Q1 2021 Pfizer Inc Earnings Call

All right.

Okay.

Good day, everyone and welcome to Pfizer's first quarter 2021 earnings conference call.

Operator: Good day everyone, and welcome to Pfizer's first quarter 2021 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations. Please go ahead, sir.

Today's call is being recorded at this time I would like to turn the call over to Mr. Chuck Triano Senior Vice President of Investor Relations. Please go ahead Sir.

Thank you operator.

Unknown Executive: Thank you, operator. Good morning.

Good morning, and thanks for joining us today to review Pfizer's first quarter, 2020 results and.

Unknown Executive: Good morning and thanks for joining us today to review Pfizer's first quarter 2020 results and financial guidance update as well as other relevant business topics. I'm joined today, as usual, by our Chairman and CEO, Dr. Albert Bourla, Frank DiEmilio, our CFO, Michael Dolsten, President of Worldwide Research and Development in Medical, Angela Wong, Group President, Pfizer Biopharmaceuticals Group, John Young, our Chief Business Officer, and Doug Lankler, General Counsel. The slides and the accompanying remarks that will be presented on this call were posted to our website earlier this morning and are available at www.pfizer.com, You'll see here on slide three our disclaimer regarding forward-looking statements we will make during this call regarding, among other topics, our anticipated future operating and financial performance, business plans and prospects, and expectations for our product pipeline and inline product, which are subject to risks and uncertainty, as well as the use of non-GAAP financial information.

And financial guidance update as well as other relevant business topics.

I'm joined today as usual by our chairman and CEO, Dr. Albert boiler, frankly, Amelia all our CFO.

Michael Dolson President of worldwide research and development and medical Angela Hwang Group, President Pfizer Biopharmaceuticals group, John Young, our Chief business Officer, and Doug <unk> General Counsel.

Slides and the accompanying remarks that will be presented on this call were posted to our website earlier. This morning and are available at Pfizer dotcom forward slash investors.

You'll see here on slide three our disclaimer regarding forward looking statements we will make during this call regarding among other topics, our anticipated future operating and financial performance business plans and prospects and expectations for our product pipeline and inline products, which are subject to risks and uncertainties.

As well as the use of non-GAAP financial information.

Additional information regarding forward looking statements and our non-GAAP financial measures is available and our earnings release, including under the disclosure notice section and under risk factors and our SEC forms 10-K and 10-Q.

Unknown Executive: Additional information regarding forward-looking statements and our non-GAAP financial measures is available in our earnings release, including under the disclosure notice section and under risk factors in our SEC Forms 10-K and 10-Q. Forward-looking statements on this call speak only as of the original date of this call, and we undertake no obligation to update or revise any of them.

Forward looking statements on this call speak only as of the original date of this call and we undertake no obligation to update or revise any of these statements.

Albert and Frank will now make prepared remarks, and then we'll move to a question and answer session.

Albert Bourla: Thank you, Chuck, and hello, everyone. I couldn't be prouder of the way Pfizer has started 2021. During the first quarter, we delivered strong financial results. Even excluding the revenue provided by our COVID-19 vaccine, our revenues grew 8% operationally, 10% reported, and this 8% growth includes a negative 5% impact from price. We continued to accelerate production and shipments for our COVID-19 vaccine, in many cases exceeding our contractual obligations for delivery timelines, and we achieved several important clinical, regulatory, and commercial milestones. Let me start with commentary on some of our biggest growth drivers in this quarter.

With that I'll now turn the call over to Albert Albert.

Thank you talked and Hello, everyone and I can.

And then big browser all the way Pfizer has started 2021 during the first quarter, we delivered strong financial results.

Even excluding whatever you can provide just from our COVID-19 vaccine.

All revenues grew 8% operationally, 10% reported and this 8% growth includes a negative five per cent impact from price.

We continued to accelerate production and shipments to our COVID-19 vaccine in many cases exceeding our construction of all obligations for delivery timelines.

And we achieved several important clinical regulatory and commercial amongst all.

Let me start with commentary on some of our biggest growth drivers and this quarter.

But pfizer buy them for COVID-19 vaccine contributed three and there are billions of dollars and global revenues during the first quarter.

Albert Bourla: The Pfizer-BioNTech COVID-19 vaccine contributed $3.5 billion in global revenues during the first quarter. As of May 3rd, 2021, Pfizer, along with its partner BioNTech, has shipped approximately 430 million doses of the vaccine to 91 countries and territories around the world. I will share some thoughts on the sustainability of this revenue stream later in my remarks. Eliquis has continued to deliver a strong performance, with revenues up 25% operationally to $1.6 billion in the first quarter. In the U.S., Eliquis sales growth was driven mainly by strong volume. Vintagel and Vintamax generated revenues of $453 million, representing operational growth of 88%.

So many start 2021 John.

Riser along with its partner volume because the brokers might be 470 million doses all.

And the vaccine to 91 countries and territories around the world.

I would share some thoughts on the sustainability all of these revenues three later in my remarks.

And it has continued to deliver strong performance with revenues up 25 per cent of personally it's $1 $6 billion and different workload.

Yes and liquid.

Sales growth was driven mainly by strong volume growth.

And Vince I'm doing all right.

Revenues of $453 million, representing operational growth of eight 8%.

Our disease education, and therefore, it seems the U S continue to support the appropriate diagnosis and increasingly make the diagnosis rates at almost 24% at corporate and up from 21% It's Ian.

Albert Bourla: Our disease education efforts in the U.S. continue to support appropriate diagnosis, increasing the estimated diagnosis rate to almost 24% at quarter end, up from 21% at the end of 2020. At the end of the quarter, more than 23,500 patients had been diagnosed, more than 17,000 patients had received a prescription, and more than 10,500 patients had received the drug, including patients who received the drug at no cost through our patient assistance program.

And the trend.

And at the end of the course and Morgan RMB 3500 patients have been diagnosed more than 17000 patients have received the prescription and more of them themselves and five times all the basins that we received the drugs, including patients would receive the drug at no cost through our patient assistance program.

And while there are still read you'll know differences in cardiology, and DVD and electric diagnostic procedures due to COVID-19 guidelines.

Albert Bourla: While there are still regional differences in cardiology activity and elective diagnostic procedures due to COVID-19 guidelines, on a national basis, Diagnosis rates in the U.S. have now recovered and exceeded pre-COVID levels as compared with the first quarter of 2020. We also have seen strong growth from Japan and from developed Europe, where it is the largest contributor to our revenues outside the US. Xeljanz also performed well, with global revenues up 18% operationally to $538 million.

And the National base diagnosis rate and the U S now recover and exceed pre COVID-19 levels as compared with the first quarter of all started when.

We also have seen strong growth from John and from developed Europe, where is the largest contributor to all revenues outside the U S.

Sales and also performed well with global revenues up 18% operation and are going to $538 million.

Growth was primarily driven by 16% growth in the U S and 14% growth operational and international developed markets.

Albert Bourla: The growth was primarily driven by 16% growth in the U.S. and 14% growth in international development. The underlying prescription demand in the U.S. grew 9% compared with the first quarter of 2020, outpacing the advanced therapy market by 3% We have invested in formulary access in the U.S., which has played a vital role in enabling this policy. In the U.S., Ibrance revenues declined 7% compared with a year ago.

The underlying prescription demand and the U S grew 9% compare with the first Scorpio strength, it's Randy outpacing the advanced therapy market by three percentage points.

We have invested and formulary access and the U S, which has played a vital role in enabling this volume growth.

And the U S revenues declined 7% compared with a year ago quarter total prescription volume is relatively stable and we continue to be the leading productivity CDK class.

Albert Bourla: Total prescription volume is relatively stable, and we continue to be the leading product in the CDK class by a wide margin, with 84% of total patient share in first-line units. However, we saw increased enrollment this quarter in our patient assistance program, which provides Ibrance free of charge to certain low-income patients. We believe this increase is due to COVID-19-related economic hardships that are affecting, particularly the demographics of the high-branch patient population.

Wide range with an 84% of total patient share in first line.

However, we saw increased enrollment this quarter in our patient assistance program, which provides I brunch and free of songs restart and low income patients.

We believe this increase is due to COVID-19 related economic hardships that are affecting particularly the demographics of the Rd brands patient population and we do expect this to normalize over time as the economic impact from the pandemic subsides.

Albert Bourla: And we do expect this to normalize over time as the economic impact from the pandemic subsides. As of mid-April, we had contracted for approximately 1.6 billion doses of our COVID-19 vaccine to be delivered in 2021. As a result, based on the contract signed through mid-April, we are increasing our revenue guidance and now expect revenues of approximately $26 billion from the vaccine in 2021. We also are in ongoing discussions with multiple countries around the world about their needs, and we expect these discussions to lead to additional supply agreements.

And as of mid April we had contracted for approximately $1 6 billion doses of all COVID-19 vaccine expected to be delivered in 2020 one.

As a result.

Just on the contract signing through mid April we are increasing our revenue guidance and now expect revenues of approximately $26 billion from the vaccine in 'twenty to 'twenty one.

We also are in ongoing discussions with multiple countries around the world and balls. There means and we expect these discussions to lead to additional supply agreements.

Based on what we have seen we believe that the durable demand from our COVID-19 vaccine similar to that of the flu vaccines is a likely outcome.

Albert Bourla: Based on what we have seen, we believe that durable demand for our COVID-19 vaccine, similar to that for the flu vaccines, is a likely outcome. We want to be a long-term partner to health authorities around the world in their ongoing efforts to combat COVID-19, including their planning for an ongoing pandemic vaccination approach that is fit for purpose for local requirements. To that end, together with our partner BioNTech, we expect to have the capacity to manufacture at least 3 billion doses in 2022.

We want to be a long term partner because of all Florida, just around the world and their ongoing efforts to combat COVID-19, including their blogging for and ongoing pandemic vaccination approach, but is fit for purpose and local requirements.

And together with our partner volume tick we.

Great to have the capacity to manufacture at least 3 billion doses in 2020 two.

We are in discussions with a number of Congress around the world. So a multiyear contract for the potential supply of COVID-19 vaccine doses during 'twenty two and beyond.

Albert Bourla: We are in discussions with a number of countries around the world for multi-year contracts for the potential supply of COVID-19 vaccine doses during 2022 and beyond. In fact, we recently signed an agreement with the UK to supply 60 million additional doses in 2021 and with Israel to supply millions of doses in 2022, enough for the government to boost every eligible citizen, subject to local guidelines, with the option to purchase millions of additional doses for an additional boost. We have also reached an agreement with Canada to supply up to 125 million doses in 2022 and 2023, with options to supply up to 60 million additional doses in 2024.

In fact, we recently signed an agreement with the U K to supply 60 million and additional doses and so and agenda.

And with Israel to supply millions of doses in 2020, two and novel the government to boost every eligible and she did them subject to local guidelines.

The option to persist millions of additional doses for additional boost.

We have also reached an agreement with a ton of them.

To supply up to 125 million doses, and 22 and 23 with all sorts of supply up to 60 million and additional doses. So Andy 24.

It is our hope, but the Pfizer ballroom and big work stream will continue to have a global impact by helping to get the devastating pandemic under control and hoping economies around the world and that's the only open but stay open and creating a scenario and weeds Pfizer can continue to be both and leader and the beneficiary.

Albert Bourla: It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open, but stay open, creating a scenario in which Pfizer can continue to be both a leader and a beneficiary. To realize this goal, we are continuing to lead with strong science not only to maximize the impact of our COVID-19 vaccine in preventing disease, but also with the work we are doing to develop two potential novel protease inhibitors.

To realize this goal we are continuing to lead with strong science not only to maximize the impact of all COVID-19 vaccine and preventing disease.

But also with the work we are doing to develop two potential novel protease inhibitors walnuts administered intravenously and wanted the minister Ora.

Albert Bourla: One administered intravenously and one administered orally. As you can see on the accompanying slide, we have many clinical studies ongoing and expect to have multiple results and submissions throughout the remainder of the year. Let me touch on a few.

As you can see them and be a companion slide we have many clinical studies ongoing and we expect to have multiple readouts and submissions throughout the remainder of the year.

Let me touch on a few.

First while we are currently distributing other vaccine in the U S. Under an emergency use authorization, we expect to submit these moms and biologics license application to the U S food and drug administration.

Albert Bourla: First, while we are currently distributing our vaccine in the U.S. under an emergency use authorization, we expect to submit this month a biologics license application to the U.S. Food and Drug Administration seeking full approval for our COVID-19 vaccine for individuals 16 years of age and older. Second, we are evaluating the safety and immunogenicity of a third dose of the existing formulation of our COVID-19 vaccine to understand the effect of a booster dose on immunity against the SARS-CoV-2 variants in circulation. Additionally, we have started an evaluation of an updated prototype variant version of our vaccine that encodes the spike protein of the lineage B.1.351 SARS-CoV-2 variant, which includes the mutation E484K. It was first identified in South Africa.

Full approval for all COVID-19 vaccine for individuals and 16 years will face and all of them.

Second we all know about the safety and Immunogenicity and also showed a dose all the existing formulation of our COVID-19 vaccine.

And the effect of a booster on immunity against the Sars Cov, two variance in circulation and <unk>.

And really we have started and evaluation and updated prototypes very and regression all far vaccines are encodes the spike protein all the leads.

The 135 once our scope two very quick.

Which includes the mutation in 48 for K <unk>.

