Warm welcome to everyone joining us for this update call on our announcement today to acquire SpringWorks Therapeutics. My name is Florian Schröder. I'm the Head of Investor Relations at Merck. I'm delighted to be joined by Belén Garijo, Group CEO, Peter Guenter, CEO Healthcare, and Danny Bar-Zohar, Designated CEO Healthcare. In the first few minutes of this update call, we would like to guide you through some key slides we published this morning. After that, we would be more than happy to take all of your questions. With this quick introduction, I believe we are ready to begin. Over to you, Belén, to kick us off.
Thank you, Florian. Hello, everyone. A very warm welcome from my side to this call. I will make a brief introduction to then hand it over to Peter and to Danny for further details on the planned acquisition. As you may have seen from our announcement this morning, we have signed a definitive agreement to acquire SpringWorks Therapeutics for $47 per share. You will find the key metrics and the timelines on this slide. Allow me to simply provide some context to what you have on the slide. First of all, let me tell you, we are genuinely excited about this deal. This deal is a clear testament to our ambition to pursue acquisition in innovation-driven growth areas. Most importantly, it is addressing the long-term growth sustainability of our pharma pillar.
This follows our successful acquisitions last year, such as Mirus Bio in viral vector bioprocessing, and Unity- SC in optronics, together with the announcement of the investment of Surface Solutions. SpringWorks is an emerging leader in rare oncology and really aligns very nicely with our external innovation agenda in healthcare, where licensing remains the base case. This acquisition is bringing us a significant step closer to achieving our long-term guidance of mid-single digit for healthcare. We also see a compelling strategic and financial value on this deal. Our healthcare portfolio will be strengthened by two recently approved products that address high unmet medical needs. Most importantly, we anticipate immediate top-line acceleration in healthcare, and we expect the deal to be attractive to group EPS by 2027. While the transaction will be funded with new debt, we will maintain significant balance sheet flexibility for future larger deals.
As you know us, you will understand that we will continue to adopt a very disciplined and unhurried approach in line with our M&A guidelines. Just to emphasize, the priorities around M&A that we have communicated several times before have not changed. We plan to use the majority of our M&A capital to support the long-term leadership of our life science business. With that brief introduction, as I mentioned, I only want to emphasize that this is important for our entire Merck Group. To provide additional insights on what the deal means for our healthcare business, I now give the floor to Peter.
Yeah, thanks a lot, Belén. Also welcome from my side to the call. What I'd like to do is expand a bit on why we believe that this planned acquisition of SpringWorks represents really a highly compelling opportunity for value creation and that it fits really seamlessly within our healthcare strategy. We're actually expanding into a highly attractive and innovative rare tumor space, which perfectly complements our existing pipeline. Importantly, very important, this is a de-risked transaction, as both products have already received FDA approval. These assets will immediately accelerate top-line growth for our healthcare business while offering attractive medium-term margin profiles. We're not just acquiring two great assets. We're also bringing in a strong organization with excellent rare tumor capabilities. This expertise will be invaluable as we continue to build our presence in this specialized therapeutic area.
Finally, we can clearly see sustainable value creation through geographical expansion and further U.S. reinforcement. I want to emphasize that we don't stop here. This acquisition provides an attractive foundation for more assets in this space as we continue to build our rare tumor portfolio. Now, let me introduce you to SpringWorks. This is a remarkable company with two exciting assets that address significant unmet needs. The first asset to the left of the slide is Ogsiveo, the first in disease therapy for desmoid tumors, FDA approved in November 2023. Our established commercial infrastructure and global footprint will be instrumental in taking this launch to the next level, both in deepening U.S. market penetration and executing successful international launches. While the initial launch has laid a solid foundation, we believe there is substantial untapped potential. Launching a first-in-disease therapy in a rare tumor indication requires scale and requires reach.
