Q2 2020 Pfizer Inc Earnings Call

[music] Good day, everyone and welcome to Pfizer's second quarter 2020, <unk> earnings Conference call. Today's call is being recorded at this time I would like to turn the call over to Mr. trajectory.

Operator: Good day everyone, and welcome to Pfizer's second quarter 2020 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.

No senior Vice President of Investor Relations. Please go ahead Sir.

Thank you operator.

Unknown Executive: Thank you, operator. Good morning, and thanks for joining us today to review Pfizer's second quarter 2020 financial results, our updated 2020 financial guidance, Pfizer's progress in helping find solutions for the COVID-19 pandemic, as well as other relevant business topics. I'm joined today, as usual, by our Chairman and CEO, Albert Bourla, Frank D'Emilio, our CFO, Michael Dolsten, President of Worldwide Research and Development, Angela Wong, Group President, Pfizer Biopharmaceuticals Group, John Young, our Chief Business Officer, and Doug Lankler, General Counsel. The slides that will be presented during this call were posted to our website earlier this morning and are available at Pfizer.com forward slash investor. You'll see here that slide three covers our legal disclosure. Albert and Frank will now make prepared remarks, and then we'll move to a question and answer session. With that, I'll now turn the call over to Albert Bourla. Albert?

Good morning, and thanks for joining us today to review Pfizer's second quarter 2020 financial results, our updated 2020 financial guidance Pfizer's progress in helping find solutions for the cobot 19 pandemic as well as other relevant business topics.

I'm joined today as usual by our chairman and CEO Albert Bourla, Frank Demilio, our CFO, Michael Dolan President of worldwide research and development.

Andrew Wong group, President Pfizer Biopharmaceuticals group.

John Young, our Chief business Officer, and Doglike, where general counsel.

Slides it will be presented during this call were posted to our website earlier. This morning and are available at Pfizer dotcom forward slash investors.

You will see here that slide three covers our legal disclosures.

Oh burden Frank will now make prepared remarks, and then we'll move to a question and answer session with that I'll now turn the call over to Albert Bourla Albert.

Thank you talk and good morning, everyone.

Albert Bourla: Thank you, Chuck, and good morning, everyone. In my remarks, I will discuss our second quarter business performance, provide an update on our pipeline, and, of course, speak to the progress we are making to combat the global public health challenge posed by the COVID-19 pandemic. Our continued strong performance demonstrates the resilience of our business, even during the most challenging times. The second quarter was the first full quarter impacted by COVID-19. Revenues in the quarter included an estimated net unfavorable impact of approximately $500 million or 4% due to COVID-19, primarily reflecting unfavorable disruptions to wellness visits for pediatric and declines and adult patients in the U.S. and lower demand for certain products in China. These declines were partially offset by increased U.S. demand for certain sterile injectable products and increased adult demand for Prevnar-13 in certain international markets.

During my remarks, I will discuss our second quarter business performance.

An update our pipeline and.

Equal to the progress, we're making to combat the global public health challenges posed by the government being funded.

Our continued strong performance.

We just keep resilience your business even during the most challenging times.

The second quarter was the first few corporate impacted by called 19.

I understand the corporate included Dennis the amazing net unfavorable imports of approximately 500 million.

Oh person.

Good night.

Primarily reflecting I'm favorably disruption wellness visits could be the operating.

And the garden and adult patients with cigarettes, and lower demand for something that's in China.

These declines were partially offset by increased U.S. demand for second Steripack injectable products increased demand for Britain 15 in certain international there.

Let me start with an update on all borrowed from actually began.

Albert Bourla: Let me start with an update on our biopharmaceuticals group. For the quarter, our biopharma business grew 6%. Due to strong performances from many of our key growth drivers, including Winterkelwinter, Eliquis, Ibrance, Inlita, Xtandi, and our Biosimilars portfolio, was particularly strong, up 20% operationally compared with a year ago quarter. Global Ibrance revenues increased 9% operationally to $1.3 billion during the quarter.

For the quarter, our Biopharma business grew 6% <unk> driven by strong performances from many good grade drivers, including vendor curbing tomorrow.

We are right in line.

Andy and our Biostimulants platform.

Our oldest business was particularly strong up 20% operationally compared with a year ago.

Global our gross revenues increased 9% operationally the $1.3 billion during her yes.

The U.S. <unk> do you live in person and our best convenience to retain a strong leadership position within the syndicate.

Albert Bourla: In the US, Ibrance revenues grew 11%, and Ibrance continues to retain a strong leadership position within the CDK class. The international markets delivered strong 18% volume growth in the quarter. This volume growth was partially offset by price reductions in certain EU markets, which resulted in 3% operational revenue growth outside the US. The price reductions occurred last year as a result of renegotiating long-term agreements, and we expect their impact will continue through to the fourth quarter of 2020 when the price changes annually. We were surprised and disappointed by the outcome of the PALAS trial.

The international markets deliver strong 18% volume growth either.

Before we go after.

Yeah, sure said bike price reductions in sharpening your markets.

This resulted in 3% operational revenue growth Oh, sorry configuration.

The price reductions occurred last year as a result of renegotiating long term agreements and we expect that you continues to me.

Warfare trended Randy when the right changes.

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We were surprised and disappointed by the outcome of the policy right.

However, we remain confident you are against strong positioning and expected future performance within the current labeled metastatic setting given the different treatment paradigms and put any government point yours, emphasizing as opposed to the Osbournes shopping.

Albert Bourla: However, we remain confident in Ibrance's strong positioning and expected future performance within the currently labeled metastatic setting given the different treatment paradigms and clinical endpoints used in the setting as opposed to the adjuvant setting. For Xtandi, Alliance revenues in the U.S. were up 32% for the quarter, and when combined with our royalty income on ex-U.S. sales, totaled $374 million for a quarter. The strong growth in the U.S. was driven by continued strong demand for both the metastatic and non-metastatic castration-resistant prostate cancer indications. We now have a leading share of new patient starts in both indications, and in the non-metastatic indication, we are also seeing the benefit of a longer duration of therapy. Further strengthening Xtandi's performance during the quarter was the metastatic castration-sensitive indication driven by our artist's study.

For extending alliance wherever you are saying that you guys were up 32% semiconductor and when combined with our royalty income on ex U.S sales totaled $374 million for at work.

The strike roles in the U.S. was driven by continued strong demand in both the microscopic no metastatic castration resistant prostate cancer indication.

We now have leaving sure well new patient starts to both indications.

And even knowing that this topic indication we are interesting the benefit for longer duration of stark.

Further strengthening extend this performance during the quarter was meant to stopping frustration, especially the indications driven by you all ARX <unk> Bobby.

Extended this sarah or new patient starts increased by 24% discount.

Albert Bourla: Xtandi's share on new patients started to increase by 24% this quarter, a strong early signal of the potential adoption by both oncologists and urologists. Global Inlighter revenues increased 89% operationally to $195 million during the quarter.

Strong early single well get potential adoption by both oncologists and urologist.

Global seemed like a revenues increased 89% depression or $295 million during the calendar.

The U.S. Yoo market revenues more than doubled given by the strong uptake following last year's or the approval for checkpoint inhibitors in combination with in life up for first line treatment of patients with advanced renal cell carcinoma.

Albert Bourla: In the U.S., Enlita revenues more than doubled due to the strong uptake following last year's FDA approvals for two checkpoint inhibitors in combination with Enlita for first-line treatment of patients with advanced renal cell carcinoma. The international markets also contributed to the performance of InLive with 48% personal growth. Looking outside of Oncology, Eliquis has continued to deliver strong performance. Pfizer's share of the Global Alliance revenues, including direct sale markets, was up 19% operationally to $1.3 billion. I would also point out that the Bristol-Mayer-Squibb-Pfizer alliance has not yet received the decision from the U.S. District Court related to the patent litigation for two patents covering Eliquis. The court has stated that it will issue its decision on or before August 7.

The international markets.

Tribute to do the performance of Green light, but with 48% personal growth.

Looking outside of oncology everything from scratch continued to deliver strong performance.

Why is there are several of the global alliance revenues, including the right say markets was up 19% of progression or $1.3 billion.

I would also point Oh, but the British the mayor sweep Pfizer Alliance, Chris no yet to receive the decision from the U.S. distinct cost related to the toughened integration for <unk> patents covering.

The court has stated that the Easter seasonal on or before August seven.

We remain confident in the party will far innovate science and the strength of our package.

Albert Bourla: We remain confident in the value of our innovative science and the strength of our patent. Vintagel and Vintamax continue to show strong U.S. performance. Our disease awareness efforts helped drive the estimated diagnosis rate to 15% in the second quarter, compared with only 1% to 2% prior to launch. At the end of the quarter, more than 15,000 patients had been diagnosed. More than 10,000 patients have received a prescription, and more than 6,200 patients have received the drug. For the quarter, we estimate the average number of patients in the U.S. taking Vinteco to be approximately 6,000 people. These numbers include patients who are receiving the drug at no cost through our Patients Assistant Program.

Moving the German Vince <unk> continued to show strong U.S. performance.

Our disease awareness efforts helped drive they see made diagnosis rate to 16% in the second quarter.

Paired with only 1% to 2% prior to launch.

It's the ended the quarter.

60000 patients have been diagnosed more than 10000 patients cover to see prescription.

More than 6200 patients have received the drop.

For the quarter, we estimate the average number of patients in the U.S. taking into account.

It was approximately 6000 people.

These numbers include patients who are receiving the dark at no cost through all basins.

I see some programs that said as the result of stay at home orders as expected we did see a slow down in your diagnosis and you do.

Albert Bourla: That said, as a result of stay-at-home or, As expected, we did see a slowdown in new diagnoses, as fewer patients were visiting doctor's offices for consultations or scintigraphy tests. However, as health systems have recently begun to resume effective procedures... We are seeing a gradual increase in diagnosis rates and will continue to monitor. Global Xeljanz revenues were up 5% operational in the quarter to $635 million. Revenues outside the U.S. were up 20% of Russia's, while U.S. revenues were flat.

As fewer patients were visiting doctors' offices for comes on patients or since seadrift test.

However, as Curtis systems have recently begun tourism effective procedure.

We are seeing a gradual increase in diagnosis rates and we'll continue to monitor.

Global Zeppelins revenues were up 5% depression or need to go after two $675 million revenues outside the U.S. were up 20% of personal Y U S revenues were flat.

The underlying prescription demand in the U.S. growing 14% compared with the second well go to 2019 and 16% compared with the first six months of 2019.

Albert Bourla: The underlying prescription demand in the U.S. grew 14% compared with the second quarter of 2019 and 16% compared with the first six months of 2019. However, higher rebates resulting in a lower net price have offset this volume growth. The higher rebate is a result of investments we have made in formulary economics. Excess is driving our volume growth, and we are pleased to have attained favorable excess with most major payers in the US. Our global biosimilars portfolio grew by 36% operationally to $289 million. This was driven mainly by oncology biosignals, which increased 120% operationally to $139 million during the quarter. In the US, revenues from our Oncology Biosimilars portfolio grew by 181%, driven by continued strong demand for our supportive care brands, especially Retacrit, and from early results from our free monoclonal antibody Biosimilars, which launched earlier this year. The international markets also contributed with 61% operational growth, led by growth from Trasimera and our supportive care brand. Global Prevnar 13 revenues were down 2% operationally to $1.1 billion.

However, higher rebates, resulting in a lower net price because I've said this volume growth.

Hi are debating is resolved those investments we have made him formulary access.

The exit is driving our volume growth and we are pleased to have attained favorable axis with most major payers in the U.S.

Our global BARDA cigarettes, before you're getting by surface, 6% of pressure to do $289 million.

This was driven mainly by caused by cigarettes, which increased 120% of personally.

Under $79 million during the course.

In the U.S. revenues from our oncology Barcelona before you grew up by 181 person.

Driven by continued strong demand for our supportive care bronze, especially remarkably and freight early results from our free monoclonal antibodies, but a seamless which launched earlier this year.

The international markets also contributed with 61% operational growth led by growth from <unk> and our supported care Brock.

Global broaden our 13 revenues were down 2% of pressure to $1.1 billion.

Revenues outside the U.S. getting 18% of Bardessono.

Albert Bourla: Revenues outside the U.S. grew 18% operationally, driven primarily by significantly increased adult uptake resulting from greater vaccine awareness due to the COVID-19 pandemic. However, we should note that Prevnar-13 is indicated for another type of pneumonia, as well as continued strong pediatric uptake in China. In the U.S., revenues were down 22%.

Driven primarily by significantly increase adult uptake, resulting from greater vaccine I wanted you to the Golden I think pumping.

Overall, we signaled that Ive nothing you indicated for another type of pneumonia.

As well, it's convenient stones pediatric uptake in China.

In the U.S. revenues were down 22%.

My memory restricting you expected impact the Colby 19, most BBB restrictions craveable wellness visits, but because you have said by the timing C. difficile.

Albert Bourla: Primarily reflecting the expected impact that COVID-19 mobility restrictions had on wellness visits, particularly offset by the timing of CDCR. Looking at our sterile injectables portfolio, our global revenue from the injectables portfolio grew 4% operationally in the second quarter and 10% operationally in the first half.

Looking at dollar sterile injectables portfolio.

Our global revenue from the Injectables portfolio grew 4% compression or in the second quarter and 10% of personally in the first.

More than 95% of our Injectables from Ford you're using stock today.