Are you going to fight and South Africa.

This study is designed to establish a regulatory parcel weight to update the car and vaccine to address and if its ovarian or a potential concern and approximately 100 days you've made.

Albert Bourla: This study is designed to establish a regulatory pathway to update the current vaccine to address any future variant or potential concern in approximately 100 days, if needed. We expect to have immunogenicity data for both studies in early July. Third, we are continuing our efforts to evaluate the Pfizer-BioNTech COVID-19 vaccine in additional populations. We expect to hear back shortly from the FDA on our application for expanded emergency use authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age.

We expect to have Immunogenicity data for both studies in early July.

Third we are continuing our efforts to evaluate the Pfizer environment COVID-19 vaccine in additional novel duration.

We expect to hear Buck shortly from the FDA on all applications for expanded emergency use authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age.

The Pfizer biometric pediatric study evaluating the safety and efficacy of all COVID-19 vaccine and feel that six months to 11 years of phase is ongoing.

Albert Bourla: The Pfizer-BioNTech Pediatric Study Evaluating the Safety and Efficacy of our COVID-19 Vaccine in Children 6 Months to 11 Years of Age is ongoing. We expect to have definite readouts and submit for an EUA for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children six months to two years old are expected in the fourth

We expect to have definitely $3 and submit Florida and EUA for two cohorts, including children two to five years, all states and five to 11 years phase in September.

The readout and submission before they go all of those children six months to two he is all unexpected in the fourth quarter.

We also expect phase two safety data from our ongoing study in pregnant women by late July early August.

Albert Bourla: We also expect to have Phase 2 safety data from our ongoing study in pregnant women by late July-early August. Fourth, we are making progress with improving the stability of our COVID-19 vaccine. On Friday, we submitted new stability data to the FDA, and we believe we could soon receive an update to our EUA prescribing information allowing the vaccine to be stored at standard refrigerated temperatures of 2 to 8 degrees Celsius for up to four weeks. We are also working on a ready-to-use formulation that, subject to generating supportive stability data and obtaining regulatory approval, could potentially be stored at standard refrigerator temperatures for up to 10 weeks and up to six If successful, we expect to have data to support this formulation.

Fourth we are making progress with improving the stability of our COVID-19 vaccine on Friday, we submitted new stability data for the F D. A.

We believe we could soon receive and update to our EUA prescribing information, allowing the vaccine to be stored its thunder, but if and it's a range of temperatures of tooth weighted degrees Celsius for up to four weeks.

We are also working on and they're ready to use formulation, but subject to generating supported stability data and obtaining regulatory approval could potentially be store its thunder refrigerated temperatures for up to 10 weeks.

And up to six months at minus 50 to minus seven and if so.

We expect all kinds of data to support this formulation and numbers.

As we move closer to a potential approval for all of our investigational 20, valent pneumococcal conjugate vaccine for adults, which if approved may be launched during and ongoing and Jamie we plan to begin this month, they stop deal and the ministration of the Pfizer biotech COVID-19 vaccine with a trend develop.

Albert Bourla: Fifth, as we move closer to a potential approval for our investigational twin-developed pneumococcal conjugate vaccine for adults, which, if approved, may be launched during an ongoing pandemic, we plan to begin this month a study of co-administration of the Pfizer-BioNTech COVID-19 vaccine with a twin-developed pneumococcal conjugate vaccine. Moving to COVID-19 tracking We have early studies ongoing for two protease inhibitors, antiviral candidates; one administered intravenously and one orally.

Cocoa conjugate vaccine.

Moving moving to COVID-19 treatment and small.

We have barely started this ongoing for total protease inhibitors and D. Var candidates, one administered intravenously and one Oregon, we expect to begin a phase II free site for the intravenously administered compound in me and for the orally administered compound in July.

Albert Bourla: We expect to begin our Phase 2-3 study for the intravenously-administered compound in May and for the orally-administered compound in July. With regard to our oral protein inhibitors, we are planning to evaluate their safety and efficacy through three development pathways. We are studying it compared to a placebo to confirm whether it is efficacious against COVID-19. We are studying it against monoclonal antibodies to assess relative efficacy against current circulating strains. Mutations of spike protein may lead to diminished efficacy of presently available monoclonal antibodies, and our intent is to bring about a therapy with durable efficacy through a different mechanism of action and conservation of the 3Cl protein.

With regard to our all of our brothers inhibitor, we are planning to evaluate its safety and efficacy free development pathways.

We are starting it compared to a placebo to confirm whether it is efficacious against COVID-19.

We are starting use against monoclonal antibodies to assess relative efficacy against current circulating strains.

Patients of Spike protein may lead to diminish, especially cash presently available monoclonal antibodies and our intent is to bring about the therapy.

And with efficacy through a different mechanism of action and conservation of the three steel products.

Also we are starting it in Amdocs and age and household convex.

Albert Bourla: Also, we are starting it in unvaccinated household contents exposed to someone infected with COVID-19 to evaluate if it prevents close contacts from contacting COVID-19. It has been well established with flu antiviral drugs that administering them to close contacts of subjects who have the flu reduces the chance of them also getting the flu by more than 80%. Though SARS-CoV-2 is a different virus than the flu, we are hopeful the principle will be the same. If we administer the investigational treatment to those who are at risk from close contact, does it prevent them from getting sick?

Polls to someone infected with COVID-19 to evaluate if it prevents close contacts from contracting COVID-19, it has been and well established with flu antiviral drugs, but administering them to close contacts of subjects, who have flu reduces that sounds all of them also getting.

Blue by more than 80 per cent.

Those are COVID-19 is a different buyers and Peru, we are hopeful the principal will be the same.

If we administer the investigational treatment to those who are at risk from close contract doesn't prevent them from getting sick.

And as you can see on our timeline if things go well, we could potentially apply for approvals before V and over the year.

Albert Bourla: As you can see on our timeline, if things go well, we could potentially apply for approvals before the end of the year. The intravenously administered protease inhibitor is being studied. Inpatient Phase 1B studies in the U.S., Spain, Belgium, and Brazil. We expect to begin a Phase 2-3 study in which the IV compound will be tested against the current standard of care this quarter. With the current unmet global medical need for antivirals, we are constantly assessing how we can accelerate the development of this potential treatment.

The intravenously administered protease inhibitor is being studied.

In patient and inpatient phase one studies in the U S, Spain, Belgium, and Brazil, we expect to begin a phase II III study and with the IV compound will be tested against the current standard of care this quarter.

With the current unmet global medical need for Antivirals, we are constantly assessing how we can accelerate the development of this potential treatments.

Pfizer has emerged as the leader in mrna development and we are exploring a wide range of opportunities for the technology.

Albert Bourla: Pfizer has emerged as a leader in mRNA development, and we are exploring a wide range of opportunities for the technology. We are making rapid progress with our potential flu mRNA program, and we aim to maintain mRNA leadership with two potential game-changing mRNA approaches to a flu vaccine expected to enter clinical trials in the third quarter of 2021. We will test multiple constructs in Phase 2 and 2 to facilitate swift selection of an optimal tetravalent flu product dose regimen. We aim to develop initially a tetravalent flu vaccine using the modified mRNA plot.

We are making rapid progress with our potential flu mrna program.

And we aim to maintain mrna leadership with two potential game changing mrna approaches where flu vaccine expected to enter the clinic in the third quarter of two and 21.

We will test multiple constructs and phase one to two facilitates free selection of an optimum tetravalent flu products dose regimen.

We aim to develop initially and tetravalent flu vaccine using the modified mrna blocks and pending.

Pending the generation of favorable immune and Tolerability phase one data and.

Albert Bourla: Pending the generation of favorable immune and tolerability phase 1-2 data, a potential rapid progression to phase 3 is possible, given our large-scale pharmaceutical science and manufacturing capabilities. We are also exploring the potential to address other infectious diseases that we plan to discuss in the near future. In addition to prophylactic vaccines for infectious diseases, we believe mRNA has the potential to address a wide range of therapeutic areas, including cancer and genetic disease.

And so rapid progression to phase III is possible given our large scale pharmaceutical science and manufacturing capabilities.

We are also exploring the potential to address other infectious diseases, and we plan to discuss and many of yours.

In addition to Brookfield.

Scenes floating fixtures diseases, we believe mrna has the potential to address a wide range of therapeutic areas, including cancer and genetic disease.

As you have seen the day, we have increased our 2021 R&D guidance to reflect our plans to increase our mrna capabilities.

Albert Bourla: As you have seen today, we have increased our 2021 R&D guidance to reflect our plans to increase our mRNA capabilities, build momentum in our targeted areas of interest, and deliver on mRNA's breakthrough potential for the benefit of people worldwide. We can expect to hear more about our plans and potential applications in the coming weeks. Now let's turn to the Pfizer R&D Pipeline, which continues to be one of the greats. Our pipeline currently includes 99 potential new therapies or indications. That's 99 potential opportunities to change the lives of patients around the world. I will now provide an update on some of these exciting, promising candidates.

Momentum in our targeted areas of interest and deliver an mrna breakthrough potential for the benefit of people worldwide.

We can expect to hear more about our plans and potential applications in the coming weeks.

Now, let's turn to Pfizer R&D pipeline, which continues to be one of the great strengths. Our pipeline. Currently includes 19 mine potential new therapies, all indications, that's 99 potential opportunities to change the lives of patients around the world.

I will now provide and update on some of these exciting exciting candidates.

Vaccines as referenced earlier the FDA is reviewing the biologic license application for our investigational 20, valent pneumococcal conjugate vaccine and for adults 18 years of age and older with it but do her day in June of 'twenty to 'twenty one.

Albert Bourla: In vaccines, as referenced earlier, the FDA is reviewing the biologic license application for our investigational 20-valent pneumococcal conjugate vaccine for adults 18 years of age and older with a PDUFA date in June of 2021, and non-pneumococcal conjugate vaccines on the market or in late-stage development, if approved, we believe it could provide the most comprehensive coverage against pneumococcal pneumonia disease in adults. In internal medicine, In December 2020, we enter into a collaboration with Myovan Sciences to commercialize Relugolix combination therapy with uterine fibroids and endometriosis pending FDA approval, as well as Relugolix for advanced prostate cancer. We are excited about the prospect of soon commercializing this product for its potential indication of uterine fibroid. If approved.

And long pneumococcal conjugate vaccines and the market or in late stage development. If approved we believe it could provide the most comprehensive coverage against the pneumococcal pneumonia disease in adults.

And in terms of all medicine.

And in December of 'twenty, two and do we enter into a collaboration with Michael <unk> Sciences to commercialize.

<unk> combination therapy with fiber.

Fibroids, and endometriosis pending FDA approval and so.

And we're less robotics and advanced prostate cancer we.

We are excited about the prospect of soup commercializing this product for this potential indication of uterine fibroids.

And the FDA has a <unk> date of June 1st and 21.

And estimated 5 million women and the U S suffer from symptoms of <unk>.

And certainly fibroids and an estimated 3 million women are.

Inadequate and reduced by car and therapy and require Starbucks.

We are also working on our planned NDA submission for the endometriosis indication, which we hope to submit this year.

Albert Bourla: And the FDA has a PDUFA date of June 1st, 2021. An estimated 5 million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated 3 million women are inadequately treated by current therapy and require further treatment. We are also working on our planned FDA submission for the endometriosis indication, which we hope to submit this year. An estimated 6 million women in the U.S. suffer from symptoms of endometriosis, and an estimated 1 million women are inadequately treated by current therapy and require further treatment. Unfortunately, in inflammation and immunology. Alopecia areata is an immune disease that causes hair loss and has no approved treatments in the US and Europe.

And estimated 6 million women and the U S software for and symptoms of endometriosis and an estimated 1 million women.

And nothing could be three day by car and therapy and require and further treatment. Unfortunately.

And in inflammation and immunology.

La <unk> is and immune disease that causes total loss and because not approval treatments and the U S and Europe.

Phase two be free people don't clinical trial to evaluate our JAK <unk> inhibitor.

And she'd bitter but at the Sydney in Alopecia route there is expected to read out late in the third quarter of strength in 'twenty one.

And if approved.

We've received and it has the potential to transform the lives of certain patients with dish and dish.

The FDA has extended the priority review period of our new drug application for our proceeds and you for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

Albert Bourla: The Phase 2b3 Pivotal Clinical Trial to evaluate our JAK3 tech inhibitor, ritlicitinib, in alopecia areata is expected to read out late in the third quarter of 2021. [inaudible] Ritlicitinib has the potential to transform the lives of certain patients with this condition. The FDA has extended the priority review period of our new drug application for abracitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

The <unk> date has been expend extended three months to early third quarter 2021 as the FDA has requested additional information and it will require additional time to review this day.

And we'd be leaving the efficacy and safety profile other pursuits of Ibrutinib, which has demonstrated inc.

Phase III clinical trial of more than 2000 and compensation.

We look forward to working with the FDA and other guys around the world over the coming months and thanks.

And bringing this important and option.

And <unk>.

It is important to note.

But each decade.

Albert Bourla: The PDUFA date has been extended 3 months to early 3rd quarter 2021 as the FDA has requested additional information and will require additional time to review this date. We believe in the efficacy and safety profile of abracitinib, which has been demonstrated in a Phase 3 clinical trial of more than 2,800 patients. We look forward to working with the FDA and other regulators around the world over the coming months to potentially help bring this important option to market. It is important to note that each DEC inhibitor is unique, and potential risks identified in one molecule do not necessarily implicate other molecules.

