Hello, and welcome to Ipsen's Conference Call and Webcast on H1 2024 results. I'll now hand you over to David Loew, Ipsen's CEO.
Thank you, Operator. Good afternoon or good morning, everyone. I'm delighted to welcome you to our latest results call. As you just heard, I'm David Loew, Chief Executive Officer of Ipsen, and it's a pleasure to take you through our performance in the first half of the year.
Please note that our presentation is available on ipsen.com. Please turn to Slide two. Before we begin, here is our safe harbor statement, which outlines the routine risks and uncertainties contained within this presentation.
Also, any commentary on growth you'll hear today will be based on constant exchange rates unless stated otherwise. Please turn to Slide three. I'm joined today by Christelle Huguet, Head of our Research and Development, who will provide an R&D update, while our CFO, Aymeric Le Chatelier, will take you through the financials. We'll then be happy to take your questions. Please turn to Slide four.
I want to begin with our business update. Please turn to Slide five. Today's headlines illustrate real delivery and progress so far this year. Starting with the strong financial performance, total sales grew by 9.5% in the first half, accompanied by a core operating margin of 32.4%. We also generated free cash flow of EUR 394 million.
Regulatory success came in the form of the FDA approvals of Onivyde in first-line pancreatic cancer and Iqirvo in second-line PBC, respectively. We also anticipate published opinions from the CHMP tomorrow in respect of both Iqirvo and Bylvay, the latter in Alagille syndrome. Finally, we made good progress with our pipeline and external innovation strategy. Today, we in-licensed ex-US rights to a late-stage asset, tovorafenib, in pediatric oncology.
We also executed four early-stage transactions across oncology and neuroscience while we expanded our collaboration and license agreements for the development of Cabometyx in advanced neuroendocrine tumors. Please turn to Slide six.
Turning to more details of our sales performance, the growth of 9.5% in H1 was mainly driven by the performance of Cabometyx and Dysport, as well as the contributions from Bylvay and Onivyde. Somatuline's sales decline was limited to 1%, as we benefited from generic lanreotide shortages in several countries in Europe.
In North America, Somatuline sales fell by 6.3%, with solid volume growth outweighed by adverse US pricing. We anticipate a sharper decline from Somatuline in the US in the second half based on increased generic penetrations. Dysport sales were up by 12%, with continued growth in the therapeutic and aesthetics markets, partially offset by adverse phasing in Q2.
Cabometyx sales grew by 17%, though Decapeptyl sales growth was temporarily limited to 1%. The launch in first line contributed to the 25% growth in Onivyde sales, while Bylvay delivered an excellent Q2 and is now annualizing at over EUR 100 million. I will now provide more details of our main launches this year.
Please turn to Slide seven. Onivyde is on track to become a standard of care in the US in first-line pancreatic cancer. Although it will take time to change long-term prescribing habits, we're clearly aware of the significant potential of Onivyde over time. 80% of relevant physicians can prescribe Onivyde in first line, while 90% of payers already have access. We're seeing update in use in first line, and this is illustrated by a 17% increase in post-approval weekly demand.
We're also delighted with the performance in the major centers, as demonstrated by 34% demand growth in the top 10 accounts. Now, let's turn to the launch of Iqirvo. Please turn to Slide eight. Iqirvo is having an encouraging early start, and I'm delighted that patients very quickly had access to our new innovative option to treat their PBC.
Following last month's PDUFA, Iqirvo became the first and only approved PPAR to come to market to treat PBC. The approval was based on the ELATIVE phase III trial data that showed a rapid and sustained response, lowering ALP and the level of bilirubin. The unmet need just in the uncontrolled population is extensive, with only a minority of eligible patients receiving a second-line treatment today. The launch is fully on track.
Patients were covered and on treatment within the first week of launch, and we already recorded some sales in June. Feedback from physicians has been very good. 50% of healthcare providers surveyed one week post-launch were likely to prescribe Iqirvo, while there were early positive coverage determinations from commercial and government payer segments. I look forward to providing a further update on launch at our Q3 results.
Please turn to slide nine. Turning to our pipeline, as at the end of June, we have a nice mix of trials across the therapy areas and phases of clinical development. We also anticipate some of our preclinical assets entering phase I in the coming month. I will now pick out some highlights from the pipeline. In oncology, we have the opportunity with Cabometyx in advanced neuroendocrine tumors, and we anticipate filing in due course .
