Q1 2025 Soleno Therapeutics Inc Earnings Call
Greetings and welcome to the Soleno, Therapeutics, First Quarter, 2025, Earnings Conference Law. At this time, note that all participants are in a listen-only mode.
Should you require operator assistance, please press star zero on your telephone keypad.
A question and answer session will follow the formal presentation. You may press star 1 at any time to be placed into the question queue and we ask that you please ask one question and one follow-up then return to the queue.
As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to Brian Richie of Lifesci Advisors. Please go ahead, Brian .
Thank you, operator. Good afternoon, everyone, and thank you for joining us to discuss Salino Therapeutics, First Quarter 2025 Financial, and Operating Results.
Please note, we'll be making certain forward-looking statements today.
We refer you to Soleno's SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements.
Speaker Change: On the call with me today from Soleno, our Anish Bhatnagar, Soleno's chairman and chief executive officer, Meredith Manning, Soleno's chief commercial officer, and Jim MacKaness, Soleno's chief financial officer.
Speaker Change: Anish will begin with a review of the company's progress during the first quarter and subsequent period, including FDA approval of ICAT-XR and commercial launch.
Speaker Change: Meredith will then review the company's commercial progress to date and Jim will cover the company's financial statements for the first quarter. We will then open the call for questions. With that, I will now turn the call over to Anish.
Speaker Change: Thank you, Brian , and thank you everyone for joining us for our very first quarterly results earning call.
Aneesh: It's been a momentous couple of months for our company highlighted by our announcement on March 26th that the FDA approved ViCAT XR.
Speaker Change: previously known as Disoxide Calling and Extended Release Tablets, or DCCR, as the first medicine for the treatment of hyperfagia in people four years of age and older with Prada Willy
Speaker Change: This approval is a culmination of many years of tireless work by the entire Soleno team, without whom none of this would have been possible.
Speaker Change: I would also like to recognize the significant contributions of the entire PWS community, including study participants in their families.
The Study Investigators, and Study Site Team Members.
Speaker Change: as well as the major PWS advocacy organizations, the foundation for probably research and the PWSA USA and the UK.
Speaker Change: We are very pleased to offer ViCAD XR for individuals and families who have been waiting for a treatment option for the symptoms related to the devastating disease since it was first recognized in 1956.
Speaker Change: Following approval and reflecting our progress and establishing our commercial readiness, we were able to move very quickly to launch.
Speaker Change: We announced on April 14 that the first patients had received and are currently being treated with by Cadix R. And this was about a week ahead of our internal forecast.
Speaker Change: Meredith will provide some additional color on the initial launch in a moment.
Meredith: For those who may be new to the story, I would like to briefly remind you of the key characteristics of PWS and discuss the impact that hyperfagia can have on the lives of people with PWS, their caregivers, their families, and the healthcare professionals who treat them.
Meredith: PWS is a rare genetic disease. It occurs spontaneously in about 15,000 to 125,000 live births due to the deletion or lack of expression of a certain set of genes in chromosome 15.
Meredith: This translates to approximately three to 400,000 individuals living with PWS around the world.
Meredith: By the age of around seven or eight years, although sometimes as early as four, individuals with PWS typically will begin to exhibit the hallmark characteristic of the disease, hyperphagia, which is an insatiable desire to eat. This is essentially your brain telling you that you're starving despite having eaten.
Meredith: The only thing families and caregivers have been able to do to try to control hyperfagia is restrict access to food, such as locking refrigerators, trash cans and pantries.
Meredith: Constraint food preoccupation contributes to significant behavioral problems that can substantially disrupt daily life for those living with PWS and their families.
Meredith: Kairgiver burden increases after the onset of hyperfagia and in fact has been measured to be higher than the burden experienced by Kairgivers for patients with Alzheimer's.
Meredith: So hyperfagia is a truly terrible condition for which no approved treatments have existed until the approval and launch of Vicatix are.
Meredith: Recapping our label, the indication is for the treatment of hyperfagion adults and pediatric patients four years of age and older with PWS.
Meredith: We believe that our label reflects vicar XR's favorable safety and tolerability profile, contains no box warning, no contraindication for diabetes, no exclusions for severity of hyperfagia, or no requirement for a risk evaluation and mitigation strategy or REMS program.
Meredith: Bicad Xsaurus to be taken orally once daily. Do thing is weight-based.
Meredith: There is a titration period for about six weeks after which all people taking bycadx are should be on or close to their maintenance dose.
