Merck at BofA Securities: Strategic Insights on Policy and Growth

On Wednesday, 14 May 2025, Merck & Co. (NYSE:MRK) presented at the BofA Securities 2025 Healthcare Conference. The discussion focused on strategic developments, highlighting both opportunities and challenges. Key areas included the impact of policy changes, particularly the Most Favored Nation proposal, and the future trajectory of Keytruda, Merck’s flagship oncology product.

Key Takeaways

• Merck is dedicating significant resources to understand the implications of the Most Favored Nation proposal, which could impact international pricing.
• Keytruda, accounting for nearly half of Merck’s revenue, faces loss of exclusivity in 2028, but Merck plans to mitigate this through pipeline advancements.
• The oncology pipeline, including PD-1 VEGF bispecific and TROP-2 ADC strategies, is a focus for future growth.
• Gardasil’s performance is strong, despite reduced shipments to China, with continued growth potential in the US market.

Policy Landscape

• Most Favored Nation Proposal:

- Merck is actively preparing for the MFN proposal’s potential effects, which could address international pricing disparities.

- The proposal’s implementation details remain uncertain, with potential legislative requirements.

• Drug Pricing Delta:

- There is a significant price difference between US and European drug prices, varying by product lifecycle.

• Commercial Spillover:

- The impact of government channel pricing on commercial markets depends on reimbursement mechanisms.

Keytruda Performance and Future

• Current Performance:

- Keytruda generates approximately $32 billion, with an underlying growth rate of 11%.

- Recent launches are maturing, with future growth expected from new indications and geographies.

• Growth Catalysts:

- The subcutaneous formulation of Keytruda is anticipated to gain traction, though it may not significantly alter market share.

• Impact of the Inflation Reduction Act:

- Proposed regulations could affect pricing flexibility, but Merck aims to maximize accessibility.

• Loss of Exclusivity (LOE):

- LOE is expected in December 2028, with Merck focusing on pipeline development to offset revenue loss.

• Pipeline Progress:

- Merck’s phase three assets have tripled since 2021, with projected revenues of $50 billion by the mid-2030s.

• Patent Protection:

- Additional patents could extend protection into 2029, but biosimilar entry is planned for December 2028.

Oncology Pipeline

• PD-1 VEGF Bispecific:

- Merck is developing a molecule with potential advantages over anti-VEGF monotherapy.

- The focus is on maximizing patient benefit through combination strategies.

• AVANZAR Trial:

- Merck is developing a TROP-2 ADC, with results expected from AstraZeneca’s trial by year-end.

Gardasil

• China Impact:

- Gardasil shipments to China have been halted, but the region represents less than 1% of revenue.

• US Market:

- Gardasil grew 10% in the US in Q1, with significant room for increased coverage.

• One-Shot Regimen:

- Merck is monitoring ACIP discussions on a potential one-shot regimen, though FDA approval is uncertain.

For a detailed understanding, readers are encouraged to refer to the full transcript provided below.

Full transcript - BofA Securities 2025 Healthcare Conference:

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Off our next session. Thanks for joining us for this meeting. I’m Tim Anderson, the US Large Cat Pharma and Biotech Analyst at Bank of America. We have the pleasure of speaking with Merck today. Three folks on stage, Jani Oyslisen, did I get it right?

Who’s President US Human Health. He’s held this role since 2022. He joined Merck in 2014, serving in various roles internationally as well. Most recently led global marketing for oncology. And prior to Merck, you were at Lilly for a long time, think twenty years.

We have Doctor. Marjorie Green, Senior Vice President, Head of Oncology Clinical Development at Merck. She joined the company in 2023 from C Gen. And then of course we have Peter Dannenbaum, Investor Relations who many of you will have known. And Peter, you joined Merck, what year was that now?

2017. Okay, 2017. So we’re gonna start off with some policy questions and same questions you’ve heard me ask many others. And I know some of these will be difficult to answer. Lots of headlines on lots of different things MFN being the most recent topic.

How much time is that taking internally from you, let’s say?

