Ipsen SA reported robust financial performance for the first quarter of 2025, surpassing revenue forecasts and showcasing strong growth across its therapeutic areas. The company’s revenue reached 918.8 million USD, significantly exceeding the forecasted 807.84 million USD. Despite this positive earnings report, Ipsen’s stock saw a decline of 3.23% in early trading, closing at 99.15 USD. According to InvestingPro analysis, Ipsen currently appears undervalued, with the company maintaining an impressive "GREAT" overall financial health score of 3.22 out of 5. For detailed insights into Ipsen’s valuation and 10 additional exclusive ProTips, explore the comprehensive Pro Research Report available on InvestingPro.
Key Takeaways
- Ipsen’s Q1 2025 revenue exceeded expectations by 13.7%.
- Total sales grew by 11.6% year-over-year.
- Stock price fell by 3.23% despite strong earnings.
- Continued strong performance in oncology and rare disease sectors.
- Ipsen confirmed its 2025 guidance with expected sales growth above 5%.
Company Performance
Ipsen’s first quarter of 2025 demonstrated strong growth, particularly in its oncology, rare disease, and neuroscience sectors. Total sales increased by 11.6%, building on the company’s impressive 8.11% revenue growth over the last twelve months. With an exceptional gross profit margin of 82.69% and strong cash flows that adequately cover interest payments, Ipsen continues to maintain its leadership position in the PFIC indication and is expanding its market presence across various territories. InvestingPro subscribers can access detailed financial metrics and peer comparisons to better understand Ipsen’s competitive positioning.
Financial Highlights
- Revenue: 918.8 million USD, up 11.6% year-over-year.
- Oncology sales: Increased by 8%.
- Rare Disease: Significant growth observed.
- Neuroscience: Close to double-digit growth.
Earnings vs. Forecast
Ipsen’s actual revenue of 918.8 million USD surpassed the forecasted 807.84 million USD by 13.7%. This outperformance indicates strong market demand and effective execution of the company’s strategic initiatives. The magnitude of this earnings beat is notable compared to previous quarters, highlighting Ipsen’s growth momentum.
Market Reaction
Despite exceeding revenue expectations, Ipsen’s stock price declined by 3.23% in early trading, with shares closing at 99.15 USD. This movement contrasts with the broader market trend, which has generally been stable. Notably, InvestingPro data shows the stock is trading near its 52-week low of 105.27 USD, though it historically trades with low price volatility (Beta of 0.4). The company has maintained dividend payments for 20 consecutive years, demonstrating consistent shareholder returns despite market fluctuations. The stock’s decline could be attributed to investor concerns about potential market softening in the US aesthetics segment and ongoing generic competition in the Somatuline market.
Outlook & Guidance
Ipsen has reaffirmed its 2025 guidance, projecting total sales growth of over 5% at constant exchange rates and a core operating margin exceeding 30% of sales. The company is preparing for key milestones, including an EMA decision on Cabometyx for neuroendocrine tumors and pivotal data for Fitusertib in FOP.
Executive Commentary
CEO David Lowe expressed confidence in the company’s performance, stating, "We continue to deliver strong top-line growth in quarter one." He also highlighted Ipsen’s commitment to advancing its pipeline and preparing for upcoming milestones, emphasizing, "We are increasing our investment in our launches and preparations."
Risks and Challenges
- Generic competition in the Somatuline market could impact revenue.
- Potential market softening in the US aesthetics segment.
- Tariff impacts remain uncertain, although manufacturing is primarily in Europe.
- Ongoing investment in pipeline and launches requires careful financial management.
Q&A
During the earnings call, analysts inquired about the potential impact of tariffs and the dynamics of the Ikorvo launch. Ipsen clarified that its manufacturing is primarily based in Europe, mitigating some tariff concerns. The company also explored the potential of new assets in PSC, indicating a strategic focus on expanding its therapeutic offerings.
Full transcript - Ipsen SA (IPN) Q1 2025:
Conference Moderator, Ipsen: Hello, and welcome to Ipsen’s Conference Call and Webcast for the First Quarter twenty twenty five Results. I’ll now hand you over to David Lowe, Ipsen’s CEO.