Meredith: The label has clear directions on how physicians should modify the dose if needed to address any side effects and minimize any dose interruptions.
Meredith: The commercial opportunity for Waikad XR as a first-to-market therapy is significant. We have used existing claims data to confidently identify approximately 12,000 individuals diagnosed with PWS in the United States, of which approximately 10,000 should represent our total on-label addressable market.
Meredith: This excludes those individuals with PWS who are younger than 4 years old, others who may not be experiencing hyperphasia, or who may have comorbidities that make them ineligible for
Meredith: As mentioned, as soon as we received FDA approval, we were prepared to begin accepting by KXR's start forms immediately, and patient treatments commenced in mid-April.
Speaker Change: This is a testament to the efforts of Meredith Manning, RCCO, and our world-class commercial team whose pre-launch efforts to patients, physicians, and peers set the stage for a strong and successful launch and to all of our employees who worked so hard to prepare the company for this day.
Speaker Change: I will now turn the presentation over to Meredith to discuss the early days of the launch and a few performance indicators that we plan to provide for the next several quarters to assist you in tracking our progress.
Thank you Anish, and good afternoon everyone.
Meredith Manning: As Anisha indicated, the launch readiness activities that we have been diligently executing for the past several months has ensured that we are well positioned to deliver this much needed treatment to patients as quickly as possible.
Meredith Manning: We previously discussed three pillars of activity that we view as crucial to a successful launch.
Meredith Manning: First, to establish Vicat XR as the standard of Karen Hyperphasia in PWS.
2nd to deliver operational excellence
and finally to communicate the compelling bycotics our value proposition.
Meredith Manning: And while it is still very early in the launch cycle of a new therapy, I am nonetheless very pleased with our launch efforts to date.
Meredith Manning: We are seeing awareness on the part of people living with PWS and their caregivers, a willingness to prescribe on the part of treating physicians, and a recognition of the unmet need on the part of payers.
Thank you.
Meredith Manning: We outline several performance indicators we plan to provide over the next several quarters to help track our progress.
The first of these is patient start forms. [inaudible]
Meredith Manning: As of the end of day, yesterday, we have received 268 start forms, and that's in 29 business days since approval.
and while it's early, it is very encouraging.
Meredith Manning: We look forward to future quarterly updates when we will have an opportunity to collect more data and identify trends that are emerging.
Meredith Manning: On April 14th, we announced the first shipment of ViCAD XR to individuals living with Hyperphasia in PWS.
Meredith Manning: Since then, many patients have received their first dose of IKEDXR and have started treatment. This reflects our dedication to ensuring timely access to treatment.
Meredith Manning: The second performance indicator that we will be providing is the number of prescribers, which is 131 unique prescribers as of yesterday.
Meredith Manning: Our Field Force is prioritizing engagement with top-tier providers with high-patient volumes, which includes pediatric and adult endocrinologist, geneticists, and psychiatrists.
Meredith Manning: We have also been impressed with the adoption of ICADXR from a broad base of prescribers, including those practicing in the community.
Meredith Manning: This expanded reach indicates that our efforts to drive awareness of viacadx are availability to communicate the efficacy and safety profile and the need for a therapy across a broad prescribing spectrum is strong.
Meredith Manning: Finally, in the future, we will be covering a detailed update on payer coverage.
Meredith Manning: That will be covered live and some color on payer policies, as this is critical to patients initiating and remaining on therapy.
Meredith Manning: We previously talked about our payer outreach, which was mostly focused on emphasizing the complexity of hyperphasia in PWS patients, the consequences of not controlling hyperphasia, and the need for a new therapeutic option.
Meredith Manning: We are very pleased with the feedback we have received from payers as a result of this outreach and we are confident the ViCADXR value proposition is resonating with commercial and government payers alike.
Meredith Manning: While formal coverage policies can take anywhere from three to six months and sometimes longer to develop and implement, we do expect that
Meredith Manning: We are fully committed to ensuring that by-catexR is available to all eligible patients and that affordability is not a barrier to treatment. To the end, we have stood up Soleno One, our single point of contact for patient services.
Meredith Manning: Soleno won with operational day one upon approval and is dedicated to supporting caregivers and healthcare providers in minimizing and navigating payer access obstacles.
Meredith Manning: I will now turn the call over to Jim for a review of the company's financial statements for the first quarter. Thank you, Meredith.
Jim: We used 32.8 million of cash in operating activities during the three-month-ended March 31st, 2025, and ended the period with 290 million of cash, cash equivalents and marketable securities compared with 318.6 million as of December 31st, 2024.