Albert Bourla: More than 95% of our injectables portfolio is in stock today. In response to the increased demand during the early stages of the COVID crisis, we provided significant incremental shipments of sterile injectable medicines and largely maintained supply continuity. Demand for most of these medicines has since normalized, but we continue to monitor the situation. Let me now briefly speak to some of the modifications we have made to our go-to-market approach that have allowed us to continue to effectively communicate with and serve healthcare providers and patients during the pandemic. We quickly adapted our promotional platform, amplifying our existing digital capabilities to reach healthcare providers and customers and provide critical education and information during this time. This included increasing the scale of our remote engagement. All our U.S. sales representatives are digitally enabled, and we are currently conducting virtual detailing and remote sampling, which has proven to be an efficient way to interact with healthcare providers during this crisis. Overall, more than 75 markets have utilized virtual communication, with about two-thirds of our sales reps using the platform.

In response to the increased demand during the early stages of the colby's crises, we provided significant incremental six minutes sterile injectables medicines and largely maintain supplied continuing.

Demand for most of its maybe since it seems normal lives, but we continue to money sort of a situation.

Let me know briefly speak to some of that modifications will have made to our go to market approach.

I Love US the continued to effectively communicate weve and sure healthcare providers and patients during depending.

We can we adopted our promotional plucked from I'm going to find our existing b cell capability, the streets healthcare providers and customers and provide the garbage occasionally in information during this time.

These include increasing the scale of our remote engagement.

Oh are you a sales representatives are digitally enabled.

And we are currently conduct conducting vintro detailing and remote sensing.

'cause proven to be and efficient way to interact with health care providers. During this crisis.

Overall more than 75% markets have utilized video communication with about two thirds of our same thrips using the platform.

This enabled us to reach 70% of our health care providers. During this time.

Albert Bourla: This enabled us to reach 70% of our healthcare providers during this time. Even after the pandemic is behind us, we anticipate digital will remain an important tool for our sales reps as they continue to tailor their approach to physicians and to help us communicate information on our medicines and vaccines when and how these healthcare providers want to receive it. As expected, we understandably saw a significant decrease in in-person patient-physician engagements during the second quarter.

Even after the pandemic is behind US we anticipate needs that they would remain an important tool for our sales reps as they continue to tailor their approach to physicians and to help us communicate information well know medicines and vaccines when and how these health care providers.

Once pretty soon.

As expected we under.

Turning to be so a significant degrees in person patients physician engagement during the second quarter and we continue to believe accused to and specific on April.

Albert Bourla: And we continue to believe that Q2, and specifically April, should be the low point in terms of physician engagement with their patients. We have begun to see a gradual recovery from the largest impact seen in April, and we anticipate healthcare activity to continue its gradual uptick, but we have not yet reached our pre-COVID trap. There are several factors playing out in real time, such as reopening and potentially closing efforts in certain states and countries, as well as timing for resuming effective elective surgery. As we said last quarter, we see different business units and brands responding differently based on several factors, primarily including medical necessity, reliance on new patients for growth, oral administration, and patient affordability. APJOM's second quarter revenue decline was, of course, driven by the impact of generic drugs in the US.

Should be the low point in terms of physician engagement with their patients.

We have begun to see a gradual recovery from the largest impact seen in April and we anticipate could get activity to continue its gradual uptick.

But we have not yet the read a brief cobiz trends.

There are several factors playing out in real time subs as reopening and potentially re closing efforts in certain states and conference as well as timing for resuming effective elective surgeries.

As we said last quarter, we see different business units and bronze responding differently based on several factors, primarily including the medical necessity reliance on new patients for growth.

Oral administration and basin upward.

Second quarter revenue decline was of course, driven by the impact of lyric I've genetics in the U.S.

These wars are lost food court there over the years ago embark on the year over year comparisons and excluding this impact absent revenue declined 6% on an operational basis.

Albert Bourla: This was our last full quarter of the Lyrica Impact on the year-over-year comparison, and excluding this impact, Abjon revenue declined 6% on an operational basis to $2 billion as compared with a 31% operational decline without the Lyrica impact. I know, from an upjump perspective, there is a lot of focus on time, and I was very pleased to see that Abjon's China business delivered 17% operational growth during this quarter compared with the second quarter of 2019. This growth was driven primarily by Lipitor and Norco. Mylan shareholders have voted nearly unanimously to approve the combination of Abjon and Mylan to create Vietcong. APJON also completed a successful debt offering, raising approximately $7.5 billion in U.S. dollar-denominated nodes and 3.6 billion euros in euro-denominated nodes.

Limb Dulles as compared with a 31 on personal decline we've been regarding.

I know from and I'll jump perspective, there's always a focus on time.

And I was very pleased to see that I'm sort of starting a business the liebert, 17% professional growth during this quarter compared with the second quarter of 2019.

There's no was driven primarily by lipitor in northwest.

Marlim start holders have voted nearly unanimously to approve the combination of comes on in Mylan grid via Trish.

I can also completed successfully debt offering raising approximately 7.5 billion Doris U.S.

Dollar denominated notes and 3.6 billion euros in Euro denominated notes.

The proceeds we almost entirely funded the $12 billion dividend to be paid to Pfizer once I'm zone you separate.

Albert Bourla: The proceeds will almost entirely fund the $12 billion dividend to be paid to Pfizer once Abzone is separated and the completion of the transaction. We are continuing to progress towards a successful close of the transaction, which is now expected in the fourth quarter of 2020. Now I will turn to our R&D pipeline, beginning with an update on our COVID-19-related efforts. Yesterday, Pfizer and our collaboration partner, BioNTech, announced the start of a global, except for China, Phase 2, 3 safety and efficacy clinical study to evaluate a single candidate from our BNT-162 mRNA-based vaccine program against SARS-CoV-2. After extensive review of preclinical and clinical data from approximately 120 patients in B2 from phase 1-2 clinical trials in the US and Germany.

And the completion of the Trans arc.

We are continuing progress toward its obsessed with girls or the transaction, which is now expected in the fourth quarter offended drain.

No I will turn to our R&D pipeline, beginning with an update on our Cobiz 19 related efforts.

Yesterday, Pfizer and our collaboration partner biotech announced the start of the global except for China Phase two pretty safety and efficacy cleaning up study to evaluate a single candy that from our BMT hundred 60, do and are in need based vaccine program against South.

Spoke to.

After extensive review.

I forgot empirical data from unfortunately, nearly 220 patients he would be to face you want to clinical trials in the U.S. in Germany and in consultation with the F.D.A. in other global kind of all 40 days. We can songs you consultant to advance our would be to vaccine candidate into the face to face.

Albert Bourla: And, in consultation with the FDA and other global health authorities, we have chosen to advance our B2 vaccine candidate into the phase 2-3 study at the 30-microgram dose level in a two-dose regimen. Dosing began in the U.S. yesterday. RB2, which recently received fast-track designation from the FDA and codes an optimized SARS-CoV-2 full-length spike glucose protein, which is the target of virus neutralizing antibodies, during preclinical and clinical studies of four RNA vaccine candidates. Both B1 and B2 emerged as strong candidates based on assessments of safety and immune response. Pfizer and BioNTech selected B2 as the candidate to progress to a Phase 2-3 study based on the totality of available data from our preclinical and clinical studies, including select immune response and tolerability parameters.

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The 30 microgram dose level in two dose regimen.

Dozing begun in the U.S. yesterday.

HM.

We recently received fast track designation from the FDA and codes and optimized sauce comes to full length Spike Google propane.

Which is the target the virus neutralizing antibodies.

You're bringing to go and clinical studies of for our neighbors in kind of defense, both be one and beat to emerge as strong candidates based on assessments safety and immune response.

Pfizer and biotech selected we do as the economy that progressed the phase three study based on the totality of better than data from our preclinical and clinical studies, including select immune response and Tolerability parameters.

In the preclinical studies do you want to be some county, that's induced favorable viral Andres and specific see before and see a T cell responses.

Albert Bourla: In preclinical studies, B1 and B2 candidates induced favorable viral antigen-specific CD4 and CD8 T cell responses, high levels of neutralizing antibody in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model. Preliminary clinical phase one data from nearly 120 patients demonstrated a favorable overall tolerability profile for BNT162B2 from our B2 candidate as compared with our B1 candidate, with generally mild to moderate and transient systemic events such as fever, fatigue, and chills and no serious adverse events. I also want to specifically mention that the effect we have observed in our preliminary data of the second boosting dose is important, and we believe it reflects the strength of RNA plus. The ability to boost is important because it means that if immunity fades over time, it can potentially be restored by repeating immunization.

Hi, so high levels of neutralizing antibodies voters animal species and beneficial protective ethics in a private school kids Holland smoke.

[noise] preliminary taminco phase one data from nearly 120 patients demonstrated the favorable overall tolerability profile for B and C. Onesix it would be too from our beaten counted as compared with our be one candidate.

Generally mild moderate and trying to insisting events, such as fever, fatigue, and seals and no serious adverse.

Yes.

I also want to specific arguments from the.

We have observed you know preliminary data over the second boosting dose is important and we believe it reflects a strength over the are in a platform.

The ability to boost is important because it means that you immunity fades overtime.

Can potentially be restored by repeat immunizations.

We continue to evaluate the potential bucks intended spins, we look for work gaining additional insights.

Albert Bourla: As we continue to evaluate the potential vaccine candidates, we look forward to gaining additional insight. Yesterday's announcement is an important and encouraging milestone in our collective efforts to find potential medical solutions to help combat the current global health crisis. It's the culmination of an extensive collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants, who all have a singular form. Developing a Safe and Effective COVID-19 Vaccine. We will continue to work closely with regulatory authorities, including the FDA, to advance our program while ensuring we maintain high standards of quality, safety, and compliance in our development process. We know the FDA and other regulatory bodies will continue to uphold their high standards and work hard if the phase 2-3 trial is successful. Pfizer and BioNTech expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October 2020. If authorization or approval is obtained, our companies currently aim to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Yes. The this announcement he is an important and encouraging milestone in our collective efforts to find potential many goes to listen to kind of come but the current global health crisis.

It's the culmination of an extensive collaborative and unprecedented R&D program involving Pfizer biopic clinical investigators and study participants who all have a singular focus.

Developing a safe and effective Colby are in a vaccine.

We will continue to work closely with regulatory authorities, including the SD eight to advance our program, while ensuring we maintain high standards of what did they safety and compliance you know development process, we know the FDA and all the regulatory bodies, we continued to uphold there.

Hi standards as well.

In the phase two three prior uses successful.

Pfizer and violent they expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October trended trend.

He also has Asian or approval is obtained our company has gotten we aim to supply globally up 200 million doses by the end of 20 to 20 and approximately $1.3 billion just by the end of 20 to 21.

Last week, we announced two agreements that will help ensure people have access to this potentially breakthrough vaccine.

Albert Bourla: Last week, we announced two agreements that will help ensure people have access to this potentially breakthrough vaccine, assuming, of course, clinical success and regulatory approval. On July 20th, we announced an agreement with the United Kingdom to supply 30 million doses of our vaccine candidate, which we expect to be delivered in 2020 and 2021, assuming clinical success and regulatory approval or authorization. Then, on July 22nd, we announced an agreement with the U.S. government for up to 600 million doses. Under the agreement, the U.S. will pay Pfizer and BioNTech a total of $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The US also can acquire up to an additional 500 million doses.

Assuming of course, you didn't go success and the regulatory approval.

Do you like when do we announced an agreement with the United Kingdom supply a 30 million doses are far vaccine candidate, which we expect to be delivering 2020, and 2021, assuming clinical success and regulatory approval or authorization.

Then on July 32nd we announced an agreement with the U.S. government for up to 600 million those under the agreement the U.S. when pay Pfizer in biomedical both below one point 95 billion a form the receipt of the first hundred milligram dose.

Following a differentiation or approved.

The U.S. also can acquire it off to additional 500 million dose.

Pfizer's unique combination of experience resources and manufacturing could give I believe it just seemed vaccines is a competitive advantage for us and one of the reasons I'm confident the potential for collaboration with biotech to be successful.

Albert Bourla: Pfizer's unique combination of experience, resources, and manufacturing capabilities in vaccines is a competitive advantage for us, and one of the reasons I'm confident in the potential of our collaboration with BioNTech to be successful. We are also moving forward with the development of a potential novel antiviral, which we hope to have in the clinic by September. Now let's look at some highlights from the rest of the pipeline, which continues to be one of Pfizer's great strengths. In addition to our COVID-19 vaccine program, we recently started four, I repeat four, phase three studies for vaccines that we hope will make meaningful contributions to the lives of people everywhere. These include... Two studies of the trend-developed pneumococcal conjugate vaccine candidates. Evaluating a four-dose series in infection, starting at two months of age.

We also moving forward with the development of a potential novel anti virus, which we hope to have in the clinic by September.

Now, let's look at some highlights from the rest of the pipeline.

Which continues to be one of pfizer's great strengths.

In addition to our call with 19 Vexing program. We recently stopped it for Ari bid for Phase three studies for vaccines, but we hope will make meaningful contributions to the lives of people everywhere.

These include.

So let's start there so the trend developing pneumococcal conjugate vaccine candidate.

Evaluating afford dose series D infants stopping it's two months will phase.

I study a phase three study will far respiratory seen keep the virus vaccine candidate.

Albert Bourla: A study, a phase 3 study, of our respiratory syncytial virus vaccine candidate, RSVPREF-S, in pregnant women to evaluate the safety and efficacy of the candidate in infants born to immunized pregnant women as compared with placebo, and a Phase 3 study of the pentavalent vaccine candidate, meaning a coca vaccine. ABCWY in adolescents and young adults to assess the safety, tolerability, and immunogenicity of the vaccine candidate compared with the licensed meningococcal vaccine.

RSV Brett if.

In pregnant women to evaluate the safety and efficacy over the conducted in infants born to immunize pregnant women as compared with placebo.

And in Phase three study over the pent up villain, meaning a corporate vaccine candidate.