David Lowe, CEO, Ipsen: Thank you, and hello, everyone. I’m delighted to welcome you to our Q1 sales presentation this afternoon, which can also be found on ipsen.com. Please turn to Slide two. Please take note of our forward looking statements, which outline the routine risks and uncertainties contained within this presentation. Also any of my commentary on growth will be based on constant exchange rates.
Please turn to Slide three. I’m going to take you through our sales performance of the first quarter and provide you with a business update after which our CFO, Emeric Le Chatillier, will join me for the question and answer session. Let’s begin by looking at today’s highlights. Please turn to Slide four. We continue to deliver a strong top line growth in quarter one.
Total sales grew by 11.6%, driven by all three therapeutic areas and including an increase in contribution from ICORIVO and BILBEY. Since the beginning of the year, we have made good progress with our pipeline, including the EMA regulatory submission of tovarafenib for pediatric low grade glioma, the entry in Phase one of a third generation RAF inhibitor, complementing our ERK inhibitor with both being in the clinic. On the financing side, we announced in March a successful refinancing of 2,000,000,000, including a 500,000,000,000 rated public bond supported by investment grade ratings from Standard and Poor’s and Moody’s. This provides long term funding of the firepower for our external innovation strategy. Looking ahead, 2025 promises to be another exciting year for our pipeline with several key milestones, including the expected decision from the EMA for CABOMETYX in neuroendocrine tumors in Europe, Fitusertib pivotal data in Fever Diplasia ossificans progressiva or FOP, and the first proof of concept data for our long acting neurotoxin in aesthetics.
Lastly, we confirm today our 2025 guidance with total sales growth greater than 5% at constant exchange rate and a core operating margin greater than 30% of sales. Please turn to Slide five. All three therapeutic areas have seen strong growth in this quarter. Oncology has performed well growing by 8%, driven by the strong performance of somatolim. Rare disease continues to stand out propelled by the sustained performance of Bilve and IKORBA launches.
Neuroscience comprising this work delivered strong and consistent growth close to double digit. I’ll now turn to oncology for more detail. Please turn to Slide six. Starting with somatolins sales were up 19% in the first quarter with good performance in The U. S, Europe and rest of the world.
This growth reflects the continued shortages of generic Llanreotide in The US and Europe. During the quarter, we saw some limited signs of generic Llanreotide supply progressively recovering in The US and Europe, still with some inconsistency. Sun Pharma along with its partners, Beatriz and Sintiva have received several local approvals following the decentralized procedure, but have not yet launched. Approval in The US is still expected later this year. Cabometyx sales were down by 3% driven by a very high 2024 baseline, as well as price pressure in some rest of the world markets.
However, Cabometyx performance was strong in Europe with increased volumes in both first and second line renal cell carcinoma. Decapeptil was back to growth in quarter one with sales up by 3.4%, driven by solid volume growth in Europe and China, despite continued competition and pricing pressure. Onivy sales rose by 6.3% with a limited market share growth in The US in the first line metastatic pancreatic ductal adenocarcinoma indication. We continue to work on driving first line differentiation and on addressing some challenges with access to payers that we have been facing since the start of the year. Now, let’s turn to rare disease.
Please turn to slide seven. On the rare disease, Billvay continues to perform nicely with Q1 sales of 43,000,000 representing growth of 63%. This performance was driven by increased sales in The US in the PFIC indication where we enjoy a strong leadership position and in Alagille syndrome with uptake from naive and switch patients. We also see a strong momentum in Europe, mainly driven by the PFIC indication and market expansion. Turning to IKORVO, the launch continues to track well in line with our expectations with sales reaching 23,000,000 this quarter.
The growth in The US was driven by an increasing patient uptake from new patients and patient switches from Ocaliva. Additionally, I’m also pleased by the successful launches in Germany and The UK contributing to the strong performance. We’re expecting more countries to launch in 2025. Moving to neuroscience, let’s turn to slide eight. This board delivered another solid performance with sales growth of 9.6% for the quarter.
In aesthetics, sales grew by 16% driven by continued expansion in most territories, including The U. S, Europe and rest of the world. On the therapeutic side, reported sales were flat despite a solid growth in North America and Europe, offset by shipping phasing and high 2024 baseline in Brazil. Moving to the pipeline, please turn to Slide nine. You can see our well balanced portfolio that continues to grow across the therapeutic areas and phases of clinical development.
