So delighted to introduce, Mikael Dolsten. Mikael is President, R&D, Chief Scientific Officer. Did I miss out any other titles?
You did very well.
That's it. And also, Chris Stevo, the Head of IR, and then we have several other members of the Pfizer team with us today. So obviously, there's a lot of change going on. Oh, sorry, forgive me. Chris is gonna make some opening comments. Then he, he's gonna pass to Mikael, then I'll ask the questions, so-
So this is gonna be very scintillating and interesting for all of you, I can assure you of that. In the course of this presentation, Mikael might make some forward-looking statements. If we do, these forward-looking statements are limited in their validity only to today, and if you have any further questions about forward-looking statements, please see our SEC filings under Forms 10-Q and 10-K. Thank you.
I just thought I'll start up by saying I think 2023 is turning out to be a very strong R&D year for Pfizer. This far, we have had nine approvals, and we expect another up to six to come, and the nine have included some really exciting products like PCV20, the pneumococcal vaccines for pediatrics; Abrysvo, the only RSV vaccines with two approved indications, old to adult, maternal vaccination; Litfulo, a novel TEC inhibitor with some transient JAK activity for alopecia, and in the future, opportunity our bifunctional antibody for myeloma. The more to come include products that are in the later step of registration, like etrasimod, a new oral agent for inflammatory bowel disease, pending final regulatory step.
A pentavalent meningococcal vaccine could also be the first one where you consolidate vaccination of the various ACWY and the Bs. Xtandi, in the most early line of prostate cancer, the non-metastatic hormone-sensible, the full reach to prostate cancer patients, and XBB 1.5, that we're eagerly waiting for the new updated Comirnaty 2023-2024 approval. In addition, we have a few really intriguing readouts that I'm looking forward to. As I spoke about vaccine, I can't resist, of course, to look forward to concluding the flu vaccine study now ongoing in the Southern Hemisphere. I think we and other players have been seeing considerable flu, but very few this far globally flu B cases.
However, our immunity this far have, that we reported, has been very robust, particularly for the A, which is the dominant strain, so we look forward to concluding that study. We have GBT601, a new, powerful drug for sickle cell disease that are going to have a readout. We have the oral GLP. We have our DMD gene therapy that, we have said could report some interim data that could lead to acceleration year-end, or otherwise finalizing the study mid of next year, and our EZH2 inhibitor for prostate cancer. So I hope you got the sense this is year has had a good start, and it has a good rhythm of more to come.
Well, thank you for those words of introduction, and thank you also for doing this panel today, because many of you may not know that Mikael endured about two hours of questions from me over dinner last night at an investor event. So it's very good of him to come back for round two. So at the risk of, you know, some things we obviously touched upon last night, this is a pivotal year, because obviously you've made your first major transactions for many years with the acquisition of Seagen.
There's also been a significant change in the structure of Pfizer, with you separating oncology and going straight into you and Albert. So perhaps you could talk to how that reshapes and what you're trying to achieve with all of this, and then within that, yes, with Seagen, you want the existing approved assets, the pipeline technologies, the linkers, the conjugates, but also you want the people and the talent.
So to what extent, because obviously all of us have seen transactions where the talent goes once the company is acquired, are there lock-ins on the key talent within the organization, or are you just reliant on individuals hoping to buy into the Pfizer culture?
This is a great question for the ongoing integration planning and pending close the future combined company. I think the structure that we have chosen very much sets us up for success. On one hand, we have gained a lot of experience, particularly of course, during the pandemic era, where we already had a vaccine organized end to end, and we could see as you run trials fast from early to late stage, as you have a portfolio with increasing opportunity for product combinations, as you have new platforms, an end-to-end organization gives you that oversight and opportunity to take fast decisions. We thought it was time to do that in Pfizer Oncology, as it has grown and become a very large pillar of our both R&D and revenues.
