far and we'll go from there.

Speaker 2

And then what about Angela on the Ibrance?

Speaker 6

I can confirm that The patient assistance program is indeed the primary reason for the decline in volume that you've seen on Ibrance. Just to give you some perspective, in Q4 of 2021, our PAP prescriptions were up 32% compared Where it was in Q4 of 2020. And all of this is 53% more than what it was pre COVID. And so this is really what has cost us A tremendous amount of paid prescriptions and I can and that's really the primary reason. We also saw and And this has been something that we've been watching quarter over quarter, just some slowdown in new patient starts.

Speaker 6

And we've seen this sort of phenomenon Multiple products in our portfolio. So there's a small contribution from that, but the largest contribution by far is truly this

Speaker 2

Thank you, Angela. Before we move to next question, I realize that I didn't answer one of the questions that Steve May, Steve Scala, about if we believe that we need business development to grow in the period 25 $230,000,000 And clearly, this is not the belief right now. We think that we have a clear LOE number. We estimate around $17,000,000,000 and we have a pipeline that delivers more than the LOEs. So only organically what we have right now In our calculations, we are a positive growth trajectory.

Speaker 2

The €25,000,000,000 I just mentioned Needs to be on top of everything, the balance between LOEs and internal Fireflies does, Everything new that will be invented in the meantime and of course the COVID trajectory through 2,030. But we don't need Right now, Business Development at all to grow, what we need Business Development is to maintain high level of 6% growth top line All the way to 2,030, for example. Let's go now to the next question, please.

Operator

Your next question comes from Andrew Baum from Citi.

Speaker 15

Thank you. A couple of questions. First, what are your expectations that you'll need 2 shots of Omicron as opposed to 1? The reason I ask is, recently published animal models suggest that 1 omicron mRNA vaccine actually generates Lower levels of neutralizing antibody against domicron than the ancestral spike variant, presumably due to antigenic sin. It obviously has implications for both revenues in terms of 2 shots, but also compliance.

Speaker 15

And then second, perhaps you could comment On the outlook for CD47 and talk to the differences between your molecule and Gilead's, which obviously has run into some safety issues with trial suspensions. Many thanks.

Speaker 2

Yes. I will take the first one very quickly so that I can give time to Michael to speak about The second one. Look, we have to wait to see the results, but I don't think it is all mRNA vaccines are the same. So I don't think We should extrapolate preclinical data for one effort to what will be the clinical, let's say, results of the other effort. We are testing both, one shot we are testing, 2 shots we are testing pretty soon, hybrid vaccines, but everything what we have seen so far Give us confidence that we will have a very strong reaction and immunogenicity of an omicron against omicron.

Speaker 2

But of course, That's based on preclinical, we need to wait to see the first clinical data so that this assumption can be validated. Without Michael, what about the Gilead? Yes. And by the way, also, Andrew, you said what about your expectations. Our expectations are not based on 1 shot or 2 shots or 5 shots.

Speaker 2

Our expectations, as I said, it is contract signed as for last week With Comirnat. So what we'll sign further on will be in addition to whatever we have given so far. Michael, overzylia.

Speaker 3

Yes. The interest in our product from Pralium Was triggered by its unique design. It is what we call receptor fusion Blocker protein in contrast to magrolumab that you referred to that's on hold, the Gilead antibody, It binds with a lower affinity to the target and that was by purpose To allow it particularly to accumulate on high expressing cancer cells and less Accumulate on red blood cells to cause not to cause anemia or hemolytic anemia. And indeed, in our studies that have generated proof of concept, we have seen single agent activity in blood cancers We basically negligible effect on red blood cells. So this is playing well out.

Speaker 3

We don't know do not know While magrolabab is on clinical hold, but of course, this differentiation that we have in our molecule may be One example of why our molecule has been doing so well this far. While we initially focus on lymphoid malignancies Of the B cell type, we think we also may become increasingly interested in to go to the myeloid Today, where mabrolumab has been AML and MDS, particularly if our profile now may be superior, And we're waiting readout from such studies also. So for us, the Trillium deal is delivering on All what we expected and may actually have upside due to its more unique profile.

Speaker 2

Thank you, Michael. Next question, please.

Operator

Your next question comes from Chris Schott from JPMorgan.

Speaker 16

Great. Thanks so much for the questions. Maybe just 2 to start with Just some clarifications around guidance. I know you're not giving a lot of details around core versus COVID related earnings this There are a lot of questions on that front, but if I just take the low end of your sales range at $45,000,000,000 apply a 40% margin, Tax adjust that. I think I'm getting a number somewhere around $2.60 per share at the low end.