As I mentioned earlier, in our oncology portfolio this quarter, tovorafenib was accepted by EMAI for review, marking an important step forward in the development of this potential treatment for pediatric low grade glioma and reinforcing Ipsen’s commitment to innovation in rare and difficult to treat cancers. I’m pleased to see that the third generation RAF inhibitor from our preclinical pipeline has entered Phase one trial. This asset will reinforce our ERK inhibitor and tobarafenib to other assets targeting the MAPK pathway. We are anticipating more preclinical assets to progress this year and in the near future. I would also like to draw your attention to the Iqorvo Elmwood Phase two trial results in PSC, which are going to be presented in a late breaking session at EASL beginning of May.
Now, I would like to share more about our upcoming data readouts this year. Please turn to Slide 10. There are a lot of exciting milestones that we expect this year and next year. Let’s focus on 2025. First, in oncology, we are expecting a decision from the European authorities on Cobrametik in pancreatic and extra pancreatic neuroendocrine tumors.
In rare disease, we are looking forward to the readout of FALCON, our registrational Phase two study with fiducerative in FOP. Lastly, we anticipate the first proof of concept data for our long acting neurotoxin anesthetics. We believe LAND has the potential to deliver better outcomes for patients with an increased duration of action, leading to a reduction in injection frequency. In that context, I’m delighted that Olivia Bryan recently joined our executive team to help build an integrating neurotoxin franchise and drive and accelerate our development growth and innovation in neurotoxins, both in the therapeutic and aesthetic space. I will now move to conclusion at outlook for 2025.
Please move to Slide 11. Ipsen has delivered a strong start to 2025. We are on track to build further momentum in our transformation and to achieve our objectives for the year. Our top line continues to deliver driven by the launches and continued portfolio performance. We are increasing our investment in our launches and our preparations for upcoming milestones as we advance our pipeline.
To further strengthen our pipeline, we will continue to diligently evaluate external innovations, leveraging our firepower. With that, please turn to Slide 12. This concludes our presentation. Emmerich and I will now take your questions. Operator, over to you.
Conference Moderator, Ipsen: Thank Thank you. We’ll now take our first question. This is from the line of Shan Hammer from Jefferies. Please go ahead.
Shan Hammer, Analyst, Jefferies: Hi. Thank you so much for taking my questions. Just two from me. Albeit, I know you can’t speak for Galderma, but what do you think has driven the strength in the aesthetics for this sport in its respective markets? I know there was some commentary on US softening, but it looks as if maybe Ipsen and Galderma are pretty immune to that.
And then secondly, appreciate you may have a lot of incoming on this, but just for clarity, how do you view the potential imminent pharma tariff impact? Thank you very much.
David Lowe, CEO, Ipsen: Hi, Sharon. Thanks for your questions. Regarding your first question on aesthetics in The U. S, so we are very happy with the performance of our partner, Galderma, in The U. S.
Regarding softening of the market, think you’re better placed to ask them directly since they are really our distributor in The US. But the performance is very good. On your second question on tariffs, I mean, there hasn’t been really an announcement on tariffs yet. So it’s too early to speculate about any potential impact on the tariffs. So we are carefully watching the space, carefully watching the announcements, obviously, but we don’t want to speculate at this point on what impacts could be.
Thank you.
Shan Hammer, Analyst, Jefferies: Thank you.
Conference Moderator, Ipsen: Thank you. We’ll move to our next question. This is from John Preissner from JPMorgan. Please go ahead.
John Preissner, Analyst, JPMorgan: Hi. John Preissner from JPMorgan. Thanks very much for taking my questions. Just a couple, if I may. So maybe first on Diceport again, kind of how should we really be thinking about the growth trajectory in 2025, given you’re off to a good start?
Could it be at a similar level to 2024 in the high single digits or could it actually be even stronger? Then maybe a second question on Somatuline. So sales were very strong obviously in Q1 coming in with about 20% local currency growth. So can you help us understand the kind of how much is baked into the 2025 guidance in terms of somatuline erosion, and what are some of the pulls and pushes here? And then maybe one final question just on pipeline, which you mentioned the AQervo PSC data at EASL next month.
