Free Trial

Pfizer Q1 2023 Earnings Call Transcript


Listen to Conference Call View Latest SEC 10-K Filing

Participants

Corporate Executives

  • Christopher Stevo
    Senior Vice President, Investor Relations Officer
  • Dr. Albert Bourla
    Chairman and Chief Executive Officer
  • Dave Denton
    Chief Financial Officer and Executive Vice President
  • Mikael Dolsten, M.D., Ph.D.
    Chief Scientific Officer and President, Worldwide Research, Development and Medical
  • Angela Hwang
    Chief Commercial Officer, President, Global Biopharmaceuticals Business
  • William Pao, M.D., Ph.D.
    Chief Development Officer, Executive Vice President
  • Aamir Malik
    Chief Business Innovation Officer, Executive Vice President

Presentation

Operator

Good day, everyone, and welcome to Pfizer's First Quarter 2023 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stevo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

Christopher Stevo
Senior Vice President, Investor Relations Officer at Pfizer

Thank you, Chelsea.

Good morning, everyone. Welcome to Pfizer's First Quarter Earnings Call. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; and Dr. Mikael Dolsten, President of Worldwide Research and Development and Medical. Joining for the Q&A session we will also have Angela Hwang, Chief Commercial Officer and President Global Biopharmaceuticals Business; Amir Malik, our Chief Business Innovation Officer; Dr. William Powell, our Chief Development Officer; and Doug Lankler, our General Counsel.

Before we begin the call, I want to remind you of some logistical items. The materials for this call and other earnings-related materials are on the Investor Relations section of Pfizer.com. Please see our forward-looking statements disclaimer on Slide 3. Additional information regarding these statements and our non-GAAP financial measures is available in our earnings release, in our SEC Forms 10-K and 10-Q under Risk Factors, and Forward-Looking information and factors that may affect future results. 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 these statements.

With that, I turn the call over to Albert.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Chris. Hello, everyone, and thank you for joining us today. Q1 was a solid foundational quarter, in what we expect to be an exciting year for Pfizer and patients. Our financial results were as we anticipated. Our non-COVID revenues grew 5% operationally compared with the year-ago quarter, while overall revenues declined 26% operationally, primarily due to a previously communicated and expected decline in Comirnaty revenues.

Even with Comirnaty's decline, our COVID franchises remained significant contributors to the business with a combined $7.1 billion in revenues during the quarter. This growth was driven primarily by recently acquired products, Nurtec for migraine and Oxbryta for sickle cell disease, our anti-infective Sulperazon, Eliquis, in the non-valvular atrial fibrillation indication in the U.S., and our Vyndaqel family of products for the treatment of transthyretin amyloid cardiomyopathy.

We also continue to be proud of our patient impact. During the first quarter, more than 250 million patients were treated with our medicines and vaccines. With this solid start to the year, we remain on track to grow our non-COVID revenues by 7% to 9% operationally in 2023. That's because the majority of our potential near-term product launches, as you can see mapped out on this slide, are expected to occur in the second half of the year, following regulatory approvals where not yet secured. As such, we expect our non-COVID revenues to grow at a faster rate in the second half of the year than in the first.

Overall, we are in the midst of an 18-month period in which we expect to launch up to 19 potential new products and indications. Over the first four months of the year, we have made excellent progress toward this goal with the approval of Zavzpret, an expanded indication for CIBINQO to include adolescents, and last week's approval of Prevnar 20 for pediatric use, all in the U.S. We also have secured regulatory filing acceptances for elranatamab, for Braftovi and Mektovi for non-small cell lung cancer, and for our RSV maternal vaccine candidate, which if approved would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months.

In addition, the U.S. Food & Drug Administration has granted priority review and the European Medicines Agency has accepted our MAA filing for review of Talzenna for use in combination with XTANDI for patients with newly diagnosed metastatic castration-resistant prostate cancer, based on the TALAPRO-2 results.

Regarding our COVID-19 franchise, we continue to expect 2023 to be a transition year as the virus continues to mutate and we move from advance purchases under government contracts to more traditional supply arrangements in a commercial model for both Comirnaty and Paxlovid in the U.S.

As previously discussed, in 2023 and 2024, we expect vaccine utilization to decline compared with 2022. Then starting in 2025, and continuing in 2026 and beyond, we expect to see an increase in COVID-19 vaccination rates, assuming the successful development and approval of various COVID combination vaccines. Outside the U.S., we expect these general trends to be similar, with some variations from country to country.

Regarding Paxlovid, we continue to expect the government inventory that was built around the world last year to be absorbed by the end of this year. We then expect that in years 2024 and beyond, the courses sold and courses used will more closely align. With its robust efficacy, consistent safety profile, and potential to help mitigate the burden of COVID-19 on patients and their families, health systems and society, Paxlovid is proving to be an important and durable complementary tool to vaccination strategies for the estimated 40% of the global adult population at high risk for progressing to severe disease.

Now, let's take a look at Pfizer's next potential moonshot: the battle against cancer. Oncology remains a core therapeutic area for Pfizer, and we believe the proposed acquisition of Seagen will enhance our position in this important space. Integration planning is already underway, and we continue to expect the deal to close in late 2023 or early 2024, subject to the satisfaction of customary closing conditions.

By combining Seagen's category-leading antibody-drug conjugate technology with Pfizer's scale, expertise and capabilities, we believe we can accelerate potential breakthroughs in cancer medicines and introduce new solutions to patients around the world. The potential combined commercial infrastructure for Pfizer and Seagen will be three times the size of that of Seagen alone in the U.S., and four to five times larger globally. As a result, we believe acquiring Seagen could contribute more than $10 billion in 2030 risk-adjusted revenues, with potential significant growth beyond 2030.

Even with the Seagen deal, given the strength of our balance sheet and cash flows, we continue to have the flexibility to take additional actions to create shareholder value. Dave will provide more details on this during his presentation. One of the key areas of focus for Pfizer in 2023 is continuing to build trust, which is a key asset for every biopharmaceutical company. Since the beginning of the year, we have received two accolades that demonstrate we are doing just that.

In February, Pfizer was named to the top 10 of Fortune's Most Admired Companies List for the second year in a row. And in March, Ethisphere recognized Pfizer as one of the world's most ethical companies, also for the second year in a row. At Pfizer, trust is everything. It gives us our license to operate, allows us to attract the best talent and enables us to deliver breakthroughs that change patients' lives.

With that, I will turn it over to Dave. After Dave, Mikael will provide an update on R&D pipeline. Dave?

Dave Denton
Chief Financial Officer and Executive Vice President at Pfizer

Thank you, Albert, and good morning, everyone.

I want to begin with Pfizer's capital allocation strategy before we dive into additional commentary about our quarterly performance, and importantly, our outlook for the remainder of 2023. As you know our strategy includes three main pillars: reinvesting in our business; growing and paying dividends; and repurchasing our shares.

In the first three months of 2023, we've invested $2.5 billion in internal R&D and returned $2.3 billion to shareholders via our quarterly dividend. And importantly, allocated approximately $43 billion for the proposed Seagen acquisition.

Over the last few years, we have reinvested heavily into our business to drive long-term growth and enhance long-term shareholder value. We have invested in Pfizer's own science, while acquiring the best external science to supplement our pipeline. Since 2022, we've invested approximately $70 billion, including Seagen, in business development.

In addition, we have continued to grow our dividend. For the past 14 years, we have raised our dividend annually. Since 2010, our quarterly cash dividend grew from $0.16 a share to $0.41 a share in 2023. Looking ahead, as we exit this unprecedented period of anticipated launches, we would expect to achieve operating margin improvement over time.