Of course, with a view to the Seagen closing deal, pending final clearance, it also adds very nicely that it captures that biotech spirit of Seagen being an organization focused only on oncology, and now being part of an oncology R&D group that can have that focus and allow the talent to feel that they continue their journey in that mission-driven, purpose-driven part that made Seagen so successful. And of course, it's not like they're completely separated.
Pfizer R&D will continue to provide support and in designing small molecules, in designing antibodies, which is the dominant place where Seagen has facilities, we will become next to Microsoft and Amazon, the household names, and I don't see a lot of staff going to Amazon or Microsoft, so I think they will really see an opportunity to even flourish more than in the past without needing to disrupt their life.
So maybe turning to autoimmune, but we'll come back to oncology in a second. And Pfizer, you know, starting with Xeljanz, now more recently with your JAK and TL1A portfolio, has been a leader in that field. Could you talk to something which I know you're very interested in, which is bispecific or trispecifics or, you know, you have the TL1A P40. Maybe you could talk to the potential of that project, where it is, to the extent it can raise the bar while not showing any deterioration in safety profile compared to the naked TL1A and the existing treatment options for UC and Crohn's. So just talk to the next generation, because I think there's less awareness of that than there is of your JAK portfolio.
Yeah. I mean, clearly, we spent a long time trying to design bi- and trifunctional antibodies, but preserving the properties of really good antibodies, potency, being recognized as fully human agents with good activities and ability to deliver them with ease in a subcutaneous formulation. And we have now been able, with Elrexfio, to get the drug approved based on a bifunctional platform. We have, for some years, been applying it also to immunology and inflammation, and we have both bifunctional, which is what you spoke about, TL1A P40. I think we and Prometheus demonstrated that TL1A is another part of TNF family with really robust efficacy and good tolerability. We added on the P40 arm that has proven activity in inflammatory bowel disease.
So I see that as an additional step, not necessarily need to be instead of TL1A, and I think we and Roivant and Telavant, the particular subsidiary, have developed a great way to work together. For us, it allows us, at the same time, to pursue other programs, having them giving R&D funding, and that included a recent-to-be-launched, pending final registration here for etrasimod. That will also set us up for success a few years ahead, building up our, or expanding our presence in neurodermatitis, where we traditionally have been present with Xeljanz. On the trispecific, we have established ourselves in atopic dermatitis in the oral segment with Cibinqo. We have clearly noticed the success of antibodies, such as Dupilumab, in these patients and broadening into many allergic conditions, including different respiratory condition, asthma, COPD, with activity.
So now we have designed, more potent, with more binding breadth than that type of first generation of, of very active molecules. So we have high-potency IL-4, IL-13, and the third arm in one agent is TSLP. That has also, in clinic studies, shown good activity in, in allergic condition, or IL-33, that seems to be involved in part of the symptomology, including itch in allergic conditions. So we see this as an opportunity in the tri- trials we're now running, after having concluded favorable PK studies, now moving into patients, to really, replicate what we did in oncology with Elrexfio, move very fast with mechanisms that are likely to be highly active-... and to bring, treatment targets to a new level in allergic or inflammatory, respiratory, or g- gut conditions.
We'll see the Phase II data from them in which year?
I think we'll get some data already next year that will set us up later for decisions into phase III shortly thereafter.
Flipping back to Elranatamab, which I've been practicing pronouncing without stuttering. Could you talk to how you intend to see share what's an incredibly competitive market? You know, J&J obviously has a subcutaneous BCMA approved. Yours has a slightly more favorable dosing schedule. Maybe the CRS is a little bit less, but the treatment arm interim is looking like it may be moving to combination antibodies with, you know, GPRC5D, or you've got also the cell therapies and so on and so forth. Given you have a single agent, although it's a very big market, how do you manage to carve out your mind share, market share in this setting?