Jim: As we have stated previously based on our current operating plan, we believe our cash, cash equivalents and multiple securities are sufficient to fund our operations through cash flow
Jim: Furthermore, with the approval of ICAT XR, we now have an additional 75 million available to us in two churches over the next 18 months under our loan agreement.
Jim: Turning now to a few income statement items, the company had not commercialised by Kent XR and the three months ended March 31st, 2025, and accordingly generated no revenue
Jim: Research and Development Expenses for the first quarter ended March 31, 2025 for 13.5 million.
Jim: which includes 4.3 million of non-cash stock base compensation. That compares to 14.6 million which includes 2.4 million of non-cash stock base compensation for the same period of 2024.
Jim: The cadence of our research and development expenditures fluctuate depending on the state of our clinical programs, timing of manufacturing and other projects as we've moved through submission, approval and now preparation for commercialization.
Jim: Selling General and Administrative Expense for the first quarter ended March 31, 2025, was 29.3 million.
Jim: which includes 10.4 million of non-cash stock-based compensation and that compares to 8.5 million which includes 4.0 million of non-cash stock-based compensation for the same period of 2024.
Jim: The increased reflects our ongoing investment in additional personnel and new programs in preparation for commercial launch and a support of our increased business activity.
Jim: Total other income, net was 2.0 million for the three-month-centered March 31st, 2025, compared to total other income net of 2.1 million in the same period of 2024.
Jim: Now net loss was approximately 43.8 million or 95 cents per basic and diluted share for the first quarter, ended March 31st 2025, and 21.4 million or 59 cents per basic and diluted share for the same period in 2024.
Jim: This concludes the financial overview, and I'll now turn the call back over to Anish for closer remarks. Anish.
Thank you, Jim.
Speaker Change: While we are very pleased with what we are seeing in the early days of our US commercial launch, PWS is a global disease that impacts hundreds of thousands of patients around the world.
Speaker Change: In an effort to make Bicad XR available to as many of these patients as possible, in parallel with our US commercial launch, we continue to progress around regulatory pathways and other geography, the most important of which is the EU.
Speaker Change: We have stated previously that Europe also has a high unmet need among other patients with PWS, and as with the US, the PWS community has strong, thoughtly, received support, and patients are often concentrated around centers of excellence.
Speaker Change: Based on widely cited prevalence data, we estimate that there are as many as 9,500 patients with PWS in the EU for and the UK. As we have stated previously, the submission of an MAA to the EMA is planned for the first half of this year.
Bye.
Speaker Change: Before we open the call for questions, I want to close by reiterating how pleased we are with the early response we are seeing from the PWS community to the availability of viketics are in the US.
Speaker Change: With that said, however, I remind everyone that start forms are a leading indicator and there is a lag between receiving a start form and a specialty pharmacy partner purchasing product from us, which is when we record revenue.
Speaker Change: Therefore, as is typical in these types of launches, we expect revenues to start of modestly. It will take time to execute a full commercial launch, which includes patients scheduling visits with their healthcare providers, pairs determining coverage policies, and the sales seem being fully oriented to the territories.
Speaker Change: I look forward to sharing more details on our launch trajectory during our second quarter results, the call in August . And with that, we will now open the call to your question, operator.
Speaker Change: Thank you, sir. Ladies and gentlemen, if you do have any questions, please press start followed by one on your touch on phone. You will then hear a prompt that your hand has been raised.
Speaker Change: Should you wish to decline from the polling process, please press star followed by two and if you are using a speaker phone, please lift the handset first before pressing any keys. Please go ahead and press star one now if you do have any questions.
Speaker Change: First question will be from Yasmin Rahimi at the Piper Sandler. Please go ahead.
Yasmeen Rahimi: Good afternoon team, congrats on an outstanding quarter, two questions. The first one is just could you quantify how soon we could start converting the starting forms into revenue?
Yasmeen Rahimi: Second question is, what do you project the time to fill to be at this point and how it will change over the course of 2025 and I respect your wishes of two questions when I'll jump back into the queue.
Jim, you want to take the first question?
Jim: Yes, sure. Obviously there's a number of steps that have to go through to get the start form into the hands of the specialty pharmacy and qualify if you like for commercial drug because you're talking about the commercial drug.
Jim: and then they in turn have to turn around and obviously place the order and we anticipate that they will be cautious, if you like, in the inventory bill that they'll want to take.
Jim: Thank you for the question. We're very happy with the speed in which we're able to convert the current start forms over to ship product. Thank you for the question.
