Q3 2025 Soleno Therapeutics Inc Earnings Call

Speaker #3: Good afternoon, and thank you for standing by. Welcome to Soleno Therapeutics, Inc.'s third quarter 2025 financial and operating results conference call and webcast.

Speaker #3: Currently , all participants are in a listen only mode . After the speakers presentation , there will be a question and answer session .

Speaker #3: As a reminder , today's webcast is being recorded . I would now like to introduce Brian Ritchie of lifestyle advisors . Please go ahead .

Speaker #4: Thank you. Good afternoon, everyone, and thank you for joining us to discuss Soleno Therapeutics Inc.'s third quarter 2025 financial and operating results.

Speaker #4: Please note , we will be making certain forward looking statements today . We refer you to 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 .

Speaker #4: For Seleno are Anish Bhatnagar Delano's , Chairman and Chief Executive Officer . Meredith Manning Delano , chief Commercial officer . And Jim MacInnis , chief financial officer .

Speaker #4: With that , I will now turn the call over to Anish .

Speaker #5: Thank you , Brian , and thank you everyone for joining us for our third quarter results . Call this afternoon . Following my brief opening remarks , Meredith will review the company's commercialization progress to date and Jim will cover the company's financial statements for the third quarter .

Speaker #5: We will then open the call for questions . We had an outstanding third quarter building on the strong launch momentum from our second quarter .

Speaker #5: Our total net revenue more than doubled from the second quarter to 66 million . And the company achieved profitability with a positive net income of 26 million in the for the third quarter .

Speaker #5: Our leading indicators , including patient start forms , unique prescribers and numbers of lives covered , reflect growing awareness of Vicat xr's potential to improve hyperphagia in those with U.S.

Speaker #5: . As the first and only FDA approved treatment for patients four years and older . For the primary feature of AWS , which is Hyperphagia XR is providing a meaningful solution to individuals living with PWS .

Speaker #5: There , caregivers and physicians . I would like to take a moment to reiterate the complexity of Prader-Willi syndrome . In addition to the hallmark symptom of hyperphagia , people with AWS suffer from a broad range of potentially serious comorbidities as well as significant behavioral problems .

Speaker #5: And while people with AWS are living longer , some into their 50s and older , the mean age of death unfortunately still stands at around 30 years old .

Speaker #5: Patients with AWS experience a very high burden of disease compared to the general population . In particular , comorbidities associated with fluid overload , diabetes , respiratory failure , and congestive heart failure are common .

Speaker #5: In a recently published registry of patients with PWS in Sweden , Gizycki and colleagues observed a greater than 20 fold increase in heart failure , a ten fold increase in venous thrombosis , and a five fold increase in atrial fibrillation .

Speaker #5: In pulmonary embolism . In a 40 year survey of mortality in patients with AWS . Butler and colleagues reported that respiratory failure and cardiac disease and cardiac failure together accounted for nearly half of all fatalities .

Speaker #5: The most common causes of death are respiratory failure , uncontrolled hyperphagia , and hyperphagia related behaviors . Cardiac causes . Infection , obesity , and pulmonary embolism .

Speaker #5: With each accounting for greater than 5% of deaths . A recent study in 2020 revealed that the mortality rate in people with PWS is substantially higher than the general US population , at 2.7% .

Speaker #5: This translates to over 300 fatalities per year . Assuming a population of approximately 12,000 people living with AWS in the US . The V-card XR clinical program established both substantial evidence of efficacy and a safety profile deemed approvable by the FDA based on a comprehensive phase three clinical program in 127 patients with over 400 patient years of exposure , including patients with nearly six years of continuous treatment .

Speaker #5: At the end of Q3 at approximately six months in market , we had 764 active patients . Our real world experience , including efficacy , side effects and discontinuation rates related to therapy , have been in line with our expectations as discussed in Weickhardt Xr's FDA approved label .

Speaker #5: The most common adverse events reported in our clinical trials were hypertrichosis , edema , hyperglycemia , and rash . Most adverse events were self-limiting , with some needing dose adjustments , interruption , or other concomitant treatments .

Speaker #5: In particular , regarding fluid retention related adverse events , post-launch , we see on a percent basis the incidence being lower than what we saw in clinical trials .

Speaker #5: In spite of the post-launch patients being more complex and having more comorbidities since approval, the discontinuation rate of XR related to AEs was approximately 8% at the end of the third quarter, and the total discontinuation was approximately 10%.

