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Consensus EPS Forecast. All of that, I think, we are in a very, very good, let's say, state. And we are very encouraged with the modern pipeline, the pipeline that comes to fill the gap between 25 and And this is also where we believe that right now, we can bring it significantly up what The Street projects as a severe decline. I think, already with our pipeline, our projections are saying that we will take it to slight growth -- flat to slight growth.
Next question, please. On the oral protease inhibitor, it's closely watched by investors now that Merck has positive results with molnupiravir. But it seems like in your prepared remarks, you spent more time talking about various Phase 2 programs in your pipeline versus this one where we'll have readouts sooner. So I'm wondering if this suggests a lower level of confidence by Pfizer in these upcoming readouts.
And then, can you just talk about your views of molnupiravir and also the recent data they released? And also, how do you think drugs like this, whether it's your own PI or molnupiravir will be used in a real-world setting, will that primarily be used in the study population, which is really just the unvaccinated patients? Or will it be used more broadly? Yes, thank you very much. We are very bullish on the oral inhibitor.
We -- the studies are ongoing. So there is not much to say right now other than we feel optimistic, but we need to see the results of the studies.
And if positive, we will be ready. The way that those will be used, I think it is -- there is a significant part in the high-risk population. But because the cost of these medicines is way cheaper than the antibodies, I think in the standard-risk populations also, we'll have a significant update.
And of course, there is a high-volume opportunity in the contact population -- in household contact population that could really change the paradigm.
There will be unvaccinated population who, unfortunately, will have the majority of the infections. And I think, these medicines will be predominantly coming to them. But there will be also breakthrough infections either with people of high risk or with other people.
But vaccinated people also will be in need of something like that. Actually, Mikael made the comment about that when he spoke, that the study that we are running for standard-risk population to our knowledge is the only one that it is run.
So just to make sure that there is no misunderstanding here, we are investing very heavily, and we count -- we are cautiously optimistic that the studies will reveal the data. But we will speak when the data are here. Now as regards, Merck, I will ask Mikael to make some comments. But I would like to say that I don't think it is appropriate for us to comment on other oral inhibitor. But hopefully, if the product is approved, they will have an option in their hand. Mikael, do you have anything to add to that without going through, Mikael, through Merck's product that they should be the ones to speak about it.
I think, you outlined it very well. We are optimistic, enthusiastic. But as always, we're waiting for the data that we hope to come before year-end for the high risk. The standard risk, as you heard, we are the only one running such a study for an oral drug. It's really a unique opportunity. And it will be a growing need for those that do not get repeat vaccinations. And I think, for the household study, a protease inhibitor with its well-known safety is really intriguing. As you know, protease inhibitor of this kind do not possess risk for the type of side effects, mutagenicity that's seen of sometimes with polymerase inhibitor and require a longer follow-up before you know about their potential impact.
So that's why we think the protease inhibitor is really a perfect fit for the pandemic moving over gradually, hopefully, to an endemic. And we're just waiting eagerly to see it read out. Good morning, and thanks for taking my question. I have three, if I may. You've not commented specifically on filing for interchangeability.
Can you clarify that point? Second, it was kind of going across the wire, there are some comments from D. Is this something that drug industry can live with or not? Is this something you're objecting to? Or is this something that within a great bargain, that will settle drug prices for the -- drug price legislation for the next three years? Is this something the drug industry is comfortable with? And last, regarding your oral GLP-1, danuglipron, are you expecting results in diabetes in the fourth quarter of this year?
Some of your peers suggested that the intraday variation in blood concentration of GLP-1 is bound to lead to higher side effect profile for the efficacy delivered. Can you discuss what is your view here? Thank you very much, Ronny. I will answer the drug pricing. So let me start with negotiating the drug price. First of all, I think, that we have an issue asset in multiple times with drug pricing.
But the issue is not the cost to the healthcare system. The issue, it is the cost out of pocket for the patients that taking their medicine. So by definition, it cannot be the big problem. And this cost is going down. Actually, they are experiencing increases. And this is because there is a problem with the insurance system that forces tremendous out of pocket when it comes to medicines, which is not the case when it comes to other, let's say, medical interventions, diagnostics, physician fees, hospitals, you name it.
Now what needs to be done? It is to have a reform in the way that -- in a way that will affect out of pocket for the patients. And I truly believe that there is a deal to be made right now in Washington. I truly believe that. And I think, that the Congress should not miss the opportunity to find a deal right now that will reduce the out-of-pocket cost of patients, which is the main, main issue right now.