Meagan: You know, it's too soon right now. We're only 29 days in to give specific details on the turnaround time, but we're seeing what's, you know, ordinary with other rare disease launches and we'll look forward to giving more information on the next call.
Thank you, Marida, and thank you, Jim, and Anish.
Thank you. Next question will be from Devgett Chado Padaya at Guggenheim Securities. Please go ahead.
Meagan: Very good afternoon. Thanks for taking my question and congrats. I have a couple.
Speaker Change: If I remember correctly, about 127 patients were enrolled in the Phase 3 program.
Speaker Change: What percentage of those patients are reflected in the current stop forms?
Meredith Manning: Meredith, you want to take that? Yeah, happy to take that.
Meredith Manning: So as you'll recall in the randomized withdrawal period, we had a total of 77 patients, 60 of those patients are here in the United States.
Meredith Manning: and so the majority of those patients we've received their start form and we're looking at converting them over. So we're very pleased with how fast our clinical operations team is executing on converting those patients.
Speaker Change: Awesome. And in terms of the free drug that patients are receiving right now, how should we think about it, how many days of free drug before they read the most therapy, that's much in terms of that.
Speaker Change: Yeah, so, and I'll just remind everybody that, you know, we're really early in the launch, and it takes easily six...
Speaker Change: Months for many payers to arrive at a full coverage policy sometimes a little bit longer, but it's more very pleased with
Speaker Change: the reimbursement that we're seeing come in. We have a couple programs, one we have our bridge program with the clinical trial patients.
Speaker Change: and then, if needed, if we're seeing more of an excessive delay on reimbursement or approval of...
Speaker Change: the start form, then we have what we call quick start, and we're looking at providing a 28 day prescription.
Thank you so much.
Kristen Kluska: Thank you. Next question will be from Kristen Klasker at Cantor. Please go ahead.
Kristen Kluska: Hi, good afternoon, everybody. Let me also add my congrats on a great start here. My two questions, first, can you help us understand some of the ways we should be thinking about coverage decisions on a state-by-state level and how policies may differ? And then my second question is the International PWS Organization Conference is taking place next month, always a huge conference for these patients. So I was hoping you can get some color about ways that so
Speaker Change: will be present there now that you have an approved therapy to talk about.
Speaker Change: Let me take the second part of it, Meredith. You can take the first one then. So, we definitely will have a significant presence at this United and Hope conference. It's the first time the international organization as well as the two US based organizations are having a combined conference.
Speaker Change: It's a large conference and it's going to be very well attended.
Speaker Change: our commercial teams, metaphors teams as well as clinical developed teams, development teams will be there.
Speaker Change: We have several presentations and abstracts, so we would like to see you all there and know many of you are planning to be there as well, so we are happy to engage and tell you more about what we are doing while we are there. Mayor, do you want to take three? Sure.
Talking about state-by-state [inaudible]
Speaker Change: Soleno, we've actually, we're participating in the MDRP program, so the medicated, the medicaid program which allows for states to start uploading Vicat XR in the system as of May 1st, but I'm sure you know that
State's very some come on early and decide their policy.
Speaker Change: You know, within a month or so and others can take up to, you know, July , August or the second half of the year. So we're pleased because we've already seen several states uploaded by TEDxR in their system and we're seeing coverage across various different states.
Thank you.
Speaker Change: Next question will be from Leland Gershaw at Oppenheimer. Please go ahead.
Leland Gershel: Well, great. Thanks for taking the questions and great to see the early launch numbers. Maybe a question from Meredith, just seeing off your comment about the fact that you're seeing prescriptions coming from DOT2, maybe outside of the initial target group of applied prescribers. Could you share a bit more color on kind of what you're seeing with respect to DOT2 may not have been in that 300 or so?
Leland Gershel: that you have targeted kind of what the maybe more community type interest is looking like. And then also want to ask with respect to Europe , if you could share now maybe the earliest, it'll be time until it proves there, but.
Leland Gershel: What probably looks like in Europe in terms of dispersion of patients and how they're treated, does it look kind of like the states in terms of A sort of a smaller group of specialists who treat to take the treat those patients or is it a bit different than in the states? Thank you
Leland Gershel: Why don't you take the first one, I'll take the second one.
Leland Gershel: Sure. Happy to. So thanks for the question, Leland. We are very encouraged and very pleased by the broad spectrum of writing that we've seen.
Leland Gershel: We definitely anticipated a lot of excitement from the community, whether it be thought leaders, also community treating physicians who see PWS.