Given the significant unmet need and strong clinical profile, we see clear blockbuster potential for this asset when backed by our commercial capabilities. If you move to the right part of the slide, Gomekli. This is a first-in-class therapy for adults and a differentiated option for pediatric patients with NF1-associated plexiform neurofibromas. Gomekli received FDA approval in February 2025, and we're seeing initial signs of positive uptake, suggesting also here near blockbuster potential. By combining SpringWorks' innovative products with our global reach and commercial expertise, we're confident that we can maximize the potential of these assets and deliver meaningful benefits to patients worldwide. Let me hand it over to Danny.
Thank you so much, Peter. I'm truly excited about this acquisition and have had also the pleasure of working closely with you over the past couple of months on this deal. I can only echo that this is absolutely the right move, both strategically and financially. Now, let me give you some more color and dive deeper on Ogsiveo, for which we clearly see blockbuster potential. In the U.S. alone, desmoid tumors affect approximately 30,000 patients with something between 1,000 and 1,600 new cases annually, causing chronic pain and severe debilitation. Of note, approximately 11,000 patients are actively managed, and there are very similar numbers in the EU. Ogsiveo, an oral gamma secretase inhibitor, is the first and only FDA-approved therapy for adult patients with desmoid tumors who require systemic therapy.
It has become the new standard of care in the U.S. relatively quickly, achieving 90% penetration in new patients requiring systemic treatment with just one year post-launch. Previously, these patients, particularly post-surgery ones, have traditionally been managed with off-label prescription of tyrosine kinase inhibitors and chemotherapy, which have either limited evidence and/or are associated with significant toxicity. The product also quickly gained a spot in the NCCN guidelines, generating strong excitement within the healthcare community. Now, indeed, while the launch of Ogsiveo has been progressing well, we recognize that it can be challenging for a biotech company with slightly more than 300 employees to launch two products in the U.S. and simultaneously prepare for further launches in other regions. That said, given the integration timelines and restrictions until closing, we anticipated some volatility in the next couple of quarters..
However, we are eager to join forces with SpringWorks and take this launch to the next level immediately upon closing. One more point, as you can see at the bottom part of the slide, ex-U.S. resubmissions are taken into account with CHMPs expected in this quarter. Next slide. This gives us a taste of the robust data behind Ogsiveo that will enable us to be successful. The randomized placebo-controlled DeFi trial showed a 71% reduction in the risk for disease progression, with consistent efficacy on a set of tumor-related response endpoints, as well as patient reports. These data points have been further strengthened in a long-term follow-up with meaningful improvements in ORR and further reductions in tumor sizes, median treatment duration of slightly less than three years, and manageable saving time.
These durable results further strengthen Ogsiveo's value proposition in transforming desmoid tumor treatment, and I would say underpin our confidence in the blockbuster potential of this asset. Next one. Now we will turn our attention to Gomekli, which is the second exciting asset from SpringWorks. Gomekli represents a first-in-class therapy for adult patients and a differentiated option for patients with neurofibromatosis type 1-associated plexiform neurofibromas. Plexiform neurofibromas associated with neurofibromatosis type 1 are rare, very difficult to treat nerve sheath tumors that, depending on their location, cause chronic pain, disfigurement, seizures, loss of function, and vision impairment. The condition has a profound impact on patients' quality of life, particularly for children. In the U.S. alone, approximately 40,000 prevalent patients live with NF1-PN today. This includes approximately 10,000 pediatric patients with significant unmet need and 30,000 adult patients who previously had no approved alternative.
The annual incidence of approximately 500 new cases adds to this population with very high unmet need. Gomekli, an oral MEK 1/2 inhibitor, received FDA approval for NF1-PN fairly recently in February this year. It is already included in the NCCN CNS guidelines, and we're seeing initial signs of strong uptake based on prescription dynamics, access, and coverage, and also stakeholder feedback. Based on the clinical profile and the market opportunity, we see with Gomekli a near blockbuster potential. The potential EMA approval in 2025 will be a key milestone in expanding access to this important therapy for patients outside the United States. In this slide, I will show you reasons to believe in this product, and this is based on compelling clinical data from the ReNeu study that supports Gomekli's strong potential in both adults and children with NF1-PN.