A b C doubly why.

Adolescents and young adults to assess the safety Tolerability and Immunogenicity over the vaccine candidate compared with license, meaning book OCO vaccines.

We also announced the collaboration with Bovina excuse me with volume Eva.

Albert Bourla: We also announced a collaboration with Valvina, sorry, with Valniva, to co-develop and commercialize Valneva's Lyme disease vaccine candidate, Eberle 1.5, which is currently in phase two clinical study. Our vaccines teams accomplished all of this while also working with a deep sense of urgency in partnership with BioNTech to develop a potential COVID-19 vaccine. Despite the disruption that the pandemic has brought to our world, they stayed true to the ambitious timelines for our existing problems, and I couldn't be prouder of their commitment to our rare disease gene therapy portfolio. We had two important data readouts in the last quarter. We presented data from our investigational mini-dystrophin gene therapy program for Duchenne muscular dystrophy at the American Society of Gene Cell Therapy Annual Meeting. The preliminary data from 9 ambulatory boys with DMD aged 6-12 indicate that the intravenous administration of our program was well tolerated during the infusion period, with encouraging efficacy and manageable safety events since those original nine boys for whom we delivered data were those.

The goal develop and commercialize well leave us Lyme disease vaccine candidate and delay onefive.

Which is currently in phase two clinical studies.

Our vaccines teams are companies all of these while also working with a deep sense of urgency in partnership with biotech to develop it but then joke cobiz 19 vexing.

Despite the disruption, but the pandemic has brought to our world. They stayed true to the ambitious timelines for our existing programs and I couldn't be prouder of their commitment.

From our rare disease differently going forward here, we had two important data every dogs in the last quarter.

We presented the data from our investigational mini dystrophin gene therapy program for the same muscular dystrophy.

American Society Society, Vince cell therapy on your meeting.

The preliminary data from nine ambulatory boys with DMD AIDS six to 12 indicate that they intravenous administration of our program was well tolerated during the infuse appear.

With encouraging efficacy and Monetizable safety events.

Oh interest.

Since those or is there no nine voice for who we serve data where those.

We have dose an additional six voice at the high dose.

Albert Bourla: We have dosed an additional 6 bullets, and the high dose, in compliance with our modified protocol. To date, we have not seen any serious safety events in any of the six new bodies, five of whom have reached at least two weeks post-treatment, which is the time period in which all previous adverse events were experienced. We look forward to starting the pivotal trial for this potential therapy later this year. We also presented at the World Federation of Haemophilia 2020 World Congress Haemophilia A data from Giroctococcin Fetal Parvovic, from our partnership with Sangamon Therapeutics. The data demonstrated that five subjects receiving the highest dose of the gene therapy had, at between 30 and 61 weeks of follow-up, sustained functional factor VIII activity levels without the need for additional factor replacement following an initial use of prophylaxis. This shows the potential of our gene therapy to be differentiated from other hemophilia A gene therapies being evaluated in the clinic.

In compliance with our modified protocols.

Today, we have not seen any serious safety events in any of the seeks newborns fiber who have reached at least two weeks Boston treatment, which is the time period.

Oh previous adverse events would experience.

We look forward to starting that people don't try try out for this but pencil therapy to later this year.

We also presented at the World Federation of Haemophilia, Twentytwenty World Congress Haemophilia, a data from a Xerox local gene.

So part of organic.

From our partnership with Sangamo fewer predicts the data demonstrated some five subjects receiving the highest dose of the gene therapy at between 30, and 61 weeks or follow up sustained functional fox to raise activity levels without the need for this.

No factor replacement folding and initial use of prophylactic factor.

We sold the potential of our gene therapy to be differentiated from other haemophilia, a gene therapy is being evaluated in the clinic.

Pfizer is currently enrolling subjects in a six month phase three lead EAME stopping for the animal feed AIDS in therapy program, which will serve as the foundation of our phase three Registrational study expected to start again later this year.

Albert Bourla: Pfizer is currently a rolling subject in a six-month phase three lead-in study for the hemophilia aging therapy program, which will serve as the foundation of our phase three registrational study, expected to start again later this summer. In internal medicine, we recently presented at the American Diabetes Association Conference phase 1 data from our oral GLP-1, which showed a reduction of glucose levels and body weight. Our aspiration is to develop the most efficacious oral therapy for type 2 diabetes and develop the first small-molecule oral GLP array for both obesity and type 2 diabetes malignant. We are also aware of the increasing evidence indicating that the GLP-1 array class may offer so much promise for the treatment of NASH, and are open to further exploration as we review the data.

In internal medicine, we recently presented at the American that'd be the system. She has some conference phase one data from oral GLP, one which sold reduction of glucose level in body weight.

Our aspirational used to develop the most efficacious oral therapy for type two diabetes and develop the first small molecule oral GLP already for both obesity and type two diabetes mellitus.

We are also aware of the increasing evidence, indicating that the zero would be one already Clos may so promise for the treatment of Nash.

And our open to further exploration as we review the date.

The inflammation and immunology, we're excited that I've received any 'cause consistently song meaningful ethnic that's your gross Oh far far studies from other lessons to adult patients with moderate to severe atopic dermatitis.

Albert Bourla: In inflammation and immunology, we are excited that abracitinib has consistently shown meaningful efficacy across all of our four studies from adolescents to adult patients with moderate to severe atopic dermatitis. Results from our compared studies showed superiority in each at week 2 for the 200mg dose, and that indicates that abracitinib can demonstrate a clinical benefit over dupixazine. Our program has advanced at a rapid pace, and we intend to file with FDA this quarter, building on our presence in denaturing cancers. We are pleased by the FDA's recent approval of da Vincio as the first-line maintenance treatment for patients with locally advanced or metastatic urofilia casinoma. Pavenzio is the only FDA-approved immunotherapy with a demonstrated overall survival benefit in the first-line setting in UC, and we believe it has the potential to become a new standard of care based on its demonstrated ability to extend the lives of patients and address a significant unmet medical need. On July 16, the treatment was listed in the cancer treatment guidelines put out by the National Comprehensive Cancer Network.

Results from our compare started showing superiority in each.

We do for the 200 milligram dose and that indicates the upper Sydney can demonstrate clinical benefit over dupixent.

Problem because of bonds at a rapid pace and we intend to fight with FDA This quarter.

In oncology building on our presence in then you three cancers. We are pleased by the FDA recent approval of the events you as the first line maintenance treatment for patients with locally advanced or metastatic Urothelial casino.

Eventually <unk> is the only of da approved immunotherapy with the demonstrated overall survival benefit in the first line setting in the you see.

And we believe it has the potential to become a new standard of care based on its demonstrated the ability to extend the lives of basins and address a significant unmet medical need.

On July 16, the Threed been was listed in the cancer treatment guidelines, we filed by the National comprehensive cancer network.

We look forward to providing further R&D pipeline updates during our upcoming Investor day, which will be felt over two days individual pharma on September 14 and September 15th.

Albert Bourla: We look forward to providing further R&D pipeline updates during our upcoming Investor Day, which will be held over two days in a virtual format on September 14th and September 15th. Now, before I turn it over to Frank, I want to speak about the executive orders the President signed on Friday. Overall, I'm disappointed by this executive order. They pose an enormous distraction at a time when the industry needs to be completely focused on developing a potential COVID-19 vaccine or treatment. The international price index is a radical indicator.

Now before I started Gilbert from.

I want to speak to the executive orders the president sign on Friday.

Overall I'm disappointed by these executive or.

They post enormous construction at the time, where the industry needs to be completely focused on developing a potential corporate 90 vaccine or three.

The international price indices radical not only does imposing socialized medicine to America.

Albert Bourla: Not only is it imposing socialized medicine on America, but it also will create uncertainty and could lead to job losses. We have plans to invest in both R&D and manufacturing in the United States. If finalized, these new executive orders could force us to rethink those plans, consider job reductions, and add to the economic and health anxiety already widely felt in our country.

Also were great uncertainty Ed could do into job losses.

We have plans to invest in both R&D and manufacturing in the United States.

You finalize these new executive orders enforcers Griffin, those splunk consider jump reductions and add to the economic in Paris inside the already widely felt you know kind of.

The one concept we agree with is the rebate through because it will actually make the system work better by removing any assistance is created by the middle man.

Albert Bourla: The one concept we agree with is the rebate rule because it will actually make the system work better by removing inefficiencies created by the middlemen. It will ensure that our discounts make it to the pesos. The patients are the ones that drive the volume of our medicines and, in effect... earn the volume discounts we provide to Middlesex. The problem has been that most of these discounts don't make it back to the pace. In summary, our results continue to support our thesis of having multiple growth drivers across different therapeutic areas driving the business. As we have said in the past, By design, we are not overly dependent on any single growth driver, which gives us continued confidence in our ability to achieve our goal of at least 6% revenue CAGR through 2025, following the completion of the pending Abjon-Milan combination. Following the expected separation of Abjon in the fourth quarter of this year, Pfizer will be a more focused, science-driven company that is in an even better position to deliver And when patients win, we all win. Now, I will turn it over to Frank.

It will ensure our discounts make it to patients.

The patients are the ones that drive the volume of our medicines and in effect.

Earned the volume discounts, we provide to Midland.

The problem as being the most of these discounts don't make it back to the pace.

In summary, our results continue to support our fees or having multiple growth drivers across different therapeutic areas driving the business.

As you have said in the Pos.

By design, we are not overly dependent on any single growth driver.

Gives us continued confidence in our ability to achieve our goal of at least 6% revenue CAGR through 2025, following the completion of the pending UBS and Mylan can be nice.

Following the expected separation of UBS only in the fourth quarter of is here.

Hi, there would be a more focused science driven company that is even better positioned to delever, our innovative medicines and vaccines to patients around the world.

And when patients when we all win.

Now I will turn it over to from.

Good day everyone.

Frank D'Amelio: Thanks Albert, good day everyone. Starting with total company revenue, we generated $11.8 billion in the second quarter of 2020, down 9% operationally versus the year ago. As in each of the last three quarters, the majority of this decline is due to the fact that we no longer report revenues for our consumer. Adjusting for Consumer, Total Company Revenues Declined 3%.

Starting with total company revenue, we generated 11.8 billion in the second quarter 2020.

In person operationally versus the core.

Each of the last three quarters. The majority of this decline is due to the fact that.

Revenues for rockets.

Yes.

Adjusting for consumer total company revenues declined 3%.

As a reminder.

Frank D'Amelio: As a reminder, the formation of the Consumer Joint Venture, GSK, will annualize on July 31. The next quarter will be the last one impacted by this negative. Albert did a really nice job of describing the revenue drivers for each of our businesses, so I won't repeat them, but I do want to make one additional point: for Bio Pharma, the growth that we are seeing is not reliant on net price increases, in fact, on a global basis. Net price had a negative 2% impact on biopharma growth this quarter and in the U.S. net price, Pricing Environment.

Consumer joint venture.

Annualized.

First so next quarter will be the last one impacted by this negative driver.

It did a really nice job describing the revenue drivers.

So I won't repeat them, but I do want to make one additional points on each business.

<unk>.

The growth.

Not reliant on price increases.

On a global basis.

Negative 2% impact.

This quarter.

Price was flat.

These dynamics are consistent with the pricing environment, we have seen for several years now we continue to believe that pricing contribute toward expected.

Frank D'Amelio: Several years now, to our expected growth for the foreseeable future. For Upjohn, it is important to point out that despite a 31% operational decline in revenue this quarter, BioNTech, Xtandi, Comirnaty, CDK4, GLP-1. I should also point out that the 31% becomes minus, concluding the impact of Lyrica. Now moving down the income statement, we had another quarter with significant declines Down 17% Nearly half of that decline was due to the fact that we no longer report expenses to the Consumer Health Commander of the decrease was driven primarily by, compared to the prior year quarter, Restrictions on In-Person Meetings with Healthcare Professionals Primarily in the U.S.

For the foreseeable future.

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The point out.

31% operation.

This quarter.

Continues to perform.

With our expectations.

She is reflected.

Good luck.

I should also point out that the 31% becomes minus 6% excluding the impact.

[music].

Yeah.

We had another quarter with significant declines and adjusted <unk> expenses.

17% operationally.

Yeah.

Decline was due to the fact that.

<unk> expenses.

<unk> business.

The remainder of the decrease was driven primarily by increased sales and marketing activities compared to the prior year quarter.

Person meetings.

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Yes.

Frank D'Amelio: Lesser Extent, Lower Spending Associated Reported diluted EPS for the quarter was down, compared to the year-ago quarter, mainly driven by a one-time favorable tax settlement recorded in the prior year. Adjusted diluted EPS was down 2% compared to the prior year's second quarter, excluding the 2 cents negative impact of foreign exchange rates in the period; EPS was flat compared to Slide 13. We are providing an update to the detailed assumptions reflected in our current financial guidance related to the impact of the COVID-19 pandemic on our business. Broadly speaking, we anticipate an ongoing gradual global recovery from the macroeconomic and healthcare impacts experienced during the second quarter of 2020, beginning in Q3. The guidance also assumes we will be able to continue to operate our manufacturing and supply chain without material disruption. COVID-19 throughout, but does not. Vaccine Candidate, given that it is not. With that in mind, let's take a look at our guide.

Lower spending associated.

Functions.

Yes for the quarter was down significantly compared to the.

Mainly driven by a onetime favorable tax settlement.

<unk>.

Adjusted.

It was down 2% compared to the prior year second quarter, excluding the two cents negative impact.

Justin.

Compared to the prior year.

Foreign exchange also negatively impacted revenues and of course.

77 million 2%.

On slide 13, we're providing an update to the detailed assumptions reflected.

Guidance related to the impact.

On our business.

