Q3 2020 Pfizer Inc Earnings Call

Good day, everyone and welcome to Pfizer's third quarter 2020, <unk> earnings Conference call today's call is being recorded.

Unknown Executive: Good day, everyone, and welcome to Pfizer's 30th anniversary of the Pfizer-BioNTech 2020 conference, Ernie's Coffee. Today's call is being recorded.

This time I would like to turn the call over to Mr. Triano Senior Vice President of Investor Relations. Please go ahead Sir.

Unknown Executive: Time, I would like to turn the call over to Triano, Senior Vice President of Investments. Please go ahead.

Unknown Executive: Thank you, operator. Good morning, and thanks for joining us today to review Pfizer's third quarter 2020 financial results, our updated 2020 financial guidance, Pfizer's role 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, Dr. Albert Bourla, Frank D'Amelio, our CFO, Michael Dolsten, our Chief Scientific Officer and President of Worldwide Research Development and Medical, Angela Wong, Group President, Pfizer Biopharmaceuticals Group, John Young, our Chief Business Officer, and Doug Lankler, our General Counsel. The slides that will be presented during the call were posted to our You'll see on slide three our disclaimer regarding forward-looking statements we will make during the call regarding, among other topics, our anticipated future operating and financial performance, business plans and prospects, and expectations for our product pipeline and inline products, which, of course, are subject to risks and uncertainties, as well as the use of non-GAAP financial information.

Thank you operator good.

Morning, and thanks for joining us today to review Pfizer's third quarter 2020 financial results, our updated 2020 financial guidance Pfizer.

Pfizer's role 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 Dr. Robert borrower.

Frank Demilio, our CFO Mark.

Michael Goldstein, our Chief Scientific Officer, and President of worldwide Research development and medical Andrew Wong Group, President Pfizer Barbara Biopharmaceuticals group.

The young our Chief business Officer, and Doug Lankler, Our general counsel.

The slides that will be presented during the call were posted to our website earlier. This morning and are available at Pfizer Dot com forward slash investors.

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

Risks and uncertainties as.

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

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

Unknown Executive: Additional information regarding these forward-looking statements and our non-GAAP financial measures is available in our earnings release, including under the Disclosure Notice section and under Risk Factors in our SEC Reports 10-K and 10-Q. Forward-looking statements on this call speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. Albert and Frank will now make prepared remarks, and then we'll move to a Q&A session. With that, I'll now turn the call over to Albert Borlaug. Albert.

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

Albert and Frank will now make prepared remarks, and then we'll move to a Q1 day session with that I'll now turn the call over to Albert Bourla Albert.

Thank you talking there good morning, everyone a great day here in New York.

Albert Bourla: Thank you, Chuck, and good morning, everyone. It is a great day here in New York. During my remarks, I will discuss our strong third-quarter business performance, speak to the progress we are making in the battle against COVID-19, provide an update on our pipeline and how it is setting us up for an anticipated period of sustained growth, and briefly touch on the topic of affordable access to innovative medicines and vaccines. Let's start with an update on our biopharmaceutical group. For the quarter, revenues in our biopharma business grew 4% operationally, driven primarily by the ongoing strong performance of Vintraquel and Vintamax, growth from our leading portfolio of biosimilars and the continued strength of Kibra, including Eliquis, Ibrance, Xeljanz, Inlita, and Xtandi. These results include an estimated unfavorable impact of approximately 400 million or 4% due to COVID-19.

During my remarks, I will discuss our strong third quarter business performance speaks to the progress we are making in the button gains coming from nine de Novo.

<unk> is an up to date on our pipeline and how are you setting us up for mm dissipated period of sustained growth.

And briefly touch on the topic of affordable access to innovative medicines and vaccines.

Let's start with an update on Obama must biopharmaceutical group.

Cost of revenues you know Biopharma business grew 4% operationally driven primarily by the ongoing strong performance offer via truck rail I mean does much good.

Oh from our religion parts for them, but assuming.

And the continued strength of key brands, including Eliquis, Ibrance Xeljanz, you lie and extending.

These results include an estimated unfavorable impact of approximately 400 million or 4% do you want to call. These 90.

Year to date through three quarters, the Biopharma business.

Albert Bourla: Year-to-date, through three quarters, the biopharma business grew revenues by 7%, which includes an estimated unfavorable impact of approximately 600 million or 2% due to COVID-19. Our global oncology business was particularly strong, up 18% operationally compared to a year ago. Global Ibrance revenues increased 6% operational to approximately $1.4 billion in the quarter. In the U.S., Ibrance revenues grew 9% in the quarter, and Ibrance continues to be a leader in the CDK4-6 inhibitor class for metastatic breast cancer. Infarct, More than 8 out of 10 patients in the U.S. who are prescribed a CDK4-6 inhibitor receive IVs, which should serve as a testament to the continued benefit it delivers to patients, as well as its overall clinical profile. The international markets delivered robust 26% volume growth in the quarter.

Revenues by 7% in person.

Which includes an estimated unfavorable impact of approximately 600 million for the person you called me. Thank you.

Our global oncology business was particularly strong up 18% operationally compared to a year ago.

Global Ibrance revenues increased 6% of the restaurant to approximately $1.4 billion in the world.

In the U.S., our gross revenues grew 9% in the quarter.

And our growth continues to be a leader in the syndicate first six excuse me the glass for metastatic breast cancer.

You follow me.

More than eight out of 10 patients in the U.S. or prescribe a CDK four six in Q bigger receive ibrance.

These should serve as a testament to the continued benefit the reversed the basins as well as its overall clinical profile.

The international markets deliver robust, 26% volume growth.

The volume growth was offset by price reductions in surface, you markets, which resulted in 1% of restaurant revenue growth outside the U.S.

Albert Bourla: Volume growth was offset by price reductions in certain EU markets, which resulted in 1% operational revenue growth outside the U.S. The price reductions occurred last year as a result of the renegotiation of long-term agreements, and it is expected that their impact will continue through to the fourth quarter of 2020, when the price change is annualized. While we were disappointed by the outcomes of the PALAS and PENELOPE-B trials, for two new combination therapies, we remain confident in Ibrance's strong positioning and expected future performance for the currently approved treatment of metastatic breast cancer. This confidence is driven by data. In HR-plus HER2-negative metastatic breast cancer, Ibrance is supported by an extensive body of evidence, including strong clinical data, evidence from real-world analysis, over five years of use in everyday clinical practice, as well as continued positive patient and physician experience. For Xtandi Alliance, revenues in the U.S. were up 18% for the quarter and, when combined with our royalty income on ex-U.S. sales, totaled $374 million.

The price reductions from current last year as a result of the renegotiation of long term agreements and we expect the impact you continue through the fourth warfare, trendy trendy, where the price Saens's annualize.

While we were disappointed by the Oh gosh over the Paulison Penelope B trials.

14, new combination therapies, we remain confident in ibrance strong positioning and expected future performance for the currently approved treatment of metastatic breast cancer.

This confidence is driven by Dave.

The <unk> SAR blash after negative metastatic breast cancer.

Rusty supported by an extensive body of evidence, including strong clinical data.

Evidence from the real work when I was just over five years from using every day getting a practice as well as continued positive patient and physician experience.

For extended the alliance recognizing that you guys were up 18% for the quarter and when combined with our royalty on ex us sales, but don't see pretty hundred $74 million right.

Roll through the U.S. was driven by a continued increase in utilization I mean to me by stopping and no need to start because theres, some resistance and metastatic castration sensitive prostate cancer indications.

Albert Bourla: Growth in the U.S. was driven by a continued increase in utilization in the metastatic and non-metastatic castration resistance and metastatic castration-sensitive prostate cancer indications. Xtandi continues to lead in new patient starts across all approved indications, which tends to be a very good leading indicator of future performance. Global in light revenues increased 41% operationally to $195 million during the course.

Extending continues to lead in new patient starts across all approved indications, which tends to be a very good leading indicator of future performance.

Global enlighten revenues increased 41% operationally $295 million during the quarter.

Albert Bourla: In the U.S., In-Lite performance was driven by the strong uptake following last year's FDA approvals for two immune checkpoint inhibitors in combination with In-Lite for first-line treatment of patients with advanced renal cell carcinoma. The international markets also contributed to the performance of Enlighten, with 55% operational, Now turning to certain key products from our other therapeutic categories, has continued to deliver strong performance. Pfizer's 50% share of the Global Alliance revenues, including direct sales markets, was up 9% operationally to $1.1 billion in the third quarter. However, strong volume growth was partially offset by a lower net price due to an increased number of lives in the Medicare coverage gap and the expansion of that gap as well as unfavorable tunnel mix. Vintagel and Vintamar continued their very strong U.S. performance.

The U.S. you liked the performance was driven by the strong uptake following last years would be up through August four two immune checkpoint inhibitors in combination with you like for first line treatment of patients with advanced renal cell carcinoma.

The international markets also contributed to the performance right now weve, 55% operational growth.

Now turning to certain key products from our other therapeutic categories.

Eliquis has continued to deliver strong performance.

Pfizer's 50 person several of the global Alliance revenue.

Including direct sales markets was up 9% operationally to $1.1 billion you definitely yes.

In the U.S. strong volume growth was partially offset by a lower net price due to an increased number of lives in the Medicare coverage gap and the expansion of the Gulf as well as unfavorable.

No mix.

Been documented remarks continue their very strongest performance.

Our disease awareness efforts helped drive the estimated diagnosis rates to more than 17% in the quarter and compared with only 1.2% prior to launch.

Albert Bourla: Our disease awareness efforts helped drive the estimated diagnosis rate to more than 17% in the quarter and compared with only 1-2% prior to launch. At the end of the quarter, more than 17,500 patients were diagnosed, more than 12,000 patients received a prescription, and more than 7,300 patients received the drug. For the quarter, we estimate the average number of patients in the U.S. taking Vinteco was approximately 7,000.

At the end of the quarter more than 17500 patients have been.

Diagnosed more than 12000 patients have been received a prescription and more than 7300 patients have received the dark.

For the quarter, we estimate the average number of patients in the U.S. thank him vindictive.

It was approximately seven films.

These numbers include patients who are receiving the drug it's no cost through our patient assistance programs.

Albert Bourla: These numbers include patients who are receiving the drug at no cost through our patient assistance program. I would also point out that in Q3 we began to see a rebound from the slowdown in new diagnosis that we had expected and so it is due to due to stay-at-home orders, and we will continue to monitor. Global Xeljanz revenues were up 10% operationally in the quarter to $654 million, primarily driven by 6% growth in the U.S. and 18% operational growth in international developed markets.

I would also point out that in Q3, we began to see a rebound from a slow down we knew diagnosis.

We had expected and so in Q2 due to stay at home orders and we will continue to monitor.

Global sales of those revenues were up 10% in person I mean, the quarter to $654 million, primarily driven by 6% growth in the U.S. and 18% operational growth in international developed markets.

The underlying prescription demand either U.S. grew 13% compared with the third quarter of 2019.

Albert Bourla: The underlying prescription demand in the U.S. grew 13% compared with the third quarter of 2019. We have invested in formulary access in the U.S., which has played a vital role in enabling this volume growth. Revenues from our global biosignals portfolio grew 80% operationally to $424 million. These were driven primarily by our oncology biosimilars, which generated revenue of $261 million. Global Prevnar-13 revenues were down 3% operationally to $1.5 billion.

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

Revenues from our global bias, you must portfolio grew 8% operationally.

$424 million.

These was driven primarily.

By our own caused by seniors, which generated revenue.

$261 million.

[laughter] Global Prevnar 13 revenues were down 3% approximate $1.5 billion.

Revenues outside the U.S. grew 14% operationally driven primarily by increased adult uptake in certain international markets, resulting from greater vaccine and warn us arising from the COVID-19 pandemic.

Albert Bourla: Revenues outside the U.S. grew 14% operationally, driven primarily by increased adult uptake in certain international markets, resulting from greater vaccine awareness arising from the COVID-19 pandemic. However, we should note that Prevnar-13 is indicated for the prevention of pneumonia resulting from pneumococcal bacteria, not SARS-CoV-2, as well as continued strong pediatric uptake in China. In the US, revenues were down 14%, primarily reflecting timing of government ordering patterns compared with last year, and the impact of a shared clinical decision-making adult recommendation, meaning the decision to vaccinate should be made at the individual level between healthcare providers and their patients. However, all of this was partially offset by the recovery of a portion of missed doses from the second quarter. Now a few words about Apple. Absent revenues totaled $1.9 billion in the quarter, down 18% operationally.

Although we should note.

River, Denise indicated for the prevention of pneumonia, resulting from pneumococcal bacteria note subsequent to that as.

As well as continued strong did you actually got things in China.

The U.S. revenues were down 14% prime.

Primarily reflecting timing of government ordering patterns compared with last year.

And the impact but for certain clinical decision, making adult recommendation, meaning that the season vaccinate should be made at the individual level between healthcare providers and their patients.

All of this was partially offset by the recovery of a portion of missed doses from saying yes.

Now if you want to smoke awesome.

Optum revenues totaled $1.9 billion in the core down 18% depression.