This data formed the basis for the FDA approval and demonstrates the significant clinical benefit that Gomekli provides to patients. Looking at the upper half of this slide, you can see the impressive progression-free survival data in children with plexiform neurofibromas, with median progression-free survival not reached at 36 months for Gomekli-treated patients, compared to 12.8 months in the agreed-upon historical control cohort. The study also demonstrated highly meaningful response rates of 41% in adults and 52% in the pediatric population. Deep responses, defined as volume reduction of plexiform neurofibromas from baseline to more than 50%, were achieved for 62% of the adults and 52% of the children with confirmed response in the trial. Now, beyond the compelling efficacy of tumor measures, as well as quality-of-life parameters, we see two important differentiators. One, the oral disintegrating tablet, which is super attractive for the pediatric population.
Second, the intermittent dosing, which we believe helps maintain high efficacy while controlling some bothering tolerability issues such as GI effects. Moving on to the next one and zooming out a bit, I'd like to highlight how this potential acquisition, proposed acquisition, strategically enhances our portfolio and capabilities. This acquisition complements our existing pipeline exceptionally well, particularly with our pimicotinib program, where we recently exercised our option for worldwide rights, and also our anti-GD2 ADC, which is currently under development. Just to give you an idea about this complementarity, up to 50% of Ogsiveo's healthcare professionals overlap with those that we are targeting for pimicotinib, creating quite significant commercial synergies. SpringWorks brings deep rare tumor expertise, strong commercial assets, and durable IP protection for their key programs. The complementary nature of our organizations creates a stronger combined entity with enhanced capabilities to address significant unmet needs.
In addition, the acquisition also lays the foundation for further potential expansion into other rare tumors. Now, rare tumors are particularly attractive for us as a mid-sized pharma company because they do reflect areas of high unmet need and typically have shorter development cycles. Assets in these areas often require a partner who has the financial muscle and commercial capabilities, yet is agile enough for a niche play, which nicely reflects our strength as a strong mid-sized player with deep commercial experience. We're positioned in this sweet spot, we believe, not too small to lack impact and not too big to lose the focus, allowing us to be both powerful and nimble in these specialized markets.
Last, but certainly not least, slide 11, I think I'd like to highlight the strategic geographic fit between our organizations and how this combination will maximize the potential of our current and future rare tumor portfolio globally. SpringWorks immediately strengthens our presence in the U.S., the world's largest pharmaceutical market. SpringWorks is already preparing for ex-U.S. launches, which our global footprint will accelerate. Our established infrastructure in Europe and also key Asian markets provides the ideal platform to bring Ogsiveo and Gomekli to patients worldwide. The combination of our complementary geographic footprints serves as a, I would say, a beachhead opportunity, facilitating, as we said before, further expansion into rare tumors beyond these initial assets.
In summary, this acquisition of SpringWorks represents a major opportunity for our healthcare business, bringing two differentiated commercial products with blockbuster potential that address significant unmet needs in rare oncology while establishing a strong foundation for future growth in this attractive area. By combining SpringWorks' innovative therapies and specialized expertise with our global infrastructure and commercial capabilities, we are confident that we can maximize the potential of these assets both in the U.S. and globally, creating substantial value for patients and shareholders alike. Let me hand it back to Belén for some concluding remarks.
Thank you, Danny. We are going to move to the Q&A in a second. Allow me, before we do that, to summarize the key elements. First of all, we are truly walking the talk. This planned acquisition represents a significant step towards our ambition of achieving mid-single-digit growth of our healthcare business. It is strategically and financially very robust. Second, we stayed very disciplined and consistent. Exactly what we have told you, we have delivered on the profile, on the level of risk, on the returns, etc., etc. We have secured an attractive valuation when comparing enterprise value to assets with around blockbuster potential. We have partnered with an exceptional company in SpringWorks that allows us to leverage our globally established and proven commercial capabilities. Yet, we maintain significant financial firepower for future inorganic growth opportunities in life science.