In rare disease, we look forward to the published CHMP opinions tomorrow in respect of Iqirvo and Bylvay, while in neuroscience, we're progressing nicely with dosing in the long-acting neurotoxin trials in aesthetics and therapeutics. When we next present this chart in October, it will also include tovorafenib, the exciting pediatric oncology asset in license today.
Please turn to slide 10. tovorafenib is an attractive addition to the pipeline, and this deal perfectly aligns with our strategy. This asset is already approved in the US as a second-line treatment of the most common childhood brain tumor, pediatric low-grade glioma. We have obtained the rights outside the United States. Christelle will take you through the trial details in a moment, both in second and first line, and I want to highlight several aspects here.
Firstly, there is a high degree of unmet medical needs with a limited number of options for patients. In the top five European markets, there is a significant level of incidence and prevalence, yet there is no clear standard of care in second line.
The trial data were also compelling, with tovorafenib the only targeted therapy to show efficacy in the broad BRAF-altered population. We plan to file next year. Tovorafenib will then slot well into our expanding portfolio alongside our widening range of oncology medicines. With that, I'll now hand over to Christelle. Please turn to slide 11.
Thank you, David, and hello, everyone. I'm delighted to provide you with an update on Ipsen's R&D program. Please turn to slide 13. I want to start by reminding you of our focus strategy on innovation, which is guided by science first and unmet medical needs. We have seen that the best innovation takes place in the academic and biotech ecosystem, where deep biology and pathway understanding is built through years of research.
That's exactly why we have a successful external innovation model. What we do best at Ipsen is making a medicine out of a molecule, from the pharmaceutical development to the commercialized medicine, all the way to strong life cycle opportunities. T hrough our clinical know-how and deep regulatory expertise, we design the most effective clinical and registry path to demonstrate and bring the value of a potential new therapy to patients with unmet medical needs.
We do this right across oncology, rare disease, and neuroscience. Let's look at this approach in action. Turn to slide 13, please. In the first half of this year, we made strong additions to our preclinical oncology pipeline with both T-cell engagers and antibody-drug conjugates. Bispecifics are antibodies that have been engineered to target two separate molecules that can be circulating or present on the surface of cells.
T-cell engagers target specific T-cell markers on one hand and often use the other hand of the molecule to activate the T-cell. With a Marengo STAR platform, we can target a specific subset, a V beta subset of T-cells, thus limiting wide immune system activation and also precisely activate that specific V beta subset to kill solid tumor cells. The Tri-STAR platform operates in the same manner, though it has three hands, hands trispecific.
It recognizes a specific T-cell subset, it activates that subset, and it recognizes cold tumors that normally escape the immune system, bringing the T-cell to kill the tumor cell. Last April, we successfully selected the first clinical candidate from our ongoing collaboration with the Marengo STAR platform that focused on hot tumors.
We then added a second program in collaboration with Marengo using their novel Tri-STAR platform, where we evaluate the potential of selective T-cell engagers to reactivate, mobilize a targeted T-cell subset to boost anti-tumor activity in cold tumors. Ipsen also secured two antibody-drug conjugate assets this year with potential in solid tumors. The majority of ADCs have been directed at liquid tumors in large indications of hem-oncology.
We have been evaluating the ADC landscape for some time, and in staying true to our strategy, we have selected platforms that offer highly selective targeting to niche, biomarker-driven, and difficult-to-treat tumor types. IPN60090 targets ROR1, and IPN60300 targets a novel tumor antigen. We look forward to completing the final stages of the preclinical development for both programs to move them into phase I. Please turn to slide 14.
Earlier this month, we announced the expansion of our collaboration with Exelixis to include Cabometyx in advanced pancreatic neuroendocrine and advanced extrapancreatic neuroendocrine tumors. This decision was based on the positive outcome from the CABINET phase III trial that is led by the Alliance for Clinical Trials in Oncology and sponsored by the National Cancer Institute.
An independent data and safety monitoring board recommended to stop enrollment, unblind the study, and allow crossover from placebo to Cabometyx due to the early efficacy demonstrated at an interim analysis in both of the trial's cohort, with clinically meaningful improvements in progression-free survival, which amounted to 11.4 months in pancreatic NET versus three months for placebo, and 8.3 month months in extrapancreatic NET versus 3.2 months for placebo.
