Q1 2022 Pfizer Inc Earnings Call

Conferencing center after the tone. Please enter your pass code then entered the pound sign your line will then be placed on hold until the conference begins.

Yes.

Okay.

[music].

Thank you for your patience.

Please stay on the line for the next available operator.

[music].

Good morning, My recall infringe IV Dolby.

Okay.

If you're on a speaker phone to speak up behind chip, operator, disconnecting, which you didn't always fine.

And started a comprehensive direct to consumer and social media campaign to ensure all eligible patients are aware of the availability of cash flow.

Here in the U S. We have simple scrubbers utilization grow nearly 10 fold in recent weeks.

Excluding was administered to more than 79000 patients in the U S that weekend in April in the segment.

Up from approximately 8000 patients for the week ending February 25th and defended.

We will continue to work with the U S government and health care providers appropriately drive even higher utilization.

And based on data from IQ, we export them.

Exco with market share relative to more new PW in the retail long term care.

And mail order channels grew from 44% in the weekend in January 28.

2022 to almost 90% the week ending April 22nd 2020.

Together these channels represent an estimated 50% of extra with utilization in the U S.

The number of locations in the U S with box growing supply continues to increase with more than 33000 sites alive as of the day.

Yeah.

This is more than a four fold increase since late February .

Leading to easier patient access.

The U S government.

Declared its intention to double the size again in the coming weeks and making scrubbing available to any pharmacy, who wishes to stock.

In addition, severance.

7% of recent U S. COVID-19 cases, okay are within five miles of our closest retail point of care, which is up from only 23%.

Since February .

We expect this trend to continue to increase.

Driven by the U S government's first two <unk> initiative.

For example, nearly 1100 more first to Threep locations have been added since the beginning of April one.

They are more than 2200 locations.

Great.

Overall, we expect the recent transfer to expand access as well as inquiries received from governments as the virus mutates and caused spikes in infections around the world will result in increased orders in the coming months as governments continue to help protect their citizens who are at high risk of severe disease.

Our sterilization and death and respond to imagine variance and continuing outbreaks.

Now I will turn to our business development strategy.

We leveraged business development opportunities to advance our business strategy and objectives.

We recently announced positive top line results from a phase III trial of <unk> in moderately to severely active ulcerative colitis.

These results underscore pfizer's ability to identify strong business development targets is this potentially best in class drug.

Candidate came to us via our recent acquisition of ARINC.

We look forward to presenting these data.

Filing for approval later this year.

First quarter, we discussed how the strength of our balance sheet and cash flows gives us the ability to pursue new business development opportunities.

If successful.

Could add at least 25 billion of which cause us revenues to our 2030 top line expectations.

Our planned acquisition of revival is the first deal to be counted towards these ambitions.

Revival.

Privately held clinical stage biopharmaceutical.

Company focused on discovering developing and commercializing novel antiviral therapeutics targets respiratory syncytial virus basically they talked with RSV.

We believe annual revenue from these programs if successful has the potential to reach or exceed one five female if they're supposed to be grabbing.

We also are excited about the prospect of adding several experienced virologist Duarte.

Building relationships within the growing biotech ecosystem remains a priority.

We continue to pursue new creative ways of partnering with biotechs to inquiries or access to cutting edge innovation and to bring all resources to bear.

Drive breakthrough for patients.

We believe our scientific expertise our end to end development and manufacturing capabilities.

Makes us an extremely attractive partner.

For example through our relationship with Baylor.

And we are confident that we have the financial resources.

Business opportunities that will complement and enhance our internal R&D efforts and add capacity and flexibility to support our growing clinical portfolio.

Next I would like to discuss some of our recent ESG highlights.

First we announced in February the results of Pfizer's annual pay equity study and which are recognized compensation expert confirm equitable pay practices for employees at Pfizer.

The results indicated the Pfizer compensates female colleagues deliver greater than 99% of what male colleagues are paid across the globe.

Additionally, in the U S minorities are paid it dollar for dollar poverty of what non minority subtype.

When you look at Pfizer's median pay for women globally.

It is in high point counterpoint to 30% for the median pay of males.

However, when you look at the median pay for minority doesn't have a U S. Workforce is 85, 5% of the median pay for all non minorities.

Medium rates pick up is an area we are actively addressing.

But we expect to now.

Second I want to reiterate the Pfizer stands with a unified global community no position toothbrushes invasion food Crane.

The wildfires that is maintaining our humanitarian supply of medicine Russians its Richard.

It will be donating all profits of our Russian subsidiary to coaches that provide direct humanitarian support.

Okay.

Additionally.

We will no longer initiate new clinical trials for Russia, and will stop recruiting new patients in our ongoing clinical trials.

Pfizer will work with the FDA and other regulators to transition all ongoing clinical trials slow down at the sites outside Russia, and consistent with our commitment to putting patients first.

We will continue providing needed medicines to the patients already enrolled in clinical trials in Russia.

Lastly, we are seizing all future investments with Luca suppliers intended to build manufacturing capacity rush.

Uh huh.

Further demonstrating our commitment to equitable access we have made the decision for as long as the pandemic loss Pfizer will not profit from sales of our COVID-19 treatment through the worlds poorest countries in March Pfizer announced an agreement with unison to supply up to 4 million treatment courses of exploring.

95, low and middle income countries under the agreement or law, and lower and middle income countries will be offered the treatment courses and not for profit price, while offering middle income countries, where pay surprise define and pfizer's tier pricing approach.

Lastly, I am pleased to share that Pfizer continues to be recognized as an ethical basin focused company that constant sales and its employees and its business partners to highs.

In March Pfizer was recognized.

One of the world's most ethical companies by Ethisphere.

A global leader in defining and advancing the standards of ethical business practices.

Just last weekend, we are so proud about it.

The first time ever Pfizer on first among big pharma companies in the Basin view Global survey in 2021.

This ranking is based on feedback from more than 2000 patient organizations and associations Norway.

As recently as 2018, we were fifth.

And we have steadily climbed in the rankings ever since.

Probably the number one right.

Now I would like to welcome two new members for Pfizer Executive leadership team.

Dr. William Paul.

Joining us on March 21st.

As executive Vice President and Chief Development Officer.

Throughout his 25 year career, as an oncologist and scientists.

William has amazed extensive clinical and deep scientific expertise that make him the ideal partner to continue our pursuit and breakthrough medicines and vaccines for the benefit of patients and site.

Just yesterday, David Denton joins us.

<unk> financial Officer, and Executive Vice President.

Dave.

Brings with him more than 25 years of finance and the operational expertise, including more than 20 years in the health care sector.

As a result, he brings a pfizer a unique perspective on the role of failures the needs of patients and the rapidly evolving health care landscape.

We are thrilled to welcome these two highly effective and visionary leaders at this critical time.

Our company and global.

And now before I hand, it off to Michael I want to take a moment to thank fundamentally my best friend and Pfizer for his many contributions to price.

In addition to helping and sewer pfizer's financial strength and this.

Frank has been an incredible mentor to many of Pfizer's current leader.

I would say our long term growth strategy and work tirelessly Vincent.

So Pfizer has the resources it needs to help improve the lives of patients around the world.

Franco on behalf of all Pfizer colleagues and I'm sure all of the analysts on todays call and not all of it.

I wish you continued good health and success.

Without that I will turn it over to Michael to update you on the R&D efforts after Michael Frank will provide the financial details on the first quarter and our outlook for the remaining of the remainder of 2022.

Michael Thank you Oliver.

I would like to start by highlighting two recent external acknowledgment.

Appliances R&D turnaround.

<unk> was ranked first for innovation in the 11th annual pharmaceutical innovation and invention index.

First.

Ooh with Forbes term postal R&D productivity over 20 years.

Papers published in blood discovery today.

As a testament.

The work of all our scientists over the past year.