With this, let me now hand it over to Florian to kick off the Q&A.
Thank you, Belén. With that, we are now ready for the Q&A part of the call. Heidi, we are now ready to take the first question, please.
Thank you. We will now begin our question and answer session. If you have a question for our speakers, please dial star 11 on your telephone keypad now to enter the queue. Once your name has been announced, you can ask a question. If you are using speaker equipment today, please lift the handset before making your selection. One moment, please, for the first question. Your first question comes from the line of Matthew Weston from UBS. Please go ahead. Your line is open.
Thank you very much. Two questions, please. The first is around financial assumptions for the deal. You've obviously given the timing for where you see it being EPS accretive. Can you give us any indication of how much cost synergy we should assume in the transaction, and also the actual integration costs that we should assume you're going to take, and what proportion of that is going to be cash? The second question is one for Danny. Danny, Immunome's varegacestat is due to report phase III data in the second half of this year. How did you get comfortable with Ogsiveo's peak sales potential, given the potential for competition in the near future, especially where phase II headline data, albeit in a small number of patients, appears to be better than SpringWorks?
Matthew, with your permission, I will start with the second one and then hand it over to Belén. Is it okay?
Yeah, of course.
Point well taken, and thank you for that particular question with regard AL102. first and foremost, it is important to go a little bit backwards and talk about, first of all, Ogsiveo itself. In a randomized controlled phase III trial with 140 patients, it showed a clear PFS reduction, 71%. Highly statistically significant, with a variety of beneficial effects on PROs and a manageable safety profile. There is also, if you noticed, an extension to this trial presented a couple of months ago, with median treatment duration of more than 30 months and further even deepening of the efficacy on the long term.
Now, obviously, we are taking the potential second-in-class that you mentioned seriously, but we believe that given the first-mover advantage that Ogsiveo has, clear first-mover advantage, and the experience from an HCP perspective, SpringWorks and eventually our presence with patients and prescribers, we will be able to bring Ogsiveo into a great path in the U.S. and outside of the U.S. Now, it is very hard to compare, as you said, data from 14 patients in a phase II and 140 patients in a phase III. Also, we make note that we are not comparing actually the registrational endpoint here. The registrational endpoint is PFS, and this is a benign tumor. We will let the actual data talk, and we will rely on our first-mover advantage, very strong position with HCPs, and very compelling data that Ogsiveo has.
Okay, Matthew, let me address your question on the financial assumption, cost synergies, etc. First of all, let me say that this is not about cost synergies. We are confident that the combined business will unlock significant value by fully leveraging our global expertise and reach to deliver SpringWorks therapies to more patients and to ultimately maximize their full potential. Further, there are existing portfolio complementarities and synergies, for example, with pimicotinib and with some of the assets that we are developing on our internal pipeline. We will continue definitely feeding the baby, right, and adding external innovation in this particular nucleus that we are moving towards. In terms of cost synergies, you can expect some small cost savings coming mostly from global sanctions, but no more than this. I believe this is basically answering everything. If this is not the case, let me know.
Can I just follow up on that one, please, Belén? In the past, when you've talked about EUR 1.6 billion of R&D in pharma, there's always been a suggestion that that would allow you to also accommodate some in-licensing of future assets that you had planned. Now we see, let's call it a big in-licensing. Are we still to assume then that we add the Spring R&D spend to Merck pharma spend, or that you will be able to absorb some of the Spring spend within that EUR 1.6 billion budget that consensus has baked in in the midterm?
I mean, we are going to let me offer the high-level perspective to confirm that we are going to continue to operate on around 20% R&D ratio on sales for healthcare overall.