So maybe can you help us understand how AQervo could fit into the current treatment paradigm in PSC? How the competitive landscape is looking? I think there’s some competitors have some iBATs in development in this area and and maybe how big of an opportunity that could be and whether that’s included in your current peak sales target for a cure though? Thank you.
David Lowe, CEO, Ipsen: Thank you, John. So on the first question, yes, we continue to assume high single digit growth, so similar to what we have been observing so far. I will take your third question because then I’m going to hand over to Emrick on the guidance on somatolin. So on your third question regarding pipeline and IKORBO in PSC. So this is a Phase two trial, which had as a primary endpoint of safety, but has a secondary endpoint also liver function values like ALP, for example, but also fibrosis, as an example.
And you’re going to see data at the late breaking session at EASL. We have to now consult with regulatory authorities to see what are our going to be next steps forward. This has not been included in our guidance. The size of the opportunity, I think it’s too early to comment on. Of course, there is a very high unmet medical needs in PSC.
There is really nothing to treat these patients. And so we will have to see, you know, how big this could become and what are the timelines because FDA typically wants to see outcome driven trials. In terms of competition, it’s correct that there are some IBATs which are going to focus on pruritus, but PSC of course is larger than just the pruritus story. I mean, also have or you want to protect the liver and liver values potentially can play a role in the fibrotic process. So work in progress.
We’re pleased to see those results, but more to come and we’re going to more talk about this in future steps. Regarding somatolin, I hand over to Emrick.
Emeric Le Chatillier, CFO, Ipsen: Yes. So thank you, David. Thank you for the questions. So as you point out, our guidance is not assuming that will continue as in Q1. Clearly, we are fully on track with what we said in February that we expect an accelerated erosion of somatuline in 2025.
You asked about the push and pull. Clearly, that erosion will be driven by two elements, as David explained during the presentation. First, it’s a progressive resupply of Pharmatel impacting Cipla in The U. S. And also advanced in Europe and other territories.
And the second element is clearly the entry of an additional generic from Cipla, which has started to from Sun Pharma, sorry, from Sun Pharma, which has started to be approved in Europe and will likely be approved based on our guidance in the second half of the year. So clearly, the pull and push are going to be related to the timing of those resupply and whether Sun Pharma is going to be able to supply, launch, but also secure an approval in The U. S.
David Lowe, CEO, Ipsen: You, John. Very clear. Thank you.
Emeric Le Chatillier, CFO, Ipsen: Question, please.
Conference Moderator, Ipsen: Thank you. Next question is from the line of Florent Cespedes from Bernstein. Please go ahead.
Florent Cespedes, Analyst, Bernstein: Good afternoon. Thank you very much for taking my question. Two quick ones, please. First, on CABOMETYX, could you come back on the dynamic of this product for this year as it was a little bit short of expectation this quarter, if you see further pressure or maybe some territories that should perform better during the rest of the year? That’s my first question.
And second question is about your M and A and business development strategy. Given the uncertainties on tariffs, do you see some potential deals kind of on hold? Do you see any changes on the dynamic this strategy? Any color would be helpful. Thank you.
David Lowe, CEO, Ipsen: Thank you, Laurent. So on CABOMETYX, in the markets where we have launched first in the most of the Western markets, we are starting to achieve very solid market shares in first line. So I would say we have to expect as we guided a bit less strong growth. So it’s probably going to be in the single digits rather. And then we have seen in the some of the emerging markets, some pricing impact.
So overall, Cabo will continue to grow. We are very confident on our above $700,000,000 peak sales guidance that we have provided to the market and any additional sales coming from the neuroendocrine tumor would be on top of it. Regarding your question on M and A, we do not foresee to change our BD strategy based on tariffs. As you know, of course, the whole market has seen a correction. Many shares went down, including many of the biotech shares went down.
So that has to be taken into account as well. So but we’re not holding any activities. We are screening as we speak regularly any deals which appear interesting to us. You, Florent. Thank you very much.
Next question, please.
Conference Moderator, Ipsen: Thank you. Next question is from Xian Deng from UBS. Please go ahead.