Speaking.

And ongoing gradual recovery from the macroeconomic impacts.

During the second quarter of 2020.

In Q3 2020.

The guidance.

Well to continue to operate on manufacturing and supply chain without material disruption.

Genuine vesting of potential treatment.

<unk>.

2020.

Does not include any revenues.

Vaccine candidate.

Yep.

With that in mind, let's take a look.

Consistent with last quarter, we providing three sets of financial guidance.

Frank D'Amelio: Just in the last quarter, we are providing three sets of financial... Beginning with Total Company, we are raising our guidance range for revenues by $100 million, and our guidance range for PPS by 3 cents based on the strength and resiliency we see in our business and the dedication of our colleagues. Despite the challenges inherent in operating during this current global economic downturn, we are reaffirming all of the components of our 2020 financial guidance for total company. I want to point out that, although changes in foreign exchange rates since mid-April have marginally been, Clear Outlook for Revenue Today's guidance increases are not primary, And as a reminder... Xeljanz, Nurtec, GBT601, Prevnar, Opdivo, Sea Both of the changes we made for total Pfizer guidance this quarter are reflected in the update to our new Pfizer website. On the Upjohn side, all financial guidance components are being reaffirmed. Reflecting that, the performance of that business continues to be in line with our expectations. Moving on to Key Takeaways.

Total company.

Revenues.

Guidance range for Justin.

Three cents based on this.

Business.

<unk>.

Despite the challenges inherent.

Operating during this current global.

We are reaffirming all the components of our 2020 financial guidance for total company.

I want to point out that although changes in foreign exchange rate since mid April marginally benefited.

For revenue and adjusted.

Today's guidance increases are not primarily driven by change.

As a reminder.

Both of these guidance ranges last quarter, despite absorbing much.

Moving on to financial guidance for New Pfizer went up John.

Both of the changes we made for total size the guidance. This quarter are reflected in the update you see here.

Pfizer financial guidance.

Yes, John side.

That's components are being reaffirmed.

The performance of that business continues to track.

With our expectations.

Moving on to key takeaways and the second quarter accompany performed well driven by the strong 6% operational revenue growth from our Biopharma business.

Frank D'Amelio: In the second quarter, our company performed well, driven by the strong 6% operational revenue growth from our biopharma business. We raised our 2020 total company and new Pfizer guidance ranges for revenue. Adjusted Diluted EPS reaffirmed all of the components of our financial guidance, including all guidance ranges for our Upjohns. We raised sufficient funding through our Upjohn subsidiary to satisfy the $12 billion dividend to be paid to Pfizer upon the close of the combination of Upjohn with Mylan. Elrexfio is expected to occur in the fourth quarter.

2020 total company.

It's ranges for revenues.

Yes.

Well the components of our financial guidance, including all guidance ranges.

Yes.

We raised sufficient funding John subsidiary.

As far the 12.

To be paid to Pfizer.

Close of the combination.

Which is expected to occur in the fourth quarter.

We also MACI multiple product pipeline milestones since our last quarterly update some of which are listed here.

Frank D'Amelio: We also achieved multiple product and pipeline models, some of which are listed here. A more complete listing can be found in this morning's press release. Finally, we paid $4.2 billion in dividends to our shareholders in the first half of this year.

Complete list and can be found in this mornings press release finally, we paid 4.2 billion in dividends to our shareholders in the first half.

As always we remain committed to delivering attractive shareholder returns 2020.

Frank D'Amelio: As always, we remain committed to delivering attractive shareholder returns. Now, I'll turn it back over to you. Thank you, Frank. Operator, can we now please start the poll for questions? Ladies and gentlemen, if you would like to ask a question, please press star 1 on your telephone keypad. Your first question comes from Steve Scala from CalWORKs. Oh, thank you. One for Frank.

Now I'll turn it back.

Thank you Frank.

Operator can we now please start the poll for questions.

Ladies and gentlemen, if he would like to ask a question. Please press star one on your telephone keypad.

Your first question comes from Steve Scala from Cowen.

Oh, Thank you one for Frank <unk>.

Hi, there delivered a much stronger quarter, while some peers, including Novartis and rush or were not as strong yet the businesses are not that different to what do you attribute the disparity that we're seeing in the industry is it product portfolio or cycle, it's a geography or is it execution and then maybe from.

Steve Scala: Pfizer delivered a much stronger quarter while some peers, including Novartis and Roche, were not as strong, yet the businesses are not that different. To what do you attribute the disparity that we're seeing in the industry? Is it product portfolio or cycle? Is it geography or is it execution?

Steve Scala: And then maybe for Michael, regarding the COVID-19 vaccine, can you elaborate on the immunogenicity and safety in older adults that was touched upon in the press release? Thank you.

Michael regarding the Cobot 19 vaccine can you elaborate on the mean immunogenicity and safety in older adults that was touched upon in the press release. Thank you.

Frank D'Amelio: Thank you, Steve. Frank, why don't you take the first question and maybe Angel can also chime in, and then Michael will answer the COVID question. Frank?

Thank you, Steve probably why don't you take the first question and maybe I'm Gonna also get 10 minutes I mean, a and then that's my opinion will will answer the called me question from sure. So good morning, Steve Steve.

Frank D'Amelio: Sure. So, good morning, Steve. So Steve, obviously, I can't comment on what some of our competitors printed for the quarter, but obviously, we had a strong quarter. And I think I can attribute it to, quite frankly, the excellent execution that we continued to deliver. If you look at the biopharma business, really strong strength across the portfolio, 6% operational growth, about $600 million in revenue. Vindindiquil, I'm rounding the numbers. Vindiquil was up. So it was a really, really strong performance.

I can't comment on.

Competitors printed for the quarter, but obviously, we had a strong.

I can attribute it to.

Excellent execution that we continue to deliver you look at the fine.

Really strong strength across the portfolio, 6% operational growth about 600 million in revenue then nyquil I'm rounding the numbers when the quote was up 200 million.

Okay.

So really really strong performance.

Frank D'Amelio: And by the way, overall, that's despite a 500 million hit to revenue from COVID, 400 million of which was in our biopharma. And if you look at our spending, you know, I think we've done a nice job of managing our spending. Obviously, we're getting some help from COVID. But if you look at the rest of the business, we continue to be disciplined in how we spend money. So, you know, I think, all in all, I think we're continuing to execute in a very effective way.

Overall, that's despite.

Hundred million hit to revenue from <unk> 400 million of which.

And if you look at our spending.

I think we've done a nice job on managing our spending obviously, we're getting some help from cold.

If you look in the rest of the business, we continue to be disciplined.

We spend money.

I think all in I think we're continuing to execute very effectively.

I'm doing.

Angela Hwang: Angelo

Sure just to build up like Frank said I think a in addition to the execution, which was a critical element that.

Angela Hwang: Sure, just to build off what Frank said, I think in addition to the execution which was a critical element of this, we also have a product portfolio that, together, really works well together. As you said, there are parts of our portfolio that are similar to others, but this particular disease area is quite unique. You have, you know, oncology and our internal medicine, cardiology business that, you know, did not have, didn't feel, and didn't experience the kind of downturn in new Rxs and, unlike some other portfolios. You had the hospital BU that pulled through. You have portfolios that are very much about continuing patients, the large base of patients that are continuing with their medicine. So I think that it really speaks to the strength and the diversity of this portfolio and the unique attributes that make it very resilient in a time like this.

We also have a product portfolio, which in combination you know really work well together and as you said you know they all parts of our portfolio. There are similar to other but this particular collect.

These areas is quite unique you have on you know oncology and our internal medicine cardiology.

Yes. It did not have found didn't feel I didn't experience to kinda downturn in new our exit and unlike some other portfolios yet the hospital Bu that pulled through you had a portfolio.

That are very much about on continuing patients a large base or patients that are continuing but then medicine. So I think that it really speaks to the strength and the diversity of this portfolio and unique attributes.

That make it very resilient in the time like that.

Michael.

Michael Dolsten: Michael

Yeah. Thank you for the question we are I'm very pleased.

Michael Dolsten: Yeah, thank you for the questions. We are, you know, very pleased with both the B1 and the B2 vaccine candidates. And as you know, we have selected B2 and now started dosing our patients in a late stage trial. We studied B2 in nearly 120 patients in phase 1. And for the specific questions about older adults, we were very pleased with the safety and tolerability seen in older adults after both the first injection and the boost. In general, mild to moderate reactions, whether locally or systemic, and overall, a very stable tolerability profile. We also reported neutralizing antibodies after the boost, day 28, that exceeded a panel of convalescent plasma, which was very rewarding to see. Finally, I want to point out that in addition to neutralizing antibodies, our mRNA vaccine also elicits potent antiviral T-cell activation, including sedate T-cells that have been implicated as key cellular mediators to control viral infection, including coronaviruses.

Thank you need to be wanting to be too like seen candidate and as you know we've selected be too and I will start to do.

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We've studied be too in the near 100 and when the recent interface lawn and food is specific questions on older.

We were very pleased with them, let's see what have you seen in <unk> to be the past.

In general mild to moderate Rex.

Okay.

No rule and very stable.

We're also.

You want to neutralizing antibodies often to boost the when you.

Seed.

No.

<unk> was very rewarding to see.

I want to.

Introduce you to utilizing our.

Good morning, because he wants the leases.

Anti virus.

Including CD keys.

I have been hi, Keith.

My <unk>.

Yes.

Thank you my question, Steve I can't resist also anything about the as Youre looking at new Pfizer, what you're trying to build a much more signs are focused to Pfizer you will see three themes excellence in execution.

Albert Bourla: Thank you, Michael. And Steve, I can't resist also adding that as you are looking at a new Pfizer, but we're trying to build a much more science-focused Pfizer, you will see three themes: excellence in execution, speed, and agility. And you will see that across commercial, with the results that you see, across R&D, with our ability to advance a program like COVID, very complicated at such a fast rate, and across manufacturing, where, in the middle of a pandemic, we keep all our operational units up and running, and we experienced virtually very, very few stock disruptions in a period that demands for some inductibles went five, four, six times higher.

Pete and ideally you wish you luck across commercial women as I was that you see a gross R&D with our ability to advance the program like at Cobiz very complicated inside the speed and the great manufacturing where in the middle of the Monday me, we maintain all our personal units are often running and we experienced gets really.

Very very little spoken disruptions in Appirio developed demands for some injectables when 546 times.

Well, let's go to the next question.

Your next question comes from the line of Tim Anderson with Wolfe Research.

Operator: Your next question comes from the line of Tim Anderson with Wolf Research. Thank you.

Thank you a couple of questions. Please.

Tim Anderson: A couple of questions, please. For long-term revenue guidance in the past, you've said at least 6% on a five-year CAGR basis, and that excluded anything from COVID-19. In terms of vaccine contribution, does that guidance still stand? And then there is the second question on Ibrance. When we see the full PALIS results, will there be an obvious reason why the trial failed? Was it mostly a compliance issue, for example? If so, then it seems like docs would, you know, likely stick with the brand. But you could argue it the other way, too, which is your product, while it was first to market in the class, is the only one that doesn't have a survival benefit in metastatic cancer, and in adjuvant, it didn't work. So I guess, can you just kind of give us a little bit of insight into the PALOS results, and are you confident that Ibrance will remain a growth brand over time?

Long term revenue guidance in the past you've said at least six person on the pipe your cagar basis.

And that excluded anything from covert 19.

In terms of vaccine contribution that Titan still stand.

Second question.

On Hi, Brad.

When we see full palace result will there be an obvious reason.

Why the trial failed was it mostly a compliance issue for example.

Yes. So then it seems like dock.

Like we stick to the brand.

But you could argue with all the way too which is your product well with first oh market in the class.

Anyone that doesn't have a survival benefit in metastatic and imagine.

Work.

So I guess can you just kinda give us a little bit insights into palace.

Are you confident that eyebrows remains a growth brand overtime.

Yes, let me answer the first one of them in Michael will speak about the policy. The answer is absolutely. It is not six person is at least 6% invoking urethra right and you feel much stronger right now and Oh, that's experience obviously any impact for cold we can pick up a lot.

Albert Bourla: Let me answer the first one, and then Michael will speak about the palace. The answer is absolutely. It is not 6%. It is at least 6%. And that we are evaluating the rate, and we feel much stronger right now. And that obviously excludes, obviously, any impact of COVID on the top line. And as I explained multiple times in investor events, the reason why our approximately 6% went to at least 6% while we lost palace was because for palace, we had $2 billion of revenues in our projections at a 50% probability of success. So we lost a billion.

And it does expand multiple times in investor events, the reason why or approximately 6% when to at least six person why we lost policy was be goes for polishing type $2 billion of recognition by our or projections at 60%.

Probability of success, So we lost a baby, but at the same time. So since we said given the six person. We advanced we've had successful phase three study in adults pneumococcal. We've had success were punks in multiple vaccines, which we advanced already right no two phase three study vaccines as I say.

Albert Bourla: But at the same time, since we had given the 6%, we advanced, we had a successful phase three study in adults with pneumococcal pneumonia, and we have successful polio in multiple vaccines, which we have advanced already right now to phase three. Three vaccines, as I spoke, we advanced to phase three. We have the same muscle dystrophy, and positive pox. We have a lot of positive news, but when we update the probabilities of success in our model, they are more than offset.

Spoke you have to Washington phase three we'd have to saying muscle dystrophy. What was the books were locked for ER positive news, but when we update the probability of success and almost more than offset the problems and without I want to <unk>.

I just might go to comment on a why are you seeing smallest failed.

Yeah. Thank you for the question.

Michael Dolsten: The powers. And with that, I want to ask Michael to comment on why he thinks PALAS failed.

No we are now analyzing.