Our purpose Paul airports to improve our R&D engine over the past 10 years.

Today, I will share updates on Covid, 19, inflammation, and immunology Odyssey oncology Lyme disease in hemophilia.

Some cases.

I referenced publicly available data on other agents.

As you can understand our enthusiasm about what we're seeing in our development program of course head to head clinical trials would be necessary to support any comparative claims.

We continue to pursue a comprehensive and data driven clinical strategy for coming up.

Focus on evaluating real world vaccine effectiveness.

Demonstrating our union.

Boosters.

Expanding access to pediatric population and addressing emerging.

Zone.

On the left in the phase two three trial of <unk> administered to Hyndman H five through 11.

We have shown that the third 10 microgram dose.

Illustrated a sixfold boost neutralizing wild type Sars cov two and.

And the 36 foot booth.

And the only conveyor.

Last week, we submitted an EUA request to the FDA for a third dose booths in this population.

On the right.

We showed that the third 30 microgram dose.

So Adam in the landmark clinical trial effectively neutralized on the consult lineages, including two one months.

Hmm.

We have also now received EUA for a second booster in people, aged 50 and older.

And for individuals 12 years of age and older.

Sometimes I mean no compromise.

This expanded authorization was based on data from Israel generated why the omicron variant was dominant.

And approximately 11 fold increase in domestic neutralizing antibody titers against wild type virus.

Northern corn belt.

Were reported at two weeks after the second booster.

Compared to five months after the first two and stuff.

Yeah, We show recently published real World data for this vote.

The fourth dose of coming up and lowered rates applicable to the station.

Illness and death.

The omicron outbreak.

The fourth dose is not recommended for something high risk populations and more than 15 countries.

It doesn't mean, a notable increase in the number of Podiatric effects.

And hospitalizations in the last few weeks and.

And we recognize that the current <unk>.

She has been in health care providers have been waiting for an effective vaccine.

We have been working with urgency to generate data.

We began the rolling submission with <unk> in children, aged six months to four years in February .

While continuing to evaluate the thud three microgram dose.

Optima deliver heightened degree of protection against only grown.

We expect that analyzed and suddenly the three dose data by late May early June and anticipate both FDA and CDC adviser.

Soon after you consider the submission.

Turning to <unk>.

Following EUA in December for both high risk adult and high risk children 12, and older weighing at least 40 kilograms, we expect to file soon and anticipate an FDA decision on the new drug application in these populations in the second of two.

Recently, the dominant HOS strongly recommended types of it for people with mild to moderate COVID-19.

We're at the highest risk posed to penetration because their unvaccinated older or compromised.

We expect pivotal readouts of the standard risk study in the second half of 'twenty, two and reported top line results from the household contact prophylaxis study last week.

In March.

We initiated a study in children and expect the second quarter of 23.

We are first enrolling children, aged six to 17 years and working to develop in Ethiopia formulation for children younger than six.

A new study.

Improvisation.

Planned to start in the second half of 'twenty two.

Some immunocompromised patients who are involved in the ft. H O study at all ever given the high unmet need we believe.

C will allow us to further evaluate efficacy in this population and ensure the treatment duration is optimized.

Given the more limited natural immune response.

Sure.

With the close of the original acquisition in March I'd like to highlight the potential for addressing mode.

Best in class oral medicine, ulcerative colitis, and its strategic fit.

Within our overall inflammation and immunology pipeline.

First <unk> is differentiated it's a once daily pill with rapid onset.

No one anticipated required titration and a promising benefit risk profile.

In the phase III elevate studies at festival demonstrated robust clinical remission in patients with moderate to severe to ask David.

With colitis.

In March we reported that elevate UC 52 trial met the co primary endpoints of clinical remission at both weeks 12, and 52 and all key secondary endpoints looking at the totality of data across phase II and phase III studies, we see a 12 week read.

Mission rate of 25% to 30% compared to placebo at 6% to 15%.

We are projecting a filing in ulcerative colitis in the second half of 'twenty two.

This candidate also has broad potential beyond UC.

The adaptive phase II III study in Crohn's disease ongoing and we expect to start phase three in atopic dermatitis in the fourth quarter.

The potential expansion into Crohn's and eosinophilic esophagitis strengths in our gastroenterology pipeline.

Overall.

Given that immune inflammatory diseases have a heterogeneous disease drivers, which would probably have multiple options for effective treatment and a continued significant unmet need of patients in achieving long term remission. We are excited about the portfolio of diverse and promising candidate for marina that nicely complements our existing iron.

<unk> pipeline.

<unk> is our unique site the <unk> modulator, it's a potent pan pick family inhibitor, which spares IL 10 protective site to come.

And Spanish dominant JAK activity of existing effective oral JAK agents.

We have seen promising phase two efficacy demonstrated across alopecia vitiligo.

Yes.

<unk> II study in Crohn's disease is ongoing.

Let's see received FDA breakthrough designation for other PCR.

We expect to file in the second quarter.

We are finalizing potential phase three study protocols for good deals.

Eagle.

And exploring.

Foreign currency crises.

In the phase II b, replacing to nib demonstrated robust efficacy in both face shell and BP.

Vitiligo area severity indexes or bus here.

Here, we showed a fascia a vast improvement.

On the left with persistent demonstrated up to 66% improvement from baseline to week 48.

Because he was observed across light and dark skin types on the right you see two visual representations of significant improvement in patient busey at 48 weeks.

Last month, we announced our intent to acquire <unk> and its respiratory syncytial virus therapeutic candidates.

RSV remains a significant unmet need globally with no approved treatments and the proposed acquisition will strengthen our capability in infectious disease R&D with a complementary strategy to help improve patient outcomes through treatment and prevent illness through vaccination.

This mirrors, our COVID-19 strategy, establishing leadership across vaccines and therapeutics for RSV to deliver potential breakthroughs.

Our RSV candidate elicited high RSV, a and B neutralizing titers in preclinical animal models and in Phase one two clinical studies and has received FDA breakthrough designation for the material maternal and adult programs we.

We anticipate Q Votel readouts of the maternal and other studies in the second half of 'twenty two.

Revivals pipeline include a lead candidate since enough Davita, which has received fast track designation and a second program focused on the inhibition of RSV replication targeting that viral and protium.

<unk> is an orally administered inhibitor designed to block fusion of the RSV virus to the host cell.

Our phase two healthy adults challenge study she was enough to significantly reduce viral load.

The data are shown on the right.

It's also an ongoing suite powered adaptive phase II study in hospitalized being funds successful completion of part a was achieved in June 'twenty, one with favorable safety and pharmacokinetics heartbeats ongoing.

We now turn to oncology and encouraging data from the phase III trial of lower Green Dot.

Three year follow up data presented at ACR confirmed prolonged progression free survival in first line <unk> positive non small cell lung cancer patient.

There was a 73% reduction in risk of disease progression or death versus consulting.

The three year PFS rate in that arena.

63, 5%.

Sui rates for second generation medicines are generally 20% points lower based on cross trial assessments.

No definitive conclusion can be drawn from cross trial comparisons.

There were no new safety as England singles, and a low permanent discontinuation rate of seven 4% for patients on low arena.

Hi, central nervous system activity is important for patients with and without brain metastasis.

325, and 40% of our positive patients present with brain metastases.

Noses.

And between 2014, and 40% of patients develop them within two years of diagnosis brain met Testacy. So one of the most common causes of death in these patient population.

Reaching our expertise in developing brain penetrant on quality treatments.

Being our specifically designed to meet the significant unmet need.

We have seen high activity in patients with or without baseline brain metastases significant intra cranial activity was observed with lorena.

As evidenced not only by truck Crane, our response rates, but also by pine to intracranial progression as shown here at.

At three years of follow up 92, 3%.

Patients treated with Lorena were alive and free of intracranial events, compared with 37, 7% treated with <unk>.