Speaker #5: While the discontinuation rate has increased , it remains below our expected long term rate based on our clinical trial data . It is worth noting that we did see a disruption in our launch trajectory in the wake of a short seller report that was released in mid-August , mostly in the form of a lower number of start forms , and increased discontinuations for non-serious adverse events .

Speaker #5: As we have anticipated , we have started to see patients return to therapy , often as withdrawal of XR can bring a rapid return of symptoms .

Speaker #5: We continue to educate physicians and families on the compelling clinical profile of XR , and we dedicated significant resources to these activities during the third quarter .

Speaker #5: Our team of patient and community educators , known as the Pace team , is educating families and caregivers on therapy expectations , administration and monitoring .

Speaker #5: At the time of first dose and throughout the patient journey . We're also hosting live community events in collaboration with advocacy organizations , healthcare providers , and caregivers of individuals already on XR , so they can share their experience with other caregivers initiating treatment .

Speaker #5: We're continuing our HCP education initiatives , including facilitating physician to physician programs , which allows physicians to learn more about XR from experts who have experience treating patients with U.S.

Speaker #5: related Hyperphagia . Salerno has received positive feedback on our engagement with the stakeholders in the community , and we believe this will continue to fuel our growth and allow us to .

Speaker #5: Establish V-card XR as a standard of care for Hyperphagia in those living with PWS . I would now like to provide a brief update on our activities in support of potential approval of Dccr in Europe .

Speaker #5: As you know , we market Dccr in the US as by . In parallel with our US commercial launch , we have continued to progress along regulatory pathways in other geographies .

Speaker #5: The most prominent of which is the EU . In May , we announced the submission and EMA validation of our marketing authorization application .

Speaker #5: We received day 120 questions during the past quarter and are preparing our responses at this time . The nature of the questions are generally similar to what we discussed with the US FDA during the approval process , gaining approval to market dccr in the EU would represent a meaningful expansion of our addressable market and remains a priority for us .

Speaker #5: While we continue to progress our US launch . Based on widely cited prevalence data , it is estimated that there are as many as 9500 people living with PWS in France , Germany , Italy , Spain and the UK combined .

Speaker #5: Diagnostic rates are high. Patient care is often concentrated around centers of excellence, and, as with the U.S., the Swiss community has strong thought leader support.

Speaker #5: We will continue to keep you apprised of our progress there and in other territories . I will now turn the call over to Meredith to provide an update on the launch .

Speaker #5: Meredith .

Speaker #6: Thank you . Anish , and good afternoon , everyone . As Anish mentioned , since approval , we've made remarkable progress in launching XR .

Speaker #6: Our success driving broad awareness and adoption reflects discipline , execution grounded in effectively introducing XR to the prescriber community . Individuals with PWS , their caregivers and payers .

Speaker #6: We also attribute our launch success to Celina's steadfast commitment to educating stakeholders, sharing individual experiences on V-card XR therapy, and robust payer access.

Speaker #6: Salerno field teams are dedicated to ensuring comprehensive educational support on therapeutic expectations , appropriate dosing and comprehensive monitoring . All critical factors for successfully integrating XR into clinical practice and optimizing patient outcomes .

Speaker #6: It is worth noting that many prescribers and academic centers are still in the process of setting up their designated U.S. clinics . As a reminder , Venkat XR is indicated to treat hyperphagia in adults and children four years of age and older with Prader-Willi syndrome and Hyperphagia is defined as extreme hunger , constant thoughts about food and constant urge to eat that cannot be satisfied with food .

Speaker #6: Throughout the last several months , we have been hearing from families who are seeing meaningful benefit after completing titration and finding their optimal dose .

Speaker #6: While all experiences with vicar are unique , these experiences continue to reinforce the possibilities and real world impact of XR . And through our responsibility to comprehensive education , we always encourage people to review the full prescribing Information and Medication guide for important safety information , which can be found on Liquor.com .

Speaker #6: Our commitment to patient services and market access underpins these efforts , ensuring ensuring timely access and reimbursement across all payer channels . I will now share the results of our key performance Indicators .

Speaker #6: Patient start forms , unique prescribers , and number of covered lives , cumulative patient start forms from launch through September 30th totaled 1043 , of which 397 were in the third quarter .

Speaker #6: We previously commented that obtaining 646 patient start forms , in our first quarter of launch was outstanding , and included a bolus we recognize the rapid uptake was due to strong operational excellence , a large unmet need and pent up demand that carried into the early part of Q3 .

Speaker #6: By the end of Q3 , 764 individuals were actively treated with XR . We believe that as more and more success stories are shared with the community , they will help create a firm foundation for continued growth .