Albert Bourla: The decline that was expected was driven primarily by three factors that we had anticipated. The significant volume declines for Lyrica in the U.S. due to multi-source generic competition that began in July of 2019. Lower revenues for Lipitor and Novavax in China due to the impact of the Volume-Based Procurement Program, which was initially implemented in March 2019 and expanded nationwide in December 2019, and lower volumes for Celebrex in Japan resulting from generic competition that began in June of 2020. We continue to expect the closing of the APJOM transaction with Milan to occur this quarter. Now I will turn to our R&D pipeline, beginning with an update on our COVID-19-related efforts. The Global Phase III study for our mRNA vaccine candidate that we are developing with our partner BioNTech is ongoing at approximately 150 clinical sites around the world, including the United States, Germany, Turkey, Brazil, South Africa, and Argentina. To date, the trial has enrolled more than 42,000 participants, with nearly 36,000 of them having received their second dose. We expanded our initial planned enrollment in the study from 30,000 people to approximately 44,000 people.

The decline was expected it was driven primarily by three factors that we had anticipated.

The significant volume declines for you regarding the U.S. you do multi source generic competition that began in July of 2019.

Lower revenues for Lipitor and Novartis in China due to the impact of the volume based procurement program, which was initially implemented in March 2019, and expanded national wide in December 2019.

And lower volume for celebrities uptime, resulting from generic competition weve begun easily offended plant.

We continue to expect the closing over the optimum transactional with Mylan to occur this fourth.

Now I will turn to our R&D pipeline, beginning with an update on our corporate name deal related efforts.

The global Phase three study for our Ameren name vaccine candidate that we are developing with our partner biotech is ongoing at approximately 350 clinical sites around the world.

Including the United States, Germany, Turkey, Brazil, South Africa and Argentina.

Today, the trial has enrolled more than 42000 participants.

Nearly 36000 of them having received the second dose.

We expanded our industrial planned enrollment in the study from 30000 people to approximately 44000 people.

This allows us to include additional populations you know study include.

Albert Bourla: This has allowed us to include additional populations in our study, including people as young as 12 years old and people with chronic, stable HIV, hepatitis C, and hepatitis B. As we reiterated in an open letter... We may know whether or not the vaccine demonstrates efficacy soon. In the case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know. I can say today that the Data Monitoring Committee has not been unblinded to efficacy data, nor has it conducted any interim efficacy analysis today. But I want to be clear that, after today's earnings call, we do not intend to speak publicly about interim analysis until we have a conclusive readout from the Data Monitoring Committee. For emergency use authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine.

Including people as young as 12 years old and people with chronic stable HIV hepatitis C and b.

B.

As we reiterated in an open letter.

We may know whether or not the vaccine demonstrates efficacy.

He gave a conclusive read though positive or negative we will inform the public as soon as we complete the necessary I mean, it's sort of the war, which we estimate to be completed within one week from in time, we know.

I can start today, but the data monitoring committee.

It's not being unblinding to actually doesn't they.

Nor has it conducted an interim efficacy analysis today.

But I want to be clear about after todays earnings call. We do not intend to speak publicly about interim analyses and feel we have a conclusive result from the data monitoring committee.

For emergency use authorization in the U.S. for potential COVID-19 vaccine.

M.D.A. is requiring the companys provide two months of safety data on half of the trial participants following the final dose of the vaccine.

Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November.

Albert Bourla: Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. And finally, Pfizer has been investing at risk since the early days of the pandemic in an effort to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.

And finally, Pfizer has been investing at the risk since the early days of the pandemic in an effort to perfect our manufacturing processes and rapidly build up capacity.

We expect to have our manufacturing data ready for submission before the safety milestone you streets.

So assuming positive data Pfizer will apply for emergency use authorization in the U.S. soon after the safety milestone is achieved which we expect to be in the third week of November.

Albert Bourla: Assuming positive data, Pfizer will apply for emergency use authorization in the U.S. soon after the safety milestone is achieved, which we expect to be in the third week of November. Regarding our antiviral candidates, we believe this potential first-in-class protease inhibitor may give us the opportunity to demonstrate meaningful antiviral activity to help treat COVID-19 patients, which initiated the Phase IB study in September. And we are planning a pivotal Phase 2-3 study to start in late 2020 and early 2021, with the hopes of submitting for approval in the second half of 2021. Let's look at some highlights from the rest of the pipeline, which continues to be one of Pfizer's great strengths. At our Virtual Investor Day event in September, we presented data from our Phase 1b Duchenne muscular dystrophy gene therapy project. Since our update at Investor Day, we have dosed an additional boy at the high dose, bringing us to a total of 16 treated with a high dose and 19 boys treated overall. Importantly, no serious adverse events were observed among the 10 additional boys who were treated using a modified immunomodularity regimen and monitoring.

Regarding our on the virus kinda do we.

We believe these potential first in class protease inhibitor may give us the opportunity to demonstrate meaningful anti viral activity.

Three copied 90 basis.

We initiated the phase one B study in September.

And we are planning people with a phase two three study start late Twentytwenty early 2020, one with a host of submitting for approval in the second half of Wendy Wendy Wong.

No.

Let's look at some highlights from the rest of the pipeline.

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

During our virtual Investor day event in September.

We presented data from our phase one b descent muscular dystrophy deep therapy program.

Since our update at Investor Day.

We have dosed and additional boy the high dose, bringing us with total of 16 treated with high dose and 90 boys three did overall import.

Importantly, no serious adverse events were observed among the 10 additional boys who were three D. Using modified even minimal you lazy regimen and monitoring.

Arrangement. Additionally on October 1st we received fast track designation from the FDA for this program.

Albert Bourla: Additionally, on October 1st, we received fast track designation from the FDA for this product. We plan to begin dosing participants in our Phase 3 clinical study before the end of the year. On October 7, we, along with our partner Sangamon, issued a joint press release to announce that we have dosed the first participant in the Phase III F-ing study of SB525, which is an investigational gene therapy for hemophilia A patients.

We plan to begin dosing participants in our phase three clinical study before the end of the year.

On October seven.

We along with our partner Sundar, you suit and joint press release to announce that we have dosed. The first participant in the phase three efficacy study of SB Fivetwenty five we seize an investigational gene therapy for M. A C D eight patients.

Albert Bourla: The primary endpoint is... Impact on annual bleed rate through 12 months following treatment compared with Factor VIII replacement therapy collected in the Phase III leading study period. On October 8, we issued a press release with our partner, OPCO, announcing that our Phase 3 randomized, multicenter, open-label, crossover study, evaluating somatrogon dosed once weekly in children 3 to less than 18 years of age with growth hormone deficiency, met its primary endpoint of improved treatment burden compared to xenotropics. For injection, administer once daily. No serious adverse events were reported.

The primary endpoint is.

Impact on annual bleed rate through 12 months following treatment compared with Fox door eight replacement therapy collecting the phase three leading study period.

On October eight we saw a press release with our partner optical announcing that our phase three randomized multicenter open label crossover study evaluating so my problem dosed once weekly in children three two less than 18 gifts are faced with.

Growth hormone deficiency met its primary endpoint of improved treatment burden compared to do not dropping 40.

40, Dexter administered once daily.

No serious adverse events were reported.

We plan to file our biologics license application with the FDA the score.

Albert Bourla: We plan to file our biologics license application with the FDA this quarter, our next generation CDK inhibitor program, built on our Ibrance leadership and our deep knowledge of metastatic breast cancer. Our CDK4-selective inhibitor has been shown preclinically to target CDK4 with more than 10 times the potency of Ibram and without the neutropenia sometimes seen with CDK6 inhibition. This improved therapeutic index may provide more opportunity for potential safe combination treatments in breast and other cancer types. Our CDK2-selective inhibitor has been shown in preclinical models to combine with Ibrance to prevent or overcome resistance in HR-positive breast cancer and has the potential to drive efficacy in a variety of tumors, including CDK2 activation, especially in combination with standard-of-care therapy.

Our next generation CDK inhibitor programs built on our Ibrance leadership, and our deep knowledge of metastatic breast cancer.

Our CDK for selective inhibitor has been shown preclinically meet the target CDK for with more than 10 times, the buttons, you'll fibers and without the neutropenia, sometimes seen Cindy.

Syndicates seeks distribution.

These improved for a few big index may provide more opportunity for potential safe combination treatments in breast and other cancer types.

Our syndicate to selective inhibitor.

Its been shown in preclinical models to combine with ibrance to prevent or overcome resistance in HR positive breast cancer and has the potential to drive efficacy in a variety of tumor tumors, including syndicate to activation, especially in combination.

Standard of care therapy.

Because of the strong preclinical results we've started dosing patients in phase one studies for these two programs for both.

Albert Bourla: Because of these strong preclinical results, we have started dosing patients in phase one studies for these two programs. For both, or BCMA-CD3 bispecific monoclonal antibody, generated phase one data supporting a strong clinical signal of efficacy with a very high response rate in heavily pretreated multiple myeloma patients. We plan to soon expand the program into a pivotal study and multiple clinical drug combination projects. Our new drug application for Abracitinib, for the treatment of moderate to severe atopic dermatitis in patients aged 12 years old and up, has been accepted by the FDA with a priority review PDUFA date in April of 2021. Additionally, the European Medicines Agency has validated the marketing authorization application for review. Our Phase 3 clinical trial program has shown that abracitinib demonstrated statistically superior improvements in skin clearance, disease extent, and severity, as well as improvements in itch versus placebo.

Oh, we see a me cdthree these bi specific monoclonal antibody.

Generated phase one data supporting a strong clinical signal.

Efficacy with very high response rate in heavily pretreated multiple myeloma patients.

We plan to expand the program into pivotal study and multiple clinical drug combination projects.

Our new drug application for upper Sydney.

For the treatment of moderate to severe atopic dermatitis in patients aged 12 years old and.

Has been accepted by the FDA with pricing.

If you would have you been due for a day in April of 2021.

Additionally, the European Medicines agency has validated for review the marketing authorization application.

Our phase three clinical trial program has shown that I've received demonstrated statistically superior improvements in skin clearance disease extend and severity as well as improvements he eats versus placebo.

Lastly, our partner <unk> Mi.

Albert Bourla: Lastly, our partner, Valneva, announced positive initial results for its second phase 2 study of its Lyme disease vaccine candidate, VLA-15. Compared with the first study, which had a dose schedule of months 0, 1, and 2, this study investigated a vaccination schedule of months 0, 2, and 6, based on matching doses. The VLA-15 vaccine candidate displayed an encouraging immune response profile with seroconversion rates of greater than 90%, including in all the adults, and the serum bactericidal assay demonstrated antibodies were induced against all studied serotypes.

Announced positive initial results for its second phase to stop you'll for Lyme disease vaccines conducted via late 15.

Compared with the first study.

Had a dose schedule of months zero, London do this study investigated the vaccination schedule of Zuma zero, two and seeks base.

Based on matching those.

The ventilation steam vaccine candidate displayed and encouraging immune response profile with senator conversion rates of greater than 90%.

Including in older adults.

And the second but could you size up and see demonstrated anti bodies were used against all stobie sewer pipes.

We are late 15 was found to be generally well tolerated across all doses and age groups density and the tolerability profile, including fever rates were comparable to our liquidated recombinant vaccines or leap containing formulations.

Albert Bourla: VLA-15 was found to be generally well-tolerated across all doses and age groups tested, and the tolerability profile, including fever rates, was comparable to other lipidated recombinant vaccines or lipid-containing formulations. Most important, no related serious adverse events were observed in any treatment group. Given these two positive Phase 2 studies, we feel increasingly confident about this Lyme vaccine candidate and are eagerly awaiting the final Phase 2 study to define the Phase 3 dosing regimen, followed by an expected pivotal event study. As you know, following the expected closing of the Abjon-Milan transaction, Pfizer will be a smaller but focused and innovative biopharma. Following the Absent separation, we expect a five-year revenue CAGR of at least 6% on a risk-adjusted basis and continued growth beyond that time frame from the next wave of our patent-protected portfolio. Our adjusted EPS during that same five-year period is expected to grow approximately 10%.

Most important no related serious adverse events were observed in any treatment group.

Given these two positive phase two studies, we feel increasingly confident about this mine machine can do that and are eagerly awaiting the final phase two study to define phase three dosing regimen, followed by an expected people don't even started.

As you know following the expected closing of the UBS on Mylan transaction, Pfizer will be smaller, but focused and innovative biopharma companies.

Following the absence of horizon, we expect a five year revenue cagar of at least 6% on a risk adjusted basis and continued growth beyond that timeframe from the next wave of our patent protected portfolio.

Our adjusted EPS during the same five year period is expected to grow approximately 10%.

I would remind you that these projections exclude any potential impact from our krave vaccine and on the viral programs.

Albert Bourla: I would remind you that these projections... exclude any potential impact from our COVID vaccine and antiviral products. We believe that during our Investor Day, we provided a clear path to this growth project. In fact, we indicated that by 2025, we need only about 40% of our non-risk-adjusted projected pipeline revenue to achieve the expected 6% 5-year capability. So we believe we have a very good safe margin of error. Abracitinib is the one potential near-term compound where we see the biggest difference compared with consensus. We see Abracitinib and Zaks, in general, serving to increase the number of patients treated and that this is not a zero-sum game with the biologics in the treatment of moderate to severe atopic dermatitis. Lastly, we are finalizing our enabling functions review and related actions and expect the anticipated financial benefits from these actions to begin being realized in 2021. Before I close, I want to say a few words about affordability.