In Lorena treated patients without brain metastases only one out of 112 patients had evidence of intracranial progression, suggesting a potential protective effects against development of brain metastases with Lorena treatment.

Here, we show the first data from the pediatric cohort of the phase II trial of our Lyme disease vaccine candidate, they're only one of its kind in clinical development.

<unk> disease effects all age groups of children are considered the population most at risk due to their outdoor activities we.

We saw robust immunogenicity across all pediatric age groups and serotypes and the safety profile was similar to that previously reported in adults.

The program has received FDA fast track designation and we plan to include pediatric participants in the phase III trial expected to start in the third quarter.

As an adult Immunogenicity and safety data to support a three dose primary vaccination schedule.

<unk> participants in the phase III study.

Now I'd like to highlight our robust portfolio of investigational therapies to potentially treat all people with hemophilia.

We expect the number of clinical trial for our hemophilia portfolio to read out in 'twenty three Mara stuffs demob.

Our novel non factor treatment candidates with the potential to address a broad patient population.

As a new subcutaneous prophylactic treatment for patients with hemophilia, a or b, including those with inhibitors.

We anticipate the pivotal readouts in second quarter 2003, <unk> has FDA fast track designation for heme, a and b patients with inhibitors. If successful we predict submitting for the non <unk> inhibitor indication in both EMEA and be in the third quarter of 'twenty three.

Turning to our gene therapy candidates last year at Ash, we presented updated phase <unk> data from the largest cohort of persons with hemophilia B whoever that leaves he is a fill up with AAV gene therapy.

93% of participants achieved benign activity in the milder normal range between three to five and half years of follow up we.

We expect the pivotal readout in the first quarter of 'twenty three.

<unk>. We also presented updated phase <unk> data at Ash factor eight activity was 25% of normal after two years in the highest dose cohort.

The FDA has lifted the clinical hold on our phase III pivotal study and we anticipate study resumption in the third quarter of this year with a pivotal readout estimate that in the second half of 'twenty three.

Finally here are the top 25 key milestones achieved and anticipated for the rest of the year six in the regulatory space 12 people to readout and seven early stage Readouts.

Also note that last week, we announced the planned opening of the first U S sites in our phase III trial evaluating our investigational minions Dauphine gene therapy for ambulatory patients with Duchenne muscular dystrophy.

Trial also received regulatory approval to restart.

Other countries pending regulatory feedback, we anticipate that nearly all sites will open by the end of June in addition.

The European Medicines Agency's committee for medicinal products for human use granted prime designation for GBS six our maternal vaccine candidate against won't be skeptical co infection. It's currently being evaluated in an ongoing phase II study.

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

Thanks, Michael I know you've seen our release, let me provide a few brief highlights regarding the financials turning to the income statement revenue increased 82% operationally in the first quarter of 2022, driven by COVID-19 vaccine and <unk> sales and strong performance for a number of our other key growth drivers.

And looking at the revenue excluding the COVID-19 vaccine direct sales and alliance revenues and <unk> contribution and increased by 2% operationally.

Effect of fewer selling days year over year decreased revenues by about 1% and losses of exclusivity negatively impacted revenues by 2%.

Operational growth would've been approximately 5% without these also please remember that Q1 2021 grew 8% operationally, excluding commonality versus the prior year quarter, resulting in a very different comparable.

This is bradley broadly as expected in this embedded in our current guidance.

The adjusted cost of sales increased year on year reduced this quarters gross margin by approximately 10 percentage points as compared to the first quarter of 2021 with 14 percentage points attributable to the impact of higher COVID-19 vaccine sales year over year, partially mitigated by new favorable product mix for other products, primarily driven by higher sales of <unk>.

And higher alliance revenues.

Adjusted SG&A expenses in the first quarter decreased primarily due to lower spending on corporate enabling functions, partially offset by increased spending to co minority excellent.

The increase in adjusted R&D expense. This quarter was primarily driven by increased investments in multiple late stage clinical programs as well as additional spending on programs to prevent and treat COVID-19.

The growth rate so reported diluted EPS was 59%, while adjusted diluted EPS grew 76% operationally.

Foreign exchange movements resulted in a negative 5% impact to revenue as well as the negative 4% impact or <unk> to adjusted diluted EPS.

Now, let's move to our updated 2022.

We expect total company revenue to be in a range of 98 to 102 billion, representing an operational growth rate of 27% at the mid.

The revenue range absorbs an additional $2 billion of anticipated negative impact from changes in foreign exchange rates as the U S. Dollar continued to strengthen against other currencies since we last updated our exchange rate assumptions.

Regarding our regarding our COVID-19 related revenues, we continue to expect the vaccine revenue for the year to be approximately 32 billion unchanged compared to our prior guidance provided on February eight despite the impact of $1 billion of incremental negative foreign exchange for <unk>, We expect sales of approximately 22 billion.

He'd been the guidance unchanged, despite an incremental 500 headwind due to foreign exchange.

This means that excluding the COVID-19 related revenues, we expect sales to be approximately 46 billion at the midpoint, representing operational growth of 5% and absorbing the increased negative impact of about 500 million foreign exchange.

This is slightly below the 6% CAGR and we continue to expect between 2020 in 2025, we continue to be confident in our ability to achieve that 2025.

Now, let me give some detail on our cost and expense guidance, we slightly improved our guidance for adjusted cost of sales, reducing the entire range by 20 basis points, the new range being 32% to 34%.

We separated the former R&D line into two R&D and a new line for acquired IP R&D isolate the IP R&D charges, which are driven by business development transactions.

Our guidance includes $900 million of this expense for 2022 based on business development transactions, which have either already closed or already signed as of mid April of which only $100 million was previously assumed in our R&D guidance for adjusted results, we will not forecast acquiring R&D with transactions, which are not.

Those were soft.

We've also increased our adjusted R&D expense guidance by 500 million to reflect incremental lifecycle spending for COVID-19, vaccines and anti Virals and investments and other projects. In addition, as noted with fourth quarter results. We've made a decision to modify our adjusted results treatment of amortization of intangibles.

Previously, we only excluded amortization related to large mergers and acquisitions and we will now exclude all intangible asset amortization expense. This is anticipated to contribute <unk> <unk> to our 2022 adjusted diluted earnings per share and improves comparability with our peers. This expense was previously included in our <unk>.

22 items.

These assumptions yield an adjusted diluted EPS range of 625 to 645 or 61% operational growth at the midpoint compared to 2020.

This updated EPS guidance includes a <unk> <unk>.

Operational improvement offset by a negative <unk> 11, due to foreign exchange and another 11.

IP R&D together these impacts net out to an adjusted EPS range, which is turn slower than our initial guidance.

2022 guidance once again assumes no incremental share repurchases beyond the $2 billion of share repurchases. We completed in March going forward, we will continue to be prudent in our capital allocation activities with the opportunities for deployment shown here on this slide.

So before I turn the call back to Chris to start the Q&A session I wanted to make a personal comment.

This conference call and Mark My last response, as CFO , I wish, Dave and Pfizer or the success in the world. It has been my immense pleasure and privilege to serve as Pfizer CFO for nearly 15 years I've always enjoyed my interactions with you our investors and our analysts element.

To my Pfizer colleagues I am so proud of what we have accomplished together and look forward to you achieving a more success in the future and is a large pfizer shareholder you can be sure that I'll be watching with that let me turn it over to Chris for Q&A.

Thanks Frank.

Let's start the Q&A session, we will answer as many questions as time permits and as always Investor relations will be available after the call to answer any questions you weren't able to ask operator first question. Please.

Yes.

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

Hi, Thanks for taking my questions and Frank Thank you for all your contributions besides area, we will really Miss working with you. So first question I had for you is really and what are your initial impressions of Pfizer, having come recently from the outside.