Speaker #6: The second performance indicator is the number of prescribers we are continuing to make great strides with expanding our prescriber base in Q3 , we added an additional 199 new prescribers , bringing total unique prescribers .

Speaker #6: As of September 30th to 494 . Third quarter performance highlights significant progress within our key accounts . Over 50% of our top 300 providers have submitted start forms , signaling strong adoption .

Speaker #6: Importantly , a significant share of Start forms originated from healthcare providers who are associated with our Kol network . This is underscoring the effectiveness of our ability to educate physicians who play a pivotal role in influencing practice patterns .

Speaker #6: We are also seeing strong adoption among community treaters , highlighting our expanded reach and continued growth beyond our core targets . We have further strengthened our messaging this quarter by spotlighting real patient experiences , launching a new campaign , Make space for What matters that highlights V-card XR as a treatment that has the potential to lessen the relentless burden of Hyperphagia , creating mental space for individuals living with PWS to focus on what truly matters to them .

Speaker #6: Our third performance indicator is payer policies . We have been working diligently to secure broad coverage for vicar , resulting in policies that cover approximately 132 million lives .

Speaker #6: At the end of the third quarter , including coverage policies with appropriate criteria from the top three national PBMs , we have achieved broad access coverage across all channels , commercial , Medicaid and Medicare with a strong uptick in state Medicaid coverage , where we had received reimbursed claims from approximately 40 state Medicaid programs through Q3 .

Speaker #6: As I stated during our last earnings earnings call , these positive coverage decisions demonstrate payers recognizing the seriousness of U.S. that that pairs recognize the seriousness of U.S.

Speaker #6: , understand the true unmet need in treating hyperphagia and appreciate the meaningful value of icat XR can deliver . This is great progress this early in launch , because one of the perceived barriers to adoption among prescribers is the lack of coverage , or the lengthy reimbursement path .

Speaker #6: As we move forward , we continue to invest in stakeholder awareness , education and access resources to ensure every individual being treated with .

Speaker #6: Vicar , their family and clinician feels supported throughout the treatment journey . I will now turn the call over to Jim for a review of the company's financial statements for the third quarter .

Speaker #7: Thank you . Meredith . Total net revenue for the third quarter ended September 30th , 2025 was 66.0 million , which was more than doubled from 32.7 million in the second quarter of 2025 .

Speaker #7: And we achieved profitability with a positive net income of 26.0 million for the quarter . In addition , we generated 43.5 million of cash from operating activities during the three months ended September 30th .

Speaker #7: At the end of the third quarter , we had 556.1 million of cash . Cash equivalents and marketable securities . This includes the 230 million of gross proceeds that we raised through an underwritten offering of our common stock in July .

Speaker #7: Our strong balance sheet ensures that we are sufficiently capitalized to continue to execute on an effective US launch of Viasat XR , while in parallel progressing towards regulatory approval and commercialization , either on a standalone basis or with partners in the EU and other geographies .

Speaker #7: As a reminder , vicar was approved in March of this year and therefore the company generated no revenue in the third quarter ended September 30th , 2024 .

Speaker #7: Cost of goods sold was 1.1 million for the third quarter . Please note that prior to the FDA approval costs associated with manufacturing Vicar were expensed as research and development expenses .

Speaker #7: As such , a portion of the cost of goods sold during the period included inventory at zero cost , going forward , as we continue to sell vicar , we will deplete our zero cost inventory and replenish it with at cost inventory and consequently cost of goods sold as a percentage of revenue will increase .

Speaker #7: Research and development expense for the third quarter was 8.4 million , which includes 2.2 million of non-cash stock based compensation , compared to 30.1 million , which includes 18.5 million of non-cash stock based compensation for the same period of 2020 .

Speaker #7: For the cadence of our research and development expenditures fluctuates depending upon the state of our clinical programs , timing of manufacturing and other projects as we've moved through submission approval and now commercialization , selling , general and administrative expenses for the third quarter ended September 30th , 2025 was 33.8 million , which includes 7.8 million of non-cash stock based compensation , compared to 49.2 million , which includes 38.1 million of non-cash stock based compensation .

Speaker #7: For the same period of 2020 . For the increase in expense after removing stock based compensation reflects our ongoing investment in additional personnel and new programs to .

Speaker #7: Support vicar commercial launch and in support of our increased business activities . Total other income , net was 3.9 million for the three months ended September 30th , 2025 , compared to total other income , net of 3.6 million , in the same period of 2020 .

Speaker #7: For net income was approximately 26.0 million , or $0.49 per basic and $0.47 per diluted share for the third quarter ended September 30th , 2025 , compared to a net loss of 76.6 million , or $1.83 per basic and diluted share , for the same period in 2020 .