We believe that during our Investor day, we provided a clear path to these growth projects.

In fact, we indicated but by 20 to 25, we need only about 40% of our non prescriptive projected fiberlan revenue, but.

Let's see we expected 6% five year CAGR.

So we believe we have a very good safe margin of error.

He is the one potential near term compound, where we see the biggest difference compared with consensus.

We see <unk> and ducks in general serving to increase the number of patients treated and that this is not a zero sum game with a biologics in the treatment of moderate to severe atopic dermatitis.

Lastly, we are finalizing our enabling functions review and related auction.

We expect the anticipated financial benefits from these actions to begin <unk>.

Being realized in 2021.

Before I close I.

I want to say a few words involved affordability.

As we have said in the past our breakthrough medicines and vaccines one do anyone any good if people can afford monthly accident.

Albert Bourla: As we have said in the past, our breakthrough medicines and vaccines won't do anyone any good if people can't affordably access them. We are committed to working with both parties in Washington to put patients first. That means prioritizing policies that aim at better aligning insurance design with patient needs, like reforming Medicare Part D to create an out-of-pocket cap and ensuring that rebates are passed on to patients instead of being kept by the middle.

We are committed to working with both parties in Washington to put patients first.

That means prioritizing policies, but take aimed at better aligning insurance design with patient needs like.

Like reforming Medicare part D to create an out of pocket CCOP and ensuring that the rebates are passed on to patients instead will be kept by the middlemen.

Regardless of what happens in November.

Frank D'Amelio: Regardless of what happens in November, we will be ready to take a seat at the table and play a constructive role in shaping the debate for the benefit of the people. Now, I will turn it over to Frank. [inaudible] In our release, so let me provide a few highlights regarding the quarterly Pfizer, following $1,000,000 in revenue for the quarter, which represented 84% of total company revenue. Biopharma revenue grew 4% in the quarter.

We will be ready to take a seat at the table and play a constructive role in shaping the debate for the benefit of a pace.

Now I will turn it over to Frank.

Thanks, Albert Good day, everyone.

So let me provide a few highlights regarding the quarterly financials.

Our biopharma business, which will become new Pfizer following the close of the up John transaction.

The rate of $10.2 billion in revenue for the quarter, which represented 84% of total company revenue.

Operational basis.

On the revenue, 4% in the quarter and 7% for the first nine months of the year.

Frank D'Amelio: 7% year-to-date operational revenue growth for biopharma was driven by, Price-to-volume mix was a 9% increase in volume for Upjohn, although the year-over-year comparison is skewed again by the impact of generic lyric, China Market. The business continues to perform in line with our expectations and assumptions Prevnar Upjohn, Now, moving down Quickly on Gross, or a slight negative impact. Driven by lower sales from Lyrica, Celeb, are all part of our. There was some offset to this impact due to low inventory right. We had another quarter where we. There are two obvious factors at work here. The exclusion of consumer Covid but also a third factor, which is a planned reduction in spending associated with our Pfizer Structure, which will be a smaller We are finalizing this initiative and will be able to better quantify the expected financial benefit when we provide Supported diluted EPS for the quarter. Adjusted diluted EPS was down 3% compared to the prior year.

The 7% year to date operational revenue growth was driven by continued solid volume growth in our price to volume mix.

The increase in volume.

Two 2% negative impact from price.

For up John although the year over year comparison is skewed again by the impact of generic.

Changes in the China market. The business continues to perform in line with our expectations and assumptions are already reflected in our up John guidance for the year.

Now moving down the income statement.

Touch quickly on gross margin, which saw a slight negative impact during the quarter, mainly driven by lower sales from lyric Celebrex Laboratory mask, which are all part of our up John business as well as some incremental cost.

<unk>.

There was some offsetting this impact of the lower inventory write offs compared to the year ago quarter.

We had another quarter, where we saw a significant year over year decline adjusted <unk> expenses, which were down 10% operationally.

There are two obvious factors at work here, the exclusion of consumer health expenses, and lower selling expenses due to cold, but also a third factor, which is a planned reduction in spending.

With our corporate enabling functions.

The midst of aligning those functions to the new structure, which will be a smaller and less complex organization.

We are finalizing this initiative will be able to better quantify the expected financial benefit we provide our 2021 financial guidance.

Right.

Reported diluted EPS for the quarter was down significantly compared to the year ago quarter.

Driven by the non recurrence of a one time.

From the consumer joint venture formation in the year.

Quarter.

And adjusted diluted EPS was down 3% compared to the prior year quarter.

Unknown Executive: Including the two cents negative impact of foreign exchange rates in the period, adjusted diluted EPS was a penny lower compared to the prior year, by about $100 million, or. In addition, with last quarter, we are providing three sets of, The guidance continues to only include the at-risk spending on our COVID vaccine candidate, but does not include any potential revenue. The vaccine is authorized and we deliver doses to various... In terms of our broader COVID-related... I expect a gradual recovery in health care activities, and also note that upon the closing [inaudible] All guidance we are providing will not be, Start by saying, there were no... Pfizer or Upjohn, 2020 Guidance Factors, and only slightly, Total Company, we are tightening our guidance This is mainly a factor of reducing the top end of the range as opposed, CODS as a percentage of revenue is slightly, The S-RNA range is lowered a bit at the midpoint, mainly COVID, and enabling function-driven, and R&D increases slightly.

The two cents negative impact of foreign exchange rates in the period.

Yes, it was a penny lower compared to the prior year.

Foreign exchange also negatively impacted revenues in the quarter.

Hundred million dollars or 1%.

Consistent with last quarter, we are providing three sets of financial guidance a few points here regarding our assumptions the guidance continues to include.

On a cold and vaccine candidate, but does not include any.

Central revenue, we may receive this year.

The rise then we deliver doses the various governments.

Agreements.

In terms of our broader broader cobot related assumptions, we expect a gradual recovery in health care activity.

I'd also note that upon the closing of the transaction, we will treat the up John business as a discontinued operation.

So assuming the completion of the up John transaction before December 31st.

Guidance, we are providing will not be aligned with the ultimate numbers we print.

I'll start by saying there were no changes made to either the new Pfizer up John 2020 guidance factories, and only slight refinements total company guidance.

Total company.

Our guidance range for revenues, which results in a small decrease in our mid point.

And this is mainly a factor we're reducing the top end of the range as opposed to a change in our forecast.

Cogs as a percentage of revenue slightly increased mainly due to cold weather related cost.

Signed a range is <unk> point.

Unknown Executive: This nets out to a slight increase in the midpoint of our... Moving on to Financial Guidance for New Pfizer and Upjohn, which is shown here. As I referenced, we are not. We are not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Not Narrowed ranges for our 2020 total company guidance, including Sinae, R&D, and Adjusted Diluted EPS, and we reaffirmed our existing guidance components for both new Pfizers. We also achieved multiple product and pipeline milestones since our last quarterly update, some of which are listed here. A more complete listing can be found in this morning's press release to our shareholders for the first nine months of this year. As always, we remain committed to delivering attractive shareholder returns in 2020 and beyond. Now I'll

Mainly.

Enabling function, driven and R&D increases slightly mainly due to additional spending.

This nets out to a slight increase in the midpoint of our adjusted EPS range.

Moving on to financial guidance for New finds went up John which is shown here.

As I referenced we are not making any changes either.

<unk>.

Moving onto the key takeaways in the third quarter, our company performed well driven by strong revenue growth from our Biopharma business.

We narrowed ranges for our 2020 total company guidance for revenues cost of sales.

R&D.

Yes, and we reaffirmed our existing guidance components for both new Pfizer and up John.

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

A more complete list and can be found in this mornings press release finally, we paid 6.3 billion to our shareholders in the first nine months of this year as always we remain committed to delivering attractive shareholder returns 2020.

Now I'll turn it back over to Chuck.

Unknown Executive: Great. Thank you, Frank and Albert, for the prepared remarks. So, time now to start our Q&A session. And operator, can I ask you to please poll for the questions? Ladies and gentlemen, if you will. Press star 1 on your telephone. The next question comes from the line of Umer Raffat.

Right. Thank you Frank and Albert for the prepared remarks, so a time now to start our Q and a session and operator can I ask you to please poll for questions.

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

Your first question comes from the line of thought from Evercore.

Hi, guys. Thanks, so much for taking my question I know, there's a ton of questions.

Albert Bourla: Hi guys, thanks so much for taking my question. I know there's a ton of questions that everyone has, but let me just ask one, Albert, for all the generalist investors listening in, which I think all the specialists understand, but can you just remind everyone how a blinded trial works and how you guys don't have any visibility on where the trial is tracking for the generalists. But let me get to my question now. In your trial, the definition of positive COVID revolves around one general symptom and one positive PCR. However, the general symptoms could be very broad. So I guess my question is the fact that there wasn't any sterilizing immunity in the non-humid primates. Isn't it reasonable to assume that we could see some positive PCRs on the vaccine even though there's a good amount of neutralizing titers?

That everyone has but let me just ask one Albert for the for all the generalist investors listening in which I think was a specialist I understand but can you just remind everyone that how a blinded trial works and whether and how you guys don't have I think visibility on where the child tracking for the generalist, but let me get to my question now in your trial.

The definition of a positive coded revolved around one general symptom in one positive Pcr.

However, the general symptoms could be very broad so I guess my question at the fact that there wasn't any sterilizing immunity in the non human primates isn't it reasonable to assume that we could see some positive PCR is on vaccine, even though there's a good amount of neutralizing titers and if you could remind us what's the cycle threshold for PCR you're using thank you very much.

Albert Bourla: And if you could remind us, what's the cycle threshold for PCR you're using? Thank you very much. Thank you, Umer, and I will ask Michael to comment on that, just a couple of words before. Usually, in a study like this, people in that study need to be blinded so nobody knows if they have received the vaccine or the placebo. That includes the doctor or the nurse that administers the vaccine or the patient who is receiving it. And, of course, all are going to a database that is locked with a code so no one can have access from Pfizer except a very small team that is protected by Chinese walls. And of course, the DMC is going to, is periodically receiving unblinded information, but they haven't started yet. So, the data monitor committee is composed of independent experts.

Thank you Omar and I will ask Mike to comment on but just a couple of was before.

As far the A. usually people.

People to study needs to be blinded somebody nobody knows if has received the vaccine or placebo, but includes the doctors or the nerve administer the vaccine or the patient was receiving it and of course all are going to databases I think this law.

With a cold so no one can has access from the Pfizer, except the very small team, but it is a perfect. Thanks, a lot for Chinese walls and of course, the DMC is going to use receiving could pay off the gully information on blinded, but not very easy to spot.

Yes, so the data monitoring committee there is a oh, it's composed by independent experts about the they haven't seen any unblinded data yet and they haven't performed any analysis interim analysis yet.

Albert Bourla: But they haven't seen any unblinded data yet, and they haven't performed any interim analysis yet. And with that, I will ask Michael to speak a little bit about the specific technical questions. Yeah, thank you for the question. Umer, we have, as you know, two primary endpoints. The first relates to the impact of a naive patient on the first infection, and the second one relates to the same but also adds reinfection in those that were previously infected with SARS-CoV-2. We use

And we got that were lost my so to speak a little bit about the especially if they can go question.

Yeah. Thank you for the question.

<unk>, we have them as you know in two primary endpoints first relates to the impact of the naive patients to the pros can pick one and the second one relates to the same but also adding reinfection instill in those that were previously.

Yes.

Infected with the soft Cook too we use.

PCR machines on a commercial platform that we have thoroughly validated and feel very comfortable with and use established criteria for positive cases.

Michael Dolsten: PCR machines on a commercial platform that we have thoroughly validated and feel very comfortable with and use established criteria for positive cases. The central read in our large laboratory is the crucial one. We are also able, at the end of the study, to look at patients that did not develop symptoms since, as you said, we are particularly focused on illness cases. So we use a serology test for the nucleocapsid protein that allows us also to look at the impact at the end of the trial on patients that are symptomatic. The Symptom Illness Scale that we use was established in consultation with many KOLs and FDA, but we also have a secondary endpoint that uses CDC's Symptom Scale.

The Central read you know were large laboratory is the crucial one here.

We are also able at the end of the study to look at a patient that did not develop symptoms since as you said.

We are particularly focused on illness cases, so we use that several of your test for the nuclear Pepsi protein that allow us also to look at the impact.

End of the trial for patients that word symptomatic does seem to unit scale that we use what's established in consultation with many K well and if you say, but we also have secondary endpoint that uses cdcs that's.

Symptoms game, so I think hopefully that covered many aspects of your question.

Angela Hwang: So I think I've covered many aspects of your question. Thank you, Michael. Can we move to our next question, please, operator? Great, thanks for taking my question. So if you won on Eliquis and then won back on the COVID-19 vaccine. On Eliquis, I saw the commentary around the net price being lower due to the coverage gap and also the channel mix.

Thank you Michael how can we move toward next question. Please operator.

Next question comes from the line of Yvonne.

Uh huh.

Great. Thanks for taking my question so.

If you have one on Eliquis in one back on the on the combination vaccine one locos I saw the commentary around the net price being lower in the coverage gap a channel mix I'm wondering if you can maybe just sort of quantify that a little bit more for us is there any sort of sense, how we should think about the pricing dynamic for that going forward.