Yeah. Given the drug is now approved, we think it will, the drug class, the first two that are now going to be increasingly tried in the triple-class refractory or penta-agent refractory myeloma. I think the activity of bifunctional BCMA antibodies is so profound that it will be the first choice and displace cell-based therapy to a more later stage. So I think you will see long-lasting, high response rate already visible in our reported data set for registration and approval, and we are now running numerous studies to move into what we call double-exposed patients or patients that are in the very first line of treatment, either compatible with transplant or not.
And what we can see is that a bifunctional antibody seem in general to combine very well with either CD38 or some of the other oral agent that are used. Of course, there are three classes to combine already, and some of them are, you know, going off patent, which is favorable for the patient and healthcare system. But there may be also novel combinations, and one that we feel intrigued about is the Maplirpacept or the TTI-622 agent from Trillium that we acquired. That is the only CD47, to my knowledge, that have shown single-agent activity, and we have become increasingly confident that it can achieve a good clinical activity without causing a meaningful anemia removing red blood cells, but being sparing. So we think it's a unique agent.
That is one of my first on the list things when I discuss with Chris Boshoff what I'm excited about. But I, I think also pending close with Seagen, it's intriguing to see how they have been successful in blood cancers with Adcetris, and I think there will be ability to look together on things that we could do together to become a really strong combination player here. So, I'm optimistic that this drug class will be very prominent and that we will see a lot of new combinations and leverage a combination that are now starting to go off patent to keep very favorable health economics for patients in the healthcare system.
So if anyone has a question in the room, please raise your hand. Happy to take it. Let's just segue to, metabolic disease and, Danuglipron. Now, you obviously had two compounds, and the first one you terminated through to hepatotox, or rather the second one you terminated. The first one you are looking at, reformulating as a once daily. Could you just talk to, a couple of things? So number one, if the option of reformulation for Danuglipron was already on the table, why invest the time and bandwidth in prosecuting the second compound, which blew up? Was that because you didn't believe at the time it was gonna be so straightforward, and now you do?
And then second, in terms of the timelines and the registration and the launch strategy, it's clearly important because Lilly is somewhat ahead of you. So what exactly are you gonna be taking to phase III? Do you bridge while you're doing the phase III to the once daily, so therefore, you can enter the market a similar time? And then the last question is, your molecule, I think, is a full agonist. The Lilly one is a partial agonist. Could you talk to what that means in terms of either efficacy or tolerability, and the evidence that supports that? So whichever part of the question you want to take.
Well, you very skillfully put in a whole book chapter into that question, so I'll do my best to respond without being too lengthy. Well, first of all, obesity, diabetes, and the GLP drug class currently stands in particular on the injectable delivery system, which is a very large market. And I think our presence is particularly focused in contributing to making this drug class oral and by embracing combination of the future as oral drugs, as we see multi-active peptides being used for various patient segments. So we are quite excited about that journey, and danuglipron data will read out later this year. And it's been in 1,400 patients, so we feel absolutely convinced that it does not have the type of adverse events that, unfortunately, our other oral GLP had.
And it really will be to look at the overall integrated profile of that drug. The thing we have made progress gradually and more recently, is to be able to advance our modified release capabilities. And we had really made that platform much better today than it was a few years ago. So we have some very sophisticated modified release systems that can allow you even to incorporate, starting with one molecule, like Danuglipron being BID, and turning it QID, with a sustained level rather than the peaks, which we are looking forward with intrigued eyes to see if that can also attenuate some of the nausea and vomiting that the drug class of GLPs are associated with. And that the MR once-a-day option that now has opened up for us, could also be a platform for adding other drugs into it.
So we will look forward to the Danuglipron data end of this year or late this year, and then make a decision on that. We have a significant metabolic portfolio, including obesity agents, that will come over a period. Next year, we have a readout of our DGAT2 in NASH. That's an area, I think, coming back a bit as the focus on obesity has increased, and many of those patients are suffering from NASH. And I think for us, we see an opportunity to leverage this oral approach, obesity to NASH, to diabetes in the future, because we have been a strong company in the cardiovascular arena, and we're trying to translate that into metabolic, but staying more focused on oral companies like Lilly, Novo Nordisk, that have been very successful with injectable.