Speaker #7: For . This concludes the financial overview , and I'll now turn the call back over to Aneesh for closing remarks . Aneesh .

Speaker #5: Thank you , Jim . In closing , we're very pleased with the trajectory we're on , and we will continue to work tirelessly to make this safe and effective therapy available to as many people living with Poupées related Hyperphagia as possible .

Speaker #5: We had an outstanding Q3 marked by noteworthy advancements in each of our key metrics from start forms to new prescribers to lives covered .

Speaker #5: All resulting in the doubling of our revenues from Q2 and leading to the company being cash flow positive . We look forward to continuing to deliver on the successful launch .

Speaker #5: We have seen to date . And with that , we'll now open the call for questions .

Speaker #3: Thank you , ladies and gentlemen , we will now begin the question and answer session . To ask the question , you may press star then one on your touchtone phone .

Speaker #3: If you are using a speakerphone , please pick up your handset before pressing the keys . To withdraw your question , please press the pound key .

Speaker #3: Thank you . Our first question comes from the line of Paul Choi from Goldman Sachs . Your line is open .

Speaker #8: Hi . Congrats on the good performance in the quarter . With regard to the sales , my first question for the team is , can you maybe comment on the restart rate with regard to the discontinuations you're seeing any color from the field in terms of how many patients are restarting and sort of the time to restart .

Speaker #8: There would be helpful . And then second , in terms of the number of patients on active drug that you disclosed with the press release , can you maybe comment on just how many of those are still waiting for insurance clearance versus the patient start forms ?

Speaker #8: Any color there helping us connect the dots would be great. Thanks for taking the questions.

Speaker #5: Sure . Thanks , Paul . So on the restarts , this is early , so we're just starting to see it now . There's a handful of people who have already started and we've anecdotally heard of others who are planning to start .

Speaker #5: So this is not a metric we can give meaningful numbers on . But it's early . Your second question around number of patients on active drug .

Speaker #5: Meredith, do you want to answer that?

Speaker #6: Yeah . So I think , Paul , what you're looking at is active versus or paid versus free . And that's still a number that we're not reaching steady state .

Speaker #6: And evolving . So all of the 764 have claims that are being reimbursed is that the is that exactly what you're asking for ?

Speaker #8: Maybe just some clarity on any color you can offer on the the lag time between the start forms and the patients actually getting getting coverage , that would be helpful too , just so we can sort of triangulate maybe how many patients might be backfilled in the quarter to come .

Speaker #5: Yes , Jim . Go ahead .

Speaker #7: Yeah . So I've been working closely with the specialty pharmacy on this . So you get your start forms and then obviously there's a discontinuation cancellation that we've spoken to .

Speaker #7: And then we're seeing the fill rate somewhere around 30 days . It's plus and minus obviously depending on where the patient comes from and the amount of time to get through the benefits .

Speaker #7: But probably we're carrying about one month in backlog, if you like, of star forms.

Speaker #8: Okay , great . Thank you for taking the questions .

Speaker #5: Thanks , Paul .

Speaker #3: Our next question is from Tyler Van Buren from TD . Your line is open .

Speaker #9: Hey guys . Congratulations on another strong quarter of sales and achieving profitability . Curious to hear you elaborate on the impact on Discontinuations and lower patient start forms due to the short report during the quarter .

Speaker #9: And I guess how you're confident that it had an impact . And then , you know , is this impact going away as we enter Q4 , what can you tell us about the early launch momentum observed into Q4 here and into year end ?

Speaker #5: Yeah . Thanks , Tyler . So what we can tell you is that as we look at the quarter , we saw , I would say , a decrease in the August , September time frame .

Speaker #5: Now realize there's complexity of summer as well as the short report around the same time . So with the slower August , September , we're also seeing no meaningful changes into October .

Speaker #5: So we think that there is an effect and we unfortunately think that this is on patients who have had the non-serious adverse events .

Speaker #5: Probably the people who would have benefited tremendously had they stayed on therapy . So . As Meredith has mentioned , as I also talked to , we're making a lot of efforts in reaching out to these people .

Speaker #5: We're having individuals who are on drug , talking to other patients who are on drug . Yesterday we had a webinar with about 80 plus families on that , listening to a patient who's been on Vicat and they're experiences .

Speaker #5: So we think that it's hard to say exactly when the effect would go away , but it's certainly something that we're making serious efforts on .