As we begin to de-lever our capital structure after the closing of the Seagen transaction, we expect to return to a more balanced capital allocation mix between our three pillars. While we will continue to invest in our business, we do expect more balance between that priority and returning value to our shareholders via increased dividends and value-enhancing share repurchases.

Our capital allocation strategy is squarely focused on driving shareholder value while at the same time remaining committed to a high investment grade, Tier-1, commercial paper rating. Now turning to the quarter. As Albert said, our results were in line with our expectations, albeit slightly better than consensus. As expected, overall revenues declined 26% operationally, primarily driven by the anticipated decline in Comirnaty, which was partially offset by strong Paxlovid sales.

I want to point out that our COVID-19 products produced $7.1 billion in revenues in the first quarter alone. Our non-COVID operational revenue growth was solid at 5% year over year. Primarily driving this growth was the inclusion of Nurtec ODT and Oxbryta, and an increase in Sulperazon revenues in China. Revenues for Eliquis in the U.S. and the Vyndaqel family globally also contributed to this growth.

Now, I want to remind you of the seasonality of some of our products. In the first quarter, Nurtec ODT and Oxbryta typically have lower sales quarter-on-quarter due to annual copay reset dynamics, with higher sales anticipated in latter quarters. Most important, both products continue to experience strong growth in demand.

Sulperazon revenues increased more than $100 million year-over-year, due to higher demand in China during the quarter, which we do not expect to be sustained going forward. The demand was due to increased bacterial infections from patients being hospitalized for COVID. To help ensure the success of the expected launches of our large number of new and acquired products and indications, we increased our investments in SI&A. These investments are squarely focused on Pfizer's 2025 to 2030 growth aspirations.

Now, moving to the bottom line, reported diluted EPS this quarter declined by 29% to $0.97 a share, while adjusted diluted earnings per share of $1.23 declined 20% on an operational basis during the quarter. Once again this quarter, foreign exchange movements significantly impacted our results, reducing first-quarter revenues by $730 million, or 3%, and adjusted diluted earnings per share by $0.07, or 4%, compared to LY [Phonetic].

Now, turning to the full-year financial outlook for the company. Our full-year 2023 guidance remains unchanged. On a total company basis, we continue to expect revenues of $67 billion to $71 billion, reflecting an operational decline of 31% at the midpoint. With 5% operational growth in our non-COVID revenues this quarter, we are on track to achieve our non-COVID revenue guidance of 7% to 9% operational growth for the full year. Given that a large number of launches are expected to occur in the third and fourth quarter of 2023, we anticipate our quarterly revenues will not be linear this year, and that our non-COVID revenues will grow more quickly in the back half of this year versus the first half of '23. In terms of our COVID products, Comirnaty and Paxlovid, we expect sales to trend more seasonally this year. Given these dynamics, we expect significantly lower sales contributions from our COVID products in the second quarter versus the first quarter.

In fact, given the anticipated timing of approvals for a fall vaccine with strain change, we would expect more substantial vaccine deliveries to start in September, which is late in the U.S. third quarter and the beginning of our international fourth quarter.

With respect to Paxlovid, we continue to expect 2023 to be a transitional year as we anticipate shifting to a commercial market in the second half of this year.

We are reaffirming our Adjusted diluted earnings per share guidance range of $3.25 to $3.45 per share. On a full-year basis, we expect that foreign exchange will have an unfavorable impact compared with full-year 2022 of approximately $0.13, on Adjusted diluted earnings per share. We are also reaffirming the remaining components of our full-year 2023 guidance, which you can find in the Appendix of the Q1 '23 earnings presentation.

So in closing, this is an exciting period for Pfizer as we continue to invest to drive long-term growth and importantly enhance long-term shareholder value. With that, now let me turn it over to Mikael.

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Thank you, Dave.

Today, I'd like to start off with one of the four pillars of our oncology portfolio, which are breast, urogenital, blood cancers and precision medicine. Within urogenital, prostate cancer is an area in which we have strong momentum. Recent positive study results further strengthen our franchise, building upon the global standard of care set by XTANDI, and underscoring our long-standing commitment to the pursuit of breakthroughs that define new standards of care in prostate cancer.

I'll highlight data from two Phase 3 studies: EMBARK and TALAPRO-2, as well as early, but promising signals from our EZH2 inhibitor, each of which has the potential to reach broader patient populations across the treatment continuum in prostate cancer. Final analysis from TALAPRO-2, evaluating our potential blockbuster PARP inhibitor TALZENNA in combination with XTANDI were presented at ASCO GU. Results showed significant and clinically meaningful improvement across the all-comers population in radiographic progression-free survival, or rPFS, in men with metastatic castration-resistant prostate cancer, with or without homologous recombination repair or HRR gene mutations.

There was a 37% reduction in risk of disease progression. Median rPFS in patients treated with TALZENNA and XTANDI was not reached at the time of analysis versus 21.9 months for placebo plus XTANDI. A trend in overall survival favoring TALZENNA plus XTANDI was also observed, though these data are immature. The final OS data will be reported once the predefined number of survival events has been reached.

Treatment with TALZENNA and XTANDI resulted in statistically significant improvement in overall response rates, which suggest a potential cooperative effect between the two treatments. The U.S. FDA has granted Priority Review for our sNDA for TALZENNA in combo with XTANDI for metastatic castration-resistant prostate cancer, with a decision expected in '23. The ongoing TALAPRO-3 study, if successful, may further expand the reach of this potential blockbuster into the HRR-deficient metastatic castration-sensitive population.

We recently presented data from our Phase 3 EMBARK study evaluating XTANDI plus leuprolide in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence at the American Urological Association's '23 Annual Meeting. The study met its primary endpoint with statistically significant and clinically meaningful improvement in metastasis-free survival, with a 58% reduction in risk for radiographic progression or death. Key secondary endpoints were met including time to PSA progression.

These results suggest XTANDI, the only novel hormone therapy approved for three disease states of prostate cancer in the U.S. has the potential if approved to expand to patients in the hormone-sensitive, or castration-sensitive setting, for the first time.

Next, I'd like to share early data from one of our next-wave candidates, a potential first-in-class and best-in-class EZH2 inhibitor, which we shorthand as 1497. EZH2 is an epigenetic transcriptional repressor that is frequently overexpressed in prostate cancer. We believe that inhibition of EZH2 may provide synergistic effects in combination with XTANDI, with the potential to address unmet needs of patients with androgen-sensitive and resistant disease.

Here are data from our ongoing Phase 1/2 study evaluating 1497 in second-line mCRPC patients with prior abiraterone and/or XTANDI, and up to one line of chemo. On the left are updated data from a Phase 1 dose escalation study shared at ESMO last year. These encouraging results show durable anti-tumor activity in both XTANDI-naive and -experienced patients, with all XTANDI-naive patients having received prior abiraterone. Importantly, this suggests that the addition of our EZH2 inhibitor has the potential to sensitize XTANDI-resistant tumors, which is an increasing clinical unmet need.

The early rPFS data are also highly encouraging, reaching 8.7 months in the XTANDI-experienced and 17.1 months in XTANDI-naive, both of which are notably longer than historical controls. For example, in the control arm of the CARD study, rPFS for XTANDI alone was only 4.8 months in XTANDI-naive patients.

And although cross-trial comparisons cannot be made, these results, in combination with the emerging objective response rate and PSA50 response, are supportive of the contribution of our EZH2 inhibitor candidate in driving these responses. From a safety perspective, the combination was generally well tolerated, with mostly Grade 1 and Grade 2 events. The randomized Phase 2 study in second-line mCRPC is ongoing, with data expected in early '24.