So you'll be initiating, all being well, the phase III with the twice-daily Danuglipron, correct?
I would put it like this: we'll review the data. If we would take a decision to progress, I would see that a target profile for us would be once daily. And, I'm feeling that the type of technology platform we have today, which we didn't have a while back, will allow us to make drugs of this type, with high probability to once a day. And that's really some technical improvement we have done. So that would be the target profile, as we would possibly conclude, phase III, with a drug like Danuglipron.
Skillfully answered. Partial versus full agonist, and whether that pharmacologic difference translates to a different clinical profile?
I think it's just too early to know. We'll look at the data set and try to have very sharp eyes to see what could be differences. But so in general, we have liked to have full agonists, and now it's a real opportunity as the Orforglipron data is available to learn from this and incorporate that in our plans.
Your GDF-15 antagonist, which, you know, you know I care a lot about, and we've spoken much over the last 12 months or so. It seems like the appetite of Pfizer has waxed and waned over the years. Could you just update us on the levels of internal enthusiasm, commitment to this now, and where the key focus is given, you know, there are regulatory uncertainties that, you know, need careful thought and planning?
You know, since this is a continuation of treating body weights abnormalities or deviations, treating either those with obesity or those with cachexia, it's been an area that has grown upon us. And you look at the body weight curve and look at long-term impact, mobilities, or lifespan, you actually note that whether you have too low or too high body weight, you suffer from accompany diseases, and your life expectancy will be shortened. So, clearly, enthusiasm from you and others just ignites further our interest to participate in both ends of the obesity and the cachexia spectrum. I think there's been increasing the number of publication also that cachexia contribute to a fatal outcome in about 20% of cancers.
It's associated in 50%-80% of the cancers as a major negative factor prognostic, and many patients are unable to go through treatment unless they can deal with the cachexia. We completed a study that showed our GDF-15 antibody led to quite a fast improvement in body weight, and also other patient reported very favorable outcomes. So clearly, our enthusiasm because of these many factors, is now quite high, and we're looking at the readout from a second cancer cachexia study earlier part of next year, and it's interesting to notice that we have seen a really good enrollment in this study, it's indicating that the whole field is starting to be recognized as increasingly important as part of supportive cancer care.
You know, a vision could be that a drug, if you can make it really help with nutrition, body weight, ability to go through treatment, ability to be mobile for these cancer patients, you may be seeing a product as big as the growth factors that were established with the erythropoietin and G-CSF in cancer, but now focusing on reestablishing a healthy body weight in patients suffering from difficult-to-treat cancer. So that's a bit our vision, and we are really encouraged about the journeys for. I should say, it's not just cancer, but other chronic conditions, heart failure and COPD, where you have a substantial number of patients that are impaired because of cachexia.
Related but slightly different, could we talk about development speed, risk appetite at Pfizer, and how things could be further optimized? Danuglipron, you know, you're clearly behind Novo, you're behind Lilly. Ibrance, you know, it took some time before it became the drug that it was, and there were several years that were gone there. To what extent, You know, when I look, trying to be objective, it seems that there's still a fair degree of white space for projects which ultimately turn to be important drugs, where development speed and time to market could be accelerated. Second, could you comment on the risk appetite, and one, you know, companies like humans, they're impacted by what went before. Obviously, Torcetrapib was many years ago, but it was a pretty heavy body blow.
One wonders whether that and other similar failures have taken away some of the risk appetite. Now, obviously, COVID talks away from that because there it was. But how do you think those observations are fair? Do you think there is additional work that is being done or can be done on taking out the white spaces? And do you think there is still any legacy of risk appetite and talk to ways that you are addressing that calibration of not to overdo the risk, but also not to be cautious or overly aggressive?
