Soleno Therapeutics Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 7, 2025
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Operator

Greetings, and welcome to the Celeno Therapeutics First Quarter twenty twenty five Earnings Conference Call. At this time, note that all participants are in a listen only mode. A question and answer session will follow the formal presentation. You may press star, one 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.

Operator

It is now my pleasure to turn the call over to Brian Ritchie of LifeSci Advisors. Please go ahead, Brian.

Brian Ritchie
Managing Director at LifeSci Advisors, LLC

Thank you, operator. Good afternoon, everyone, and thank you for joining us to discuss Celino Therapeutics' first quarter twenty twenty five financial and operating results. Please note, we'll be making certain forward looking statements today. We refer you to Solano's SEC filings for a discussion of the risks that may cause actual results to differ from the forward looking statements. On the call with me today from Solano are Anish Bhatnagar, Solano's Chairman and Chief Executive Officer Meredith Manning, Solano's Chief Commercial Officer and Jim McInnis, Solano's Chief Financial Officer.

Brian Ritchie
Managing Director at LifeSci Advisors, LLC

Anish will begin with a review of the company's progress during the first quarter and subsequent period including FDA approval of VICAT XR and commercial launch. 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.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Thank you, Brian, and thank you everyone for joining us for our very first quarterly results earning call. It's been a momentous couple of months for our company highlighted by our announcement on March 26 that the FDA approved VICAT XR, previously known as Dioxide Choline Extended Release Tablets or DCCR, as the first medicine for the treatment of hyperphagia in people four years of age and older with Prader Willi syndrome or PWS. This approval is the culmination of many years of tireless work by the entire Celeno team without whom none of this would have been possible. I would also like to recognize the significant contributions of the entire PWS community, including study participants and their families, the study investigators and study site team members, as well as the major PWS advocacy organizations, the Foundation for Productivity Research and the PWSA USA and The UK. We are very pleased to offer VICAT XR for individuals and families who have been waiting for a treatment option for the symptoms related to this devastating disease since it was first recognized in 1956.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Following approval and reflecting our progress in establishing our commercial readiness, we were able to move very quickly to launch. We announced on April 14 that the first patients had received and are currently being treated with VICAT XR and this was about a week ahead of our internal forecast. Meredith will provide some additional color on the initial launch in a moment. 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 hyperphagia can have on the lives of people with PWS, their caregivers, their families and the healthcare professionals who treat them. PWS is a rare genetic disease.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

It occurs spontaneously in about one in fifteen thousand to one in twenty five thousand live births due to the deletion or lack of expression of a certain set of genes in chromosome 15. This translates to approximately three hundred to four hundred thousand individuals living with PWS around the world. 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. The only thing families and caregivers have been able to do to try control hyperphagia is restrict access to food such as locking refrigerators, trash cans and pantries.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Constant food preoccupation contributes to significant behavioral problems that can substantially disrupt daily life for those living with PWS and their families. Caregiver burden increases after the onset of hyperphagia and in fact has been measured to be higher than the burden experienced by caregivers for patients with Alzheimer's. So hyperphagia is a truly terrible condition for which no approved treatments have existed until the approval and launch of VICAT XR. Recapping our label, the indication is for treatment of hyperphagia in adults and pediatric patients four years of age and older with PWS. We believe that our label reflects VICAT XR's favorable safety and tolerability profile, contains no box warning, no contraindication for diabetes, no exclusions for severity of hyperphagia, or no requirement for a risk evaluation and mitigation strategy or REMS program.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

VICAT XR is to be taken orally once daily. Dosing is weight based. There is a titration period of about six weeks after which all people taking VICAT XR should be on or close to their maintenance dose. The label has clear directions on how physicians should modify the dose if needed to address any side effects and minimize interruptions. The commercial opportunity for VICAT XR as a first to market therapy is significant.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

We have used existing claims data to confidently identify approximately twelve thousand individuals diagnosed with PWS in The United States, of which approximately ten thousand should represent our total on label addressable market. This excludes those individuals with PWS who are younger than four years old, others who may not be experiencing hyperphagia or who may have comorbidities that make them ineligible for VICAT XR. As mentioned, as soon as we received FDA approval, we were prepared to begin accepting VICAT XR start forms immediately and patient treatments commenced in mid April. This is a testament to the efforts of Meredith Manning, our CCO, and our world class commercial team whose prelaunch efforts to patients, physicians and payers set the stage for a strong and successful launch and to all of our employees who have worked so hard to prepare the company for this day. 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.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Meredith?