Speaker #9: And when you say no meaningful impact in October , are you saying that October looks similar to August and September , or that there's no meaningful impact from the report and you're seeing some of what of a rebound in October ?

Speaker #5: I'm saying it's looking somewhat similar to what we saw in September .

Speaker #9: Okay . Thank you .

Speaker #3: Our next question is from Morris Reiterer from Guggenheim . Your line is open .

Speaker #10: Hi . This is Morris on for Debjit . Congrats on a strong quarter . I have two questions . First of all , could you elaborate a little bit on the average dose across all patients that are currently on drug and secondly , for your existing prescribers , could you estimate what percent of the U.S.

Speaker #10: patients are currently on vadakkekad ? What I'm trying to get at is there's still room to grow within those existing prescribers . Or does future growth need to come from new prescribers ?

Speaker #10: Thank you .

Speaker #5: Yeah , I'll take the second part of it . And Meredith can elaborate on it . There's definitely room to grow . We have about a thousand start forms right now .

Speaker #5: That's about 10% of the TAM. So I would say across the board there is room to grow. And that's particularly the case with our KOL accounts, where Meredith mentioned that more than half of them have written scripts.

Speaker #5: But as we had anticipated , there , practices are pretty full and they are they appear to be prescribing more when they see patients in their regular cadence of one to 2 to 2 times a year .

Speaker #5: So we expect that to remain , and we expect that over time , we'll be getting access patients . But Meredith go ahead .

Speaker #5: to those Our

Speaker #6: Yeah . Adding on to what Aneesh said , you know , we're very pleased with the broad prescriber base . And we continue to add new prescribers on a daily basis .

Speaker #6: So we know that there's , you know , significant amount of room for growth . And as the niche is stated on the numbers with regard to the Tam , you had asked about the average dosing .

Speaker #6: So again , that's still an evolving number . One thing that we shared last earnings call , which we'll

Speaker #6: our patient population is coming in between 4 and 26 and we are continuing to make progress in the younger adults . So the 27 to 45 , if you will .

Speaker #10: you .

Speaker #3: next question is from Kristen Kluska from Cantor . Your line is open .

Speaker #11: Yeah . Hi , this is Rick Miller on for Crispin . Thanks for taking our questions . So you mentioned the discontinuations being up after some of the non-serious aes after the short report .

Speaker #11: Can you give us a sense for kind of the the kind of the profile of the aes that were kind of leading to these discontinuations was this strictly sort of the on label safety profile that we're used to or anything else ?

Speaker #11: Anything else you could talk about there ? Thank you .

Speaker #5: Sure . So , yes , these are on label AES . Typically , you know , low levels of peripheral edema . Or you can have hypoglycemia .

Speaker #5: And when I was referring to non-serious adverse events , as you know , you can look at fares and you can see that a vast majority of events that are reported are non-serious .

Speaker #5: So I think what's happened is a concern that's been created because of the adverse event profile of the drug , which if non-serious , most patients are able to sort of power through and will start to see the benefits .

Speaker #5: And we're seeing that in real life . We've had numerous anecdotes of people who have stayed with low levels of edema , some levels of hypoglycemia , and have done really well from an efficacy perspective .

Speaker #5: So , yes , the adverse events remain sort of on label . And what we are seeing is predominantly non-serious .

Speaker #12: You .

Speaker #3: Our next question comes from Yasmeen Rahimi from Piper Sandler . Your line is open .

Speaker #13: Hi , Tim , congrats on a strong quarter . I guess team , when you look at , given that August and September was impacted by the short report , like what is this is the hesitation among patients that are under the care of general endocrinology ?

Speaker #13: Is there is there quantification on who are the type of patients or the type of physicians that need additional outreach and communication ? Like what is that profile look like , where you guys are targeting to really have in-depth education for that sort of question ?

Speaker #13: One . And then question two is like , how do you obviously , I think to Tyler's question , you noted that October is looking like more like September .

Speaker #13: How will you continue to communicate when we're going to when are we going to be out out of this ? I guess fear or worry by this report , like any , any visibility , like that , you know , the rest of the quarter could be very much rebounding substantially .

Speaker #13: And what are your what would your disclosures be around it ?

Speaker #5: So we don't expect to do sort of intra-quarter disclosures. And as you can imagine, Yasmeen, you know that there's a lot of complexity in treating hyperphagia in the U.S.

Speaker #5: we're the first drug and we're learning what the market's like . And the prescribers are learning how to use the drug . So we we realize that last quarter was perhaps a short report .

Speaker #5: Perhaps it was somewhere perhaps it was people going to summer camp . And now this quarter we're going to have Thanksgiving and Christmas , which obviously have meaning for everyone .