Now when it comes to negotiating drug pricing, negotiation is good and are happening right now. Medicare negotiates very effectively with us. What people, some parts of the political spectrum wants to see is not negotiation. It's price fixing. So this is not negotiation. This is clearly a price fixing. But I think, we -- it's gonna be a very big mistake to see that happening to our objective. But what I want to emphasize here is not if we are disagreeing in negotiating with our pricing, I think it is that it's a great opportunity to have a deal right now in the Congress.
And that will significantly reduce the out-of-pocket cost of the patients when they're taking their medicines. Now with that, I'm passing to Angela to speak about adalimumab. So for the biosimilar for adalimumab, we will have interchangeability studies, and we're filing that in December The oral GLP-1, I think, it's a class with a lot of promise. I think, danuglipron is currently the most advanced true oral small molecule.
It has not at all the same type of food effect interaction as been seen with oral delivered peptides. As you stated, we'll have soon this year a readout with a slower titration for diabetes to optimize efficacy, convenience and tolerability.
This is well known for all introduced GLP-1 peptide. We'll later next year have an obesity readout. And the drug players of an oral has an opportunity to be possibly the most powerful within the oral segment and a much more convenient form for the injectable, particularly for the new emerging segment of obese patients that need metabolic control. This is a very attractive type of treatment to come. And we look forward to generate more data and understand this type of new emerging true oral how to optimally position it.
A couple of questions. The initial data seems to have been delayed from the third quarter or the fourth quarter of this year to the fourth quarter of this year and the first quarter of next year.
So what is the reason for the delay? For instance, are the events tracking below expectations? And secondly, a follow-up on danuglipron. So the readout in obesity in the first half of next year is quite intriguing. How quickly thereafter, assuming it's positive, could a Phase 3 study in obesity alone generate results? Very good question. By the way, I don't think that we ever expected the oral in Q3. I'm not sure if something like that was ever said. I think, we were always expecting it in the Q4.
And still, this is a very big chance that this will be the expectation. We give a range of Q4 to Q1 of next year. But still, this is the expectation that there's very highly chance that we will have it by the end of the year. Again, things are moving nicely in all three studies of the oral. But sometimes, you need to stop and wait for the data to speak for themselves.
So that's our attitude. We are preparing for it. We are manufacturing. And we will be ready if, hopefully, the data are positive. Now about our obesity drug, Mikael, can you take this question? Yeah, just wanted to echo what you said, Albert. We have sites enrolling well across all the oral PI, and we have used this target base for the quite -- last periods. So we are on track and all looks well.
We'll just wait for the readouts. Danuglipron in obesity, we optimize, obviously, for the titration, as I discussed, because that's important in order to deliver this quite encouraging data that has recently been seen with the GLP-1 class injectable.
So that's really the purpose, to get the right titration, stage titration. And this is a small molecule that we have developed manufacturing processes. So pending data and dialogue with regulators, I think this is a study that would progress quite fast to Phase 3 as the CMC is not complicated. And the drug class is very well known for regulators. It's just that this is an oral with an upside. Hi, thanks for taking my question. Just curious how much you think you can -- manufacturing?
How much you can manufacture? What do you think about the durability of these sales? And then, is there any first-mover advantage to getting on the market with this? And then, my second question is just on CD47, quite a few in development.
So how do you plan to differentiate your Trillium assets? On the oral, as I said, we keep manufacturing. It depends on how much we will have already product available this year. And then, of course, as we are moving into next year, our manufacturing capacity is ramping up. The durability, I think, of this franchise is more or less an analog to the durability of the COVID vaccines as a franchise. And then, you will have a need to treat and save lives.
And I think, the durability, I expect to be -- given that COVID has been really across the globe and it is in so many parts of the globe. And I think, we are speaking about the years, I think, of durability.
But of course, that remains to be seen. That's only my assessment. Mikael, can you speak about the CD47? Yeah, no, that's a great question. We think there are several aspects of unique differentiation, and that's, obviously, why we were keen to work on the Trillium product. Number one, this is a ligand trap with an Fc fusion to provide longer half life.
So it has a lower binding to CD47 than a typical antibody. And it has shown both in preclinical studies and now in clinical studies that you do not get the problematic on-target anemia that you see with antibodies.
So that's an important unique thing. It matters a lot, particularly for blood cancer patients, which already have a fragile bone marrow function, but also for potential solid cancers that are treated with various chemotherapy backbone.
Number two is this product is, to the best of my knowledge, the only one that have showed single-agent activity in blood cancers. And we have the most advanced data set coming out in lymphoid malignancies both related to B-cell malignancies, lymphomas and myelomas.