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Thank you, Anish, and good afternoon, everyone. As Anish 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. We previously discussed three pillars of activity that we view as crucial to a successful launch. First, to establish VICAT XR as the standard of care in hyperphagia in PWS. Second, to deliver operational excellence.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

And finally, to communicate the compelling VICAT XR value proposition. 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. 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. We outlined 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.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

As of the end of day yesterday, we have received two sixty eight start forms and that's in twenty nine business days since approval. And while it's early, it is very encouraging. We look forward to future quarterly updates when we will have an opportunity to collect more data and identify trends that are emerging. On April 14, we announced the first shipment of VICAT XR to individuals living with hyperphagia in PWS. Since then, many patients have received their first dose of VICAT XR and have started treatment.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

This reflects our dedication to ensuring timely access to treatment. The second performance indicator that we will be providing is the number of prescribers, which is 131 unique prescribers as of yesterday. Our field force is prioritizing engagement with top tier providers with high patient volumes, which includes pediatric and adult endocrinologists, geneticists, and psychiatrists. We have also been impressed with the adoption of VICAT XR from a broad base of prescribers, including those practicing in the community. This expanded reach indicates that our efforts to drive awareness of VICAT XR availability, to communicate the efficacy and safety profile and the need for a therapy across a broad prescribing spectrum is strong.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Finally, in the future, we will be covering a detailed update on payer coverage. That will be covered live and some color on payer policies, as this is critical to patients initiating and remaining on therapy. We previously talked about our payer outreach, which was mostly focused on emphasizing the complexity of hyperphagia in PWS patients, the consequences of not controlling hyperphagia, and the need for a new therapeutic option. We are very pleased with the feedback we have received from payers as a result of this outreach, and we are confident the VICAT XR value proposition is resonating with commercial and government payers alike. While formal coverage policies can take anywhere from three to six months and sometimes longer to develop and implement, we do expect that VICAT XR will achieve broad payer coverage in The United States.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

We are fully committed to ensuring that VICAT XR is available to all eligible patients and that affordability is not a barrier to treatment. To this end, we have stood up Celena one, our single point of contact for patient services. Selena one was operational day one upon approval and is dedicated to supporting caregivers and healthcare providers in minimizing and mitigating payer access obstacles. I will now turn the call over to Jim for a review of the company's financial statements for the first quarter.

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

Thank you, Meredith. We used $32,800,000 of cash in operating activities during the three months ended 03/31/2025 and ended the period with $290,000,000 of cash, cash equivalents and marketable securities compared with $318,600,000 as of 12/31/2024. As we have stated previously, based on our current operating plan, we believe our cash, cash equivalents and marketable securities are sufficient to fund our operations through cash flow breakeven. Furthermore, with the approval of VICAT XR, we now have an additional $75,000,000 available to us in two tranches over the next eighteen months under our loan agreement. Turning now to a few income statement items.

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

The company had not commercialized VICAT XR in the three months ended 03/31/2025, and accordingly generated no revenue for the period. Research and development expenses for the first quarter ended 03/31/2025, was $13,500,000 which includes $4,300,000 of non cash stock based compensation. That compares to 14,600,000.0 which includes $2,400,000 of non cash stock based compensation for the same period of 2024. The cadence of our research and development expenditures fluctuate depending upon the state of our clinical programs, timing of manufacturing and other projects as we've moved through submission, approval and now preparation for commercialization. Selling, general and administrative expense for the first quarter ended 03/31/2025 was 29,300,000.0 which includes $10,400,000 of non cash stock based compensation and that compares to $8,500,000 which includes $4,000,000 of non cash stock based compensation for the same period of 2024.