Now, we turn to the potential for near-term growth across our respiratory vaccine franchise. Prevnar 20 or our 20-valent pneumococcal conjugate vaccine, is now approved for children aged six weeks through 17 years. We are confident in our ability to maintain leadership in the pneumococcal vaccine space with Prevnar 20, which offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against the 20 serotypes in the vaccine.

We have strong momentum with our RSV vaccine candidate, having received a positive VRBPAC [Phonetic] Committee vote supporting potential approval to help combat RSV in older adults and PDUFA dates for our older adults and maternal indications in quick succession in the coming months. And just last month, the New England Journal of Medicine published results from the two positive Phase 3 studies. Emerging data from the middle of the second RSV season in the Northern Hemisphere in the Phase 3 older adult study support meaningful durable vaccine efficacy; we will share the data once complete.

In the coming months, we plan to start a Phase 3 study of the RSV vaccine candidate in 18-year-olds to 60-year-olds at high risk for RSV and in immunocompromised adults 18 and over, and a Phase 1 study in two-year-olds to 18-year-olds at high risk, with the potential to expand broadly the reach of our vaccine candidate both to those aged 18 to 60 with high-risk conditions as well as to pediatrics and adolescents.

Our RSV-Flu coadministration study met its primary endpoint, demonstrating non-inferiority for all four flu strains and the RSV A and B strains. This suggests the RSV vaccine candidate, if approved, could be co-administered with flu vaccinations and add an important component of seasonal protection against respiratory pathogens.

Finally, the FDA recently updated the EUA for our Omicron BA.4/BA.5 [Phonetic] bivalent COVID-19 vaccine to enable those at high-risk of severe COVID-19 illness, including the elderly and immunocompromised, to partner with their healthcare providers to be proactive and in helping them to protect themselves against COVID-19. We anticipate another update from FDA in June that will provide guidance on COVID-19 vaccine strains and vaccination timing for the 2023 fall and winter seasons.

Beyond vaccines, antivirals are an important component of our strategy in respiratory viruses. Here we share data for the first time from our second-generation oral COVID-19 antiviral candidate, a potent and selective SARS-CoV-2 Mpro inhibitor that is currently in Phase 1.

We designed this candidate to achieve clinical exposure that would have similar anti-viral activity to PAXLOVID but without the need for ritonavir boosting and with the potential for reduced drug interactions. Early results from Phase 1 dose escalation are encouraging, with no dose-limiting safety or tolerability findings. Dosing achieved concentrations many-fold over in vitro EC90 and is therefore expected to have similar antiviral activity to PAXLOVID.

On the right are preliminary results from a Phase 1 pharmacokinetic study of midazolam drug interaction, which is a well-known standard for indicating CYP3A4-mediated drug-drug interactions. These data show there is a lack of such drug-drug interactions, suggesting there may be no related restrictions of co-dosing with drugs metabolized by CYP enzymes.

Based on these encouraging data, we are planning to advance to a Phase 2 dose-ranging study in the first half of this year. In addition to the assets I spoke about today, we continue to make progress on the pipeline with more than 25 milestones recently achieved or anticipated through the first half of '24.

As an example: in inflammation & immunology, the FDA has approved our sNDA for CIBINQO, enabling a label expansion for adolescents with moderate-to-severe dermatitis. In internal medicine, ZAVZPRET, the migraine nasal spray has received FDA approval, expanding our migraine portfolio. Recently, the FDA Advisory Committee voted in support of PAXLOVID's favorable benefit-risk profile, with a soon PDUFA date in May.

In closing, we are very excited about the potentially transformative catalysts expressed across the pipeline as we work with continued urgency to bring breakthroughs to patients.

Thank you. Let me turn it over to Chris to start Q&A.

Christopher Stevo
Senior Vice President, Investor Relations Officer at Pfizer

Thank you, Mikael.

All right. Chelsea, please queue up the list for Q&A. We have at least 30 minutes for Q&A.

Questions and Answers

Operator

[Operator Instructions] And our first question will come from Umer Raffat with Evercore ISI. Your line is open.

Umer, your line is open.

Umer Raffat
Analyst at Evercore ISI

Hi guys. Apologies. Thanks for taking my question. I have two here, if I may, first your expectations on Cisplatin eligibles in the ev3 or ev2 trial, especially because it's so significant to the acquisition you're going down the track on?

And then secondly, based on my analysis of -- [Speech Overlap]

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Umer, can you repeat the question? I'm not sure we understood it.

Umer Raffat
Analyst at Evercore ISI

Sure. On the Seagen trial on PADCEV, EV-302, I know there's been a huge emphasis on Cohort K which is Cisplatin ineligibles. So my question is: this ongoing trial also has Cisplatin eligibles, which is two-thirds of the target population. What's your expectation there? Because it was -- I felt like it was not a coincidence, Seagen never showed any data disclosure from the eligibles Part A.

And secondly, for the guidance for the full year, I noticed there is perhaps a $1 billion or so worth of contribution from new launches and I'm just trying to make sense of that in light of the fact that these are going to be launches, sort of, in fall of this year. I realize it's an important drug like RSV, [Phonetic] elranatamab, but is it reasonable to expect $1 billion so early into the launch from those? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Yes, thank you very much. Angela, why don't you take the second question about the guidance, about the $1 billion estimate [Speech Overlap] sales in the last quarter?

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Sure. So from a launch perspective, I think the two big ones to look out for this year are our Prevnar 20 Peds and the RSV adult. And as you know, it goes through the typical ACIP process or recommendation, and then launches can really only happen, or commercialization, after the publication of the MMWR. So if you consider all of that, that puts us into fourth quarter, which is when Prevnar 20 Peds as well as when RSV older adult will actually be commercialized and revenue being generated.

And so, yes, we are anticipating that there's going to be a big bolus of revenue because, first of all, if you think about Prevnar 20 Peds, that is going to be a conversion from Prevnar 13 Peds, and Prevnar 13 today has a significant market share, right, in pediatric pneumococcals, 80% market share.

So we're going to be converting those, the accounts, the physicians, the inventory, all of that from Prevnar 13 over to Prevnar 20. And so if you look at I guess a good analog for that would be our Prevnar 20 adult launch which was the conversion of the Prevnar 13 adult launch, and there it went really well. Today, we have worked over 95% market share.

And then, of course, the second one is the RSV adult, and there it plugs into an already established commercial infrastructure that we've built around COVID, around Prevnar, around the Prevnar franchise, the adult franchise. It comes at a great time during the fall and the winter when vaccinations for season -- for respiratory vaccines actually increases. So there's a lot of reasons to believe why that fourth quarter's going to be a really big quarter for both Prevnar Peds as well as RSV adult.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Angela. On the question about the Seagen asset, although we should be very careful because we can't comment on that, but maybe you can make, William, a quick comment, generally speaking.

William Pao, M.D., Ph.D.
Chief Development Officer, Executive Vice President at Pfizer

Yeah, sure. I would say, we were just very excited about the recent approval in the first-line Cis-ineligible population which Seagen just got, which is about eight 89,000 patients in the US, and we're excited to see additional data coming in the first-line Cisplatin-eligible EV-302 study, which as you know is PADCEV plus pembro versus platinum gemcitabine. But we can't comment any further as that's Seagen study. And if that's positive then that would increase the eligible population by another 10,000 to 12,000.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Yeah, and no doubt, the population that excites us. But of course, we can't comment on Seagen's programs. Next question, please.