Speaker 16

Is there any issues with that math I'm doing? Or am I in the right Ballpark there, if I just want to think about a low end of core guidance for this year. My second question was on paxlovid and you're referencing here typical Small molecule, I guess, gross margins for this one. Just help us frame that a bit more. I guess, is something in the mid-80s a reasonable level to about for gross margins for this product or is it substantially higher or lower?

Speaker 16

I'm just trying to better understand profitability as we maybe think about some of these contracts Coming forward to this year and maybe that tax a little bit number moving. And then just the final one just to wrap up. I'm still trying to get my hands around the BD side of the Business and kind of the approach, I guess, should we be thinking about a significantly different approach to business development for Pfizer today What the company was doing 2 or 3 years ago prior to the COVID upside? Or is this more just a continuation of, I guess, the focus on what you were looking at if we're thinking back to like 2019 as an example. Thanks so much.

Speaker 2

Yes. I'll take very quickly the third one and then Frank can take the first two questions. I wouldn't I would say it is a continuation, but with a way more accelerated pace. I don't think we are changing what we're Since 2019, we are going into the science, as Amit said, we are going into areas that we think will make fewer mistakes in selecting the right targets. We will be more successful, so we will be able to meet at least the success rates of the industry.

Speaker 2

Our aim is to exceed them as we are selecting assets. We prefer to go to areas that we can add value and there are significant areas that we can add value by becoming the preferred partner of several Biotech. And also we have seen, as Amir said, that some of the best deals we have done were not the most Capital intensive deals, right. So there are so all of that we are learning. We are not going to relax The discipline that we are having in selecting, but we are going to intensify a lot our activity in that area Because of course, we think that now is the time science is at the stage that we can find enough targets to be able to add value and create value.

Speaker 2

So that's On the BD side. Now, Frank, a lot of financial questions for margins, guidance, etcetera.

Speaker 4

Good. So Chris, on the walk through you did on the, I'll call it the business excluding co minority impacts a little bit, I would use the midpoint on the revenue. You used, I think, a 40% income before tax margin, then you got to tax effect that. I didn't hear you say tax effected. So if you do the math, you do the walk through and then you tax affected, obviously dividing that by shares outstanding.

Speaker 4

That'll give you, I think, a number that's in the ballpark. On PACS, little bit gross margin, let me answer the question this way. 1, the PACS, we don't give margin information by individual margin on that. The margin profile is similar to our other solid oral dose products. And remember, when you look at the gross margin, There's going to be SI and A investment in PAXLOVA this year because we're launching that product.

Speaker 4

There's additional R and D investment product that year because we're continuing obviously to evolve that product. All of that obviously is captured in the income before tax margin on that business, which is similar to our other solid oral dose products. It's all factored in our guidance. The one place where you can really see the impact and hopefully this is helpful. You look at our cost of sales as a percentage of revenue last year, For the full year, 37.7 percent.

Speaker 2

If you

Speaker 4

look at our guidance this year, 32.2% to 34.2%, the midpoint is 33.2%, That's down at the midpoint 4.5 percent, most of which is being driven by the Paxlovid revenue this year.

Speaker 12

So maybe that's a way

Speaker 4

to help you in terms of just how to work the numbers.

Speaker 2

Thank you, Frank. Next question please.

Operator

Your next question comes from Chris Shibanti from Goldman Sachs.

Speaker 15

Thank you very much. Two questions. One, again, just to make sure I understand clearly the thinking about what underpins the intermediate Growth expectation through 2025. I believe when that was originally issued back in 2019 that did not assume contribution from business development to achieve that CAGR of 6% to 25%. Is that still the case?

Speaker 15

That would be the first question. And then the second question Relates to PAXLOVID, we have the standard risk study that you've modified expanding. Can you talk about what kind of result We would need to see in order to influence the kinds of decisions and discussions that Angelo Having with governments, in particular, the primary endpoint, which just missed statistical significance on the alleviation of symptoms, do you need to hit that? Or are the discussions being guided around the ability to meet the secondary endpoint, which was the decreased risk

Speaker 2

And maybe I can take both in the interest of Time, I can confirm that our guidance for 6% was excluding BD. So that was from 2019 all the way to 25%, 6% CAGR From the things that we had at the time. As regards the standard risk primary endpoint, I think most of the governments, If not all, they are focusing right now all their purchases and their discussions that we're having on the ability to reduce hospitalization. And by the way, most of the FDA, for example, has already approved vaccinated and unvaccinated, which is included that means that includes also If we go the standardisk, I think, will contribute, but I think everybody is moving with the assumption that we give it to all people to prevent hospitalization. That's The main and that's that's the main thing that everybody is looking.

Speaker 2

Now the in house contact, it is very different and I can say Very much the landscape, there are no discussions around that right now. But if it comes positive, clearly that could be used also in preventing infections In high risk corporations, when someone in the household or in the senior house or in other, let's say, business in other, let's say, Setting that people are living together, 1 is getting infected, but this is something that will come on top of any discussions that we are having right now if It is positive. Let's go to the next question please.