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

The increase reflects our ongoing investment in additional personnel and new programs in preparation for commercial launch and in support of our increased business activity. Total other income, net, was CAD2.0 million for the three months ended 03/31/2025, compared to total other income net of CAD2.1 million in the same period of 2024. And our net loss was approximately CAD43.8 million or $0.95 per basic and diluted share for the first quarter ended 03/31/2025 and £21,400,000 or $0.59 per basic and diluted share for the same period in 2024. This concludes the financial overview, and I'll now turn the call back over to Anish for closing remarks. Anish?

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Thank you, Jim. While we are very pleased with what we are seeing in the early days of our U. S. Commercial launch, PWS is a global disease that impacts hundreds of thousands of patients around the world. In an effort to make VICAT XR available to as many of these patients as possible, in parallel with our U.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

S. Commercial launch, we continue to progress around regulatory pathways in other geographies, the most important of which is The EU. We have stated previously that Europe also has a high unmet need among other patients with PWS. And as with The U. S, the PWS community has strong thought leader support and patients are often concentrated around centers of excellence.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Based on widely cited prevalence data, we estimate that there are as many as nine thousand five hundred patients with PWS in The EU4 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. 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 VICAT XR in The U. S. 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 our specialty pharmacy partner purchasing product from us, which is when we record revenue.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Therefore, as is typical in these types of launches, we expect revenues to start up modestly. It will take time to execute a full commercial launch, which includes patients scheduling visits with their healthcare providers, payers determining coverage policies and the sales team being fully oriented to their territories. I look forward to sharing more details on our launch trajectory during our second quarter results call in August. And with that, we will now open the call to your questions. Operator?

Operator

Thank you, please press followed by 2. And if you are using a speakerphone, please lift the handset first before pressing any keys. Please go ahead and press 1 now if you do have any questions. First question will be from Yasmeen Rahimi at Piper Sandler. Please go ahead.

Yasmeen Rahimi
Yasmeen Rahimi
Sr. Research Analyst at Piper Sandler Companies

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? 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?

Yasmeen Rahimi
Yasmeen Rahimi
Sr. Research Analyst at Piper Sandler Companies

And I respect your wishes of two questions, and I'll jump back into the queue.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Jim, you want to take the first question?

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

Yes, sure. Yes, so, obviously, there's a

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

number of steps that have to go through to get 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. 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 build that they want to take. So that's why we're just being mindful and say we think modest revenues for Q2.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Do want to

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

take the second one, Matthew?

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Sure. Thank you. 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. You know, it's too soon right now.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

We're only twenty nine 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.

Yasmeen Rahimi
Yasmeen Rahimi
Sr. Research Analyst at Piper Sandler Companies

Thank you, Meredith, and thank you, Jim and Anish.

Operator

Thank you. Next question will be from Debjit Chattopadhyay at Guggenheim Securities. Please go ahead.

Debjit Chattopadhyay
Senior Managing Director at Guggenheim Partners

Hey, good afternoon. Thanks for taking my question and congrats. I have a couple. If I remember correctly, about one hundred and twenty seven patients were enrolled in

Debjit Chattopadhyay
Senior Managing Director at Guggenheim Partners

the Phase III program. What percentage of those patients are reflected in the current stock forms?

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Meredith, do you want to take that?

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Yeah, happy to take that. So as you'll recall in the randomized withdrawal period, we had a total of seventy seven patients. Sixty of those patients are here in The United States. 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.

Debjit Chattopadhyay
Senior Managing Director at Guggenheim Partners

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 reimburse therapy?