Dave I need to making it very sub analysis and sensitivities. So it's still too early to view on.

Michael Dolsten: Thank you for the questions. You know, we are now analyzing what made this study not successful. And, as Albert alluded to, Ibrance has been and is a very strong brand in the metastatic setting. It has a favorable tolerability profile and is supported by a number of randomized controlled clinical studies. And I wanted to just add that real-world data studies have also replicated the progression for survival and added overall survival data using real-world evidence for Ibrance in the metastatic set. Now we'll continue to share with you the learnings we have, and of course, we have the Penelope B-study to read out, which we, you know, comment on. It includes a different patient type than in PALA.

What made you study like system.

I'm just alluded to <unk> Ibrance is being and he is a very soon brown in Dominican stats existing it tends to <unk> to an ability coupon and is supported by a number of none of the Muslim seasons and I wanted to just.

Well they must not.

Hootsuite replicate the progression free survival and added.

They are using real world evidence.

[laughter] existing.

I will continue to see how would you loans we have.

And we have.

Be decided to read out there with me.

Doing it includes <unk> Eastern time, then huh.

Maybe just like it out on the commercial front for Ibrance.

Michael Dolsten: Maybe Angela could add on the commercial front for Ibrance.

Sure. Thanks, Chad and actually we continue to see great opportunities in the metastatic indication for Iran.

Angela Hwang: Sure. Thanks, Chuck.

Angela Hwang: Actually, we continue to see great opportunities in the metastatic indication for eye brands. As you can tell, we are firmly entrenched as a leader in metastatic, and even recent research that we conducted with our prescribers, our physician prescribers, indicates that they see early treatment, so the early indication as well as metastatic indication quite differently. And that what is being used within each of these indications will have its own role. So when you look at our market share, both in terms of in-line as well as across all the lines, after five years in the market, our brands have consistently had a dominant market share.

As you can tell we often the in cranes escondida in metastatic and even the recent research that we conducted with prescribing physicians prescribe it indicates.

I think early treatment. So the early indication as well as metastatic and they indication you know quite differently and that you know what is being used in each of these indications will have on their their own role. So when you look at our marketshare, both intent, but in line as well as across all the lines on the five years.

In the market I, Brent has consistently had dominant marketshare. So we come into this with a you know, but confident owning metastatic but I think it's also important trend, but the at the out of the experience and the confidence at both prescribers and patients have I'm just not men metastatic disease that is.

Angela Hwang: So we come into this with confidence in owning metastatic disease. But I think it's also important to remember the experience and the confidence that both prescribers and patients have in metastatic disease that has been established through time. And to build off of what Michael said, we do have overall survival benefit.

At this time and to build off up what Michael said, we do have overall survival benefit and we still that in our <unk>, We'll we'll we'll studies and where the only be CDK inhibitor that has these will that studies and certainly on these studies will further strengthen our leadership.

Angela Hwang: And we saw that in our real-world studies, and we're the only CDK inhibitor that has these real-world studies. And certainly, these studies will further strengthen our leadership in metastatic. So I think on all accounts when we look at where we are, the real-world data that we've generated, the experience, as well as new data and new studies that are ongoing that demonstrate that patients can be retreated. So, therefore, if you have already treated a patient early with a different CDK, you can certainly treat them again when they become metastatic with something like an eyebrand. And so, on all accounts, we continue to be very bullish about our position with eyebrands in metastatic cancer, metastatic breast cancer. Thank you.

Metastatic and so I think on all accounts I mean look at way we are on the real world data that we've generated experience as well that new data and new studies that I'm going that demonstrate that patient can be treated so therefore.

You have already treated a patient in early you can't win with a different CDK you can certainly we treat them again, when they become metastatic with a with something like an eye brands and so on all accounts are we continue to be very bullish about our position.

What I brands in metastatic.

Metastatic breast cancer. Thank you.

Thank you Angela let's go to the next question. Please.

Your next question comes from from yields Alon from Mizuho Securities.

Hi, great. Good morning, Thanks for taking my question to just a couple of they could one on the vaccine I just can't say Michael before we are now expected Kobe vaccine would be a recurring vaccine that people would take annually or to be just so the two shots initially they get three then asking and.

Albert Bourla: Thank you, Angela. Let's go to the next question, please.

Vamil Kishore Divan: Your next question comes from Vamil Devon from Mizuho Security. Hi, great. Good morning.

Vamil Kishore Divan: Thanks for taking my question. So just a couple if I could. One on the vaccine. I'm just curious, as for Michael, based on what we know now, do you expect this COVID vaccine to be a recurring vaccine that people would take annually or to be just sort of a two-shot initially? And I guess the reason I'm asking is when you think about sort of the longer-term outlook, I think a lot of people want about five years beyond 2026 when you start losing patent protection for some of your key products. Do you see this as potentially a meaningful contributor at that point in time or just maybe more of an opportunity for the next two to three years? And are there any other questions just on the executive orders?

When you think about sort of longer term outlook I think lumpier one of the fight it out but beyond 2026, we certainly think patent protection. The some of your key product do you see this is potentially meaningful contributor at that point in time as it maybe more of an opportune for the next two to three years. My other questions just back on the executive orders appreciate the comments you made a albert.

In your prepared remarks, just any I know, there's bolivia's meeting today potentially with the Trump administration, because it's the orders that canceled I'm wondering if you have any insight you can share on that or are there any other plants to discuss theaters with the administration over the next month or so thank you yeah.

The first question, Mike They can speak about go shopping on silicon and how we see vis a Italy. So and then I will answer the second one Michael.

Yeah. Thank you for the question.

There's a lot of unknown here, we did this season.

Vamil Kishore Divan: I appreciate the comments you made, Albert, in your prepared remarks. Is there any, I know there's supposed to be this meeting today potentially with the Trump administration to discuss the orders that were canceled. I'm wondering if you have any insights you can share on that or are there any other plans to discuss the orders with the administration over the next month? Thank you.

No.

The medical community, if more maybe six months.

But we have seen dramatic expansion.

You know virus, so let's talk to the blue including appearance on new variants.

So we looked at 22 seasons.

Huh.

Pandemics.

We're coming with Ses high quality indications that you soon you see import and that's why we are pleased to be ounces. We did yes, the dosing patients no people.

Albert Bourla: On the first question, Michael can speak, but I think Angela can add how we see this evolution. And then I will answer the second one. Michael?

Michael Dolsten: Yeah, thank you for the questions. Of course, there is a lot of unknown here with a disease that has just been known to the medical community for maybe six months. But we have seen a dramatic expansion of the coronavirus SARS-CoV-2 across the globe, including the appearance of new variants. So we look upon it as in two phases. The first one is the pandemic phase, where coming with a safe, high quality, efficacious vaccine soon is important, and that's why we are so pleased to be able to announce that we did dose patients yesterday in our Pivotal trial. And for that, you know, a two-shot vaccine is likely to give protection, and was successful in the clinical study based on both antibody-mediated and cell-mediated CD8 T-cells, Considering the beyond the pandemic phase, which may likely at the global level last a few years, it is hard to be certain about the future, but I do think there are scenarios which are very reasonable, and we need to be prepared for them, that COVID-19 has established itself as a prominent, virus, you know as

And with that I, you know it's too soon.

He is likely to be in a particular <unk>.

<unk> is successful independent study based on booth.

In cell mediated cdeight T cells that seems to be.

In particular got against viruses.

Considering.

You want to condemn <unk>.

Yes.

Last a few years.

It is hard to be.

Sorry about the Q2, but I do think scenarios.

I recently.

We need to be passed.

Yeah.

He will be 19 established.

So.

<unk> virus, you know asked.

Mark.

Mm Hmm.

And as we will understand.

Oh, no long lasting.

It will allow us to better clarity.

How often ones are considered to review.

A platform such as Alan.

That's the advantage there was no.

Community and if needed you could immunized annually every two years every four years.

And I also wanted to add that beyond the D.

Very important to indisputably defense against to be 19 and.

Michael Dolsten: And much is circulating in society as the flu. And as we will understand how long-lasting the various vaccines are, it will allow us to better predict. How often should one consider re-immunizing? A platform such as MNI has the advantage that there is no anti-vector immunity, and if needed, you could immunize annually, every two years, or every four years. And I just wanted to add that beyond being a very important pillar in the future defense against COVID-19... and probably reasonable to assume that there will be other coronaviruses, as we have seen how they have accumulated in recombined form in many different species, this platform will make it possible to also disrupt the flu market, novel vaccines against CMV, and even go into a novel age group of RSV. So we see a very large opportunity based on the leadership we have with this M1A platform, particularly by being able to engage both neutralizing antibodies and antiviral CD8 cells. Angela, please.

The reason.

That's it will be Andre.

Yes, we have seen hotel acumen I did you read combined whom many different species.

This maximum will be possible to once it is not the flu market novel.

The good CMV and even to go into new policemen.

So we see a very reluctant to put unit based on the leadership.

I'm wondering.

Particularly the by being able to engage those neutralizing antibodies and.

Yeah.

Thanks, Michael I'm still picking up on your the points about you know the two phases and some additional comments on our these two phases I think when we come to the pandemic. They were thinking about it from the perspective or the fact that he could last a till the end of 2021 I'll owing to 2022.

Where high volumes up doses will need to be provided for mass back.

Right and so I think in this pandemic period, the way that we're thinking about it.

Angela Hwang: Thanks, Michael. So picking up on your points about the two phases, you know, some additional comments on these two phases, I think when it comes to the pandemic phase, we're thinking about it from the perspective of the fact that it could last till the end of 2021 or into 2022, when high volumes of doses will need to be provided for mass vaccinations to take place, right? And so I think in this pandemic period, the way that we're thinking about it, and as you've seen, is that we're pricing the vaccine for broad access. Broad access is our main goal, and making sure that we can supply it to multiple governments around the world. After that...

Yes theme is that what pricing the vaccine for broad access what access is our main goal.

And making sure that we can add supply it to multiple governments around the world after that.

The next phase.

It's a phase where we think it'll become more standard most seasonal as I'm as as you described it I think a way we anticipate that we will have to have continued vaccination number up.

This is gonna be important to create and maintained a herd immunity globally. So I'm in that time period, we anticipate to return to more regular supply channels animal value based pricing approach. So a combination of both of these two it's how we see.

The next many is playing out.

Thank you are underlying thank you Michael that was very comprehensive I think you know as regards the executive order as I said, obviously I was very disappointed to see those orders coming because I feel that they are coming at the periods of time, but this is not what is needed.

Angela Hwang: The next phase is a phase where we think it will become more standard, more seasonal, as you've described it, I think, where we anticipate that we will have to have continued vaccination for a number of years. And this is going to be important to create and maintain herd immunity globally. So in this time period, we anticipate a return to more regular supply channels and a more value-based pricing approach. So a combination of both of these two is how we see the next many years playing out.

The theater to find that our scientists are worrying to develop a vaccine or threedemin and our manufacturing workers are working day and night to maintain under cobiz conditions supply or for medicines and also provide additional supplies for Remoxy ER.

They should worry only about how to defeat this virus and how to maintain the supply and should not start worrying about the results.

Albert Bourla: Thank you, Angela, and thank you, Michael. That was very comprehensive, I think. Now, as regards the executive order, as I said, obviously, I was very disappointed to see those orders coming because I feel that they are coming at a period of time when this is not what is needed. This is a period of time when our scientists are working to develop a vaccine or a treatment, and our manufacturing workers are working day and night to maintain, under COVID conditions, a supply of medicines and also provide additional supplies for this vaccine. They should worry only about how to defeat this virus and how to maintain the supply and should not start worrying about their jobs. I think the timing was wrong, and I believe that there is a need for a dialogue so that we can move forward, rather than look backwards.

I think the timing was wrong and I believe that Oh, there is a need for a dilo.

So that we can move up for work like look backwards, but there clearly are there is a need for <unk> on that picking go live on first to be an agreement I don't think there's a need for right now for White House.

Emitting since there's a need for Oh people, but are they understand the topics from both sides walked to find solutions, how we can degrees.

The contribution how can we decreased the out of spoke of expense will be Americans, but because done levels, but they are unacceptable right. Now. This is the real problem. In this is what we see is that we need to reform.

Thank you.

Next question please operator.

Our next question comes from Randall Stanicky from RBC capital markets.

Great. Thanks, Albert I want to follow up in the last question the vaccine opportunity could be a very big one.

But perhaps may not so for the 2026.

Albert Bourla: But clearly, there is a need for, on the technical level, first, to be in agreement. I don't think there is a need right now for White House meetings; there is a need for the contribution. How can we decrease the out-of-pocket expense of the Americans? That has gone to levels that are unacceptable right now. This is the real problem, and this is what we see that we need to reform. Thank you.

And arguably a could could add to it so.

Think about business development priorities near term has anything changed on that front and when we expect to see Pfizer get more out there and then the second question just on the vaccine how should we think about U.S. versus Oh U.S. pricing.

Given that you disclose the U.S. contract with the U.S. government, but we may not get close.

Thanks.

Yes. Thank you very good two questions both of them.

Terence Flynn: Next question, please, operator. Your next question comes from Rendell Stanicki from RBC Capital Markets. Great. Thanks, Albert.

In our M&A started is nothing has changed is exactly what we said before we are industry to be aggressive in deployed copy, though to licensing or acquire or early two midstates kidney go projects that could become medicines in the years, some different before 25 and usage and.

Terence Flynn: I wanted to follow up on the last question. The vaccine opportunity could be a very big one, but perhaps it may not solve the 2026 LOE problem, and arguably it could add to it. So as you think about business development priorities for the near term, has anything changed on that front? And when can we expect to see Pfizer get more active there? And then the second question, just on the vaccine, how should we think about U.S. versus O.U.S. pricing, given that you disclosed the U.S. contract with the U.S. government, but we may not get a call over OBS? Thanks.