Speaker #5: But for U.S. and those with Hyperphagia , it has a very different meaning . So we have to we have to navigate this .

Speaker #5: We have to see what it looks like , and we have to see how prescribers also get accustomed to it . As we said earlier , there are some some hospitals , institutions that are trying to create U.S.

Speaker #5: clinics to sort of figure out how to best administer vicar and sort of make sure that they can follow these patients . Meredith , would you like to add something ?

Speaker #6: Yeah , I think hi , Yasmeen . We're really pleased about the program that actually we launched in August . More of your traditional speakers bureau program , and we've had really strong adoption with that .

Speaker #6: So we have recruited some of the national experts to be speakers in the program , which allows for both virtual and in-person , as well as an opportunity to do expert on demand .

Speaker #6: And we've seen really strong interest in that . And you asked about the profile of the prescribers who are being educated . I think what you're leaning towards and you're correct in thinking that as we're adding these new prescribers on a daily basis , on a daily basis , who are out in the community , who potentially have only 1 or 2 U.S.

Speaker #6: patients , those are the ones who really need additional education on the disease state . In general , as well as how to integrate vicar into their practice .

Speaker #6: So we've received as a niche , said in his prepared comments , really positive feedback on these programs and additionally , we're continuing to educate families .

Speaker #6: So we've had live patient programs , and we'll continue to do that in Q4 , as well as webinars . All received very well .

Speaker #13: Thank you .

Speaker #3: Our next question is from Leland Kershaw from Oppenheimer . Your line is open .

Speaker #3: Our next question is from Leland Kershaw

Speaker #14: want to to maybe understand with respect to the treating physician population of patients who are on Vicodin XR , you're having close to 500 unique prescribers at the end of Q3 .

Speaker #14: But in your investor materials , you said that about 300 providers are primarily caregivers and treaters of about 2100 AWS patients . So just going back to something we've talked about in the past , is it the case that we should think about these reports of adverse events as more likely to occur amongst patients who are being cared for by those who are less specialized in early treatment , and therefore may be less astute at managing some of the side effects .

Speaker #14: Wondering if you could share your insights there ? Thank you .

Speaker #5: Yeah , thanks , Leland . I think it's fair to say that just a reminder , the adverse event profile , and if you look at edema as an example or fluid retention related events in our clinical trials was about 20 some percent .

Speaker #5: What we are seeing now , at least the reported events are actually lower than that . So it's actually a pretty small minority that has these events .

Speaker #5: And most of the events that are happening are low grade events . So these are most often things that may not even need treatment .

Speaker #5: So would you really probably concerned about is significant adverse events or serious adverse events . And those we do worry that physicians who are out there who don't have experience in using vicar and have one patient on it and choose a patient who had significant comorbidities , etc.

Speaker #5: , and how would they manage the side effects . So we do . We are concerned about that . And that's something , as Meredith mentioned , we have a significant effort in trying to mitigate .

Speaker #5: So we have our field teams , our msls who who go out , have conversations with these physicians about how to manage these things better .

Speaker #5: And we have physician to physician programs where there's an expert on demand thing where you can call a physician who has significant experience , and that's actually been used very successfully recently .

Speaker #14: Great . And just wanted to ask , is the time to securing reimbursement ? Does that changed from the past ? Is that improved , increased , or is it the is it about the same in terms of going from start form to pull through ?

Speaker #14: Thanks .

Speaker #5: Where it is .

Speaker #6: Yeah . So Leland , I think on our last earnings call , we mentioned that we were looking at a turnaround time targeting for 30 days .

Speaker #6: That's still our target . That's still optimal . But as you know , during the first year of launch , it can vary depending on the channel .

Speaker #6: But that's exactly what we're targeting . Is the 30 days .

Speaker #14: Great . Thanks very much .

Speaker #3: Our next question is from Brian Skorney from Baird . Your line is open .

Speaker #15: Hey . Good afternoon everyone . Thank you for taking the question . I just wanted to try to get a little more clarification on your comments on the disruption that occurred over the summer and how it's specifically manifesting in the numbers .

Speaker #15: Was there both a slowdown in start forms that you're saying and an increase in discontinuations in implying that you would otherwise have more than 400 start forms and or lower than 8% discontinuation due to AES otherwise ?

Speaker #15: Or is there another figure in terms of missed refills that isn't specifically being called out on a quantification measure ?

Speaker #5: So thanks , Brian . I think where I was trying to go with this is that we saw a decrease in August , September , and a we realize it's also summer .