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Yeah, so I'll just remind everybody that we're really early in the launch and it takes easily six months for many payers to arrive at a full coverage policy, sometimes a little bit longer. But we're very pleased with, the reimbursement that we're seeing come in. We have a couple programs. One, we have our bridge program with the clinical trial patients. And then if needed, if we're seeing, more of an excessive delay on reimbursement or approval of, the start form, then we have what we call quick start.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

And we're looking at providing a twenty eight day prescription.

Debjit Chattopadhyay
Senior Managing Director at Guggenheim Partners

Thank you so much.

Operator

Thank you. Next question will be from Kristen Kluska at Cantor. Please go ahead.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

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 month, always a huge conference for these patients.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

So I was hoping you can give some color about ways that Selena will be present there now that you have an approved therapy to talk about?

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

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 U. S.-based organizations are having a combined conference.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

It's a large conference and it's going to be very well attended. Our commercial teams, med affairs teams as well as the clinical development teams will be there. We have several presentations and abstracts. So we would like to see you all there. I know many of you are planning to be there as well.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

So we're happy to engage and tell you more about what we're doing while we're there. Meredith, do you want to take the first?

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Sure. So talking about state by state, Selena, we've actually, we're participating in the MDRP program, so the Medicaid program, which allows for states to start uploading VICAT XR in the system as of May 1. But I'm sure you know that states vary. Some come on early and decide their policy, within a month or so and others can take up to July, August, or the second half of the year. So we're pleased because we've already seen, several states upload VICAD XR in their system, and we're seeing coverage across various different states.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Thank you.

Operator

Next question will be from Leland Gershell at Oppenheimer. Please go ahead.

Leland Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

Great. Thanks for taking the questions and great to see the early launch numbers. Maybe a question for Meredith, just teeing off your comment about the fact that you're seeing prescriptions coming from docs who may be outside of the initial targeted group of high prescribers. Could you share a bit more color on kind of what you're seeing with respect to docs who may not have been in the 300 or so that you had targeted, kind of what the maybe more community type interest is looking like? And then also wanted to ask with respect to Europe, if you could share, I know maybe a bit early as it'll be time until you approve there, but what credibility looks like in Europe in terms of dispersion of patients and how they're treated?

Leland Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

Does it look kind of like The States in terms of a smaller group of specialists who tend to treat those patients? Or is it a bit different than this in The States? Thank you.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Why don't you take the first one? I'll take the second one.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

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. We definitely anticipated a lot of excitement from the community, whether it be thought leaders, also community treating physicians who see PWS.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

I think what we can attribute that to is the fact that we had a lot of strong prelaunch awareness efforts 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. 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 omni channel efforts have enabled us to reach a broad spectrum of those physicians including those in the community.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Biren, regarding Europe, in general I would say that the care for PWS in Europe is similar. But I would say that in some cases probably more organized than The U. S. 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.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

We believe something similar exists in Germany 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 VICAT is quite similar to what you would expect here.

Leland Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

That's very helpful. Thanks very much.

Operator

Thank you. Next question will be from Brian Skorney at Baird. Please go ahead.

Brian Skorney
Senior Research Analyst at Baird

Hey, good afternoon, everyone. Thanks for taking the question and congrats on the initial launch metrics.

Brian Skorney
Senior Research Analyst at Baird

I hate to put you guys on

Brian Skorney
Senior Research Analyst at Baird

the spot and make a direct comparison to another drug launch, but since Dolan Bear is on your board, I can't imagine that this conversation hasn't come up. But at two fifty eight StarForms over a little more than a month, you seem to be pacing Skyclaris almost exactly. They had 500 StarForms a little over two months. Their first quarter sales were almost half of what your full year consensus estimates here are right now. So I'm just wondering, why shouldn't ViCat, given the start form, given sort of a similar reimbursement dynamics, why would it track lower than SkyClaris?

Brian Skorney
Senior Research Analyst at Baird

Because that's a much better launch curve than where consensus is currently modeling you at.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Brian, thanks for putting us on the spot. Jim wants to take the question.

