Q2 2022 Pfizer Inc Earnings Call

[music].

Yeah.

Good day, everyone, and welcome to Pfizer's second quarter 2022 earnings conference call.

Good day, everyone and welcome to Pfizer's second quarter 2022 earnings Conference call.

Today's call is being recorded.

Your next questions come from the line of Chris Schott with KP Morgan.

Today's call is being recorded.

At this time, I would like to turn the call over to Mr. Chris Thibault, Senior Vice President and Chief Investor Relations Officer.

At this time I would like to turn the call over to Mr. Chris Stipo Senior Vice President and Chief Investor Relations Officer. Please go ahead Sir.

Please go ahead, sir.

Great.

Thank you, Chelsea.

Thank you Chelsea and good morning, everyone.

Good morning, everyone.

Thanks so much for the questions.

Welcome to Pfizer's second quarter earnings call. We anticipate that this call will last 90 minutes I'm joined today by Dr. Albert for large chairman and CEO , Dave Denton, our CFO and Michael Dalton President of worldwide research and development in medical.

Welcome to Pfizer's second quarter earnings call. We anticipate that this call will last 90 minutes.

Just one follow-up on the Paxlovid comments.

I'm joined today by Dr. Albert Bourla, our Chairman and CEO, Dave Denton, our CFO, and Michael Dolston, President of Worldwide Research and Development in Medical.

As we move, I guess, from some of these large government orders that we saw with the US, etc., earlier this year to maybe these more kind of on-demand smaller contracts, how do we think about what the impact that has on pricing?

Because I think you were giving some volume-based discounts before.

Joining for the Q&A session, we will also have Angela Huang, Group President, Pfizer Pharmaceuticals Group, Amir Malik, our Chief Business Innovation Officer, William Powe, our Chief Development Officer, and Doug Lankler, our General Counsel.

Joining for the Q&A session. We will also have Angela Hwang group, President Pfizer Biopharmaceuticals group Amir Malek, our Chief business Innovation Officer, William Powell, Our Chief Development Officer, and Doug <unk>, Our general counsel.

Materials for this call and other earnings-related materials, are on the Investor Relations section of Pfizer.com.

Materials for this call and other earnings related materials on the Investor Relations section of <unk> Dot com.

Please see our forward-looking statements disclaimer on slide 3, and additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC Forms 10-K and 10-Q under Risk Factors and Forward-Looking Statements.

Please see our forward looking statements disclaimer on slide three and additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC forms 10-K, and 10-Q under risk factors and forward looking statements.

Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.

We're looking statements on the call are subject to substantial risks and uncertainties.

Only as of the calls original date, and we undertake no obligation to update or revise any of the statements with that I will turn the call over to Albert.

With that, I will turn the call over to Albert.

Just help us, I guess, to think about kind of 2023 and beyond what pricing does for that business.

Thank you, Chris.

And then kind of the bigger question I had was just on IBRAN's dynamics.

Thank you Chris Hello, everyone.

Hello, everyone.

I think you mentioned in the prepared remarks you're seeing signs of a recovery for your business there.

Proud to say that Pfizer continue to deliver strong operational performance in the second quarter and has increased its full year 2022.

I'm proud to say that Pfizer continues to deliver strong operational performance, in the second quarter and has increased its full-year 2022 operational financial forecast for revenue and adjusted earnings reserves, all while operating in a challenging foreign exchange environment. Compared with the second quarter of 2021, global revenues were up 53% operationally to $27.7 billion and adjusted diluted EPS increased 100% operationally to $2.04. Both results exceeded consensus analyst expectations, and the quarterly revenue figure represented the largest in Pfizer's history.

Operational financial forecast for revenue and adjusted diluted earning per shares.

While operating in a challenging foreign exchange environment.

I'm just interested in how you kind of see the balance of just overall market dynamics relative to the competitive landscape with obviously all your competitors with an adjuvant indication.

Compared with the second quarter of 2021 global revenues were up 53% operationally to $27 7 billion and adjusted diluted EPS increased hundreds of percent operationally to two point awful.

Thank you.

Thank you very much.

Chris, we do not provide, let's say, forward-looking projections on pricing, and particularly every time I speak about pricing, it's becoming big news.

So I want to make sure that we respect that.

Bolsa results exceeded consensus analyst expectations on the quarterly revenue figure represented the largest in Pfizer's history.

I know what you are asking, and I can give a very high-level answer.

Clearly, we are providing special pricing when we are contracting very, very big quantities with governments. That's also the incentive for the government to buy big quantities because the price is really, really very attractive.

Key growth drivers for the quarter included PaxCovid, Comirnaty, Eliquis, and Vintakel-Vintamax globally, and our prevalent family of products in the U.S. Year-to-date, we have reached an estimated 845 million patients around the world, with our innovative medicines and vaccines, which represents a 77% increase from the prior year period.

If we move to a normal market, the prices would reflect both in vaccines and in antivirals the prices of similar value, similar technology products that are out there.

Key growth drivers for the quarter included <unk> love it.

Clearly, also when you move to private commercial markets, the complexities are getting way, way higher.

Comparing that to <unk>, and <unk> globally, and our breadth and our family of products in the U S.

Year to date, we have reached an estimated 845 million patients around the world with our innovative medicines and vaccines Switzer presents a 77% increase from the prior year period.

And we did all of this while also taking steps to help address broader issues, impacting global health, including climate change, equitable access, and the war in Ukraine.

And we did all of these wireless are taking steps to help address broader issues impacting global health, including climate change equitable access and where we can create.

So where do we go from here?

So where do we go from here after two and a couple of years like everyone else. We would hope that this global crisis will be over soon.

After two and a half long years, like everyone else, we would hope that this global health crisis would be over soon. But as much as hope is important, hope is not science, and science is telling us that COVID-19 likely will remain a major global health care concern for years to come.

We will need to go to single doses in the vaccine, so manufacturing complexities are very higher.

We need to have distribution to small distribution centers, including physicians' offices.

So all of that creates a very big complexity, but also could be taken into consideration as we price our products at that time.

But it's not just hope is important hope as much science and science is telling that the COVID-19 are likely will remain a major global healthcare concern for years to come.

We believe that Pfizer is well-positioned not only to maintain, but to grow both our commercial and scientific leadership in the battle against COVID-19.

We believe that Pfizer is well positioned not only to maintain but to grow both our <unk>.

COVID-19.

And scientific leadership in the battle against COVID-19.

In terms of our commercial leadership, we believe Pfizer's skills are even better, suited for operating in open markets than they are for government contracting markets and will be even more competitive when this transition happens.

In terms of our commercial leadership, we believe farther skills are even better suited for a variety of the open markets than they are for government contracting markets and will be even more competitive when these transitional Hopkins.

I want to emphasize that also those present significant opportunities for us because the open market is way more complex, way more diverse.

Recently, Angela announced a new commercial structure that prepares us to provide even better support for the ongoing Comirnaty and Paxlovid revenue streams.

Simply Angela announced a new commercial structure, but prepares us to provide even better support for the ongoing commitment and Mark scrubbed our.

In terms of our scientific leadership, we expect, to further enhance our position through the continued introduction of new innovations, including preparation of new variants of concern and potentially improving the durability of protection.

Our revenue streams.

In terms of our scientific leadership, we expect to further enhance our position through the continued introduction of new innovations, including preparation of new variants of concern and potentially improving the durability of <unk>. So.

So far, we have been fortunate that most of the variants have led to less severe illness, but there remains the possibility that a future variant could emerge that combines Omicron's contagiousness with the original virus' severity.

So far we have been fortunate that most of the variance could lead to less severe illness, but very amazed that possibility, but the future variants could emerge that combines <unk> condensers, Ms, where the original borrowers with severity.

This is a scenario no one, wants to imagine, but one for which we need to be prepared, and that's why we're doing all these investments.

This is a scenario no one wants the months, but the ones, where which we need to be prepared and that's why we're doing all of these investments.

That's why also it is critical that Pfizer continues to invest in the research and development of COVID-19 vaccines and treatments.

So that's why I also have discretion to go without Pfizer continues to invest very starts in development of COVID-19 vaccines.

With this context as a backdrop, let me provide an update on our current COVID-19 offerings and then continue with other products I would start with what's going on it today.

With this context as a backdrop, let me provide an update on our current COVID-19 offerings and then continue with other projects.

You have millions of customers rather than one or two, and this plays to our strengths in terms of having global presence or within the U.S. dramatic presence in every single territory of the country with thousands of people that they are calling, physicians, hospitals, accounts, payers' accounts, etc., etc.

It's something that if we see a turn into this market, also we will see us being able, to compete more of a position of strength than not.

As regards Ibrance, Angela.

Well, as you say, the metastatic breast cancer CDK4-6 market is incredibly competitive yet.

I will emphasize that Ibrance continues to be the leading CDK4-6 inhibitor. In fact, we have a 74% market share across all patients in first-line therapy.

I will start with Comirnaty.

So, and I think that this number has been pretty consistent because we talk about it every quarter.

Today, we have received more than 36 billion doses of our vaccine to 180 countries and territories around the world.

More than 36 billion doses will far vaccine 280 countries and territories around the world.

Comirnaty remains the most utilized COVID-19 vaccine in the markets in which we operate that report market share data. Pfizer's cumulative share of doses administered in these markets have increased from 52% in January of this year to 63% in July of this year. In developed markets, our share has increased from 59% to 68% over the same time period.

Community remains the most utilized COVID-19 vaccine in the markets in which we operate.

Ah report markets update.

Pfizer's cumulative doses administered in these markets have increased from 52% in January of this year to 63% in July .

Year.

In developed markets, our share has increased from 59% to 68% over the same time period.

Next I'd like to briefly touch on the topic of the vaccine boosters for before.

Next, I would like to briefly touch on the topic of vaccine boosters for the fall. Outside the U.S., global regulators have issued guidance to advance an Omicron-adapted bivalent vaccine candidate to help address the continued evolution of the virus. As such, Pfizer and BioNTech have submitted data to the European Medicines Agency on the safety, tolerability, and immunogenicity of the company's bivalent Omicron BA1-adapted vaccine candidate.

Outside the U S global regulator script useful guidance to advance a nonrecurring adopted bivalent vaccine candidate to help address the continued evolution of the virus.

Sucks Pfizer in biotech have submitted data to the European medicines agency on the safety Tolerability and Immunogenicity of the companies by that one can be a one adopted vaccine candidate.

We also continue to work with health authorities around the globe on regulatory submission.

We also continue to work with health authorities around the globe on a regulatory submission.

The U.S. Food and Drug Administration recently asked biopharmaceutical companies, including Pfizer, to develop a modified vaccine containing an Omicron BA4-BA5 component, and we begin clinical trials with these vaccine candidates. Pfizer is currently proceeding with development of a COVID-19 bivalent Omicron BA4-BA5 booster, candidate and is targeting this fall for rollout in the U.S., subject, of course, to regulatory authorization. Pfizer is well-positioned to satisfy its current contractual obligations and potential demand within its production capacity through the end of the year.

The U S food and drug administration recently asked biopharmaceutical companies, including Pfizer to develop a modified vaccine containing an armageddon b a b a five component.

And we begin clinical trials with these vaccines countries.

Pfizer is currently proceeding with the development of a COVID-19, bivalent Omi gonna be a Ford five booster vaccine candidates.

Targeting this fall for rollout in the U S subject of course to regulatory authorities.

And Pfizer is a well positioned despite its got and contractual obligations and potential demand within its production capacity.

Because of our robust manufacturing capabilities, we are planning to deliver both variant vaccines in the fall, pending regulatory approval.

The end of the year.

Because so far for the Boston manufacturing capabilities, we are planning to deliver both varian vaccines in the fall pending regulatory approvals.

Turning to PaxLovic, we continue to be very pleased with how things are progressing, in the U.S., as we are seeing several initiatives supporting increased access for eligible patients. First, the number of facilities with PaxClovid supply have continued to increase with more, than 41,000 sites live as of July 15, an increase of more than 7,000 sites since early May.

Turning to park slope, we continue to be very pleased with how things are progressing in the U S. As we are seeing several initiatives to support the increased access for eligible patients. So that was the number of facilities with <unk> to supply have continued to increase with more than 41000 sites.

As of July 16, an increase of more than 7000 sites since early may.

We are pleased with the FDA's July 6 revision of the Emergency Use Authorization for PaxClovid, that authorized state-licensed pharmacists to prescribe the treatment under certain conditions, thereby expanding access for patients.

We are pleased with the Fda's July six revision of the emergency use authorization for box club at the authorized state licensed pharmacies to prescribe the treatment under certain conditions, thereby expanding access for patients.

As you can see on this slide, we have seen a nearly fivefold increase in PaxClovid utilizations, since the first quarter.

As you can see on this slide we have seen a nearly five fold increase in park scrubbed utilization since the first quarter.

We also continue to retain greater than 90% market share of oral COVID-19 treatments in, the U.S. and are taking a state-by-state approach to engaging key government officials to discuss their access strategies.

We also continued to retain greater than 90% market set a floor on COVID-19 treatments in the U S and are taking a state by state approach to engaging key government officials to discuss their exit strategies.

We are also continuing to work with states to educate consumers, healthcare providers, and pharmacists about the importance of treating all appropriate high-risk patients rather than limiting treatment to the severely immunocompromised and unvaccinated.

We are also continuing to work with states to educate consumers health care providers and pharmacists about the importance of treating all appropriate high risk patients rather than limiting treatment to the severe to the severely immunocompromised and I'm vaccinate.

In spite of the strong growth we have seen in PaxClovid uptake in the U.S., due to our, and our government's efforts, we estimate that a significant amount of eligible patients outside the U.S. are not yet being treated with the drug and may not know they are at high risk of progressive to severe disease. So we believe there remains substantial opportunity to grow PaxClovid utilization.

In spite of the strong growth we have seen in scrubber uptake in the U S. Due to our and our government's efforts, we estimate that the significant amount of eligible patients outside the U S are not yet being treated with the drug and may not know they are at high risk of progression to severe disease. So we believe.

There remains substantial opportunity to grow our scrubbing utilization.

For international developing markets, we are seeing significant increases in usage across, many markets, reflecting the recent wave of BA45 and resulting increases in hospitalization, ICU admissions, and deaths.

For international developing markets, we are seeing significant increases in usage across many markets, reflecting the recent wave will be a four five and the resulting increases in hospitalization ICU admissions and deaths.

For example, over the month from June 24 to July 24, average daily deaths in Europe, almost doubled from a low of 0.6 per 1 million people to 1.15 per 1 million.

For example over the months from June 24th to July 24.

Average daily deaths in Europe , almost doubled from a low of six per 1 million people to 116 1 million.

In Japan, they almost tripled from 0.12 per 1 million people to 0.34 per 1 million people.

In Japan, they almost tripled from point 12 per 1 million people to <unk> 74.

And in Australia, they increased from 178 per 1 million people to 259 per 1 million.

And that's relevant increase from 178 per 1 million people to $2 59 per $1 million.

While we have less precise numbers on market shares outside the U.S., our internal estimates, indicate that we saw an estimated 116% increase in usage between June 24 and July 15 across international developed markets, where we have supply agreements.

Wireless have less precise numbers on market.

Outside the U S. Our internal estimates indicate that we saw an estimated 116% increase in usage between June 24, and July 16 across international developed markets, where do we have supply agreements.

So we believe there is a significant opportunity to continue the growth outside the U.S. as, physicians become more knowledgeable about PaxClovid and treat appropriate patients.

So we believe there is significant opportunity to continue that growth outside the U S. As physicians become more knowledgeable about exploded and treat appropriate patients.