And potentially even.

And in Guatemala.

Not necessarily all of them all of it.

We continue to remain confident and the importance of a duck and keeping surplus for appropriate patients with inflammatory diseases, given theyre all of that plus the waste.

Non majority question.

Based on safety.

And most important.

And we continue and good morning, John all components of our portfolio growth 95.

And as well as after regulatory approval.

In oncology and we continue to evolve.

The other part three studies and perforating guns.

First Paul offer one phase two study.

Second line plus.

The army patients, who recently had a positive result, as a monotherapy and providing key proof of concept and move forward per se contract combination shops.

Albert Bourla: We continue to remain confident in the importance of a ZAK inhibitor class for appropriate patients with inflammatory diseases, given the role of ZAK pathways in inflammatory processes. Patient safety is of utmost importance, and we continue to monitor all compounds in our portfolio to identify signals both in development as well as after regulatory approval. In oncology, we continue to evaluate talazoparid in three studies in prostate cancer.

And secondly, while operating and <unk>.

Phase III starts being first line metastatic castration resistant prostate cancer.

And in an unselected population and what was the primary completion date is expected in the second half of February.

And finally I'll offer a free.

And is beginning and.

And we started in terms of borrowing in combination with and so on.

Albert Bourla: The first is TALAPRO1, a phase 2 study in second-line plus patients with DDR mutations, which recently had a positive result as monotherapy, providing the key proof of concept to move forward to prostate cancer combination studies. The second is TALAPR2, a phase 3 starting first line metastatic castration-resistant prostate cancer in an unselected population for which the primary completion date is expected in the second half of 2021. And finally, TALAPR3, which is beginning soon, and we'll study thalassofirin in combination with enzalutamin. Indeed, they are deficient in metastatic testosterone-sensitive prostate cancer.

And beyond the TCM and the stock and penetration of SaaS and prostate cancer.

And in February 2021, we announced.

And it does.

And the registration and.

Margaret and then free Savi.

And I'll, let Tom.

And investigation of all B cell maturation and again should be.

Three targeted specific antibody in patients with relapsed and refractory multiple myeloma.

New enrollment and we start because we oppose why do we provide additional information regarding.

Regarding COVID-19 cases.

And we observed and the ongoing cash.

One Mark and Ed and then warm stacked.

And who are irrelevant.

And the benefits plan and on that number may compete.

It's a rare disease.

Our phase III <unk>.

Sure.

She's done a cozy and let Tom over.

And I will be fully enrolled with more than 40 patients. We remain on course, and complete dosing and expect to come down to conduct the problem and as a reminder, I was just thank you.

Albert Bourla: In February 2021, we announced that the first participant has been dosed in the Registration-Enabling Phase 2 Magnetism MN3 study of Ternalatumab, an investigational B-cell maturation antigen. CD3 targeted this specific antibody in patients with relapsed refractory multiple myeloma. New enrollment in this study has been discontinued while we provide additional information to the FDA regarding three cases of peripheral neuropathy observed in the ongoing Phase 1 Magnetism M1 study. Patients who are deriving clinical benefits from Erlanataba may continue treatment, and Revdizy. Our phase 3 lead in starting gene therapy, Fidana Kodzine, and Ella Parvovek in Amophilia B, have now been fully enrolled with more than 40 patients.

Turning now beginning this year and Kevin to try and do you want.

We also continue to progress, our and Mafia age et cetera.

And our portal.

Good day.

Peter.

Which one was developed in collaboration with Sangamo Therapeutics, we anticipate presenting two year phase one and the fourth quarter of 2021 and <unk>.

Currently we are pleased to report that our <unk>.

Leasing started before our phase III study.

And then will be fully enrolled which could lead to a pivotal readout in 2020.

For our gene therapy candidate.

For Duchenne muscular dystrophy.

And approved generic name.

For the knee surgery and move.

And part of it.

And we are progressing our phase III prior year sitting here today, we have opened 15 three all sites in eight countries.

Italy, Spain, the UK, South Korea, Japan, Russia, and Canada.

Albert Bourla: We remain on course to complete dosing and expect to conduct a plan interim analysis for a potential data redoubt this year in 2021. We also continue to progress our hemophilia-aided therapy, Xerocotocozine, and Fetal Parvovac, which was developed in collaboration with Sangam Therapeutics. We anticipate presenting two-year Phase 1-2 data in the fourth quarter of 2021. Additionally, we are pleased to report that our leading study for our Phase 3 AFIM study in hemophilia A is now fully enrolled, which could lead to a pivotal result in 2022 for our gene therapy candidate for Duchenne muscular dystrophy. We now have an approved generic name for the distrogene Movaparvovac.

And the U S. We are actively working with your day to address outstanding questions related to our investigational new drug application and crude.

Thank you and John aspect, so far all P&C SA manganese, some guys who can begin enrolling patients in phase III study sites.

Why do we have high confidence and our current according to control overall and where the profit metrics.

Metrics, which has been accepted and Congress outside of the U S. The FDA and additional secondary regression and working to address.

We understand that sense of urgency among.

Men and women in the U S. We're hoping our size scope and scale.

While we cannot speculate at this time as to when sites opened and the U S. We do not expect there is a looser and the first half of 2021, we are working with a central and <unk>.

Hope to read alignment with the FDA as soon as possible.

We will continue to progress our trial globally and.

And rate base and others.

We can be and will allow our program remains on track.

Albert Bourla: And we are progressing our phase three trial, CIFRA. Today, we have opened 15 trial sites in eight countries, Italy, Spain, Israel, the UK, South Korea, Japan, Russia, and Canada. In the U.S., we are actively working with the FDA to address outstanding questions related to our investigational new drug application, including technical aspects of our potency assay matrix so that we can begin enrolling patients in Phase III U.S. studies. While we have high confidence in our current quality control overall and with the potency HA metrics, which have been accepted in countries outside of the US, the FDA has additional technical requests that we are working to address as quickly as

Okay.

And on the warm.

And the U S.

Now I will try to address and keep quantities, which.

We continue to be actively engaged and <unk>.

First of all extra.

We expect that Pfizer administration.

And our human and capital component to their infrastructure and pockets, but will include Karen.

Yeah.

Pfizer is mobilizing for the administration as well as LOE, many cars and both political parties on meaningful solutions for patients.

Specifically there are three key areas, where we could we would like to see Congress and the administration.

Repairs and copying beneficiaries cost sharing and Medicare part D and centralizing the uptake of Biosimilars.

And the states all of them, we have focused our efforts on meaningful share repo.

Based on all of them.

This concludes legislation requiring 100% of chemical sales based on the pass through consumers and the pharmacy come and we can also work with state policy makers to advance legislation and several state and ensuring the patient assistant provided by manufacturers would come towards.

Albert Bourla: We understand the sense of urgency among many families in the U.S. who are hoping for sites to open soon. However, while we cannot speculate at this time as to when sites may open in the U.S., we do not expect a resolution in the first half of 2021.

The patient deductible and all.

Okay.

Albert Bourla: We are working with a sense of urgency and hope to reach agreement with the FDA as soon as possible. In the interim, we will continue to progress our trial globally and enroll patients at other sites, which we believe will allow our program to remain on track to potentially enable travel around the world, including the U.S. Now, I would like to address a key policy issue in which we continue to be actively engaged, and Portable X.

Looking ahead.

And we remain focused and be nimble and investing in our R&D organization. So we can build on the strong improvement in the clinical success rates, but can be seen over the past five years and potentially.

Success, Inc, strong commercial launches the benefit base.

Excluding any income.

From a COVID-19 vaccine we are on track and continue to expect and when you can't get all 56% on a risk adjusted basis towards the end of 2020 five as well as double digit growth on the bottom line.

We remain very confident and our ability to watching this growth rate.

Albert Bourla: We expect the Biden administration will soon announce a human capital component to their infrastructure packets that will include health provisions. Pfizer is mobilizing to work with the administration, as well as lawmakers in both political parties, on meaningful solutions for patient access. Specifically, there are three key areas where we would like to see Congress and the administration focus.

Thanks, Nicole so the strength of both our current product portfolio and.

Our R&D pipeline at the same time, we will continue to pursue business development opportunities with the potential further and enhance our long term growth.

Just last week for example, Pfizer acquired and Flex Pharmaceuticals, and privately held company dedicated to the development of therapies for David.

And.

Albert Bourla: Rebate reform, capping beneficiary cost-sharing in Medicare Part 2, and incentivizing the uptake of biosimilars. At the state level, we have focused our efforts on meaningful solutions to directly address patient affordability challenges. This includes legislation to require 100% of negotiated rebates to be passed through to consumers at the pharmacy counter.

Debilitating and life threatening disease.

People with compromised immune system and.

And so its lead compound is a novel investigational assets under development for the treatment of invasive fungal infections.

And now I won't even past and stay.

<unk> our CFO.

Thank you Albert Good day, everyone.

I know you've seen all released so let me provide a few highlights regarding the financials.

Clearly the COVID-19 vaccine has had a dramatic positive impact on our year over year results and Albert has addressed the key points on the COVID-19 vaccine landscape.

Albert Bourla: We have also worked with state policymakers to advance legislation in several states, ensuring that patient assistance provided by manufacturers will count towards the patient's deductible and out-of-pocket maximums. Looking ahead. We remain focused on being nimble and investing in our R&D organization so we can build on the strong improvement in clinical success rates that have been seen over the past five years and potentially translate that success into strong commercial launches that benefit patients.

Looking at the income statement revenue and adjusted cost of sales was significantly impacted by COVID-19 vaccine sales and the associated 50% gross profit split with bio and tech, which we recognize on the cost of sales line.

Revenue increased 42% operationally and the first quarter of 2021, driven by COVID-19 vaccine sales and solid performance from a number of our other key growth drivers.

The adjusted cost of sales increased shown here reduced gross margin by 10 percentage points compared to the first quarter of 2020, which primarily reflects the impact of the COVID-19 vaccine gross profit split which accounted for approximately eight percentage points to a much smaller extent product mix.

Albert Bourla: Excluding any impact from our COVID-19 vaccine, we are on track and continue to expect a revenue kager of at least 6% on a risk-adjusted basis through the end of 2025, as well as double-digit growth on the bottom line. We remain very confident in our ability to achieve this growth rate because of the strength of both our current product portfolio and our R&D pipeline. At the same time, we will continue to pursue business development opportunities with the potential to further enhance our long-term growth.

Looking at the business, excluding the COVID-19 vaccine contribution we saw a continuation of solid revenue growth for the business and the quarter, which nicely supports our projected revenue CAGR and at least 6% through the end of 2025 as a reminder, this growth projection continues to exclude any contribution.

From the COVID-19 vaccine.

In addition, compared with the prior year quarter first quarter 2021 revenues were favorably impacted by approximately $400 million as a result of the first quarter 2021, having three additional selling days and the U S and four additional selling days and international markets. This increase and selling days will be offset and.

Albert Bourla: Just last week, for example, Pfizer acquired Amplix Pharmaceuticals, a privately held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. Anthrax's lead compound is a novel investigational asset under development for the treatment of invasive fungal infections. Thank you. And now I will pass the stage to our CFO, Frank D'Emilio.

Fourth quarter of 2021, resulting in essentially the same number of selling days and full year 'twenty, one as compared to full year 2020.

However, and the favorable impact on quarter over quarter comparisons and first quarter 2021, selling days, partially offset by the non reoccurring and favorable revenue impacts related to COVID-19, and first quarter 2020.

Frank D'Emilio: Thank you, Albert. Good day, everyone.

Including increased demand for certain products of approximately $150 million and additional wholesaler inventories of approximately $100 million.

Frank D'Emilio: I know you've seen our release. So, let me provide a few highlights regarding the finances. Clearly, the COVID-19 vaccine has had a dramatic positive impact on our year-over-year results, and Albert has addressed the key points on the COVID-19 vaccine lens. Looking at the income statement, revenue and adjusted cost of sales were significantly impacted by COVID-19 vaccine sales and the associated 50% gross profit split with BioNTech, which we recognize on the cost of sales line.

Given these factors and net favorable impact on first quarter 2020. One revenues is approximately $150 million or approximately one five percentage points of operational growth, which in effect reduces a strong 8% operational growth rate to about 7%.

Reported diluted EPS for the quarter was up 44% compared to the year ago quarter, while adjusted diluted EPS grew 47% per quarter.

Foreign exchange movements resulted in a 3% positive benefit to revenue and a 1% benefit to adjusted diluted EPS.

Frank D'Emilio: Revenue increased 42% operationally in the first quarter of 2021, driven by COVID-19 vaccine sales and solid performance from a number of our other key growth drivers. The adjusted cost of sales increase shown here reduced gross margin by 10 percentage points compared to the first quarter of 2020, which primarily reflects the impact of the COVID-19 vaccine gross profit split, which accounted for approximately 8 percentage points and to a much smaller extent product, Looking at the business excluding the COVID-19 vaccine contribution, we saw a continuation of solid revenue growth for the business in the quarter, which nicely supports our projected revenue CAGR of at least 6% through the end of 2025.

Let's move to our revised 2021 guidance. We've again provided total company guidance, which includes the business with the COVID-19 vaccine and then we provided some additional sub ledger detail on our assumptions regarding the projected COVID-19 vaccine contribution. So you can also see our projections for the business without.