Albert Bourla: I'm wondering if you can maybe just sort of quantify that a little bit more for us and maybe any sort of sense of how we should think about the pricing dynamic for that product going forward. It is obviously an important product for you guys. And then on the COVID-19 vaccine, Albert, I appreciate your comments today around communicating when you have conclusive information. I think one thing that's just sort of been a little bit confusing before, maybe you're trying to address this now, is this sort of view that you'll have conclusive results in an interim analysis. And so maybe, can you just sort of talk about that, or maybe Michael would want to comment on sort of the confidence you have that an interim analysis in this trial should be sufficient to show conclusive efficacy in the post-event analysis? Thank you.

Yes.

Obviously, an important product you guys it mentally culminating vaccine Alberta.

Albert appreciate your comments today around communicating when you have people its innovation I mean, one thing that's just sort of been a little bit confusing.

And maybe it's only a guess that now is the sort of view that you'll have conclusive result on an interim analysis. It's maybe can you just talk to that or maybe Michael a comment I would say that the confidence you have that that interim analysis of this trial should be sufficient to show inclusive that's because we're still waiting for the point.

Yeah.

Thank you.

Albert Bourla: I will ask Angela to speak about Eliquis, but first, let me take a little bit about COVID-19. Look, we are cautiously optimistic that we will have results and possibly in the interim analysis. You never know before you have the final analysis.

I will ask ons I want to speak about the L. It was let me take first a little bit. The these are covered 90.

We are cautiously optimistic that we will have results and possibly in the interim analysis. We never knew you never know before you have to find that on I guess is this a cautious optimism is coming from the very strong immunogenicity data that we have very strong neutralizing titles and a very strong.

Albert Bourla: This cautious optimism is coming from the very strong immunogenicity data that we have, very strong neutralizing titers, and a very strong T cell response, including CD8, which is one of the most important. But as I said, you never know until you have a study result. And we have reached the last mile here, right?

So response, excluding city, Hey, which is one of the important but as I said you never know you have a.

I started to read out and we have no worries.

Last March you're right. So we expect that these things will start coming soon so let's all having the patience, but is required or something so important for a public health and global economy.

Angela Hwang: We expect that these things will start coming soon. So let's all have the patience that is required for something so important for public health and the global economy. And with that, I will ask Angela to comment on Elixir. So, thanks for the question. So this gross to net adjustment is clearly a key feature of Eliquis because of the large number of Medicare patients. And every year, not only are there a different number, an increasing number of Medicare patients, but there are changes in the coverage. And as we mentioned, the key change this time is the length of time that patients are on this catastrophic coverage. It was longer in Q3 of 2020 compared to Q3 of 2019 by about 25%.

And that was up and I wouldn't ask it ends I want to comment on Eliquis.

So thanks for the question and that is gross to net adjustment is that clearly a key feature of illiquid because of the large number of Medicare patients that we have and that every year not only are there.

A different number one an increasing number of Medicare patients.

But also they are changes in the coverage gap and as we mentioned.

He changed this time is the length of time that patients in the catastrophic coverage gap, which is longer in Q3 up 2020 compared to Q3 of 2019th by about 25% and this is sort of be at that level of impact that we saw.

Angela Hwang: And this is sort of the level of impact that we saw. So obviously, this increases our expenses and is the reason for the unfavorable, but hopefully that gives you some sense of what happened in Q3 of this year. All right. Thanks, Angela and Albert. Operator, let's move to the next question, please. The next question is from Greg Gilbert from Tru. Hi, thanks for the questions. First, Albert, you noted that there's still that gap on Abracitna versus street estimates and what the company sees. I was hoping you could provide a little more detail behind your bullish view beyond what you offered on the call about it not being a zero-sum game. The second part of my question is, Albert, you've expressed a lot of confidence in Pfizer's ability to hit that revenue CAGR, and you did so again today, without COVID and without a deal. But how focused are you and the team on bringing in assets to buttress that growth and or add growth drivers that come later in the decade? Thanks. Thank you very much.

Obviously this increases I spend and the reason for the unfavorably impact I.

Hopefully that gives you some sense of what happened between Q3 of this year and keep me honest here. Thank you.

Thanks, Angela and Adelbert, operator, Oh, let's move to the next question. Please.

Next question is from Gregg Gilbert from Trust.

Hi, Thanks for the questions first Albert you noted that there's still that gap on Abra sitting there versus the street estimates and what the company sees I was hoping you could provide a little more detail behind your bullish view beyond what you offered on the call about it not being a zero sum game and the second part of my question is Albert Youve expressed a lot of confidence in pfizer's ability to hit that.

Revenue CAGR and and you did so again today without covance without deals.

But how focused are you and the team on bringing in assets to buttress that growth and or add growth drivers. That's come later in the decade. Thanks.

Oh, Thank you very much I wouldn't answer the second part of that than I was I'm actually to walk us through they're proceeding there are transactions that than we are we are having we're very confident on big 6% CAGR and I think we haven't broken down to one.

Albert Bourla: I will answer the second part and then I will ask Angel to walk us through the difficult projections that we are having. We are very confident in the 6% CAGR, and I think we have broken it down to what we believe it will take to get there. Right now, if you take the middle point of our guidance with $41.6 billion, we will need $14 additional billion by 2025 to achieve 6% growth. We believe $8 billion are projected to come from our in-line portfolio, and we announced that during our earnings release.

We believe we can take the two rigs there right now or you could take the midpoint of our guidance was 41.6 billion. We will need 14 additional billions by 25, let's see a six person growth.

We believe $8 billion are projected to come from or in line for young people documenting our earnings release. So that's the main but though we are having a 6 billion that needs to come from our current pipeline based.

Albert Bourla: So that means that we have $6 billion that needs to come from our current pipeline. Based on our projections of revenues, this requires only a 40% adjustment.

Based on our projections on the revenue.

This requires only 40% that's awesome. So six on the 15th opinions, but we are expecting to have known risk adjusted in W. Books. It's a very good safety margin Buzby said also we generate a lot of cash and we want to reinvest the skus and but no our business development strategy.

Albert Bourla: So six of the 15 billions that we are expecting to have non-risk adjusted in that year. It's a very good safety margin. That being said, we also generate a lot of cash, and we want to invest this cash. And right now, our business development strategy is to invest in something that we believe can generate significant value for the shareholders. And this is our R&D machine. An R&D machine that has completely turned around its productivity. And right now, it's having industry leading metrics on multiple fronts.

These two invest in something that we believe can generate significant focus are homeless nvcs <unk> R&D machine and R&D machine, that's that's completely.

Now turning around its productivity and right now he's having industry leading metrics in the multiple phones. So our business development will be invested in a face to face.

Albert Bourla: So our business development will be invested in phase two, phase three ready programs that could become medicines in the period 23, 24, 25, 26. And those will, from one hand, enhance the 6% growth, but, even more importantly, will allow us to maintain and sustain this growth beyond 2026. So without further clarification, and thank you very much, Greg, for the question, I would like to ask Enzo to speak a little bit about Ambrositin.

Phase three ready programs, but could become medicines in the theater up from the 324 25 56, and those were going from one can can enhance our that 6% growth.

But even more importantly, it will allow us to maintain and sustain this growth beyond 2026 [noise].

We thought that clarification and thank you very much for the question I would like to Oscar and they'll have to speak a little bit about diversity than it.

Thank you Albert and thanks for the question and giving US the opportunity to my follow up since our discussion.

Angela Hwang: Thank you, Albert. And thanks for the question and giving us the opportunity to follow up on our discussion during R&D day. We are really excited about this opportunity, and we're enthusiastic about it because it is a condition that has a large number of, and a significant unmet need, and both of these things are what we believe drive the size of the opportunity for Avro. So let me unpack that.

R&D day.

We are really excited about this opportunity and when did you think about it because it is a condition that has a large number of patients a significant unmet need in both of these days is what we believe drives the size of opportunity for aberle. So to me unpack that a little bit.

First of all there I think nipigon number 80 suffered globally. They are 60 million 80 separate age 12, and 27 million up though.

Angela Hwang: First of all, there are a significant number of A.D. sufferers. Globally, there are 60 million A.D. sufferers aged 12 and up, and 27 million of those are... and just for a bit of context, that is 10 times the number of RAs Of those 60 million, only 7% of them today are being treated with a systemic treatment. And so the systemic market opportunity has the real potential to more than double with the introduction of better systemic treatment because the patient need is just so high. And let me also put that in context with a market that we know very well today, which is psoriasis. The market for systemics in psoriasis doubled over the last 10 years with the introduction of advanced systemic biologics and also, more recently, the ILS.

And just for a bit of content that is 10 times the number of Ari stoppers today.

Although 60 million only 7% of them today are being treated with a systemic.

And so the systemic market opportunity has the real potential to more than double with the introduction of better systemic treatments because the Haitian need is just so high and images also put that in contact with a market that we know very well today, which is the right.

The market for systemic in psoriasis doubled over the last 10 years with the introduction of that bond systemic biologic and often more recently the island.

So if we step back and take a look at the numbers even at a modest 1% share of the 60 million patient population or if you think about the future.

Angela Hwang: So if we step back and take a look at those numbers, even at a modest 1% share of the 60 million patient population, or if you think about the future systemic market, all I need is 8% of that systemic marker for Abro to reach $3 billion in revenue. And so when you think about all of that and think about the advanced systemic markets that are also in place today, of which there's just one, and 60% of those patients who are on this product are not reaching clear or almost clear skin at 16 weeks, it demonstrates that there really is a lot of room for additional. So, to Albert's point earlier about the fact that this is not a zero-sum game. We don't see the opportunity for Abro as only being about gaining market share from competitors.

Yes, a systemic market.

All I need is 8% of that systemic market calabro to reach 3 billion dollar.

Revenue at peak.

And so when you think about all of that and think about.

We had one systemic markets I don't want to in place today of which there's just one and 60% of those patients go on that and on this product are not reaching clear almost clear skin.

That's 16 weeks it demonstrate that there really is a lot of room for additional systemic option.

So to Elbit point earlier about the fact that this is not zero sum game.

We don't see the opportunity to appro as only seeing about gaining market share from competitors actually the way we see it is that it is an opportunity to grow yet by systemic market through the introduction of excellent treatment options and we believe that the differentiated profile that Apple had will allow us to.

Angela Hwang: Actually, the way we see it is that it is an opportunity to grow the advanced systemic market through the introduction of excellent treatment options, and we believe that the differentiated profile that Avro has will allow us to be a leader in this growing market. And also, don't forget that market development and creating new markets is a real sweet spot for Pfizer. So we are very excited about the launch and look forward to bringing this important service to our customers. Thanks, Angela.

Be a leader in this growing market.

And also don't forget market development, and creating new markets is a real sweet spot for us. So we are very excited about the launch and look forward to bringing this important medicine to the market. Thank you.

Thanks, Angela and and Greg just one comment on your first or second question about the deals you know reminder, that they'll neither in the Lyme disease vaccine area with is going well Irix a deal. We just announced antibiotic segment. So clearly Pfizer is still going to remain active in bringing in assets that can help.

Albert Bourla: And Greg, yeah, just one comment on your first or second question about the deals, reminder that Valneva and the Lyme disease vaccine area are going well, and the Erixa deal we just announced in the antibiotic segment. So clearly, Pfizer is still going to remain active in bringing in assets that can help bolster the long-term revenue growth of the company there. With that, let's take our next question, please, operator. The next question comes from the line of Terrence Flynn from Golden. Thanks for taking the question, and thanks again for all the work on the COVID treatment and vaccine front. I guess, I know you can't provide a lot of commentary, but I think what people are trying to understand is just if there have been any changes to the mandate of the DMC with respect to some of the new FDA guidance, so regarding the timing of the interim efficacy analysis.

Bolster the long term revenue growth of the company there are.

With that let's take our next question. Please operator.

Next question comes from the line of Terence Flynn from Goldman Sachs.

Hi, Thanks for taking the question and thanks again for all the work on the Covance treatment in vaccine front I guess I know you you you can't provide a lot of commentary, but I think what people are trying to understand is just.

If there been any changes to the mandate or the D.M.C. with respect to some of the new ft guidance. So regarding the timing of the interim efficacy analysis so essentially.

Albert Bourla: So essentially, is the DMC mandated now to wait for either, you know, a certain number of severe cases that have to happen or two months of safety follow-up data to kind of, at that point, take a look at the efficacy basis? Because I think you guys have been pretty confident about reporting data in October, by the end of October, and so just trying to understand kind of the timing of the analysis and maybe any new inputs there. Thank you.

The DMC mandated now to wait for either you know a certain number of severe cases that have to happen or two months of safety follow up data to kind of at that point I take a look at the efficacy basis, because I think you guys have been pretty confident about reporting date in October it by the end of October and so just trying to understand kind of the timing of the the analysis.

Maybe any new inputs there. Thank you.

No. Thank you Terence and I understand how or walk is looking for any possible information and that we tried to make sure that we maintain a very responsible way awful from onetime thing correspondent and from the other have not feeding speculation. So what I can tell you to them. Your very specific question on these I'm thinking now.