While COVID-19 remains top of mind for many people, we are seeing encouraging performance, with some of our other innovative products as well. And I wanted to take a moment to highlight two of them. We are very pleased with the success of our U.S. launch of Prevnar 20 for adults. Two-and-a-quarter U.S. revenues for our Prevnar family of vaccines for adults were up 337% operationally compared with a prior year quarter to $431 million, with Prevnar 20 representing more than three-quarters of the total adult revenue.

While COVID-19 remains top of mind for many people we are seeing encouraging performance with some of our other innovative products as well and I wanted to take a moment to highlight two of them.

We are very pleased with the success of our U S launch of <unk> Grande for adults.

Second quarter U S revenues for our brand and our family of vaccines for adults were up 337% operationally compared with the prior year quarter to $471 million with bremner to MDA, representing more than three quarters of the total adult Bourbon.

The great majority of U.S. healthcare networks, IDNs, and retailers who have made formula, decisions have chosen Prevnar-20 alone as their higher valency pneumococcal vaccine of choice to help protect adults. This has resulted in Prevnar-20 having a 97% market share.

The great majority of the U S health care networks.

<unk> and retailers, who have made fortinet that'd be seasons have chosen pregnancy.

No.

A higher valency.

You won't broker vaccine of choice to help protect adults.

Please schedule resulted in Primrose, two MD hiring and 97% market share.

This is also the first time that there has been a routine recommendation for Prevnar, for people in the 19 to 64 age group with underlying medical conditions. This group has an increased risk for contracting pneumococcal pneumonia and unfortunately has, historically been the hardest to activate.

This is also the first time, but because it's been a routine recommendation for pregnant for people, even 19% to 64 age group with underlying medical conditions.

This group has increased the risk for contracting pneumococcal pneumonia and unfortunately crashed historic has been the hardest work debate.

Lastly, we believe the simplicity of Prevnar-20 being the only vaccine that can help protect, patients with one dose in one visit is preferable to competitor's offerings.

Last week, we believe the simplicity of <unk> being the only vaccine that's going to help protect patients with one dose in one visit is preferable to competitors' offerings.

Quarterly revenues for IBRANs grew 1% in the U.S. compared with the same quarter last year, despite a continued increase in the proportion of patients accessing IBRANs through assistant program.

And I think it demonstrates, you know, just the tremendous experience that physicians, and patients have and the confidence they have in Ibrance despite new competition.

Quarterly revenues for <unk> grew 1% in the U S compared with the same quarter last year.

Spite of continued increasing the proportion of patients accessing I'm Bruce through our system program.

This marked the first quarterly revenue uptick in the U.S. since the fourth quarter of 2020, which is an encouraging sign. Total volume in the U.S. increased 3% compared with a year ago quarter.

You know, the patient experience, the fact that we have real-world clinical evidence, all of this really adds to the, you know, the confidence that we have in this brand.

This marks the first quarterly revenue uptick in the U S. Since the fourth quarter of 2020.

Which is an encouraging sign.

Volume in the U S increased 3% compared with a year ago quarter.

Before I turn it over to Michael, I want to touch on some actions we have taken recently, to further demonstrate our commitment to environmental, social, and governance ESG principles.

And even though Ibrance is a mature brand, we do continue to see growth.

Yeah.

Before I turn it over to Michael I wanted to touch on some actions we have taken recently decided that demonstrate our commitment to environmental social and governance.

And where the growth will come from are from the following places.

Zip principles.

We recently announced an accord for a healthier world. Under this accord, we are offering all of our patented high-quality products that are, available in the U.S. or the EU on a not-for-profit basis for 1.2 billion people living in 45 lower-income countries. This includes all future Pfizer products as well.

You know, you're going to see growth from the CDK class.

Recently announced in our core for a healthier war under this of course, we are offering all of our patented high quality products are available in the U S or the U and not for profit basis for one 2 billion people living in 45 lower income countries. This includes all pizza.

You're going to see growth from the recovery of new patient stocks, which as you know, has not recovered, you know, to the levels of prior to the pandemic.

As well as stabilization of the PAP through time when economic conditions, you know, improve.

And I actually want to make a special point of this class growth because therein lies, I think, a tremendous opportunity for all of us. Today, well, last year this time, the CDK class was 48% in first-line metastatic breast cancer use. This quarter, it was 54%.

Pfizer products as well.

I am thrilled to say that the first product under this accord has arrived in Rwanda with, more on the way.

I am thrilled to say, but the first product under this of course has arrived in Rwanda with more underway.

Pfizer experts also held a session with 100 Rwandan medical professionals to discuss efficacy, safety, and dosing of this milestone.

Pfizer experts also heard this session with hundreds of Rhonda medical professionals to discuss efficacy safety and dosing of these milestone. This is just the first step of a court implementation, but an important one but will impact many lives.

This is just the first step of accord implementation, but an important one that will impact many, lives.

We also recently announced our commitment to achieve the net zero standard across our, value chain by year 2040. This is 10 years ahead of a new voluntary external standard. This includes aiming to reduce our company emissions by 95% and value chain emissions, by 90% within the next roughly 18 years.

We also recently announced our commitment to achieve net zero standard across our value chain by year 2014.

This is 10 years ahead of a new voluntary external foundries.

This includes aiming to reduce our company emissions by 95% and value chain emissions by 90% with the next roughly 18 years.

In response to the war in Ukraine, we are donating the equivalent of all profits from, sales in Russia to causes that provide direct humanitarian support to the people of Ukraine.

In response to the awarding of Crane, we are donating the equivalent of all profits from sales in Russia to closes I'll provide direct humanitarian support with the people of Ukraine.

Our first down payment of 5 million is going to aid global and local NGOs to support humanitarian, relief and the sports efforts.

First on payment of 5 million going to eight global and local Ngos, which supports humanitarian relief and support efforts and we will continue to channel. This brokerage to week random people until piece ease of cheap.

And we will continue to channel these profits to the Ukrainian people until peace is achieved.

I'm also very proud to share with you that in a recently published report from MSCI, Pfizer's annual ESG rating increased three notches compared with June 2021, going from, B to A.

I'm also very proud to serve with you but in a recently published report from MSCI Pfizer's on Europe ESG rating increased three notches compared with June 2021 going from B to <unk>.

This is just the latest external recognition we have received for our commitment to sustainable and ethical business practices.

This is just the latest external recognition we've ever received for our commitment to sustainable and ethical business practices.

I couldn't be prouder for our colleagues' commitment to good governance practices, quality and integrity.

Can be prouder for our colleagues' commitment to good governance practices quality and integrity.

With that, I will turn it over to Michael to update you on our R&D efforts.

With that I will turn it over to Michael to update you on our R&D efforts after Michael Dave will provide financial details from the second quarter and our outlook for the remainder of 2022.

After Michael, Dave will provide financial details on the second quarter and our outlook for the remaining of 2022.

Thank you, Albert.

So even though it's grown, it still means that the majority of the time CDKs are not being used.

I'd like to start by highlighting two recent leadership appointments. I've appointed Annalise Anderson to lead vaccine research and development, succeeding Katherine Jensen, who previously announced her retirement.

Thank you Albert.

To start by highlighting two recent leadership appointments.

I've appointed analyst Anderson to lead vaccine research and development, succeeding Catherine Jensen, who previously announced her retirement with more than two decades, so biopharma R&D experience.

With more than two decades of biopharma R&D experience, Lisa most recently served as CSO for bacterial research and hospital. Over the last two years, she has led a team of infectious disease biologists that designed and delivered Paxlovid to an emergency use authorization.

Most recently you saw the CSO for bacterial with such an hospital over the last two years. She has led a team of infectious disease qualities that design that is levered <unk>, it's an emergency use authorization.

Under her leadership, we also advanced several bacterial vaccine programs into clinical development and approval.

Her leadership, we also advanced several bacterial vaccine programs into clinical development and approval of <unk>.

I've also named Charlotte Allerton, CSO for anti-infective, a new research unit. Creating this new research unit allows us to expand our focus beyond medicines that typically are used in hospitals. Charlotte is an esteemed scientist who will broaden our antivirus strategies with additional efforts in antibacterial and antifungal science and medicine.

Also named Charlotte I'll, let Tony CSO for anti infective.

Our new research unions.

These new research unit allows us to expand our focus beyond medicines that typically are used in hospitals.

Charlotte is any steam scientist, who will broaden our antiviral strategies with additional airports and antibacterial and antifungal science and medicine Charlotte has been our head of medicine design, most notably call. It in the discovery and development of Opex, a little bit and we'll continue in that world as well.

Charlotte has been our head of medicine design, most notably co-leading the discovery and development of Paxlovid, and will continue in that role as well.

I have had the privilege to work closely with Lisa and Charlotte for more than 10 years and have been continuously impressed by them as world-class scientists in their respective fields of expertise.

I had the privilege to work closely with Nissan Charlotte for more than 10 years and have been continuously impressed by them as world class scientists in their respective fields of expertise both have demonstrated good product hunting skills and a sound business mindset I'm looking forward to working with them in their new roles.

Both have demonstrated good product hunting skills and a sound business mindset.

I'm looking forward to working with them in their new roles.

Let's begin with COVID-19. The pandemic continues to evolve into a disease which is causing significant disease burden, including high rates of acute disease, medical care utilization, hospitalization, and death during the entire year. A growing number of patients affected by acute COVID infections are developing chronic disease and suffering from long COVID symptoms affecting multiple organs, such as the lung, heart, kidney, brain, and vascular system.

And I think we all of us in this class really need to focus on this as, you know, the leading priority in helping to grow each of our brands, but also to grow the class to impact patient outcome.

Let's begin with COVID-19.

Thank you, Angela.

<unk> continues to evolve into a disease, which is causing significant disease burden, including high rates of acute disease medical care utilization hospitalization and deaths during the entire year.

Next question, please.

A growing number of patients affected by acute COVID-19 infection or developing chronic disease and suffering from low COVID-19 symptoms affecting multiple organs, such as the lung heart kidney brain and the vascular system.

We have seen major waves of variants of concern emerge quickly, become dominant, then be superseded by the next variant. Omicron and its sub-lineages are the most antigenically distinct compared to prior variants of concern, most more transmissible, and show evidence of partial immune escape from existing vaccines.

Your next questions come from the line of Chris Shibutani with Goldman Sachs.

We have seen major of a wave so barring some concern emerge quickly become dominant than be superseded by the next version.

Thank you very much.

Omicron and its sub limited.

Most MTN.

It stinks compared to prior year volumes themselves on and move more transmissible and show evidence of partial immune escape from existing vaccines.

As the composition of SARS-CoV-2 changes, it is essential we advance new approaches to extend the level of protection that Comirnaty originally conveyed.

First, a quick word of welcome and appreciation to David for your proactive commentary, on the phasing of revenues.

It really mirrors what your predecessor had often referred to as the rhythm of the numbers.

The composition of Sars Cov two changes.

Essentially we had bonds new approaches to extend the level of protection that may not be what originally conveyed.

In a clinical trial, we evaluated the safety, tolerability, and immunogenicity of mono- and bivalent Omicron-B1-modified vaccines administered as a fourth dose in more than 1,900 participants over age 55.

Very helpful to get insights on near-term factors that are generating push-pulls on those numbers.

The clinical trial, we evaluated the safety Tolerability and Immunogenicity of mono and bivalent Omicron via one modified vaccine administered as a fourth dosing more than 1900 participants over age 55, well.

We are also evaluating different doses of mono- and bivalent B1 in participants 18 to 55 years of age.

Also evaluating different doses of molding bivalent pier, one and parties have been 18 to 55 years of age why do we saw promising responses to both mono and bivalent versions in the over 65 population, we move forward with bivalent following guidance from regulators.

While we saw promising responses to both mono and bivalent versions in the over 55 population, we moved forward with bivalent following guidance from regulators.

The BA1 vaccine candidate elicited a superior immune response for BA1 compared to the current, version of the vaccine, a zero response rate which exceeded non-inferiority and neutralization activity which increased substantially.

The <unk> one vaccine candidates elicited a superior immune response would be a one compared to the current version of the vaccine.

As CMO response rate, which exceeded non inferiority and utilization activity, which increased substantially.

The BA1 vaccine utilized wild type and delta similarly to the current version of the vaccine, suggesting that omicron modified version maintained response for the ancestral and other viral variants.

One vaccine neutralized wild type and desktop similarly to the current version of the vaccine, suggesting that omicron modified version maintained response.

<unk> and other viral variant based on these states following guidance from regulators, we have completed regulatory submissions in Europe , UK and Canada with a 30 microgram bivalent vaccine individuals 12 window and plan submissions in other markets soon.

Based on these data and following guidance from regulators, we have completed regulatory, submissions in Europe, UK, and Canada for the 30-microgram bivalent vaccine in individuals, 12 and older and planned submissions in other markets soon. The data also showed this vaccine candidate neutralized omicron BA4 and 5, though to a, lesser extent than BA1.

Data also showed inspecting candidate utilized only Colombia, four and five though to a lesser extent than be alone. These suggested a need to develop both that'd be a modified vaccine and it would be a four to five more device vaccine.

This suggested a need to develop both a BA1 modified vaccine and a BA4, 5 modified vaccine. We studied BA4, 5 monovalent and bivalent booster candidates in mice and found a substantial, increase in neutralization responses to all omicron variants of concern. Neutralizing titers against BA4, 5 increased 11-fold for the monovalent and 4.8-fold for, the bivalent compared to monovalent BA1 vaccine.

We started before five one of valent and bivalent boosted candidates in mice and found a substantial increasing utilization responses to all on the core environmental concern neutralizing titers against the up 45 increased 11 fold for the monovalent and $4 eight for the bivalent.

And compared to Monovalent pier one vaccine.

These data were shared at the recent FDA advisory committee meeting as a potential surrogate, to help expedite development of a BA4, 5 vaccine.

This data was shared at the recent FDA Advisory Committee meeting.

Tension surrogate for hill exited Bedight development of our <unk>.

We plan to submit the BA4, 5 bivalent vaccine candidate for emergency use authorization, in the U.S. in preparation for the fall booster campaign. To that more rapidly, we've agreed with FDA that this submission will be based on safety, and immunicity data generated in adults with an omicron modified BA1 vaccine and supported by BA4, 5 bivalent specific preclinical data and BA4, 5 bivalent chemistry manufacturing and controls data.

We plan to submit the <unk> bivalent vaccine candidate for emergency use authorization in the U S. In preparation for the fall boosted campaign to adapt more rapidly we've agreed with FDA that this submission will be based on safety and Immunogenicity data generated in the adults with an armoured car modified one buy.

Z and supported by be at four five bivalent.

Pre clinical data and <unk>, five <unk> chemistry manufacturing and control and state though.

This strategy is bolstered by previous experience showing that overall responses have been similar, between human clinical and mouse data, our clinical experience with beta and omicron modified vaccine candidates, and by leveraging our mRNA platform and manufacturing experience for the current vaccine.

This strategy is bolstered by previous experience showing that overall responses have been similar between human clinical them Allstate.

Our clinical experience with beta omicron modified the vaccine candidate and by leveraging our mrna platform and then if I can't speak for the current vaccine.

To support future potential U.S. licensure and global registration, we plan to initiate, a clinical study to evaluate the BA4, 5 bivalent vaccine. The clinical study design is under discussion with FDA.

To support future tenants show U S licensure and global registration, we plan to initiate a clinical study to evaluate the.

Bivalent vaccine clinical study design is under discussion with FDA.

We aspire to continue leading with the science and are working to identify vaccines that, will help provide strong and durable protection as new SARS-CoV-2 variants emerge. We aim to deliver a next generation COVID-19 vaccine that can provide durable antibody, and so on.

We aspire to continue leading with science and are working to identify vaccines that would help provide strong and durable protection as new soft coat two variants emerge waiting to deliver a next generation COVID-19 vaccine that can provide durable antibody and T cell immune protection against <unk>.