Speaker #5: So, we think it was some combination of summer people in camps as well as this short report that caused the start forms to decrease.

Speaker #5: Now we we obviously cannot pinpoint that such and so didn't come in because of they read something or whatever . But I do think that that could that was likely a factor .

Speaker #5: We don't have any specific metrics on refills , etc. , but what we are thinking through is if you have patients who have non-serious adverse events , who discontinue and anecdotally call into the specialty pharmacy and say , you know , I read something that I didn't like and I'm concerned and I'm not going to continue on drug .

Speaker #5: That's what we are basing the idea on , that perhaps it's , you know , these these anecdotal things that are out there and misleading that are leading to discontinuation that wouldn't have occurred .

Speaker #3: Our next question is from James Kondylis from Stiefel . Your line is open .

Speaker #16: Hey , thanks for taking my question . I wanted to ask one on efficacy . You know , obviously it takes some time to see it , but we're now approaching six months kind of plus or so .

Speaker #16: And just curious what your early kind of learnings are . There , what you've heard , how you kind of think that's playing into current discontinuation rates and what that may do to discontinuation rates over time as , as kind of patients stay on drug for longer .

Speaker #16: Any color there would be appreciated . Thanks , James .

Speaker #5: Thank you for asking about efficacy . We we are starting to hear anecdotes across the board on good things that are happening to these patients .

Speaker #5: You know , there's tons of examples . You know , we got a call the other day about a child who went without food for nine hours .

Speaker #5: We talked to a mom about a child who said , in temple at a memorial service for several hours , calmly , without any tantrums .

Speaker #5: We heard from an adult who lives in a group home who will , after years , be able to travel alone to see their family in Florida alone .

Speaker #5: So, it is starting to happen. We're seeing things happen across the board, and we think it will make a difference to these discontinuation rates.

Speaker #5: And as I was mentioning , we have started a series of patient webinars where those who are on drug and their families are able to share their experiences with others .

Speaker #5: And the first one of those literally had 100 plus people who signed up for it . So there is a lot of interest .

Speaker #5: And this is exactly the sort of thing that will turn things around .

Speaker #16: Great . I appreciate it . Thanks .

Speaker #3: Our next question is from Derek Arcilla from Wells Fargo . Your line is open .

Speaker #17: Hey , thanks for taking the questions and congrats on the progress . I guess first , I guess you know , obviously you're saying what you're seeing in October is kind of resembling September trends , I guess is the bolus over , or do we think that it resumes as people get more comfortable or the messaging gets better , education gets better .

Speaker #17: So that's question number one . And then just quickly on the EU I know you mentioned about the 120 day questions . I don't know if you can kind of characterize some of those requests , but do they improve your confidence of an eventual approval in Europe ?

Speaker #17: Thanks .

Speaker #5: Sure . So in terms of the bolus , you know , we this is one of those situations where when you have the first drug for an indication , it's hard to tell what it's supposed to look like .

Speaker #5: So we're finding out as we go . But if you remember some of the conversations we had prior to launch , we said , we don't know if there will be a bolus , but what we are expecting to see is a slow , steady build up over time , with a time with a time of 10,000 patients , there's a lot of them out there and it takes time for physicians to get accustomed to using a drug for an indication that has not really had a treatment before .

Speaker #5: So it's hard for us to comment on . Does a bolus come back or not ? I think by definition , a bolus does not come back and we're looking for a steady state that will continue over time and will continue to build a solid base of revenue that we have on the EU .

Speaker #5: I can't really give you any more details on the questions , but I will say that they feel very much similar to the discussions that we had with the FDA , mostly around efficacy .

Speaker #5: The design of the studies , the sequential nature of the studies , the fact that the same patients have been used in , in , through the multiple studies , etc.

Speaker #5: but I would say that as we get these responses and as we get responses to these responses from the EU , we'll have a better sense of where it's going .

Speaker #3: My next question is from Yale . Jen from Laidlaw . Your line is open .

Speaker #18: Thanks for taking the questions and congrats on a very good , great quarters . And you basically , I have two here . The first one I sort of related to the efficacy is that you guys have talked you in the press release .

Speaker #18: You indicated you have a 100 patients have more than one year treatment , and many of those has multiple years of treatments . I just wonder whether you'll be able to do some studies of them to see over a longer period of treatments .

Speaker #18: Are those patients has been improved , and how much those improve . Maybe this will be a useful longer term historical analysis and have a follow up .

Speaker #5: Yeah , I mean , we have , as you know , been running a long term open label study . Then there was a randomized withdrawal and the patients went back on drug .