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

Well, one

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

thing I'd comment, Brian, obviously each company has its own dynamics. I would suggest 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.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Yes. And if I may, I 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, a couple months prior. Remember that we had, half of our sales team come on at the January. And then we most recently brought on the rest of our field team fully trained and they're out as of April 27. 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.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Additionally, I would also bring your attention to the fact that we had drug in channel by April 14, Skyclaris didn't. So we are also operationalizing and converting start forms into paid patients.

Brian Skorney
Senior Research Analyst at Baird

Better than start forms

Brian Skorney
Senior Research Analyst at Baird

is what you're

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Brian, I think it's also important to note that we are prescription based, as Meredith has mentioned, is 131 physicians already. So we think it's a broad based build, which will sustain us over time. We're not as in the details with Skyclaris, maybe you are, but no direct comparisons to be made. But we certainly feel pretty enthusiastic about what we've seen so far.

Brian Skorney
Senior Research Analyst at Baird

Great. Thank you.

Operator

Thank you. Next question will be from James Condulis at Stifel. Please go ahead.

James Condulis
Associate Vice President - Biotechnology Equity Research at Stifel Nicolaus

Thanks for taking my question and congrats again on a great quarter. And kind of following 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 patient start forms that actually convert to paid drug? 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, as you think about the cadence of adding start forms throughout next 2Q and beyond, do you expect it to accelerate or hold steady? Just like curious any color you can provide there.

James Condulis
Associate Vice President - Biotechnology Equity Research at Stifel Nicolaus

Thanks.

Meredith Manning
Meredith Manning
CCO at Soleno Therapeutics

Yes, happy to. So I think it's too early to give a percentage, but we definitely are expecting 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.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

I think it's also fair to say that the unmet need here is pretty significant. No other treatments are available. So we should expect to be at least comparable to other rare disease launches.

James Condulis
Associate Vice President - Biotechnology Equity Research at Stifel Nicolaus

Great, thank you.

Operator

Thank you. Next question will be from Miriam Belghetti at LifeSci Capital. Please go ahead.

Myriam Belghiti
Equity Research Analyst at LifeSci Capital, LLC

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 tariff policies are affecting your business operations during the launch?

Jim Mackaness
Jim Mackaness
CFO at Soleno Therapeutics

Tariff. Yes, we have looked through our supply chain, and I would suggest that really we don't see any significant impact with the way the tariffs are currently being phrased. We do most of our manufacturing in The U. S. So we feel that it's not something that's going to impact us to any great extent.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

So the drug substance and drug product vendors are both U. S. Based. We do source some starting materials from outside The U. S.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

But as Jim said, no major impact.

Myriam Belghiti
Equity Research Analyst at LifeSci Capital, LLC

Okay. Thank you for that clarification.

Operator

Thank you. Next question will be from Yale Jen at Laidlaw. Please go ahead.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Good afternoon, and thanks for taking the question, and congrats on the progression. Just quick two questions here. The first one is that could you give us a little bit color in terms of for new patients, what are what's the sort of steps or procedures to ultimately get the drug prescribed? Are they need to start with the request of the staff form, or do you need to visit the physician to get a prescription, and how does that work? And then I have a quick follow-up.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Yeah, so the best way to think of it is that either the patientcaregiver 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. 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.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay, great. That's very helpful. And maybe one more question. 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?

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

And thanks.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

So, continue down the path of assessing both options, whether we partner it and there is a fair bit of interest in partnering or we do it ourselves and we are continuing to assess that as well. For us, the key next step has been to get the MAA submission in place with the EMA 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.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay, great. Thanks and congrats again.

Operator

Thank you. Next, we will hear from Ram Selvaraju at H. C. Wainwright. Please go ahead.

Jade Montgomery
Consultant Research Analyst at H.C. Wainwright & Co., LLC

Hi, this is Jade

Jade Montgomery
Consultant Research Analyst at H.C. Wainwright & Co., LLC

on for Ram. Again, congrats on the fantastic launch. So I just wanted to ask a little bit about how you see the competitive landscape right now in Crater Willi hyperphagia. Do you really see there is any noteworthy potential rivals in late stage development? How are you guys thinking about this?