And then the second question I had is what is the opportunity for a potential EU pacts with a contract and sales potential in China. Thank you.

We have been wise on your stock.

Our impressions.

Louise Thanks for the question, Yes, I would say have been.

My expectations have been exceeded.

Many reasons I came to Pfizer, but one of them was the great science that's going on.

Dedication to breakthrough innovation, but also the patient with.

Which things have been done and seeing Pfizer accomplish cutbacks of it and the vaccine of really inspiring and I came to further build upon that and really transform how we do drug development.

Thank you I'm, sorry did you want to take a little bit the EU.

Uh huh.

Product contract.

Thanks for the question Lee and so.

Sure.

Europe I would say that we're really taking a M <unk>.

Q2 pronged approach to our contracting one we have bilateral.

And that actually either secured or about to be secured.

In addition to that we're also looking at E.

Do you have a contract.

I think more on that to come as we are you.

Whenever we're ready to share.

Outcome on that.

We are using pumps.

And on China.

What I am able to share is that we are working with a local distributor AMCOL mahyco.

<unk> distributed and to add to that.

Ensure access to <unk> in China.

And that's all I'm able to say right now I'm not being able to last year more tons of Ukraine and all of the volumes.

Anything related to that.

So thanks.

Thank you very much next question please.

And your next question comes from the line of Evan <unk> with BMO.

Hey, guys. Thank you so much for taking my question and congrats on the quarter. So I have two on Covid one when we think about the evolution of the booster market. How do you see this going we've seen some data, suggesting that we're kind of walking blindly into recommending boosters every so often what's the ultimate goal of destination is it to prevent.

Mild winter these or is it really just to prevent this severe disease and overloading at the hospital and then my second question is when we think about the evolution of the commercial model for <unk> and can you talk to that when do you expect to maybe file an NDA and transitioning away at least in the United States from kind of government contracting to more traditional commercial.

Our model. Thank you so much.

Thank you for your question.

Let me see if I can answer and then I will ask our scientists.

On the evolution of a poster I think all of Florida moves.

Moving blindly, we're moving based on data.

And there isn't why vertical ma'am.

And it is because states are supporting according to their opinion.

I believe that's right now the.

Therefore, it is to be able to stay ahead of the virus and the.

Novartis rebates and the most serious mutation where the question was the only girl long because there was the one.

Able to abate.

Protection of.

Apache until then I think the vaccines were offering very very good protection against <unk>.

And of course, an excellent protection against older tonnage.

With all Mcgraham, we solve the while we keep a very good protection against for sterilization from tariffs the protection against the disease.

Is going down so we have seen.

Well three of them are date for half a dose of the current vaccine.

Perfect.

Significant holds many folds.

Patients from either personalization and of course also predicts the infection, but not to the degree but if you are to be.

Everybody's working also for new vaccines.

We'll be able to protect.

Perfect better against longer term, while maintaining the same protection against the wildfires were been advanced with fabrics and we are waiting to hear from FDA.

Basic combinations, they would recommend what they would like to see.

And we won't be ready for day one.

Our our vaccines both in terms of filing and both in FEMSA for manufacturing.

Or is it.

Profit.

Right now we are completing the establishment I will ask Michael.

To comment when we think that we can file for a while.

MBA.

Yeah.

We will file our NDA quite soon this half of the year.

Look forward to it.

As soon as possible.

Let me review getting it approved which would allow even more engagement with the.

The medical and other communities. So we think that would be very helpful. In order to increase education and access to the medicine and anything to add on that on the booster and how we are looking at it.

You said just got very well how this has been science driven NAND prices is proud to be leading a singleton. The first fall whether it is primary series a boost to new.

Age groups. So I just wanted to add that we expect pending <unk> to start the fall season.

We the vaccination campaign, a new boost which will be critical then to regain and as Albert alluded to possibly further strengthen versus new evolution that we're seeing in omicron.

And it's likely going to be an annual procedure with these type of public recommendation about strains in for some more vulnerable patient groups.

Immunocompromised older we have learned that it may be even in between an extra dose.

So we are on top of that.

Science, and we expect every year to be able to incorporate new science, we're doing multiple learnings on how to further evolve the vaccine.

And see us as a natural leader as we've established such deep insights will have anything to add.

Thank you. Okay next question please.

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

Great. Thanks for taking my question.

Maybe one question regarding back slowly so it seems like you had mentioned 6 million courses. The sales is about $1 $5 billion. So this calculates to about $250, but core for ice so am I calculating it right and number two it seems like you're suggesting that Oh 20 million course.

In <unk> would be shipped.

So is that correct and the pricing should be lower or higher than $250 of course. Thank you.

Thank you very much that mortgage not because there is this.

We tried to explain it we did produce 6 million doses in.

And by the end of March from them only for Boeing.

For important three were shipped outside remarks, the remainder we're simply in the first week of favorite basically.

But also from the $4 two that we received a very small proportion.

Smaller proportion was recorded as revenues in this quarter why because most of them were shipped in March and everything with received in the U S. In March comps for Q1, but everything that we see internationally.

One <unk> for Q2 due to the accounting calendar overtime. So the doses that are made.

$1 5 billion of sales is way smaller than six 7 million doses.

You refer.

In terms of what we expect we expect this quarter to have a $24 million by the end of June to have been able to produce 30 million doses altogether clearly some of them again will be saved in.

In July clearly some of that.

We have received in June in international markets. So you should not be calculating is recovering the risk corridor.

Everything will go into.

I'd say the second quarter of all of this volume.

Our next workers.

Your next question comes from the line of parents Flynn with Morgan Stanley .

Great. Thanks, so much for taking the questions.

It's a little too early to give 2023 guidance, but maybe Angela or Frank if you could just help us think about the puts and takes for comber Naughty for next year and if you think consensus is in the right range at 17 $2 billion to $18 billion and then my second question relates to <unk> for.

For ulcerative colitis.

Michael based on your comments it seems like the placebo response rate in the phase III trial might have been slightly higher than phase. Two just wondering if that's accurate and any additional insight you could share there. Thanks so much.

Thanks Alan.

I will ask Frank Good luck, she was not giving you guidance.

And she will give you guidance for 'twenty three.

But let's see how is your response to that question and then micro can you speak about the pricing.

So I'm not going to provide.

But obviously you saw what we did for 2020 to guidance, we reiterated the guidance on tax low that we reiterated the guidance on <unk> by the way 54 billion approximately revenue, while absorbing $1 5 billion of foreign exchange and you know if you listened to the commentary we've had so far in <unk>, we remain bullish on tax low, but if you.

Look at some of the recent trends and look at some of the charts that Albert <unk> provided in terms of 10 top 10 fold growth from the end of February or April the number of sites that were at 33000 sites now so the rhythm of that of that product looks very good and we remain very bullish.

I will say that for 2023, theyre all going to be a lot of puts and takes because there would be great.

With new innovations coming that we need to see how that plays.

And also on the changes in their business models right.

There is a chance of the U S will grow with the private market.

Peter.

Things like that.

Our national they will continue with for government purchases and we do have a contract for these practices.

'twenty three and beyond during before so there are a lot of wood.

Puts and takes with them.

We're being played here, but let's move to something that is.

It's very interesting of Trustmark.

Thank you for your interest Terence.

And.

I think of course, the MTS as my shed was based on the pivotal studies that will be filed.

Your show up I note that at one of them.

We did have a placebo rate slightly higher than more extensive of the phase III had a traditional placebo rate and a very nice delta between treated and untreated as you know for great drugs, you would like to see in the range of maybe a 20% delta.

And while we won't give you all details as we expecting data soon to be presented this year at appropriate conferences I can assure you that we saw a very nice favorable delta for addressing that treated.

We talked about 12 week remission rate in our earnings talking point to drive did very well in the 52 week maintenance phase.