And what's the legislation for at least one year, we plan to take a step wise approach by designing and testing different candidates engaged multiple arms of the immune system, including antibodies and T cells.

So let's start the research.

My question is on business development, however, and I'm not sure that Amir has joined us.

By designing and testing different candidates that engage multiple arms of the immune system, including antibodies and T-cells.

First, yesterday we announced the start of a phase two study evaluating a bivalent, modRNA, vaccine candidate, which consists of RNA encoding novel enhanced pre-flusion spike protein for the SARS-CoV-2 ancestral strain and an omicron variant. The enhanced spike protein encoded from mRNA has been modified with the aim of increasing, the magnitude and breadth of antibody neutralization response that could better protect against, COVID-19.

Perhaps if you could update us on your latest thoughts, the team, in terms of how you're feeling about areas of focus, particularly in view of recent broader commentary, for instance, from the FTC, taking a look at competitive dynamics there.

And then secondly, as you reflect upon the overall ecosystem and the receptivity, given things like lowered, relatively speaking, budget valuation, are you sensing any shifts or trends or changes in the mindset of potential targets, partners, acquirers?

Yesterday, we announced the start of.

Phase two study evaluating the bivalent model RNA vaccine candidate, which consists of ornate and coding noble Hans <unk> Spike proteins for the Salt score two and system strain and then omicron buyer.

Thank you.

Thank you very much.

Amir is here, and he will be happy to speak about it.

Then Hans Spike protein encoded from them on that.

<unk> with the aim of increasing the magnitude and breadth of antibody neutralization response that could better protect against COVID-19, we predict delivering key clinical data for <unk>.

We project delivering key clinical data this fall.

Second, we plan to initiate the proof of concept study with a potential pan-SARS-CoV-2 vaccine, candidate by the end of the year. This combines the super-stabilized spike sequences with a T-cell-enhancing construct aiming to, extend durability or protection against severe disease and new emerging SARS-CoV-2 viral variants.

We plan to initiate the proof of concept study with a potential pen. So it's cool to vaccine candidate by the end of the year. This combines the super stabilized spike sequence with a T cell enhancing contract.

Aiming to extend durability.

Fiction against severe disease, and new emerging thoughts come to Barbara volume.

Now, turning to PaxLibid, last month we submitted a new drug application to USFDA seeking approval, for the treatment of COVID-19 in both vaccinated and unvaccinated adults and pediatric patients aged 12 years and over weighing at least 40 kilograms and at high risk for progression to severe illness. We anticipate a PDUFA date in the first quarter of 2023.

Amir.

Now turning to <unk> last month, we submitted a new drug application to the U S. FDA seeking approval for the treatment of COVID-19 in both vaccinated alone vaccinate, the adult and pediatric patients 12 years and over weighting at these 40 kilograms and at high risk for progression to severe illness.

Chris, thank you for the question.

Let me just start with your specific FTC point.

I think we've demonstrated a very strong track record of shepherding our transactions to date, through the regulatory process, and that's been largely built on having just a close, successful, constructive, and collaborative relationships with regulatory bodies globally.

In addition, our business development focus, and I'll recap our priorities in a second, is focused on how do we use our unique abilities to translate emerging science into breakthrough medicine.

So most of the deals that we do are pro-patient and they're pro-innovation.

So we're confident that we can continue to advance our BD strategies in a successful way.

We've been very clear that our goal is to add $25 billion of risk-adjusted revenue by 2030, and I think we are making very good progress against that. This year you saw our transaction with Reviral and subsequently with Biohaven, which respectively we believe have the potential to add $1.5 billion and $6 billion in peak sales to our business.

And this is on the back of a very active 2021.

And going forward, we're leaving very few stones unturned when we look at opportunities, and our focus is going to be consistent.

We anticipate that Purdue date in the first quarter of 'twenty to 'twenty three we plan to generate further date than those who are immunocompromised hospitalized with severe COVID-19, and at increased risk for poor outcomes due to disease or who are pregnant with.

It's on scientific substrate that has the potential breakthrough for patients, deals that accelerate our top-line growth in the back half of the decade, and then opportunities where we can add substantial value, whether that's through our scientific chops and or our commercial capabilities.

And we're going to be very open to deal structures, and we've said before we're also going to be agnostic to size.

We've been clear about the fact that cost-energy-driven deals are not where our focus is going to be, and we're going to be extremely disciplined.

I think we're very excited about the opportunities that are ahead of us, and the flexibility that our balance sheet gives us to pursue those.

We plan to generate further data in those who are immunocompromised, hospitalized with, severe COVID-19, and at increased risk for poor outcome due to the disease or who are pregnant.

With that, let's go to the next question.

And on your question on valuation fluctuations, those market valuation fluctuations are not going to drive our BD strategy.

We're going to remain focused on fundamentals in the way that I described. It is very important when we are aiming very high to also be able at the same time to be, disciplined. Discipline in valuing the science and paying the right price for the right science so that the capital that we will dispose of will be maximized in producing value for patients and diverse shareholders.

So we go very big, 25 billion, but as we are proving, we are very, very disciplined in how we are allocating our capital and we will continue doing that.

Thank you, Amir.

Your next questions come from the line of Andrew Baum with Citi.

We also are considering multiple collaborative studies to evaluate potential treatment for, long COVID.

Thank you.

We also are considering multiple collaborative studies to evaluate potential treatment for long Colby.

A two-part question, please.

Your former head of vaccines is now in sconce, your competitor, GSK.

Finally, we're working with FDA to finalize a protocol to study patients who may be in, need of re-treatment.

Finally, we are working with FDA to finalize the protocol to study patients who may be in need of retrieving them.

According to CDC, a brief return of symptoms may be part of the natural history of SARS-CoV-2, infection in some people.

According to CDC brief return of symptoms may be part of the natural history of Sars Cov, two infection and some people. We believe the assurance of COVID-19 rebound is uncommon and most uniquely associated with any specific treatments.

We believe the occurrence of COVID-19 rebound is uncommon and not uniquely associated with, any specific treatment.

At this time, cases are being reported at the rate consistent with the epic HR trial.

When he top-lined the recent positive phase three data for their RSV vaccine candidate, which is adjuvated, observation he made was he stressed the same level of efficacy in the older patient cohort than in the younger patient cohort.

It's possible to imagine that this may be uniquely related to the adjuvant that they have given the immunosenescence of the aging population's T cells.

This time cases are being reported at the rate consistent with the epic HR trial.

Turning now to flu, we know that currently available vaccines are not optimal in addressing, the unmet need as each year many people are infected, hospitalized, and die resulting in tremendous public health and economic impact. In part, this is because the flu vaccine development cycle is inefficient and even when the current, seasonal vaccine strains match circulating strains well, they typically confer only 40 to 60% protection. Potential advantages of the mRNA platform include shortened timeline to enable a quicker, response each season, improved strain matching, faster and more reliable manufacturing, and broader immune response from both antibody and T-cells, the latter needed particularly in older adults. Based on our experience with COVID-19, T-cell responses appear to be critical for the protection, against severe disease and hospitalization in infectious viral diseases, disease.

Turning now to flu.

That currently available vaccines are not optimal in addressing the unmet need as each year. Many people are infected hospitalized and die, resulting in tremendous public health and economic impact.

In part this is because the flu vaccine development cycle, it's inefficient and even when the currencies in the vaccine strain match circulating since well the typically convert our own reported 60% protection.

Given your vaccine does not have an adjuvant, and given your background, is that a concern, particularly over long years follow-up?

Potential advantages of the mrna platform include short term timeline to enable a quicker response, you've seen some improved strain matching.

<unk> more reliable manufacturing and broader immune response from both antibody and T cells that left the needed particularly in older adults.

Based on our experience with COVID-19, T cell responses at peer to be critical for the protection against severe disease and hospitalization in infectious viral disease.

Here we show phase two T cell data for our quadrivalent mod mRNA flu vaccine candidate in subjects 65 and older. We believe this is the first evidence of a flu vaccine candidate inducing substantial responses for both CD4 and CD8 T cell.

And then second, just following up on the question on iBran, could you talk to your, Arvinus compound, ARV471?

We come up with market shares which are materially lower than yours, but whatever the number is, it's clearly reducing quite significantly as competition builds momentum in the market.

How are you thinking about, as you transition this drug into phase three, both what combinations you're going to run and what are you going to use as a control arm for the combination of a SIRV plus a CDK46?

Here, we show a phase two piece of data for our quadrivalent mud mrna flu vaccine candidate.

Thank you, Andrew.

Just to make a correction, it was not the head of our vaccines that joined, it was another member of the vaccines team, but by no means was the head.

65 and older. We believe this is the first evidence of a flu vaccine candidates using substantial responses for both Singapore and CD eight T cells on the left.

Let's move to Michael.

On the left, at day seven, the CD4 T cell response was more than twofold for all four flu strains for our vaccine compared to a current high-dose vaccine now recommended in the U.S. for adults 65 and older.

Yeah, you know, I am very optimistic about our RSV vaccine construct. We have seen, high immune titer that are critical for the vaccine across all ages.

They send them the CD four T cell response was more than two fold for all four flu strain for our vaccine compared to our current hydrous vaccine a recommended in the U S but six.

In fact, we are the only one that have showed cross strain A and B for RSV, the very high titers, which differ between all the vaccines, including the one that you mentioned, because they mainly measure cross reactivity from A to B strain.

Over half the cohort receiving our vaccine candidate had a more than twofold response.

So that was supported also by our challenge data that looks formidable.

65 and older.

Over half the cohort receiving our vaccine candidate at a more than twofold response.

On the right, at day seven, the CD8 T cell response and responder rates were greater for all four strains for our vaccine candidate versus the comparator.

Underwrite at day seven to see the 18th response and responder rates, we're grateful for all four strain for our vaccine candidate buses the comparator.

Our belief is that these encouraging T cell responses combined with higher seroconversion rates for flu A strains, which are the most predominant circulating strains and have pandemic potential, may translate into improved efficacy over current seasonal flu vaccines, particularly those 65 and older.

Our belief is that these quality and T cell responses combined with higher seroconversion rates for <unk>.

<unk> strengths, which are the most predominant circulating strains and pandemic potential may translate into improved efficacy of our current seasonal flu vaccines particular, those 65 and older based on these data we plan to initiate the phase III efficacy study this year.

So while nobody can predict exactly outcome of studies and compare one study to another, we remain very bullish that our bivalent vaccine should stand out in performance and in tolerability.

Based on these data, we plan to initiate the phase three efficacy study this year.

Please note, some of the arguments, including the one that you referred to, often associated with somewhat unpleasant side effects.

And that was one part of our differentiation to achieve with the bivalent very high.

We are excited to share that new data on our <unk> one receptor agonist.

We are excited to share that new data on our oral GLIP-1 receptor agonists, two abstract on twice-daily dianogliferone, and one on our once-daily candidate known as 1532, have been accepted for the European Association for Study of Diabetes Conference in September.

And what about Ibrance?

The ARV-471, I can only speak about the science here, that we see that drug being active in, several lines, as by itself, best-in-class estrogen receptor, Protech, and we are going to set up our studies in a patient population which contains many estrogen receptor mutants, which often are poorly managed by the current available Fulvestrant or other SERDs, and we think this is a unique opportunity, and number two, the drugs seem to combine very well with our own CDK4-6 drugs, and we think it could advance into early metastatic lines, and possibly over time, even to early breast cancer, maybe there, combined with our CDK4, so we have very high hopes for that class of drugs, ARV-471, combined with our pipeline.

Two abstracts on twice daily tablet phone and one on our once daily candidate known as but 50 30 to have.

Thank you.

Have been accepted for the European Association for the study of diabetes.

These investigational medicines were designed in-house by Pfizer's innovative chemistry and discovery teams.

Anything to add, William?

In September .

These investigational medicines were decided in house by prices innovative chemistry and discovery teams.

In our phase one study in adults with type two diabetes.

In a phase one study in adults with type 2 diabetes, after only six weeks of treatment, 1532 drug robustly reduced mean daily glucose to, almost near normal levels. Participants also experienced weight loss of up to five kilograms compared with two kilograms for placebo.

The only six weeks of treatment.

And start to two drug robustly reduce new daily glucose to almost near normal levels.

<unk> also experienced a weight loss of up to five kilograms compared with two kilogram for placebo.

We believe this to be a potentially best-in-class profile across both injectables and orals.

We believe this to be a potentially best in class profile across both Injectables and oreos.

Similar changes in body weight were observed in participants with non-diabetic obesity.

Similar changes in body weight were observed in participant with non diabetic obesity.

1532 is characterized by favorable once-daily pharmacokinetics, low risk for drug-drug interaction, robust efficacy across multiple metabolic endpoints, and GLIP-1 receptor agonist class-like tolerability, which overall encourages us to plan for a phase two study to pick the winning candidate prior to a potential phase three study start. These development programs may lead to potential indications in type 2 diabetes, obesity, NASH, and cardiovascular risk reduction in type 2 diabetes and obesity patients.

<unk> 32 is characterized by favorable one study the pharmacokinetics low risk foot Viking direction robust efficacy across multiple metabolic endpoints.

<unk>, one receptor agonist class like probability, which overall encourage us to plan for a phase two study at the peak the winning candidate prior to a potential phase III studies.

These development programs may lead to potential indications in type two diabetes, obesity, and Nash and cogent, but that's still a risk production in type two diabetes and obesity patients.

Over the 12 past months, we have built a strong inflammation and immunology portfolio with diverse products to help address multiple drivers of disease, an unmet need.

Over the 12 past months, we have built a strong inflammation and immunology portfolio with diverse products to help address multiple drivers of disease and unmet need.

CBINCO was approved for atopic dermatitis in adults and last week received priority review designation in the U.S. for adolescents 12 to 18.

<unk> was approved for atopic dermatitis in adults and last week received priority review designation in U S for adolescents 12 to 18 years.

We are nearing a regulatory submission for retracimod in ulcerative colitis.

We are nearing a regulatory submission for <unk>.

Colitis we.

We have submitted regulatory applications in US, Europe, and UK for ritlicitinib for, the PCR reactor and are awaiting acceptance. We also plan to start a phase 3 study of ritlicitinib in vitiligo this year.

We have submitted regulatory reputation in U S Europe and UK for regular Tiffany for the PCI react and are awaiting acceptance.

We also plan to start a phase III study of <unk>.

And you can get the language this year.

We are pleased to now share promising new updated data from our anti-interferon beta, monoclonal antibody in specialized rheumatology. Patients with diatomaceous show elevated type 1 interferon gene signature in blood, skin, and muscle, correlating with disease activity in skin.

We are pleased to now which are promising you updated data from our anti interferon beta monoclonal antibody in specialized rheumatology.

Patients we've done with them at site is elevated type one interferon gene signature in blood screening Muslim correlate and we did see some activity and scheme.

As we continue our development of this candidate, a potential breakthrough therapy for hard-to-treat, diatomaceous, which attacks skin and muscles, we believe it may have the ability to address a broader set of inflammatory autoimmune diseases, possibly including poliomyocytes and lupus. On our third quarter 2021 call, I shared data from our ongoing phase 2 diatomaceous study, focused on skin inflammation and showing significant reduction in disease activity when compared with placebo in just three months of treatment. Now, both doses met the primary efficacy endpoints in skin-predominant disease. The disease also manifests with progressively debilitating muscle weakness and fatigue.

As we continue our development of these candidates and potential breakthrough therapy for hard to treat them with many sites, which are tech skin and muscles. We believe it may have the ability to address a broader system inflammatory autoimmune diseases, possibly including all the new sizes and lupus.