And they can start picking their sales so that we can maintain bolstering the seeks the 6% growth and boxes will change we never say never to anything, particularly if people are asking if we wanted to do a bigger acquisition, we never say never do anything and by the way Alfaro power allow.

Just to do that skirting Detroit anything, but we could decide but our strategic direction is tier laser focus on this area. So what we can maintain the girl and we did have significant achievements in the up from there I will mention to you they lost two.

Albert Bourla: Thank you; very good questions, both of them. In our M&A strategy, nothing has changed. It is exactly what we have defined. We are in the industry to be aggressive and deploy capital to license in or acquire early to mid-stage clinical projects that could become medicines in the years 23, 24, 25, 26, and and that has not changed. We never say never to anything, particularly if people are asking if we want to do a big acquisition. We never say never to anything, and by the way, our firepower allows us to do vertically virtually anything that we could decide. But our strategic direction is clear laser I will mention to you the last two vaccines that we licensed, which are the Lyme vaccine a few months ago and the COVID vaccine under our agreement with BioNTech. What was the second question?

Vaccines up we license they would seize.

The line vaccine few months ago end the call me vaccine in our agreement with a with a biomarker.

What was the second question U.S. pricing versus outside pricing for the vaccine, yes, yes, why don't I, let the underlying so the question on there on the U.S. pricing over arching.

So pricing strategy by vaccines is on universal across the board and it is based on volume.

Ask commitment equity and affordable affordability practical so disagreement on in the U.S. that you referred to as it relates to the first hundred million doses for which by the will receive $1.95 billion and this is Dan assuming the a regulatory approval on authorization.

And if the government would like to purchase an additional 500 million doses. It would be at that same price and it's also subject to future mutual agreement.

Albert Bourla: It was U.S. pricing versus outside pricing for the vaccine.

Angela Hwang: Yes, yes. Why don't I let Angela answer the question on US pricing for the vaccine?

Switching over to the you or at all if you Act I think with your other question, how we're thinking about that again, we're using the same price in principle across the globe and specifically I won't be able to disclosed to you. The a the content of those confidential discussions, but again that print.

Angela Hwang: So our pricing strategy for our vaccines is universal across the board, and it is based on volumes, advanced commitments, equity, and affordability. So this agreement in the U.S. that you referred to relates to the first 100 million doses, for which Pfizer will receive $1.95 billion. And this is assuming regulatory approval or authorization, and if the government would like to purchase an additional 500 million doses, it would be at that same price, and it's also subject to future mutual agreement. Switching over to the EU or ex-US, I think was your other question, how we're thinking about that. Again, we're using the same pricing principles across the globe, and specifically, I won't be able to disclose to you the content of those confidential discussions, but again, the principles are the same, and because of that, no country in the developed world will receive doses at a lower price than the US for similar volume commitments.

I, suppose odyssey and because of that no country in the developed well well with deep doses at a lower price than the U.S. puts them a lot bhagyam commitment.

No and I will give a size what I'm jealous setting for statement that no company in the developed work, which means europes jump on all the Congress, but there are develop right now we're not going to see at lower price for the same volume commitment then the U.S., but of course extreme offered in Congress or other companies, but they don't have that means to pay over there we may do access.

<unk> in a in offer to lower priced. Thank you very much gondola, let's go to the next question.

Your next question comes from Terence Flynn with Goldman Sachs.

Hi, Thanks for taking the questions and congrats on all the progress of the vaccine I guess, a this might be a question for Frank just wondering based on a commentary in the press release versus what you guys outlined in first quarter. It seems to suggest that maybe you're now assuming a somewhat more gradual recovery in the second half just wondering if I'm interpreting that correctly and is that driven by glow.

Albert Bourla: and I want to emphasize what Angela said in her statement that no country in the developed world, which means Europe, Japan, all the countries that are developed right now, will not receive a lower price for the same volume commitment than the US, but that, of course, excludes African countries or other countries that they don't have the means to pay for over there; we may make exceptions in offering lower prices. Thank you very much, Angela. Let's go to the next question.

Mobile data points you guys are seen or is that really a result of what's been going on in some states in the U.S. and then the second question relates to the phase three covered 19 vaccine program was just wondering if you can give anymore details on the powering assumptions are the primary endpoint and then also you talk about the interim analyses any more details on.

That front. Thank you.

Probably go ahead please.

Yes, so so terence you're absolutely right, we talked about a gradual recovery in the quarter and saying that in terms of patient visits to doctors vaccination rates elective surgeries.

Albert Bourla: Your next question comes from Terrence Flynn with Goldman Sachs. Hi, thanks for taking the questions and congratulations on all the progress of the vaccine. I guess this might be a question for Frank.

We're expecting a gradual increase a gradual improvement over Q2 levels beginning in Q3 same thing with new to brand prescriptions.

Terence Flynn: Just wondering, based on the commentary in the press release versus what you guys outlined in the first quarter, it seems to suggest that maybe you're now assuming a somewhat more gradual recovery in the second half. Just wondering if I'm interpreting that correctly, and is that driven by global data points you guys are seeing, or is that really a result of what's been going on in some states in the U.S.? And then the second question relates to the Phase 3 COVID-19 vaccine program. I was just wondering if you could give any more details on the powering assumptions of the primary endpoint, and then also you talk about the interim analyses; any more details on that front? Thank you.

Gradual improvement.

Over to levels beginning in Q3, and then in the U.S. just the gradual improvement in terms of our reps visiting and getting to meet face to face health care professionals. So it's it's definitely gradual improvement.

From the language, we put into Q1.

Most importantly, all of which we have factored into the latest guidance that we provided to you.

But 2020.

It's public company.

And the up John guidance that we provide.

Thank you very much from getting there Michael can you just because it would be the ball with Oh study designed to farming assumption going on obviously et cetera.

Yeah. Thank you for the question so.

Seeing no <unk>.

We do you.

No.

Frank D'Amelio: Frank, go ahead, please.

He's going to be fine.

Frank D'Amelio: Yeah, so Terrence, you're absolutely right. We talked about a gradual recovery in the quarter, and we're saying that in terms of patient visits to doctors, vaccination rates, elective surgeries, where we're expecting a gradual increase, a gradual improvement over Q2 levels beginning in Q3. Same thing with new to brand prescriptions, where we're expecting a gradual improvement over two Q levels beginning in Q3. And then in the US, just a gradual improvement in terms of our reps visiting and getting to meet face-to-face with healthcare professionals. So it's definitely a gradual improvement. That's an update from the language we put into Q1. And most importantly, all of which we have factored into the latest guidance that we provided to you all for 2020. And that includes Total Company, the new Pfizer, and the Upjohn guidance that we provided.

What do you use the U.S. do you now is that the will contribute to go mmm <unk> supplemented by.

South America and <unk>.

When it comes to Oh decided will be executed.

It is currently soon we will have sufficient number of individuals and route but honestly.

No simple easy.

To support within some filing.

<unk> in September.

Mm hmm depending on.

Event.

Well I see nothing disease.

And you standpoint, I think you don't want to give them more deepen the primary endpoint.

No it's against coupon Patronising.

[laughter] <unk> as well.

Hmm.

Oh <unk> nation.

We use it he's doing technology <unk> from <unk>.

Michael Dolsten: Thank you very, very much, Frank. And Michael, could you speak a little bit about our study design, the firing assumptions, interim analysis, etc.

Sixtym system to ask when I was using antibodies tends to be music solution.

Michael Dolsten: Yeah, thank you for the question. So we started dosing yesterday, which will be 30,000 healthy adults aged 18 to 85. We have more than 30 states and the U.S. picked in areas that will contribute to both enrollment as well as event rates, and that is supplemented by South America and Europe. When it comes to how the study will be executed, it is currently assumed that we will have a sufficient number of individuals enrolled by early September to allow several interim analyses to support potential filing that could start in September or in October, depending on event rates, as well as vaccine efficacy. And at this time point, I don't think I want to give more details. The primary endpoint is... Advocacy against confirmed COVID-19 in participants without evidence of infection before vaccination.

So why don't you will probably would not be.

Amelie [laughter].

Interim analyses, who needs to do need you to Stockton finding from September running through <unk> and this is most pending our assumptions on your density I meant to say that assumption.

The two weeks ago looking at incidence of disease and use the <unk>.

Over the last few de <unk>, what you do they use it is right.

Do you need.

So if anything we would expect.

I mean today, he didn't meet sooner rather than the <unk>, which is <unk>.

Finding music scene.

September to December timeframe.

Thank you very much.

Thanks. Thank you very much my comment again, we had very clearly in our press release. The study design has been discussed extensively whatever the a and b are following all the guidelines. So if the a has put out there and that should be the golden splenda for anyone who is doing studies for probably maybe.

Michael Dolsten: as well as efficacy against confirmed COVID-19.

We can go through the next question.

Michael Dolsten: and without evidence of infection before vaccination. We use PCR technology to confirm infection of SARS-CoV-2 as well as using antibody tests to confirm previous exposure.

Your next question comes from Louise Chen from Cantor.

Hi, Thanks for taking my questions here. So my first question is basically there's been some concerns that Pfizer could have a hard time meeting the 6% CAGR projection or at least 6% CAGR projections are 2025, what do you think the street is missing here and then at your upcoming Investor day on the R&D.

Michael Dolsten: So all in all, it's a well-powered study to detect meaningful vaccine efficacy, and the interim analysis could lead to an opportunity to start planning for filing from September running into October. And this is, of course, pending our assumptions on event rate. I want to say that our assumptions were made a few weeks ago, looking at the incidence of the disease in the US and elsewhere. And over the last few weeks, unfortunately, the incidence rate has made the disease even more prevalent. So if anything, we would expect that planning to be able to hit the event rate sooner rather than later, which is, of course, favorable for a potential filing for this vaccine in the September to October timeframe. Thank you very much.

Okay, what kind of new data and pipeline can we expect to see and where do you hope to address the key things that you want to address this meeting and then last question I have for you with it as you move towards being a bio pharma pure play what kind of margin expansion can we expect to see over the next several years. Thank you.

No I lost over 6% and then I will ask John young to speak Elizabeth watching should expect during the are in the day and then obviously from can speak about the marketing Sponsons no I as I said, the 6% Cagar, we feel very strongly multi band or.

Dumping, but the time, where I'm going to school, we allow me to speak about the they oh, the and pretty Lucky we had no mogens Blicher I don't see frankly in most of for a the I'm going to expectations, but let me try.

Albert Bourla: Thank you very much, Michael. And again, we had it very clearly in our press release. The study design has been discussed extensively with FDA, and we are following all the guidelines that FDA has put out there. And that should be the golden standard for anyone who is doing studies for COVID-19. Now, we can go to the next question.

Let's start with vaccines, because there's so much into the.

Right now so much baked into it so much into the news.

And I think that to me I noticed archiving as appropriately.

Louise Chen: Your next question comes from Louise Chen from Cantor. Hi, thanks for taking my questions here. So my first question is basically, there have been some concerns that Pfizer could have a hard time meeting the 6% CAGR projection or at least 6% CAGR projection through 2025. What do you think

Expectations for human cocoa 20, as reasonable, but I haven't seen anyone having anything about the question, even before which is a running or face. Some saga and is expected to do leave out I think that late this year beginning of getting regulators here I don't think anyone that has a anything about our.

As me about Pistacchi that people have them study I don't think but anybody has anything about a <unk> been davila meaningful corker well start people got starting I don't think anyone has anything about the line.

Louise Chen: The last question I have for you is that as you move towards being a biopharmaceutical pure play, what kind of margin expansion can we expect to see over the next several years? Thank you.

Vaccine, but it seems in phase two study and is progressing and it is all about their vaccines that there there's no basically.

Albert Bourla: I will answer the 6% and then I will ask John Young to speak a little bit about what you should expect during the R&D day and then obviously Frank can speak about the emerging expansions Now, as I said, the 6% CAGR, we feel very very strongly about it and I don't think that the time horizon of this call will allow me to speak about the entries that we have in our models that I don't see, frankly, in most of the analysts' expectations but let me try Let's start with the vaccines because it's so much into the... right now it's so much dated and it's so much into the news I think that the analysts are having, as appropriately, expectations for Pneumococcal 20 as we do but I haven't seen anyone having anything about Clostridium difficile which is running a phase 3 study and is expected to read out, I think, late this year or beginning, I think, late this year I don't think anyone has anything about RSV that has started a pivotal study I don't think that anybody has anything about Pentavalent, meaning Ococcal, that has started a pivotal study I don't think anyone has anything about the Lyme [inaudible] A similar vaccine in development, you can say Pneumococcal 20 has a competing Pneumococcal 15 but the rest I don't think anything like that. We have right now together with COVID-19 seven vaccines in the clinic. 7.

Assuming youre seeing in development you can say you booked when he has a competing pneumococcal 50.

But the rest of the thing anything.

We have right now together with Corbett seven vaccines indicated.

Seven right.

Let's go now to a rare diseases I think everybody's putting some some revenues on the.

Vince to kill ER, and the right and so but I don't think anyone is having anything about or a discovery platform.

Almost nothing and there's not one which is the one of their discussing recently because she said that data releases like given the same muscle list of it there always are coming soon the markets like him today or in a very upbeat and these are very very big markets and we're having very very stronger data shows significant for babies are there will be successful I don't think.

Anyone restructuring there and also some smaller programs, but both together they said her contributions like the via more feeling other pump hemophilia product. If the high end also about the growth hormone I looking anyone is five putting anything there.

When you look in Thermo medicines are the thing anyone is marketing anything.