And all secondary endpoints are looking very favorable so that's really why we think it can be both a best in class.

And in some way a best in disease, given its convenience is rapid onset of action.

It's well tolerated profile.

So thank you for your interest.

Operator next question please.

Your next question comes from the line of the male demos with Mizuho.

Great. Thanks for taking my questions, maybe just shifting gears a little bit to that.

Quarter end.

Our core products here, so one I'm curious about especially in the U S. Because I know you mentioned again the relief is down 5%.

As to the patient assistance program and I guess I thought that that was more of a 2021.

Dynamic kind of going through the pandemic.

Here, you may actually be more of a.

Positive pricing benefit that you see so maybe you can just share a little bit more color on what youre seeing in the market. There and then the second one is on Xeljanz as long as he down quite a bit.

Safety issue that label update and I'm, just trying to get a better sense of how you.

You see that clinic.

Oh, good immunology pipeline and a lot of them.

Deliberate here, but do you see.

Stabilizing here in <unk>.

And as we continue to decline so how would you sort of.

To that point it sounds like all of them.

And the next year or two going forward. Thank you.

Very very good questions both of them. So I'm there I started with Ibreath radio growth results.

So let's talk about <unk> first.

From a performance perspective, I just want to emphasize that IRA.

Far and away the anchors.

Actually in an ex.

<unk> grew 12% this quarter and as you mentioned accurately it didn't have a negative 5% growth in the U S. This was largely due to a path.

In fact, if you strip that out TRA volume actually grew 3%.

U S five brands.

So it's really the high proportion.

Jade I'm Rs II.

This revenue growth. So just to give you a sense of the scale.

Compared to a year ago, we've seen a 32% increase on path applications.

And however, Q1 similar to way we were in Q4.

Number of enrollees.

But maybe if we step back.

Not so surprising that I brands would have such a high proportion of pop because it is the market leader more than 75% of all of its Greg.

Along two lines.

A part of.

And so as you think back to the financial hardships that off.

So in the economy.

Angie link back to the fact that they are reduced alternate sourcing financial assistance, which is driving more people to our brands.

And also just from an annual perspective patients enroll in January .

And if they stay for the year I think what we're seeing is approximately what we're going to continue to see further.

But maybe the important message here is that this does not mean that there is no growth opportunity. Even in 2019, we know that there is tremendous growth opportunity in <unk>.

K class.

Our ability to make this pie.

It's going to be great for patients as well.

So just in the last year, an increase of the CDK class one way.

In Q1 of 2021, which was just 48% to a way we are now this quarter in 'twenty, two which is 54%. So this positive momentum.

It's something that we are very focused on.

In addition to the fact that of course.

The pandemic, we did see some lag in new patient starts.

Diagnosis.

Static breast cancer patients with delays and putting them on treatment and so that's another area of focus for us as well.

The increase in Arlington.

But that's our brands so let's spend a minute talking about downtime on your question around sort of where are we with xeljanz and what do we see and we definitely see 2022 as a year of transition for us why.

First let me step back and look at Dow Jones performance, you have to look beyond and it's not just about the product.

And so just to give you some numbers on what it is.

It happened in the class over the last year. So between this quarter and same quarter last year in 2021, the new to brand prescriptions in the JAK class actually went down 40.

Now tell transplant down 50, we also saw a product like <unk> of that product in the JAK class go down by 35%.

So when we look at growth it is important.

Returns to growth as well.

I would say that's 22 is going to be a transition for <unk>, because we finally have a clear legal and with this label that are going to be extra focus on post TNF.

CNS segment as our place.

At the place we sell to.

<unk> can play.

And this market is also significant because we note that many patients don't respond to TNF and most will need options beyond CNS.

Finally, we're seeing some nice signs of stabilization compared to compared to where we were over the last year as well.

The first time, our new to brand Rx's are stable.

Timing.

Our switches back into Xeljanz versus just purely away from downtown.

And our market research, we see a increase in the intention to prescribed by health care professionals.

And then finally I'm also on the market research, we see that safety perceptions of xeljanz equivalent to that debt.

Demonstrate this.

Our playing field and the Jack Lascar.

So we are really focused on education.

With education efforts behind Xeljanz to reestablish.

And how they will generally be used and that's what gives us confidence that we can return to growth.

Thank you for your answer as always.

Very comprehensive are awesome.

The next.

Question. Please.

Your next question comes from the line of Kerry Holford with Baron Berg.

Hi.

A question firstly on <unk>.

Okay.

Yes.

11 8 billion.

2020 looks great.

Think about that.

We'll go next to Nathan.

The contraction already.

Let's say you start getting inside the contracts for delivery in 2023 and beyond since you published on February .

Secondly, on the honest feedback C&I, calling slide taking a stake in that.

Spanning.

From the data readout pretty old Atlanta.

Now in the second half.

Is that fairly reflect the expansion of the.

The patient population study.

Jeannie kill anything like that.

In Tennessee.

We're kind of evaluating.

It's been cancellations in that study and lastly, when he entered launch I'd put up to me.

Okay.

Thank you very much circuits.

Frank do you want to give you the answer.

In terms of 2023, we'll talk about 2023 in detail when we provide 2023 guidance, which will be on our fourth quarter earnings call.

Talk about the puts and takes will explain.

Where we are this year, where we are next year with the growth drivers are.

And then obviously that will include what the revenues will be for the Coca taxi. So that's to come.

And then Michael you want to take the RSV question about the CJR filings.

Maybe you have anything to add please yeah.

As I've spoken introduction prices very excited about the portfolio of the RSV vaccine in the RSV therapeutics and.

And I think we have had very strong data in the phase II Challenge study complete protection and also in the maternal study, where we actually with small numbers had a two 5% efficacy and very strong immunogenicity cros.

B strains I believe we are the only one with such a comprehensive data set.

Talking with him our tunnel.

To the best of my knowledge, we are really the only advanced RSV vaccine.

We took the opportunity as we had sites opening up in Latin America to also capture.

From that region of the world and in this.

No 2020 to see some more cases for add to our study.

We expect in a couple to a few months to have the readout.

Based on.

We're going out.

For the maternal and relatively shortly thereafter this year. The adult trial is expected based on comprehensive.

Set of sites also in the southern Hemisphere, So it's really a <unk>.

Perfect composition of.

RSV cases from different parts of the world.

And I look forward very much to the Readouts and remain very optimistic he is one of my favorite programs.

Minus web widget American correct, Yes, I would just add that you mentioned already Michael that both programs got breakthrough designation and so we're very excited.

Everybody recognizes that.

Upon entering their favorite programs in favor of the asthma, let's move to.

The next question please.

Your next question comes from the line of Steve Scala with Cowen.

Thank you very much and thank you Frank for everything and all the best to you in the future.

You have a follow up on the RSV vaccine in which a CIP meeting in 2023 with the Pfizer vaccine most likely be considered.

And.

I assume of course, you have not seen premature birth in the maternal study, but do you have a theory as to why you havent when your competitor has.

And then a question on Ela quest for Angela.

To what degree has bleeding risk limited prescribing of Ela with MFA drug came along and that was associated with less bleeding do you think that would be a significantly preferred agent. Thank you.

Correct Angela why don't you take the ACI be meeting and then also the question about the bleeding and then we can go to Michael.

Yes.

ACI P and the scheduled ACI P is on just closely held by the AIP, the working group and the CDC.

Pretty typical thing for me to be able to predict.

But typically it's sort of within within the.

The two to three month period from.

From launch Mike as you know that it only happened several times of the year. So you need to be able to catch it right to be able to take T lab to be able to land to meet.

Whenever that next meeting so I wonder if you think SMA difficult question to answer, but suffice to say that of course, we will look as rapidly as possible to ensure that it gets on the schedule at the very next one person launch.