We have now engaged with regulatory agencies and will submit on the basis of this data. Please turn to slide 15. Looking now at the newest addition to our late-stage pipeline, tovorafenib is an oral once-weekly type two pan-RAF inhibitor approved with orphan drug designation under accelerated approval by the FDA in April.
The pivotal phase II FIREFLY-1 trial delivered strong data, with a best overall response rate of 51%, as evaluated by an independent radiology review committee using the RAPNO LGG criteria, specifically designed for pediatric low-grade glioma. We are focusing on regulatory submissions outside of the U.S. now that the deal is signed.
We also await the results of the phase III FIREFLY-2 trial, evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF altered low-grade glioma requiring first-line systemic therapy. Please turn to slide 16. Now turning to our rare liver disease, we continue to explore the full potential of Iqirvo to ensure every eligible patient can benefit from this important new treatment.
I want to draw your attention to ELSPIRE, a phase III randomized parallel group, double-blind, placebo-controlled global multicenter study enrolling PBC patients with ALP levels between 1 and 1.65, the upper limit of normal. In this population, which is typically classified as having an adequate response to standard of care UDCA, there remains a negative outcome of death or liver transplant at 10 years, comparable to patients with higher ALP levels.
Therefore, the goal for patients with PBC is to shift towards ALP normalization. ELSPIRE data are expected in 2026, and the trial is part of Ipsen's strong set of clinical programs in rare liver diseases listed here on the right. Please turn to slide 17. Let's conclude with a summary of the major forthcoming milestones. We expect regulatory decisions for Iqirvo and odevixibat in the EU soon.
Next year, we look forward to a potential EU decision for Cabometyx in advanced neuroendocrine tumors, as well as pivotal trial data for our ALK2 inhibitor fidrisertib in FOP. Finally, in 2026, a number of phase III trials are expected to read out, including Bylvay in biliary atresia, Dysport in both chronic and episodic migraine, as well as the combination of Tazverik and R2 in second-line follicular lymphoma. With this update, I'll hand you over to Aymeric now. Please turn to slide 18.
Thanks, Christelle, and hello, everyone. I will now take you through the details of our financial performance in the first half of this year, as well as our upgraded guidance for 2024. Please turn to slide 19. We delivered another set of strong financial results in the first half across sales, core operating income, and cash flow. Our total sales over EUR 1.6 billion grew by 9.5% at constant exchange rate.
Our core operating income grew by 2.8% to EUR 538 million, while our free cash flow increased by 5.9% to EUR 394 million. Given our high level of EBITDA and this solid cash flow generation, we keep a very strong balance sheet with no debt and have, at the end of June, EUR 2 billion of firepower available for external innovation. Let's go now into the detail of those financials in the following slide. Please turn to Slide 20.
Starting with the core P&L, the growth in total sales of 9.5% at constant exchange rates translated into 8% at current rates, given the adverse currency movements from emerging markets. Gross margin decreased as planned by 1.6 points, driven by an unfavorable sales mix and the higher level of royalties paid. R&D costs increased by 11% to reach 19.5% of total sales, driven mainly by the continuous investment in our pipeline, including Iqirvo studies and Dysport migraine programs.
SG&A costs increased only by 4%, with the ratio to sales at 34.6%, improving by 1.4 points. It reflects our commercial investment to support the launches, but also the impact of our efficiency programs, including the synergies, Post-Albireo and Epizyme acquisitions. As a consequence, as you can see, our core operating income increased by 2.6%, with the core operating margin standing at 32.4%, declining by 1.6 points. Please turn to Slide 21.
Turning to consolidated net profit, I wanted to highlight several movements. Firstly, the amortization of intangible assets increased by 36% to EUR 123 million, mainly related to Bylvay and Somatuline. Restructuring and other operating expenses amounted to EUR 97 million, a decline of 22%, reflecting integration costs last year related to the acquisition of Albireo.