Albert Bourla: Thank you, Terence, and I understand how the whole world is looking for any possible information, and we try to make sure that we maintain a very responsible way of, on the one hand, being transparent and, on the other hand, not feeding speculation. So what I can tell you about your very specific question is, until now, as we are speaking of today, no, DMC has not been changed to their mandates, there have not been any changes yet, and we believe that the analysis will start soon on efficacy. And if the efficacy is positive, or if the efficacy is negative, we will announce it. And that will happen just a few days after the DMC announces it to us, which usually takes five, six, or seven days. And that it happens before the third week of November, which is very likely because, as I said, we're expecting it soon. A few days before the end of October, and a few days after the end of October, but if it happens before the 15th of November, we will announce it before the 15th of November.

As long as we're speaking of today no DMC has not been changed their mandates there has not been any changes like that and I can still repeat but we haven't.

Perform an interim analysis.

Yep.

And that we believe that a the analysis, we start soon on efficacy and if the efficacy.

These positive already the Efficacies magazine, we will announce it then but ER will happen just a few days after the DMC announced its got to watch, which usually takes 567 days and Vox if it happens before.

Third week of November, which is very likely because as I said, we expect to get soon.

A few days before the end of October a few days after the end of <unk>.

But the even happens before the 15th of November we will announce it before that make them or whatever but as I said right now no. One I was this has been a platform.

Albert Bourla: As I said, right now, no analysis has been performed, DMC is completely blinded to any data, of course, we are completely blinded to any data, and once we have the conditions met, they will unblind their data, and they will start informing us. So let's all be very patient. I know how much the stress levels are growing. I know how much a vaccine is needed in the world. We are seeing right now that the worst fears that we had before during the fall are coming true.

The M.C. is completely blinded in the in any data of course, we are completely blinded him any data.

And the one so oh he have a conditions met they will unblind the data and they were stuck informing us.

So let's all.

Be very pacing I know how much the stress levels are growing I know how much vaccine is needed for the world. We are seeing right now are the worst fears that we've had before during the fall are becoming through a colby disarming bark in Europe and the U.S.

Albert Bourla: COVID is coming back into Europe and the US and globally. And we are working very diligently, very carefully to make sure that we will bring this project through the finish line. Thank you. Right. Thanks, Albert. Very helpful. Next question, please. Operator.

Globally and we.

We are working very diligently very carefully makes here, but we will bring this project.

Through the finish line.

Thanks.

Right. That's a that's Albert very helpful. Next question. Please operator.

Your next question comes from the line of Geoffrey Porges.

Leerink.

Okay. Thank you very much for taking the question, but I'm sorry to keep pushing on this co that.

Albert Bourla: Thank you very much for taking the question. And Albert, I'm sorry to keep pushing on this COVID readout. But you seem very bullish that you will have a positive efficacy readout, I think you said by the end of October, and that you will disclose it. Now it's clear it will be within five to seven days after that. So that suggests that you believe that you will, I think the hurdle for the first interim, something in the range of 75 to 80% efficacy. So is that your expectation?

Okay.

Got you you seem very bullish that you will have a positive efficacy read out I think you said by the end of October and that you will disclose it now it's clear it will be within five to seven days after that.

So that suggests that you believe that you I think the the hurdle for the first interim something.

Something in the range of 75% to 80% efficacy. So is that your expectation and then secondly could you comment on the realistic timing for the first dosing given that the FDA has said they need to contain an AD com, presumably you also need to have the I P. Recommendation then you.

Albert Bourla: And then secondly, could you comment on the realistic timing for the first dosing? Given that the FDA has said they need to convene at ADCOM, presumably you also need to have an ACIP recommendation, then you need to distribute the vaccine. Can you comment on whether it's realistic in your planning right now that anyone will be vaccinated outside a clinical trial by year-end? Thank you, Jeff, and no apologies are needed to be asked. I understand that this is very important for the whole world issue. Let me try five.

I need to distribute the vaccine.

Can you comment on whether it's realistic and Youre planning right now that anyone will be vaccinated outside the clinical trial by year end. Thank you.

Oh, Thank you, Jeff and the no no bonuses are needed to be honest I understand that's a this is a very important for the whole world that these.

Hi, I look basis, that's a vaccine were war I'm cautiously optimistic there.

Albert Bourla: I'm not bullish that the vaccine will work. I'm cautiously optimistic that the vaccine will work. What I said very clearly, it is that we may know by the end of October if it works or not, and I think I reiterate this statement today it could be as I said the October is not for us is I know it's compared with the elections many times but for us the elections is an artificial milestone this is going to be not a republican vaccine or a democratic vaccine that will be a vaccine for the citizens of the world and this is how we see it so I hope that it is going to be effective I hope that it is going to be effective with very high protection ability but we have to wait to see the results of the study now when it comes to distribution assuming we have positive data, Assuming, that means that we will be ready to apply in the U.S. for emergency use authorization soon after we receive the safety data.

Well, what I said very clearly it is but we may know by the end of October if it works or not.

And I think Oh, you're right the right vision statement today it could be as I said the October is not.

For us.

Yes.

I know its compared with the elections, many times, but for us the election season, or if you still might have some this is going to be not the Republican vaccine or Democrats watching those would be the vaccine for this is and some of the world and this is how we see it so I hope, but these are going to be effective.

I hope that it is going to be effective with very high protection, a baby, but do we have to wait.

To see the results are overstocked no when it comes to distribution, assuming we had positive day.

Assuming.

That means that we will be ready.

To to apply in the U.S. for medicines because of regulation.

Soon after we receive the safety.

Data so the safety data are expected to maturity. The third week of November So, let's say, we apply around what that felt fourth week of November then he does I'll split the a.

Albert Bourla: So the safety data is expected to mature in the third week of November, so let's say we apply around that time, the third or fourth week of November. Then it is up to FDA to take as much time as they need to make their approvals. It's not up to us, so I cannot comment on that. What I know is, but we will be ready with the product available.

Take as much time as they need to make a their approval.

He is not up to us so I cannot comment on but one thing, though it is but we will be ready with ER product available again.

Albert Bourla: Again, if all goes well, but we are very well progressing through our plans, we will be ready to distribute an initial number of doses. And I believe that in the U.S. that you are asking about, we have a contract with the U.S. government that we should provide them with 100 million doses by March. And we are feeling very good about our ability to do it. But also, there's a provision that we should provide 40 of these million doses this year. So I think we should be able to provide 30 to 40 million doses if we receive approval and if the U.S. government distributes the vaccines. Just to put things into perspective, let's say 30 million doses; it's 15 million people.

If all goes well, but we are very well and they are going through our plans, we will be ready to distribute.

And then you see a number of doors.

And then I believe that in the U.S., though if you are asking a we have a contract with the U.S. government, but we should provide them hundred million doses by March and we are feeling very good about our ability to do it but also there is a provision up we should provide 40 over this a million doses in this year. So I.

We should be able to talk to the market to be able to provide if we receive approval and if the U.S. government distributes the vaccines just to put things into perspective, let's say $30 million. This it's a 50 million people. So if we make available in the U.S. and their marketing doesn't before 15 million.

Albert Bourla: So if we make the vaccine available in the U.S., that will be for 15 million people by the end of the year, which is a very small part of the population. So it's not going to be massively available; it's going to be targeted in its availability. As we move into the first months of 2021, then we are going to have a much more massive distribution of the vaccine around the world. So I hope that helps put things into perspective. Again, thank you for your interest. We all keep our fingers crossed that science will win.

People by the end of the year, which is a very small part of the population. So it's not going to be massively available is going to be targeted in its availability as we move into the first month. So for 2021, then we are going to have much more massive distribution of the vaccine around the world. So I.

I hope that helps put things into perspective.

Again, thank you for the interest we all keep our fingers crossed but sometimes we win.

Right. Thanks, Albert next question. Please operator.

Albert Bourla: All right. Thanks, Albert. Next question, please, operator. [inaudible] Hi, thanks for taking me here. The first question I had was, is there any way to help us? We have 32 events yet.

Your next question is from Louise Chen from Kantar.

Hi, Thanks for taking my questions. Here first question I had was is there any way to help us think through if you've reached these 32 events. Yeah. I know, there's a lot of investor interest here. So just trying to get as much color as we can.

Albert Bourla: I know there's a lot of investor interest here, so just give us as much color as we can. And then, can you provide an update on how many actual doses of vaccine you've already manufactured? Sounds like you're obviously very positive about your goals here. And the last question is, will you continue to look at potential adjuvant opportunities for Ibrance, or are you really just going to focus on next-generation CDKs? Thank you very much.

Then can you provide an update on how many actual doses of vaccine you've already manufacture it sounds like obviously very positive on your goals here and the last question is will you continue to look at potential acquisition opportunities for Iran. Are you really just going to focus on next generation CDK. Thank you very much yeah, Yeah, again, let me and fake or this.

Question. So far we have heard from your sort of hundreds of thousands of those.

And then moving very rapidly with both sides to start things shaping up much larger production.

Albert Bourla: Again, let me take this question. So far, we have produced hundreds of thousands of them, and we are moving very rapidly with both sides to start initiating a much larger project. When it comes to thinking through it, I don't think I can help you think more than what we have said so far. We are blinded.

When it comes to thinking through I don't think I can have you seen more than what we have said so far we are Ah we are blinded.

Events will accumulate we will unblind the data the M.C. would tell us.

Negative positive or continue if it does not get there were positive we'll let you know if it is and then maybe just continue we will continue on through the next milestone is recently, there's nothing else to think but I'd say as I said.

Albert Bourla: Events will accumulate. We will unblind the data. DMC will tell us if it is negative or positive, we will let you know if it is, and then if it is, we will continue until the next milestone is reached, and there is nothing else to think about, but as I said, we will start this process very soon. Now, for Ibrance, I will ask Angela to comment. So yeah, thanks for the question on Ibrance.

We started this process very soon.

No fly principal loss trends over the coming.

So yeah, I think with that thanks for the question on eyebrows on in terms of focus the librarian when we've been as you know and must be really looking at the I'm not really breast cancer indications.

Indications, which disappointingly did not pan out.

So we are very much focused on metastatic breast cancer as well as our opportunity with Iran, and and here. We continue to feel really confident about what we've seen without data as well as what we're seeing from a market share perspective right. So.

Angela Hwang: In terms of our focus for Ibrance, where we've been, as you know, we've been really looking at the early breast cancer indications, which, disappointingly, did not pan out for us. So we are very much focused on metastatic breast cancer as our opportunity with IBRAN. And here we continue to feel really confident about what we've seen with our data as well as what we're seeing from a market share perspective, right? So first-line use of CDKs in metastatic breast cancer as a class is still only at 52%, so we have a long way to go in terms of our ability to grow this class. But actually, for IBRAN itself...

First line use of CDK in in.

Metastatic breast cancer as a class is still only at 52, but that's what we have a long way to go in terms our ability to grow this class a but.

But actually for Ibrance itself.

It has a very high market share and 87% in fact, and we and we've had this leadership position in first line treatment for many years and in fact since may even post the announcement of the monarchy data. We have seen this consistent market share. So I think that our focus on metastatic.

Angela Hwang: It has a very high market share, 87% in fact, and we've had this leadership position in first line treatment for many years, and in fact, since May, even after the announcement of the Monarch E-Data, we have seen this con... So I think that our focus on metastatic breast cancer and our focus on growing the use of the CDK class in metastatic cancer will continue to provide us with a tremendous amount of information. I think just as a follow-up to your question in terms of, you know, are there other ideas and other thoughts for iBrands, just to remind you that we still have the patina trial that is ongoing, which we'll read out in the second half of 2022 for a different population, the HR positive and HER2 positive population. So it's a slightly different question but really touches on, you know, additional expansion opportunities. Great

Cancer and I'll focus on growing the use of the CDK class in metastatic cancer will continue to provide us a tremendous amount of opportunity I think just as a as a follow up to your question in terms of you know all the other ideas and other support for our brands and just to remind you that we do have still the patina trial that.

Ongoing.

Which will read out in the second half of 2022 for a different population HR positive age and her two positive population. So slightly different question, but I really touches on you know additional expansion opportunities vibrant. Thank you.

Right. Thanks, Angela Thanks for the question Louise Let's take our next question. Please.

Question is from Navin take up from <unk> S.

Thanks, So much for taking my question and I will be a very.

In line with my colleagues about a classroom.

A question on the corporate vaccine, maybe let me try this a different way.

Hi.

Versus your original assumptions when you were designing the trial.

Angela Hwang: Thanks, Angela. Thanks for the question, Louise. Let's take our next question, please. I'm Naveen Jacob from U-B-I-N-T-E-C-H-O-L-D-E-C-H-O-L-D-E-C-H-O-L. Thank you so much for taking the question.

And based on the literature and the dataset data that are out there.

Not necessarily in the fall, but just from what you're seeing outside of the trial.

How do you think the symptomatic wait for folks that are infected compared to when you. Originally designed the study that's question number one and similarly I suppose also with infection rate itself that you know I think when you and and you know when you it and has the size of the.

Albert Bourla: And I will be very in line with my colleagues about questions. Questions about the COVID vaccine. Maybe, let me try this a different way, versus your original assumption when you were designing the trial, and based on the literature and the data that are out there. Not necessarily in the trial, but just from what you're seeing outside of the trial.

Study from 30000 to 44000 patients.