The COVID-19 vaccine to.

To start the adjustments we've made to our total company guidance are almost entirely due to the anticipated impact of the COVID-19 vaccine and R&D spending on incremental COVID-19 programs and non COVID-19 mrna programs, along with a small increase and the revenue outlook for the business excluding the.

COVID-19 vaccine.

And adjusted cost of sales the ranges have increased to 38% to 39%, which incorporates the incremental anticipated COVID-19 vaccine revenue, which has a significantly higher cost of sales due to the gross margin split with <unk> as compared to the rest of the business there.

Frank D'Emilio: As a reminder, this growth projection continues to exclude any contribution from the COVID-19 vaccine. In addition, compared with the prior year quarter, 1st quarter 2021 revenue was favorably impacted by approximately 400 million as a result of the first quarter 2021 having three additional selling days in the U.S. for additional selling days in international markets. This increase in selling days will be offset in Q4 of 2021, resulting in essentially the same number of selling days in FY21 as compared to FY22.

And the projected COVID-19 vaccine revenue as a percentage of total company revenue has increased to 36% as compared to 25% and our initial 2021 guidance.

On adjusted ESI and a we have maintained our initial guidance of 11 to 12 billion. In addition, we increased our adjusted R&D guidance range to nine 8% to $10 3 billion to incorporate anticipated spending on incremental COVID-19 related programs and other mrna based projects that are <unk>.

Part of the biotech partnership.

Working through working this through with a projected 15% effective tax rate Nielsen increased adjusted diluted EPS range of $3 55 to 365 or 59% growth at the midpoint compared to 2020, including expected 4% benefit from foreign exchange.

Frank D'Emilio: However, the favorable impact on quarter over quarter comparisons in first quarter 2021 from selling days was partially offset by the non-reoccurrence of favorable revenue impacts related to COVID-19 and First Quarter, including increased demand for certain products of approximately 150 million and additional wholesaler inventories of approximately 100. Given these factors, the net favorable impact on first quarter 2021 revenues is approximately $150 million or approximately 1.5 percentage points of operational growth, which, in effect, reduces a strong 8% operational growth rate to about 7%.

Let me quickly remind you of some assumptions and context on the projected COVID-19 vaccine contribution and our collaboration agreement.

As referenced earlier, the Pfizer <unk> COVID-19 vaccine collaboration construct is a 50 50 gross margin split.

Pfizer all book the vast majority of the global collaboration revenue, except for Germany, and Turkey, where we receive a profit share from biotech and we do not participate and China.

We now expect that we can manufacture up to $2 5 billion doses and 21 subject to continuous process improvements expansion net current facilities, and adding new suppliers and contract manufacturers.

As of mid April and we have contracted for approximately $1 6 billion vaccine doses to be delivered in 2021 and still have contracts for potential additional doses under review.

Frank D'Emilio: Reported diluted EPS for the quarter was up 44% compared to the year-ago quarter, while adjusted diluted EPS grew 47% for the quarter. Foreign exchange movements resulted in a 3% positive benefit to revenue and a 1% benefit to adjusted diluted EPS.

Based on the approximately $1 6 billion doses, we are now forecasting approximately $26 billion and COVID-19 vaccine revenue. This year, we continue to have three pricing tiers for government contracts, depending on the relative wealth of nations.

Our cost of sales for the COVID-19 vaccine revenue continues to include manufacturing and distribution cost applicable royalty expense as well as a payment to biotech representing the 50% gross profit split.

Frank D'Emilio: Let's move to our revised 2021 guidance. We've again provided total company guidance, which includes the business with the COVID-19 vaccine. And then we provided some additional levels of detail on our assumptions regarding the projected COVID-19 vaccine contribution. So you can also see our projection for the business without the COVID-19 vaccine.

We continue to expect that the adjusted income before tax for the COVID-19 vaccine contribution to be and the high twenty's and as a percentage of revenue <unk>.

This margin level also includes the anticipated spending on additional mrna programs.

Frank D'Emilio: To start, the adjustments we've made to our total company guidance are almost entirely due to the anticipated impact of the COVID-19 vaccine and R&D spending on incremental COVID-19 programs and non-COVID-19 mRNA programs, along with a small increase in the revenue outlook for the business, excluding the COVID-19 vaccine. For adjusted cost of sales, the ranges have increased to 38 to 39%, which incorporates the incremental anticipated COVID-19 vaccine revenue, which has a significantly higher cost of sales due to the gross margin split with BioNTech as compared to the rest of the business.

As I noted earlier the COVID-19 vaccine is now projected to account for 36% of total revenue for 2021 up from 25% and our initial guidance for the year let.

Let me add that if we contract for additional delivery of doses during the year, we will provide a guidance update and our subsequent earning releases.

If we remove the projected COVID-19 vaccine and contribution from both periods you will see that we slightly increased 2021 revenue range to be between $44, six and $46 6 billion, representing approximately 6% operational revenue growth at the midpoint.

Frank D'Emilio: The projected COVID-19 vaccine revenue as a percentage of total company revenue has increased to 36% as compared to 25% in our initial 2021. On adjusted SINA, we have maintained our initial guidance of 11 to 12. In addition, we increased our adjusted R&D guidance range to $9.8 to $10.3 billion to incorporate anticipated spending on incremental COVID-19 related programs and other mRNA-based projects that are not part of the BioNTech partner. Working this through with a projected 15% effective tax rate yields an increased adjusted diluted EPS range of $3.55 to $3.65, or 59% growth at the midpoint compared to 2020, including an expected 4% benefit from foreign aid.

In terms of adjusted diluted EPS, we continue to project a range of $2 50 to $2 60, which represents approximately 11% operational growth at the midpoint.

These growth rates are all consistent with how we've been publicly positioning the business post the upjohn separation.

You likely saw our announcement that we have maintained our dividend payment for the second quarter and its current level. Despite the interest announcing their expected dividend payment.

For those continuing tones and <unk> shares this effectively represents an increase and the dividend income and our board felt that the strength of our business supported maintaining our dividend for.

For the foreseeable future, we expect our board to continue to support annual dividend increases and approximately this year's level. Obviously, we have no sales to what <unk> does with its future dividends.

In summary, a tremendous start to 2021, the COVID-19 vaccine and continues to benefit millions of people around the world and the business is on track for anticipated solid top and bottom line growth.

We remain focused on advancing our pipeline supporting and market brands and looking to deploy capital responsibly with a focus on initiatives that can solidify our long term revenue and earnings growth outlook with that I'll turn it back to Chuck.

Frank D'Emilio: Let me quickly remind you of some assumptions in context on the projected COVID-19 vaccine contribution and our collaboration agreement. As referenced earlier, the Pfizer-BioNTech-COVID-19 vaccine collaboration construct is a 50-50 gross margin. Pfizer will book the vast majority of the global collaboration revenue, except for Germany and Turkey where we receive a profit share from BioNTech, and we do not participate in China. We now expect that we can manufacture up to 2.5 billion doses in 21 days, subject to continuous process improvements, expansion at current facilities, and adding new suppliers and contract manufacturing.

Great. Thanks, Frank and Albert for your prepared remarks at this point operator, let's move to our Q&A session. Please.

Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypads and we'll pause for just a moment to compile the Q&A roster.

Your first question comes from the line of Louise Chen from Cantor.

Hi, congratulations on the quarter and thanks for taking my questions. Here. So first question I had for you what are your thoughts on the slowing vaccination rates and the U S. Do you anticipate things to pick up again, and when we reach that level of a herd immunity and the U S. Here and then second question I had was on <unk>.

Vaccine sales and how you think about it beyond 2021 and 2022, what gives you confidence that there's going to be a tail here and how does that look relative to the $26 billion that you're going to potentially have this year and then last question I had for you is just on how youre thinking about FDA concerns around JAK safety. Thank you.

Frank D'Emilio: As of mid-April, we have contracted for approximately 1.6 billion vaccine doses to be delivered in 2021 and still have contracts for potential additional doses under review. Based on these 1.6 billion doses, we are now forecasting approximately 26 billion in COVID-19 vaccine revenue this year. We continue to have three pricing tiers for government contracts depending on the relative wealth of nations.

Thank you very much and Louise.

So let me make some comments on the strongbox and <unk> and maybe a little bit on the capital.

Revenues were not sure Michael posting growth.

Frank D'Emilio: Our cost of sales for the COVID-19 vaccine revenue continues to include manufacturing and distribution costs, applicable royalty, as well as a payment to BioNTech representing the 50% gross profits. We continue to expect that the adjusted income before tax for the COVID-19 vaccine contribution will be in the high 20s as a percentage of revenue. This margin level also includes the anticipated spending on additional mRNA programs.

And although there and then for all of US talk I will ask you make some comments about the savings.

I think you guys have done a tremendous and includes all right.

And look we win they win.

What I'm, saying.

And as we are excited and more and more people.

And the people, but there are lots of them to get the vaccine and Richie and remaining board.

Normal and expected we would see.

And the adult in the origination, but I believe.

Frank D'Emilio: As I noted earlier, the COVID-19 vaccine is now projected to account for 36% of total revenue for 2021, up from 25% in our initial guidance for the year. Let me add that if we contract for additional delivery of doses during the year, we will provide a guidance update in our subsequent earnings release. If we remove the projected COVID-19 vaccine contribution from both periods, you will see that we slightly increased the 2021 revenue range to be between $44.6 and $46.6 billion, representing approximately 6% operational revenue growth at the mid-pandemic.

The entering all additional pools like younger people.

Mostly expected.

Okay.

And 11 15 years old.

And Asia also provides an additional increase and the recognition rates.

All in all I think you.

You guys are doing very good job and they had hope it all should.

To convince those people.

Thanks, and I am still fear.

If all of the vaccine.

All right.

And then beyond 'twenty, two and three.

We believe as we've said multiple times, but they would be and need for boosters and.

There is a need.

For now all the way.

Frank D'Emilio: In terms of adjusted diluted EPS, we continue to project a range of 250 to 260, which represents approximately 11% operational growth at the mid-period. These growth rates are all consistent with how we've been publicly positioning the business post the Upjohn separation. You likely saw our announcement that we have maintained our dividend payment for the second quarter at its current level, despite Beatrice announcing their expected dividend payment. For those continuing to own Viatrix shares, this effectively represents an increase in dividend income, and our board felt that the strength of our business supported maintaining our dividend payment.

And good evening.

And Europe pretty much Nathan.

All I'd say irregular route expansion.

And it will be.

Wise.

Yes.

And believe it's based on vapor products evidence and months.

And that started up ahead and read out right now.

This is Tom again.

Evidence are having to do with the fact that.

And we still kind of very high efficacy.

All 90 above 90% in all.

Six months, but it is slower at 90 195, but we said at the beginning so there are some indications.

And there is a drop and the I think that's what we're buying.

No.

Frank D'Emilio: For the foreseeable future, we expect our board to continue to support annual dividend increases at approximately this year's level. However, obviously, we have no say as to what Viatris does with its future. In summary, a tremendous start to 2021. The COVID-19 vaccine continues to benefit millions of people around the world, and the business is on track for anticipated solid top and bottom line. We remain focused on advancing our pipeline, supporting in-market brands, and looking to deploy capital responsibly with a focus on initiatives that can solidify our long-term revenue and earnings growth outlook. With that, I'll turn it back to you.

All right.

And then Ecb's RV sales and use our lives and antibodies.

But also.

And these antibodies and bulk affects not only.

People.

It's amazing, but also and that's what exactly we also know.

After six months and increased.

Thanks, John So people that they had previous infection.

Increasing and real.

So no other.

All right now our vaccine at least effective against all the other areas. We have seen but there is an adult and yogurt rising all right, so which means that the main sooner, but maintain good day.

Operator: Great, thanks Frank and Albert for your prepared remarks. At this point, operator, let's move to our Q&A session, please. Ladies and gentlemen, if you would like to ask a question, please press star 1 on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Louise Chen from Cantwell. Hi, congratulations on the quarter and thanks for taking my questions.

And that's against the variance you'll need to increase per Immunogenicity and this is <unk>.

And we're doing the stocks so net.

And with events are pointing out.

There's a reason why.

Basically all and governments around the world, where an hour and discussing with us.

About procurement agreements work and discipline.

And Brent Nicole.

But that last quarter Michael.

Let's see.

And Ah.

Some comments on the.

Why are we seeing growth.

And the boosters and repeaters and explanation is the likely scenario and also a comment on the dock space all right.

Operator: Ladies and gentlemen, if you would like to ask a question, please press star 1 on your telephone keypads. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Louise Chen from Kantor.

No.

Yes, Thank you Albert and I thought.

And so what you outlined and an excellent manner that we.

We have identified a handful of key points related to.

Albert Bourla: Thank you very much, Luis. Let me make some comments on the slowing vaccinations and maybe a little bit on the 2022-2023 revenues. I will ask Michael Dolsten to add some comments on that. And then, also, for Zach, I will ask him to make some comments about the savings.

Immunity wood and used by convalescence, all my lesson after and put offering a pitch and a vaccine that will over time and as expected showed some decline antibodies would show some decline as their half life or limited.

And of course, particularly and contains other immune mechanism and.

Albert Bourla: Look, I think the U.S. has done a tremendously good job, and they have reached vaccination levels that we didn't think that they would. The truth is that as we are vaccinating more and more people, the people that are reluctant to get the vaccine are enriching the remaining poor. So it's normal to expect that we will see a drop in the vaccination rate, but I believe that the entry of additional pools like younger people post the expected approval of our 11 to 15-year-olds.