You know, I think you ask a very important question about culture in innovation companies, and there is a spectrum from risk-averse to overly risk-tolerant, and I would say that we currently are risk-curious. We welcome to take thoughtful risks, and, like you said, COVID showed it twice, where we found a way to shorten timelines drastically. And we are embedding that culture in our go-forward strategy, both when it comes to move things in parallel, trying new technology platform, as well on new internal programs. One example was the alliance we made with Flagship, where we are able to partner with them in looking at 40 of their companies, 20 of their different technology platform, with the aim to co-create 10 new companies with new science to address big medical problem and particularly pursuing new platforms.
So I think what you raised is part of the new Pfizer being risk-curious, just right on the spectrum, because you need to be careful. There is a rise of new technologies, and some collapse, and then they become re-engineered and are on a much more healthier path. So you want to hit the perfect inflection point, and the deal with Seagen, I think, is another one. Right now is the era where a couple of companies that specialize in ADC, Seagen and Daiichi, seems to have reached that sweet spot of being able to pursue it in many different types of programs. So I hope you will see increasingly Pfizer being risk-curious.
So turning to some novel platforms, obviously, you know, Pfizer is one of the leaders in mRNA through the relationship BioNTech on COVID and, and now flu. An area that I don't think you are currently active in, and correct me if I'm wrong, is mRNA therapeutic vaccines for oncology. Obviously, we've seen the Moderna, Merck data and the BioNTech, Genentech data in pancreatic. Now, yes, it's early or very early in either case, but the signals are quite strong and compelling for a significant unmet medical need and a platform that could go very broad indeed. Given that you have, you know, many of these competencies, what's the appetite? And Pfizer has a history, historically of interest in cancer vaccines. So is this enough to get you re-engaged?
Well, you never say never. So, we always try to have an open mind and look at data and at medical advances in this case, in the cancer field, but using the mRNA platform. I would say right now we are prioritizing higher to use our mRNA resources to expand our vaccine portfolio and to deploy it possibly in common diseases for gene editing. So I spoke briefly in my introduction of mRNA for flu vaccines, which would allow you to mount both an antibody and a T cell response and may much better deal with the variability of flu. I see that's an intriguing path. We also see opportunity to break into other areas where you can take benefit on the potency of mRNA, like
SOST treatment that has it turned out to be highly active hepatitis C, but it's associated currently with adverse side effects, and with mRNA, you really don't need more adjuvant than the product itself. And we're looking at numerous other, in more increasingly common respiratory viruses as we start to diagnose respiratory diseases increasingly. Now, in gene editing, we have a collaboration with Beam, and our particularly internal medicine group are looking at a few different indications, including some liver targets, some non-liver targets. So I hope we'll also be able to report advances in that field. And on top of it, we are looking at ways to augment the mRNA platform by itself, which could mean incorporation of more different antigens, like the saRNA platform that we put some efforts into increasing durability, possibly circular mRNA.
So expect us to add one of those two, likely to our toolbox, and that includes working with biotech and major academic centers. We have been a little bit more watchful in the cancer vaccine, and while I welcome some of the advances there, it should be a real acknowledgment. It's still more of a personalized approach, and where you incorporate a collection of mutated cancer antigens or neoantigens. And the question is, how broad can that be, or much of a niche vaccination will it rather be? And will it, similarly to CAR T, that has been initially seen with a lot of enthusiasm, now maybe being displaced by a functional antibody, multifunctional.
So that's just where we want to be careful, and also looking at when you deploy ADCs and combine them with PD-1s, like data of PADCEV and Keytruda, you may actually generate immune responses to new antigens, because you bring in immune-mediated cell death, you take away a checkpoint blockade. So that is another way to treat cancer and strengthen the ongoing immune response than necessarily need to combine almost person-specific or subpopulation-specific cancer vaccines. We are keeping an eye on it. Should the area break, we may jump into it, but at the moment, we see bigger drugs coming from these other approaches I alluded to.