On your question around eating it has not been one that has come up actually for my other question.

In large measure I have to say.

Our performance continues to be really strong we're the number one <unk> in 24 markets with the number one on oral anti coagulant in 'twenty one other market.

So I would say that the uptake of eloquence outperformance, which as you can see this quarter continues to be double digit I think its the 10th year in a row that we've had double digit growth on eloquent and we continue to see tremendous market share and utilization.

So I would say that that has not been an issue that we have.

And if I could just punctuate if you look at the revenue number this quarter for <unk>. The revenue number is $1 8 billion almost up 12% operationally continued continued strong performance by that by that product.

Exactly and also I wanted also to address.

There are strong but of course, we can't predict when ACI appear.

I'll do whatever they think is appropriate to do but we do know that RSV is considered by the CPUC is a major disease threat.

And.

I'm sure.

Is there one of them demonstrate the appropriate.

To deal with a vaccine if it is.

Alright.

Mike There was this question about pretty much bare, but we do not have.

If you can provide from why are we done.

The way our estimate.

We have a very deep.

Deep and long experience how to design in.

Scenes and for different patient groups.

As this is for them a ton of.

We obviously have developed very well tolerate the vaccine and we were able without the need of any harsh adjuvant to get very high.

Immune responses that included we use both RSV, a and BMS against I believe would own the one.

That have that going.

You know I cant really bizarre than on the other vaccine you're referring to but certainly it's not an advantage to us and that event that was known to give a very significant.

Local and systemic adjuvant directions.

For a fragile patient group like my tunnel. So we feel very bullish that we are the main vaccine and the baton with only that type of a bivalent arnolds strong data behind it.

Look very much forward to the Readouts.

Yes, Sir.

Operator, let's move to the next.

Caller please.

Your next question comes from the line of Colin Bristow with UBS.

Good morning, and thanks for taking my question and I wanted to say all the best to Frank.

So a couple of months on the business development front could you comment on how large a deal you would be willing to consider.

Is there a preference a multitude of assets or pipeline or some combination of the two and then just intensive disease spaces.

I'd be curious.

Good to hear how you view the rare disease category as an area of potential business.

Business development from here and then just a quick one on Covid.

Understanding your prior comments, but I just wanted to get a sense on what is the with the <unk>.

And 'twenty two and obviously these days have been put it essentially stockpile utilized which could subsequently impact 'twenty three onwards, thanks a lot.

Thank you very much Oh, why don't we started with the BD question since I will ask Amir market to.

To speak about it.

Thanks for your question on our BD focus I think we've been very clear that compounds that have the potential to be breakthroughs is where our focus has and these can be in the form of late stage clinical development that can be an earlier medical innovations as well as well as early launches.

We're gonna bias to the Tas, where we have a scientific and commercial expertise because we can add value.

Can be flexible on deal structures and on your question on size, we've been very clear in the past that we're agnostic to size, but we're not going to focus on deals where cost synergies are the primary source of value creation and a focus on deals where we can add value scope to have impact and where there's times to be revenue impact.

On the 25% to 30 time period, so that is our current focus.

Thank you very much.

Cycle multiple times it is important to see.

<unk> as a partner of choice. So it is important to see Pfizer is the company that can add foggy view.

Either by acquiring or by partnering molecules with companies to the same extent, though to have proven with other biotechs.

We can provide benefits to patients by putting our capabilities into work and thoughts I think it is the way moving forward and clearly we're focusing on.

Filling the gap between 25 I'm sorry.

Started this call again, I'm, making myself, making comments, we reiterate the three prime broker.

<unk> of our risk adjusted revenues with analyst expectations for the year trying to set up and we feel that.

We are moving.

As per plan, let's say vertical now, let me turn to Andrew to speak a little bit about.

Scrub it and.

The question about is that a risk.

The Congress repurchases, we must be July August .

Yeah.

So I think when you think about.

Our contract in what has been purchased and we also think a lot about demand.

Generating demand and utilizing.

And I think that the U S gives us a good example of what you can see when utilization and adoption picks up you had somehow this opening presentation.

In the last few weeks, we saw a prescription capex low risk growth.

<unk> and just in one week alone.

It got as high as 80000 prescriptions.

And you also heard that there are 30000 sites that are available now in the U S.

<unk> talked a little bit and that has increased.

Deep dive to those test between sites, which let me 1100 at the beginning of April and now have doubled since 2000.

And then you add upon that the U S government announcements around.

There their focus on increasing more sites all of this is showing.

Showing momentum around tax a little bit is beyond and that there are a few sort of like key levers that open up.

One is the number of sites and our proximity to patients and to its the education around how to use tax Logan.

Ah patients that are eligible.

And so when you think about what has happened in the U S. Now are beginning to see that happen around the world as well.

We see that demand is increasing are you heard Albert speak about how countries that have purchased from US are now coming back with Reorders, you're also seeing across many countries how they are changing.

Ability for criteria for Copaxone as well as.

As well as a number of sites with tax low that can go can be yeah.

Much like what we're seeing here in the U S.

So I think when you add all of this up.

What we are seeing is the fact that there is demand for this product.

We also see that the social.

The removal of the math mandate, the social distancing requirements that had been removed. You'll also note that Andy is that just in the last week.

Emergency.

Jesse period off the EUA that means that people are going to get out there. We know with all of that infections are going to increase and that's the role that passionately complaint.

We are intently focused on working with national governments state governments.

And and helping them to educate to take great lessons learned from around all the different countries to help them to utilize tax loaded and importantly, what we're also seeing is that it's not as you know we don't have any inventory at hand every dose that we produce is being shipped out and is being recorded.

So I think all of these give us in a lot of confidence that there is a demand for pets little did we know what we need to do to support the utilization of <unk> and will continue to drive that throughout the year as we anticipate further surges that COVID-19 infection.

And also what the Angela said I want to reiterate that unlike what we have seen with the partnership vaccines. The government's worth trying because of lack of manufacturing capacity.

Bill stocks right now the orders.

Our August not for the entire year, where orders or the immediate needs of our confidence and this is why we have received orders of Congress that's across basically all Congress what they see.

Nationally.

Okay. Thank you very much let's move to the next question. Please.

Your next question comes from the line of Carter Gould with Barclays.

Great Good morning, and best of luck.

Post Pfizer endeavors.

I appreciate all the color on Pax look right there may be moving to.

The pipeline in highlighting here you see franchise. The slides you focused on smart and notably didn't mentioned you tell when a program has your enthusiasm there shifted now that you have the induction data in house and on the Iraq for side I saw the discontinuation in Hs has that changed in any way, how we should think about development.

I believe that got removed from your early stage readout.

Thank you.

Very much Carter, Michael Florida Yours, Yeah, you know I did speak about <unk> creates a very rounded and comprehensive pipeline.

I think the Tijuana 90 days that we have in our hands and it would be I Chad earlier at <unk>.

This earnings call and some of it is very strong.

Actually.

To the best of my knowledge in the biomass market selected group, it's probably the strongest or among the very strong growth there.

I have seen.

I think it can be a very much complementary.

Roger to address some odd.

And we also know that the tier one a principle not just its anti inflammatory but also play a role in fibrosis.

We didn't have much time to speak about <unk> beyond.

Our.

Real exciting data that we shared in vitiligo. We also have additional in summit inflammatory drugs that are coming to readouts with strong data behind them for potential start the pivotal.

Such as in different base in the inflammatory muscle diseases.

So I would just say we have the <unk>.

Vantage of a richness now of inflammatory drugs and really building a pipeline with complementary approaches and we hope to share more which are the ones that will be kicked off soon us from the many options that we now have in our hands, but still want a clearly a very active drug.

Thank you next question please.

Your next question comes from the line of Andrew Baum with Citi.

Thank you a couple of questions. Please.