I'm one of the reasons rationale for increasing the size was because of a what you deem to be a slower infection rate wondering about that as well as the sun come rate relative to the original assumption. Thank you so much.

Albert Bourla: How do you think the symptomatic rate for folks that are infected compared to when you originally designed the study? That's question number one. And similarly, I suppose, also with the infection rate itself, I think when you increased the size of the study from 30,000 to 44,000 patients. Time. One of the reasons for increasing the size was because of what you deemed to be a slower infection rate. Wondering about that as well.

Yeah. Thank you know I mean, and again I understand a dangerous thing here.

I don't want to come in much smaller, but what oh, we see it or our infection rates, but the aligned with what we see in the continent absence in order to be a surprise of course is that a lot of the study, but we tried to position or geographic I mean multiple sites that represent basically the tons through the U.S., we don't have the bulk of the pace.

<unk>.

The increase of 30 to 44000 anyway, it wouldn't make any difference in the early results.

Albert Bourla: [inaudible] Thank you, Navin, and again, I understand the interest here. I don't want to comment much more, but what we see are infection rates that are aligned with what we see in the country. That's not to be a surprise because it's a large study that we try to position geographically in multiple sites that represent basically the country in the U.S. where we have the bulk of the patients. The increase of 30,000 to 44,000 wouldn't make any difference in the early readouts.

Would only make the difference because of the lots of numbers and delivery like $3 or so I don't think that was the reason, but oh, we did it was mainly because we felt very very good about the safety profile. So we started the we open.

Our vaccination with two kids of 16 years old and beginning then we went to 12 years old and then we went to people, but they are suffering from HIV from hepatitis B from there, but I do see so this is why it doesn't we used it to improve the diversity of besides liquids, we have make it public so its very very.

He goods right now she's very good about the diversity of our study so.

Albert Bourla: It would only make a difference because of the larger numbers in the very late readouts, so I don't think that was the reason why we did it. It was mainly because we felt very good about the safety profile. So we started; we opened our vaccination to kids aged 16 years old in the beginning. Then we went to 12 years old, and then we went to people that were suffering from HIV, from hepatitis B, from hepatitis C. So this is what we did, and also we used it to improve the diversity of the study, which we have made public. So it's very, very good right now. We feel very good about the diversity of our study.

No I mean, thanks for your question, let's all keep our fingers crossed but are we going to have positive results.

Right now, let's move to the next question. Please operator.

Question is from Chris Schott from JP Morgan.

Hi, great. Thanks, so much for the questions I guess my first was on <unk> and had been and market development Ah. Thank you for your earlier comments I guess my question <unk>, if I look at the already situation. It took some time for the jacks to gain traction obviously now the class is doing really well.

You expect a similar situation in a decent launched it.

Eventually gets pretty large, but maybe take some time to build momentum or are there differences in this market that could allow for faster uptake here and then my second question was on was on the Anticalin. How we think about growth from here should we think about the ratio of diagnosed patients. So those who receive drug to shrink shrink significantly over time.

Albert Bourla: So, Navin, thanks for your question. Let's all keep our fingers crossed that we will have positive results. Great. Let's move to the next question, please, operator. Shot from JPEG, OK.

Or should we think about there being a persistent gap between diagnosis rates and those who actually receive the product. Thank you.

Angela Hwang: Thanks so much for the questions. I guess my first question was on Aberystwyth Nib and market development. Thank you for your earlier comments. I guess my question is, if I look at the RA situation, it took some time for the JACs to gain traction. Obviously, now the class is doing really well. Do you expect a similar situation in AD, so a launch that eventually gets very large, but maybe takes some time to build momentum? Or are there differences in this market that could allow for faster uptake here?

Yes excellent questions. Both I think are appropriate to be answered by Angela so answering my wife numbers, starting with ever since anything or how you think.

The market will evolve given the experience on Irene's arcs, and then of course, and we don't know what target change between diagnosis and treatment that can evolve overtime.

Great. Thank you you know I think you know in all the I. Eni areas, what we're dealing with very complex diseases chronic diseases, where there is a tremendous amount of active patient <unk> patients and a lot of suffering so I think our first and foremost you know I think those are a.

Angela Hwang: And then my second question was on VenteCal and how we think about growth from here. Should we think about the ratio of diagnosed patients to those who receive the drug shrinking significantly over time? Or should we think about there being a persistent gap between diagnosis rates and those who actually receive the product? Thank you. Yeah, excellent questions.

And they topic timeshare that that maybe the difference that I see the greatest between the two is that already is a pretty well established disease for full at home even at the time when we launch without an right. There was a lot of treatments. There was a lot of biologics there was not an oral but there was a lot of biologic.

That in fact is quite different a when we think about where we are with a topic Don indebtedness topic done today.

Angela Hwang: Both, I think, are appropriate to be answered by Angela. So, Angela, why don't you start with abrasitinib and how you think the market will evolve, given the experience of RA and JAX, and then, of course, in vitro, how the change between diagnosis and treatment can evolve over time. Thank you. You know, I think, you know, in all the INI areas, what we're dealing with here are very complex diseases, chronic diseases, where there's a tremendous amount of debilitation for our patients and a lot of suffering. So I think, first and foremost, you know, I think both RA and atopic derms share that. But maybe the difference that I see the greatest between the two is that RA is a pretty well-established disease for which, even at the time when we launched Xeljanz, there were a lot of treatments.

Well it does not great treatment, we talked earlier today about.

The opening up at the systemic treatments that there was a lot of their.

Clearly there is a depicting that has no that has been a you know a great solution for many patients, but even with all of that they're just not a lot of submissions at all and and today. There is still a high mix is really a significant unmet need in terms of.

In terms of what patients are being able to do so I think with all market development with all with all new treatments. It takes time for you to reach peak, but we believe that given the significant unmet need and in particular boy topic, Dan patients aware I think typically we've been focused on skin clearing what we will.

So no for patients is that the number one condition they something from its part right and that when you have agent that can really resolve that and there's all that very quickly. It will open up opportunities that didn't previously exist before.

So that's how I see the market I think were really excited about it we see a great ability to to really meet patient unmet needs and that is going to dry dock right.

Angela Hwang: There were a lot of biologics. There was not an oral, but there were a lot of biologics. That, in fact, is quite different when we think about where we are with atopic derm in that in atopic derm today, there are just not great. We talked earlier today about systemic treatments, right? There's a lot of use of steroids.

Your second question was around the towel and how to think about diagnosis. This is.

The people that we see the drug and and I think on this regard what you should expect to see if there will be some gap right. So between those who are diagnosed and there's always a difference between those that are diagnosed and those will I be eligible to receive treatment.

Angela Hwang: There is a duplexant that has been, that has been, a great solution for many patients, but even with all of that, there's just not a lot of solutions at all, and today there is still a high, which is really a significant unmet need in terms of what patients are being able to do. So I think with all market development, with all new treatments, it takes time for you to reach your peak. But we believe that given the significant unmet need, and in particular, for atopic derm patients, where I think we've typically been focused on skin clearing, but what we also know for patients is that the number one condition they're suffering from is pruritus. So that's how I see the market. I think we're really excited about it.

And then there's a difference between GAAP then that what the next step that you have to take it but those are not treated how many of them actually get the prescription and receive a prescription and I think that actually on that front, we've been doing rather well this quarter Q3, 82%.

Of those who were deemed treatment eligible were able to receive even to Cal prescription.

And that is in fact up from last quarter, where it was actually seven 878% of those lifting eligible for treatment received the script. So the gap is not all that wide and we see an improvement from last quarter to this one so I think along the entire patient final for them to tell.

Now we have great opportunity to lot too you know improve how the patient flows from diagnosis to treatment treatment to receiving a scrip receiving a script actually getting the the medicines in the hands to a specialty pharmacy, it's still a new condition and one that's early in its launch so I think that we have great opportunities to improve.

Angela Hwang: We see great abilities to really meet patients and their needs, and that is. Your second question was around Vindicale and how to think about diagnosis versus the people that receive the drug. And I think in this regard, what you should expect to see is there will be some gap, right? So between those who are diagnosed, there's always a difference between those that are diagnosed and those who are deemed eligible to receive the medicine, and then there's a difference between, or a gap between, or the next step that you have to take is for those that are treated, how many of them actually get the medicine and receive a prescription? and I think that actually on that front, we've been doing rather well. This quarter, Q3, 82% of those who were deemed treatment eligible were able to receive a Vindical prescription, and that is, in fact, up from last quarter, when 78% of those who were deemed eligible for treatment received it.

Every step of the way.

Thank you.

Right. Thanks for the comments Angela.

Next question please operator.

Question comes from Steve Scala from Cowen.

Thank you Albert.

Albert with all due respect could you please be absolutely clear whether the 32 event had been reached already it seems that the answer is yes.

Hi, Sir has the 32 other than otherwise I think you would say no.

And onto the D.M.D. gene therapy will phase three start this year.

And as Pfizer and F.D.A. agreed on a potency assay. Thank you.

Yes, Steve.

[music].

I appreciate it.

The curiosity and I appreciate the creativity and everybody can drive every possible angle, but I think I have on some business foolish. We're not prepared no you used a very creatively you're asking so I wouldn't tell you clearly no. We don't have affected two events right now so.

Angela Hwang: So, the gap is not all that wide, and we've seen improvements from last quarter to this one. So, I think along the entire patient funnel for Vendacal, we have great opportunities to, you know, improve how the patient flows from diagnosis to treatment, treatment to receiving a script, receiving a script to actually getting the medicines in their hands through specialty pharmacy. It's still a new condition and one that's early in its launch, so I think that we have great opportunities to improve every step of the way. All right, thanks for the comments, Angela. Next question, please, operator. Thank you. Albert, with all due respect, could you please be absolutely clear whether the 32 events have been reached already? It seems that the answer is yes.

Oh, no that's what I can say, so and I.

I have to say I am sorry can you remind me what was the second part of my question.

Yes. The question was in DMD has the FDA agreed on a potent T I say.

And Michael maybe you can take it up.

Absolutely.

I think Steve you opposed doors will pay three stores. This year, we expect and I believe play three when starts this year and relatively soon.

That's you know the profile through modification of the stair radone from one week, but keep the to make picky looks really great now and Oh that spoke in his introduction to the nine countries did boys in which.

In the recent often disturbed change we have had no cases with a complement activation. So we're very excited about.

The current plan now for them.

Albert Bourla: Pfizer has 32 events. Otherwise, I think you would say no, and on to DMD gene therapy. We'll phase three start this year, and as Pfizer and FDA agreed on a potency assay. Thank you. Yes, Steve, um... I appreciate the curiosity and I appreciate the creativity, and everybody can try every possible angle, but I think I have answered this as fully as we are prepared. Now, you used a very creative way of asking, so I will tell you clearly, no, we don't have the 32 events right now, so yeah, that's what I can say. Now, and I have to say, Jack, can you remind me what the second part of the question was? Yes, the question was in DMD, has the FDA agreed on a potency assay? Michael, maybe you can take that.

I'd say, yes, as part of our final protocol development with <unk>.

We changed from an initial limbert determined on repeat methodology into a transocean methods.

As suggested by SK, along with the weight of the patients to determine dose.

And that's all in place and made the initial dose of what was expressed as free you two to 14 or go down to the two each reporting it's the very same dose that would use all the time, it's just that the different that's to use the Dupont read out but all of that is in place we have.

Terrific technology platform.

I think it's the leading in this field how to measure the various endpoints, including the concentration of the virus gene therapy.

Great. Thanks, Michael Thanks for the question, Steve I, let's move to our next questioner. Please operator.

Your next question comes from Tim Anderson.

Research.

Michael Dolsten: Absolutely. I think, Steve, you first asked when will Phase 3 start this year. We expect, and I believe Phase 3 will start this year and relatively soon. As you know, the profile through modification of the steroid dose from 1 mg per kick to 2 mg per kick looks really great now, and Albert spoke in his introduction to the 1930 voice in which, In recent years, after the steroid change, we have had no cases with complement activation. So we're very excited about the current plan now for the Essay, yes, as part of our final protocol development with FDA. We changed from an initial inverted terminal repeat methodology to a transient method, as suggested by FDA along with the weight of the patients to determine the dose, and that's all in place and determined the initial dose of what was.

Thank you I have a non covered question.

Oh, along the initial news.

John.

You describe the company is likely to pay less of its free cash back to shareholders in the form of dividends and buybacks and I'm wondering if that's still the current view.

Specialist you can achieve revenue growth targets, you've given up 6% for the next several years.

That's the question ties into another question on M&A.

What's the upper limit on the size of the deals you might be considering should likely be sub 10 billion dollar transactions.

Or larger deals also potentially.

Okay.

Thank you again for asking a non covered your question.

Appreciate it really and also it came at the time that they sold to Frank I will not the kind of it sounds to speak but now you got to give me the exact right home. So Frank take it from here. Thank you Albert Tim Thanks for the question so on M&A.

We always say, we never say never because.

One of the one of the nice things about being part of Pfizer is we have the firepower to pretty much do any kind of a deal.