Operator

Our next question will come from Evan Seigerman with BMO Capital Markets. Your line is open.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

You there, Evan?

Operator

Evan, your line is open. The next question.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Chelsea, why don't we go to the next [Speech Overlap]

Operator

And we'll be moving to the next question. Yes, sir. Mohit Bansal with Wells Fargo. [Speech Overlap]

Keith Tapper
Analyst at BMO Capital Markets

All right.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

All right.

Keith Tapper
Analyst at BMO Capital Markets

Sorry.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Evan, go ahead.

Operator

Go ahead, Evan.

Keith Tapper
Analyst at BMO Capital Markets

Terrific. Thanks for taking our call. This is Keith on for Evan.

Maybe just shifting to M&A execution thinking about your recent acquisitions, with Nurtec and Oxbryta, you've done a great job describing the plans to add value, drive commercial and clinical synergies. We're seeing the outcomes on our end, could you comment on how this is going from your end?

And then could you talk about the specifics for operationalizing the same for Seagen integration and how this would differ from recent examples? That would be great. Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Again, Angela, back to you.

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Sure. Well, so we are incredibly proud of the work that we've done -- with by -- on Nurtec since the acquisition. As you know, in July of 2020 -- 2022, we had already begun a co-promote with Biohaven to ensure that we were co-promoting the product early. And I think that has really paid off. If you really look at what has happened from just leading indicators as well as actuals, today, Nurtech is the leading product in the oral CGRP class with over 47.5% market share. It is also the leading product when it comes to new-to-brand prescription share at a high of 46%. It also has the highest number of prescribers at over 110,000 prescribers, and 80% of new CGRP prescribers choose Nurtec.

So, I think we've demonstrated in the time that we've had it that we are able to drive performance and drive excellent education and awareness of the product. And we're seeing consistent great metrics as it pertains to Nurtec. And of course, the opportunity is huge, right, because now we have Zavegepant launching later this year. We also know that -- as a whole, there are over 1 billion migraine sufferers and only 18% of them are using CGRPs today.

So we have a great opportunity to expand the class of CGRPs, but specifically Nurtech.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Angela. Next caller, please.

Operator

Our next question will come from Mohit Bansal with Wells Fargo. Your line is open.

Mohit Bansal
Analyst at Wells Fargo & Company

Great. Thanks for taking my question. If I may ask two questions here. So on European negotiation just -- because there was some news this week, just how much can you comment on that? And the real question there is that, I know you -- when you provided guidance in the beginning of the year, you anticipated some of that. But so far has the negotiation [Technical Issue] any risk to the guidance as the negotiations had finalized in that?

And the other question I have is more about the -- your demand charge for Paxlovid in vaccination support. It seems like you are assuming both Paxlovid and vaccination utilization going up into 2024-plus timeframe. Would it be both demand going -- demand swing up or you think it would be either/or as vaccinations come down, probably the demand for Paxlovid would go up? How should we think about that? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Maybe I can answer those questions.

On the EU negotiations, they are still ongoing, so we can't comment on that. Yes, we had included part of -- yes, we had included our estimation of how this negotiation will end up in our guidance, and still we are not close. So I can't make any comment on that, it wouldn't be appropriate as the discussions are still ongoing.

As regards the demand for Paxlovid or for vaccines, as we had said, we expect that the demand for vaccines will go down. We gave estimations that it will go down to approximately 24% of people in the US, and relevant numbers are different country by country as underlying demand, that for boosters. And things, I think, our progression towards that goal, we will have to see as most of these will happen in the last -- after summer when it is the traditional period that Flu is, also vaccinations are happening.

Demand for Paxlovid right now is following very, very accurately the infection rates. So when we -- we monitor it on a weekly basis and really it is going one-third -- almost equal percentage of infections is equal percentage of the equation for Paxlovid then the -- so we expect that will continue going like that. And because we have less compliance with vaccination recommendations across the world, as people are tired with COVID, and we expect that fewer people, as I said, this year would get the vaccine compared to last year, and o this means that the immune protection of the equation will go down. As a result, we expect that we will have more infections and that will drive more use of Paxlovid.

But of course, that's what our logical models are telling us, we'll have to see what eventually will happen in real life. Thank you for your question.

May we go to the next question, please.

Operator

Next, we have Robyn Karnauskas with Truist Securities. Your line is open.

Robyn Karnauskas
Analyst at Truist Securities

Thanks for taking my question. Just two big-picture ones.

And just first on, for your Vaccine franchise, we think about the competitive landscape. A couple of things: what do you think is going to be the most important differentiation for you versus the competition that will drive the most uptake as people have different options? And have you developed any new LMP technology that might reduce the biggest pushback with the vaccines as people still stick still when they get them for some of your products?

And then lastly [Speech Overlap]

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Which product? We didn't hear which product you spoke about.

Robyn Karnauskas
Analyst at Truist Securities

I was just talking about the [Indecipherable] Vaccine franchise for RSV and Flu and COVID, thinking big-picture, and how you are differentiated? And what do you think it's going to be key because you're all competing to make -- to determine who is going to be the winner?

And the second question is there's the big proposal out of Europe for new legislation for drugs. And since you're launching all the new products in Europe, just wanted to get your thoughts on whether or not you think that legislation they hold or what kind of impact that might have?

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. And maybe I can give a very general answer. And then if Angela wants to chime in, please.

On the COVID, we are the winners right now, all right? We have the big markets there, and we plan to maintain that so I think we are there. When it comes to our RSV, we are the only ones, but we have both or we have positive data on both, on adults and on maternal, and we have already approval for the adults. And then we are expecting approval for the maternal. So that -- the strength of our data with efficacy and safety profile that we think is differentiated, will provide us with -- but we hope also to be the winners in that one.

The Flu on mRNA technology, till the jury is out, we are very optimistic with the totality of the data that we are having from our -- the Flu Vaccine. And we will wait to see, of course, how that we continue. And then of course, the winners will be also those that would be able to build a combination or follow that. So the fact that we have all three of them, or we have a good chance to have all three of them if the starts are successful and if the products are approved, of course, also provides a good differentiation.

In addition to all of that, I think the trust the Pfizer brand name, which has been very, very strong, I think also plays a key differentiator.

Now, as regards to the EU legislation that we have just seen in the recent days, we are noticing the positive things of EU trying to be more competitive in attracting research, and creating the regulatory framework for more rapid approvals. Clearly, we are also concerned at the same time with provisions that would like to reduce the exclusivity of data and other provisions. So we hope that there will be an open dialog with the EU so that we can create a framework that really will enhance innovation.

Angela, anything that you want to add to all of that?

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Maybe just to add to your question specifically about the adult portfolio, I really do believe that this plays into our sweet spot. Through the last several years, both from the Prevnar franchise for vaccinations -- vaccinating adults through our work in COVID, we've learned that the clinical profile is one thing, but you really need reliable supply; you need a commercial infrastructure; you need a great ability to educate, raise awareness and drive people to vaccination. And I think on all of those counts, Pfizer is a winner.

And so we look forward to having a growing and a very robust respiratory portfolio that really leverages off of this incredible commercial machinery.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Next question, please.

Operator

Next, we have Louise Chen with Cantor. Your line is open.

Louise Chen
Analyst at Cantor Fitzgerald

Hi. Thank you for taking my question.