Well notwithstanding quarter to 'twenty to 'twenty, one call I shared data from our ongoing phase II <unk> study focused on skin inflammation and showing the significant reduction in disease activity, when compared with placebo and yes three months of treatment.

Now both doses met the primary.

At the end.

And Steve predominant disease.

<unk> also many firsts with progressively debilitating muscle weakness and fatigue.

Early data suggests that in a small cohort of patients with muscle-predominant disease, our candidate resulted in numerically better efficacy score across all key muscle endpoints, including patient-reported outcomes of the three weeks. We plan to submit the data for presentation once the study completes.

Early data suggests that in a small cohort of patients with muscle predominant disease. Our candidates resulted in numerically better efficacy across all key muscle endpoints, including patient reported outcomes after three weeks.

We plan to submit the data for presentation, Washington study completes.

Now, a promising update on Elviranatamab, our investigational B-cell maturation antigen, CD3 targeted by specific antibodies. At ESCO, we present the data from a phase 1 trial in people with relapsed refractory, multiple myeloma, whose disease is refracted to at least one agent in each of the three major classes of medications approved for the disease. We saw a confirmed overall response rate of 64% and 35% of patients achieved stringent, complete response or complete response. More than half who received prior BCMA-directed therapy, such as antibody-drug-conjugate or, chimeric antireceptor T-cell therapy, achieved a response.

No.

Missing update on it ran at them up our investigation of B cell maturation antigen.

Targeted bispecific antibody.

At school, we presented data from a phase one trial in people with relapsed refractory multiple myeloma, whose disease is refractory to at least one agent in each of the three major classes of medications approved for the disease.

We saw a confirmed overall response rate of 64% and 35% of patients. She had stringent complete response or complete response more than half will received prior <unk> directed therapy, such as antibody drug conjugate or Kamerick MTN receptor T cell therapy achieved.

Our response.

The average probability of being event-free at 9 months was 77%. Elviranatamab elicited durable minimal residual disease or MRD negativity, meaning no disease, was detected after treatment in all available patients who experienced a complete response or stringent complete response. Molecular responses were durable as well, with 62% of those complete responders documented, to have MRD negativity at more than 6 months, including two patients who were MRD negative beyond 18 months.

Responders probability of being event free at nine months was 77%.

And we're not the mob Elisa durable minimal residual disease or <unk> negativity, meaning no disease was detected after treatment and all the value for both patients who experienced a complete response with stringent contingence bonds molecular responses were durable as well with 60% 62% of those.

Complete responders.

Two commensurate with <unk> negativity at more than six months.

Turning to patients who are <unk> negative.

Negative beyond 18 months.

Magnetism M1 results and emerging data from Magnetism M3, which is studying triple-class, refractory multiple myeloma, supports further development across a broader program with potential registration enabling studies Magnetism M5 in patients with double-class exposed multiple myeloma and Magnetism M7 in newly diagnosed post-transplant patients with multiple myeloma.

Maintenance is and one with <unk>.

And the emerging data for Magnetics and suite, which is studying triple class refractory multiple myeloma supports further development across a broader program with potential registration, enabling studies manganese and five in patients with Dublin plastics, both multiple myeloma and maintenance fees and seven in.

Newly diagnosed post transplant patients with multiple myeloma.

There is potential for deep and durable results that can be broadly accessible to patients, due to off-the-shelf, subcutaneous and convenient dosing.

There is potential for deep and durable results that can be broadly accessible to patients, Utah officer, Jim <unk>.

Containers and convenient dosing the efficacy and safety profile, we've seen to date in a challenging patient population support advancement into earlier lines of treatment.

The efficacy and safety profile we have seen to date in a challenging patient population, support advancement into earlier lines of treatment.

Finally, here is a snapshot of select milestones for this year, showing healthy progress in, the pipeline.

Finally here is a snapshot of select milestones for this year showing healthy progress in the pipeline.

It was an important quarter for COVID execution, and we look forward to sharing complete readouts, from Antientifrombase and the Mod Flu candidate for the end of the year.

It was an important quarter for Covid execution, and we look forward to sharing complete readouts for <unk> and interferon beta and the multiple 10 to date before the end of the year. Thank you for your attention, let me turn it over to Dave.

Thank you for your attention.

Let me turn it over to Dave.

Thank you, Michael, and good morning, everyone.

Yeah, I would just add, as you mentioned, Michael, the preclinical data shows that the, AR degradation could be superior to selective estrogen receptor degraders, and so we're very excited about this potential to be superior to SERDs that are being developed.

Thank you Michael and good morning, everyone. As this is my first call as CFO I thought I would set the stage for the next chapter of Pfizer and our relentless focus on creating long term shareholder value over.

As this is my first call as CFO, I thought I would set the stage for the next chapter, of Pfizer and our relentless focus on creating long-term shareholder value.

Thank you, from your lips to God's ears.

Also, I want to add on the RSV, because it's the second question that came, and maybe gave, the impression that we are not very hot on it.

Over the past few years, Pfizer's cash generation capabilities have expanded significantly, and the efficient deployment of this capital is more critical than ever.

We are extremely hot on it.

Over the past few years Pfizer's cash generation capabilities have expanded significantly and the efficient deployment of this capital is more critical than ever.

Clearly, a very important product for us, clearly a very important product for GSK, so there will be a lot of speculation.

It's clear to me the company is uniquely positioned for both growth and at the same time enhancing, financial returns.

Maybe the other one will do that, or maybe the other thing will do this.

It's clear to me the company is uniquely positioned for both growth and at the same time enhancing financial returns.

I think data will speak on themselves.

And as we look to the future of the company, we are focused on three primary areas to drive, significant shareholder value.

And as we look to the future of the company. We are focused on three primary areas to drive significant shareholder value.

First and foremost is our continued emphasis and investment in science and innovation. We are investing internally and externally to create breakthrough medicines, deploying, more than $50 billion in this area in the past three years alone.

With the totality of data available so far that I have seen, we have high reasons to, believe we are better.

First and foremost is our continued emphasis and investment in science and innovation.

We are investing internally and externally to create breakthrough medicines deploying more than $50 billion in this area in the past three years alone.

Our second priority is maintaining and growing Pfizer's dividend, paying out more than $25, billion to shareholders over this period. We recognize that our dividend represents an important component of returns for our, investors.

Our second priority is maintaining and growing pfizer's dividend paying out more than $25 billion to shareholders over this period.

We recognize that our dividend represents an important component of returns for our investors.

And finally, from time to time, we return capital to shareholders through value-enhancing, share repurchases. Over the past three years, the company has allocated nearly $9 billion in this area.

And finally from time to time, we returned capital to shareholders through value enhancing share repurchases.

Over the past three years the company has allocated nearly $9 billion in this area.

Clearly maximizing shareholder value will be a major focus, and I believe that all three, areas will contribute to our success. More recently in year-to-date, we deployed more than $12 billion into innovation, paid, dividends of $4.5 billion, and we purchased $2 billion worth of our shares. This demonstrates an ongoing commitment to our robust capital deployment framework.

Clearly maximizing shareholder value will be a major focus and I believe that all three areas will contribute to our success.

More recently in year to date, we deployed more than $12 billion into innovation.

Paid dividends of $4 5 billion.

We purchased $2 billion worth of our shares this.

This demonstrates an ongoing commitment to our robust capital deployment framework.

With that, now let me briefly review our financial results for the quarter.

But you never know before the end of the trials.

With that now let me briefly review our financial results for the quarter.

I will confine my remarks largely to adjusted and operational growth figures. According to the income statements, revenues increased 53% operationally in the second, quarter of 2022. These results were driven by momentum in PaxLoban sales, strong sales of the COVID-19 vaccine, and underlying strength from a number of our key products.

But right now, with all in all, looks like we have a very, very strong profile with all, the data that we have seen so far.

We are waiting a lot, with a lot of excitement, to unblind the data and see the realities, and then, of course, the best will win.

I will confine my remarks, largely to adjusted and operational growth figures.

Let's move now to Steve.

Turning to the income statements.

Revenues increased 53% operationally in the second quarter of 2022. These results were driven by momentum in <unk> sales.

Your next question comes from Steve Scala with Cowen.

Thank you so much.

Strong sales of the COVID-19 vaccine and underlying strength from a number of our key products.

I would just like to understand more deeply Pfizer's thinking on factor XI.

Excluding PaxLoban and Comirnaty, BioPharma product revenues grew operationally by 2% compared to the prior year, respectively.

I can think of three possibilities.

Excluding <unk> and commodity <unk>.

Pharma product revenues grew operationally by 2% compared to the prior year.

In line products, <unk>, and <unk> were impacted by labeling changes and a global pods and shipments respectively.

While Ibrance continued to transition into a new COVID normal market environment.

While I brands continued to transition into a new COVID-19 normal market environment.

PC1, our contract manufacturing business, grew 89% operationally in the second quarter of 2021, and therefore faced a tough comparison versus last year, with PC1 declining by 25% operationally. And now bringing that all together, Pfizer's non-COVID related revenues grew by 1% operationally in the second quarter. Adjusted cost of sales dollars grew more slowly than revenue, resulting in gross margin rate expansion of 570 basis points versus the second quarter of LY. This improvement in gross margin is largely due to the impact of higher margin Paxlovid sales, partially offset by higher COVID-19 vaccine sales, and the impact of a $450 million write-off of COVID-related inventory that had expired or is expected to expire.

<unk> our contract manufacturing business grew 89% operationally in the second quarter of 2021, and therefore faced a tough comparison versus last year with PC, one declining by 25% operationally.

First, Pfizer believes there is simply no room to improve upon Eliquis.

Second, Pfizer believes factor XI could be very useful, but you haven't found the ideal, candidate.

And now bringing that altogether pfizer's non COVID-19 related revenues grew by 1% operationally in the second quarter.

Or third, Pfizer is not sure the jury is still out.

Adjusted cost of sales dollars grew more slowly than revenue, resulting in gross margin rate expansion of 570 basis points versus the second quarter about why.

This improvement in gross margin is largely due to the impact of higher margin <unk> sales, partially offset by higher COVID-19 back sales vaccine sales and the impact of a $450 million write off of Covid related inventory that had expired or is expected to expire.

Given the unpredictable nature of the virus, we chose to manufacture and hold excess stock to ensure we can meet any global health demand for products if an extreme need were to arise.

Given the unpredictable nature of the virus, we choose to manufacturer and hold excess stock to ensure we can meet any global health demand for products.

Adjusted SINA expenses in the second quarter grew by 7% operationally. The increase was primarily driven by spending for Paxlovid and Comirnaty and higher healthcare reform fees.

If an extreme need were to arise.

Adjusted SG&A expenses in the second quarter grew by 7% operationally.

The increase was primarily driven by spending for Pac slowed it takes a little bit in commodity and higher healthcare reformed fees.

The 27% operational increase in adjusted R&D expense in Q2 was primarily driven by investments in multiple late stage clinical programs.

The 27% operational increase in adjusted R&D expense in Q2 was primarily driven by investments in multiple late-stage clinical programs, including programs to both prevent and treat COVID-19 and costs to develop recently acquired programs.

Including programs to both prevent and treat COVID-19 and cost to develop recently acquired programs.

The affected tax rate on adjusted income in the quarter of 15.4% declined by 170 basis points versus last year, driven by a favorable jurisdictional mix of earnings.

The effective tax rate on adjusted income in the quarter, a 15, 4% declined by 170 basis points versus last year, driven by a favorable jurisdictional mix of earnings.

As a result, reported diluted earnings per share of $1.73 grew by 77%, while adjusted diluted earnings per share of $2.04 grew 92%, and on an operational basis, adjusted diluted earnings per share grew 100% in the quarter. Foreign exchange movements continued to dampen our results, negatively impacting revenues and, adjusted earnings per share by 7% and $0.08 per share.

And as a result reported diluted earnings per share of $1 73 grew by 77%, while adjusted diluted earnings per share of $2.04 grew 92%.

On an operational basis adjusted diluted earnings per share grew a 100% in the quarter.

Foreign exchange movements continued to dampen our results negatively impacting revenues and adjusted earnings per share by 7% and eight in <unk> per share.

Any thoughts?

So with that let's move on to our 2022 guidance.

So with that, let's move on to our 2022 guidance. Given our strong second quarter performance and our improving outlook for the year, we are increasing our operational expectations for both revenues and adjusted earnings per share. For the full year, we are increasing our operational revenue expectations by $2 billion, and operational adjusted diluted earnings per share expectations by $0.24.

I think we have answered it before, and maybe Michael also can give some color, because, it's a very, very good question.

But bottom line is we are looking for science that it could provide hope that we can have, something better than Eliquis, and we haven't found yet.

Given our strong second quarter performance and our improving outlook for the year, we are increasing our operational expectations for both revenues and adjusted earnings per share.

So that's the reality.

According to our opinion, there is not much maturity right now to overcome the brilliant, the very good profile of Eliquis.

Michael, anything to add?

For the full year for the full year, we are increasing our operational revenue expectations by $2 billion.

And operational adjusted Diluting earnings diluted earnings per share expectations by 24 cents.

Unfortunately, given additional U.S. dollar strengthening since we last updated guidance in early May, foreign exchange negatively impacts revenues by approximately $2 billion, leaving our reported revenue guidance range unchanged at $98 to $102 billion.

Unfortunately, given additional U S dollar strengthening since we last updated guidance in early May foreign exchange negatively impact revenues by approximately $2 billion, leaving our reported revenue guidance range unchanged at $98 billion to $102 billion. This represents an.

This represents an operational growth rate of 29% at the midpoint compared to 2021, a 200 basis point improvement over prior expectations.

<unk> growth rate of 29% at the midpoint compared to 2021, a 200 basis point improvement over prior expectations.

The improvement in our Operational Adjusted Diluted Earnings Per Share Outlook of $0.24, is also negatively impacted by foreign exchange movements, compressing EPS by $0.19.

The improvement in our operational adjusted diluting diluted earnings per share outlook up 24 cents is also negatively impacted by foreign exchange movements compressing EPS by 19 cents.

The net impact of these cross-currents allows the company to raise the low end of its Adjusted Earnings Per Share Outlook by $0.05 to $6.30 to $6.45 a share.

The net impact of these cross currents allows the company to raise the low end to low end of its adjusted earnings per share outlook by five.

This represents 65% operational, growth at the midpoint compared to 2021.

To $6 30 to $6 45, a share this represents 65% operational growth at the midpoint compared to 2021.

Regarding our COVID-19 related revenues, we continue to expect the vaccine revenue for the year to be approximately $32 billion, unchanged compared to the prior guidance provided on May 3rd, despite the impact of approximately $1 billion of incremental negative foreign exchange.

Regarding our <unk>.

Our COVID-19 related revenues, we continue to expect the vaccine revenue for the year to be approximately 32 billion.

Unchanged compared to the prior guidance provided on may 3rd despite the impact of approximately $1 billion of incremental negative foreign exchange.

For <unk>, we expect sales of approximately $22 billion, keeping the guidance unchanged again, despite an incremental 300 million dollar headwind due to FX.

For Paxlovid, we expect sales of, approximately $22 billion, keeping the guidance unchanged, again, despite an incremental $300 million headwind due to FX.

Our non-COVID related revenues are absorbing approximately, $700 million of impact from negative foreign exchange. Now, given the seasonality that we expect, I'd also like to give you some color on the expected, cadence of these COVID-related revenues across the second half.

Our non COVID-19 related revenues are absorbing approximately 700 million of impact from negative foreign exchange.

That simple as that.

Now given the seasonality that we expect I would also like to give you some color on the expected cadence of these COVID-19 related revenues across the second half.

Based on current guidance for Comirnaty, we expect approximately 25% of second half sales in Q3 and 75% of sales in Q4, driven, by expected deliveries of Omicron adapted vaccines in Q4, again, subject to regulatory approval. Conversely, for Paxlovid, we expect approximately 60% of sales in Q3 and 40% in Q4.