Jani Oyslisen, President US Human Health, Merck: Yeah, it’s taking a fair amount of time. I think right now it’s a question of not just what are you hearing and seeing, but what are you potentially missing, right? So I think we definitely do spend a lot of time. We’ve got a small team set up across the enterprise to really catch as much as possible, start to think about what are implications, how do we need to think about it, does it become part of long term planning, etcetera. And just things we need to react to, but it does take a lot of time.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Marjorie, how much time is that taking for you? There’s FDA disruption in the mix as well, right? So maybe one of the questions for you is folks that you’ve interacted at the agency with, are some of those folks gone? We asked this question to Regeneron yesterday and they admitted, yes, some of the longstanding ophthalmology relationships are no longer there.

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: I think we have so many interactions because of our broad portfolio with the FDA that we’ve got good relationships with the depth of the different divisions. And so yes, some senior people are gone and have moved on, but there’s still a lot of continuity across the FDA for the interactions that we’re having.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Let’s start off with most favored nation, which obviously broke in full force on Monday. Your thoughts? Super high level question.

Jani Oyslisen, President US Human Health, Merck: Yeah, so at this point in time we probably have more questions than answers, right? It’s kind of in a way it’s a bit of round two given that the current president wanted to do this in his first term as well. So we’ll definitely learn more over the next few weeks as CMS probably start to engage on the topic and the list of to dos that they have. You know there’s the obvious questions like how is this going to work, what’s going to be possible to implement under an executive order versus potential legislation, will it have to go through congress, what elements will have to go through congress. So all of those are just questions in terms of how this is really going to shape up and how is it going to feature from an implementation perspective.

Is it just a means to get a negotiation with the industry going right. So I think we have a lot of questions in terms of what is the end goal and what is the real objective. Within that I think there’s some positive things. I think we’ve all struggled with foreign governments and countries outside The US not paying a fair share for innovation and reflecting the value of what we’re bringing to those markets. It’s been difficult to change that price policy from an industry only standpoint.

So I think having the US government engaged on the topic hopefully is positive and useful. And then some acknowledgement of the role that middlemen PBMs are playing in the market, right? And how much is being absorbed into the pockets of others within the system. And is there a way in which we can pull some of that back and really get it to patients ultimately?

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: So to achieve this equalization in price, at least a couple of companies yesterday did throw out if it’s possible, maybe it’s government to government and maybe that’s what you’re suggesting as It’s certainly hard to see drug companies being able to influence that directly. One question I’ve been asking companies is, this isn’t specific to Merck’s book of business, but just your longstanding perception, I don’t know, the last five years of the delta between net US drug prices and let’s call it developed Europe prices. You see numbers all over the place.

Jani Oyslisen, President US Human Health, Merck: Yeah. And it’s also a matter of where are you in the life cycle, right? Because we all we usually start much, much closer. And then in The United States, have an ability to increase price, whether it’s inflation increases or some would go beyond that. But in the rest of the world, it’s pretty much no price increase and more often continuous price decreases.

So you have a divergence that really gets increasingly bad over time. So it’s also a question of how recent was the launch. And then in the HDA markets, It’s really, it’s not a negotiation. Governments take a very firm position on what they believe is cost effective or what they’re gonna pay in this kind of take it or leave it equation. But the Deltas could be two X to 10 X, Across the industry.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Okay, so yesterday I published a simplistic scenario where I looked at all my covered companies and I said, no, we’re gonna assume a certain level of price cut across Medicare and Medicaid and flow through the numbers and hear what the earnings impact would be. Immediately we got feedback, oh, you’re not taking into account commercial spillover. And so that’s the question I have for you and you’re well qualified to answer that. And we’ve asked this of other companies, the company just before this felt there really wouldn’t be commercial spillover if MFN is applied just to government channels. That has been my view too, just because I think Medicaid shows there’s precedent for a government channel to get steeply discounted prices as much as commercial payers would love access to that price, they can’t get it.

So why would it be different if MFN was applied to Medicare?

Jani Oyslisen, President US Human Health, Merck: Yeah, and a lot of it depends on the reimbursement mechanism as well. You know if it’s rebates you know etc like certain Medicaid you can kind of ring fence it this earlier the conversation was you know if you do something in Medicaid it could bleed into 340B right which then becomes a much broader exposure beyond just Medicaid itself. So can you reinvent some of these? I think on the medical benefit products, when your product is ASP based in terms of reimbursement, the ASP does bleed into other segments in the market. And I think that’s where companies are saying that you might well see the price in Medicare ultimately impacting your ASP and that ASP affects your commercial business because the reimbursement is ASP based.