Michael Dolsten: [inaudible] Great. Thanks, Michael. Thanks for the question, Steve. Let's move to our next questioner, please, operator. Thank you Tim for asking a non-COVID question; I really appreciate it, and also, it came at a time when I thought Frank would not have a chance to speak, but now we are giving him the exact right forum, so Frank, take it from here. Thank you Albert, and Tim, thanks for the question. So on M&A, you know we always say we never say never, because one of the nice things about being part of Pf Albert mentioned earlier, you know, our focus has been mid-phase, phase two, phase three, the kind of things that would impact our revenue base, 24, 25, 26. But in terms of capacity, you know, quite frankly, we're very much unlimited. With a strong balance sheet, strong capital structure, and strong investment grade, we generate lots of operating cash flow.

We've been able to demonstrate that in the past, it's why wouldn't limit cap.

On some specific dollar amount given the firepower that we have.

As mentioned earlier, our focus has been mid phase two phase three kind of things that would impact our revenue base 24 25 26.

In terms of capacity quite frankly, we're very much strong balance sheet strong capital structure strong investment grade well generate lots of operating cash flow.

You know in a very good position quite frankly to be very proactive as we need to be on.

And then in terms of.

You're up John question.

From my perspective, we get the up John deal done we formed Beatrice.

I'm going to get 12 billion in cash tied with that 12 billion in cash used to pay down debt given we're transferring give or take about 4 billion of EBITDA.

John but our capital in our capital deployment priorities don't change as a result of that transaction will still return.

Capital to our shareholders as we have been doing well continue to invest in the business and our pipeline obviously.

In capital and then we'll continue to invest so from my perspective capital priorities don't change the terms M&A capacity and we're fortunate enough, where we really have lots and lots of fire.

Frank D'Amelio: So, you know, we're in a very good position, quite frankly, to be very proactive as we need to be in M&A. And then, in terms of your Upjohn question, from my point of view, but our capital, you know, our capital deployment priority. Great. Thank you, Frank. Thanks, Tim. And can we move to our next question, please?

Thank you Frank Thanks, Tim and we move to our next question. Please.

Your next question comes from rentals, Nicky from RBC capital market.

Great. Thanks, Albert you guys can you talk about P. Post you weigh or post approval plan around communicating safety data to the public on the <unk>.

Albert Bourla: Thanks, Albert. You guys, can you talk about the post-EUA or post-approval plan around communicating safety data to the public about the vaccine just to make people more comfortable? Because one of the concerns is going to be that the percent of people willing to take a vaccine earlier may be lower than it had been in previous months. And obviously, those numbers would be higher to get herd immunity.

Vaccine just to get people more comfortable because one of the concerns is gonna be that the percent of people willing to take.

Hi back seeing earlier may be lower than it had been in previous months and obviously those numbers should be higher to get to herd.

Immunity and then a second question for Frank going back to the enabling function costs you guys called out a January 4.5 billion there.

Albert Bourla: And then a second question for Frank, going back to the enabling function costs, you guys called out January 4.5 billion there, can you maybe just help frame that for us? How much of those savings have you already realized, and how quickly can you realize additional savings in 2021? Just trying to understand the margin opportunity there. Thanks. Let me take the first before I pass it to Frank, and actually, I will ask the help of Angela here also in answering this question I do see, because we are watching the polls and also I speak to people, my neighbors, my friends, and I do see that there is some skepticism that is mainly because of the politicization of the vaccine. This is real, and I think we need to address it, but we started addressing it a long time ago.

You know, maybe just help frame that for us how much of those savings have you already realized how quickly.

Quickly can you realize additional savings in 2021, just trying to understand the margin opportunity there. Thanks.

Yes.

Let me take the first before I pass it to two prong industry I will ask the help of Enzo Hiroshima answering this question I do see because yeah watching the olson the old so I speak to people Oh, My neighbors, my friends and I do see that the there is a some skepticism that.

Has been mainly because of the politicization of the vaccine. So this is a real and I think when it will address it but we started addressing at the loan book we are doing for this disease for this vaccine things up and have never done before and those are first of all things up and have to do with transparency.

I'm just our protocol we have we are publishing real time, I'll say Swann a data so community into poverty can but also the other side understand the other companies developing coming vaccines can see them and learn from that.

Albert Bourla: We are doing for this disease, for this vaccine, things that we have never done before. And those are, first of all, things that have to do with transparency. We have published our protocol. We are publishing real-time our phase one data so our community and the public, but also the other scientists and the other companies that are developing COVID vaccines can see them and learn from that. We have announced the first results of our pivotal study. I'm blinded data, of course, on the safe. We signed a pledge that made very clear to the world that we are going to follow the highest ethical and quality standards, and we will continue being very transparent and very quality science driven which I think it is the best way to overcome the public's opinions and by the way we didn't even take money from the government so to make sure that Pfizer will stay out of the politics and this vaccine at our risk financial risk will not be characterized as the republican vaccine or the democratic vaccine it is a vaccine for the world that we are developing, Now, going forward, I think we will do also, we will continue doing things, our safety data, according to the FDA, will be reviewed publicly by an advisory committee, so that will be another additional good step, for Transparency. Angela, you want also to add a few things that we are planning to do?

We have a oh my mom. So that's the first $30 of vivo study unblinded data of course on the safety.

We signed the play it's about the made very clear from the World. That's we're going to to follow the highest and best ethical and quality standards and we will continue being very transparent.

Very quality science, driven which I think is the best way to overcome the public's opinion, so anyway, we didnt even take money from the government so to make sure like Pfizer, we stay on the politics and this vaccine.

Oh, great financial results will not be characterized as a republican touching on the Democratic election is not it is an option for the work that will develop.

No going forward I think we will do also continue doing things all safety data. According to the FDA, we'd be able to view to publicly by an advisory committee so that would be another additional good steps.

Towards finished modestly until I do want also to add two things that we are planning to do.

Well over and above what Albert said.

You know, obviously, having clear a public education, and a well a well supported public education effort is going to be critical right, we need to educate the public on the importance of actually getting the vaccine and then of course around the the safety processes and creating confidence around the development process that has gone into that.

Looking back then and so this happened sort of that two level Ah.

But it is about how Pfizer is working through intermediaries and opinion leaders to provide that education and then secondly, what we can do at Dallas I'm done.

Angela Hwang: Sure. Well, over and above what Albert said. You know, obviously, having clear public education and a well-supported public education effort is gonna be critical, right?

On the first Frank we have already been and are continuing our <unk>.

It's too, but the industry partner patient organizations government and other public health institution to.

Angela Hwang: We need to educate the public on the importance of actually getting the vaccine and then, of course, around the safety processes and creating confidence around the development process that has gone into developing it, and so this happens sort of at two levels. First, it's about how Pfizer is working through intermediaries and opinion leaders to provide this education. And then, secondly, what we can do. So on the first front, we have already been and are continuing our efforts to work with industry partners, patient organizations, government, and other public health institutions. We share with them our expertise so that they can create and build content and also deliver education as they need. So, as I said, this is well underway, there's a multi-channel approach that includes CCC, and these experts are already deploying a wide range of channels and forms of communication to educate and inform On the other hand, for us, once we have authorization and once we have a label, we'll be able to do additional communication and more education around our vaccine. We also recognize that, of course, there are certain communities that have been, minority communities specifically, that have been more affected by this disease than others.

He shared with them our expertise so that they can create and build content and also deliver education as they need said that as I said this is like well underway. There's a multi channel approach that includes D.C. and these experts already deploying a wide range of channels and bombs that come in.

Indication to educate and to educate specific.

On the other hand, Florida, a once we have authorization and once we have a label well be able to do additional communication and more education around that specifically.

We also recognize that of course, there are certain communities that have Vietnam minority communities in specifically that I've been more affected by this disease and others. So were also supporting the development of specific content in education that can more effectively reach the that these communities and.

And be more customize the sort of the approach and the content that we're sharing so this is a very big effort that is already underway and I think you're going to see more and more of this build up towards.

Towards the end of the year.

Thank you and then before I ask Frank to take a quick question about the Costco for Navy function and I would like question Michael to comment about the or a pharmacovigilance program, but we have put in place and how about on some could play a significant role in ensuring about the vaccine to say Michael.

Angela Hwang: So we're also supporting the development of specific content in education that can more effectively reach these communities and be more customized with the approach and the content that we provide. So this is a very big effort that is already underway. And I think you're going to see more and more of this build up towards, you know, towards. Thank you, Angela. And before I ask Frank to take the question about the cost of enabling functions, I would also like Michael to comment on our pharmacovigilance program that we have put in place and how that also could play a significant role in ensuring that the vaccine is safe.

Thank you Albert So we have.

The.

Tomoka video lungs platform in the industry that has experience to handle the largest number of UBS.

So then supporting by four and we have started very proactively and being an open dialogue with the British awards, what speed and if they are.

About putting these pharmacovigilance platform.

To play to monitor or sophisticated.

Participant where do you bring in potentially E Bay and later approval and that includes building control cohorts already know for understandings continues the seeds reporting or what we expect to be the first group of responders, such as healthcare workers and.

Michael Dolsten: Thank you, Albert. So we have the Tomoko Vigilon platform in the industry that has experience of handling the largest number of Adverse Events reporting by far, and we have started very practical and are in open dialogue with Operation Wood. Speed, and FDA about putting this pharmacovigilance platform in play, to monitor, sophisticated. Participant, whether during a potential EUA and later approval, and that includes... Building control cohorts already now for understanding spontaneous disease reporting among what we expect to be the first group of responders, such as healthcare workers and first-line responders. We also recognize the big need for many stakeholders, from pharmacists, nurses, patients, and physicians, to have access to rapid information. We have a very strong medical information platform across the globe, and we have now augmented it, both with staff and with a self-serving Webex platform to be able to respond to many aspects of how we store, distribute the vaccine and expected, so far, mild to moderate tolerability issues, et cetera So I think we feel we are very well prepared for that. Thanks.

<unk> language for Windows.

We also recognize the big need for many stakeholders from pharmacies nurses patient physician to have access to rapid information, we have a very strong medical information platform across the globe and we have now augment that it both with stuff and will self serving web.

Platform to be able to respond to man aspects of the how we store distribute the vaccine and expected.

So far.

Mild to moderate tolerability issues et cetera seem we just exceeding them seamlessly and so I think we feel we're very well prepared for that thank you.

Thank you Michael Knott from back to you Yep and Randall the way I'll do this let me run some numbers and provide some I'll call. It financial context, and then I'll drill down and I'll answer your question. So just first.

Because you're talking about enabling functions.

For the quarter, we were $270 million down 10%.

It's really driven by three things.

Consumer separations, which was give or take about half the reduction.

We just spending and enabling functions and some of it was cold.

I called that out because he said that.

Functions, which is probably what triggered the question, let me run the overall numbers and I'll drill down.

So the question so our previous guidance for the year.

<unk> 0.5 to 12.5 billion.

We tightened the range to 11.5 to 12 billion.

Was really driven by cold it savings.

Frank D'Amelio: Thank you, Michael. Now, Frank, back to you. And Randall, the way I'll do this is, let me run some numbers and provide some, I'll call it, financial context, and then I'll drill down and I'll answer your question. So, first, you know, on SINA, because you're talking about the enabling function.

Obviously, we know about consumer we had.

Function spending.

Our plan. So it was really driven primarily by <unk>.

None of that 11, and a half to 12 billion I think four to four and a half.

Enabling functions, which is now getting to your question.

Think about this is you look at that four to four and a half.

<unk> expense to revenue ratio the total company as it exists today.

The new company.

The company because of the revenues that move to Chris we want that expense to revenue ratio to say.

Frank D'Amelio: So on SINA, for the quarter, Griffiths. Now, let me run the overall. So our previous guidance on SINA for the year was 11.5 to 12.5 billion. We tightened the range to 11.5 to 12 billion. And that was really driven by COVID savings. Of that $11.5 to $12 billion, think $4 to $4.5 billion is for the enabling functions, which is now getting to your question. The way I think about this is, you look at that $4 to $4.5 billion as an E to R, an expense to revenue ratio of the total companies that exist today, and the new company, when we're a smaller company, because of the revenues that move to Viatris, we want that expense to revenue ratio to be the same or less than what it currently is today.

The same or less.

So that's kind of a simple way to think about how we're thinking about this and how were planning in terms of what to do.

Second question you asked wasn't Frank Wesley your pacing question in terms of you know 21 22.

We'll obviously go as fast as we can and get as much of it as we can at the 2021, obviously some of that will fall into 2022, just because of the nature of some of the places where we do business and certain things take more time than others and I'll provide more clarity on this when we provide our 2021.

That's including the assigning.

Next earnings call.

Right.

It would be more clear, yes, Doug or excuse me I'm sorry.

Yep sure got another question here please operator.

Next question comes from Geoff Meacham from Bank of America.

Hi, guys just got on for Geoff. Thanks for taking my question you disclosed last quarter that the FDA indicated an AD com eating as locking system anticipated for today's about but seems like they want one now in March 21. So you know that a push out the December that you've Oh, so what changed and maybe you can give us some more insight into your discussions with the.

Frank D'Amelio: So that's kind of a simple way to think about how we're. We'll obviously go as fast as we can and get as much of it as we can into 2021, and I'll provide more clarity on this when we provide... Thank you for listening. Yes, sure.

Okay, and then maybe as a follow up you know the asset itself wasn't highlighted as an asset peak sales rose from Investor day.

So what do you expect kind of internally the PICC sales upside to be here she received approval. Thanks.