Xian Deng, Analyst, UBS: Hi, thank you very much. Thank you for taking my questions. I guess the first question, I have a few, please, if I may. So the first one, just want to sort of follow-up a little bit more in terms of potential tariff and manufacturing locations. Just wondering if there’s any color that you could give us terms of percentage of sales that are manufactured in The US, if you have any royalty structures, let’s say, from your US subsidiary to European subsidiary, if you have any of that.
Any color on that sort of just how you actually structure the logistics, that would be great. That’s the first question. And then the second one is on Diceboard. Just wondering, yeah, first of all, thank you very much for the color on your expectation of high single digit growth. But just wondering, let’s say if US goes into recession this year, just wondering, what are your thoughts on the potential impact into your guidance?
And what have you assumed for DIVOR to perform in your guidance, please? And the third, just a quick one on Somatuline. So you mentioned some generics start to pick up in supply, but they kind of intermittently. So just wondering, you know, from what you’ve seen at the kind of at the similar pace as what you expected at the beginning of the year, what you assumed in guidance or have they been either faster or slower than what you have assumed? Thank you very much.
David Lowe, CEO, Ipsen: Thank you, Issian. On your first question, I just want to make sure that I got the question correctly. So, you were asking regarding where we manufacture and where we sell. I didn’t quite understand the royalties question there. Can you perhaps just specify that?
What do you mean by the royalties question?
Xian Deng, Analyst, UBS: Oh, yeah. Sorry. It’s just to do with, you know, some companies like, so for example, they have the IP rights located in Europe. Then sometimes they use a US subsidiary to pay a royalty to the European subsidiary to access a patent. So some company does that.
So, yeah, just wondering.
David Lowe, CEO, Ipsen: Okay. Yeah. So I I can just repeat because that’s a very specific question. I can just repeat what I said before. Tariffs are not in place.
There are no details that we know, like on what they would be applied exactly, etcetera. So I don’t want to actually speculate on this. What I can tell you is that most of our manufacturing comes currently from our current production sites, which most of them are in Europe. We have some CMOs also in The US, but the large majority is coming from Europe. So that’s all what we can say currently.
On this part, if there would be a recession, yeah, I mean, we would have to potentially assume that it could impact our aesthetics business most probably. But again, we don’t observe this right now. And I think for further clarifying questions, I think it’s best that you actually talk to our distributor, Galderma, because they have the majority of our disparate aesthetic sales. And it’s also they have the distribution in The US. So currently, what I also can say is that we have not included a recession in the guidance so far.
So we would have to take this into account.
Emeric Le Chatillier, CFO, Ipsen: And maybe, Christian, to remind everybody, D Sport aesthetic in The U. S. Is less than 5% of our sales. So the impact is pretty limited to the overall guidance. And as we know, Toxin is a pretty resilient product even if it’s out of pocket.
So I won’t think that we have a significant exposure to a U. S. Recession.
David Lowe, CEO, Ipsen: Regarding your third question on somatoline generics and the pace of return, I would say, ADVANCE and Cipla have in the past made statements that they’re going to be back in a given timeframe, and then this has actually not materialized. So, the current comeback of somatoline is in fact in line with our expectations. It’s very gradual, sketchy, as I said before, when we went through our slides. But, you know, we want to be careful, because it could be that they are fixing their problem. And that’s why we have guided as we have guided.
So we do assume an acceleration in the coming months and in the second half of the years with the potential entry also of Sun Pharma. Thank you. Next question, please.
Conference Moderator, Ipsen: Thank you. Next question is from Simon Baker from Redburn Atlantic. Please go ahead.
Simon Baker, Analyst, Redburn Atlantic: Thank you for taking my questions. Just to revisit the manufacturing footprint, perhaps if I can ask in a slightly different way. I believe you manufacture Onivyde in Cambridge, Massachusetts. Are there any other significant manufacturing activities at the product level you would call out for The U. S?
And then moving on to iCurvo, perhaps you could just give us an update. It was a good performance in the quarter, an update on the dynamics between you and Gilead in PBC. And also an update on the nature of the patients you’re getting, where they’re coming from and any characteristics that are developing there? And then finally, on fitrusertib, in light of the SHAHONAS experience, I wonder if you could give us an idea how we should be thinking about what looks like a clinically meaningful result from that data? Thanks so much.