I think you said it very well.

You know, in the ATL field, platelet inhibitor and ASI are or are going to be genericized.

Eliquis and rivaroxaban, great drugs.

Eliquis being a market leader, factor X inhibitor, are by the time factor XI comes to market, close to or already genericized.

So the room for an expensive drug in an area with this many great treatments that requires, tremendously high R&D expense, and the others coming off the patients have gone through multiple other great drugs.

For us, it doesn't look like the best area to deploy Capiton.

We always wish other good luck for the benefit of patients.

Based on current guidance for commodity we expect approximately 25% of second half sales in Q3, and 75% of sales in Q4, driven by expected deliveries of Omicron adapted vaccines in Q4 again subject to regulatory approval.

Thank you.

Let's go to the next question.

Your final question will come from the line of Elliott Bosco with UBS.

Conversely, slow, but we expect approximately 60% of sales in Q3 and 40% in Q4.

So with that, let me give you some detail on changes in our cost and expense guidance. We are decreasing our expected adjusted SINA spend by $300 million across the range to $12.2 to $13.2 billion.

Hi, this is Elliott Bosco from UBS on for Colin Bristow.

So with that let me give you some detail on changes in our cost and expense guidance. We are decreasing our expected adjusted <unk> spend by $300 million across the range to 12.2 to $13 $2 billion.

Thanks for taking our questions.

Additionally, we are also increasing our guidance for adjusted R&D expense by $500 million, at the low end only, with the new range of $11.5 to $12 billion, reflecting incremental investments in multiple programs, including mRNA vaccine programs outside of COVID-19 and other programs.

Additionally, we are also increasing our guidance for adjusted R&D expense by $500 million at the low end only with the new range of 11 $5 billion to $12 billion, reflecting incremental investments in multiple programs, including mrna vaccine programs outside of COVID-19.

We are also slightly reducing our expected effective tax rate on adjusted income by 50 basis points to approximately 15.5%. 2022 guidance once again assumes no incremental share repurchases beyond the $2 billion of share repurchases that we completed in March of 2022.

<unk> and other programs.

We are also slightly reducing our expected effective tax rate on adjusted income by 50 basis points to approximately 15, 5%.

2022 guidance once again assumes no incremental share repurchases.

And the 2 billion of share repurchases that we completed in March of 2022.

So in closing, it's an exciting time in the history of Pfizer.

Just a few on Paxlovid.

So in closing, it's an exciting time in the history of Pfizer, we believe that our strong financial performance in the quarter and are improving our operational outlook for the year sets the stage for long term shareholder value creation, and so with that now I'll turn it over to Chris and start the Q&A session.

We believe that our strong financial performance in the quarter and our improving operational, outlook for the year sets the stage for long-term shareholder value creation.

You mentioned countries needing to manage older supply.

And so with that, now I'll turn it over to Chris and start the Q&A session.

Thanks, Dave.

Do you think that current Paxlovid use trends will result in excess inventory versus what, has been contractually purchased?

Thanks, Dave.

At this time, let's start the Q&A session. Please limit yourself to one question per caller and if you have additional questions. We ask you to please get back in the queue and we will address as many questions. As we have time to do so and if you have any remaining questions. Afterwards, the R&D team will be available to answer those questions for you as well Chelsea if you could queue up.

At this time, let's start the Q&A session.

And additionally, could you comment on the recent Codexis retainer arrangement and how, we should think about that with regard to a 2023 Paxlovid demand?

Callers please.

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

Please limit yourself to one question, per caller.

Thank you.

I'll pause a moment to compile the Q&A roster.

And if you have additional questions, we ask you to please get back in the queue and we'll address as many questions as we have time to do so.

Angela?

Your first question comes from the line of Carter Gould from Barclays.

And if you have any remaining questions afterwards, the R&D team will be available to answer those questions for you as well.

Sure.

Great. Good morning, I appreciate all the disclosures there at the end, but I wanted to follow up on the commonality guide again.

Chelsea, if you could queue up the callers.

Obviously, you had some incremental contracts that got signed since the last time, you gave guidance you highlighted sort of the FX headwind. So I guess I'm trying to tease out exactly kind of explicitly kind of what you're assuming around potentially I guess doses getting question to into 2023.

And just.

Ladies and gentlemen, if you would like to ask a question, please press star and then, the number 1 on your telephone keypad.

Kind of color there if you can please thank you.

For this.

Carter This is Dave Thank you for the question.

We will pause a moment to compile the Q&A roster.

No.

Let me walk you the guidance for this year from a from a vaccine perspective.

Your first questions come from the line of Carter Gould from Barclays.

As you as you well know we had a guidance of $32 billion to begin with as we entered Q come out of Q1, there's really three moving parts as I think about our guidance for the year. One is we do have an incremental contract from the U S. G. Four 105 million doses this year, which is an uptick to that guidance.

Great.

Good morning.

I appreciate all the disclosures there at the end, but I wanted, to follow up on the Comirnaty guys.

Again, obviously, you had some incremental contracts that got signed since the last time you gave guidance.

Secondly, we're experiencing headwinds from an FX perspective to the tune of $1 billion since Q1, but for the year really $2 billion in that product alone and then third as I just articulated the cadence of deliveries in the back half is really skewed to Q4 and with that.

You highlighted sort of the FX headwind.

So, I'm just trying to tease out exactly kind of what you're assuming around potentially, I guess, EU doses getting pushed into 2023.

Some ex U S deliveries could move from November into December of the calendar year, and if that were to occur given a one month lag from a reporting perspective that would fall those revenues would fall into Q1 of 2023 I do not know.

That's going to happen, but I am planning.

That it might happen. So therefore, I, probably being conservative in my approach and my outlook to the revenue guide for that specific medicine.

Okay, Let's go to the next question.

And, you know, just some additional color there, if you can, please.

Your next question comes from the line of Robyn <unk> with truly securities.

Thank you.

Hey, guys. Thanks for taking my question and all the color on the call today, I guess minus on textbook.

Carter, this is Dave.

Maybe you could talk a little bit about why you said theres, a low rate and in line with clinical trials for a rebounding maybe that's under reported and you outlined your plans for new trials. What are you doing it's potentially retreat that potential for rebounding and the new studies are you extending doubling.

Dose.

And.

Maybe some trends.

Give us some more color on trends that youre seeing on taxes paid.

I know you mentioned globally, we're hearing in some states, it's more limited versus others.

Some more color there on on trends you're seeing on access thank you.

Well why don't you speak a little bit about the program, but we havent rebounding and then Angela you speak a little bit about the trends of where our revenues in the uptake.

Thank you for the question.

Thanks, Albert and thanks for the question so as we reported earlier in the Epic HR study, we did see.

Let me walk you the guidance for this year from a vaccine perspective.

<unk> agents.

<unk> potential rebound, but we also saw it in the placebo arm with a very similar rate.

As you well know, we had a guidance of $32 billion to begin with as we entered Q1, come out of Q1.

Since then.

We have seen other studies coming out including from the Mayo Clinic case, Western and Kaiser Permanente and others showing data that is very consistent with ours in terms of the single digit percent rebound and it's also been seen not only with placebo, but also with a competitor antivirals.

And internally, we also have data from real world data as well as additional pharmacovigilance data showing again that it's a very similar low percentage rate of recurrence that said, though we are working with the FDA to finalize plans for a trial in which we will treat such patients.

And we're still deciding on the final outlines of that and in addition, as Michael outlined we will be looking at other cohorts of patients for example, immuno compromised patients who have a large unmet medical need and in that setting we will be looking at for example, 510 and 15 days of dosing to determine the optimum.

Most regiment for those patients. Thank you William.

I need to say that we are very serious about park slope with them through our looking very diligently all the anecdotal reports that are coming but all of the data or if at all the data our internal data, but we are detecting early bonds by proactively checking viral loads or the external data that have been.

Ported through five micro vigorous to wash or restocking fees that have been performed by Charlotte Park was very reputable.

Third parties like Kaiser Permanente or Mayo clinic, we are consistently look this is low single digit actually less than 1% in the external studies and it was as we indicated around 2% in the methodology, we use in dollars and very consistent with the numbers awful awful.

The placebo.

Although we try to see.

There is a need to do something about it.

Sure.

Seriously, we confined Ami data set other than anecdotal reports also I want to emphasize but even the anecdotal reports they are all indicating that it is a mild so we don't have any rebound, but it was more severe right and clearly we havent identified any single.

Cases that do have resistance to the park slope itself, we are looking into it and do it in the Williams said, but we are going to what I'm also some slides discussing our articles with FDA to receive re treatment of those cases.

But so far our conclusion that we are looking at a low it is very small percentage similar.

To cover it.

Our siebel or other.

Other items and with a better margin.

Angela what about a V a.

The trends are.

Internationally and in the U S.

There's really three moving parts as I think about our guidance for the year. One is we do have an incremental contract from the USG for 105 million doses this year, which is an uptick to that guidance.

I think that the way we are manufacturing Paxlovid with, of course, great knowledge, from our prior experience as a community but also in terms of our negotiations and discussions with countries is actually allowing us to do supply planning very well. So we are manufacturing as we need and according to the contracts and according to the demand, that the countries are providing us.

Secondly, we're experiencing headwinds from an FX perspective to the tune of, a billion dollars since Q1, but for the year, really $2 billion in that product alone.

So globally, I think that where we're doing really well and we're making excellent progress.

We have made and manufactured 30 million doses and we delivered 23 and a half of those doses. So I think that the contracting is going well the demand in and and expectations for that for the need for <unk> is done is definitely up there, but maybe let me use some view as examples where things.

And then third, as I just articulated, the cadence of deliveries in the back half is really skewed to, Q4. And with that, some ex-US deliveries could move from November into December of the calendar year.

So I think we're doing that in a very prudent and in a very, you know, in a prudent and, an effective way.

We have a little bit more data and we think that I think are going, particularly well and the U S actually contracted a $10 8 million doses with us so far and $7 4 million doses up all of those have already been allocated to all the states.

And if that were to occur, given our one month lag from a reporting perspective, those revenues would fall into Q1 of 2023.

I didn't, we didn't, your second question?

I do not know whether that's going to happen, but I'm planning that it might happen.

That gives you a sense of how much demand is coming in from all of the states and then every single week utilization Opex levels. It has also increased in fact, most recently.

So therefore, I'm probably being conservative in my approach and my outlook to the revenue guide for that specific medicine.

Hit an all time high of 389.

<unk> thousand doses doses opex low debt that we used in just in one week. So that gives you a sense instead of the increase and the momentum.

Okay.

And what's really driving this is it.

Education, and familiarity and experience now physicians as well as patients, but also the excellent work that is being done at the federal as well as the state level at the state level in terms of education, and and utilization and I wanted to call out in particular that the test to treat program that I think has been particularly effective and very positive.

Let's go to the next question.

Your next questions come from the line of Robin Karnaskis with Truist Securities.

To date more than 41000 pharmacies are now tested treats centers and that means that that just gives access to.

Thanks for taking my question and all the color on the call today.

Mendes now.

Mt off alpha the population to be able to access tax loaded.

I guess mine is on, text a little bit.

And maybe you could talk a little bit about, I know while you said there's low rates in line with clinical trials for rebounding, maybe that's underreported.

And also recently pharmacists are now able to prescribe <unk>.

Limitations.

And you outlined your plan for new trials.

And over and above whatever states and the federal government not doing either is also aggressively and instead of the supporting education. So actually we have leveraged the entire size of field force and to provide education, we're running webinars.

What are you doing to potentially decrease that potential for rebounding in the new studies?

And to date, we've reached over 300000 health care professionals as well as 80000 bonuses just to give you a sense of the extent and the breadth of reach that we have accomplished and then all of that and also complemented by public service announcements about driving awareness of the treatment, but also the individual risk.

And that each end and each patient could carry and making them aware that they could.

It could be a potential candidates for tax loaded.

Are you extending and doubling the dose?

So I think with all of these efforts that have gone on and that we're continuing and we feel really good about the momentum opex a little bit the utilization of tax loaded and the benefit that they can bring particularly in a time when their surgeon is going on around the entire world.

And maybe some trends, help us give us more color on some trends that you're seeing on text a little bit.

I know you mentioned globally, we're hearing in some states it's more limited versus others.

Maybe, just give us more color there on trends you're seeing on access.

Thank you.

Yeah.

Thank you.

William, why don't you speak a little bit about the program that we have in rebounding?

Sure.

What was the second question?

Thank you Robyn next question please Chelsea.

And then Angela, you speak a little bit about the trend of the revenues and the uptake.

Thanks, Albert.

I'm not sure.

Your next questions come from the line of parents Flynn with Morgan Stanley .

And thanks for the question.

Codexis, the enzyme supplier for Paxlovid.

So as we reported earlier in the EPIC-HR study, we did see a single agent percent of potential rebound, but we also saw it in the placebo arm with a very similar rate. Since then, we have seen other studies coming out, including from the Mayo Clinic, Case Western, Kaiser Permanente, and others showing data that's very consistent with ours in terms of single digit percent of rebound. And it's also been seen not only with placebo, but also with competitor antivirals.

And internally, we also have data from real world data, as well as additional pharmacovigilance data, showing again, that it's a very similar low percentage rate of recurrence.

Ah, yes.

Hi, Thanks for taking the question I had a two part one on your earn a seasonal flu vaccine program. I was just wondering if you had any hai titer data that you can share from the trial we saw the.

It was the, you want to, I did refer to it but maybe also you can reiterate it, David.

That said, though, we are working with the FDA to finalize plans for a trial in which we would treat such patients.

Yeah.

I think Albert indicated this earlier in his remarks is that, in fact, over the last several, quarters we've improved our manufacturing process, reduced the cycle time, and importantly improved the yield from an output perspective. So therefore, we don't need as much raw materials and API to produce the same amount of finished, goods.

And then finally, we've actually invested in our network to make sure that we can actually, produce some API as well.

C D. The T cell data, but again I'm wondering if there's any tighter data you can share and then anything on the safety Tolerability. There is it fair to assume that the profile is similar to comer naughty or are there any particular differences you'd like to call out. Thank you.

And we're still deciding on the final outline of that.

So we're in good shape.

And in addition, as Michael outlined, we'll be looking at other cohorts of patients, for example, immunocompromised patients who have a large unmet medical need. And in that setting, we will be looking at, for example, 5, 10, and 15 days of dosing, to determine the optimum dose regimen for those, patients.

What I said before, we are moving most of it now because we could way faster than what, we anticipated, move it inside.

So that creates some cancellations of raw materials to some external suppliers.

Thank you very much to answer Michael why don't you take this question, yes, we will share details in upcoming conference, but I can just give a little bit more color.

Thank you, William.

I'm sorry about that.

And I need to say that we are very serious about Paxlovid and we are looking very diligently at all the anecdotal reports that are coming.

But all the data, I repeat, all the data, our internal data that we are detecting rebounds by proactively checking viral loads or the external data that have been reported through pharmacovigilance to us or through studies that have been performed by third parties is very reputable.

For parties like Kaiser Permanente or Mayo Clinic, they are consistently that this is low single digit, actually less than 1% in the external studies.

And it was, as we repeated, around 2% in the methodology we used in ours and very consistent with the numbers of the placebo.

So although we try to see if there is a need to do something about it, seriously, we can't find any data set other than anecdotal reports.

As you know the highest medical.

Also, I want to emphasize that even the anecdotal reports, they are all indicating that it is a mild.

Hospitalization of choice in the 65 plus.

Ace strains are the most dominant and we had very strong titers against the east trends.

And exceeding what you would see with the current recommended vaccines.