Leland Gershel: I think what we can attribute that to is the fact that we had a lot of strong pre-launch.
Awareness Efforts
Leland Gershel: and an opportunity to partner very closely with many thought leaders as well as advocacy in the community.
to hold various different types of webinars upon launch.
Leland Gershel: We have a lot of promotional materials and digital assets up and running so we believe that not only our sales force but also our omnichannel efforts have enabled us to reach a broad spectrum of those physicians, including those in the community.
Leland Gershel: William, regarding Europe , in general I would say that the care for PWS in Europe is similar.
Leland Gershel: But I would say that in some cases it's probably more organized than the US.
Leland Gershel: So for example, when you think about a place like France, our understanding based on conversations and visiting some of the centers there is that virtually every individual with PWS there is seen at one of the few centers of excellence. And virtually all of them are tracked by a centralized system.
We believe something similar exists in Germany.
Leland Gershel: and we think that the care of those patients is quite similar to here with growth hormone being administered to the ones who are qualified for it and really no other treatments being available. So, the environment for the use of a drug like vicar is quite similar to what you would expect here.
That's very helpful. Thanks very much.
Speaker Change: Thank you. Next question will be from Brian Scorney at Baird, please go ahead.
Brian Scorney: Hey, good afternoon, everyone. Thanks for taking the question and congrats on the initial launch mattress. I hate to put you guys on the spot and make a direct comparison to another drug launch, but since Dawn Bear is on your board, I can't imagine that this conversation hasn't come up, but at 256 star forms over a little more than a month, you seem to be chasing Skyclaris almost.
Brian Scorney: Exactly, they had 500 star farms a little over two months. Their first quarter sales were almost half of what you're full year of consensus estimates here are right now. So I'm just wondering, you know, why shouldn't buy cat?
Brian Scorney: Given this start form, given sort of a similar reimbursement dynamics, why wouldn't it track lower than Sinclair's? Because that's a much better launch curve than where consensus is currently modeling U.F.
Speaker Change: Brian , thanks for putting us on the spot. Jim wants to take the questions. Well, the one to go on
Speaker Change: You know, each company has its own dynamics. I would suggest, you know, with our weight-based pricing one has to be sensitive to the sort of the weight profile of the patients. And if you remember we sort of anticipated that we might have a younger set of patients coming through. So that's one variable that we have to consider. Yeah.
Speaker Change: Yeah, and if I may, would also just mention that I think Skyclaris had a lot of their commercial team in place for many years prior to launch and their field team was out.
Speaker Change: a couple months prior. Remember that we had half of our sales team come on at the end of January and then we most recently brought on the rest of our field team fully trained and they're out as of April 27th.
Speaker Change: So I think if you could give us some time to get our team out there to sell, I'm confident that we'll produce similar as well. Additionally, I would also bring your attention to the fact that we had drug and channel by April 14th, Skyclaris didn't.
Speaker Change: So we are also operationalizing and converting start forms into paid patients.
So better than Segrin, this is where he's going to end up.
Speaker Change: Yeah, Brian , I think it's also important to note that we are prescription base, as Meredith has mentioned is 131 physicians already, so we think it's a broad-based build which will sustain us over time.
Speaker Change: It's, you know, we're not as in the details with Sykes Guy Claris, maybe you are, but no direct comparisons to be made, but we certainly feel pretty enthusiastic about what we've seen so far.
Right. Thank you.
Speaker Change: Thank you. Next question will be from James Condolus at Steve Fowl. Please go ahead.
James Condoulis: Thanks for taking my question and congrats again on a great quarter and kind of falling up on that last kind of discussion point in looking at other rare disease launches. Is there a general ballpark on sort of the percentage of. [inaudible]
James Condoulis: You know, patient start forms that actually convert to paid drug is you know it typically all patients actually convert and it's just a matter of when like just curious if you can provide any color there and kind of along those lines. You know what I'm saying?
James Condoulis: as you think about the cadence of adding start, you know, start forms throughout next, you know, 2Q and beyond, like do you expect it to accelerate or hold steady, just like curious any color you can write there. Thanks.
Speaker Change: I think it's too early to give a percentage, but we definitely are expecting in
Speaker Change: To be comparable to other very strong rare disease launches, we have our internal metrics, but I think it's too early to share what we're looking at.
Speaker Change: I think it's also fair to say that the unmet need here is pretty significant, no other treatments are available.
Speaker Change: So, we should expect to be at least as comparable, at least comparable to other areas of these launches.
Great, thank you.