So might take a bit of time, but ultimately the ASP is gonna catch up across all your segments.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Okay, let’s move to oncology. There’s a lot to cover here and you’re both quite versed in this area from different perspectives. And this actually ties into some of this policy stuff, if you think about it from some of the IRA news yesterday. So Keytruda, biggest product, 32,000,000,000 this year, at least in our model, nearly 50%, five zero of total company revenues, It’s been doing absolutely fantastic and it’s growing 20 per year on average for the last five years. Q1 was soft, but there was some explanation behind that.

If you kind of strip that out, those one time effects, I think the underlying growth is more like 11%. But as we think about this brand going through ’twenty five into ’twenty six, into ’twenty seven, won’t that very strong growth trajectory likely continue as you continue to penetrate other indications, roll out in more geographies? Q1 looked like a slow number, but is there really any sort of slowdown ahead?

Jani Oyslisen, President US Human Health, Merck: Yeah, you’re right. I mean, Q1, there was some Q4 to Q1 inventory, channel inventory movements that bring down the absolute Q1 growth, but we still see good growth on KEYTRUDA. We will continue to see it. We continue to see indications coming forward. What we’re seeing right now is a lot of our launches from about twelve, eighteen months ago were starting to mature in terms of market penetration and share.

So we do need more catalysts to come in. So, know, more launches this year and beyond will continue to be the catalyst for growth in KEYTRUDA. So we will continue to see growth in KEYTRUDA. You know, some of these are smaller indications. It’s a big base, right?

So, you know, we need to take that into account, but we will definitely continue to see growth. And then we also have subcutaneous, which would be another, it’s not necessarily a growth driver, but I think it continues to build a positive momentum around the use and hopefully compliance as well.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Will SubQ help actually grow Merck’s overall share within that or will SubQ just most likely switch just from IV?

Jani Oyslisen, President US Human Health, Merck: Yeah, we believe that based on the broad clinical benefit in this class for products physicians first make a brand decision in terms of whether are they going to use Keytruda and then subsequent they will decide is it going be IV, is it going to be subcutaneous, right? So from that perspective, we don’t see SubQ to be a significant share contributor. But having said that, if it does help with broader access for patients and better compliance, we could well see some volume benefit if you could keep a patient to complete all their cycles, right? That is needed for instance in an adjuvant setting.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Yeah, okay. So the question I asked about growth, as you noticed, was up to 2027 or through ’27. So you get to 28 IRA kicks in most likely at the start of the year. There was news on this front yesterday now that in the proposed regulations that they will treat SubQ, Keytruda and products like that, that combine an active ingredient and an inactive ingredient as just the same as the parent molecule suggesting that the subQ would get subjected to IRA negotiation as well in that window. And the stock went down on that and Bristol went down and J and J went down as well.

Your views of that?

Jani Oyslisen, President US Human Health, Merck: Yeah. It is Did it

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: come with a surprise out of the blue or did you see the writing on the wall?

Jani Oyslisen, President US Human Health, Merck: We didn’t really speculate in the past. We looked at the previous rule from CMS which suggested that two active mobilities will define a different product and therefore the product will not necessarily be negotiated and that was our assumption for subcutaneous not being negotiated with IV. This rule to your point might well change that and it could be subject to negotiation. Having said that, you know our objective with SubQ has always been to bring it in in a way that physicians can use it, patients have broad access. So we were always going to price subcutaneous in a way to really maximize accessibility and reimbursement for SubQ use so that we can get the level of adoption that we think is needed in the market.

So what I’m saying is that effectively a negotiation of SubQ will not really change the financials for subcutaneous moving forward. We would have liked to have more discretion on how we price and have our own flexibility on what we do from a pricing perspective. This might be more of a given in terms of how we need to do it, but financially it’s not gonna be much of a difference to us.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Okay, so the next event past that implementation of IR is LOE, which I believe starts in December 20, so at the very tail end of the year, so functionally from ’29 onwards. How do you manage that as an organization? As I’d mentioned at the outset, this is a product that’s 50% of revenues, high margin, high priced product. So when we look at benchmarks for erosion of drugs like this, US and Europe that are injectable cancer drugs. We’ve got several of those.

It looks like it’s been running thirty, thirty five, 40 percent per year erosion. That’s a big loss. So what is the organization gonna do? That’s what’s weighing on the stock as you know, and that is fully in focus.