Speaker #5: So we've had the ability to follow these patients very carefully for a very long period of time . And as you know , it's very unusual in a rare disease to have such long term data .

Speaker #5: And we have seen improvements of many different kinds in these patients . And this is obviously anecdotal and doesn't apply to everyone . But only yesterday we were looking at we were talking to a patient who is running a triathlon or preparing for a triathlon .

Speaker #5: This is a person who's in college . We are aware of a person who's a sous chef . We're aware of numerous people who have graduated from high school .

Speaker #5: So the long term effects will vary by patient . But we think that taking away the hyperphagia , which is the hallmark symptom of the disease , will , over a period of time , really alter their lives .

Speaker #18: Okay , great . That's very helpful . Maybe one more question here , which is about the patient size that you already have on your over a thousand starting form .

Speaker #18: And you suggest there may be about 10,000 patients give and take . And that at this stage , do you feel that you need to have additional effort to finding more patients , new patients , or how how would you prescribe ?

Speaker #18: Describe your effort on that regard ? And thanks .

Speaker #6: Yeah . So I think as we've said previously in our earnings call , that we have a claims database where we're confidently able to identify approximately 12,000 claims and individuals who have p.w.s and that when we look at that information that brings our Tam down to around 10,000 .

Speaker #6: So we know where the patients are and where they're being treated . I think one thing that we're very excited about that we're working on is more around machine learning to identify specifically when these patients might be coming into the physician's office to really optimize our effective targeting for the sales team .

Speaker #6: But with regard to traditional , rare disease , patient finding , we have the claims . So we know that where they're being treated .

Speaker #18: Okay . Great . Thanks a lot . And again congrats .

Speaker #6: Thank you .

Speaker #3: Our next question is from Katherine de la Rosa from Live Sire Line. It is open.

Speaker #19: Hi . Congrats on the strong quarter and thanks for taking the question . So I was just curious if you have a sense of the proportion of patients who are able to reach or be maintained on their on label dose versus those who undergo dose reduction , and I guess apologies if I missed this , but for those who discontinue treatment , do you have a sense of how long they're on therapy before they're coming off and kind of expectations for that going forward ?

Speaker #5: Yeah , I can address the second part of it . So we see the discontinuations happening earlier in treatment . So they are either in titration or just after .

Speaker #5: So think of it as sort of the first three months . By the way of the active patients , we think about two thirds are beyond the three month time frame at this time .

Speaker #5: Do you want to address the first question ? Meredith .

Speaker #6: Yeah , I think it's a little more complicated than that with regard to reducing dose , because if you look at our label , really the therapeutic window , if you will , is between , I think like 3 to 5 mgs per kig .

Speaker #6: So any dosing around there is , is considered off label dosing .

Speaker #5: So I think if you are looking at on target dose for a given weight band , then I think it's fair to say that there's a very small minority that undergo dose reductions .

Speaker #5: In general , you would expect people to get to their target doses .

Speaker #19: Great . Thanks so much .

Speaker #3: Again , if you would like to ask the question , please press star and then the number one on your telephone keypad . Our next question is from Ram , from H.C.

Speaker #3: Wainwright . Your line is open .

Speaker #20: Hi, this is Jade on the forum. Thanks for taking our questions, and congrats on the profitability this quarter. That actually leads me to my first question.

Speaker #20: Do you have some sort of idea when you might be in a position to start providing annualized revenue guidance and secondly , as I'm sure you know , rhythm is pursuing an expansion into AWS first at do you think of that purely as a competitor drug , or do you think there's a possibility for synergism between between the two drugs ?

Speaker #20: There ? Thanks .

Speaker #5: I'll answer the second part . Jim can take the first part in terms of rhythm drug . You know , we we still have to see efficacy as you know , the one study that's been conducted with the drug in U.S.

Speaker #5: , which was a large randomized phase two study , was negative for weight loss . And hypophagia , I believe they are conducting an open label study .

Speaker #5: So we'll have to see what the data shows in terms of whether it's competitive or potentially synergistic . It can be potentially synergistic because the two mechanisms are different from each other .

Speaker #5: So on the competition piece , we'll have to see the data . And certainly at least theoretically , potentially synergistic .

Speaker #7: Yeah . And with regards to guidance , I'd say it's a bit early at this stage . We're obviously looking for a little bit of maturation in the various components of the business , but we'll we'll continue to investigate that .

Speaker #20: Great . Thank you so much .

Speaker #3: There are no questions at this time . I would like to hand the call Anish . Please go ahead .

Speaker #5: Thank you all for listening in today . Have a good evening .