Speaker Change: Thank you. Next question will be from Miriam Belgity at Lifestyle Capital. Please go ahead.
Speaker Change: Hello, congrats on the update and thank you for taking my question. A little bit off topic here. I was wondering if you have any comments on how or if the evolving terror policies are affecting your business operations during the launch.
Speaker Change: Tara, I'm sorry. Yes, we have looked through our supply chain and I would suggest that really we don't see any significant impact with the way that Tara is currently being phrased. We do most of our manufacturing in the US, so we feel that it's not something that's going to impact us to any great extent.
Speaker Change: So the drug substance and drug product vendors are both US-based, we do source some starting materials from outside the US but as Jim said no major impact.
Okay, thank you for that clarification.
Thank you. Next question will be from Yale Gen at Leid Law. Please go ahead.
Speaker Change: Good afternoon and thanks for taking the question and congrats on the progression.
Speaker Change: It's a quick two questions here. The first one is that could you give us a little bit of color in terms of for a new patient?
Speaker Change: What are the sort of steps of procedures to ultimately get the drug prescribed audience need to start with the
Speaker Change: Request of the staff form, or they need to visit the physician to get a description and how does that work, and then I have a quick follow-up.
Speaker Change: Yes, so the best way to think of it is that either the patient slash caregiver will reach out to a physician or the physician will reach out to them. They would need to typically see the physician, the physician would need to fill out a start form.
Speaker Change: The start form would go to the specialty pharmacy and the specialty pharmacy would then take it from there to start the process of providing drug to the patients.
Okay, great, that's very helpful. And maybe one question.
Speaker Change: In terms of the European development, I know you guys were talking before whether you want to launch the product by yourself or seeking a partner, was there anything close to any decision at this point? Thank you. Thank you.
Speaker Change: So we continue down the path of assessing both options whether we partner it and there is a fair bit of interest in partnering.
Speaker Change: or we do it ourselves and we are continuing to assess that as well.
Speaker Change: For us, the key next step has been to get the MA submission in place with the EMA.
Speaker Change: and that should be happening in this quarter, and the decisions to commercialize and how to do it best will be following that, so we'll certainly keep you posted.
Okay, great. Thanks, and congrats. Okay.
Thank you.
Speaker Change: Ladies and gentlemen, a reminder to please press star one on your telephone keypad. Should you have any questions?
Speaker Change: Next, we will hear from Ram Silvich Raju at H.C. Wainwright. Please go ahead.
Speaker Change: Hi, this is Jade on For Ram. Again, congrats on the fantastic launch.
Speaker Change: So I just wanted to ask a little bit about how you see the competitive landscape right now in prairie rilly, hyperphasia. Do you really see there is any...
Speaker Change: No worthy potential rivals in late stage development. How are you guys thinking about this?
Speaker Change: So I would say the the late stage rival, the obvious one is Acadia with Carbitoson, which as you know has already been studied in a large phase two as well as a large phase three study.
Speaker Change: It was submitted to the FDA and got an advisory committee where it was voted down, received a CRL and they're running another study at this time. I would say that is kind of the later stage competitor. It is, as you know, a three times a day nasal product that requires temperature control.
Speaker Change: The other one, Ardvark is apparently starting a phase three study. The data that is publicly available is short term early data. It's hard for us to gauge what that will look like in a controlled study. Those are probably the two life stage comparators.
Speaker Change: and how are you seeing the S.U.S. opportunity for the stride shaping up?
Speaker Change: I know you said about submitting the MMA, but how do you see this doing in Europe ?
Speaker Change: Yeah, we think the opportunity is very significant. The genetics of Prado-Willis and Roma are such that the birth incidence is the same regardless of geography or ethnicity.
Speaker Change: So you will see the same numbers of patients who have PWS based on population.
Speaker Change: So if you look at the EU 4 plus UK, you're seeing about the same number as the US, in the EU 27 it's obviously a proportionately larger number.
Speaker Change: The unmet need is the same everywhere, so nothing really exists to treat hyperfagia, so we think it's a pretty meaningful market.
Speaker Change: In terms of rare disease pricing, we see that while Europe is a challenging place for pricing, rare disease is the one place which appears to be an exception. So we are pretty enthusiastic about it in Europe as well as in other geographies.
Alright, thank you so much.
Speaker Change: Thank you, and at this time we have no other questions registered, so we'll turn to call back over to Anish.
Speaker Change: Thank you everyone for listening in today and we look forward to talking again for the second quarter call.
Speaker Change: Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending, and at this time we ask that you please disconnect your lines.
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