When you put all of this in context.

Q2 is global and circulate and to extend and we have rarely see and where ever seen in our lifetime all of a virus.

And the inability to control and it across the globe will of course need to numerous changes.

And the viral load and mutation rate. So it just punctuate what Albert said, we read we need continuously to keep up a very high.

Albert Bourla: Vaccination also will provide an additional increase in vaccination rates. All in all, I think the US is doing a very good job, and the focus of everyone should be to convince those people that they still have fear about the vaccine and that they must do the right thing. Now, beyond 22 and 23, first of all, we believe, as we have said multiple times, that there will be a need for boosters, and there will likely be a need likely from now all the way to the end, and then we believe that the likely annual revaccinations, or let's say regular revaccinations, will be required. Clearly, this belief is based on the totality of the evidence and not on studies that they have read out right now to convince us that this is the case.

Pressure against the virus to stay ahead of the curve and the best way to do that is with regular boosting.

And finally, a herd immunity.

All we would like to see it to establish.

And what you hear from a lot of public health day.

Global real estate all emerging.

Instead, it will be really difficult on indulge continents to establish such a high utilization rates across all ages.

And to ensure that.

C immunized, one part of the continent.

And that immunity is maintained at the and other parts.

So I think we would really need to rely on regulating and ascension and.

And of course, other public health measures brought it and hoping that the herd immunity across the globe can be established finally on the Jack.

Albert Bourla: And the totality of the evidence has to do with the fact that we still have very high efficacy of 90, above 90% in our six months, but it is slower at 91 than 95 that we had in the beginning. So there are some indications that there is a drop in efficacy over time. We know from immunogenicity studies of neutralizing antibodies that there is also a drop in these antibodies, and that affects not only people who are vaccinated but also naturally infected. We also know that after six months, the increase in infections to people who have had previous infections is increasing.

And you know already in February 'twenty one.

They made it public about our day thought and 11 33 related to <unk>.

Increased risk of serious heart related problems and surf and cancer when compared to and.

The other type of medicines that TNF inhibitors.

So these states all clearly north new FDA, EMA and other agencies work and dialogue with us to finalize the outcome of this review.

On the other hand, I think Jack.

Albert Bourla: And we also know that our vaccine is, at least, effective against all the variants that we have seen, but there is a drop in neutralizing antibody levels, too. This means that to maintain good efficacy against the variants, you need to increase the immunogenicity, and this is why we are doing the studies with the boosters. So the totality of the events is pointing to this, and this is the reason why basically all governments of the world are now discussing with us about procurement agreements for 2022, 2023, and 2024. But I will also ask Michael Rossi to make a comment on why we think that boosters and repeated vaccinations are a likely scenario and also a comment on drug safety. Michael?

Jack class has shown to be an important contribution that's and oral alternative for many patients.

And you avoid other issues such as anti drug antibodies with the biological and so.

So we continue to wait for Finalization of adult Com all of the 11 33 trial. We think you Chuck inhibit these unique and needs to be assessed by itself and we continue to believe that with Cooper labeling and given the tremendous experience of failure and since 2012.

It will continue to have a potential to be and important medicine.

All right. Thank you operator next question please.

Your next question comes from Terence Flynn.

Sacks.

Great. Thanks for taking the questions and thank you for all the work on the vaccine front.

I just had a follow up on the boost your question.

Do you think that will be uniform across different groups or will there be any differences by baseline characteristics such as age in terms of the timing and or the need for a boost and then would you expect FDA and CDC to issue a recommendation on the need for boosters sometime this year.

Michael Dolsten: Yeah, thank you, Albert. I thought you outlined in an excellent manner that we have identified a handful of key points related to immunity being induced by convalescence of the infection of the vaccine that will, over time, as expected, show some decline. Antibodies will show some decline as their half-life is limited. Of course, protection contains other immune mechanisms.

Michael Dolsten: When you put all of this in context, that SARS-CoV-2 is globally circulating to an extent we have rarely seen or never seen in our lifetimes of a virus, and the inability to control it across the globe will, of course, lead to numerous changes in the viral mutation rate. So I just punctuated what Albert said; we need to continuously keep up a very high immune pressure against the virus to stay ahead of the curve.

And then my second question for Alberta, Frank is just would welcome your perspective on the potential impact of tax rate changes and the U S and and any thoughts on how that might change your capital allocation strategy and our views on inversions. Thanks.

Michael why don't you take the question from the boosters.

Yeah, I think we cannot of course predict what the CDC and seemed malaysians will do but what seems to be the general public dialogue and and which.

Michael Dolsten: And the best way to do that is with regular boosts and, finally, herd immunity, although we would like to see it established. What you hear from a lot of public health data and emerging global health data is that it will be really difficult on large continents to establish such a high immunization rate across all age groups and to ensure, as you immunize one part of the body, that immunity is maintained at another part.

Of course builds and experience with other viral.

Epidemics and this is of course, the pandemic is that you would like and start with those that are most susceptible.

Older adults those with chronic diseases, such as cardiovascular obesity, COPD asthma, and I need it or and union pad and.

Michael Dolsten: So I think we would really need to rely on regular immunization and, of course, other public health measures rather than hope that herd immunity across the globe can be established. Finally, on the Jack Faith. You know, already on February 21. FDA made it public about our data in 11.33 related to increased the risk of serious heart-related problems and certain cancer when compared to another type of medicine, the TNF inhibitors. So these dates are clearly not new.

Of course that constitute a very large population while you may start windows, if we all ought to really maintain control of the virus.

And we'll be very reasonable to assume the importance of also vaccinate and younger groups.

All the severe COVID-19 is less common and younger groups. Some patients may suffer severely from such infection and they all are at risk also of acquiring non COVID-19 syndrome, which can cause significant impediment or participation in functional.

Michael Dolsten: FDA, EMA, and other agencies will work in dialogue with us to finalize the outcome of this review. On the other hand, I think the JET class has shown to be an important contribution as an oral alternative for many patients, and you avoid other issues such as anti-drug antibodies with the biological... So we continue to wait for the outcome of the 1133 trial. We think each JAK inhibitor is unique and needs to be assessed by itself. And we continue to believe that with proper labeling and given the tremendous experience of Xeljanz since 2012, it will continue to have the potential to be an important medicine.

Life for young individuals as well as one.

No.

And all and all.

Yes regular boost of the entire population is.

The airports ability.

Northeast and start of course with a menu vulnerable from H to chronic diseases, which is a large number of the adult population.

Thank you Michael and Frank would you like to take the <unk>.

And about the tax sure. Thank you Albert So I think it's premature to comment on one impact and the proposed tax what happened.

How we view capital allocation and inversion simply because these counterproposals typically go through.

Operator: Right. Thank you. Operator, next question, please.

Multiple iterations multiple discussions multiple negotiations obviously, we're staying very close to this doing all the analytics analytics that you would expect us to do but I think what's really important is how we think about tax taxes and tax policy two.

Operator: Your next question comes from Terrence Flynn from Goldman Sachs.

Operator: Great. Thanks for taking the questions and thank you for all the work on the vaccine front. I just had a follow-up on the booster question. Do you think that will be uniform across different groups, or will there be any differences by, you know, baseline characteristics such as age in terms of the timing of a need for a boost? And then would you expect the FDA and CDC to issue a recommendation on the need for boosters sometime this year?

<unk> thousand 17 tax reform leveled the playing field for U S multinationals against foreign competitors and that was enabled and enabler from my perspective much of what we've done with capital deployment, particularly in the U S.

We committed to $5 billion of Capex investment between 2018, and 2022, we and you know we committed a few billion dollars of at risk capital and order to develop they called it a vaccine.

Operator: And then my second question for Albert or Frank is just to welcome your perspective on the potential impact of tax rate changes in the U.S. and any thoughts on how that might change your capital allocation strategy and or views on inversions. Thanks.

Funding of our U S qualified pension plan that we did last year to the tune of over $1 billion. All of those from my perspective were enabled by the level playing field that we now get to compete on against all foreign competitors and so what we want from tax reform and all of a sudden and done as we want that level playing field to continue so that we have the ability to <unk>.

Pete on AR and AR.

Michael Dolsten: Michael, why don't you take the question from the booth? Yeah, I think we cannot, of course, predict what the CDC and similar agencies will do. But what seems to be the general public dialogue, and which, of course, builds on experience with other viral epidemics, and this is, of course, a pandemic, is that you would likely start with those that are most susceptible, older adults, those with chronic diseases such as cardiovascular, obesity, BOPD, asthma, and many that are immune impaired.

On a level playing field. So that's my answer.

All right that's right.

Next question please.

Your next question comes from Geoffrey Porges.

Laura Inc.

Thank you very much.

And again congratulations John.

A remarkable quarter and really tremendous progress.

And quick questions first on pricing you mentioned deposits.

And.

Could you give us a sense of what that looks like for the rest of the year or is that something that we should be expecting for the full year or is it just a Q1 phenomenon and.

And then related to that all but you disclosed.

Your view on the pricing policy and regulatory and legislative update.

Michael Dolsten: And, of course, that constitutes a very large population. While you may start with those, if we are to really maintain control of the virus, it will be very reasonable to assume the importance of also vaccinating younger groups. Although severe COVID is less common in younger groups, some patients may suffer severely from such infections. And they are also at risk of acquiring long COVID syndrome, which can cause significant impairment of participation in functional life for young individuals as well as old. So, all in all, yes, a regular boost of the entire population is the, Clear possibilities, and priorities to start, of course, with many vulnerable from age to chronic diseases, which is a large number of the adult population.

But it's what you described a realistic case or is that the best case.

And then a couple of questions for Michael.

Michael I've asked you this before but given what we're seeing and India and in other geographies.

Is it your view that.

And part of it and it's got to be a case of convergent evolution or continuous evolution and we.

We're seeing new mutations beyond before I before COVID-19.

And have additional resistance.

And that resistance mechanisms to the first generation and vaccines.

And then just lastly.

You mentioned them out and.

You have the maternal.

And so your vaccine.

Are you planning to apply them all day is a more efficient.

Frank D'Emilio: Thank you, Michael. And Frank, would you like to take the question about the text? Sure. Thank you, Albert.

And the approach to getting me and Nigel and its.

Coverage against them on that.

I guess total power space.

Frank D'Emilio: Sure. Thank you, Albert.

Thank you Jeff all other questions.

Very important and I'll, let me speak a little bit about the policy of the prices and then I'll ask Frank to commend Elizabeth and the pricing and defensive and used to add something.

Frank D'Emilio: So I think it's premature to comment on what impact the proposed tax reform would have on how we view capital allocation and inversion simply because these kinds of proposals typically go through, you know, multiple iterations, multiple discussions, multiple negotiations. Obviously, we're staying very close to this doing all the analysis that you would expect us to do. But I think what's really important is how we think about taxes and tax policy.

As for free and then and the two other areas clearly Michael will speak about the resistance and the MRO mix on the pricing reforms. These are our stronger position, but I will try to explain how I feel about the pricing reforms and I have said it in multiple locations. We don't think that stock is always good for anyone.

And I don't think is good for the industry I don't think is good for the Americans because there is a problem with the current way.

For the COVID-19 kind of system and this is a problem, but basically every American is paying for their medicines and this is unique to medicines multiple other medical interventions is paying out of pocket like if they don't have insurance, although they do have insurance and this is the fundamental thing that needs to change because this is.

Frank D'Emilio: 2017 tax reform leveled the playing field for U.S. multinationals against foreign competitors, and that was an enabler from my perspective of much of what we've done with capital deployment, particularly in the US. You know, we committed to $5 billion of CapEx investment between 2018 and 2022. We also committed a few billion of at-risk capital in order to develop the COVID vaccine. Funding of our U.S. Qualified Pension Plan that we did last year to the tune of, you know, over a billion dollars.

And to the overall per care it is.

7%, so by definition and cannot be the big east but.

But it is becoming the biggest during the discussion because everybody because the basis thing from out of pocket almost.

Sure.

Unlike other interventions.

So what I'd sales could look like and for us and <unk> could look different.

Different forms it could be consistent from different areas may not be the rebate reform, which I think is one of the systemic issues you are having.

Frank D'Emilio: All of these, from my perspective, were enabled by the level playing field that we now get to compete on against our foreign competitors. And so what we want from tax reform, when all is said and done, is that level playing field to continue so that we have the ability to compete on a level playing field. So that's my answer.

And our pricing, but it could be that out of pocket comps.

Fundamental thing it is that there will be of course, the industry I'm sure will be willing to take our fair share as long as all the savings all of the contributions of what we are doing right now from this interest they will go to the pockets of the American place.

And this is a fundamental difference with people that we're discussing right now because we are hearing a lot of additions, but they won two tax day pharmaceutical companies or box the sort.

Operator: Your next question comes from Jeffrey Porges from SVB LaRinque.

Operator: Thank you very much for attending. Again, congratulations on a remarkable quarter and really tremendous progress. Some quick questions. First, on pricing, you mentioned the 5% price. Could you give us a sense of what that looks like for the rest of the year? Is that something that we should be expecting for the full year, or is it just a Q1 phenomenon?

And those components, but the proceeds will just fall in the block all over the first of all Bob.

It is not what we want.

If all contributions to the patients we are sitting down with all of that part is trying to do a decent price reform and the way that the Americans are experiencing.