And we haven't been able to present recently very good data Oh, not sports for EUV is progressing very nicely, but also it's you'll be hoops it could be a tremendous opportunity tools and I can go in and long so.

Albert Bourla: Let's go now to rare diseases. I think everybody is putting some revenue on Vindakel, and rightly so. But I don't think anyone is having anything about our gene therapy platform, almost nothing, and there's not one which is the one that we're discussing recently because we have data releases like Duchenne muscle dystrophy. There are others that are coming sooner to the market, like hemophilia A or hemophilia B, and these are very, very big markets, and we're having very, very strong data, so there are significant probabilities that I don't think anyone is factoring in there and also some smaller products, but all together they have a contribution like the hemophilia, the pan hemophilia product TFPI, and also growth hormone. I don't think anyone is factoring anything in there. When you go to internal medicines, I don't think anyone is factoring anything in, and we have recently been able to present very good data from our NAS portfolio that's progressing very nicely, but also the GLP, which could be a tremendous opportunity to move. And I can go on and on.

There is a lot of four or stuff like I think right now people are looking modeling and that's going to explain why people. Some of that people are or may be talking about the 6% isms four or five or so but they don't want even as anyway. When I see the analysts expectations are very big discrepancy between the.

<unk>, but I think that well, yes, we are proving to all of you into the market.

Our ability to execute on which saw this and best response, having their results I think people love when we see it would assign there I'd love.

With that being said.

A good way to do bought the fish to have a good discussion with you during the investor and analyst zone to discuss with us what salary expects to shoot up there.

Thanks, and thanks for the question Louise.

It's just given you some great highlights of some of the programs.

Our pipeline that we believe are potentially under appreciated and maybe you know haven't been as visible to the analyst community. So our goal for the Investor Day is that we really wanted to highlight what we're very excited about it in terms of the strong capability and the productivity of our R&D organization, we're going to provide an update on each of our five core.

R&D doesn't business units and our pipeline.

And I think we feel this is exactly the right thing to do that with the announcement to the up John transaction.

Pipeline as Albert just comment said, you know really being stronger than it's been in years.

Do you feel this is a perfect time to share the excitement about five this profile as a leading pure play innovative biopharmaceutical company so to peek into the detail that Albert's gone through but I would just say that will focus today on.

Albert Bourla: So there is a lot of stuff, but I think right now people are not modeling, and that could explain why some people are maybe factoring that the 6%, I don't know, it's 4% or 5%. But I don't think there is any way when I see the analysis expectations of a very big discrepancy between the six. But I think as we are proving to all of you and to the market our ability to execute on these studies and as we start having readouts, I think people will see it and will assign the right value. A good way to do that is to have a good discussion with you during investor day. And I will ask John to discuss with us what we should expect to see that day.

Programs that we expect the launch by 2025 2026 programs that analyst community are generally not currently modeling in their valuations.

Programs, where there's new data so I expect that we'll be able to shed some light on several pipeline opportunities that we see is promising and certainly including some of the specific programs that Albert mentioned.

Thank you very very much on and of course also the unique thing with this days nothing we tried to also present the people behind the success. So we will give you a visibility to our scientists and their commercial people that are driving.

Each one of this and units.

Frank can you. Please to answer the question what their margin sure. So Louise let me just start with what's in the.

Switches, if you look at our guidance for new Pfizer one of the things. We say is 37% we call. It IBT adjusted margin not just refresh everyone's memory IBT as income before taxes, but in Pfizer. That's basically operating income and then in includes other income because we have significant equity income coming into that.

Albert Bourla: So I think Albert's just given you, you know, some great highlights of some of the programs in our pipeline that we believe are potentially underappreciated and maybe, you know, haven't been as visible to the analyst community. So our goal for Investor Day is that we really want to highlight what we are very excited about in terms of the strong capability and the productivity of our R&D organization. We're going to provide an update on each of our five core R&D-driven business units in our pipeline. And I think we feel this is exactly the right time to do that, with the announcement of the Upjohn transaction and our pipeline, as Albert's just commented, really being stronger than it's been in years.

From the consumer joint venture so that what that is framing.

The way I think about this is we grow the topline talbot's point.

6% on a CAGR basis to 2025.

Well leverage that to the bottom line, we're growing one with her on the topline at least 6%.

Clearly have operating income that's growing at a rate that's greater than that we also believe I also believe there's opportunities to be more efficient than <unk>.

So that that 37%.

Albert Bourla: We really do feel this is the perfect time to share the excitement about Pfizer's profile as a leading peer-play innovative biopharmaceutical company. So I won't repeat, you know, the detail that Albert's gone through, but I would just say that we'll focus today on programs that we expect to launch by 2025-2026, programs that the analyst community is generally not currently modeling in their evaluations, and some programs where there's So I expect that we'll be able to shed some light on several pipeline opportunities that we see as promising, and certainly including some of the specific programs that Albert mentioned.

We'd like to do what we expect to do.

I see that go from 37 into the higher 30, So 30, 39, and ultimately I'd like to see that begin one for that's how we think about it.

Thank you for I mean, I realize there's always trying to save some fine, but I didn't speak about oncology and the in inflammation in things that the elements are not Oh, no mobilink and Warid because I may go into trouble with the people of his units.

Bob talked but anything you know inflammation I think a lot of I noticed our modeling the upper season, but I don't think about if anybody is moving all the rest of there.

Doc portfolio right now we have five.

The new molecular entities, but we are trying in 10 different indications and that was by design. Our strategy was very different than the struggling or for other companies. That's usually they tried for efficiency to select the best targets in developing for everything once we do we selected the best target for a specific disease.

John Young: Thank you very, very much, John, and of course, the unique thing about this day is that we will try to also present the people behind this success, so we will give you visibility to our scientists and commercial people that are driving each one of these units. Frank, can you please answer the question about the margin?

Because different products all different.

Molecules they respond very differently, maybe this isn't the skin on the GAAP or on the old beef is enough writers. So they struggled to now he's about to start giving us significant write downs for all the other molecules that are Tommy and of course in them policy. In addition to the or what.

Frank D'Amelio: So Louise, let me just start with what's in the release, which is if you look at our guidance for new Pfizer, one of the things we say is 37%; we call it IBT adjusted margin. Now, just to refresh everyone's memory, IBT is income before taxes, but at Pfizer, that's basically operating income, and then it includes other income because we have significant equity income coming into that line item from the consumer joint venture.

And what is happening in the new model should be case, and the resistance to cancer from all the whole year group don't forget the acquisition of already about these are the Boulder Plaza Boulder, we call. It dry mouth, let's see I am extremely productive group, but they are keep providing new leads.

And you're expecting to have a into clinic from this group was due largely to.

You Mallinckrodts every month.

Frank D'Amelio: So now what that is framing. The way I think about this is we grow the top line to an average point of at least 6% on a CAGR basis through 2025, and we will leverage that to the bottom line. So we're growing, and when we're growing the top line at at least 6%, we're going to clearly have operating income that's growing at a rate that's greater than that. We also believe, I also believe there are opportunities to be more efficient in our SINA spend so that that 37%, you know, what we'd like to do, what we expect to do is to see that go from 37 into the higher 30s, so That's how we think about it.

So oh, sorry was alone.

I'm, sorry, but you know it's a long list we can go to the next question.

Your next question comes from Chris Schott from JP Morgan.

Great. Thanks, so much for the questions.

My first what was just coming back to a co vid vaccine pricing.

I guess my question is do you see this initial 1950 per dose pricing that we saw last week as a decent proxy for pricing overtime or or should we expect price to decline here as we think about a range of potential vaccines being developed and some of your competitors, maybe different pricing strategies coming to market and then my second question was kind of a bigger.

Picture one here it seems like you're running kind of an unprecedented development program with the covert vaccines to the extent. This is successful do you see an opportunity to apply some of these approaches to broader product development.

Albert Bourla: Thank you, Frank. And I realized as I was trying to save some time that I didn't speak about oncology and immune inflammation in things that the animals are not modeling, and because I may have gotten into trouble with the people of this unit about that. In immune inflammation, I think a lot of analysts are modeling abrasifitinib, but I don't think that anybody's modeling all the rest of the JAK portfolio. Right now, we have five.

In an effort can be speed development timelines in areas of unmet need I'm trying to think here is like is there some read across the rest of the portfolio to the extent that this the study successful. Thanks so much.

[noise] Grayson dangerous to find instead of asking onset across or the first question about the piece the pressing buttons monitor.

It's a the private though we have said in a that youre surprised that the basically it's a good benchmark for the slogan the volumes that people are usually or the last of the price would be higher if they are the more could be a little bit lower but this is a very good benchmark and I don't think buddies when things during the pandemic because you are.

Albert Bourla: New molecular entities that we are trying in 10 different indications, and that was by design. Our strategy was very different from the strategy of other companies, which usually try for efficiency to select the best target and develop it for everything. What we did was select the best target for a specific disease because different drugs or different molecules respond very differently if the disease is on the skin or in the gut or if it is arthritis. So this strategy is now about to start giving a significant readout for all the other molecules that are coming. And of course, in oncology, in addition to the work that is happening in new model CDKs and resistance to cancer from our La Jolla group, don't forget the acquisition of ARAE, that is Pfizer-Bolder, we call it right now, that they are an extremely productive group that keep providing new leads, and we are expecting to have in the clinic from this group one to likely two, a few molecules every month. So, sorry, it was a long answer, but you know, it's a long list. Now, we can go to the next question.

I live in how many products would it be or it's not the irrelevant, but I assume the and I hope that many vaccines, what would be register and we'll make the car.

But the steel the demand for southern into hub being young people will be very very hard and so.

So I think it wouldnt be maintained as analysts said in her answer or after the pumping quincy's offered to have this significant sensor volumes demand for volumes now, which would take us otherwise. It's when do you want beginning there maybe of a 22, obviously, we could go through a much more normal type of.

Oh, well for a situation where volumes would be much more normal and or the price also will be based on the competition over time and doesn't really based on the volume, but the product the brakes, which is not the case right. Now obviously it is a price well well below the volume of Brinksmanship driving this.

And as regarding your second question, you said before moving to Michael about the can we usually slot for.

Okay and spot from don't forget that we're working already two years for a funny vaccine by using the organic lots, where I'm already Mike and spoke in his I think you see a question what she sees met in answer to a similar question before he sees multiple opportunities to use or the.

Chris Schott: Your next question comes from Chris Schott from J.P. Morgan. Great, thanks so much for the questions.

Chris Schott: My first one was just coming back to COVID vaccine pricing. I guess my question is, do you see this initial 1950 per dose pricing that we saw last week as a decent proxy for pricing over time? Or should we expect prices to decline here as we think about a range of potential vaccines being developed and some of your competitors with maybe different pricing strategies coming to market? And then my second question was kind of a bigger picture one here. It seems like you're running kind of an unprecedented development program with the COVID vaccines. To the extent this is successful, do you see an opportunity to apply some of these approaches to broader product development in an effort to maybe speed development timelines in areas of unmet need? I'm just trying to think here, you know, is there some reading across the rest of the portfolio to the extent that this study is successful? Thanks so much.

The platform in different type of visitors.

Thank you very much.

Next question please operator.

Next question comes from.

From Evercore.

Hi, Thanks, so much for taking my question I have two if I may and perhaps first Albert I know maternal CEO said that he expects based on his data a 75% to 80% odd declaring the phase three bar set by the FDA for the coated vaccine I'm curious axeda again, I'm not I'm not sure right you can you.

Say again, what he said sure Alberto Moderna seal believes the odds of clearing phase three it's 75% to 80% based on the data. They produced <unk> are you in the same ballpark based on the data you're seeing.

And one for Michael if I may Michael in the press released last night, where are you decided to take the b to vaccine concert the phase three.

Albert Bourla: Chris, in the interest of time, instead of asking Angela to answer the first question, but it is the person that is managing this, look, the price that we have set in the U.S. is the price that basically is a good benchmark for this level of volumes that people will order. If they order less, the price could be higher. If they order more, it could be a little bit lower, but this is a very good benchmark, and I don't think that this will change during the pandemic because it is irrelevant how many products there will be... It's not irrelevant, but I assume that, and I hope that many vaccines will be registered and will make the cut, but still, the demand for seven and a half billion people will be very, very high, and so this, I think, will be maintained.

And not the previously published be one what I noticed was the pivotal factor was perhaps that there were more spike specific T cell epitopes being seen with this second contract can you give us a little more specifics on that and can you also speak to the fact that several studies are suggesting about half of T cell response could.

Actually be on epitopes, which are beyond the spike in the first please thank you.

Yes, thank you very much warmer.

No I don't want myself to speculate now what is that <unk> ability to what I see if a the product will be successful you know the startup startup in the the only one but will tell us is the data readout.

But I will 70 offerings here because the day doesn't look I've seen so far are very very very strong, but again there had been cases that are very very strong clinical data in the face to end the phase three for some reason doesn't work, but Ah Ah I think is very high on my own.

Albert Bourla: As Angela said in her answer, after the pandemic, which is after we have this significant surge of volumes, demand for volumes now, which will take us all the way to 21, beginning maybe in 22, obviously, we could go to a much more normal type of situation where volumes will be much more normal, and the price also will be based on the competition of the time and also will be based on the value that the product brings, which is not the case right now It is priced well, well, well below the value that it brings to society this product. And as regards your second question, instead of also moving to Michael, can we use this platform? We have already been working for two years on a flu vaccine by using the RNA platform, and Michael spoke in his answer to a similar question before that he sees multiple opportunities to use the platform in different types of diseases. Thank you very much.

The Miss base and the data, but I have seen so far but you need to wait to see what are the result will be and then Michael can explain all the excellent questions, but you do your Ross.