As a consequence, and with lower financial and tax expenses, IFRS consolidated profits increased by 19% to EUR 232 million. Please turn to Slide 22. Finally, on cash flow, we continued to generate strong free cash flow in the first half of the year and have a solid balance sheet with no debt at the end of June. EBITDA grew by 2.6%, very close to the core operating income increase. Free cash flow increased even more by 5.9% to EUR 394 million.
Net investment in the first half included the payment of the Onivyde milestone following the FDA approval of the first-line indication, as well as the upfront payment related to the external innovation transaction, including Sutro and Skyhawk. With almost no debt at the end of June and based on 2x EBITDA, we have now an available firepower for external innovation above EUR 2 billion.
I would like now to conclude my financial section with our guidance for 2024. Please turn to Slide 23. Based on the solid momentum and the strong performance of this first half, we are very pleased to upgrade our full year guidance. As you can see, we now expect total sales to grow by more than 7% at constant exchange rate, as compared to our previous guidance of growth above 6%.
This assumes an accelerated erosion of Somatuline based on an increased generic competition, notably in the US, and also a higher contribution for our launches, including Onivyde and Iqirvo. On Core Operating Margin, we anticipate now a level of more than 30% of total sales.
It assumes a lower anticipated profitability in the second half of the year as a result of our continuous investment for our launches and in our pipeline, but also a higher seasonality of costs in H2 versus H1 and a lower level of milestone Onivyde in H2 versus H1. With all of that, I will now hand back to David for the conclusion. Please turn to Slide 24.
Thanks, Aymeric. Please turn to Slide 25. To conclude, there are four key messages to take away from the results today that illustrate the delivery on our ambitions. Firstly, we achieved another strong combination of total sales growth, core operating margin, and cash generation. We're making good progress on the pipeline, including regulatory success and the addition of a number of promising assets. Our launches of Onivyde and Iqirvo are on track.
Finally, our commercial and pipeline performance is being driven by continual improvements in our execution centered on our focus on patients. Please turn to Slide 26. Thanks for listening to our presentation. Christelle, Aymeric, and I now have the time for your questions. Operator, over to you.
Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take your first question. One moment, please. Your first question comes from the line of John Priestner from JP Morgan. Please go ahead.
Hi, John Priestner from JP Morgan. Thank you for taking my questions. T wo, if I may. The first is on Somatuline. I n the first half, we saw Somatuline erosion of only about 1%. C an you help us understand how that might develop in the second half, what some of the push and pulls are around that, and how much Somatuline erosion is baked into the 2024 guidance?
It seems like there would have to be quite a big drop-off to even reach a kind of double-digit decline in 2024 at this stage. T he second question would be on Iqirvo. T here is potential that the current standard of care in second-line, PBC, Ocaliva, might be removed from the market following a negative EU CHMP recommendation. I believe there's also a US FDA adcom expected before mid-October.
How are you really thinking about this opportunity and how it might impact the Iqirvo uptake? I s this at all factored into your 2024 guidance? Thank you.
Thank you, John. O n your first question on the Somatuline erosion for the second half, you're right. We have, as we have said already at the beginning of the year, guided that we assume an acceleration of the erosion given the appearance of the generic. I t has been indeed put into our guidance.
Now, the push and pull, of course, are going to be how much is the supply going to recover? I t's hard for us to tell that, but we have assumed that the supply is going to recover in Europe and that we will see a stronger erosion in the second half of this year, also in the United States. Regarding your second question on Iqirvo, the Ocaliva removal, we will really have to see what happens exactly.
In Europe, it's not clear if they are going to put in place a compassionate use program or not for the patients that have been on Ocaliva and what is going to happen with the U.S. adcom. Something similar might happen there, like in Europe.
We have, in any case, already an assumption of Iqirvo cannibalizing Ocaliva even without the withdrawal. If the withdrawal is not going to be supported by compassionate use and if it's going to happen also in the United States, there is indeed a potential upside. I t's going to perhaps then accelerate this penetration curve a bit more on patients who are on Ocaliva right now. Next question.
Thank you. Your next question comes from the line of Lucy Codrington from Jefferies. Please go ahead.
Hi there. Thank you for taking my questions. Correct me if I'm wrong, but Dysport aesthetics seemed a little weak in the US during Q2. I wonder if there's anything specific behind this and just more generally, if you're seeing any sign of a slowdown in the injectable aesthetics market, given some of the commentary we've had from consumer names over the kind of broader beauty market.