Operator

Your next question comes from Vamil Divan from Zoho Securities.

Speaker 12

Hi, great. Thanks for taking the questions. I guess I'll stick with the same theme around PAXLOVID and business development. So first on PAXLOVID, Just to make sure we're all starting on the same page, I guess, can you comment on exactly how many doses are included in the guidance that you're giving right now? You mentioned the release of 20,000,000 To the U.

Speaker 12

S, I think 2.75 to the U. K, but there's obviously been some other contracts that had been signed. So I don't know if you can give us a number or a range just so we have a sense of And what's included right now? And then on business development, I just thought one thing was sort of interesting when you're talking about Slide 13, Albert, You mentioned the strength of your balance sheet and cash flow is why you pursue new BD opportunities going forward that could add at least 25,000,000,000 of risk adjusted revenues for 2,030. And I'm just curious that $25,000,000,000 is sort of a specific number.

Speaker 12

I'm wondering, obviously, you guys did this in your prepared So I'm sure it's all thought out. So I'm just curious what sort of drove that. Obviously, the number could be much smaller or probably a lot bigger depending on what you do over the next few years. So maybe you can just

Speaker 2

Why we selected $25,000,000 to speak about $25,000,000 you mean?

Speaker 12

Yes, saying at least $25,000,000 in adjusted revenues. Yes, I

Speaker 2

got it. I got it. Yes. Frank, would you like to take the paxlovid and the doses?

Speaker 12

Of course.

Speaker 4

So Vamil, on the paxlovid guidance, you heard Angela mentioned before. We're very active right now, 100 plus Negotiations with different governments. We don't want to put any information out there that could, I'll call it, lead to misleading assumptions And those assumptions being detrimental to those contract negotiations. But now you mentioned a couple of contracts that have been announced Publicly and where the dose information was included. You mentioned the U.

Speaker 4

S. $20,000,000 the U. K. $2,750,000 If you look at everything we've announced publicly, Give or take, it's around 30,000,000 about 30,000,000 treatments. And so that 30,000,000 treatments is clearly included in the guidance that we provided In the $22,000,000,000 of revenue.

Speaker 2

Thank you. And Amir, why you selected $25,000,000,000

Speaker 7

Sure. So a couple of thoughts. One, we obviously between the strength of our balance sheet and the cash flows, We have the ability to deploy significant capital and going beyond our growing dividend, we think that those cash flows As we look across Academia Venture, Biotech, big, small, there is no shortage of external substrate that we think can complement what we're doing internally. And we're going to be thoughtful and disciplined about the science that we want to pursue. And the combination of those two things Combined with the capabilities that we have, we think that there is significant growth that we can add to our business through business development going forward.

Speaker 2

Yes. And also it is very important also to understand, I mean, that we believe that once you put a target, You better execute way better when you have a target in front of you. And actually, we believe that the target is to be public because it's a public company and we don't have a problem to do it. So also we went into to analyze the substrate and the opportunity and as always we are providing at least 25 Because as always, we like to have targets that we are putting out there and we are beating them. But we believe that with the current our all our analytics that we have done, This is a very reasonable target to achieve without, let's say, utilizing all of our firepower right now.

Speaker 2

So that will allow us to do dividend and other uses of capital and still do that. And we are confident to put it out there so that people can start measuring against it.

Operator

Your next question comes from Terry Holford from Berenberg.

Speaker 17

Thank you. So firstly, just on the oral GLP-one. I wonder if you can confirm the number of pills per day that you'll be using in your Phase 2b study up to that maximum dose 200 mgs twice a day. Was that pill burden for the highest dose? And also on obesity, you've not discussed that today, but do you have the Phase 2a data in house?

Speaker 17

I know too that you started 3, you moved another or GLP-one molecule into the clinic, and I'm just interested to know how that cassette may differ from The initial tangible front. And then lastly, just on the guidance. So if I'm thinking about the 4,000,000,000 Dollar range on your sales guidance. Given you've given us the point estimates there or thereabouts For the vaccine and the antiviral, should I have seen the majority of the flex remaining relates to the base business? And if so, you help me understand the key moving parts within that element of the business, which drugs may be a driver of that flex?

Speaker 17

Thank you.

Speaker 2

Thank you very much. Let me take very quickly in the interest of time the last one. No, the Flex is spread around everything. So you should assume, for example, In the EUR 31,000,000 of in the EUR 32,000,000 that we gave for EUR 33,000,000,000 right on the vaccines, The $500,000,000 down, that's $1,000,000,000 On the Paxlovid, dollars 500,000,000 that's another $1,000,000,000 And then on the business, as always, We gave $1,000,000,000 up and down. So whatever you think is the midpoint, dollars 1,000,000,000 up, dollars 1,000,000,000 up, dollars 1,000,000,000 up, which is consistent with what we were doing all of these years For that level of business.