Yeah. The thing John birds, So I wouldn't say was a great question and as we said we had two great 16 candidates.

And the date.

You see but to be too.

The system testing around spy, yes, we did.

A number.

In the body.

It's one [laughter] genes or B D, but.

It's too fragmented outside or B D.

And we think there is the richness of Jesus.

Cdfour T cells.

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I would like.

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The majority of the overwhelming use indicee look immunology, it's nice to them.

Viruses with immune system unique neutralizing antibodies.

Yeah.

Albert Bourla: Next question, please, operator. Your next question comes from Umer Raffat from Ivacor. Hi, thanks so much for taking my question. I have two, if I may.

But you need Cdeight T cell.

Vibrant <unk>.

Hi.

And that really.

He lasting and it's not just related to spike its related.

Right.

Umer Raffat: And perhaps first, Albert, I know Moderna's CEO said that, based on his data, he expects, based on his data, a 75 to 80% odds of clearing the phase three bar set by FDA for the COVID vaccine. I'm curious. Say it again. I'm not sure I hear you. Can you say it again, what he said? Sure, Albert. So, Moderna CEO believes the odds of clearing phase three are 75 to 80% based on the data they have received. Are you in the same ballpark based on that data? and one for Michael, if I may.

No.

How you modified overnight and we spent several years to get into that.

That's been 60, a long time [laughter] <unk>.

I'm thinking nature.

Onto something really unique.

With that you will.

Yes.

He wants it to answer was related to <unk> really good to an ability lodos <unk> nice.

No wonder and younger so one.

So a lot of encouragement for moving forward here.

Umer Raffat: Michael, in the press release last night where you decided to take the B2 vaccine construct to phase three and not the previously published B1, what I noticed was the pivotal factor was perhaps that there were more spike-specific T-cell epitopes being seen with this second construct. Can you give us a little more specifics on that? And can you also speak to the fact that several studies are suggesting about half of the T-cell response could actually be on epitopes which are beyond the spike in the first place? Thank you.

Thank you.

Next question.

Your next question comes from David Risinger from Morgan Stanley.

Yes, thanks, very much and congrats on all of the ER positive update so I have two questions on the Kogut vaccine first should we expect to see primate data in coming weeks, which provide information on the durability of your vaccine after the SEC.

Dose. The reason why ask is obviously, a there's a need for a booster just 30 days after the first dose so it'd be helpful to better understand.

Albert Bourla: Yes, thank you very much, Umer. Look, I don't want myself to speculate now on what the probability is that I will see if the product will be successful. You know, the study has started, and the only one that will tell us is the data readout. But I will share the optimism here because the data that we have seen so far are very, very, very strong. But again, there have been cases where you have very, very strong clinical data in phase two, and phase three for some reason doesn't work. But I think it's very high. Based on the data that I have seen so far, I'm an optimist, but we need to wait to see what the readout will be. And then Michael can explain all the excellent questions that you asked.

How durable the efficacy is post the second dose.

And second with respect to your arrangements that your that you've booked with the U.S. government and that you plan to a range with X U.S. government entities could you just discuss pfizer's cope it vaccine liability.

The shield expectations, specifically, what the U.S. government can protect you against in the event that there are surprising or adverse events down the line and then what you can a range with X U.S. entities. Thank you.

No. Thank good they're very good questions both of them Michael can you. Please oh I'm sorry.

Michael Dolsten: Yeah, thank you, Albert. So I just wanted to say it was a great question.

Question about when we can expect primary data the durability and by the way, our Dave or boosted its coming 21 days. After the first those and then I will ask Dr. lumpier commend them, but I mean.

Michael Dolsten: And as we said, we had two great vaccine candidates, and in the end, the data or totality favored the B2. And the specific question about spike, yes, we detected a number of epitopes in the spike S1 fragment that contains RBDE but also in the S2 fragment that's outside RBDE.

Yes, thank you on but yes department, they I think yeah.

Is that we were able to sue.

No signs.

In addition.

Negativity disease.

We were able to soon.

Oh, the wanted me to we're able to do them disease.

Michael Dolsten: And we think there is a richness of T cell epitopes for CD4 T cells and for CD8. I would like to particularly point out that the majority, or the overwhelming views in the field of immunology, are that to fight against viruses with the immune system, you need utilizing antibodies when the virus is outside the cell, but you need CDHP cells to kill viral-containing cells when the virus is hiding in the cell. And that was really part of our whole question, and it's not just related to spike.

Hi ways, including lung and also knows.

Two was there.

Suggesting that we can take individuals that we'd be exposed to the virus and.

Lucidly it needs to be <unk> also reduce the risk spreading departments.

We'll be the Beast Uh huh.

We also need in animals and humans.

There you have uses for that the neutralizing antibodies.

Michael Dolsten: It's related to how you construct the envelope, the lipid nanoparticles, and how you modify the RNA. And we spent several years trying to get into that goal that's been associated for a long time as a successful way of preventing viral infections by vaccination. And I think we're on to something really unique in our platform here with that dual way of combating the infection. And, of course, it also was related to really good tolerability, low dose, and nice immune response in older and younger patients. So all of that, of course, gives us a lot of encouragement for moving forward here.

Yes, he <unk> teams a number of <unk> <unk> to 70, <unk> insulin Liberty and that's against that we actually continue to school believes he needs me peaked in the binding antibodies.

Schools.

Tends to your ability to you.

He is looking the literature <unk>, yes.

Durability, because it's an issue he knows well sometimes.

We love field <unk> decent people.

Albert Bourla: Next question, please.

Hi, this is particularly the Cds insight to talking to them.

David Risinger: Your next question comes from David Reisinger from Morgan Stanley. Yes, thanks very much.

This is 10 years, the more or so.

So it's the one instantaneously why did we lose the durability pools lease.

David Risinger: And congrats on all of the positive updates. So I have two questions about the COVID vaccine. First, should we expect to see primate data in the coming weeks that provide information on the durability of your vaccine after the second dose? The reason why I ask is that, obviously, there's a need for a booster just 30 days after the first dose. So it'd be helpful to better understand how durable the efficacy is post the second dose. And second, with respect to your arrangements that you've made with the U.S. government and that you plan to arrange with ex-U.S. governments and entities, could you just discuss Pfizer's COVID vaccine liability shield expectations, specifically what the U.S. government can protect you against in the event that there are surprising adverse events down the line, Thank you.

Yeah.

Lets schools, that's the boosted this weekend easily use.

He needs me and <unk>.

The.

Thank you to boost foods antibodies and <unk>.

Equally.

No I think sometimes.

No that's difficult even one time, we side all of the cooler weather viral classrooms, so Steve.

Really.

Yes, we select.

They are well known Nondeal knowledge and experience will Smith to instill soon.

Thank you.

Thank you might be dogs.

Yes, thanks, a in the U.S., we expect the prep back in the vaccine, they're going to provide Pfizer broad protections against any personal injury claims that might come out of.

Albert Bourla: Thank you Dave, very good questions, both of them. Michael, can you please answer the question about when we can expect primary data, the durability? And by the way, Dave, our booster is coming 21 days after the first dose. And then I will ask Doug Lankler to comment on the reliability.

Any type upon to the vaccine or side effects or otherwise I'm. We're pursuing similar liability protection is outside the United States to contractual indoor legislative efforts and we believe this is going to be manageable.

Thank you very much Darren.

And operator, if we cannot take our last question. Please and then we'll have a closing comment for the Albert Thank you.

Michael Dolsten: Yeah, thank you, Albert. Yeah, the primate data, I think, have two key components. One is that we were able to show that there was no signs of any augmentation of the negative effect on disease outcome. On the contrary, we were able to show that B1 and B2 were able to prevent disease in airways, including the lung and also the nose. And that B2 was very effective in this, suggesting that we can protect the individuals that will be exposed to the virus and possibly, as it needs to be confirmed in humans, also reduce the risk of spreading the virus. It will still be a bit too early to have a lot of data on durability.

Your final question comes from the liner Geoffrey Porges SVB Leerink.

Thank you very much for taking my question.

Oh pull up on their toe the pivotal trial over the next few months could you clarify what you'll be telling us and win and then how that will affect the blinding and ultimately getting to pull safety data for full approval.

It sounds as though as we all know you got to get the number of events pretty quickly.

So what do you communicate when the studies enrolled.

Do you communicate the efficacy results at the interim to the extent that you hit the statistical and point and then again what effect will not have on the food safety data, but presumably you still need to get to achieve full approval. Thanks.

Michael Dolsten: We are following it in animals and in humans, and we have seen so far that the neutralizing antibodies actually tend to rise, even though the total number of antibodies tends to stabilize at some level. And that suggests that we actually continue to evolve the immune response with more potent binding antibodies. I want to also add that when it comes to durability...

Yes, so that's one of the interest of times I've.

Obviously, if we hit the unique dream approval and effectiveness and the effectiveness and point, we'd certainly communicate them and then there.

I'm not sure right now or if we will provide the regular updates as to how many are enrolled and when they're all I mean is completed as Michael said, he's going to be very lumpy doesn't hold me anyway.

Michael Dolsten: If you look in the literature, in general, antibody durability of the vaccination can last quite some time, but the really long-lasting durability is in the T-cell compartment, and for viral diseases, particularly CD8-positive cytotoxic cells, they have been detected 10 years or more after SARS-CoV-1. And we tried all of the platforms, whether viral platforms, protein-based, and mRNA, and for a pandemic like this, we selected a construct based on a large number of knowledge and experience cross-platform and cross-construct. Thank you.

So we brought on by the end of August to have enrolled the Missouri.

For a far 50000 patients and then the results could come depends on the efficacy of the vaccine and depends also on the Bevan Oh for the disease.

He from September into October this is the content assumptions Angelo Gordon will make it the no all usually would have done in the Pos ways that.

We can unblinded data for in D., and we can still maintained the blindness. When the stock. These are from TV, because we started seeing away our plan to continue 40 years.

Michael Dolsten: Thank you, Michael. Doug?

Doug Lankler: Thanks. In the U.S., we expect the PrEP Act and the Vaccine Act are going to provide Pfizer broad protections against any personal injury claims that might come out of any type of harm from the vaccine or side effects or otherwise.

Going to be monitoring our own patients.

And so that's what I can give you right now.

Let me then thank you all for joining us today and for your continued engagement with with Pfizer.

Doug Lankler: We're pursuing similar liability protections outside the United States through contractual and or legislative efforts, and we believe this is going to be manageable. Thank you very much, Doug. Operator, if we can take our last question, please, and then we'll have a closing comment from Albert. Thank you.

I mean, you really enjoy this this earnings call a very strong girl.

Oh personal performance, so very very few questions on products and a lot of questions. The dominated the called on our pipeline of course with a number I'm confident I didnt. Because this is a tremendous opportunity for the wont to be able to bring gas and effective in say.

Jeffrey Porges: Thank you very much for taking the question. Just to follow up on the COVID pivotal trial over the next few months, could you clarify what you'll be telling us and when, and then how that will affect blinding and ultimately get the full safety data for full approval? It sounds as though, as we all know, you're going to get the number of events pretty quickly. So will you communicate when the study's enrolled? Will you communicate the efficacy results at the interim to the extent that you hit the statistical endpoint? And then, again, what effect will that have on the full safety data that, presumably, you still need to get to achieve full approval? Thanks.

Vaccine.

Third our key in market medicines remain strong our pipeline remains robust and we remain we've only been in it but that's all over the long term growth strategy to yield at least 6% CAGR from agenda gratified. Following the completion of the pending opt in my life combination we discussed a lot about our hard work to come.

Corporate 19, and who have been very encouraged by the early days so far in Marina based vaccine program Weve biopic My heartfelt things go Oh, well the colleagues at both companies who are working tirelessly to find many contributions to this global funding and because of their efforts on cost.

Albert Bourla: Just for the interest of time, Jeff. Obviously, if we hit in an interim approval the effectiveness endpoint, we will certainly communicate that. I'm not sure right now if we will provide regular updates as to how many we have enrolled and when the enrollment is completed. As Michael said, it's going to be a very rapid enrollment anyway, so we plan by the end of August to have enrolled the majority of our 30,000 patients. And then the results could come, depending on the efficacy of the vaccine and also on the burden of the disease. From September to October, this is the current assumption, and that will make it known.

Then to say the science when.

Yes.

Hey, Greg or something.

Ladies and gentlemen, this does conclude Pfizer's second quarter 2020 earnings Conference call you may now disconnect.

[noise].

Albert Bourla: Obviously, we have done in the past ways that we can unblind data for FDA, and we can still maintain the blindness when the studies are continued because the studies are anyway planned to continue for two years, and we are going to be monitoring our patients. So that's what I can give you right now. Let me then thank you all for joining us today and for your continued engagement with Pfizer. I really enjoyed this earnings call, very strong operational performance, so very, very few questions on products and a lot of questions that dominated the call on our pipeline, of course, with number one COVID-19 because this is a tremendous opportunity for the world to be able to bring an effective and safe vaccine.

Albert Bourla: As you have heard, our key in-market medicines remain strong, our pipeline remains robust, and we remain fully confident in the potential of the long-term growth strategy to yield at least 6% CAGR through 2025 following the completion of the pending Abgen-Myla combination. We discussed a lot about our hard work to combat COVID-19, and we have been very encouraged by the early data of our mRNA-based vaccine program with BioNTech. My heartfelt thanks go out to all the colleagues at both companies who are working tirelessly to find medical solutions to this global pandemic, and because of their efforts, I am confident to say that science will win. Have a great rest of your day.

Operator: Ladies and gentlemen, this does conclude Pfizer's second quarter 2020 earnings conference call. You may now disconnect. [inaudible] Thank you for watching! BF-WATCH TV 2021