Secondly, I believe you previously mentioned that Bylvay can be a bit lumpy due to weight-based dosing. Sorry. Is there anything to suggest that we shouldn't consider the Q2 trend as a good guide going forwards?
Finally, just probably maybe still a bit early to say, but I wonder if you could give us an indication of your confidence in your Somatuline peak sales, given what you're seeing to date regarding, I believe, a preference for physicians to try for clinical trials rather than necessarily using Somatuline. Thank you.
Thank you, Lucy. On Dysport aesthetics, the market in the U.S. is a little bit softer, but you also need to keep in mind that we're selling to Galderma and that there are some shipment phasing. I will have Aymeric elaborate a bit more on the shipment phasing on the Dysport.
Thank you, David. M aybe to make sure the numbers on Dysport, especially if you look at them on quarter by quarter, you may have a big impact given the phasing between the supply and the retail, between the sell-in and the sell-out.
Specifically, and we see that especially on the European performance this year. Specifically in the US, if you look at our numbers, the numbers are very good and very strong. We benefited in Q1 on some of the lower inventory in Q4 of last year. A s a consequence, by definition, the Q2 was slightly lower. But overall, if you look at the performance for the first half, we have a very strong performance for at 36% growth.
Clearly, and I think it's better to listen to Galderma, my understanding is they are delivering very strong performance in line with what we see in the in-market demand, with the US market not maybe at the same level of growth as it used to be, but still a very strong market share uptake from Galderma. We're confident that this is going to continue going into the second half of the year.
On your second question, Lucy, on Bylvay and the Q1 and the Q2 trend that we have seen, it is correct that sometimes, for example, in PFIC, if you have a batch of more adult patients, the sales can go up a bit more and then it can be a bit less. But overall, mid-long term, we absolutely assume continued nice growth, which is going to come from further expansion of the penetration in PFIC, but also in Alagille.
The CHMP opinion, by the way, for the Bylvay is coming tomorrow. W e will see what that decision says, but we are optimistic. W e're also expanding still in more markets where we're going to launch. W e will see strong continued Bylvay growth. Regarding your question on Somatuline, it is correct that there are currently four trials ongoing.
Many of the patients get actually included in those trials, including, by the way, fidrisertib that Christelle talked about that we're going to have to read out next year. I t's too early to say what's going to happen to the peak sales because once these trials come to an end, then we will see what happens with the different drugs. C learly, we see FOP as a nice opportunity. W e are also excited to see the results then soon on fidrisertib . Next question.
Thank you. Your next question comes from the line of Xian Deng from UBS. Please go ahead.
Hi. Thank you for taking my question. T wo, please, if I may, both on elafibranor. T he first one is just wondering if there's any color that you could give us in terms of payer discussion you're having on elafibranor. Just wondering, do you have any sort of assumptions of possibly payer preference for elafibranor versus seladelpar once that's approved? T hat's the first question.
Second one is , fully understand you probably can't comment on your expectation for seladelpar label given the upcoming PDUFA. J ust wondering if you could comment on whether your expectation for elafibranor would change, whether seladelpar has pruritus on the label or not. I s there any sort of scenarios regarding seladelpar label that would significantly change your expectation for elafibranor? Thank you so much.
Thank you, Xian Deng. On your first question on Iqirvo and P&R discussion, there is currently absolutely no discussion on any preference status. We do not see currently any problems on reimbursement. W e get patients reimbursed. It's not an issue. We would expect that once seladelpar would launch, that there might be some of those discussions happening, but it's not totally obvious because, for example, on Bylvay, we have not experienced that neither.
Yet, of course, there are different galenical formulations, etc. W e have to see what's going to happen there. We do assume in our assumptions that there will be some P&R discussion, which is going to start. That's our base assumption. On the seladelpar label, you really have to ask Gilead. What I can say, what we have assumed in our guidance is indeed that they potentially would get the pruritus label.
That's baked in already into our guidance. Next question.
Thank you. Your next question comes from the line of Manos Mastorakis from Deutsche Bank. Please go ahead.
Hello. Thank you. Manos Mastorakis from Deutsche Bank. I have two, please. O ne on elafibranor. What is the benchmark you see for seladelpar and how do you see the opportunity there in general? A lso in light of the earlier question that was posed on the evolving, so see US and EU and potential withdrawal of Ocaliva, how do you see a readout on seladelpar kind of impacting the landscape?