David Lowe, CEO, Ipsen: Thank you, Simon. On the manufacturing, we have we don’t go into the detail for every single product on this. So as you have stated, we still have had some manufacturing on Onivyte from The U. S. And we have, for example, CMO for Zohonos also in The U.
S. To your second question on Icorvo and the dynamics in PBC, so it’s tracking actually really well and in line with our expectations. So as we have said before, we have been assuming about a third of market share, which is what we are seeing currently. And then in terms of your question on the split of patients, so we see about sixty percent of the patients coming de novo second line and the rest from Ocaliva switches, either they are currently on Ocaliva and they are being switched actively or they were on Ocaliva before and are now being put on Equival. Regarding your third question on Fidrocircuitib clinical meaningful difference.
I mean, here it’s the HO formation that we are measuring. The difference to the homozygous is that on the inclusion of the patients, we allow patients as of the age of five and above, so much younger patients and FOP actually starts at an early age when they are young. So that’s certainly going to be an advantage versus Suhonos. And also, we do not anticipate any safety problems, to Sjonas where we have seen premature growth platelet closure, as you know, and that has been a bit of an impediment on the pickup of the drug. So I think with Fidri, if the efficacy is good, it could really bring a very meaningful new option to these patients around the world.
Thank you. Operator, next question please.
Conference Moderator, Ipsen: Thank you.
Manos Masdarakis, Analyst, Deutsche Bank: Next
Conference Moderator, Ipsen: question is from Manos Masdarakis from Deutsche Bank. Please go ahead.
Manos Masdarakis, Analyst, Deutsche Bank: Hello, Manos Masdarakis from Deutsche Bank. Thanks for taking my question. So, first one, just quick comments on your overall commitment and interest in the MAPK pathway, and, what have you seen with the IPN $11.95 asset that makes you excited? And secondly and lastly, in in PSC, you mentioned fibrosis. That makes me think of, NASH.
Have you considered, or are you considering any kind of development in that space? Thank you.
David Lowe, CEO, Ipsen: Thank you, Manas. On the RAF inhibitor, it’s actually a third generation RAF inhibitor, which makes us quite excited and especially also the potential to combine it with our ERK inhibitor, which is already in Phase I, because the combination of them could be giving very beneficial effects potentially. We have to see if we get the synergistic effects. And that’s what makes us very interested because RAF inhibitors, but also ERK can be used in several different tumor types. And we will we are now entering, you know, randomizing the first patients into the dose ascending.
So we have to see how the drug behaves. And then, you know, determine in which tumors we’re going to develop it. We are, of course, also looking at potentially seeing are there accelerated approval pathways. So that makes us excited. We think it’s new generation, third generation inhibitor, and that’s quite exciting.
On your second question, regarding your question on fibrosis and mesh, remember, the PPARS were actually tested in MASH before they didn’t make it. And then they were developed in PBC where they absolutely show really good efficacy and safety. So we do not anticipate to go actually back into NASH because that trial was done at the time by Genfit, and it didn’t work out like on seladelpar, it didn’t work out on NASH either. So we don’t think that this is the indication we want to go after. Thank you.
Manos Masdarakis, Analyst, Deutsche Bank: Thank you. Next
David Lowe, CEO, Ipsen: question, please.
Conference Moderator, Ipsen: Thank you. Next question is from Alastair Campbell from RBC. Please go ahead.
Alastair Campbell, Analyst, RBC: Afternoon. Thanks very much for taking the questions. Two, please, if that’s right. Just first of all, on IKEAVO. I think if you look at ADVANCE, certainly from a European perspective, they’re talking about a significant dip in Ocliva sales this year.
So maybe if you could give some hints in terms of your European rollout, the speed of which you can roll out into more markets and potentially capture that opportunity. And then maybe just digging a bit more on the PSC area. So two assets in Phase II. And David, you touched that one might be more to do with pruritus, other the other one might be more to do with liver function. But could you see an opportunity to take both of these into Phase III and ultimately both to market?
Or do you think you kind of have to pick a favorite and how could they work together? Thank you.