Okay. That's many things.
That's my answer. Yeah.
Right. Just to complement on that, you know that our percentage to sales in the last year after the phase III setbacks has been lower than that, and that's perfectly fine. To begin with, the introduction of the R&D expenses for SpringWorks will kind of offset that, but we will continue with this discipline of around 20%, and we will make the necessary pipeline and portfolio adaptations and prioritization.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead. Your line is open.
Hi there. Thanks for taking my questions. The first one is just a big picture, just if you can give us some idea on the commercial due diligence you've done around both assets and perhaps a bit more detail. When you talk about these as de-risked assets, they clearly are from a data perspective, but the deal valuation, guess, prior SpringWorks market valuation suggests the market didn't or doesn't believe the EUR 1 billion peak. Perhaps some color you can give there and perhaps some color on how competitive the deal process was. That would be helpful. The second is you didn't, Peter or Danny, touch on the midterm guidance within Healthcare. How does this deal change that in your aspirations from accelerating from low single digit? Thirdly, this is for Belén. I apologize for the question.
It's not directly related to the deal, but it's the first forum to address. I wonder, Belén, whether you could just touch on the German press speculation around management change if you had any comments there. Thank you.
Let me start with your question, Sachin. Hi. Thanks for the question. During the due diligence process and the assessment of the potential of both products, we have performed a very, very thorough and deep bottom-up assessment of the potential, looking at it from each and every angle and particularly staying true to the data and making the necessary diligence for that. As we said, we truly believe, we wholeheartedly believe in the blockbuster potential of Ogsiveo and in the, I would say, near-blockbuster potential for Gomekli. This is and the deal and the price that was proposed, the $47 per share, reflects that valuation clear-cut. There is also a premium there that you could calculate as well. Now, when it comes to the financials, this deal will be top-line accretive as of closing, I would say.
As Peter said, it will be modestly dilutive to EPS in 2025 and 2026. In 2026, it will be, I would say, close to break-even or slight profitability, and it will be accretive to EPS as of 2027. I hope that it gives you more color on that.
Sorry, Sachin. Let me take your second question. We won't give you any specific details, but what I can tell you is that, obviously, this planned acquisition is definitely a big step towards our aspiration of mid-single-digit growth.
I would take the third question. As you rightly said, these are speculations, so we don't comment on speculation, Sachin.
Okay. Thank you. Can I just go back to Danny on commercial? Perhaps any further color you've got on what you've assumed around the competitive landscape? Related to Matt's prior question on Immunome or Koselugo getting an adult label and just what you're assuming from a penetration perspective, that might be helpful. Thank you.
We have taken into account Immunome's compound, AL102, into the assumptions of market share. We will not be able to share these numbers, as you can imagine. For Gomekli, we have taken into account as well the competition on the pediatric segment and as well the, I would say, assumed potential launch in adults. Everything is baked into the case and into the valuation.
Thank you so much.
Thank you. We will take our next question. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead. Your line is open.
Great. Thanks for taking my question. I've got two, please. Firstly, can you give us an idea of the location and the production of the SpringWorks assets, just thinking about potential exposure to tariff risks and how simple it could be to move production around into the relevant countries to reduce any risks here? Secondly, you mentioned 19,000 patients with desmoid tumors are not actively managed. How can you potentially get those patients onto therapy, and how important is that population in order to get to the blockbuster potential that you'd mentioned? Thank you.
Yeah. Thank you, James. Let me address the tariffs exposure because, as you may imagine, in this turmoil that we are living, we have been very carefully looking at this during the whole process. To conclude, the impact of tariffs, in this case, is modest, and this is depending on the way the supply chain is structured. Number two, go ahead, Danny.