My follow-up question is on M&A. I guess you've done a series of deals and those are mostly licensing deals. And it will be great to understand and get a temperature check on M&A strategy moving forward.
Thank you. Okay. Thank you, Manos. You were a little bit difficult to hear. There was a lot of background noise. I hope I got this right. I think your first question related to Iqirvo and the ELSPIRE and the opportunity there. ELSPIRE is focusing on patients which are between 1 and 1.67. So it's a less progressed patient population than what we had in the current registration trial.
There are about 20,000 patients in that pool in the US, out of which 9,000, and those are the patient populations we're addressing with ELSPIRE, have an ALP level between 1 and 1.67, but in addition, also must have symptoms. F or example, they have scratching or they feel fatigue, etc. So the ELSPIRE trial is really tapping into these 9,000.
Regarding what is included already into our guidance, we have modeled a modest spontaneous uptake with the current data in that population already. A s I said, it's modest. If that trial pans out positive in 2026, then we would assume that we will see an accelerated penetration in this pool. On your second question, what I understood was something on Ocaliva and what's going to happen.
I think we have already had that question from John from JP Morgan, if there is an upside, if Ocaliva would be removed. The answer was that yes, we assume already some penetration in that pool of Ocaliva, but if, of course, if it gets totally removed, that there is no compassionate use, then clearly there would be an upside. On our third question on the M&A strategy, our M&A strategy hasn't really changed.
We are screening on a continuous path and we are looking at opportunities which fit our strategy that we have laid out in the Capital Markets Day and where we can justify the value because we want to be disciplined in the acquisitions that we are doing. Next question, operator.
Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead.
Good afternoon. Thank you very much for taking my questions. two, please. First, regarding the guidance for the year, the upgraded guidance after a very strong first half. W e definitely understand the second half, there will be pressure on several products and on costs. I was just wondering if you could give us some comments on how do you see the new guidance.
Is it cautiously optimistic or what could bring you to a kind of stronger second half than expected? So some comments on this front would be great. S econd question on Onivyde, could you give us an update on the patent dispute on this one? If there is anything new, it would be great to know. Thank you.
Thank you, Florent. I will hand over to Aymeric on your first question regarding the guidance.
Thank you for the question. I will maybe remind what I said during the presentation. I think we are quite comfortable about this guidance. As always, when we state an upgraded guidance, we think that yes, the top line will see a lower growth in H2.
As David said, this is going to be mainly related to Somatuline rate of erosion, where we expect that the stockout in Europe will resume. This is our assumption. There is still possibility that it will go for longer. We also are assuming that there will be a further penetration of the generic in the US, which has been announced, as you say, end of May.
We think that starting in Q3, this is going to accelerate towards double digits as compared to the flat of the first half. We think that there will be, on the other side, increased contribution from all the launch and a continued good performance of the other products.
On the margin side, as I said, this will be also a lower margin in H2, which is quite customary at Ipsen, where we see less sales given the months of August and December, but also a little bit more cost given the activity that we always see in the second half of the year. On top of that, we're going to continue to invest to support the launches. Especially H2 is going to be very important for Iqirvo with the expected approval from Gilead of the competitor products.
On top of that, we have some one-off impact, one of them being the phasing of the milestone we received from Servier, which has benefited the first half, and we don't anticipate any in the second half of the year. That's really the underlying assumption where we see great confidence in being able to deliver on that guidance.
On your second question, Florent, on Onivyde patent use, you're actually most probably not going to hear for a pretty long time on the patent because these things take a very long time to pan out and we have to submit documents, etc., which we all did. We're very confident on it that we have stable patents. T hat's all I can say at this moment. Thank you. Operator, next question.
Thank you very much.
Thank you. Your next question comes from the line of Alastair Campbell from RBC Capital Markets. Please go ahead.
Brilliant. Thanks. And thanks for taking my questions this afternoon. Just a couple, please, on tovorafenib, if I may. It's not a molecule I'm afraid I'm familiar with. J ust first of all, can I ask just your sense of confidence that the Firefly One dataset should be good enough to secure approval with the European regulator?