So, before this session, I hosted a similar conversation we're doing now with a former colleague of yours, Phil Dormitzer, who is now in his new home at GSK. And, they're talking about, obviously, their new strep pneumonia drug, which is on the MAPS platform through the Affinivax transaction, and the vulnerabilities of increasing serotypes with traditional platforms, particularly for the 3 serotype, which is associated with invasive. Obviously, they are not the only competitor. You have Merck, you have Vaxcyte, you have Affinivax. To what extent do you believe that Pfizer has the technology to keep up, and do you think that the regulator has a similar understanding of the relationship between neutralization titers and incidents by the individual serotypes, which is gonna translate into a differentiated label from either the FDA or recommendation from ACIP?
Clearly, the pneumococcal space has been a stronghold of Pfizer, and we have now three generation of pneumococcal vaccine, from PCV7 around year 2000 to ten years later, when we started to introduce PCV13, and more recently, PCV20. And each time, there were various competitors sitting with Andrew Baum or his predecessors being optimistic, but none of them really has played a major role, whether GSK, the last time when they're working on a 10-valent or Merck with our current presence of a 15-valent. So I feel pretty optimistic that the depths of our skills and the new approaches we're putting in place to even go beyond 20-valent for the future will allow us to be strong and prevail, whether in the infant or in the adult sector.
So we have developed technologies that allow you to combine even more serotypes without paying a price on attenuation, and that includes more sophisticated conjugation chemistry, adding additional carrier to avoid carrier interference, and for older adults, considering mild adjuvants. Finally, when we launched PCV13 for the adult indication, it has two claims. One is prevention of invasive pulmonary disease, and the other is for community-acquired pneumonia. And we run a large study in the Netherlands, where we basically vaccinated a whole region and were able to track cases, had unique assays to address them to each of the serotypes, and that led to a unique label for pneumonia, which is, by far, the dominant reasons of illness among older adults.
That indication is transferred from Prevnar 13 to 20, based on that we have aligned conjugation process experience, bridging with similar or identical assays, and so far, that has been a unique label that we have, and I, I think that will allow us that investment and knowledge to continue to have improved label versus others, and we continuously move new generation into the clinic. You will hear about that next year, and we are not concerned about adding more serotypes-
Using the existing technology.
Using new technologies. The ones that we'll introduce next year will be based on new technologies. The current technology did us very well up to 20. As we think about, you know, in going another-
But it's not by titration, it's not like the MAPS program.
It's not. It's based on one hand, as I said, refining the conjugation, making it even better, and on the other hand, we have seen when you do new carriers, not just CRM, you can allow the response to some of the serotypes to be better, and for older adult, use of a mild adjuvant could allow also stronger responses. And I think what you were asking, could you get better responses also to some of the existing serotypes that may be, so far, none of the existing vaccines, some of them have been optimal, and that's something we are, have made a lot of progress on, that to some of the existing serotype that protects but doesn't eliminate disease, we think we have cracked that nut, how to address it.
So that's why I, I feel, it's the same game, and we were victorious with PCV7, PCV13, and I feel convinced we can prevail with our innovation and experience and bring it to new levels of protections.
So staying with vaccines, as you pointed out, yours is the only RSV vaccine with approval in two patient populations. COVID vaccinations in pregnant women turned out to be a very sensitive topic, and here, patients and their physicians have a choice. It's not an insubstantial market, you know, it's $1 billion-$2 billion. I mean, it's, it's, it's a, it's a good size opportunity. How are you thinking what the acceptance of the vaccine versus a monoclonal will be in this patient population?
You know, it's a great question. First of all, I think that having successfully concluded approval for two indications, older adult and maternal, creates a unique data set and acceptance of our vaccines for both indications. Now, when it specifically deals with the maternal, where we're the only vaccine available, we have the opportunity for seeing the patients or the person far ahead of any antibodies. So in the U.S., from week 32 to 36, where there are 2 to 3 visits in the normal practice of pregnant women to obstetrician or their offices. In Europe, we have an even wider window, and our healthcare system, similar, have multiple visits between 24 and 36. There will be an opportunity for a discussion.