Operator: And then related to that, Albert, you disclosed your view on pricing policy and regulatory and legislative updates. But is what you described a realistic case, or is that a best case? And then a couple of questions for Michael.

The cost when they go to the pharmacy to collect their medicines.

So is it realistic all optimistic I believe it is realistic.

We believe that there is room.

And for agreement.

And with <unk>.

Sides of the eye and.

And with this administration.

Michael Dolsten: Michael, I've asked you this before, but given what we're seeing in India and in other geographies, is it your view that COVID is going to be a case of convergent evolution or continuous evolution? I.e., are we seeing new mutations beyond E484K that have additional resistance mechanisms against the first generation of vaccines and antibodies? And then, just lastly, you mentioned mRNA. You have a maternal RSV vaccine. Are you planning to apply mRNA as a more efficient approach to getting neonatal and infant coverage against mRNA? against RSV, sorry.

And we will continue working on finding the solution.

Meg and this is affordable forms that patients and.

Not.

Total money to the black hole of if at all much.

No Frank if you can take the price increase and then Michael Okay.

And you've heard Albert and May talk about pricing and that pricing has been and headwind and we expect it to continue to be a headwind for the foreseeable future and that's obviously, what we saw this quarter with pricing being a negative 5% on a global basis I should also and that was a negative 5% and the U S now and in terms of our guidance.

Michael Dolsten: Thank you, Jeff. A lot of questions, very important. Let me speak a little bit about the price policy, and then I will ask Frank to comment a little bit on the price, and if Angela needs to add something, please feel free. And then on the two other areas, Michael will speak clearly about resistance and mRNA. On the pricing reforms, these are our standard positions, but I will try to explain how I feel about the pricing reforms. And I have said it on multiple occasions.

And which is what you asked Jeffrey our guidance assumed the pricing decrease negative impact I'll call. It and the range of low to mid single digits. So that 5% reduction that we saw this quarter is consistent what we assumed in our annual guidance.

Thank you Frank and by the way I wanted words this minus 5%.

And it is the reality of the numbers I'm sure I'm sure, but mainly American sniper and experienced during this quarter and 5% reduction and they're out of book because he is the system that works and away, but no matter what you do on the top the price that they have to pay.

Albert Bourla: We don't think that the status quo is good for anyone. I don't think it's good for the industry. I don't think it's good for the Americans because there is a problem with the current system.

And is derived from very different growth.

Michael can you just speak a little bit about other resistant <unk> and the amount and they were honestly.

Yeah. Thank you all start with mrna as you discussed.

Albert Bourla: And this is a problem that basically every American is paying for their medicines, and this is unique to medicines, not to other medical interventions, is paying out of the pocket like if they don't have insurance, although they do have insurance. And this is the fundamental thing that needs to change because the medicines' contribution to the overall healthcare, 12% so by definition cannot be the big issue but it is becoming the big issue in the discussion because everybody has to pay this thing from out of pocket almost unlike other interventions, So what a change could look like and for us a change could look take different forms it could be consistent from different areas may not be the rebate reform which i think is one of the systemic issues that we are having with drug pricing but it could be that out-of-pocket caps The fundamental thing is that there will be a cost that the industry, I'm sure, will be willing to take our fair share.

<unk> discussed here, yes.

Of course, there is tremendous viral amounts across the globe.

Fueled by the spread and large population areas like India, we do see several different lineages. Many idiots all sorts cook to establish.

They however seem to share them.

The most critical limitations.

Most of the variance have up to 10 mutations and they can combine and different ways.

So far we believe that our b to the current vaccine is very effective in controlling all known mutations, but that's all been alluded to we believe it's very important to keep up very high neutralizing.

Neutralizing antibody levels. In addition to the ninth T cell immune disease, and that's why a possible outcome of these tremendous spread including India is to have a regular booths.

And the pandemic continue and up to now mutations have been selected mainly because the virus is trying to spread more quickly. The virus will now face vaccinated immunity and maybe 'twenty two 'twenty three and increasingly so we needed to be per pad that there could be new.

Albert Bourla: As long as all the savings, all the contributions that we are doing right now from this industry will go to the pockets of the American patient. And this is the fundamental difference with the people that we are discussing right now.

Albert Bourla: Because we are hearing a lot of suggestions that they want to tax the pharmaceutical companies or tax the insurance companies, but the proceeds will just fall into the black hole of the federal budget, which is not what we want. If our contributions go to patients, we are sitting down with all the parties trying to do a decent price reform in the way that Americans are experiencing the cost when they go to the pharmacy to collect their medicine.

Unexpected mutations to come and that's why Pfizer.

Leaving no stone untouched and also have a barrier and vaccine.

Development and could be an alternative later.

And if that scenario would emerge but right now it seems like the current <unk>.

<unk> is very effective against all these variables despite each having up to 10 different mutations on the RSV well, we had very robust titers with our protein based RSV vaccine maternal vaccination very good tolerability and antibody positive patients.

Albert Bourla: So, is it realistic or optimistic? I believe it is realistic. I believe that there is room for agreement both with the two sides of the aisle and with this administration, and we will continue working on finding this solution but will, I repeat, make medicines affordable for patients and not throw money into the black hole of the federal budget. Now, Frank, if you can take the price increase, and then Michael. Okay.

And the cord blood and we are enrolling now well in phase III. We also have initiated a phase two <unk> study with RSV that will read out.

Mid of the year and that could possibly lead to progression swiftly into phase III.

So we are pretty advanced with a protein based it looks very good but of course, we have now.

Frank D'Emilio: So you've heard Albert and me talk about pricing and that pricing has been a headwind, and we expect it to continue to be a headwind for the foreseeable future, and that's obviously what we saw this quarter with pricing being a negative 5% on a global basis. I should also mention it was a negative 5% in the U.S. Now in terms of our guidance, which is what you asked Jeffrey, our guidance to assume the negative impact of the pricing decrease, I'll call it in the range of low to mid-single digits. So that 5% reduction that we saw this quarter is consistent with what we assumed in our annual guidance.

Mrna platform that we would like to use for multiple opportunities, we expect to put into the clinic to first in humans novel vaccines every year for the next two years certainly RSV could in the future be one alternative what it could be.

As a supplement to the protein base in order to add some T cell immunity. These are things, we'll continue to explore and then prioritize among the many exciting opportunities for our mrna platform.

Great. Thank you Michael next question please.

Your next question comes from Steve Scala from Cowen.

Well. Thank you so much I have two questions regarding the DMD gene therapy is the poll and the C pass through issue related to concerns around correlation of Biomarkers to motor function efficacy or is it simply.

Albert Bourla: Thank you, Frank. And by the way, I wanted to add that this minus 5% is the reality of the numbers. I'm sure that many Americans haven't experienced during this quarter a 5% reduction in their out-of-pocket expenses because it's the system that works in a way that no matter what you do on the top, their price that they have to pay is derived from very different rules.

And technical issue with no bearing on relevance of the endpoints.

And second question.

It's a little bit more broad based but.

When the COVID-19 vaccine Pfizer has built the world's largest global pharmaceutical franchise and six months I imagine that it is creating a substantial stress throughout the organization similar to the disruption of a major acquisition what metrics do you monitor to ensure that these stresses.

Michael Dolsten: Michael, can you speak a little bit about the resistance mechanism, the mRNA or RSV? Yeah, thank you. I'll start with the mRNA. As you discussed here, Jeffrey, of course, there are tremendous viral amounts across the globe, fueled by the spread in large population areas like India. We do see several different lineages of SARS-CoV-2 established. They, however, seem to share similarities.

Not going to show up and one to three years or so as say subpar product performances clinical trial failures that otherwise would have been successes and maybe missed M&A that would have otherwise made sense for Pfizer and thank you.

Michael Dolsten: The most critical mutation. Most of the variants have up to 10 mutations, and they can combine in different ways. So far, we believe that our B2, the current vaccine, is very effective in controlling all known mutations. But as Albert alluded to, we believe it's very important to keep up very high... Utilizing antibody levels in addition to the nice T cell immunity. And that's why a possible outcome of this tremendous spread, including in India, is to have a regular boost.

Alright, Thank you very much Steve Michael.

Michael would you like to take the DMD question is it the pecking got released and what will be yes.

Yeah. So the D&B trial first of all and I think all but mentioned that in his introductory remarks, it's enrolling in many different countries and in each of those we had a matrix of assays that were cleared and bye.

Michael Dolsten: As the pandemic continues, up to now, mutations have been selected mainly because the virus is trying to spread more quickly. The virus will now face vaccinated immunity in maybe 22, 23, and increasingly. So we need to be prepared that there could be new unexpected mutations to come. And that's why Pfizer is leaving no stone untouched and also has variant vaccines developed that could be an alternative later if that scenario emerges. But right now, it seems like the current vaccine is very effective against all these variants, despite each having up to 10 different mutations.

By the regulatory authorities that particular discussion with FDA and it's more of a technical issue on how to do a quantification in one and supportive assay, but not really as per all of you in and of the main assets.

So we continue to work with them and aim to resolve it.

Want to point out that to the best of my knowledge.

We were first to start the DMD phase III now enrolling well outside the U S and late last year and we are probably by now entering may six months ahead of anyone using gene therapy.

It needs public and it hasn't been disclosed.

Michael Dolsten: On the RSV vaccine, well, we had very robust titers with our protein-based RSV vaccine in maternal vaccination, very good tolerability, and antibodies passed efficiently through the cord blood. And we are enrolling now well in phase three. We also have initiated a phase two challenge study with RSV that will read out in the mid of the year and that could possibly lead to progression swiftly into phase 3. So we are pretty advanced with the protein base, it looks very good, but of course, we have now an mRNA platform that we would like to use for multiple opportunities.

And the other having been cleared.

Yes.

Thank you Michael and Steve It's all about.

In order to see what was achieved during the.

Vaccine.

And the ingenuity of our people was a key component, but also a lot of personal sacrifice being bolt. So a lot of other people worked day and night.

All of these people work days and nights tool to make sure all this happens and but clearly if it's taking a toll on them and.

Michael Dolsten: We expect to put two first-in-human novel vaccines every year for the next few years. Certainly, RSV could in the future be one alternative, whether it could be as a supplement to the protein base in order to add some T cell immunity. These are things we'll continue to explore and then prioritize among the many exciting opportunities for our mRNA platform.

And no matter, how proud they failed because the parcel and but they have.

Kevin and I keep them going forever.

I am concerned about we need to find ways to all these people.

And we'll know if they've been all but and it.

And also to emphasize that Pfizer is run.

Operator: Great. Thank you, Michael. Next question, please.

In the foremost business units since our 2016 when I was surrounding the the business basically annualize running right now and so we have organized the horror.

Operator: Your next question comes from Steve Scala from Cowan.

Operator: Thank you so much. Regarding DMD gene therapy, is the potency assay issue related to concerns around correlation of biomarkers to motor function efficacy, or is it simply a technical issue with no bearing on relevance of the endpoints? And the second question is a little bit more broad-based, but...

<unk> operations into six business units and.

Lapping all the R&D and the commercial and clinical development.

So the walk from COVID-19 happened in one of the six business units and the.

Top and predominantly in the R&D domain of these clinical units, but at the same time.

Operator: In the COVID vaccine, Pfizer has built the world's largest global pharmaceutical franchise in six months. I imagine that it is creating substantial stress throughout the organization, similar to the disruption of a major acquisition. What metrics do you monitor to ensure that these stresses are not going to show up in one to three years or so as, say, subpar product performances, clinical trial failures that otherwise would have been successes, and maybe missed M&A opportunities that would have otherwise made sense for Pfizer?

And the oncology business unit and the rare disease business unit and the internal medicine.

And this unit and all the other business units.

<unk> working on.

They are normal, let's say workload pleasant reported by the way. They can of course also to to overcome eastern sort related with the COVID-19, but you can make their work and very easy but.

Operator: Thank you.

Albert Bourla: Thank you very much, Steve. Michael, would you like to take the DMD question? Is it a technical issue? What is the issue?

Again, and say, we're being able to rise to the occasion, because I believe everybody and Pfizer that was so strong believer of our culture.

Michael Dolsten: Yeah, so the DMD trial, first of all, and Albert mentioned that in his introductory remark, is enrolling in many different countries. And in each of those, we had a matrix of questions that were cleared by the regulatory authorities. The particular discussion with FDA is more of a technical issue on how to do quantification in one supportive essay but not really, as per our view, in any of the main essays.

Patients come first and this is other bulk us about Jeff So this.

And.

Sense of sacrifices like what we see.

In the vaccines, where we have seen it also and the other <unk>.

And these people are very passionate about what they do and they feel very proud so.

And I'm, giving you also have to say that there is a very intense let's say disruption and about pumping Inc.

Michael Dolsten: So we continue to work with them and aim to resolve it. I want to point out that, to the best of my knowledge, we were first to start DMD phase 3, now enrolling, well outside the U.S. late last year, and we are probably, by now, six months ahead of anyone using yield therapy as it at least publicly hasn't been disclosed any other having been cleared with FDA. Thank you, Michael.

Part of the organization and the entire organization and.

But because we and offset by an incredible sense of pride, but those people are taking because of what we've achieved and control them in terms of how hard they are working right now on all the other vaccines for example.

Right. Thank you Robert.

Next question please.