Just to add to that, as you know, these are small molecules and rare diseases, so the volumes are slow. That's the basis behind the modest impact. Now, regarding the 11,000 patients, the 11,000 patients are actually a combination of, first of all, newly recurrent patients and incident patients, and they are the overall amount of diagnosed patients according to the ICD-10. Some of these are patients that are underweight and sick. Now, as you know, the trend has been to move from surgical interventions that have their own morbidity and mortality to systemic therapy. We saw that already a decade ago, and it further enhances with the introduction of Gomekli.
Now, we will need, and this is where the power and the muscle of Merck to add to the SpringWorks scheme, we will need to mobilize these patients further and make sure that the physicians and the patients understand that delaying treatment too much can cause actually irreversible procedure-related or surgical-related complications. One could even think about giving this therapy before surgery, and we have started seeing that in order to make the surgical procedure smoother and with less complications, particularly when you're talking about intra-abdominal tumors.
Thanks . Just one quick follow-up on that last point there, Danny. Is there any plans to start a clinical trial there to potentially sort of back that up with some more sort of robust evidence to sort of really help to drive that? Secondly, also on the tariff impact, just to confirm, is the IP based in the U.S. for the asset?
Yeah. The IP is confirmed in the U.S.
Thank you.
In terms of, let's go to the first one, and then I will touch the IP, or maybe I'll try to close this issue as well. When it comes to additional clinical trials, we have also baked in in our assumptions additional phase III- B and IV activity to generate additional differentiating data and will be in the forefront. We have this first-mover advantage, and we intend to keep it by, first of all, generating data and getting closer to the HCPs and to the patients. This data, further to what you have seen in the long-term extension with treatment durations of almost three years and deepening of the responses, is super, super important. We will look also in those patients that are about to get surgical intervention in order to prevent that.
Now, regarding IP, in the U.S. for Ogsiveo, we're talking about an orphan drug exclusivity. This is seven years. For Ogsiveo, we're talking about 2031 and 2032 for Gomekli. However, if you dig deeper, you will see that there is, I would say, quite an arsenal of additional secondary patents that we believe that they are strong enough in order to push this much beyond the regulatory exclusivity.
Excellent. Thank you.
Thank you. We will take our next question. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead. Your line is open.
Thank you very much. On your comments on Ogsiveo, you made some comment that you expected some volatility in coming quarters. Is that just a general comment related to a biotech launch, or have you identified some drivers or moving parts in the market that means that we should lift the volatility here? The second question is just, have you factored anything for additional indications for Ogsiveo and Gomekli in your assessment of the deal? The same thing for the early-stage pipeline. Is there basically anything for the pipeline, or is it just existing indications, there is indication for the drug that is affected in the deal value? Thank you.
Thank you for the questions. I will take one regarding the volatility that I mentioned. We need to remember that this is, as I said at the beginning, a company with slightly more than 300 employees having to manage two launches at the same time in the U.S. and also building outside of the United States. With all of this and the transaction coming, I think that one could expect some volatility in the first and the second quarter. This is, again, to Peter's point, this is exactly where we would intervene as fast as possible when the deal is closed to deepen the penetration in the U.S. and to open the gates in Europe after approval. Now, regarding additional indications, currently, there are two LCM opportunities, the ongoing trials in low-grade gliomas by SpringWorks and additional phase II studies, early studies. We will look into the data.
We have not factored them into the business case. The value of this deal is derived exclusively on the commercial potential in the desmoid tumor and NF1-PN. One could think about potential combinations with targeted therapy in oncology. We will look into that and will take decisions as appropriate.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Peter Verdult from BNP Paribas. P lease go ahead. Your line is open.
Yeah. Hi, Peter Verdult here, BNP. Just a couple of follow-ups from questions that were asked earlier and one on Peter . Danny, I think you made some comments on IP and that exclusivity ends in 2030. Please remind us the strength of that IP that goes, I think, into the next decade. Also, Peter or Danny, I think you did not answer Sachin's question. How competitive was the bidding process? I realize you cannot talk about individual companies, but I would like to get a sense of how competitive the process was. To Peter and Danny on pimicotinib, what is the earliest you think you might be launching pimicotinib in the U.S.? Because we have had good feedback on the SpringWorks assets like you have, but pimicotinib as well. I just want to know the earliest you might get that asset launched in the U.S.