So I wanted to ask you about margin improvement, you talked about that in your opening remarks. And curious when we might start to see that, and does that include the Seagen acquisition in your comments? And second question I had for you is, what are some of the key steps you've taken already to transition Comirnaty and Paxlovid to the commercial markets? And when will you know how the season will shape up? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you very much, Louise. Dave, would you want to take the margin improvements? And then, Angela, the combination of products? [Phonetic]

Dave Denton
Chief Financial Officer and Executive Vice President at Pfizer

Yes, thank you for your question.

It is our expectation that as we integrate Seagen in either late '23 or '24, early '24, we will begin to see margin improvement and that will happen as we continue to improve our performance from a topline perspective. At the same time, we're going to be very efficient and really work to minimize our SI&A investments going forward. So I think, you should start to see that post the integration and the closing of the Seagen transaction.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, David. [Phonetic] And then, Angela, how are we preparing to transition commercial Comirnaty?

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

So, Louise, as you know, both of these products, both Comirnaty and Paxlovid, are products that are very familiar to us. They fit very well in the existing portfolio of products that we have. So the ability for us to move from an EUA into a full launch or into -- so it's business-as-usual for us, right? So, the typical things that we would always do, which is awareness building with physicians and with patients, that has begun and is well underway. The things that you would do as it regards your discussions with payers to demonstrate value and to create your value arguments for reimbursement and access, that has begun.

We have done a tremendous amount of work as it pertains to retailers, and making sure that we have our distribution and our supply chain -- well-oiled and the ability to be able to supply and to vaccinate, to administer these products at both at a physical site, like a retailer, or even in the case of Paxlovid getting telehealth and sort of remote health capabilities set up.

So all of these capabilities, many of them, in fact, have been underway throughout the entire time of the pandemic. So I think we are in a very, very good position to seamlessly transition into commercialization.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Angela. Next question, please.

Operator

Our next question will come from Akash Tewari with Jefferies. Your line is open.

Akash Tewari
Analyst at Jefferies Financial Group

Hey. Thanks so much.

Can you talk about your next-gen CDK4 program? You'll have first in-human data in ASCO. What does your team believe just hitting CDK4 allows you to improve on hyper-intense efficacy? And are there any plans to combine that drug with the Arvinas' cert, given the DDI that's been shown up with IBRANCE? And then on your next-gen Paxlovid program, can you confirm that it can achieve multiple-fold over the EC91 adjusted for plasma protein binding? And is that -- for timelines on that product, is the earliest possible commercial entry 2026 or is there a path for expedited approval? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you very much. Mikael, I think both questions can go to you.

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Thank you. We are very excited about the next-gen CDK4 inhibitor. It's looking really good in two aspects. You can dose and get activity of the patient's Pal CDK4/6 because you deal with higher inhibition of this mechanism, and you have a better tolerability with no -- with much less neutropenia, less risk for infections.

We expect mid-year to report out and we have an aspirational target to start Phase 3, late this year posted earlier. At the same time as you asked, we are now running combination study CDK4 with CAT-6, another inhibitor that has nice single agent activity and seems to combine well. We have a second combination with CDK2 and we think this would allow us next year to pick one or two combinations to advance up the lines with more potent treatment than what's available today. Similarly, we're looking at combination with 471, as you alluded to, in order to benefit from Arvinas' collaboration.

Next-gen Paxlovid, yes, as alluded to in my introductory remarks, we have manifold above EC90. And as you know for Paxlovid what's unique with that drug that the manyfold exposure above EC90 as thjis all led to no detectable meaningful emergence or mutations, which is always what you fear in antiviral single agent therapy.

And this has been unique for Paxlovid versus other agents that have been used to for whether antibodies or antivirals. And this is exactly the profile for the next-gen, but without DDIs that allow us to improve and also to move into other supplementary segments. We're planning soon to start a Phase 2, and pending data, possibly move quickly to Phase 3.

And of course, we would like to see that agent introduced as soon as possible, I think we can hope to move swiftly pending event rates of COVID that will happen in the fall and further on that influence enrollment. So I think you said '26 and I would certainly hope we'd be ahead of that.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. Next question, please.

Operator

Next, we have Terence Flynn with Morgan Stanley. Your line is open.

Terence Flynn
Analyst at Morgan Stanley

Hi. Thanks so much for taking the questions. Maybe two for me because I'm not sure you'll be able to answer one of them. I guess any -- would love your latest thoughts on your seasonal Flu mRNA vaccine. Just in light of some of the Moderna data on the B antigen side, just how should we think about your profile there? And then there's been some focus on this, Adcetris versus Opdivo first-line Hodgkins lymphoma data that's going to be presented at ASCO. Just wondering if you can offer your high-level perspective on how you see that frontline landscape evolving? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Mikael, why don't you take the Flu question. And then, the oncology question will go to William.

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

You know, we are very pleased what we see so far, the totality date of our few mRNA. As you know, we have reported out very high antibody titers to A, similar or possibly lower to the B antigens versus standard Flu vaccines. But in contrast to standard Flu vaccines, we have very nice T-cell activity.

And I think we are the only mRNA platform that has those CD4 and CD8 T-cells of significance. We do think that could offer a unique profile for Flu and the tolerability with our dose is very encouraging. So, the trial is in the last leg for readout. Hopefully, we'll be able later this quarter to share an update. And we are very encouraged and we are in parallel at least investing in combination opportunities with this and COVID and RSV in various combination as Albert already alluded to.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. And William, on the oncology front, how do you feel about it?

William Pao, M.D., Ph.D.
Chief Development Officer, Executive Vice President at Pfizer

Yeah, sure. So again, this is a molecule for Seagen, and such as, which is the CD30 ADC. It's already been approved in Hodgkin's lymphoma post-transplant, and then previously untreated Hodgkin's lymphoma now with chemotherapy, absolutely [Indecipherable] vinblastine and dacarbazine. And it's already -- we anticipate actually later this year that label will be updated for overall survival. Now the data you're talking about is from the SWOG S1826 study with Nivo AVD versus Adcetris AVD, and I believe that'd be presenting PFS data. But this is a curable disease and we believe that the OS update with the Adcetris label will show that Adcetris is the favorite product at this time.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Will. Next question, please.

Operator

Our next question will come from Colin Bristow with UBS. Your line is open.

Colin Bristow
Analyst at UBS Group

Hey. Good morning and thanks for taking the questions. Maybe first on Danuglipron, the upcoming data, could you just walk us through what the key efficacy and safety thresholds you're looking to meet to move this forward? And sort of with regards to the threshold, how you think about them in light of it that this is BID dosing, and how does that potentially impact the sort of commercial opportunity?

And then, just second, a quick call on your DMD Phase 3 CIFFREO trial, you've previously guided to completion of recruitment in April of this year, just could you give us a quick update here? And then how you view the opportunity and positioning in light of the fact that there's a potential competitor approval at the end of this month? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Mikael?

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Yeah, we are very excited about our two oral GLP, the 1532, and Danuglipron 1532 called Lotiglipron, and we're looking for a differentiated profile that will be a combination of rapid onset, high control of HbA1C bringing it down, and bodyweight loss at various doses to be very competitive, and a more easily titratable drug that can optimize a preferred profile versus injectable when it comes to nausea and other well-known effects.

So, we look forward very much to data maybe later this year or possibly early next year and cherry-pick the winner here. You also asked about DMD, well if there is approval, it is based just on surrogate markers, and in this area, I think it's very important to report out data when it comes to real patient benefit. And we expect possibly already late this year, alternatively next year, to have data from the first randomized study that if positive could show favorable benefit for patients doing better according to the North Star scale. So we feel really positive about our own DMD program and I think the entry will be competitive with the real data that patients need.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. Next question, please.