Jani Oyslisen, President US Human Health, Merck: That’s right. And you’ve heard Rob speak about this, our CEO speak about this quite often, right? I mean, that has been a big focus in terms of how we continue to develop our pipeline. That’s been a big focus in terms of how we’ve executed on business development and that’s what we continue to do, right? I mean if you look at our phase three pipeline now, the assets in phase three has almost tripled from 2021 until now.

So in the last three to four years we’ve seen a threefold increase in our phase three assets. And if you take our phase three pipeline by the mid 2030s on a non risk adjusted basis that is close to $50,000,000,000 in revenue that would come from this right with 25,000,000,000 from oncology about 15,000,000,000 in cardiometabolic, five billion in immunology and 5,000,000,000 in HID, right? So we really have strength in our pipeline sitting in phase three already that’s gonna start to come through. In this phase of LOE, what I would say is that we’ve never seen any product go LOE post an IRA, right? So there’s gonna be different price points even for biosimilars to contend with.

So we will have to see if the old analogs hold in terms of erosion. But having said that it is obviously a big step down in terms of higher negotiation and then additional volume loss. And we continue to focus on what we’re launching today. So the contribution that Winterbeare is making, the contribution that Gavaxif is making is already significant. And I think how we execute on our launches in the short medium term is going to be critical in terms of starting to offset and getting beyond the LOE for KEYTRUDA.

As Rob have said, that cliff is now more of a hill. It’s still a hill we need to climb and we’re going to do more to get through that LOE fast and get back to growth. But I think everything is focused, well the whole company is focused on solving for that LOE around KEYTRUDA.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Yeah, so Rob has described it, as you mentioned, a hill not a cliff. And that is in fact what our model shows. And I go back in my model frequently and I figure out are we making the math mistake because it’s not a cliff, it actually looks like a hill. But there’s the perception that it’s a cliff and that’s the difficult thing to change. Okay, so I mentioned LOE starts December 28, there’s an asterisk there, possibly.

You guys have a lot of patents on Keytruda. This is a subject that you guys don’t proactively bring up, but there’s certainly plenty of precedent for biosimilars to get delayed. So with Humira, we’ve seen it with Spillara, Sanofi talks about it possibly happening with Dupixent. We saw Regeneron take companies to court on Eylea. Why won’t this be something that possibly pushes out the entry of biosimilar?

Jani Oyslisen, President US Human Health, Merck: Yeah, I mean for now, can comment on that as well. For now we are for planning purposes we assume the compound patent in 2028 as the date when biosimilars will come There are two patents that probably could be extended through 2029. I think it’s May and November that is related to some of the original patents that were filed and where the patent office took some time. There were some delays so could we benefit the timing aspect that extend beyond the 2028 date into ’29. So we could see some of that but for our planning purposes we assume that biosimilars will enter around the expiry of the compound patent.

Peter Dannenbaum, Investor Relations, Merck: Yeah, just to be clear on that. So our 10 back in March disclosed two additional patents that the patent office granted us. One was manufacturing, one was a formulation process patent that extend into, I think it’s May and November of twenty twenty nine. They will likely be challenged. So they may or may not hold up.

Our expectation and our planning is all under the assumption that biosimilars enter in December of twenty twenty eight.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Yeah, okay. I neglected to ask one question I wanted to on the SubQ, Keytruda, which is really in the ex US markets. You guys have given guidance for the rate of conversion in The US, but how should we think about the conversion from IVSubQ and international markets?

Jani Oyslisen, President US Human Health, Merck: Yeah, mean, we see it pretty much in that same range. We talked about 30 to 40%, some markets could probably be a little bit lower, some higher, But the 30 to 40% is really around you know where we see the indications of Keytruda in terms of monotherapy Keytruda which obviously could easily be a place where you would use SubQ and that could be in metastatic disease. It could be in early stage, especially in the adjuvant phase. It could be in combination with orals, right? Where there’s no other product being infused.