Thank you.
Yeah. Regarding IP, yes, again, for Ogsiveo, we're talking about regulatory data protection, orphan drug exclusivity until 2030 in the U.S., and the plus 10 years from approval in the EU. We expect the approval to come in a month or two. Now, when it comes to the secondary patents, there are patents in the Orange Book that take Ogsiveo to 2043. You can look into that. We cannot share the exact time of patent cliff, but this goes way beyond, I would call it, the 2030, way beyond.
On behalf of Peter, first of all, this is a very compelling offer, representing a 26% premium to the share price value in February, right before the potential acquisition speculation generated tons of volatility to the share price of SpringWorks. Number two, discuss unanimous board approval. Number three, over the process in which we have been engaging with SpringWorks, we are absolutely convinced that the time is optimal to engage a partner to leverage the commercial muscle of the partner in order to be able to drive the launches. We are that partner. You never say never to anything, but we believe this is very, very solid and a very compelling offer to the shareholders.
Yeah. Also, to add that SpringWorks will be putting out their proxy statement in due course, and you'll be able to see the background of the transaction. Regarding pimicotinib, in the U.S., we are aiming towards mid-2026 based on the data and the regulatory interactions that we're having.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Your line is open.
Good afternoon. Thank you very much for taking my questions. Two, please. First, to come back on a comment from Peter on Ogsiveo. Peter, I think you said that the product already enjoys 90% penetration in the U.S. Please, could you clarify on this point? Of course, with 90% penetration, what's the remaining opportunity for this product in the U.S.? My second question is a big picture question. I was just wondering that since the launch of Ogsiveo in the U.S., do you see more, let's say, opportunity to diagnose more patients as you have more treatment options for this disease, or is it, for instance, you keep the same assumptions for the total eligible population in the U.S.? Thank you.
Thank you, Florent. Maybe I will clarify regarding the 90%. The 90% is out of the denominator. There is the newly diagnosed patients. And these are something between 1,000 and 1,650 that we see in the U.S. every year. The landscape of actively managed patients, as we said before in previous questions, was 11,000, and these are the patients that we need to continue working on. To the other question, in terms of the potential, the answer to your question is yes, definitely yes. We believe that there are still many patients that are underdiagnosed because the diagnosis is delayed. You need a biopsy. When the tumor is very easily located, you can easily perform a biopsy, but when it's hidden in the abdomen, it's likely more complicated.
Once there are therapies and once there is a safe and efficacious systemic therapy, we believe that there will be mobilization that will enhance the potential of this drug.
Thank you very much.
Thank you. We will take our next question. Your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead. Your line is open.
Thank you. Thank you very much for taking the questions. Just firstly, a quick clarification on tariff exposure. I think this is clear, but I just want to double-check. The comment in the SpringWorks 10-K about a portion of their manufacturing taking place in China, should we assume, based on what you said, that that is active substance rather than finished drug product that's being partially made in China? Secondly, thinking about the other indications potentially for Ogsiveo, I wonder, Danny, specifically if you could talk about the opportunity in multiple myeloma, which currently is being investigated. A commercial question about Ogsiveo. If we look at the quarterly progression of revenue, there's a strong and nice positive trend there. If we look at the prescription data, be it from IQVIA or Symphony, the trend seems to be flat down. There is clearly a disconnect.
I just wonder if there are any artifacts in the script data that you would highlight. Thanks so much.