Operator

Our next question will come from Geoff Meacham with Bank of America. Your line is open.

Geoff Meacham
Analyst at Bank of America

Hey guys. Good morning. Thanks so much for the question. Just have two. The first, Angela, on the I&I landscape, can you talk about your expectations for category growth, just looking this year and next, just in light of the Humira and Stelara biosimilars to come, I'm asking just in the context for the etrasimod launch as well as CIBINQO.

And then, Albert, I know this question has been asked, but a different way though, I know you expect this year for COVID to be a down year but when you think about your scorecard outside the U.S. with payers, as you have transitioned to commercial, what's been the initial feedback from a -- sort of from a price and volume perspective, obviously, that's key to your assumptions in 2024 and beyond? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Yes. Let me answer the COVID question, and then Angela will answer the I&I landscape. We expect to have commercialization in the U.S., I think likely the U.S. Government will stop purchasing outside the normal [Technical Issue] products. We do not expect that to be the case in most of the countries internationally. We think that most of the countries will continue having governmental practices. And most of them, we have already long-term contracts. So, I don't think there will be much fluctuation over there in the price given the longevity of the product. On the products, the contracts expire, of course, the prices also will be adjusted.

Now, let's move to the question about I&I, and Angela, please.

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Sure. Well, I think to answer that question you really have to look at each product and the specific disease that they are in. So, let's start with etrasimod which is UC. There we believe that we have an advantage from a clinical profile perspective. We believe that we have the best-in-class S1B inhibitor, but there are also other great benefits such as the fact that it can be used steroid free, that we have convenient dosing. We also offer an oral option in a world that is very prevalent with injectables.

And even with all of that that's out there, we still have 50% of people that have not achieved remission. So I think that the unmet need in UC is clear. And for us, in particular, given the profile of etrasimod, what we think is the greatest opportunity for us is in earlier lines of treatment where there has not been as much advancement, right? There's a lot of anti-TNFs, there is a lot of biosimilars, there's JAK, there's other mechanisms, but in earlier lines of treatment, there really is not enough.

And so that's where we think we have an opportunity to meet an underserved need today and that's where we're going to be -- that's where we're going to be positioning etrasimod. Ritlecitinib is a different story. When you look at that particular indication for alopecia, that is really an underdeveloped market. Now there are 3 million people today, they're no great options for adults and there are absolutely no options for adolescents and children.

And so the profile that we have with ritlecitinib is a -- it's the best-in-class JAK, it's the best JAK. And I think that we're going to compete well in addition to the fact that we're going to be the only JAK compared to baricitinib that has an indication for adolescents.

So, I think in this regard because it's a new disease or a highly underserved disease, I think education and awareness, education at the level of the prescriber, the patient, but also with the payers is going to be key to our ability to access this market.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. And of course, considering these other JAKs, right. Okay, next question, please.

Operator

Our next question comes from Trung Huynh with Credit Suisse. Your line is open.

Trung Huynh
Analyst at Credit Suisse Group

Hi guys. Morning. Trung Huynh from Credit Suisse. I have two if I can. So first one, a few days ago, you saw the FDA advisory committee vote on Lynparza's PROpel trial. In that, the committee voted against the approval in all-comers. So, TALZENNA and the TALAPRO-2, what's your expectations for your label here given the strength of your data? And could that affect your $1 billion peak sales number that you gave in December? And then for the RSV Flu co-administration study, what Flu vaccine did you test that with? Is that the high dose or the low dose? And if it's the low dose, could you be approved for use with the high dose, which is more relevant today? Thanks very much.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you very much. William, would you like to take the TALAPRO part question?

William Pao, M.D., Ph.D.
Chief Development Officer, Executive Vice President at Pfizer

Yeah, sure. So thanks for the question. So as Mikael said, the study showed with enzalutamide plus TALAPRO -- Tala [Phonetic] versus ENZA, we showed a 37% reduction in the radiograph of progression-free survival. Notably, in the same presentation, we also showed the hazard ratio in the HRR deficient population of 0.48, a significant P value, and then the HRR non-deficient unknown population, HRR of 0.7 with a P value of 0.04.

So, we remain confident about our data in the all-comer population. Obviously, we can't compare it to PROpel. Notably in TALAPRO-2, we have prospective testing for HRR deficiencies, including BRCA1 and 2. I also want to point out that our control arm of XTANDI reaffirms XTANDI as a best-in-class NHT for the indication with a radiographic PFS of 22 months. And in the treatment on with Tala, rPFS was not reached.

So, we expect that the HRR population, which is 25%, will be compelling with the data. And we'll also continue to present additional data in the HRR subpopulation at ASCO in 2023. And notably, we did get prior to review and we're currently in registration.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, William. And Mikael, what about RSV and Flu?

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Yeah, we are extremely excited about the RSV vaccine and we'll provide data on co-administration of that vaccine with adjuvant of Flu. We expect it to be available and generalized to all Flu vaccines. And then when it comes to longer term, we also are already in a combination study with our RSV and using our internal portfolio of COVID and mRNA Flu, so we see this as an event developing a very strong portfolio this year with co-administration opportunities next year, possibly our own Flu vaccine and then combination thereof. So stay tuned.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. Next question, please.

Operator

The next question will come from Andrew Baum with Citi. Your line is open.

Andrew Baum
Analyst at Smith Barney Citigroup

Thank you. Just coming back to the -- your oral GLP-1 portfolio, Lily has called out an anticipated weight loss that -- first two weeks from memory of around 14%, 15%. They hesitate to give baseline. Given the competitive nature of the field, you're late to market, and the cost of running CVOT trials in this setting, where does the relative weight loss need to be from your Phase 2 for you to advance given the benchmark that Lily seems to be setting?

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

That's a good question for Mikael. Mikael?

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Yeah, no, we agree completely with you that we should have an ambitious profile. And we have certainly seen patients up to 15% weight loss, depending on different dose regimens. So for obesity, that's a really good ambition to have up to 15%. And for diabetes patients, of course, it's about having a very strong HbA1c lowering, maybe 2% or even more. So, we think it's feasible with orals. And we think that will open up a very large place. And we think that pending data readout that we may have a differentiated profile for our full agonists.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. So we are waiting to see the data, that will speak. Let's go to the next question, please.

Operator

Next, we have Chris Schott with JPMorgan. Your line is open.

Chris Schott
Analyst at JPMorgan Chase & Co.

Hi. Great. Thanks very much. Just two questions for me. Maybe first on the capital allocation comments, I guess the more balanced capital allocation post the S-gen [Phonetic] de-levering. Just on that front, where do we need to see leverage go to before we can think about that balanced allocation? And in the meantime, what is the capacity and appetite for further deal? So can we think about kind of Biohaven size deals while you're de-levering from Seagen or is it really smaller transactions?

And then my second question was just one on RSV market development. Just how quickly do you see this market developing? I guess I'm just trying to get my hands around how much education this would require? And do you worry at all about vaccine fatigue, I guess, just given all the boosters that this population has received during the pandemic, is that slow with all the uptake versus kind of a normalized environment? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Good questions, Chris. Dave, capital allocation.

Dave Denton
Chief Financial Officer and Executive Vice President at Pfizer

Yeah. So thank you, Chris, for the question. Obviously, we have invested heavily back into our business [Technical Issue] there's all with the focus of growing our business from both from a top-line perspective, and importantly, from a bottom-line perspective.

And I think now as we begin to cycle into, I'll say, post the peak of this reinvestment in the business, we should begin to harvest, if you will, some of the cash flows coming out of the investments that we made and capitalize, if you will, on the returns that we expect out of these investments.