Do you prefer to have your kid protected from day one when it's born, or do you want to wait and take the risk that you get an infection before you have had a discussion with your pediatrician that you don't know, you haven't met yet? I think that gives us a fabulous voice, long ahead of the antibody delivery dialogue, and I think there is now a strong tradition emerging with flu vaccination, with Tdap, and we also have reported real-world evidence that many used our COVID vaccine in a pregnant state, and that was associated with very, in general, favorable tolerability and protection for the pregnant women as well as possibly at birth, acquisition of disease.
So I think, it's a changing landscape, and finally, I would like to say, since you brought up COVID, we saw the importance of COVID antibodies initially, but when they were more broadly used, we saw terrible resistance because they are monoclonal. And that's the difference with a vaccine, which is polyclonal, where that you don't develop devastating resistance. I think that would be a public health burden if you extensively use monoclonal antibodies, maybe not as fast as in COVID, but already now, there are circulating RSV strains that show resistance to the type of existing antibodies. So I think there are individual reasons, there are population reasons, resistance reasons, so always first, have a good, serious dialogue about vaccination of the pregnant mother. We protect the day one rather than wait, when you have a very intense period post-birth.
That is my perspective, both as a physician and having worked with this type of prevention approaches.
Michael, as you pointed out before, that as we've seen with influenza, and as we've seen with COVID, there is tremendous advantage to having not only a prophylactic approach via vaccines, but also to have a treatment alternative available as well. So as you know, we acquired ReViral last year, and we're very excited with their fusion inhibitor, and how that's going.
That's a really nice, add-on. It's one of the projects that we're reviewing now that could be entering phase III, the final stage for registration. Based on our previous experience, we're making great progress with it, and similar like we have had Paxlovid and Comirnaty, we think to have Sisunatovir, the RSV drug, and have a maternal vaccination gives us a real good strategy for the future. And I, I think also we and others are moving the adult vaccination against RSV to younger adults and to pediatric sector, and gradually you will see RSV vaccines also for the first phases of life. So I, I think there is a lot of opportunities, but for the preventing from day one, I think vaccinating pregnant mothers is the preferred.
As you take the age down below 65 into the younger patient population, I'm assuming that coverage is going to be under what commercial? Under Medicare? How is it, and what implication does it have for pricing?
Well, I think we will see the vaccine commercially be established, and we should wait and see what happens there. I think in younger adult, there are options to vaccinate those that particular have risk groups, which are increasingly many, whether obese or other respiratory disease or cardiovascular disease.
These are the high-risk group subgroups.
I think in the younger adult, that may be the place. However, for the pediatric sector, we know that RSV can be very devastating.
Sure.
So there I see an opportunity over time to see RSV vaccine part of the annual vaccination recommendations. So that's part of the vision, where we would like to go. So that's-
Andrew, sorry, just to your point on-
Yeah
pricing, just to remind you, any ACIP-recommended vaccine in the U.S. is available for $0 out-of-pocket for anyone with insurance in the U.S., including government insurance.
I guess I was wondering, given - assuming it was a broad, not a selected patient population, given the burden of disease from RSV is a very different proposition from some others, whether it would get an ACIP recommendation, and therefore it may be a self-pay vaccination.
That's why I said that, in the younger adults, at least initially, it would be particularly focused on higher risk groups-
Yeah
where we would see a penetrance, and, we'll see how RSV evolves as a disease, and, risk groups for getting viral infections are increasing as unfortunate comorbidities and use of immunosuppressive drugs. But clearly, it's the youngest patients, the newborn in the first few years, where you have severe impact of RSV, and the older adult, and some high-risk group in between. So ample opportunity to grow beyond these two initial indications.
That seems a perfect place to stop. Michael, Chris, thank you so much for joining us, and thank you for the audience for the conversation. Appreciate it.
Thank you very much.