Great. Thank you so much. Regarding the API, we do not disclose the details of the API manufacturing, but the process is, I would say, fairly diversified, with parts of the value chain being executed in the U.S., Europe, and the rest of the world, depending on the molecule. Getting back to what Belén said a couple of minutes ago, we took that into account. We will do what we need to do upon closing in order to make sure that the supply chain is even more resilient and the tariff exposure is modest at best. Now, you asked about multiple myeloma. The scientific rationale of that is actually overexpressing BCMA. Multiple myeloma will be patients, the therapies that are directed to BCMA will be more efficacious. The study is currently ongoing.
We perceive it as, I would say, low probability of success in that regard. It is not the biggest study, and that is not playing into our strengths at this point in time. That is pretty much it from that perspective. Your third question, the quarterly progress in revenue. When it comes to the prescription data, as I said at the beginning, we do expect that volatility. Some of this volatility could come from their presence, SpringWorks' presence in the key accounts. As you know, with rare diseases, you start with the centers of excellence, and this is what they actually did, I would say, beautifully. Now it is the time to deepen that and go outside of the centers of excellence. When it comes to what we do see is when it comes to patients adhering to treatment and staying on treatment, they do stay.
It confirms the median treatment duration that we saw in the long term. We are very happy about that, but we are ready for the potential to further expand in the U.S. and outside.
Great. Thanks so much.
Thank you. We will take our next question. Your next question comes from the line of Oliver Metzger from ODDO BHF. Please go ahead. Your line is open.
Yeah. Good afternoon. Thanks for taking my questions. I have two. One is on your future M&A strategy in healthcare. In the past, you made more comments on smaller in-licensing deals and less bigger M&A. Now, $3 billion, it's occasionally reconsidered as bigger M&A or smaller M&A, at least not bigger than you did in the past. Any comments about your future strategy? That would be great. Second is on the existing R&D teams of SpringWorks. Do you plan to run this team separately, or will you create a deeper R&D hub also in the U.S.? Thank you.
Thank you, Oliver. On the first question, let me focus exclusively on healthcare because I already emphasized the priorities for the group. For healthcare, this is really a great step towards expediting the growth of the pillar towards the long-term guidance that we have communicated before. Obviously, as we progress further, we will not only leverage on the assets of SPARK, but we will move towards the licensing dimension in order to be able to fuel SPARK and potential SPARK expansion and continue to support our franchises through reasonable investment in external innovation, aiming to deliver 50% of our future launches coming from external innovation. I do not know if you want to add anything, Danny, onto that.
If nothing that I add, I just went.
If not, please go ahead on the R&D.
Regarding the R&D, we have been watching the R&D capabilities of SpringWorks and applauding them. This is a great performance in bringing two novel therapies to patients with rare diseases. We highly believe in their capabilities. Regarding integration, full integration, whatever, these are comments that we cannot make at this stage because we are still in this period between signing and closing. We will be able to comment on that in the future.
Heidi, we would have time for one more question, please.
Thank you. Please stand by. Your final question comes from the line of Peter Spengler from DZ Bank. Please go ahead. Your line is open.
Yeah. Good afternoon. Thank you very much for I have two questions, actually. One is on Pfizer. Your two main products were licensed by Pfizer. What license fees and milestones do you have to pay in the next two years or when they are due? Has Pfizer the right to market the product in the U.S.? The second question is on how is the purchase price divided between property plans, intangible assets, and goodwill, and how high are the depreciations and PPA? Thank you.
When it comes to Pfizer, there is a royalty that is, and we will honor the royalties to Pfizer. These are spun out from Pfizer, as you said. The royalties are at industry standards. Nothing more than that. Pfizer will not commercialize these products either in the U.S. or outside of the U.S. Merck KGaA, Darmstadt, Germany, EMD Serono in the U.S. will do that in the U.S. through SpringWorks. Now, when it comes to the purchase price, high-level comment, the CapEx investment or the CapEx spend with this acquisition is very modest, is minimal, I would say.
Okay.
All right?
Good.
Thank you.
That will be at the end of the call.