So we are very.

Bullish about our ability with mrna and use both.

Strong antibody response, and see the importance of <unk> T cells, which are not in use by current standard of care in this.

We are discussing our protocols with FDA to see if retreatment of those cases could help.

But so far, our conclusion, although we are looking a lot, it is very small percentage similar to COVID placebo or COVID other antivirals and with very mild symptoms.

This is the reason why we are.

So globally, I think that we are doing really well and making excellent progress. We have made and manufactured 30 million doses and we delivered 23.5 of those doses.

Sharing today that we are announcing two phase III study.

I think that was the last question.

Let me close with a few takeaways.

Just to mention a few of the potential approvals and launches that we're going to have in the next few months.

The first one, as you see, we continue to deliver strong operational performance.

See, bingo, we expect to launch the adolescence in next year.

We increased our full year 22 operational financial forecast while maintaining a challenging, foreign exchange environment.

And of course, next year will be the real first year where we expect to have full access for this drug.

So it is, this is the organic.

So I think a few companies likely will be able to do that.

We expect to launch next year RSV maternal.

I'm not referring to the bioheaven that is coming and to other molecules.

Thank you Terence next question please.

We believe we are well positioned not only to maintain but also to grow both our commercial, and scientific leadership in the battle against COVID-19.

We expect to launch next year RMV adults.

I'm referring mainly to the organically developed pipeline assets.

It will be for us a very important focus, to come.

We expect to launch next year Prevna for pediatrics.

I don't think that much of that has been a factor into what some of the analysts are projecting.

That's why we're investing so heavily.

We expect to launch next year Erlanatema for triple-class refractory myeloma.

We continue focus on driving long-term shareholder returns by remaining very disciplined both on our operations and our incremental capital deployment.

We expect to launch next year Ridlacitinib for atopic, for alopecia areata.

Sorry, I I am.

You saw even in this quarter, but even more, we are squeezing our administrative expenses.

We expect to launch, next year Pentavalent, a meningococcal vaccine.

Our SMA is going down, and then we reinvest in R&D because we have programs that we are starting that we feel is a very good return on our investment.

We expect to, next year, Calapros for prostate cancer metastatic castration patients.

And we continue to advance our internal scientific pipeline while executing against our previously announced plans to potentially add at least $25 billion of risk-adjusted revenues through business development opportunities to our 2030 top line.

We expect to launch, or we did already, Myfabry for endometriosis.

Total ability of NIS 30, microgram solitaire insight.

Just I want very quickly to see that these efforts in R&D are yielding results.

And then a little bit later, we expect maybe this in 23 or beginning of 24, DMD and flu mRNA.

Note that first Tolerability was of course supported by our billions of doses the platform in Covid.

And on top of that in older adults the thought the micrograph.

Good acceptance the main patient group.

And I believe it's going to be.

Excellent.

Very similar to.

Andre available.

Flu vaccines.

Michael you spoke about Hey, you did speak about the strength in the immuno <unk> initiatives as they were similar.

The current high dose of a quicker about it yet.

I didn't mention the B strain.

Note that in general lower response to be strained with both standard of care and.

And we urge on the lower side with our vaccine. That's why I was so encouraged to see the unique T cell response against the BSL strain and talent of that they.

That's why I'm emphasizing them so that they can pay a little bit more attention.

Those are very high probabilities of success, the ones that I mentioned.

They are not in the, pocket, clearly, all of them.

Make us encouraged that we will have a strong product for both AAM.

And some clearly might not make it to the cross line, but we believe they are seriously de-risked, all of that.

B.

And I think how confident we feel it is although the regulatory pathway.

Just to demonstrate non inferiority.

We are going for an efficacy trial. So the trial that we announced yesterday, he's going to measure efficacy in flu.

So with that in mind, I'm really looking forward to have a 6% CAGR by 2025 in our business, as we promised in 2019. In fact, year to date, we are at 6% excluding BD and excluding COVID.

And I think we will do that by 2025.

We believe that we we expect of course science, it's unpredictable, but we expect to win.

With flying colors.

Let's go to the next one.

We will maintain this 6% CAGR and we'll do more by BD that we are right now implementing.

So I think we have a very good growth prospect and we will maintain our leadership in.

Thank you very very much for your interest and for those that didn't have summer vacations yet, enjoy your summer vacations.

Your next question comes from the line of Microsoft with Evercore ISI.

Thank you.

Hi, guys. Thanks for taking my question I had a question and a clarification. The question is on tax a little bit I know the test to treat program from the bite and administration has been a big driver of volumes and my question is how would the demand dynamics change when we transitioned to a commercial purchasing model and let's say that tends to treat is still in place would that would there be any change or not.

So I think that the contracting is going well, the demand and expectations for the need for Paxlovid is definitely up there.

But maybe let me use some U.S. examples where we have a little bit more data and where things I think are going particularly well.

The U.S. actually contracted 10.8 million doses with us so far and 7.4 million doses of all of those have already been allocated to all the states.

And my clarification is Michael I think some comments you might have made at our recent non.

Non transcript.

Meeting on the <unk> program, and whether there's been a signal consistent across the phase Iia and phase two b could you. Please clarify that thank you very much and I'm, referring to the interim analysis that happened recently.

So I think that gives you a sense of how much demand is coming in from all of the states.

Angela what do you think if we go to open commercial market do you think that.

We would be better or worse.

Works for me.

So I think that there are elements and that we will be able to implement in the commercial market that currently that was down and so for sure. You've just heard me share comments about the efforts that we've put into <unk>, a little bit already I'm here in the U S and ex U S might be.

And then every single week, our utilization of Paxlovid has also increased. In fact, most recently, we hit an all-time high of 389,000 doses or doses of Paxlovid that were used just in one week.

So that gives you a sense of sort of the increase and the momentum.

What's really driving this is obviously the education and familiarity and experience now of physicians as well as patients, but also the excellent work that is being done at the federal as well as the state level in terms of education and utilization. And I want to call out in particular the test-to-treat program that I think has been particularly effective and very positive. To date, more than 41,000 pharmacies are now test-to-treat centers. And that means that that just gives access to a tremendous amount of the population to, be able to access Paxlovid.

Execution in support of education and support of them.

Tie a field forces.

In support of our retail support patients through education, again and N. P. S. A now all of that will continue.

I think what happens in a full commercial.

Our full commercial launches that you will have multiple distributors and multiple points.

And also recently, pharmacists are now able to prescribe Paxlovid within certain limitations.

Points of distribution throughout the entire country, you will have stocking by every pharmacy pharmacy, and pharmacist and various points of youth and so I think that in a commercial setting actually you'll be able to reach a much broader set of channels that we currently even do today. So I think that's why.

And over and above whatever states and the federal government are doing, Pfizer is also, aggressively and assertively supporting education. So actually, we have leveraged the entire Pfizer field force to provide education.

Defense.

I think the second difference is that what you can do from a commercial perspective, we'll also look different remember today.

Well I'm doing EUA and while we could do a lot of education and key things like sampling cannot be done in an EUA. So thats going to be you know an example of another difference.

That will happen.

Post EUA and then I think finally, and even if you think about consumer education, you know today, we've really limited ourselves to and branded instead of disease awareness education, but again and in a commercial setting you could support through branded education and talk a lot more about the product.

And so all of these are things that actually Pfizer does in the commercial organization of Pfizer does really well, that's just that sweet spot.

So I think that we look forward to building on top of what the government has been doing which is really excellent and building on top of that to do more and to support greater initiatives across the country.

We're running webinars.

And to date, we've reached over 300,000 healthcare professionals, as well as 80,000 pharmacists, just to give you a sense of the extent and the breadth of reach that we have accomplished.

And all of that also complemented by public service announcements about driving awareness, of a treatment, but also the individual risk that each patient could carry, and making them aware that they could be potential candidates for Paxlovid.

Thank you Angela what about <unk> Michael Greif.

So I think with all of these efforts that have gone on and that we're continuing, we, feel really good about the momentum of Paxlovid, the utilization of Paxlovid, and the benefit that Paxlovid can bring, particularly in a time when there are surges going on around the entire world.

Thank you.

Briefly this is our internally discovered antibody against one of your member of the TNF superfamily that is associated with inflammatory diseases. Yes, we have consistent robust efficacy for all income youll see patients and very strong efficacy consistent close to try on for.

Prospectively defined position biomarker in front of him.

He was very good. This is induction data later this year, we would have maintenance.

And as we get those data set we will decide about next steps.

Thank you, Robin.

Thank you very much let's go to the next call.

Next question, please, Chelsea.

Your next question comes from the line of Mohit Bansal with Wells Fargo.

Your next questions come from the line of Terrence Flynn with Morgan Stanley.

Great. Thank you for taking my question and congrats on the early order one data, especially for once daily <unk> Mike.

My question is how much incremental data we are going to see in September from the one you presented today and also how soon can you move this is going to be good trials.

And how do you see the biggest differentiation versus the order at this point. Thank you.

Michael maybe also you could take that question, yes, we.

Very excited about this new dataset in 32 that you will see the.

<unk> meeting in Stockholm in September that will be additional.

Data and I think you will find the.

<unk> seen very encouraging all the needs for secured side to you.

I think compared to oral sema glued tie the differentiation is substantial.

This is a true small molecule that can be given once a day, it's completely independent.

Fasting or Neil.

Concordance.

I think you will be able to reach.

Higher.

Effects on both glucose as well as on waste reduction and that's how you reported.

Almost at 100 gig, but definitely the reduction over four to six week and five kilogram.

And we haven't yet optimized the titration to even higher and that was so we are very encouraged of what we see.

We're going to.

Shad with regulators soon our next trial said and move swiftly to allow us to pick the winner in the regimen for a potential phase III starting to come off that a face to be thank you Michael and thanks to Ed. This is what is clearly a high priority project, we have a designation within the company.

We've always been lightspeed projects project of significant value to pay sort of a center as a result of significant economic value, where we give this designation until we move them or will the speed of light.

And we already invest to make sure that Oh.

And we moved faster in value you personally on a bi weekly or.

By monthly basis, and the progress of this program so that is going to be one of them.

Thank you very much next question please.

Your next question come from the line of FMC, Kerman with BMO capital markets.

Hi.

Hi, all thank you so much for taking my question and congrats on the progress I would love for your perspective on the provision for Medicare to negotiate directly with manufacturers. The part of the now coined inflation reduction now.

Thanks for taking the question.

That we have press reports reporting deal between mentioned and Schumer and kind of what's the potential long term impact on your R&D and innovation. Thank you.

Thank you.

Disappointed with what I'm reading in the newspapers of course, we'd come to no exactly what will happen because we have seen that the situation is very volatile, but everything that we are reporting.

They are going to implement.

Brian setting in our reality is not the price negotiation because they're forcing.

There will be implementing a 95% fox according to previous.

Our guidance is that one of course the industry.

Significantly we estimate to 70.

Billions over 10 years.

There is a positive provision over there but they.

They are reducing their out of pocket cost for other patients. That's a significant one but there is too little too late.

They can do way more.

Because fact workforce, 10% of the 300, <unk>, where theyre going to grow like they are basically not doing that to eliminate patients of course, because they could give all the money and then significant significantly north of the basin, they're just giving a part of it.

We won't even start before if I understood well from 'twenty to 'twenty five.

So I'll hold that for the out of pocket is a very positive provision, but the rest are one is a provision, but the I think will force the industry to.

Due to reduced R&D.

If it goes through in a big way, but they are are they are suggesting.

So other than that there are going to have anything to address we will wait to see how it would be.

Yeah.

What exactly in the reality that the means and we'll go from there and also I want to say it is very disappointing.

To single out one industry.

Everything in this.

Deal from what I understand box all of Barclays affecting everyone by vendor specific measures to affect all of it or the pharma industry, particularly when we are out of a pandemic, where we've seen the rest of his proven the.

The value that brings to probably Harrison to the global economy, Oh, we would be in a very different.

0.2, this global economy, if we didn't have the investments in there.

The life Sciences sector, and they're choosing to single out a machines are surfing is wrong.

And I hope that the reason will prevail when these discussions gross to Congress.

Let's move to the next.

I had a two-part one on your mRNA seasonal flu vaccine program.

Question. Please.

Your next question comes from the line of Louise Chen with Cantor Fitzgerald.

I was just wondering if you had any HAI titer data that you can share from the trial.

Hi, Thanks for taking my question here just curious if some of the setbacks that we have seen in the CD 47 space change your view on the market opportunity for Trillium asset. Thank you.

Yes, why don't we go to William.

We saw the, you know, the CD, the T cell data, but again, I'm wondering if there's any titer, data you can share.

Yeah sure. So thanks for the question Louise So we saw the news the other day.

Certainly we remain confident that our program with Trillium and we proceed with the programs that we are planning.

And we'll let the data speak for itself when they come out.

Andrew.

Next question please.

And then anything on the safety tolerability there, is it fair to assume that the profile, is similar to Comirnaty, or are there any particular differences you'd like to call out?

Thank you.

Your next question comes from the line of David Risinger with SBB Securities.

Thank you.

Okay.

Yes, thanks, very much and congratulations on the performance.

Thank you very much, Terrence.

I wanted to ask a little bit about <unk> been the Max.

The performance was below our and consensus expectations, if he could speak to that and also talk about.

The sequential prospects going forward.

He has the product peaked out in the U S and how should we think about future prospects relative to the sales that you booked thank you very much.

Michael, why don't you take this question?

Yes.

We will share details in upcoming conference, but I can just give a little bit more color.

Well. Thank you David Angela why do you think.

As you know, the highest medical burden and hospitalization occurs in the 65 plus, where, the A strains are the most dominant. We had very strong titers against the A strains, and exceeding what you would see with the, current recommended vaccines.

So we are very bullish about our ability with mRNA to induce both strong antibody response, and CD4 and CD8 T cells, which are not induced by current standard of care.

Thank you, Terrence.

And this is the reason why we are sharing today that we're announcing to phase three, study.

Well, we continue to be really pleased with having to counter is doing and if you look at just from a diagnosis perspective, no quarter over quarter year over year, we continue to want to do.

Next question, please.

Do a really great job of effectively.

Finding and identifying who that ATT RCM patients diagnosing them and then bringing them on to therapies. You know so a in this quarter. We have reached an all time high of a 40, 40% diagnosis rate.

And I think that this is well beyond what we thought we would be able to do in the timeframe that we have had.

So we continue to believe in the growth that this product has.

The real world data that we've been generating now and the overall survival benefits you know a really compelling ad.

And the fact that we are the only product being able to demonstrate these benefits I think speaks well to how they'll continue to be able to build in this market. Despite.

Despite competition that will arise.

I think what you're referring to in terms of the impact and the and the expectation really is a one time effect in <unk> and it was in Japan.

And this was a very specific price decrease that was planned and driven by regulation.

<unk> was launched in Japan again based on pricing regulations in the country.

The country it was that much higher priced than any other country, we had and so and by regulation again, it's the 75% price decrease that we're seeing is a function of that.

The underlying growth I've been to count in Japan is really strong we had just in the first half of 2022, 69% volume growth, we had 32% year over year, new patient starts. So hopefully this gives you a sense that and the net revenue impact you see on fact, not a reflection.

The demand and the true underlying demand whether it's in the U S.

Thank you, Terrence.

Hey.

Thank you Frank and good David Let's go to the next question. Please.

Next question, please.

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

Tolerability, sorry.

Tolerability of this 30 microgram, sorry, Terrence, I didn't know that first.

Thank you a question on your RFP that there doesn't seem to be anything but a brief mention of the program in the press release or the slides and really nothing in prepared remarks, but we have two or three data results coming out pretty soon I'm wondering why but really my main question is why you recently changed the primary end point.