David Lowe, CEO, Ipsen: Thank you, Alistair. On your first question, yes, the Ocaliva is really dipping in Europe since it is being withdrawn. So patients are being switched very rapidly. So the rollout is actually going very, very well. Europe has taken off very nicely, UK as well.
We anticipate new markets coming on, like, for example, Italy very soon, and we’re working on getting the other markets also launched and reimbursed very soon. An exciting launch definitely also ex US. On your question on PSC, So we have Rituximab in Phase two. We need to still see more results on RITI and we also have a succession compound, which is actually more potent in preclinical. So we’re just discussing which one are we going to choose.
As I said before, the IBAT inhibitors are more going to control the pruritus effects of the disease. And I think the PPAR and Iqorvo here very specifically, which has a different mechanism of action from other PPARs could potentially play a role here. We have to now assess in more details and we’re looking forward to having the discussions also with KOLs and regulatory authorities, but they’re going to satisfy two different needs. I mean, PPARS potentially would have an effect on the liver function also long term. So that’s different to just controlling the pruritus.
Alastair Campbell, Analyst, RBC: Thank you.
David Lowe, CEO, Ipsen: Thank you. Next question, please.
Conference Moderator, Ipsen: Thank you. Next question is from Laura Hindley from Morgan Stanley. Please go ahead.
David Lowe, CEO, Ipsen0: Great. Thanks for taking the question. Laura Hindley, Morgan Stanley. Just firstly, going back to somatuline, are there any key differences that we should be aware of on the expected erosion cadence between The U. S.
And Europe based on the trends that you’ve seen so far in Q1? And then on Cabometyx, how much of an incremental opportunity do you see for the neuroendocrine tumor indication? And how quickly can that ramp up just thinking about the patent expiry towards the end of the decade? Thank you.
David Lowe, CEO, Ipsen: Thank you, Laura. On your first question, actually, the speed of let’s call it like this, the speed of coming back is gradual in both regions. So in The U. S, there has been a very slow ramp up and same thing actually in Europe. So it’s clear that Advance is still struggling to really come back fully.
And we have to observe now if they’re going to be able to fix it. I mean, as you know, they have announced that by end of Q1, they expect it to be back. They are not clearly fully back. So we have to see, you know, what’s going to happen in the next weeks or months to come. It’s it’s, of course, hard for us, you know, to know the details on this.
I mean, we would have to be a fly in the wall in their manufacturing side, which of course is not possible. So it’s hard to really speculate. We can only see what happens on the market and what they are telling to countries or distributors. So that’s all what we can observe. On the CABOMETYX, on the neuroendocrine side, we have talked in the past about probably around 100,000,000 opportunity.
The ramp up would be a first launch in Germany, and then we will get reimbursements that we have to get for in the payer markets, know, where for example, in France or Italy, etc, it can take some time to get reimbursed. And then it can probably ramp up with a typical, I would say, NET speeds, knowing that this is a slow progressing disease. So it’s not going you know, jump up from one day to the other. Patients are going to gradually progress, and then they’re going to be switched. So it’s going to be a gradual ramp up, I would say, but there’s still a nice opportunity up to the patent expiration.
So we still have four years in front of us. So that’s very nice opportunity if it gets approved. Thank you very much.
David Lowe, CEO, Ipsen0: Thank you.
Conference Moderator, Ipsen: Thank you. We’ll now take our next question. This is from Shanhama from Jefferies. Please go ahead.
Shan Hammer, Analyst, Jefferies: Hi. Just a follow-up from me, if that’s okay. Just are there any updates on Onivyde’s IPs? I I think previously it was that IP should be into the 2030s. I think it might have been contingent on getting it officially settled.
So when do you expect IP to be challenged by generic manufacturers? And do you think you can ramp up sales until then? Thank you.
David Lowe, CEO, Ipsen: Yes. Thank you, Jean. Our base case assumption is for the first line 02/1931 as we got orphan drug designation. So it’s actually beyond what we have communicated in the past because we got this orphan drug designation, but we also have method of use patents, which can go up to thirty three and thirty six. So our base case is longer than the substance patent itself, which is 2027.
So if there are no more questions, this wraps up our call. Thank you very much everybody for attending. Goodbye.
Conference Moderator, Ipsen: Thank you. This concludes today’s conference call. Thank you for participating and you may now disconnect.
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