But then in Marjorie made the point earlier today, even in the metastatic setting, it could still save the practice’s time to have a two minute injection of the subQ and still give the patient the other infusion, right? So I think there’s potential for a lot of efficiency in terms of how practices are running their business too. But we kind of see the conversion or the adoption at some of the rates.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Okay, I wanna shift to a different oncology topic and Marjorie, you’ll probably be the one that answers this. PD-one VEGF bispecific. So that is a category suddenly on the map in a big way and viewed as a concern for Merck as possible competition to Keytruda because there is a head to head trial or one or more going on at the moment by Acasso and Summit. And everyone’s waiting with bated breath to see these next data updates on that approach. So there’s that product, ipanisumab is in the lead, there’s others behind it.

And you guys in fact, picked up a molecule in this space as well. So what I’ve seen Merck do sometimes in the past, feel like is take out insurance policies. So CTLA-four is a good example where I felt that the company was always denigrating CTLA-four, yet it had one in development possibly as a hedge. Is that what this is for you guys? Or is this something that you fundamentally believe in as an approach?

And if it’s the latter, then it’s a potential concern because others are ahead of you.

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: There’s a lot to unwrap in that question. So I think from a scientific standpoint there are reasons to believe that in the bispecific if you think about it preclinically what you’re doing is we know that VEGF is immunosuppressant and you can get T regulatory cells that get upregulated in the presence of VEGF. You can see problems with the tumor microenvironment. There are dendritic cell effects of VEGF. And so this is why anti PD-one or PD L1 and VEGFs have been studied so broadly including studies that we’ve done at Merck and by combining these into a bispecific there are potential advantages of the VEGF being able to do more to the immunosuppressant activity as well as providing local anti VEGF activity against blood vessels and improving the tissue microenvironment with less of the systemic issues of a free range VEGF drug and also potentially enhancing the PD one or PDL one depending on the the bispecific in what you do.

And so preclinically, it’s very interesting biology. Our portfolio is compromised of, compromised is composed. That’s the word. It’s not compromised. It’s composed of multiple drugs that have single agent activity that are combinable and we want to be able to follow science and go okay we want to be able we know that Keytruda is foundational, PD-one therapy PD L1s are foundational Keytruda in particular in multiple tumor types and we have drugs that can go across multiple tumor types.

So if there is something that scientifically makes sense we want to be able to combine with our assets to be able to buy the greatest benefits for patients. It gives us optionality in our portfolio and how we develop our drugs. If it turns out that these drugs are fulfilling the promise of some of the initial PFS data that’s been seen out of China, we’ve shown that we can come from what we perceived as behind a development plan multiple times, definitely with Keytruda. But also if you look at our Sac TMT portfolio, we came third to market. There are two that are on the market that we have a very robust development plan and are differentiated through how we develop our drug.

So I think we’re in a really good position, because of the molecule we’ve picked, our understanding of the biology of PD-one therapy and VEGFs and really can make a difference. So if this does work preclinically, it does. The initial data is very encouraging that both the cases Summit and BioNTech have generated. We’re in a really good position.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: So the big question of course is, is this very nice looking PFS benefit gonna translate into a survival benefit? And if you just look at the history of anti VEGFs in lung cancer, it’s a mixed bag on that front. You have some trials that have shown a survival benefit, others that haven’t. Dean has flagged this before as a big question mark. So do you wanna put forth a guess?

Are we gonna see a survival benefit translate? Do you think it’s high risk that it doesn’t? Do you think it’s likely that it does? How are we thinking about it?

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: This is different, I think, from what we’ve seen with both Avastin as well as the VEGF TKIs because of that fundamental structure in biology and the preclinical benefits. So I think it’s an open question. I’m not really a gambler per se, even though we are in Las Vegas. But thinking about what you’re seeing is when you look at all of the data generated to date, the efficacy that’s being produced is more robust than historically was seen with previous generations of drugs, which does give you some hope. I think people there was a big reaction to the the Harmony two, that the labeled data that got snuck in that 39% information fraction.

And I I think that analysts who do wonderful modeling had predicted the hazard ratio for us to be somewhere between 0.7, zero point eight, and that’s where it was. And then there was a huge negative reaction. So I think it’s too early to tell. We don’t know what the curves look like. Are they gonna come together?

But some of the worry in the past with VEGF inhibitors have been the toxicity associated with it. Is that contributing to the OS? And again, because of these structures and the way that these are dosed, you may not have that same issue. So I think it’s an open question still.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: One of the things that strikes me about this is who’s leading the charge here? So it’s a Kessel and Summit, it’s BioNTech, you guys have a compound. Where’s the other majors in this space? We don’t see a lot of other big established oncology players with compounds in this class yet, which begs that question, is this more of just an insurance policy for you guys, or do you really believe it?