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

So I would say the late stage rival, the obvious one is ACADIA with Carbitocin which as you know has already been studied in a large phase two as well as a large phase III study. It was submitted to the FDA and got an advisory committee where it was voted down, received a CRL and they are 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. The other one, Aardvark, is apparently starting a Phase III study.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

The data that is publicly available is short term early data. So it's hard for us to gauge what that will look like in a controlled study. Those are probably the two late stage competitors.

Jade Montgomery
Consultant Research Analyst at H.C. Wainwright & Co., LLC

Great, and how are you seeing the ex US opportunity for this drug shaping up? I know you said about submitting the MMA, but how do you see this doing in Europe?

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Yeah, we think the opportunity is very significant. The genetics of Prader Willi syndrome are such that the birth incidence is the same regardless of geography or ethnicity. So you will see the same numbers of patients who have PWS based on population. So if you look at the EU4 plus UK, you're seeing about the same number as The U. S.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

In the EU27, it's obviously a proportionately larger number. The unmet need is the same everywhere. So nothing really exists to treat hyperphagia. So we think it's a pretty meaningful market. In terms of rare disease pricing, we see that while Europe is a challenging place for pricing, rare diseases are the one place which appear to be an exception.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

So we are pretty enthusiastic about it in Europe as well as in other geographies.

Jade Montgomery
Consultant Research Analyst at H.C. Wainwright & Co., LLC

All right. Thank you so much.

Operator

Thank you. And at this time we have no other questions registered, so I will turn the call back over to Anish.

Anish Bhatnagar
Anish Bhatnagar
CEO at Soleno Therapeutics

Well, thank you, everyone, for listening in today, and we'll look forward to talking again for the second quarter call.

Operator

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.

Executives
    • Anish Bhatnagar
      Anish Bhatnagar
      CEO
    • Meredith Manning
      Meredith Manning
      CCO
    • Jim Mackaness
      Jim Mackaness
      CFO
Analysts
    • Brian Ritchie
      Managing Director at LifeSci Advisors, LLC
    • Yasmeen Rahimi
      Sr. Research Analyst at Piper Sandler Companies
    • Debjit Chattopadhyay
      Senior Managing Director at Guggenheim Partners
    • Kristen Kluska
      Equity Research Analyst at Cantor Fitzgerald
    • Leland Gershell
      MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.
    • Brian Skorney
      Senior Research Analyst at Baird
    • James Condulis
      Associate Vice President - Biotechnology Equity Research at Stifel Nicolaus
    • Myriam Belghiti
      Equity Research Analyst at LifeSci Capital, LLC
    • Yale Jen
      Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company
    • Jade Montgomery
      Consultant Research Analyst at H.C. Wainwright & Co., LLC
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Key Takeaways

  • FDA approval of VICAT XR: On March 26, the FDA approved VICAT XR (formerly DCCR) as the first medicine for treating hyperphagia in people aged four years and older with Prader-Willi syndrome.
  • Commercial launch milestones: Shipments began on April 14 – about a week ahead of forecast – and in the first 29 business days the company received 268 patient start forms and recorded 131 unique prescribers.
  • US market opportunity and access: There are an estimated 10,000 on-label PWS patients in the US, and Celino expects broad commercial and government payer coverage supported by its Selena One patient services model.
  • First-quarter financials: The company used $32.8 million in operating cash, ended Q1 with $290 million in cash and equivalents, and reported R&D expenses of $13.5 million and SG&A of $29.3 million, with sufficient runway to cash-flow breakeven plus a $75 million loan facility.
  • Global expansion plans: A Marketing Authorization Application (MAA) for VICAT XR is planned in H1 2025 for the EU4 and UK, where an estimated 9,500 PWS patients could benefit, and Celino is evaluating both internal commercialization and partnership options.
AI Generated. May Contain Errors.
Earnings Conference Call
Soleno Therapeutics Q1 2025
00:00 / 00:00

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