Albert Bourla: Let's get another question here, please, operator. Your next question comes from Jeff Meacham from Bank of America. Hey guys, just a shout-out for Jeff, thanks for taking our question. You disclosed last quarter that the FDA indicated an Adcom meeting was not anticipated for Tenazumab, but it seems like they want one now on March 21, so that'll push out the December PDUFA. So what changed?

And then my why don't you take it goes through and then also maybe Mike and can come into play there on that and it's not going to be a but you first Angela.

Sure.

So we are you know the the the <unk> today's AMAP bio represents probably one of the biggest submissions that by that has ever.

Provided the FDA and our data our extensive and there's a lot to understand so we're not surprised.

By the request to have an AD com and in fact were looking forward to having the opportunity to really you know.

Angela Hwang: And maybe you can give us some more insight into your discussions with the FDA. And then, maybe as a follow-up, the asset itself wasn't highlighted as an asset on the peak sales list from Investor Day. So what do you expect, kind of internally, the peak sales upside to be here if you receive approval? Angela, why don't you take those two and then maybe Maarten can comment later on the TANFDA, but you first, Angela. So, we are, you know, the TENASA map file represents probably one of the biggest submissions that Pfizer has ever provided to the FDA. Our data is extensive, and there's a lot to understand, so we're not surprised by the request to have an advisory committee, and in fact, we're looking forward to having this opportunity to really, you know, review and discuss what we have seen in our data and in our clinical trials and to discuss this opportunity with the advisory committee.

Did you actually discussed.

What we have seen in our data and now in our clinical trials and to Doug discussed this opportunity with the Advisory Committee. So we see that as a something that will you know Chris.

We had a good discussion in terms of the way to look at the opportunity. This is how we see it.

It's really like.

Like many conditions, but this one in particular, a significant unmet need in the treatment of osteoarthritis.

There are about 27 million American that suffer from this 11 up 11 million of whom have moderate to severe away.

And in the U.S., 80% of those moderate to severe away patients have already tried and tried and failed three or more and analgesics.

So you know we know that the patients are unable today to achieve adequate pain relief and so while they are often you know they are options out there and what we also know is that the options are.

Adequate so when you look at the patient population that's ahead of us the opportunity to provide and novel.

Angela Hwang: So, you know, we see that as something that will, you know, create a good discussion. In terms of the way to look at the opportunity, this is how we... There is really, like many conditions, but this one in particular, a significant unmet need in the treatment of osteoarthritis. There are about 27 million Americans that suffer from it, 11 million of whom have moderate to severe OA. And in the US, 80% of those moderate to severe OA patients have already trialed and tried three or more. So, you know, we know that these patients are unable today to achieve adequate pain relief. And so while there are, you know, there are options out there, what we also know is that the options are limited.

And a a non opioid form of pain relief, we think that there you know this is the kind of opportunity that I think patients will be very interested in.

Thank god that migrate where the bulk of the ism above filing under the ace or request for an advisory Committee.

Oh I thought the Angela on some great maybe a punch it two things that's a potential first in class treatment, it's not uncommon for the state to hold and I'd come to discuss the submission so in a way it was expected.

And of course, the discussion will be focused on those many patients or not well controlled or unresponsive motility, Bill who do not want to take any of the existing pain medication.

And that's an alternative to no longer use of opioids, that's where the discussion would be and that's amulet said, we always welcome outcomes in order to shut all we're experiencing gets external perspective.

Angela Hwang: So when you look at the patient population that's ahead of us, the opportunity to provide a novel and a non-opioid form of pain relief, we think that this is the kind of opportunity that I think patients will really appreciate. Thank you, Angela. Michael, anything to add about our pan-ISMAP filing and FDA's request for an advisory committee? I thought Angela answered great.

Thank you, Mike sorry, Marty Thanks for the insight folks next question. Please.

Next question comes from David Risinger from Morgan Stanley.

<unk>.

Yes, thanks very much so.

So I have one question for Alberta, and one for Frank Albert.

Thank you for the update today could you. Please define what you mean when you say you will disclose results. When there is a a conclusive readout does that mean interim efficacy success and the primary endpoint or does your definition of a conclusive read out include more than just the primary end point.

Michael Dolsten: As a potential first-in-class treatment, it's not uncommon for FDA to hold an advisory committee meeting to discuss the submission. So, in a way, it was expected, and of course, the discussion will be focused on those many patients that are not well controlled or unresponsive, not eligible, or do not want to take any of the existing pain medication as an alternative to a longer use of opioids. That's where the discussion would be, and as Angela said, we always welcome outcomes in order to share our experience and get an external perspective. Thank you, Mike. Back to you.

And for Frank.

Regarding enabling functions you've been talking about that for a couple of years and my understanding is that.

You've already been driving efficiencies in the corporate cost structure of Pfizer. So could you just update us on where the run rate stands today versus the four to four and a half billion you were discussing a couple of years ago. Thank you.

Albert Bourla: Thanks for the insight, folks. Next question, please. Yes, thanks very much. So I have one question for Albert and one for Frank.

Thank you David and me.

My definition of a conclusive results positive or negative we think is a futility or demonstrated efficacy readout in the primary endpoint.

Albert Bourla: Albert, thank you for the updates today. Could you please define what you mean when you say you will disclose results when there is a conclusive readout? Does that mean interim efficacy success on the primary end point, or does your definition of a conclusive readout include more than just the primary end?

But oh things worked so Frank.

Yeah. Thanks, Albert So Dave we had been reducing.

<unk> functions over the years.

That's obviously been reflected in the guidance that we provided over the last year or two that for four and a half billion should be thought of as a base for 2025.

Albert Bourla: and for Frank, regarding enabling functions, you've been talking about that for a couple of years, and my understanding is that you've already been driving efficiency in the corporate cost structure of Pfizer. So could you just update us on where the run rate stands today versus the four to four and a half billion you were discussing a couple of years ago? Thank you. Thank you, David. My definition of a conclusive readout, positive or negative, is a futility or demonstrated efficacy readout in the primary input.

We will go to work on that base.

I went to work on that base as we move into 21, and 22 and the intent is obviously to generate to capture as much of those savings as we can as quickly as we can but the.

The four to four and a half billion think about that as the base that will come off.

Right. Thanks, Frank and operator can we take our last question for the call. Please thank you.

Your final question comes from Andrew Baum from Citi.

Thank you couple of questions. Firstly I'm out of pocket caps seem to have been proposed twice once by the Senate and then more recently by the presence and probably the most favored nation executive order things.

Albert Bourla: That's how things work. So, Frank. So Dave, we have been reducing the enabling functions over the years, and that's our 5, and obviously we'll go to work on that base, and we are going to work on that base as we move into 21 and 22. And the intent is obviously to generate, to capture... 4 to 4.5 billion. Think about that. Great. Thanks, Frank. And Operator, can we take our last question for the call, please? Thank you. Thank you. I have a couple of questions.

Thinking about the cow and other high priced small molecules. Obviously this could be very helpful tool business. If this comes off do you think there's a high probability that regardless of which administration out of pocket caps for Medicare patients is likely to features a central part of health care reform and then second.

Just to clarify on code that the interim analysis with receiving questions from clients repeatedly about the level of disclosure will it be simple Wi Max we look forward to shed and the data or what do you actually disclosed that they threaten time the efficacy readout is given.

Albert Bourla: Firstly, out-of-pocket caps seem to have been proposed twice, once by the Senate and then more recently by the President prior to the Most Favored Nation Executive Order. Thinking about Vindickel and other high-priced small molecules, obviously, this could be very helpful to your business if this comes to pass. Do you think there's a high probability that, regardless of which administration, out-of-pocket caps for Medicare patients are likely to feature as a central part of healthcare reform? And then second, just to clarify on COVID, the interim analysis: we're receiving questions from our clients repeatedly about the level of disclosure. Will it be a simple, we meet, we look forward to sharing the data, or will you actually disclose the data at the time the efficacy readout is given? Thank you, thank you, Andrej.

Yeah. Thank you know think undertakes no both of the other positive comps.

Hi, there repeatedly in the industry as a whole is pulling the oh, but right now the way that the insurance benefits are working or is not sustainable anymore right now the Americans they out of pocket for their medicines like even if they do not have insurance, although they do and they took a very expensive.

And like you baked goods and soon to see if they didn't have to pay from their own book. So this is something that needs to change and it seems like there is a general recognition both in both sides of the aisle or we will continue working with with Oh.

And we hope that we will see a change in the design of this benefits, but will reduce the cost of that they're making sense to pay out of pocket. When they go to to collect their medicines or this is not something but then it needs to be done because.

Albert Bourla: Now, about the out-of-pocket cuts. Pfizer repeatedly and the industry as a whole has pointed out that right now the way that the insurance benefits are working is not sustainable. Right now, Americans pay out-of-pocket for their medicines as if they do not have insurance, although they do have it, and it is very expensive. [inaudible] It seems like there is a general recognition, on both sides of the aisle. We will continue working with everyone, and we hope that we will see a change in the design of these benefits that will reduce the cost that Americans have to pay out of pocket when they go to collect their medicine. This is something that needs to be done because it will help the financial bottom lines of the industry.

Hello.

If I could not sell the bottom line so for opening those things just because at least from.

The patients and the healthcare system costing them right now the fact that some patients don't have the out of pocket to take their medicine.

As a result of that we.

We have significant number because they do not take their medicines, but medicines that doesn't mean it matters that have been prescribed by their physician and this one is although patients are ending up in the health care system in hospitals and they close their healthcare system much more so there is a need or any way you see cost wise.

Or a human pain wise, but this needs to beautiful.

Albert Bourla: It's because it needs to help the patient and the healthcare system cost in general. Right now, the fact that some patients don't have the money out-of-pocket to take their medicines has resulted in a significant number not taking their medicines but medicines that are needed, medicines that have been prescribed by their physicians, and as a result, patients are ending up in the healthcare system in hospitals, and they cost the healthcare system much more. So there is a need, any way you see it, cost-wise or human pain-wise, that this needs to be reformed. Now, in terms of COVID-19, and I think that was the last question that we had today, so it looks like it's going to be a COVID-19 question, the last question.

No in terms of a cold winter 19, and I think about was the last person, but we said today. So it looks like it's going to be probably going to be the last question.

Huh.

I think right now we are planning to as always well. This thing is to have a press release, but ER will speak about topline met the endpoint or not and then of course, we plan to publish data in a peer reviewed.

Cousin, so that they know they will be all available, but keep in mind that bunch of summit data or if things goes according to plan by the third or fourth week of November and everything else I think because they plan to make them public during the up Confair advisor told me that they were [noise].

Albert Bourla: I think right now, we are planning to, as always with these things, have a press release that will speak about whether or not the trial met the endpoint, and then, of course, we plan to publish data in a peer-reviewed magazine, so that they will all be available, but keep in mind that we'll also submit data if things go according to plan by the third or fourth week of November, and FDA also plans to make them public during the So I think that concludes our call, Chuck, isn't it? That's correct, Albert.

So I think that concludes our call lets talk isn't it.

That's correct Albert back to you for closing remarks.

So I I just want to thank all of you for joining us today and of course, you're continuing engagement with Pfizer as was Oscar.

Our continued strong performance speaks to the resiliency of our business and the strength of our portfolio things. He knew anything in the resolve of our people and I think the power of our business as we indicated during our Investor day, we are very confident in our pipeline.

We like it's Brett.

We like its depth and we will continue to be opportunistic about bringing in additional promising offices where appropriate.

No we need to continue to execute and deliver for patients.

Albert Bourla: Back to you for closing remarks. Yeah, so I just want to thank all of you for joining us today and, of course, your continued engagement with Pfizer as you just heard our continued strong performance. It speaks to the resiliency of our business, the strength of our portfolio, the ingenuity and the resolve of our people, and I think the power of our pets. As we indicated during our investor day, we are very confident in our pipeline. We like pizza bread.

Of course, we continue to monitor global economies related to Colby.

Colby is affecting not only our business from spoke quantified people junior people than what it was but if.

If we tried to quantify the opportunities whether it's doing to the global economy. We are speaking about three years and now has become a more oh, we use them and you find that the.

Many things to be done to control. This pandemic vaccines are expected if successful to play a key role to become a very important yeah.

Albert Bourla: We like its depth, and we will continue to be opportunistic about bringing in additional promising assets where appropriate. Now, we need to continue to execute and deliver for patients. Of course, we continue to monitor global economies related to COVID's impact. COVID is affecting not only our business. Frank Spock quantified the opportunity today, but to us, but if we try to quantify the opportunity what COVID is doing to the global economy we are speaking about three years ago, it has become more obvious than at any time that many things need to be done to control this pandemic, but vaccines are expected, if I understand and appreciate your interest. That became very obvious.

We are working very diligently I understand and appreciate your interest I became very obvious I, just ask everybody to be a little bit basin, So and we all cross our fingers, but science would win thank you very much.

Ladies and gentlemen, this concludes pfizer's third quarter 2020, <unk> earnings Conference call. Thank you for your participation you may now disconnect.

[music].

[noise] Oh [noise].

[music].

Albert Bourla: I just ask everybody to be a little bit patient. So, and we all cross our fingers that science will win. Thank you very much, everyone. [inaudible] BF-WATCH TV 2021