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: I wanna be able to maximize benefit to patients with our portfolio, and so this gives us the option to do that.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Okay, let’s shift to another possible threat to Keytruda, which comes up, which is the AVANZAR trial from AstraZeneca. So head to head with ERTROP-two versus Keytruda frontline lung, that data comes out maybe around end of the year. Should we be nervous about that?

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: I look at you, we have a TROP-two ADC that we’re developing, I think in a different way than both Gilead and AstraZeneca Daiichi have been developing their drugs. I’m very confident in our ability to find clinical value for patients and therefore for the health care systems, payers and company with our development strategy. There’s still unmet need in the frontline non small cell lung cancer space. So as an oncologist, I want to do better. I think we all want to do better.

So I look at this as an opportunity. Antibody drug conjugates, do have a cytotoxic payload. They’re not sort of kind and gentle medications necessarily. When you add platinum based therapy on top of it, there is the potential to have compromise in your dosing and your ability to stay on regimens. And so I think that our frontline strategy of both combining with pembrolizumab and using the knowledge we have from our extensive pembrolizumab studies and how we’ve designed our studies and designed our inclusion criteria helps us.

In addition, we have a maintenance strategy approach, which really is designed to keep that benefit going long term for patients to get additional responses, those people who have stable disease. So I think that we’re in a really good position. And I look at this as a great time for patients ultimately because of the innovation that’s happening with antibody drug conjugates.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: Great, okay, let’s move to a couple other disease areas in the remaining time, which is not a lot, just vaccines, GARDASIL of course has been a focused product because of the slowdown in China. And I know you’re responsible for The US market at the moment, but you have some perspective probably on what’s the latest is in China. The guidance has been expected to be slow going forward in China for the time being, is that still the current thinking?

Jani Oyslisen, President US Human Health, Merck: Yeah, I mean, assume no further shipments into China for the remainder of this year, right? So I think we de risk the Gardasil number. It’s less than 1% of our total revenue now sitting in Gardasil. What I would say, Tim, is outside of China as we saw in the first quarter, I mean we still have like 16% growth of Gardasil and then the rest of the world including The United States we grew Gardasil ten percent in the first quarter so that makes it rest of the world outside of China greater than 16% of growth. There still is a lot of opportunity, right.

I mean we’ve been I would say save lives for the last ten years you know with HPV vaccination and we’re still sitting at only about ten fifteen percent of patients being covered with this vaccine. So there still is a tremendous opportunity and we obviously continue to work whether it’s an Alimai low low middle income countries, whether it’s the adult segment in Europe, where there’s still room for, whether it’s in The United States still completing the series as well as further penetration beyond the seventy five, eighty percent that we see today, there’s still a lot of opportunity for

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: A SIP in The US is gonna be discussing the idea of only giving one shot of Gardasil. And there is data out there, think it was WHO study recently that showed that you get pretty much the same efficacy with one shot versus giving two or three, which is current standard and that’s current label in The US. So if that were to happen, I mean is the competitive response just to double the price of Aracel?

Jani Oyslisen, President US Human Health, Merck: Well, we’re going to take a measured approach, right? We will see where ACIP land. There’s been about 10 different scenarios being discussed by the working group. The recommendation could be gender specific, it could be different across different age cohorts, it could be shared clinical decision making at the end of the day. We have a bit of a different view in terms of the data set being used and the FDA I think has a different view as well.

Evidence being put forward for ACIP is not evidence that FDA would for instance accept to change the label, right? So I think there are some big question marks in terms of the bar that is required to make this change. This is a vaccine that works exceptionally well but there are real differences between males, females between ovarian versus cervical versus head and neck cancers. We continue to engage on this and we’ll see where this lands.

Tim Anderson, US Large Cat Pharma and Biotech Analyst, Bank of America: I have about 10 really important questions, but we’re out of time. So we’re gonna call it there. So I wanna thank you, Yoni and Marjorie and Peter for presenting at our conference this year.

Jani Oyslisen, President US Human Health, Merck: Thank you very much. Thank you.

Marjorie Green, Senior Vice President, Head of Oncology Clinical Development, Merck: Thank you all.

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