So having said that, we expect because of that, we should get ourselves back more balanced into the three pillars, again, reinvesting back in our business, growing our dividend, and doing value-enhancing share repurchases.

From a leverage perspective, obviously, we want to maintain our high investment grade rating in access to Tier 1 commercial paper, that would say that we would probably be in the low 3 times levered ZIP code from that perspective.

And then from a M&A perspective, we are still active in the M&A market. Obviously, first and foremost, on our objective now is close and begin to integrate Seagen. So that's priority number one. Having said that, we will still look at the M&A marketplace, understand if there is assets that meet our criteria to supplement our business, and we could theoretically execute against that, given our capital structure. Having said that, in the near term, those will probably be smaller, little tuck-in type deals given our leverage ratio in the very near term.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Dave. Angela, what about RSV and the educational efforts that the market would need.

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Well, with all launches, education is really important and that's why we have already begun our unbranded disease education with physicians, laying the groundwork for the importance of vaccinating with -- or vaccinating for RSV.

But of course, with all launches and with all new diseases, an education is important to consumers, it's important to caregivers, to payers. And so on all of those fronts, those discussions have either begun or are beginning, and we plan to obviously implement a robust market development plan like we do for all of our vaccines. However, I think that the biggest advantage here is in the synergies of RSV together with our other adult vaccines, right?

We have Prevnar 20 Adult, we have had COVID, we -- all of these vaccines follow a very similar pattern in terms of the commercial needs that they have. And I think that we have the opportunity to quickly and seamlessly bring RSV on into our portfolio and use the very same approaches and mechanisms and the same conversations that were -- whether it's with a retailer, whether it's with a payer, whether it's with our points of vaccinations to bring RSV on.

So actually, I think that this is a very exciting time, and we feel very confident about the ability to seamlessly introduce RSV as another vaccine in our respiratory portfolio.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Next question, please.

Operator

Our next question comes from David Risinger with SVB Securities. Your line is open.

David Risinger
Analyst at SVB Securities

Yes. Thanks very much. First, could you discuss the Paxlovid private market sales potential in China after March 31 that isn't included in your Paxlovid guidance for the year? And also, could you comment on the late-stage competitive threats from Sanofi's 21-Valent Pneumococcal Conjugate vaccine in adults and infants and Merck's 21-Valent in adults? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Angela, Paxlovid equity in private market in China.

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Sure. So, after April, we continue to have Paxlovid available. And -- but it will be accessed through an out-of-pocket payment mechanism. So if you are a private patient, you can get it; if you're a public patient, you can get it, you just need to be able to pay out-of-pocket for it. And we intend to continue to work with the public and with the Chinese Government to ensure its access.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

We can't give now guidance for a particular product in a particular country. So -- but, Angela explained the dynamics. Mikael, very quickly on the competition of pneumococcal.

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Yeah, I mean, we are extremely excited about the PCV20 recent pediatric approval with a Stellar label reflecting the strengths of our data. We monitor carefully competitor activity, as you alluded to, and are planning ourselves to enter next year further expanded PCV vaccines, followed by additional expansion a few years later, including optimization of the conjugation procedures, including different carriers, and possibly for the adult also adjuvants that we think could be useful.

So this is a market where we have been the leaders, we have a unique platform, and we monitor and feel very confident that we are going to have a bright future, although you mentioned competitor, which is a nature of markets that are becoming, of course, more saturated like the adult market, but there we also hope to benefit from our broader portfolio of respiratory vaccines from COVID, Flu, RSV, that cannot be much broader -- at the moment.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mikael. Next question, please.

Operator

Our next question will come from Steve Scala with Cowen. Your line is open.

Steve Scala
Analyst at Cowen

Thank you. I have two follow-ups. First on pneumococcal vaccine. So Pfizer just started a study of a vaccine including a new ingredient. Is the new ingredient an adjuvant, is it more valent, or is it something else? And then a follow-up on the Opdivo versus Adcetris study, can you say whether you were aware of the data at the time of announcing the Seagen acquisition? And why should we not view this as a significant risk? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Mikael, what is the secret ingredient?

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

The secret sauce in this particular trial is a new adjuvant that we think could play a potential nice role in the PCV adult market as you go to increasing valency in this phase. As I said before, in parallel, we are working on looking at different carriers, different chemistries, and we will shortly reveal for next year a start of a broader expanded PCV vaccine that will cooperate all these learnings. So stay tuned.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

And William, again on the Opdivo study.

William Pao, M.D., Ph.D.
Chief Development Officer, Executive Vice President at Pfizer

Yeah, sure. So again, on the Opdivo study, that SWOG study has been ongoing for a while, we were not aware of the data that's going to be presented at ASCO. I would reiterate again, it's early PFS data from what we see, and the most important measure of activity in Hodgkin's lymphoma would be overall survival. And again, we expect Seagen to get an updated label showing overall survival benefit in first-line Hodgkin's lymphoma.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Next question, please.

Operator

Our next question will come from Kerry Holford with Berenberg. Your line is open.

Kerry Holford
Analyst at Berenberg Bank

Thank you very much. Two questions on the RSV vaccine. Firstly, on the older adult vaccine, on Slide 22, you note emerging mid-second season data supporting durable vaccine efficacy. I wonder if you can elaborate a little more here? What data do you have in hand today? And you want to act against that second-season data in front of the FDA approval? And assuming you do see protection into that second season, how might that influence your pricing in the U.S.?

And then, secondly, on the maternal vaccine, you have that [Technical Issue] report scheduled in Q4 on Slide 6, but this dossier implies that that may not happen till the first quarter of next year. So could you just provide more clarity on when you could launch that maternal vaccine? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Yeah. Mikael, what about the RSV vaccine?

Mikael Dolsten, M.D., Ph.D.
Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer

Yeah, we were very pleased to get our first data chunk from second-season/mid-season data for older adult. And it clearly shows that robust data that we shared, for example, we shared high 80% reduction in lower respiratory tract infections with three symptoms. We see also on this and similar on other endpoint, a very robust, very meaningful protection also in the second season. Now, as you know, at the same time, we are preparing for the future combination vaccines. And we think in general that you will see an evolution in the adult market with simplified vaccination schedule, and your revaccination of COVID, Flu, RSV. For those that for some reason, this vaccination, we think the second season data will be very good.

On the maternal, we are preparing for an advisory committee. We think we have great data, we are the only one that have been able to conclude the maternal vaccination, we're the only one that were able to construct an RSV vaccine without using an adjuvant.

And we think it's a differentiated product, and I assume will be sooner after a potential approval, ACIP, and opportunity for Angela to launch to a very eagerly awaiting community of increasingly attentive pregnant women and maternal clinics to protect the newborn.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you, Mike. As we said, in our -- as we have it in our Slide, we expect to be approved in this year in the last quarter, so a good launch. We expect the publication of the MMWR likely to happen beginning of the next year. So that plays also a key role in the uptake with the vaccine. But keep in mind, the launch of vaccines starts before the approval, right? We have done a lot of educational efforts and there are a lot of investments that we are doing in that field. So in that aspect, the launch already has started from our side at least.

Next question, please.

Operator

Our next question will come from Carter Gould with Barclays. Your line is open.

Carter Gould
Analyst at Barclays

Great. Thank you for taking the questions. I guess, first on the decision to establish a new operating segment, and specifically launch this Pfizer IGNITE offering. Can you talk about what drove that? And if there's sort of like an aspirational target, and how meaningful of a driver that could be? And then secondly, sort of on the decision to divest Bavencio, did that reflect a sort of a signal you got from FTC or a proactive move in your mind, or are there other factors we should think about? And the fact that we haven't seen other divestments to that, should that reinforce our confidence that you think that the deal can go through without other issues? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you very much.