Firstly, Pfizer as a leader in cardiology thrombosis and hemostasis.

Four of your competitors have actually <unk> inhibitors in clinical development, there is still significant unmet needs.

In thrombosis, despite and they'll ask I'm curious as to why you've passed on the opportunity and what data would make you change your mind to review your decision and then the second question is going back to the barriers to pack flavored adoption that have existed historically, you've addressed addressing the access barriers in terms of.

Physician education, and holding back prescribing because of fear of supply patient awareness, how would you delineate the percentage contribution of those to the current under utilization of <unk> and what do you think are the timelines for knocking down the separate recent thank you.

Thank you.

Michael why don't you take that kind of the <unk> question.

Yeah first of all.

We think the breakthrough.

With <unk>, they know us well so dramatic.

For patients and physicians from warfarin, which are you know had many issues of significance, including a very complicate the dosing and risk for bleeding.

While we monitor new drug classes, including the one that you ever mentioned, we really want to see a similar step up in breakthrough potential as we saw with the illiquid and.

We haven't yet been convinced about that step up but we are carefully monitoring and.

Internal medicine in cardio metabolic diseases.

It's an area that we think are very interesting and you of course heard us speak about roughly one is another very important Rosario.

And then Angela what about the education with a plan to do it alone or with a <unk>.

Governments to address other barriers of backlogs like the perception, but these are variable or others.

Andrew spoke about.

Well education is key and it underpins.

The promotion of all of our products, but I think the first comment I have to make is that you will know.

Hey.

And this EUA, where really we are limited by what we are allowed to talk about and.

And also limited by the level of promotion that we typically deal and that's why you see that much of the education that is occurring right now is coming from the government, whether that's a C D C or at the state level state departments of health and how they how they chose the messages regarding.

You know anti viral treatment of course, we're supplementing that by what we can do.

Public service announcements out there we've utilized our field force in the <unk>.

Appropriate way to convey what we're able to through an EUA and.

There is a just a significant amount of medical education as well that we are doing again also in an EUA appropriate way to support our brand.

Of course, this doesn't look anything like what we would typically do if we had a full commercial launch where we would have.

We would have the ability to really deploy the entirety of our promotional engine towards education and towards support offer patients and physicians.

So I would say that the education is happening and we are doing our part.

I think that there is a lot more that can be done.

The second part of your question was also around how much how much does this contribute to the bigger issue and I wanted to say that I truly the ability to access. This product quickly is one that even though it's been great improvements I think that there's still a long way to go even with all the improvements that we've had.

We're still a fraction.

I would say on behalf of all the possible retail locations, where tax law, which could be found.

It's tremendous that we're seeing this uplift, but I would say that we need to continue on the path of where we've been and continue to do more because there's still a lot more that can be done.

Thank you Angela and of course, I won't reversal forever Andre.

But also remember seeing the government being so occupancy.

We really believe that.

It is the way to control hospitalizations and deaths and we see that their own educational campaigns our work.

Grocery foreseen.

As a tenfold decrease asking a few weeks and both of them together with all the measures that they're taking.

I think.

It will yield even more impressive results.

Let's go to the next.

Question. Please.

Your next question comes from the line of Chris Schott with J P. Morgan.

Alright, great. Thanks, very much just a traditional <unk> ones.

This question of kind of contracting it seems like we saw a lot of activity late last year early this year, but it's been a bit more quiet I guess more recently on the contracting front so.

No youre expecting more contracts for packs love it but just qualitatively can you just give us a sense of how broad of a swath of the market has already entered into contracts theyre going to satisfy demand. This year relative to how large of a portion of I guess, a realistic global market are still in negotiations and still need to come up with some agreements necessary incentive.

What is the Tam look like versus what's been contracted.

Secondly, just one on <unk> was there seems like there's been several data points of kind of <unk> I guess like kind of COVID-19 rebound occurring in some patients is that something youre seeing in your data and just how you're thinking about it kind of addressing that as we kind of learned more about the longer term outcomes in some patients there. Thanks so much.

Thank you very much Chris excellent question, Angela what about our contracting.

Well I have to say that I'm really pleased with how our contracting hasn't gone you heard Albert talked about 100 countries.

Engaging with and.

Actually compared to where we were last last quarter, we've made some really nice.

Michigan.

Progress in terms of the number of countries just to give you a sense, we've actually and when you think about the 22 billion in guidance plus the 500 that we're after.

Moving from foreign exchange when you think about that part of revenue.

It really consists of countries that we have finalized contracts with as well as countries that we anticipate to close them.

And to anticipate to close shortly.

Sort of two buckets of countries.

But I'm happy to say is that.

Compared to where we were in the first quarter. We are three times larger in terms of the number of countries that are actually on.

Contract. So that's a good thing.

But in addition to that we have bilateral that's either been completed or about to be completed with 60.

With 60 country and that doesn't count a multilateral agreement.

The agreements that we're also having you've heard about UNICEF earlier today from Albert we have others as well.

So I think when you think about the total addressable market as you say.

Think that we are we are not done, but we have come through a large proportion of that and that gives me great confidence in our ability to meet the guidance.

We provided you.

And also I want to reemphasize, what it's worth is different.

<unk> complex, which.

We signed that contract.

We've typically they start with smaller volumes and then they keep ordering and reordering is very important to have the legal framework, so where the conflict in order first.

You have done there.

Our ordering based on their needs rather than based on demonstration to build stocks.

That also by itself. So we have a signed contract do you expect more because there is an offer of the cover or the whole year, but of course will depend on the UCITS or in the field, we are optimistic, but we need to see how big your sits in the field will go.

William.

You want to take very Kobe rebound.

Sure. So we take very seriously in the case reports.

Had been anecdotal so far in terms of potential rebound in September investor.

Excellent.

To respond to that we've taken some preliminary look at our epic high risk data.

And so we've seen for example that we have.

About an incidence of about 2% of that viral load rebound, but.

But we also see the same or close to the same percent in the placebo arm. So its something thats not particularly associated with back slowly, but may have something to do with the virus itself.

We've also looked for patient characteristics and potential recurrence of severe symptoms and we haven't seen any association with patient characteristics or.

Severe symptoms developing in these patients who rebound.

And then finally, we haven't seen any association with mutations in the <unk>, which is the target.

So its preliminary data so far we again take it very seriously but.

Cutting into very low incidence and.

We continue to learn as we go.

I mean, that's where I think.

There was a very.

Good day response wheel, so I'll just add as we do our surveillance of patients in very large databases and we have access to more than 300000.

<unk> treated in one of the databases, we have reports of this happening in less than about <unk>, 5% or less which is less than one out of 3000 treated patients. So.

Overall, it's a quite uncommon.

But as we spoke about it it's not really related to pick slowly but more to the individuals starting then needs to clear the virus and it is a virus that can either reinfect patients order can be reservoirs are left in the patients.

Now what we also learned is that for some patients immuno compromised. They may carry this virus for very very long time.

And we see that the area as a real new opportunity growth area for park slope to do very well.

You may need to take multiple quarters over a year or even <unk> with extended duration and that's something we're now planning to study in order to expand the use of <unk>.

Whereas maybe the most appropriate and life saving drug.

And as Michael said, the work of our exposures to reduce viral load and so as a result.

Buddy and overcome the disease faster and without serious consequences.

It could be that in some cases, there's any problems as well as far as the label speaks about the second treatment, but it can be given.

Also under the thing.

By reducing essentially in all these cases are formidable.

So what we did was they were supposed to do which is reduce device because they became negative. So then they came back.

I can only imagine.

Without.

What would be the clinical symptoms of the patients, but the restaurant is coming back so because don't forget that this is for people that they are already sick and we help them go easy with a disease easier them without a control with them so far as servicer working extremely well, let's go to the next question. Please.

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

Hi, I have a couple of questions <unk> 'twenty in pediatrics.