Tolerability is, of course, supported by our billion of doses of the platform in COVID.

COVID-19.

And on top of that, in older adults, the third microgram have a very good acceptance, the main patient group.

In the phase III trial.

And I believe it's going to be excellent and very similar to other available flu vaccines.

Including downsizing of the trial and that comes on top of a delay in the readout as announced earlier this year.

And if I can slip one in on your quadrivalent mrna with glue when would we likely see results from your phase III that youre starting up.

Thank you Michael <unk> question on grocery I think the first question I think was for RSV right.

Yes, we are.

We've made great progress in the RSV adult trial as you know we run it through two different season in the northern and southern Hemisphere to make sure. We had a good patient experience in cases things are looking good for readout that will come soon.

Remain very.

Positive about ours, we idled based on our phase II challenge state that it was stellar and the road is particular entered yet that we're targeting play and as you know we had one to one targeting the two forms of these pre infusion.

Michael, you spoke about, you didn't speak about the B strains in the immunogenesis results. They were similar to the current high dose of quadrivalent.

You also asked about more of the mrna in flu.

Yes, as Albert mentioned, we are going big here with an efficacy study. We are encouraged about the date that we're seeing we think it's a unique data set.

Yeah.

And we plan to.

Soon embark on a phase III.

After a proper dialogue with regulators.

Of course this is an event, but if the season is robust, which you can never know.

Would you expect the phase III to readout next year.

Exactly.

Also I'm sorry, if we gave the impression but RSV.

What's important to us it is extremely important because there is no better. Good news. This is why we did then.

<unk> mentioned as much but still remains at a very good news.

The previous slide this were extremely strong in that.

<unk> studies are progressing very well so we have very high confidence options a surprise, but we will launch next year, a very robust program.

Both in adults and in the bin.

Sure.

In Matera.

You know, I didn't mention the B strains.

But that all of our small sizes are progressing very well.

Thank you very much let's go to the next question.

We noted in general, a lower response to B, strains with both standard of care.

Your next question come from the line of Geoff Meacham from Bank of America.

And we edged on the lower side with our vaccine.

That's why I was so encouraged to see the unique T cell response against the B cell, strain.

Hey, guys. Thanks, so much for taking the question just had a couple on <unk> real quick.

Can you give us an update on the number of countries are in contract discussions with them just thinking relative to the start of the year and then related what's been the biggest contributor.

And the totality of that data make us encouraged that we will have a strong product for both A and B.

And the thing, how confident we feel it is that although the regulatory pathway, it is just to demonstrate non-inferiority in immunogenicity, we are going for an efficacy trial.

So the trial that we announced yesterday is going to measure real efficacy in flu, which we believe that we expect, of course, science is unpredictable, but we expect to win with flying colors.

Supply expansion in <unk>.

When do you think you guys will be fully fully normalized thank you.

Let's go to the next one.

Let's go to Angola for the number of countries, where we are with us.

Your next question comes from the line of Umar Rafat with Evercore ISI.

So we are in contract with.

A significant number of countries at this point.

Maybe I can talk about it from a dosing perspective, so more than 35 million treatment courses have already been contracted with a number of countries.

Hi, guys.

And this is what we publicly disclose there are additional doses that I can't talk about because either the country didn't want a Q1 Q that disclose them publicly or we're in the middle of negotiations with them. So I think to answer your question since we last left off.

Thanks for taking my question.

I had a question and a clarification.

<unk> made progress without contracting I think what maybe what's more important to let to clarify it's just that the approach that countries are taking too.

The question, is on PaxLovid.

I know the test to treat program from the Biden administration has been a big driver of volumes.

To contact with us, it's just really different to where we were and community.

And my question is, how would the demand dynamics change when we transition to a commercial purchasing model?

Amenity they were interested in securing large amounts of doses upfront.

But that's in fact, not the case and here impacts loaded and the reason being that number one and they are being prudent with how they are ordering and and they are able to do that because they know that we have the manufacturing capacity and that we can pivot as we need them.

The countries are also trying to manage inventory and not to have too much as to product lying around and so I think that this is what's driving the more smaller more frequent contracting rather than big big contracts that like you saw in community.

The other thing I will also say is and the reason why I'm talking in doses rather than a specific country is because.

We're also working with Super National organizations, who are acting on behalf of multiple countries.

Global Fund UNICEF.

These are you know.

In addition to the Bilaterals are also important organizations, who are helping us to supply and bring doses into the country.

So I think all in all great progress and I think you should expect to see that this is one of these things with that we'll just keep inching away.

Because of how countries want to manage the inventory and the supply. Thank you Angela and also to do too because you had also a question of supplier of buffer we have done tremendous tremendous progress on battlefield actually we have been able to reduce dramatically. The lead time. So how much time, it's needed for manufacturing and to have improved dramatically.

And let's say the test to treat is still in place.

So supply is another new structurally removed almost everything in house now.

In terms of API and finished.

Finished products. Thank you very much next go to the next question.

Would there be any change or not?

Your next questions come from the line of Chris Schott with J P. Morgan.

And my clarification is, Michael, I think some comments you might have made at a recent non-transcripted meeting on the TL1A program and whether there's been a signal consistent across the phase 2A and phase 2B.

Great. Thanks, so much for the questions just one follow up on on the <unk> comments.

Could you please clarify that?

As we move I guess from some of these large government orders that we saw with the U S et cetera earlier. This year to maybe this is more kind of on demand smaller contracts. How do we think about what the impact that has on pricing I think you were giving some volume based discounts before is just help us I guess as we think about kind of 2023 and beyond but what pricing does for that business.

And then it kind of a bigger question I had was just on <unk> dynamics I think you mentioned in the prepared remarks, we are seeing signs of a recovery.

For your business, there and just interested in how you kind of see what the balance of just overall market dynamics relative to the competitive landscape with a with obviously one of your competitors with an adjuvant indication. Thank you.

Thank you very much.

And I'm referring to the interim analysis that happened recently.

Oh, Thank you very much.

Yeah.

We do not provide.

Let's say forward looking.

Exactions from pricing and particularly every time I speak about pricing is becoming big news. So I want to make sure about the with respect to that.

Angela, what do you think?

I know, what you're asking and I can give.

Keep it very high level answer clearly.

We are providing.

Especially on pricing when we are contracting.

We better be Congress with governance, that's also the incentive for the government.

Big quantities, because the prices really really very attractive.

If we go to open commercial market, do you think that, we will be better or worse off with PaxLovid?

Yeah.

If we move to normal market, but prices would reflect both vaccines and.

In Antivirals.

The prices for similar volumes similar technology products, but they are all there and you also wanted to move to.

The private commercial markets, the complexities are getting way way higher.

Need to go through single doses in the in the vaccines for manufacturing complexities are very higher we need to have distribution to small.

Distribution centers, including physician offices, so all of that creates a very big complex sugar, but also could be.

Taking into consideration as we price our products of our part and I want to emphasize that the.

Also voss.

Presents significant opportunities for us because of the open market.

It is way more complex way more diverse you have millions of customers rather than one or two.

This plays to our strengths in terms of curbing global presence or within the U S.

The dramatic presence in every single territory over the country with thousands of people.

People are calling physicians crush because.

Our accounts are in.

Bayer's oncologists or the rest of them so.

So I think that there are elements that we will be able to implement in the commercial market that currently that we don't.

So for sure, you've just heard me share comments about the efforts that we've put into PaxLovid already here in the U.S. and ex-U.S., right? The execution and the support of education, support of our entire fuel forces, support of retail, support of patients through education again, and PSAs.

It's something that we see it turn into this market also we would see them.

US being able to compete more of a position of strength.

Now, all that will continue.

No.

But I think what happens in a full commercial launch is that you will have multiple distributors and multiple points of distribution throughout the entire country. You will have stocking by every pharmacy and pharmacist and various points of use.

I promise I'm done.

And so I think that in a commercial setting, actually, you'll be able to reach a much broader set of channels that we currently even do today.

The metastatic breast cancer CDK four six market is incredibly competitive yet I will emphasize that our brands continues to be the leading CDK four six inhibitor.

So I think that's one difference.

I think the second difference is that what you can do from a commercial perspective will also look different.

Remember today, we're under an EUA.

And while we can do a lot of education, key things like sampling cannot be done in an EUA.

In fact, we have a 74% market share across all patients in first line therapy, So I and I think that this number has been pretty consistent as we talk about it every quarter and I think it demonstrates just the tremendous.

Experience that physicians and patients have and the confidence they have in Iran. Despite new competition.

The patient experience. The fact that we have real world clinical evidence and all of this really adds to the yen did that the confidence that we have in this brand.

And even though.

<unk> is a mature brand, we do continue to see growth and where the growth will come from.

Going places you know you're going to see growth from the CDK class, you're going to see growth from the recovery of new patient starts, which as you know and has not recovered to the levels of prior to the pandemic.

As well as stabilization of the path through time, when economic conditions improve and actually want to make a special point of this class growth because they're in line I think a tremendous opportunity for all of us.

Today, well last year at this time.

CDK class with 48% and in first line metastatic breast cancer this quarter it was 54%.

So even though it's grown it still means that the majority of the time Cdk's are not being used and I think we all of us and in this in this class I really need to focus on this as you know the leading priority and helping to grow each of our brands, but also to grow yeah that the class to impact patient outcomes.

So that's going to be an example of another difference that will happen post-EUA.

And then I think finally, even if you think about consumer education, today we've really limited ourselves to unbranded and sort of disease awareness education.

Thank you Angela next question please.

Your next questions come from the line of Christopher <unk> with Goldman Sachs.

Thank you very much first a quick word of welcome and appreciation to David for your proactive commentary on the phasing of revenues.

But again, in a commercial setting, you could support through branded education and talk a lot more about the product.

And so all of these are things that actually Pfizer does, and the commercial organization of Pfizer does really well.

Really mirrors, what your predecessor had often referred to as the rhythm of the numbers very helpful to get insights on near term factors Center.

Push calls on those numbers. My question is on business development Haliburton I'm not sure that Nir has joined US perhaps if you could update us on your latest thoughts the teams in terms of how you're feeling about.

Areas of focus, particularly in view of recent broader commentary points since from the FTC, taking a look at competitive dynamics. There and then secondly, as you reflect upon the overall ecosystem and the receptivity given things like lower relatively speaking biotech valuations are you sensing any.

Hips or trends or changes in the mindset of potential targets partners acquires. Thank you.

Thank you very much I made is here and he will be happy to speak about it I mean, Chris. Thank you for the question. Let me just start with your specific FTC point.

This is our sweet spot.

So I think that we look forward to building on top of what the government has been doing, which has been really excellent, and building on top of that to do more and to support greater initiatives across the country.

Thank you, Angela.

Well said.

I think we've demonstrated a very strong track record of shepherding our transactions.

Date through the regulatory process and that's been largely built on having just a close successful constructive and collaborative relationships with regulatory bodies globally.

What about TL1A, Michael?

Briefly, this is our internally discovered antibody against TL1A, a member of the TNF superfamily that is associated with inflammatory diseases.

In addition, our business development focus and I'll recap our priorities in a second is focus on how do we use our unique abilities to translate emerging science into breakthrough medicine. So most of the deals that we do our pro patient and their pro innovation. So we're confident that we can continue to advance our BD strategy and our success.

Yes, we have consistent, robust efficacy for all common UC patients and very strong efficacy, consistent across the trial for a prospectively defined precision biomarker. Solubility was very good.

Now, this is induction data, and later this year we will have maintenance data, and as we get those data set, we will decide about next steps.

Thank you very much.

Let's go to the next call.

Your next questions come from the line of Mohit Bansal with Wells Fargo.

So like we've.

We've been very clear that our goal is to add $25 billion of risk adjusted revenue by 2030, and I think we are making very good progress against that this year you saw our transaction with viral and subsequently with bio Haydon, which respectively. We believe have the potential to add one point.

Great.

Thank you for taking my question, and congrats on the early oral GLP-1 data, especially for once daily.

5 billion and $6 billion in peak sales to.

To our business and this was on the back of a very active 2021 and going forward, we're leaving very few stones unturned. When we look at opportunities and our focus is going to be consistent it's on scientific substrate that has the potential breakthrough for patients.

Deals that accelerate our topline growth in the back half of the decade, and then opportunities where we can add substantial value whether that is through our scientific chops and or our commercial capabilities and we're going to be very open to deal structures and we've said before we're also going to be agnostic to size. We've been clear about the fact that cost synergy driven deals are not where.

Our focus is going to be and we're going to be extremely disciplined I think we're very excited about the opportunities that are ahead of us and the flexibility that our balance sheet gives us to pursue those.

My question is, how much incremental data we are going to see in September from the one you presented today?

On your question on valuation fluctuations those market valuation fluctuations are not going to drive our BD strategy, we're going to remain focused on fundamentals and the way that I described.

And also, how soon can you move this agent into bigger trials, and how do you see the biggest differentiation versus the oral semaglutide at this point?

Thank you.

Michael, maybe also you can take that question.

Thank you and this is very important when we are aiming very high to also be able at the same time to be discipline discipline in advising the science and paying the right price for the right science, so that the capital, but we will disposal will be maximized and producing value for patients.

Yeah.

You know, we are very excited about this new data set, 1532, that you will see at the EAST meeting in Stockholm in September.

There will be additional data, and I think you will find HbA1c very encouraging, although this was a short study.

I think compared to oral semaglutide, the differentiation is substantial.

This is a true small molecule that can be given once a day.

It's completely independent on fasting or meal concordance, and I think you will be able to reach higher effects on both glucose as well as on weight reduction.

As I reported now, we were almost at 100 mg per deciliter reduction over four to six weeks and 5 kg, and we haven't yet optimized the titration to even higher doses.

So, we are very encouraged of what we see.

So we go very big 25 billion, but as we are proving we are very very disciplined in how we allocate our capital and Google something Youre doing that.

With that let's go to the next question from Jeremy.

Your next questions come from the line of Andrew Baum with Citi.

Two part question please.

Former heads of vaccines, just now and your competitor GSK when he topline the recent positive phase III data for that RSV vaccine candidate, which is activated adjuvant data as well.

Observation. He made was he stressed the same level of efficacy in the older patient cohort.

And the younger patient cohorts, it's possible to imagine that this may be.

It relates to the adjuvant then they have given the even the senescence of the aging population of T cells, giving you a vaccine because we don't have an adjuvant. Thank you.

Is that a concern particularly overhead.

He has a follow up and then second just following up on the question on <unk>.

Can you think talk to.

Our venous compounds a L V for one week.

Come up with market shares, which should materially lower than yours.

But whatever the number is it's Kitty, which you seem quite significantly as competition builds.

Builds momentum in the market how are you thinking about as you transition this drug into phase III.

Combinations you can run them what are you going to use it as a control arm for the combination of <unk> plus <unk>.

CDK four six.

Thank you Andrew and started to make a correction it was not the head of our vaccines joins was another member of the vaccines team, but by no means.

The facts are.

Let's move to <unk>.

Michael Yeah.

Yeah, you know.

I am very optimistic about the R.

RSV vaccine construct.

We have seen high immune tighter.

That are critical for the vaccine across all ages. In fact, we are the only one that have shown cause.

Strain a and b.

For RSV.

Tied to us which differ between all the vaccines, including the one that you mentioned in the call is that mainly measure cross our activity from a to b strain. So that was important and wants to buy our challenge dates.

Formidable so while nobody can predict exact held almost thought is and comparing one started to another we remain very bullish.

Valent vaccine should stand out.

Performance and in total ability. Please note some of the edge events, including the one that you referred to often associated with it somewhat unpleasant side effects and that was one.

Part of our differentiation to achieve when the bivalent very high.

Data is for and with best in Class Columbia Lydia.

And what about <unk>.

<unk>.