Albert Bourla: And Steve, it's true that in order to achieve what was achieved with this vaccine, the ingenuity of our people was a key component, but also, a lot of personal sacrifice had to be involved. So a lot of people worked day and night, many, many of these people worked days and nights to make sure that this happened, and that clearly has taken a toll on them. And no matter how proud they feel because the passion that they have can keep them going forever, I am concerned that we need to find ways so that these people will not be burnt out.

Your next question comes from per meal demand from Mizuho Securities.

Great. Thank you so much for taking the questions and.

Thanks, so much for.

Oh, Yeah, that's right and COVID-19 so.

Couple of questions that I have.

And one I guess, there's obviously some debate around the durability of your vaccine sales and cash flows, but you clearly have a lot more sales and a lot more free cash now to pinch and invest and you try and vision a couple of years ago because of the vaccine.

And just thinking that you are obviously investing more behind that and COVID-19 vaccine.

<unk> and therapeutics, but can you just talk about your priority and it's really a capital allocation perspective now I don't think you mentioned you don't want to do share repurchases.

Albert Bourla: But I need also to emphasize that Pfizer has run in the form of business units since 2016, when I was running the business that basically Angela is running right now, and we have organized the whole operation into six business units, and that includes R&D, commercial, and clinical development. So the work for COVID happened in one of the six business units and happened predominantly in the R&D domain of these clinical units.

But at least there other priorities that you could maybe look to weather.

Bringing in external assets, what I can do larger deals given the extra cash that you now will house and then maybe the second one I guess per Albert and maybe a little bit more of a personal angle here, but I. Appreciate your comments you made around the COVID-19 crisis and yet recently I'm. Just wondering if you can provide some clarity on the status of getting your vaccine to the market. There I think you've called that.

In February and then there was some question about maybe doing a trial and India I think some question John.

Albert Bourla: But at the same time, the oncology business unit and the rare disease business unit and the internal medicine business unit and all the other business units that were having, kept working on their normal, let's say, workload. Let me put it that way. They also had to, of course, overcome issues related to COVID-19 that didn't make their work very easy. But again, they were able to rise to the occasion because I believe everybody in Pfizer right now is such a strong believer in a culture where patients come first, and this is not about us, it's about them.

And then the case center outside of thanks.

Can you just clarify where things stand there and what might be reasonable in terms of timing to get the vaccine available and the patient there.

Thanks.

Yes. Thank you very much in terms of.

And we started with us in terms of all.

So the vaccine in India, we applied months ago, and as you can all and.

<unk>.

And we have and we apply exactly the same client what they gave it to the entire war FDA you made upon and everybody in the world.

India and wanted to do additional and Cypress.

Albert Bourla: So this sense of sacrifice that we see in the vaccines, we have seen it also in the other units. People are very passionate about what they do, and they feel very proud. So I'm giving the answer to say that there is a very intense, let's say, disruption that happened in part of the organization, not in the entire organization, but has been offset by an incredible sense of pride that those people have because of what has been achieved, which I can't control in terms of how hard they are working right now on all the other vaccines, for example.

In order to approve the sort of like signals are there, which clearly we were not ready to allocate the resources and something like that whether when we were allocating all of the resources to do things into the variance the kids pregnant women and back and go on and things that Havent done it before.

But the Indian government.

And really very good and having discussions right now with us.

About all these issues right. So we are.

But they would change its policy about the conduct and some local trials and.

We will find a path forward so that we can provide to their vaccines.

Albert Bourla: Great. Thank you, Albert. Next question, please.

That being said.

Operator: Your next question comes from Vamil Devon from Zoho Securities.

And right now today and the next one or two months and fees.

People are dying and hospitals.

Operator: Great, thank you so much for taking the questions. And, like I said, thanks so much for all the efforts around COVID. So, a couple of questions that I have.

And vaccines were not things up and the next one or two months I think but it would be a reality that we have.

And right now and what.

Operator: So one, I guess, is obviously some debate around the durability of your vaccine sales and cash flows. But you clearly have a lot more sales and a lot more free cash now to potentially invest than you probably envisioned a couple years ago because of the vaccine. So I'm just thinking you are obviously investing more behind the COVID vaccine and therapeutics. But can you just talk about your priorities from a capital allocation perspective now?

What.

It's more important and is to make sure that the Indian government has enough medicines.

<unk> the people that are going to be hospitals, right now and.

And this is why it yesterday, we announced that.

For four of our medicines, but they are in their governmental protocols because they all go forward to discover develop and protocols treating COVID-19 patients and there are four of our maintenance and Walgreens broker growth, we will provide enough all this.

Listens.

For every basin in every public cost revoked and the next 30 days and.

As we speak we are ramping up production all these medicines in Europe, and the U S and Asia.

Operator: I don't think you mentioned that you don't want to do share repurchases. But are there other priorities that you could maybe look to, whether it's bringing in external assets or maybe even doing larger deals, given the extra cash that you will now have?

And we are ramping up distribution channel so.

We can see as quickly as possible those medicines.

Due to India, because they need is immediate.

Albert Bourla: And then maybe the second one, I guess, for Albert, maybe a little bit more of a personal angle here, but I appreciate your comments you made around the COVID crisis in India recently. I'm just wondering if you can provide some clarity on the status of getting your vaccine to the market there. I think you filed for it back in February.

No.

And the comfort and location and I'll ask Frank to make some comments here, but very few things are changing.

Changing because sales are or what was the strategy on capital allocation was not driven voice and how much capital we have risen with how much opportunity is there.

So we never say never to anything.

And so we maintain the right to.

Be flexible, but clearly Frank spoke about it a growing dividend. It is a part of our investment thesis all box that will be maintained.

Albert Bourla: And then there's some questions about maybe doing a trial in India. I think there are some questions around identification, and around side effects. Can you just clarify where things stand there and what might be reasonable in terms of timing to get the vaccine available to patients there?

And also we said that all of our investment in research and our investment and manufacturing.

Our investments of our capital are all aiming to improve that.

Albert Bourla: Let me start with that. In terms of the vaccine in India, we applied months ago, as you know, and we applied exactly the same file that we gave to the entire world, FDA, UMA, Japan, everybody in the world. India wanted to do additional studies in order to approve this vaccine over there, which clearly, we were not ready to allocate resources to something like that, whether when we were allocating all the resources to do things for the variants, the kids, the pregnant women, and I can go on, things that we haven't done before.

TBD, how durable it is our growth.

In the second part of a decade, so you should expect to see.

A larger phase II phase III business development.

So that will allow us to bring in house.

A lot of Oh for potentially all medicines, but could become medicines and the industry a timeframe.

Frank anything to add.

And just at the mill Youre, absolutely right the them all.

Obviously, the COVID-19 and is generating incremental free cash flow for us, but from my perspective and material enough to have any any major impact on our capital structure and to average point. The term I would use is we will stay the course and terms of how we deploy our capital and and Albert obviously sanctioned areas, where we would deploy it right the.

Albert Bourla: But the Indian government is really very good at having discussions right now with us about all these issues that you have raised. So we are hopeful that they will change this policy about conducting some local trials, and we will find a path forward so that we can provide the vaccine. That being said, the key thing right now and in the next one or two months is that people are dying in hospitals, and vaccines will not change that in the next one or two months. I think that will be a reality that we have to live with right now.

And investing and the business and you saw that with the R&D guidance increase this quarter, and then M&A and M&A really focused on growth second half of the decade.

Great. Thanks, and thanks for those insights both let's move to our next question. Please.

Next question comes from from Evercore ISI.

Hi, Thanks, so much for taking my question.

Frank There was a comment you made back in March which got a lot of.

Attention and I thought, perhaps you could elaborate a bit more on how you were thinking about the durability of COVID-19 revenues and perhaps lay out the sort of the volume and the price element of it beyond 2022, and if you could also perhaps speak to the.

Albert Bourla: And what is more important is to make sure that the Indian government has enough medicine, to treat the people that are going to the hospitals right now. And this is why yesterday we announced that for four of our medicines that they are in their governmental protocol, because the authorities have developed a protocol of treating COVID patients, and there are four of our medicines involved in these protocols, we will provide enough of these medicines, for every patient in every public hospital in the next 30 days, and as we speak we are ramping up production of these medicines in Europe, in the US, in Asia and we are wrapping up distribution channels so that we can ship as quickly as possible those medicines to India because the need is immediate.

Pricing seen in your Canadian contracts, whether it's consistent in 2023 24 versus where it was in the 'twenty one contract and then I had a quick R&D, one as well if I may.

I know there's these additional FDA technical requests on the gene therapy assay for D. M D.

I recall, you guys were using itr and phase one and then you switch to a trans gene assay and phase III because it was a little more.

LOE variability is that'd be and now thinking the variability is higher than they want and the trans gene assay as well I'm just trying to understand what the word Concord matrix means is it still just the transit and assay with different methods are there multiple assets that play now. Thank you so much.

Albert Bourla: Now on capital location, I will ask Frank to make some comments here, but very few things are changing because of that. Strategy on capital allocation was not driven by how much capital we have; it was driven by how much opportunity we have. So we never say never to anything, so we maintain the right to see, to be flexible, but clearly Frank spoke about it, a growing dividend. It is a part of our investment thesis, so that will be maintained. And also, we said that our investment in research, our investment in manufacturing, our investments in our capital are all aiming to improve the longevity of, how durable our growth is in the second part of the decade.

Frank.

Thank you average so on pricing rumor.

I really want to not get into detail on pricing other than obviously there are certain contracts, what we disclosed with the prices and terms of.

The way I think about this what we're really focused on now is getting doses to the patients that need doses around the world to patients and getting people vaccinated. That's been our focus that we're acutely focused on that you heard and our prepared remarks. We said we can make approximately $2 5 billion doses. This year, we can take that up to 3 billion doses next.

And that's what we're really focused on getting those made getting them delivered and getting vaccines into patient Tom So that's the focus.

On the Canada contract, we didn't discuss pricing.

Albert Bourla: So you should expect to see a lot of phase two, phase three business development deals that will allow us to bring in-house a lot of potential medicines that could become medicines in this time frame. Frank, anything to add?

On that contract what we did say it was up to 125 million doses and 2022 and 2023, when and option for more doses and 2024.

Frank D'Emilio: Just like Vamil, you're absolutely right. Obviously, COVID is generating incremental free cash flow for us. But from my perspective, not material enough to have any major impact on our capital structure. And to Albert's point, the term I would use is, we will stay the course in terms of how we deploy our capital, and Albert obviously mentioned the areas where we would deploy it, right? The dividend, investing in the business, and you saw that with the R&D guidance increased this quarter.

And then in terms of the durability and the franchise.

Tried and not to repeat what Albert said, but I thought app and went into a lot of detail on why we believe the.

COVID-19 revenue franchise, a significant durability and why we think we see that is.

Something that is going to take place for the foreseeable future and album went through a lot of other details while we believe that is.

Thank you Frank Michael about the technical question.

Yeah.

The core assays that you alluded to related to.

AAV and.

Thanks Ian.

Effectiveness.

Our all without any real and comments by a day and so day all fine. This is what I call the supportive us and.

Operator: Great. Thanks. Thanks for those insights, both. Let's move to our next question, please.

Operator: Your next question comes from Umer Raffat from Evercore ISI. Hi, thanks so much.

And the junked assay that was more related to co localization of the DMD protean.

Operator: Hi Frank, thanks so much for taking my question. Frank, there was a comment you made back in March that got a lot of attention. And I thought perhaps you could elaborate a bit more on how you're thinking about the durability of COVID revenues and perhaps lay out the sort of the volume and the price element of it beyond 2022. And if you could also perhaps speak to the pricing seen in your Canadian contracts, whether it's consistent in 2023-24 versus where it was in the 2021 contract.

And discussions on various technologies help to measure that.

And as I said.

In Europe.

This was an adjunct us and other countries we have.

Cleared and then enrolled efficiently and progressing towards that.

And next step of the trial very well so it's a very technical it's you how to do a depiction, but not related to the core potency assays and obviously, we're working to resolve it but.

But what I understand and currently there is no other potential new therapy and U S that have clear to get to a phase.

Operator: And then I had a quick R&D one as well, if I may. I know there are these additional FDA technical requests for the gene therapy assay for DMD. I recall you guys were using ITR in phase one, and then you switched to a transgene assay in phase three because it had a little lower variability. Is FDA now thinking the variability is higher than they want in the transgene assay as well? I'm just trying to understand what the word, quote-unquote, matrix means. Is it still just a transgene assay with different methods, or are there multiple assays at play now? Thank you so much.

Phase III and we obviously would like to be first and not just ex U S, where we've been going on for six months, but and you asked and work diligently to resolve these very technical question.

Alright. Thank you Michael next question please.

Your next question comes from Jason from Wolfe Research.

Hi.

Frank D'Emilio: Thank you, Albert. So on pricing, Umer, I really want to not get into detail on pricing other than, obviously, there are certain contracts where we disclose what the price is. In terms of the way I think about this, what we're really focused on now is getting doses to the patients that need them around the world. So basically, getting people vaccinated. That's been our focus. We're acutely focused on that. You heard in our prepared remarks that we said we could make, you know, approximately 2.5 billion doses this year.

A couple of questions. Please on mrna and your flu vaccine plans, how would a trial be constructed and really what's the goal are you looking to show superiority on efficacy or just hoping to achieve parity with existing vaccines.

And you talk about yours being quadrivalent, and so presumably if there is a comparator that would be something like San if he's flu block also what would be the likely development timeline.