Important franchise piece is 75% of current usage it looks like the readout of your pizza trials has slipped from first half second half.

I'm wondering if you can explain why.

That impacts your confidence in the readout at all.

Question, your Biosimilars or growing your press release mentions interchangeable with Humira.

We have no real precedent with part D biosimilars.

In the U S. My view has been that Abbvie is going to hold onto more share than what <unk> been guiding for but as youre on the other side of this I'd love to get your perspective, I know youre launches a year away, but what are your expectations for uptake in the U S for Biosimilar humira, whether it's yours or anyone else's and how do you think that will compare.

<unk> to what we've seen with Biosimilars with part B drugs like Avastin.

Thank you Michael for Iraq, Brenda Yeah, you know, it's a very minor shift.

We're predicting earlier mid of the year and we now see it will come in the second half.

Not too far away from our original prediction is what I believe and it was just affected by Covid.

<unk>.

The ease of which we could get infants.

Vaccinated so overall.

On track for a readout.

We had a very good readout with adult I have no reason to believe that we won't have also very good performance in the clinical trial or the pediatric or.

Okay about the uptake or Biosimilar humira.

Alright.

So we are we are optimistic about the uptake.

And I think we've learned a lot over the last several years and you look at our experience with <unk> you look at our experience recently with our six biosimilars in oncology and there's just.

Tremendous market share.

I think that physicians and institutions have become extremely comfortable with the use of biosimilars, if I compare I experience with inflexible and that was the launch of Infliximab and I compare that to what I see now with the six Biosimilars. We just launched an oncology very different experiences in terms of willingness.

Uptake and contract book position tickets.

So I think we're very far from where we were when we first launched our first biosimilar here in the U S that coupled with the interchangeability data should mean that we would be able.

To gain you know.

Their market share.

Thank you next question please.

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

Hi, This is Alex on for Geoff Meacham. Thanks for taking our question maybe just following up on a previous of thought what's the type of a capacity like to what extent the extent is that essentially constrained by any limiting factor there in terms of production obviously distribution in other words it's.

The contracts are there to what extent do you think that could address the near term and then can you maybe comment on the pace of business development and you think about some of your longer term growth targets and where you sit now.

Are you still comfortable with the current trajectory. Thank you very much.

On the extraordinary capacity.

We are plant. So we will make 30 million treatments available this year excuse me this.

June the first half of the year.

We have already built our capacitor can make under the $20 million.

The end of the year I don't think given.

It's very high ramp up.

Capacity will become a limiting factor through governors to place orders in any way there as we receive we don't have situations that they are placing orders that they are keeping their warehouse or they're placing orders. So that they can use it so it's always manageable.

Reordering and we will be able to meet this demand for big revenue are really cognizant of that.

Waves are coming so far not necessarily in terms of <unk> Suisse.

Seasonality, but everybody is expecting.

When does it come after must governance into summer or as we are entering into the flu season that would be let's say dramatic uptake so in that period.

But we have really a look.

Oh for <unk> product available, so I don't foresee any.

And then on the what was the second patient business development.

So from a business development.

Maybe you want to take that sure Alex. Thanks for the question you heard Albert very clearly reiterated our commitment to the 25 billion and risk adjusted revenue by 2030, and we fully believe that we can and we will get there.

We're going to be very active in BD and that also means being thoughtful and thorough and disciplined so when we see a great opportunity, we're not going to hesitate to move fast and I think some of our recent deals are good examples of that and our <unk> acquisition is a good example of our first move towards that goal and at the same.

Time, we're not gonna be hurried or Cavalier.

For the sake of doing deals quickly. So we will move fast we will be thoughtful we'll be disciplined and we are very confident in.

The aspiration that we put out.

And I want to once you work through today.

We certainly think various substrates to do good deals that will provide us flexibility and reduce congestion, but we are going to be very disciplined.

We can accomplish them.

<unk> bye.

We accomplished all of them.

Oh compromising on the financial returns of our expert and we truly feel.

We can accomplish both Andrew will accomplish of course in the next few years, we need to do to complete this activity shows up we will be able to have a <unk>.

Impacting the 'twenty five 'twenty certainty a theater the fact.

Right right.

Substrate.

The good deals and we will do and.

It looked like only.

Good.

$25 billion by 2025 driven by brands.

You said $30 million.

$25 billion by 20 vessels.

Okay.

So let's go to the next question.

Your final question comes from the line of Robyn <unk> with <unk> Securities.

Hey, guys. Thanks for taking my question. So just first unpack a little bit contracts you'd mentioned that there's a bucket of contracts where you're further away from signing can you just give a little bit more color on.

What's the rate limiting steps are for signing in those countries are signing those contracts are they in areas, where there's less infection for example.

And then second on the booster just a follow up question. It seems like Theres a lot of debate about how long the immunity last with the boosters and so how far away do you think we are scientifically from a longer asking longer.

Last thing mrna booster.

For Investor questions.

What about or the contracts.

So theyre not infection related it literally is just time.

We have many countries to get to and each one of them have their own internal process to that.

They need to come through so there really is nothing here other than just getting through at that time.

Thanks, John So on the let me make up for some final comments because you don't know all the time.

Those will drive lots of Ottawa.

Clearly COVID-19 it is uncertainty for the world and for which the Companys true.

Trying to read through.

To make a difference with call it.

But I think we don't know the future, but there are some scenarios in there are the more selective I believe are the most likely scenario that you should be seeing right. Now it is the virus will be around the virus.

Your faith.

As we know about the characteristic of this virus.

The mutations doesn't produce long lasting immune protection I'm, telling me flu vaccinations, a bushel through natural infection people getting sick they were gift seeker, breaking that can get against sick.

With different or with a safe very novak on for some time.

Second thing that we know is this vote.

Sure.

The social distancing measures.

One of the main way to control the disease spreads in the first few years of the conversion of the pandemic.

It is happening because now.

Do habits III.

And which they can counsel that can release, let's say the measures. They are not escape the guidance before to see overwhelming cost results.

You described it because the societies are pushing product. So there is a tremendous pressure across the world to get our large park.

The result of all these things.

Very clear.

We will have waves.

We will be more and more we're gonna be affecting people and before varco in April have crossed them vaccination compliance with a explanations and that in fact is true.

Right now people it's clear.

Skeptical.

And vaccines, but it's not clear if it will be maybe to take another one and another one.

Apart from the repeated pushed up so.

It is extremely important to come to a vaccine could.

Could be a year reduction.

So that is not secondary ease towards it but we are.

Having vertical scientifically it somewhat so we are working on that so when it comes to vaccines. I think this is what this will be the next steps to be able to stay ahead of the borrowers, which we are in terms of a venue a variance, but also trying to grow for the next generation that would be a year of production.

And of course, when it comes to the treatment, we need to make sure that we go with the manufacturing and the availability because the UCITS. Unfortunately.

Expect that Nathan.

Unfortunately, I think we will increase.

We are moving to less social distancing measures.

The salary of it so that's how I will just answer the booster question in terms of a long acting booster.

And I want also to thank you everyone.

For today's call.

We are we are seeing very strong signs of increasing demand for books, Florida.

Remains one of the vessels reserve I'm proud to have been able to recruit some of the best and brightest external minds to add to our talented roster of people I'm proud that we have remains the most patient centric company based on feedback from Morgan 2000 patient organizations and associations, It's a testament to the important and innovative work out.

According to do every day in pursuit of our purpose and I wont close one smart thinking Frank.

About the tremendous contributions and his friendship to not only meet but many of our executives at Pfizer and wish him well.

After Pfizer alive, although as you said you Didnt mentioned, a major shareholder so she would be attending or everything thats happening here with a lot of progress. Thank you very much everyone.

Yeah.

This concludes today's conference call. Thank you for participating you may now disconnect.

[music].