And we see opportunities to combine it with several existing Pfizer assets to give us unique life cycle management. So several unique aspects. We look forward to see a potential deal closure and to work with the staff in Trillium to accelerate these exciting assets.
Thank you, Mikael. And Angela, I didn't ask if you have to add anything on the oral in terms of the durability of the revenues, other than what I said. Well, the market that we're looking at, we estimate to be about million -- up to million people.
When we look at the -- just vaccination rates, infection rates, and then on the various risk groups that we talked about today, the high risk, the low risk, as well as those who just may be in contact with those that are infected, this is the size of population that we are looking at.
So I think, that this opportunity will -- is a very attractive one. And I think, that, again, the disease patterns will determine where we go with this. But certainly, it looks to be a durable opportunity as well. And also not to forget, this is probably something that governments would likely -- would be interested in stockpiling, right, like we saw in the flu.
So I think, that that's an additional commercial opportunity to consider here. And just give us some sense of what of that is primary series and what of that is boosters and just how you think about that developing over time? Then second, on your flu data for your mRNA vaccine. Can you, I guess, comment, one, on if you've had any regulatory discussions and if you think you could get approved for just titer data alone or you need to run an actual efficacy study?
And then, secondly, what should we expect to see with that initial readout? And then, third, can you just detail what the protocol changes for hem A and what you think the underlying factors are that are driving those high levels of factor? Those doses, when it comes to high-income countries, they are mainly boosters.
When it comes to middle-income countries and to low-income countries, there is a mix of second doses, of primary doses, particularly second, because it will be given a lot this year for first and also some of them are boosters. This is why I said that the low- and middle-income countries, particularly the low-income countries where we do not -- we give it at cost, right, they need to place orders so that they can secure allocations of our quantities for their boosters.
They need to think that. Now I will ask Mikael to speak a little bit about our regulatory discussions on the efficacy or not for flu and then why we are doing in HA the protocol changes. Yeah, we are very intrigued by the use of mRNA for flu as it can generate both an antibody response against hemagglutinin and the T cell response that can be protective, particularly for more severe flu cases.
The current flu vaccine, the protein-based, are not very potent on T cell responses and generate more intermediate level of antibodies. Whether you can register a product on those type of immune parameters is something we are, of course, considering.
And as we generate data, we'll have dialogues with regulators. But it's, of course, advantageous not just to get approval, but to have a strong data set on an outcome such as vaccine efficacy. So the program will include both outcomes. As always, you do non-inferiority of antibodies, and you may have additional immune parameters that do not exist very much with the traditional flu.
But the entire program will, of course, look at vaccine efficacy to also take into account this broader immune response. But we'll, obviously, always keep our regulatory dialogues open for opportunities to serve patients as quick as possible. We didn't see -- actually, we have not recorded any issues in the hemophilia patients with this. We want to just have abundance of caution to have a protocol that would allow active management. And of course, if there are any patients with some risk factors, they could easily use oral anticoagulants such as Eliquis.
I want to just put this into context as we finalize the regulatory submission on this protocol update that having high Factor 8 level has also some potential longer-term advantage on sustainability of gene therapy.
The Factor 8 data that you have seen also from others in the field have shown some more attenuation over time for the Factor 8 molecules. We have reported so far very good efficacy with no need for transfusion and no bleedings. And also let me add in my previous answer when I said that for the high-income countries, it's predominantly boosters. Of course, there are also -- as vaccine rates are getting higher, they are primary doses.
But also, I forgot to mention the pediatric. And the pediatric will be predominantly in the next year's revenues. Keep in mind that in Europe, Japan, all the international markets, all revenues of COVID that will be realized next month are going to the next financial year.
And over there will be a lot of pediatric. Of course, in the U. Thanks so much. Just two for me. I guess, first, coming back to the vaccine targets for ' As we think about the doses beyond the 1. Or have most governments contracted already? I'm just trying to get a sense if we should be thinking about most of those doses, I think, as you mentioned in the call a few times, going to emerging markets and lower-priced geographies where the vaccines sold closer at cost.
Or could there actually be some still higher kind of price per dose business to be had? My second question on the vaccine is also just on the margin. Just talk about that standard-risk trial when you're looking at both vaccinated and unvaccinated populations.
Is that study powered to look at those populations separately if we were to see different outcomes in that readout as we think about later this year or next year? And Frank, if you can give an answer on the margin. And then, Mikael, the standard-risk study. Yeah, thanks for the question, Chris. No, we are not all done with the developed markets.
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