And I'm guessing, it's not as fast as a COVID-19 vaccine and it would take something something longer and maybe a couple of years.

Frank D'Emilio: We can take that up to 3 billion doses next year. And that's what we're really focused on, right? Getting those made, getting them delivered, and getting vaccines into patients' arms. So that's the focus. On the Canada contract, we didn't discuss pricing on that contract. What we did say was up to 125 million doses in 2022 and 2023, with an option for more doses in 2024. And then in terms of the durability of the franchise, I'm gonna try not to repeat what Albert said, but I thought Albert went into a lot of detail on why we believe the COVID revenue franchise has significant durability and why we think we see that as something that's going to take place for the foreseeable future. And Albert went through a lot of the details on why we believe that.

And then a separate question on your five year guidance, just what just to make sure I understand your earlier comments on pricing what is your five year guidance assume about drug pricing, especially in the context of their possibly being a European drug pricing austerity measures due to COVID-19.

Okay. Thank you team and.

Michael do you want to take a break.

And about the flu.

Yeah.

Lou vaccine given the.

Drawing.

Immune response, we have seen for our mrna platform and we.

And we certainly hope to be able to show since then sales and differentiation versus current flu vaccine. This is of course, the aspiration with hub.

Technically there will be two components one is to look at the.

Michael Dolsten: Thank you, Frank. Michael, about the technical question. Yeah, you know, the core essays that you alluded to related to AAV and Transien effectiveness are all without any real comments by FDA, so they're all fine. This is what I call the supportive assay, an adjunct assay that was more related to co-localization of the D&D protein and discussions on various technologies how to measure that. And as I said, in Europe, as this was an adjunct assay in other countries, we have cleared and enrolled efficiently and are progressing towards that, the next step of the trial, very well.

Immune response on the antibodies that have set them.

And our standards reported related to increase in the tighter and we will be able to compare to the current protein based flu vaccines.

And then we also plan to run a vaccine efficacy study, where we think it's not just what we hope to be a very.

Potent antibody response, but also the T cell response, so I would certainly aspire to that we would have a vaccine to be substantially meaningful net.

Better than the current fixed based on the platform by itself, but also based on that we are able to pass to align the platform with the sequence of the emerging and fluids things while as you may know many years the protein base all meets aligned and that's why you get better and.

Michael Dolsten: So it's a very technical issue how to do detection, but not related to the core potency assays. And obviously, we're working to resolve it. But currently, there is no other potential gene therapy in the US that has cleared yet to phase three. And we obviously would like to be first, not just in the US, where we've been going for six months, but also in the US and work diligently to resolve this very technical question.

Modest vaccine efficacy.

And on May be up to 50% and similar for immune responses. So you know given that we saw and 95% efficacy against COVID-19. We think there is a large.

Operator: Great. Thank you, Michael. Next question, please.

Operator: Your next question comes from Sam Anderson from Wolf Research.

Volume for us improves and the current flu vaccine.

Operator: Hi, a couple of questions, please. On MRN...

And the timing you know all that said we are moving to this thought human trials in Q3 and.

Operator: [inaudible]

Operator: Presumably, if there is a comparator, it would be something like Sanofi's FluBlock.

And we will obviously.

Operator: Also, what would be the likely development timeline?

Oh on generates day thought on the Immunogenicity and if that continues to.

Operator: I'm guessing it's not as fast as the COVID-19 vaccine.

Operator: COVID-19 Vaccine think that it would take something longer, maybe a couple of years.

As well as our aspiration, we think we can move very fast.

Operator: And then a separate question on your five-year guidance. Just to make sure I understand your earlier comments on price.

And with this.

Vaccine and also utilizing.

The type of approach, where you establish a large number all of a site in the regions to study in order to enroll very fast and we will look at various ways to registered this vaccine and also how that could coincide with the recommendation by a steep so you know why.

Operator: What is your five-year guidance assumption about drug pricing, especially in the context of there possibly being European drug pricing austerity measures due to COVID?

Michael Dolsten: Thank you, team. And Michael, do you want to take a question about the flu? Yeah, with the flu vaccine, given the... strong immune response we have seen for our mRNA platform, we certainly hope to be able to show substantial differentiation versus the current flu vaccine. This is, of course, the aspiration we have. Technically, there will be two components.

We don't.

All the time.

And exact faith, but anticipate that we will move very fast there may not be as fast as the pandemic developments, but much faster than a traditional fluids developing them.

Thank you Michael and then Frank I know your Ddos and pricing, but did you want to say a little bit more about it.

Michael Dolsten: One is to look at the.., immune response on antibodies that have a certain standards reported related to increase in Pfizer and we will be able to compare to the current protein-based flu vaccine, and then we're also planning to run a vaccine efficacy study where we think it's not just what we hope to be a very potent antibody response but also the T cell response so I would certainly aspire to that we would have a vaccine that is to be substantially meaningful better than the current vaccine based on the platform by itself but also based on that we are able to test to align the platform with the sequence of the emerging flu while as you may know many years the protein base are misaligned and that's why you get very modest vaccine efficacy on on maybe just 50 percent and similar for immune responses so you know given that we saw 95 percent efficacy against COVID we think there is a large margin for us to improve on the current flu vaccine. On the timing, you know, Albert said we're moving to start human trials in Q3.

Albert and this one is more about the five year CAGR through 2020.

I think Tim the way that the way I think about and as we really look at pricing by geographic region and.

And we can we can we consider we and continue to believe it's going to be a headwind.

By geographic region, you know what would be examples of that the U S would be one emerging markets would be one developed Europe be it would be one just as an example, they all range and I'll call. It negative pricing increases and the range is low single digits to high single digits, and obviously, we blend that altogether, it and an overall global rate.

And that's what we've assumed and our and our CAGR assumptions through 2025.

Great. Thanks, Frank Operator, we can take one more question and then we'll have some closing remarks from Albert and following that.

And final question comes from the line of Navin Jacob from UBS.

Hi, Thanks, so much for fitting me in here just a couple on the mrna.

<unk> seen a vaccines that you are pushing forward you had been working with our biotech for your flu vaccine.

And confirm that you are using the Pfizer mrna technology for the flu vaccine that you're moving forward with.

Michael Dolsten: And we will obviously, early on, generate data on the immunogenicity. And if that continues to... go as well as our aspiration, We think we can move very fast with this vaccine and also utilize the type of approach where you establish a large number of sites in the regions to study in order to enroll very fast, and we will look at various ways to register this vaccine and also how that could coincide with the recommendation by ACIP.

And I'm curious as to why Youre going with that approach beyond just the economic benefit of using your own tech versus something that's you're collaborating with on is there something different about your MRI technology, whether it's in the.

The non COVID-19 portions of the of the other vaccine or the LNP.

And then secondly, again on the on the flu vaccine and what is your ability to co formulated with the COVID-19 vaccine.

Michael Dolsten: So, you know, while we don't give, at this early time, an exact date, it's anticipated that we will move very fast, may not be as fast as the pandemic developed, but much faster than a traditional fluid developer. Thank you, Michael. And then, Frank, I know you asked about the pricing, but do you want to say a little bit more about that?

I'm wondering why you're moving forward at a co formulated prep and our 20, plus a 106 to be too and not looking for the flu vaccine and co formulation.

Thanks for your thoughts I appreciate the time.

Thank you very much I think that's the flu vaccine and we had to cover our collaboration with bio and think that goes back to 2018 at the time and pick announced also publicly some of the terms of this agreement and.

Frank D'Emilio: Sure, Albert, and this was more about the five-year CAGA through 2025. So, I think, Tim, the way I think about it is we really look at pricing by geographic region, and we continue to believe it's going to be a headwind by geographic region. What would be examples of that? The U.S. would be one. Emerging markets would be another. Developed Europe would be one, just as an example. They all range, and I'll call it negative pricing increases, and the range is low, single digits, to high. And obviously, we blend that all together into an overall global rate, and that's what we've assumed in our category assumptions through 2020.

The developments are based on Oh, the work has been done so far by both comp and some on the flow.

As regards to the court.

Question of corporate weighted within announced the co formulation with with right now we announced co administration with revenue.

We are looking at options to co formulate.

Bye bye and with Pfizer mrna vaccines against COVID-19 with other.

With all the other let's say and vaccines, but this is not what we spoke about big day and just doesn't make.

A final decision from co formulation.

Operator: Great. Thanks, Frank. Operator, we can take one more question and then we'll have some closing remarks from Albert following that.

And I think Chuck we do not have time for and another question right.

Right.

Okay, and then just to flow.

That's all I wanted to thank everyone for joining us today and for your continued engagement with Pfizer.

Operator: Your final question comes from the line of Naveen Jacob from UBS.

And I think the pandemic has been the ultimate best for Pfizer and introduce the entire pharmaceutical industry capabilities and credibility and and my view, we have thus far and passed with flying colors.

Operator: Hi, thanks so much for fitting me in here. Just a couple of questions on the mRNA vaccines that you're pushing forward. You were working with BioNTech on your flu vaccine. I just want to confirm that you're using the Pfizer mRNA vaccine.

The success of our COVID-19 vaccine has led to an important question.

Operator: and curious as to why you're going with that approach beyond just the economic benefit of using your own tech versus something that you're collaborating on. Is there something different about your MRI technology?

If we could do this for COVID-19, why not sort of other diseases.

There are so many people suffering from other theaters diseases and their needs are and any less.

Operator: Whether it's in the non-coded portions of the...

We now see and opportunity to take the lessons learned and new ways of thinking and apply them across our entire portfolio.

Operator: of the vaccine or the LNP. And then secondly, again, on the flu vaccine, what is your ability to co-formulate it with the COVID vaccine? Wondering why you're moving forward with a co-formulated Prevnar, 20 plus 162B2.

Speed with which we interact with the regulators as well as the continued acceleration of digital solutions, such as artificial intelligence electronic diaries and I'll.

Operator: plus 162B2 and not looking for the flu vaccine co-formulation. Thanks for your thoughts. I appreciate the time.

<unk> and extraordinary coastal records are just some of the things we plan to free too.

Albert Bourla: As regards the flu vaccine, we have had a collaboration with BioNTech that goes back to 2018. At the time, we also announced publicly some of the terms of this agreement. And the developments are based on the work that has been done so far by both companies on the flu. As regards the question of co-formulating, we didn't announce a co-formulation with Prevnar just now. We announced a co-administration with Prevnar. Clearly, we are looking at options to co-formulate the BioNTech-Pfizer mRNA vaccine against COVID with other, let's say, vaccines. But this is not what we spoke about today, and we haven't made final decisions on co-formulation yet. And I think, Chuck, we do not have time for another question, right? That's right, Albert.

And to all of our clinical trials. So we can continue to move and the speed of assignments.

And now before we end the call and I want to take a moment to extend my thanks, and very best wishes to our colleague and good friend of mine sector, Yamana, who will be retiring at the end of September.

Chuck has been interacting with the global Investor and community for nearly 35 years, including the past a few years here at price.

And I think all of you would agree that during the time, she says elevate tyler's investor relationship and Blackstone's function to our best in class.

Because he Rogers clarity integrity and transparency in the way you communicate and.

And it is because she has a passion for our company and our industry, but makes him an outstanding champion for both.

Albert Bourla: Okay, then, I wanted to thank everyone for joining us today and for your continued engagement with Pfizer. I think the pandemic has been the ultimate test for Pfizer's and, in truth, the entire pharmaceutical industry's capabilities and credibility, and, in my view, we have thus far passed with flying colors. The success of our COVID-19 vaccine has led to an important question: If we could do this for COVID-19, why not for other diseases? There are so many people suffering from other serious diseases, and their needs aren't any less urgent.

The good news is it would be wrong for at least one and more earnings cycle and perhaps another and she says they're going to stay on and I suppose adviser during this transition.

Chuck Thank you for being a valued colleague and friend Pfizer will Miss you, but on behalf of all of US I wish you all the best and the next part of your journey. Thank.

Thank you everyone and have a great rest of your day.

This concludes today's conference you may now all disconnect.

Albert Bourla: We now see an opportunity to take the lessons learned and new ways of thinking and apply them across our entire portfolio. The speed with which we interact with regulators, as well as the continued acceleration of digital solutions such as artificial intelligence, electronic diaries, advanced analytics, and electronic health records are just some of the things we plan to bring to all of our clinical trials so we can continue to move at the speed of science.

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Albert Bourla: And now, before we end the call, I want to take a moment to extend my thanks and very best wishes to our colleague and good friend of mine, Chuck Triano, who will be retiring at the end of September. TAC has been interacting with the global investment community for nearly 35 years, including the past 13 years here at Pfizer, and I think all of you would agree that during that time, he has elevated Pfizer's investor relationship structure to best-in-class.

Thanks, Tom.

Tom.

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Albert Bourla: That's because he values clarity, integrity, and transparency in the way of communication, and it is because he has a passion for our company and our industry that makes him an outstanding champion for both. The good news is he will be around for at least one more running cycle and perhaps another as he has agreed to stay with us as an advisor during this transition. Chuck, thank you for being a valued colleague and friend.

All right.

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Albert Bourla: Pfizer will miss you, but on behalf of all of us, I wish you all the best in the next part of your journey. Thank you, everyone, and have a great rest of your day. This concludes today's conference. You may now all go.

Tom.

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Operator: This concludes today's conference. You may now all disconnect.

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