<unk> hundred 71, I cannot speak about the science here that we see that being active in several lines as by itself best.

Best in class.

Receptor prototypes and we are going to.

Set up our studies in a patient population, which contains many estrogen receptor <unk>, which often are poorly managed by the current available for investment.

And we think gives us a unique opportunity and number two.

The drugs seem to combine very well with our own CDK six dogs, and we think it could advance into a limit that decline.

Possible, but Todd even toilet breast cancer, maybe they are combined with CDK. Four so we have very high hopes for that cost of products every 471 combined with all the pipeline. Thank you.

Anything to add William Yeah, I would just add.

As you mentioned, Michael the preclinical data shows that the degradation could be superior to selective estrogen receptor degraders and so we're very excited about the potential to be superior to services that are being developed.

From a from your lips to God's ears also I went through a thread on the RSV because it was the second question, but Oh.

Thats game and maybe you gave the impression but we are not.

Very hard on it we are extremely hard on it.

Clearly a very important product for us do you have a very important product for GSK. So there will be a lot of speculation maybe the other one will do that or maybe the other thing. We do this I think data will just become themselves with the totality of data available. So far about like I've seen we've had higher reasons to believe we are better.

You never know before the end of the triangles, but right now with all in all it looks like we have a very very strong profile with all the data. So far we are waiting a lot with a lot of excitement.

I'm blind data.

We're going to share with regulators soon our next trial set and move swiftly to allow us to pick the winner in the regimen for a potential Phase III study to come after the Phase IIb.

See the reality for somebody and of course, the best win win.

So let's move now to Steve.

Yes.

Thank you, Michael.

And also, to add that this is for us clearly a high-priority project.

Your next question comes from Steve Scala with Cowen.

We have a designation within the company that we call the Light Speed Project, a project of significant value to patients and, as a result, also significant economic value, where we give this designation and we move them with the speed of light, and we overinvest to make sure that we de-risk and we move fast. And I review personally on a bimonthly basis the progress of this program.

So, that is going to be one of them.

Thank you very much.

Next question, please.

Thank you so much.

We'd just like to understand more deeply pfizer's thinking on factor 11, I can think of three possibilities first Pfizer believes there is simply no room to improve upon our quests second Pfizer believes factor 11 could be very useful, but you havent found the ideal candidate or third.

Hi all, thank you so much for taking my question and congrats on the progress.

I would love, for your perspective on the provision for Medicare to negotiate directly with manufacturers the part of the now coined inflation reduction act that we have press reports reporting a deal between Manchin and Schumer.

And what's the potential long-term impact on your R&D and innovation?

Thank you.

I'm disappointed with what I'm reading in the newspapers.

Of course, we can't know exactly, what will happen because we have seen that this situation is very volatile.

But everything that they are reporting, they are going to implement a price setting.

In reality, it's not a price negotiation because they are forcing their will by implementing a 95% tax according to previous guidance.

That will cost the industry significantly.

We estimate $270 billion over 10 years.

There is a positive provision there, but they are reducing the out-of-pocket cost for the patients.

That's a significant one, but it's too little and too late.

They could do way more because that will cost them 10% of the $270 billion that they are going to collect.

They are basically not doing that to alineate patients' costs because they could give all the money and make significant, significant difference to the patient.

They're just giving a part of that.

And they won't even start, if I understood well, from year 2025.

So although the out-of-pocket is a very positive provision, the rest one is a provision that I think will force the industry to reduce R&D, if it goes the way that they are suggesting.

Pfizer is not sure the jury is still out.

So other than that, I don't have anything to add.

We will wait to see what exactly in reality that means, and we'll go from there.

And also I want to say it is very disappointing that they are choosing to single out one industry.

Everything in this bill, from what I understand, tax, all of that is affecting everyone.

Any thoughts.

But then there are specific measures to affect only the pharma industry, particularly when we are out of a pandemic or this industry has proven the value that brings to public health and to the global economy.

We would be in a very different point in this global economy if we didn't have the investments and the thriving life sciences sector.

I think it would have answered it.

And they are choosing to single out this industry.

I think it's wrong.

And I hope that reason will prevail when this discussion goes to Congress.

Before I, maybe Michael can give some color because it's a very very good question, but bottom line is we're looking for signs that the it.

<unk> provides the hope that we can have something better than their liquids.

We have been home yes.

So that's a very August according to our premium but it's not.

Months maturity right now to overcome the beryllium.

Very good.

Five of our liquids.

Michael anything to add but simple its about I think you said it very well.

A T L feel the platelet inhibitor in ASI.

Or are going to be generous sized L inquiries and rocks have been great products illiquid as being a market leader in fact attaining EBIT.

Or by the tie in fact 11 comes tomorrow get close to or already Genericize. So.

The room for an expensive drug in an area with this many great treatments that required tremendously high R&D expense.

Coming off the patients have gone through month to provide a great product for us it doesn't look like the best target to deploy capital and we always wish either.

For the benefit of patients.

Let's move to the next question, please.

Sure.

Let's go to the next question.

Your next questions come from the line of Louise Chen with Cantor Fitzgerald.

Your final question will come from the line of Elliot Bosco with UBS.

Hi, thanks for taking my question here.

Hi, this is that'll be basket from UBS on for Colin Bristow. Thanks for taking our questions. Just a few unpacks a little bit you mentioned countries needing to manage folder supply.

Just curious if some of the setbacks that we have, seen in the CD47 space change your view on the market opportunity for your Trillium assets?

Do you think that current tax law would use trends will result in excess inventory versus what has been contractually purchased and additionally could you comment on the recent Codexis retainer arrangement and how we should think about that with regard to 2023 pack slow demand. Thank you.

Thank you.

Yes.

Why don't we go to William? Yeah, sure.

So thanks for the question, Luis.

Angela.

And no I think that the way we are manufacturing a pecs loaded.

Of course, great knowledge, but you know from my prior experience as a community, but also in terms of our negotiations and discussions with countries is actually allowing us to do our supply planning very well. So are we on manufacturing as we need and according to the contract and according to the demand that the countries.

Providing us so I think we're doing that.

Very prudent and in a very.

Yeah.

And a and effectively.

I didn't we didn't get your second question what was the second question I'm not sure Codexis enzyme supplier.

Yes, it was there.

I did refer to eat but maybe also you can yes.

Reiterated that David Yeah, I think Albert indicated this earlier in his remarks is that in fact over the last several quarters.

We've improved our manufacturing process reduce the cycle time, and importantly improve the yield.

From an output perspective, so therefore, we don't need as much.

Raw materials and API to produce the same amount of.

Finished goods and then finally, we've actually invested in our network to make sure that we can actually produce some API as well. So we're in good shape, what I said before Ram moving most of it now because we could way faster than what we anticipated with insights or create some consolidations will for all materials too.

To some external suppliers I'm sorry about that.

I think a factor was the last question, let me close with a few takeaways.

So we saw the news the other day.

Internally, we remain confident in our program with Trillium, and we proceed with the programs that we are planning.

And we'll let the data speak for itself when they come out.

The first one as you see we continue to deliver strong operational performance, we increased our full year 22 operational by non stop focus while maintaining maintaining a challenging foreign exchange environment. So I think few companies likely we'd be able to do that we've.

Thank you.

Next question, please.

Thank you.

Your next question comes from the line of David Reisinger with SBP Securities.

We believe we are well positioned not only to maintain but also to grow both our commercial and scientific leadership.

Yes, thanks very much, and congratulations on the performance.

I wanted to ask a little bit about Vendiquel and Vendamax.

The performance was below our, and consensus expectations.

In the battle against COVID-19.

It would be for us a very important focus.

We believe that the.

The medical need will be there for the years to come.

If you could speak to that and also talk about the sequential prospects going forward, i.e., has the product peaked out in the U.S., and how should we think about future prospects relative to the sales that you booked?

That's why we're investing so heavily we continue focus on driving long term shareholder returns by remaining very disciplined both on our operations and our incremental cost of deployment you saw even in this quarter, but even more we are squeezing out of administrative expenses.

Thank you very much.

Thank you, David.

Angela, what do you think?

<unk> is going down and then we reinvest in R&D because of programs, but we're expecting that if he was a very good return on our investment.

Well, we continue to be really pleased with how Vendiquel is doing.

And we continued to advance our internal scientific pipeline, while executing against our previously announced plans to potentially add at least 25 billion of risk adjusted revenue sort of business development opportunities as well <unk> topline zoster.

If you look at just, from a diagnosis perspective, you know, quarter over quarter, year over year, we continue to do a really great job of effectively finding and identifying who the ATTRCM patients are, diagnosing them, and then bringing them on to therapies.

Very quickly to see the results in R&D are yielding the result, VSAT 14, R&D arguably results just to mention a few of the potential approvals and launches that we're going to have.

So in this quarter, we have reached an all-time high of a 40 percent diagnosis rate, and I think that this is well beyond what we thought we would be able to do in the time frame that we have had.

So we continue to believe in the growth that this product has.

The real-world data that has been generated now and the overall survival benefits are, you know, are really compelling.

Next a few months see bingo, we expect to launch.

And the fact that we are the only product being able to demonstrate these benefits, I think, speaks well to how we'll continue to be able to build in this market, you know, despite, you know, competition that will arise.

The adult lessons in next year and of course next year. It would be very our first of the year, where we expect to have full access for this drug we expect to launch next year RSV maternal we expect to launch next year RMB adults. We expect to launch next year up to AMD for Pediatrics, we expect too.

I think what you're referring to in terms of the impact and the expectations really is a, one-time effect, and it was in Japan. And this was a very specific price decrease that was planned and driven by regulation.

You know, when Vindical was launched in Japan, again, based on pricing regulation in the country that was specific to the country, it was a much higher price than any other country we had.

And so by regulation, again, it's the 75 percent price decrease that we're seeing is a function of that.

But the underlying growth of Vindical in Japan is really strong.

We had just in the first half of 2022, 69 percent volume growth.

We had 32 percent year-over-year, of new patient starts.

Launched next year, although not come up for Triple class refractory myeloma, we expect to launch the next year or the dry side.

So hopefully this gives you a sense that the net revenue impacts you see are, in fact, not a reflection of the demand and the true underlying demand, whether it's in the U.S, or ex-U.S.

Syed.

But sitting here for our topic before.

Im a PCR out there, but we expect to launch next year.

Thank you.

Thank you, Angela.

Meningococcall Remoxy.

We expect to like severe year collaborators for prostate cancer metastatic castration pace.

Thank you, David.

Let's go to the next question, please.

Patients, we expect to launch.

Or are we already made my fabri for endometriosis.

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

And then a little bit later expect maybe this metric in 'twenty, three or beginning of 'twenty for DMD and <unk>.

Thank you.

A question on your RSV vaccine.

Through M&A. So it is this is.

There doesn't seem to be anything but a brief mention, of the program in the press release or the slides and really nothing in prepared remarks, but we have phase three data results coming out very soon.

So I'm wondering why.

But really, my main question is why you recently changed the primary endpoint in the phase three trial, including downsizing of the trial, and that comes on top of the delay in readout as announced earlier this year.

And if I can slip one in on your quadrivalent mRNA flu, when would we likely see results from your Phase 3 that you're starting up?

Thank you, Michael.

I'm not referring to the barrel Heaven, Norfolk, scamming and two other molecules that are mainly.

Both questions go to you.

I think the first question was for RSV, right?

Yes, as Albert mentioned, we are going big here with an efficacy study.

Yes.

We have made great progress in the RSV adult trial. As you know, we ran it through two different seasons in the Northern and Southern Hemisphere, to make sure we had good patient experience and cases.

Things are looking good for a readout that will come soon.

I remain very positive about RSV adult based on our Phase 2 challenge data that was stellar, and the role this particular antigen that we're targeting play.

Mainly to be organic.

And as you know, we're the only one that are targeting the two forms of this prefusion.

You also asked about more mRNA flu.

Well look our pipeline assets I don't think that the muscle vodka has been a factor into it.

What are some of your analysts are projecting that's why I'm emphasizing them so that they can pay a little bit more attention.

Those are very high probabilities of success.

The ones that I mentioned are not.

Not in the pocket cleared.

All of them and some clearly might not make it to the gross line, but we believe we're seriously derisk all of them so with that in mind I'm really looking forward to.

We are encouraged about the data we're seeing.

We think it's a unique data set, and we plan to soon embark on a Phase 3 after proper dialogue with regulators.

Of course, this is an event trial, but if the season is robust, which you can never know, we would expect a Phase 3 to read out next year.

Exactly.

And also, I'm sorry if we gave the impression that RSV is not important to us. It's extremely important.

A 6% CAGR by 'twenty five.

There is no better good news.

This is why we didn't mention it much, but still remains the very good news that the previous studies were extremely strong and that the current studies are progressing very well. So we have very high confidence, absent a surprise, but we will launch next year a very robust product, both in adults and in the maternal version. Both studies are progressing very well.

Our business as we promised in 2019.

Thank you very much.

Year to date, and we are at 6%, excluding BD and excluding coffee and I think we will do.

But by 2025 were maintained the 6% CAGR and we'll do more by B deal.

Let's go to the next question.

Your next questions come from the line of Jeff Meacham from Bank of America.

Hey, guys.

Thanks so much for taking the question.

Just had a couple on tax levied real quick.

Can you give us an update on the number of countries you're in contract discussions with?

I'm just thinking relative to the start of the year.

Alright, Martin implementing so I think we have a very good.

And then related, what's been the biggest contributor of supply expansion in 2Q, and when do you think you guys will be fully, fully normalized?

Our growth prospects and we will maintain already there should be Michael.

Thank you very very much for your interest in <unk>.

The protocols.

Summer vacations, yet enjoy your summer vacation.

Ladies and gentlemen, this concludes Pfizer's second quarter 2022 earnings Conference call you may now disconnect.

[music].

Okay.

[music].

Okay.

Okay.

[music].

Thank you.

Let's go to Angela for the number of countries and where we are with that.

So we are in contract with a significant number of countries at this point.

Maybe I can talk about it from a dose perspective.

So more than 35 million treatment courses have already been contracted with a number of countries. And this is what we publicly disclosed.

There are additional doses that I can't talk about because either the country didn't want us to disclose them publicly or we're in the middle of negotiations with them.

So I think to answer your question, since we last left off, we have made progress with our contracting.

I think maybe what's more important to clarify is just that the approach that countries are taking to contract with us is just really different to where we were in Comirnaty.

In Comirnaty, they were interested in securing large amounts of doses up front, but that's in fact not the case here in Pax Lovid.

And the reason being that, number one, they're being prudent with how they are ordering. And they're able to do that because they know that we have the manufacturing capacity and that we can pivot as we need.

The countries are also trying to manage inventory and not to have too much aged product lying around.

And so I think that this is what's driving the more, you know, smaller, more frequent contracting rather than big, big contracts like you saw in Comirnaty.

The other thing I will also say is, and the reason why I'm talking in doses rather than specific countries is because we're also working with supranational organizations who are acting on behalf of multiple countries.

So think Global Funds, think UNICEF.

You know, these are, you know, in addition to the bilaterals are also important organizations who are helping us to supply and bring doses in.

All in all, great progress and I think you should expect to see that this is one of these things that will just keep inching away because of how countries want to manage the inventory and the supply.

Thank you, Angela.

Because you had also a question on supply ramp-up, we have done tremendous, tremendous progress on that field. Actually, we have been able to reduce dramatically the lead time, so how much time is needed for manufacturing, and we have improved dramatically our yields, so supply is not an issue.

Actually, we moved almost everything in-house now in terms of API and finished the product.

Sure.

[music].

Thanks.

[music].

Okay.

[music].

Okay.

Thanks.

[music].

Thank you very much.

Let's go to the next question.