Just thinking about sales potential. If I use the Ojemda price in the US, look at the response rate and duration of responses and sort of anchor into that 700 incident cases per annum population you talk about, that sort of drops out of the sort of sales figure for the E5 of around about EUR 150 million. I just wonder if that's a reasonable anchoring point to think about in terms of the sales potential for the product or whether you'd like to do substantially better than that.
Thank you.
Good. Thank you. On tovorafenib, yes, we believe that the data that they have is strong and looks convincing. If not, we would not have done the deal. There is some CMC work that still needs to be done for the European filing. Day One Biopharmaceuticals has really focused on the U.S. filing. W e're going to work together very closely to try to generate the CMC data as quickly as possible and then file sometime next year.
We're certainly going to come back to you to give you more guidance when exactly that could be. So the information is going to come fairly soon once we have started that work. In terms of the sales potential, the 700 incidents and 2,000 prevalence relate to the big five EU markets. W e are assuming a couple of hundred million EUR.
Probably your sales figure for the five EU is probably somewhere there. But we're not guiding officially on this one.
Great. Thank you.
Thank you, Alastair. Operator, next question.
Thank you. As a reminder, if you would like to ask a question, please press star one and one. We will now take the next question. Your question comes from the line of Emily Field from Barclays. Please go ahead.
Oh, hi there. Thanks for taking my questions. I just wanted to ask a high-level one. Thinking about your three commercial divisions, the new US commercial launches you're focusing on, as well as constantly screening for business development opportunities to enhance the pipeline. Just a sort of broad question about where do you spend your time and where is the focus on internally?
That's the first one. Second question is on Bylvay versus Livmarli. What are you hearing from the physician community in terms of different indications on label for Alagille and PFIC respectively? Are there advantages or disadvantages associated here in the different indications? Would you feel you broadly share the market? J ust a quick one on Dysport.
Are you concerned at all about Dysport growth being impacted in the medium term by Galderma's potential approval of their liquid neuromodulator, QM1114, which is a more profitable product for them, and therefore they may be incentivized to switch patients in the mid to long term? Thank you very much.
Thank you, Emily. O n the first question on where is the focus, I guess you mean my focus or perhaps my management team's focus? I will start with my focus. I have to focus, of course, in a mid-size company on all three of them, right?
Because we have said we have four strategic pillars and we want to really execute on the in-market drugs we have and on our launches. I have a strong focus on this. E qually, of course, I'm also going to make sure that we can continue to expand the pipeline and to do more acquisitions. T his is with the scope that we have at Ipsen, it's feasible.
Of course, we then have in the executive leadership team very qualified people who are going to be fully dedicated, like Mari, for example, for the international markets or Stewart or the US or Christelle, of course, for external innovation, but also advancing the pipeline. W e have a very, very strong management team. I have to say it is only with them that we were able to actually deliver these strong results that we have seen in the past years.
On your second question regarding Bylvay and Livmarli and the age in the label, so it's, of course, in the US, Livmarli got a label which is five years and above. C learly for us in PFIC, that's an advantage. We haven't, however, on the Alagille syndrome, we have a label of 12 months and above. They have six months.
That's a slight disadvantage, but I would not over-exaggerate this because many babies are being diagnosed as of 12 months and over. In Europe, it's fairly similar, in fact. T here's not really a big disadvantage.
I would say where the real disadvantage is coming for us is on the granulate form because babies, toddlers, and adults, they can either take a capsule, they can take the granulate, which you can, for example, for a smaller baby, put in chocolate sauce or in apple sauce, and you can also dissolve it, the granulate, in a liquid, for example, in milk.
We do have all three options, and this is really what convinced us to go for Bylvay and the Alagille. On the Dysport growth, the two products have a different profile, right? Dysport is in powder and QM is in a liquid.
We know that many physicians have a preference for powder because they want to reconstitute it and administer exactly as they want in aesthetics. We also have to see then in QM if that is really having it in liquid is such a big advantage.
We have seen that Alluzience, which is a liquid, which Galderma has already from us in Europe, gained some market share, but not massive. I t has been baked into our guidance so far. I think that's our last question, operator. W ith this, we're wrapping up the call. Thank you very much for attending, everybody, and hopefully have a nice break. Bye-bye.
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