Speaker 2

And Michael, on the oral?

Speaker 3

Yes. Danagliptone is BID drug and pill burden will be relatively low. You also asked for the Additional GLP-one drug we have in clinical development, that's a once a day drug. As we have now, I think, really Defined what will be soon optimal situation for oral GLP-one, and we were, of course, Pioneering that, there isn't really a date on it. We may actually consider to take The once daily in the same study as Danublipron given that we have now this unique opportunity to Looks through what seems to be 2 great directs.

Speaker 3

But currently, I believe Danubloprone has all what it takes to Go forward to a potential pivotal study based on this study that we shared with you. But it's of course a unique situation to have more than one molecule and it gives us The very best option for going into Phase 3 quite rapidly after concluding that Phase 2b Pending, of course, expected outcome.

Speaker 2

Thank you, Michael. And the last question please.

Operator

Your final question comes from the line of Carter Gould from Barclays?

Speaker 9

Great. Good morning. Thanks for taking the question. I'll keep it the one since we're at the end. And at the risk of not getting an answer On OUS pricing for Paxlovid, I understand the underlying aspects driving sort of your pricing strategy between GDP and the volume based discount.

Speaker 9

But In practice, how consistent has the pricing been across geographies? Any color at a high level would be helpful. And as we think about potentially The standard risk data, the PROFI data kind of playing out over the course of the year, should we anticipate that pricing will be relatively consistent per course in the second half relative to the first half? Any color there would be helpful. Thank you.

Speaker 2

Yes. Our pricing for Paxlovid is a tier pricing. So there is a tier for high income countries, and that is more or less in line with what You have seen published for Merck's, for example, product and we have seen published ourselves. Only exception was the U. S.

Speaker 2

That they got a very special price because of Higher orders, but the rest are more or less consistent. And then there is, of course, there is a second tier for middle income countries. And for the low income countries, We are going to provide it at cost, but also for the low income countries in addition to our own providing at cost. Of course, we have also initiated a process that A very big number of generic companies will start manufacturing for the low income countries, which will be 53% of the global population. Now, If the price will remain consistent and clear, this is nothing to comment here.

Speaker 2

We will not, let's say, commenting on how prices may or may not evolve in the future. Thank you very much. Now some closing comments very quickly. We have generated strong results, of course, for both patient impact and financial performance, And we look forward to continue that in 2022. I want to speak a little bit about few changes in people that we are doing.

Speaker 2

Speaking about that, we continue to attract visionary purpose driven leaders with a track record of delivering breakthrough results for patients. Case in point, last week, we announced that Doctor. William Powell will join Pfizer as Executive Vice President and Chief Development Officer effective March 21 of this year. Doctor. Paul brings more than 25 years of experience as an oncologist and scientist.

Speaker 2

He joins us from Roche, Where he most recently served as the Head of Pharma Research and Early Development, he oversaw the discovery and early development of a portfolio of new molecular entities to treat diseases related to cancer, neuroscience, ophthalmology, rare diseases and can go on and on and on. Of course, cancer is a very big part of Hizol's portfolio. Clearly, I want to mention that Doctor. Paussek is Rod McKenzie, a legendary leader in Pfizer, who recently announced intent to retire after 35 years of Pfizer. I want to thank Rob, his incredible contribution to Pfizer, including the outstanding leadership in helping bring Comirnaty and Paxlovid to the world so quick.

Speaker 2

Of course, also I want touch base on something that everybody has in mind, I want to take a moment to recognize my trusted colleague and friend, Frank de Mille, who also has announced His intention to retire from Pfizer after an incredibly impactful decade and at the half with the company as CFO. Frank is one of the smartest, more respected and most effective leaders I have ever had, the good fortune to work with And the positive impact he has had on Pfizer and all our stakeholders is immeasurable. Frank isn't going anywhere yet, just to clarify, as he has agreed to stay on board and as we search for his successor and also to serve in a consulting role through the transition. That said, I wanted to take the opportunity to thank him publicly for all He has meant to Pfizer and to me personally. And Frank, on behalf of our 80,000 colleagues around the world, I wish you good health, Every happiness as you begin and your stop, sir, when this time comes because it's not yet, wherever life's journey takes you, I'm sure It will be directionally correct and that will bring an end to our call.

Speaker 2

Thank you for joining us. Have a great rest of your day.

Operator

Ladies and gentlemen, this does conclude Biodes 4th Quarter 2021 Earnings Conference Call. You may now all disconnect.

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