On the Bavencio question, the discussions to return the rights for royalties, in exchange for royalties, it started well before Seagen, so it has nothing to do with the acquisition of Seagen. It was something that was ongoing between us and ex-Serrano for the benefit of the product and for simplicity reasons. Just was completed after we announced the deal shortly after, but it had started way, way before.

Amir, would you like also to explain the IGNITE business?

Aamir Malik
Chief Business Innovation Officer, Executive Vice President at Pfizer

Yeah, Carter, thanks for the question. I think you have seen us collaborate with the biotech ecosystem in lots of different ways, and Pfizer IGNITE is another way in which we can effectively do that. Frankly, there is a lot of interest and demand on the part of particularly biotechs for working with us to access some of our distinctive research and clinical development capabilities.

And we think IGNITE gives us a platform to do that, to work with these companies, get closer to the science, which over time also then improves our ability to access that science and make determinations about what we would like to bring in-house. So, we think this is a excellent way for us to continue to collaborate with the biotech ecosystem and add to our growing and compelling pipeline over time.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Next question, please.

Operator

Our next question will come from Chris Shibutani with Goldman Sachs. Your line is open.

Chris Shibutani
Analyst at The Goldman Sachs Group

Thank you. On Paxlovid, the U.S. commercial opportunity, can you update us on any framing of what you are thinking in terms of pricing, and when we will know that? And in particular, with the commercial availability, are you anticipating much in the way of sort of payer engagements in terms of thinking about how that process will unfold utilization management-wise?

And then on the business development front, if we go to the $30 billion that you had outlined for a while now, and think about what is remaining from that unadjusted target in terms of 2030 revenues, let's say, approximately $5 billion is left. As we are thinking about how you guys are contemplating what areas to go into in terms of verticals or therapeutic areas or modalities, would it be fair to expect that at this stage a consideration might be to minimize the extent that you would have to rebuild or sort of refurbish on the SI&A front given your margin objectives longer-term? Thank you.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. Angela, on Paxlovid commercialization.

Angela Hwang
Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer

Sure. So hi, Chris. Yes, we are preparing for launch now. But as we have said, we have shared before the date of launch and exactly how that's going to happen is still very much subject to our discussions with the U.S. Government. So, we are going to align with guidance from them in terms of how that's going to happen. Of course, in the meantime, we are preparing for the commercialization of Paxlovid and payer discussions around the world is critical.

So, those have begun. Obviously, it's too early for me to share the price of Paxlovid. But suffice to say that the price ranges that we have brought to our payers together with the value arguments that we have been able to develop through robust real-world evidence from the number of hospitalizations, the number of deaths that we have been able to avert through the treatment with Paxlovid is very much supportive of the pricing ranges that we are talking about. So, I think very soon we will be able to share more.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. And Amir about -- what is the profile of future BD activities.

Aamir Malik
Chief Business Innovation Officer, Executive Vice President at Pfizer

Yeah. Chris, as you mentioned, we have a goal of $25 billion in risk-adjusted revenue by 2030, and I should remind everyone that is a 2030 goal. We -- with the deals that we have done have a remaining balance of less than $5 billion against that goal. And I think our strategy to pursue that is going to be consistent with what we have employed to date. First and foremost, it's going to be about compelling science that we can add value to, that's also going to contribute growth in the '25 to '30 period and take lots of things into consideration, including the impact on the P&L profile.

So, that will continue to be our focus, and we'll continue to be disciplined in the opportunities that we look for. And as Dave mentioned earlier, our priority right now is ensuring that we close out and successfully integrate the Seagen transaction, as well as drive value from the other deals that we've done and we'll continue to actively look for opportunities.

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you. And we are a bit out of time, so last question, please.

Operator

Our last question will come from Tim Anderson with Wolfe Research. Your line is open.

Tim Anderson
Analyst at Wolfe Research

Thank you. A couple of questions. The first is, how much of your future COVID vaccine revenue forecast are tied to the ability to have a combination product if something like mRNA Flu ends up not being viable, and a knockout of Flu-COVID combo, would that impact your anticipated uptake in 2025 and beyond? Or can you get to those longer-term guidance levels regardless of whether you have any combos or not?

And then last question, Albert, I'm guessing, there's some frustration among management with what the stock's been doing, a tough 2023; 2022 wasn't a great year. This is despite Pfizer helping lead the world out of the pandemic, which was a remarkable accomplishment. Even today, the consensus stock is down a little bit.

So as you talk to analysts and investors, what are you hearing are the biggest concerns that you think could explain this? And what do you think analysts and investors are missing or misunderstanding?

Dr. Albert Bourla
Chairman and Chief Executive Officer at Pfizer

Thank you -- thank you, Tim. Let me start with the first one. We do expect that if there are successful combinations with Flu, that would drive the utilization of the COVID vaccine much higher. As you know, in our estimations, would be -- expect, for example, in the U.S., around 24%, 25%, in the next few years of COVID vaccine. The Flu right now utilization around 50%. So, there is a big gap. So, that's why we believe that the combination between Flu and COVID will arise also to the COVID. And eventually, potentially, it can go all the way up to the same utilization like Flu, particularly given that there are no copays in approved and recommended vaccines.

Now as regards the frustration of the 2023, clearly, I believe that the stock price right now does not reflect the value that Pfizer has. The fact that we are so proud because of our contribution in saving the world, I don't think that we expect the stock price increases because of that, we did it because it was the right thing to do. And I think we are very, very proud of that. And we expect to see stock price increases as we are executing our plan, which is to create sustainable top-line revenue growth that will allow us to leverage the bottom line, that will grow faster than the top line.

And I think we articulated the plan about that, and that plan was to invest in acquiring good scientific substrate that will allow us to launch products that will give us $25 billion revenues by year 2030. And we have done tremendous progress on that by having already according to our calculations $20 billion [Phonetic]. We are also invested in R&D in the last -- in the past few years, and we have now an unprecedented launch of new products. And I think the street is expecting to see how those launches will evolve.

Clearly, I think there is overhang over the COVID revenues. There is uncertainty if their COVID revenues will materialize, we don't have any precedents to show that we know how to predict it well. So our predictions are based on epidemiological science, and based on trends that we are testing with market people.

So, I think that from my perspective, what I said was we're confident, we are very committed to creating value for the shareholders. We know that everything we do, we do it with their money, it's not our money, and we want to be very good stewards of that. So, it's not enough to save the world. I think also, we need to increase their surprise, and we are highly committed to do that by explaining better the strategy, more importantly, executing on it.

So with that, I think, it gave me also -- team a good segue to close. In summary, we believe that was a solid quarter. We delivered on our commitments, we exceeded actual expectations, we know from history. And we will continue doing so with a compass that we will create serious value for patients and that we are certain will translate into value for shareholders. We are executing our plan and we will remain very committed to doing that.

Thank you very much to all and have a nice day.

Operator

[Operator Closing Remarks]

Alpha Street Logo

 


Featured Articles and Offers

Recent Videos

NVIDIA Tops Microsoft and Apple for Most Valuable Company
Dividend Kings: The Secret to Steady and Growing Income
3 Strong Buy Stocks for a Summer Surge

Stock Lists

All Stock Lists

Investing Tools

Calendars and Tools

Search Headlines

More Earnings Resources from MarketBeat

Upcoming Earnings: