Q4 2025 Soleno Therapeutics Inc Earnings Call

February 25, 2026

Brian Ritchie: Good afternoon. Thank you for standing by. Welcome to Soleno Therapeutics' Q4 and full year 2025 Financial and Operating Results Conference Call and Webcast. Currently, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. As a reminder, today's webcast is being recorded. I would now like to introduce Brian Ritchie of LifeSci Advisors. Please go ahead.

Operator: Good afternoon. Thank you for standing by. Welcome to Soleno Therapeutics' Q4 and Full Year 2025 Financial and Operating Results Conference Call and Webcast. Currently, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. As a reminder, today's webcast is being recorded. I would now like to introduce Brian Ritchie of LifeSci Advisors. Please go ahead.

Good afternoon, and thank you for standing by welcome to <unk> Therapeutics fourth quarter, and full year, 2025, and Nashville, and operating results conference call and webcast.

Currently all participants are in a listen only mode.

After the speaker presentation, there will be a question and answer session.

As a reminder, today's webcast is being recorded.

I'd now like to introduce Brian Ritchie of lifestyle Advisors. Please go ahead.

Brian Ritchie: Thank you. Good afternoon, everyone, thank you for joining us to discuss Soleno Therapeutics' Q4 and full year 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. On the call with me today for Soleno are Anish Bhatnagar, Soleno's Chairman and Chief Executive Officer; Meredith Manning, Soleno's Chief Commercial Officer; and James MacInnis, Soleno's Chief Financial Officer. With that, I will now turn the call over to Anish.

Brian Ritchie: Thank you. Good afternoon, everyone, thank you for joining us to discuss Soleno Therapeutics' Q4 and Full Year 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. On the call with me today for Soleno are Anish Bhatnagar, Soleno's Chairman and Chief Executive Officer; Meredith Manning, Soleno's Chief Commercial Officer; and Jim Mackaness, Soleno's Chief Financial Officer. With that, I will now turn the call over to Anish.

Thank you good afternoon, everyone and thank you for joining us to discuss <unk> therapeutics fourth quarter and full year 2025 financial and operating results. Please note, we will be making certain forward looking statements. Today, we refer you to so I know its SEC filings for a discussion of the risk.

That may cause actual results to differ from the forward looking statements.

On the call with me today for Solana, or a niche, but nagar, So I know as chairman and Chief Executive Officer Meredith. Many so I know as chief commercial officer, and Jim mechanism. So I know its chief financial officer with that I'll now turn the call over to a niche.

Anish Bhatnagar: Thank you, Brian, and thank you everyone for joining us for our Q4 and year-end results call this afternoon. As has been our practice, 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 Q4 and for the year. I will spend a few minutes outlining our thoughts and plans on expanding beyond Prader-Willi syndrome, after which we will open the call for questions. We finished 2025 on a very strong note, driven by a continuation of many of the positive trends that we have seen since VYKAT XR was commercially launched in the Q2 of last year.

Thank you, Brian and thanks, everyone for joining us for our fourth quarter and year end results call. This afternoon.

As has been our practice following my brief opening remarks, <unk> will review the company's commercialization progress to date and Jim will cover the company's financial statements for the fourth quarter and for the year.

I will spend a few minutes outlining our thoughts and plans on expanding beyond probably can grow after which we will open the call for questions.

We finished 2025 on a very strong note driven by a continuation of many of the positive trends that we have seen despite that it was commercially launched in the second quarter of last year.

Anish Bhatnagar: Consistent with our pre-announcement press release from 12 January, total net revenue for Q4 was $91.7 million, which brings our total net revenue for the full year, which was less than 9 months of sales, to $190.4 million. We achieved profitability with positive net income for the year of $20.9 million, became cash flow positive, including generating $48.7 million of cash from operating activities in Q4, and ended the year with over $500 million of cash equivalents, and marketable securities. All of these are outstanding results. This has been an incredibly successful launch, made possible by the entire team at Soleno, who come to work each day to help fulfill our mission of improving the lives of people with serious rare diseases.

Anish Bhatnagar: Consistent with our pre-announcement press release from 12 January, total net revenue for Q4 was $91.7 million, which brings our total net revenue for the full year, which was less than nine months of sales, to $190.4 million. We achieved profitability with positive net income for the year of $20.9 million, became cash flow positive, including generating $48.7 million of cash from operating activities in Q4, and ended the year with over $500 million of cash equivalents, and marketable securities. All of these are outstanding results. This has been an incredibly successful launch, made possible by the entire team at Soleno, who come to work each day to help fulfill our mission of improving the lives of people with serious rare diseases.

This is with our pre announcement press release from January 12, total net revenue for the fourth quarter was $91 7 billion, which brings our total net revenue for the full year, which was less than nine months of sales to $119 4 million, we achieved profitability with positive net income for the year of $20 nine.

Became cash flow positive, including generating $48 seven millions of millions of cash from operating activities in the fourth quarter and ended the year with over $500 million of cash cash equivalents in marketable securities.

All of these outstanding results.

It's been an incredibly successful launch made possible by the entire team Mr. Leno, who come to work each day to help fulfill our mission of improving the lives of people with serious rare diseases.

Anish Bhatnagar: We are very pleased to see such durable and exciting growth 9 months post-launch. Looking ahead, our leading indicators are strong. Since launch through 31 December 2025, we received 1,250 patient start forms, which represents approximately 12.5% of the US VYKAT XR addressable market. As of 31 December 2025, there were 859 people on active treatment. We believe we can sustain our current momentum and capture an additional approximately 1,000 start forms over the next 9 to 12 months. This bodes well not only for the thousands of people with PWS and their caregivers, which struggle with the significant daily burden of hyperphagia, but also for our company, which is poised to generate significant long-term value. Importantly, the real-world safety profile of VYKAT XR continues to mirror our expectations and the clinical long-term safety profile of the product.

Anish Bhatnagar: We are very pleased to see such durable and exciting growth nine months post-launch. Looking ahead, our leading indicators are strong. Since launch through 31 December 2025, we received 1,250 patient start forms, which represents approximately 12.5% of the US VYKAT XR addressable market. As of 31 December 2025, there were 859 people on active treatment. We believe we can sustain our current momentum and capture an additional approximately 1,000 start forms over the next nine to 12 months. This bodes well not only for the thousands of people with PWS and their caregivers, which struggle with the significant daily burden of hyperphagia, but also for our company, which is poised to generate significant long-term value. Importantly, the real-world safety profile of VYKAT XR continues to mirror our expectations and the clinical long-term safety profile of the product.

We are very pleased to see such durable and exciting growth nine months post launch.

Looking ahead, our leading indicators are strong.

Launch to December 31, 2025, we received $12 50 patient start forms which represented approximately 12, 5% of the U S that takes our addressable market and as of December 30 foot were 859 people on active treatment.

We believe we can sustain our current momentum and captured an additional approximately 1000 stock problems over the next nine to 12 months.

Well not only for the thousands of people with PWM and their caregivers with struggled with the significant daily burden of hyperphagia, but also for our company, which is poised to generate significant long term value.

Importantly, the real World safety profile of <unk> XR to mirror, our expectations and the clinical long term safety profile of the truck.

Anish Bhatnagar: This is significant when you reflect on the complexity of PWS and all the serious comorbidities of this very vulnerable and fragile patient population. The cumulative launch-to-date discontinuation rate of VYKAT XR related to adverse events was approximately 12% as of the end of Q4, and the total discontinuation rate was about 15%. As stated earlier, we expect a long-term discontinuation rate of 15% to 20%. We're now seeing more and more success stories emerge as individuals with PWS related to hyperphagia have been on therapy for multiple months, and we have seen interest spread across all stakeholders, particularly among caregivers, who endure a very significant burden in caring for someone with PWS who exhibits hyperphagia. We believe this dynamic will build as we progress through 2026.

This is significant when you reflect on the complexity of gws and all the serious comorbidities of the very vulnerable and fragile patient population.

The cumulative loss today discrimination radar striker XR related to adverse events was approximately 12% as of the end of the fourth quarter and the total of the saturation rate is above 15%.

Stated earlier, we expect a long term discontinuation rate of 15 to critical states.

We're now seeing more and more successful or even merge as individuals with PW escalated to hyperphagia had been on therapy for multiple months and we are seeing interest credit across all stakeholders, particularly among caregivers.

You are a very significant burden and caring for someone with gws waves of this type of feature.

We believe this dynamic will build as we progress through 2026.

I would now like to provide a brief update on our activities in support of potential approval of <unk> in the EU.

Anish Bhatnagar: I would now like to provide a brief update on our activities in support of potential approval of DCCR in the EU. Last May, we announced the submission and EMA validation of our marketing authorization application. We subsequently received Day One 20 questions. All responses were submitted before the end of the year. As we've indicated before, the nature of the key questions centered around the adequacy of the data to prove efficacy, based primarily on our randomized control study. The next step is for us to receive Day One 80 questions from the EMA around the end of February. We continue to anticipate a decision in the mid-year 2026 timeframe. We are considering a range of commercialization options in the EU and have continued to develop our own team and capabilities on the ground. It is a significant market opportunity.

Lastly, we announced the submission in EMEA validation of our marketing authorization application.

Subsequently the team Dave one question.

All responses were submitted before the end of the year.

As we've indicated before the nature of the key questions David around the adequacy of the data to prove efficacy based primarily on a randomized withdrawal study.

The next step is for us to receive day 180 questions from the EMA around the end of February.

We continue to anticipate a decision in the midyear 2026 timeframe and they're considering a range of commercialization option in the EU and have continued to develop our own team and capabilities on the ground.

It is a significant market opportunity. We have said previously that we believe that there are about 9500 people living with PW in the UK and the in store.

Anish Bhatnagar: We have said previously that we believe that there are about 9,500 people living with PWS in the UK and the EU4. Further, perhaps more so than in the US, it is a concentrated market driven by centers of excellence, and there is strong thought leader support for VYKAT XR. We look forward to keeping you apprised of our progress over the next few months as we approach a regulatory decision and potential commercial launch. Now, I'd like to turn the call over to Meredith for a detailed commercial update. Meredith?

Further perhaps more so than in the U S. It is a concentrated market driven by centers of excellence and then a strong thought leader support for <unk> com.

We look forward to keeping you apprised of our progress over the next few months as we approach a regulatory decision and potential commercial launch now I'd like to turn the call over to <unk> for a detailed commercial update.

Operator 2: Thank you, Anish, good afternoon, everyone. As Anish mentioned, 2025 was an important year for the PWS community and Soleno as we brought to market the first FDA-approved medicine for the treatment of hyperphagia in adults and children four years of age and older, living with Prader-Willi syndrome. We are encouraged that 1,250 new patient start forms were submitted for VYKAT XR from launch on 26 March through year-end, which included 207 in Q4. This represents approximately 12.5% of the total US VYKAT XR addressable market.

Meredith Manning: Thank you, Anish, good afternoon, everyone. As Anish mentioned, 2025 was an important year for the PWS community and Soleno as we brought to market the first FDA-approved medicine for the treatment of hyperphagia in adults and children four years of age and older, living with Prader-Willi syndrome. We are encouraged that 1,250 new patient start forms were submitted for VYKAT XR from launch on 26 March through year-end, which included 207 in Q4. This represents approximately 12.5% of the total US VYKAT XR addressable market.

Thank you Annie and good afternoon, everyone.

You mentioned 2025 was an important year for the tw at community and millennials as we brought to market. The first FDA approved medicine for the treatment of hyper payback and as Alison Sternberg four years of age and older.

Our living with <unk> syndrome.

We are encouraged that 1250, new patients our carbon score.

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This represents approximately 12, 5%.

Although U S biotechs, our addressable market.

Operator 2: At the end of Q4, 859 individuals were being actively treated with VYKAT XR, up from 764 at the end of Q3, indicating that VYKAT XR is being adopted into clinical practice and reflecting our ability to convert start forms into treated patients. On the prescriber side, our efforts to raise awareness of VYKAT XR's availability and clinical profile have driven strong engagement. In Q4, we added 136 new prescribers, bringing the total unique prescribers to 630 as of 31 December. We continue to hear that VYKAT XR delivers meaningful clinical benefits, and physicians plan to proactively discuss the first-to-market therapy with caregivers and patients as they consider treatment options.

Meredith Manning: At the end of Q4, 859 individuals were being actively treated with VYKAT XR, up from 764 at the end of Q3, indicating that VYKAT XR is being adopted into clinical practice and reflecting our ability to convert start forms into treated patients. On the prescriber side, our efforts to raise awareness of VYKAT XR's availability and clinical profile have driven strong engagement. In Q4, we added 136 new prescribers, bringing the total unique prescribers to 630 as of 31 December. We continue to hear that VYKAT XR delivers meaningful clinical benefits, and physicians plan to proactively discuss the first-to-market therapy with caregivers and patients as they consider treatment options.

At the end of the fourth quarter 859 international toward being actively treated with <unk> XR.

From 764 at the end of Q3.

Indicating that <unk>, XR athene adopted into clinical practice, and reflecting our ability to parts farquar treated patients.

On the pharma side, our efforts to raise awareness of <unk> availability and clinical profile has driven strong engagement.

Q4, we added 130, new prescribers, bringing its total unique prescribers to 638 as of December 31.

We continue to hear that <unk>, XR delivers meaningful clinical benefits and transition.

Plans to proactively assess firsthand market therapy, with caregivers and patients as they consider it an option.

Operator 2: Our field teams are not only educating but also activating the prescriber base by providing comprehensive support on therapeutic expectations, monitoring, and dose modification where necessary. These are critical elements that give physicians the confidence to initiate and maintain patients on VYKAT XR and to integrate our medicine into routine clinical practice. A few things stand out when we look at who is being treated and who is prescribing. While most patients are between 4 and 26 years of age, we are also seeing meaningful utilization in adults, particularly those 27 to 45 years old. This speaks to VYKAT's relevance across the PWS population. Side effects recorded in the real-world setting have been consistent with those observed in our clinical trials and with the FDA-approved label.

Meredith Manning: Our field teams are not only educating but also activating the prescriber base by providing comprehensive support on therapeutic expectations, monitoring, and dose modification where necessary. These are critical elements that give physicians the confidence to initiate and maintain patients on VYKAT XR and to integrate our medicine into routine clinical practice. A few things stand out when we look at who is being treated and who is prescribing. While most patients are between four and 26 years of age, we are also seeing meaningful utilization in adults, particularly those 27 to 45 years old. This speaks to VYKAT's relevance across the PWS population. Side effects recorded in the real-world setting have been consistent with those observed in our clinical trials and with the FDA-approved label.

Our field teams are not only educate but also activating the prescriber base.

If I had any comprehensive support on therapy that expectation monitoring and thats modifications where necessary.

These are critical elements that gives physicians the confidence to initiate and maintain patients on <unk> XR and to integrate our medicine into routine clinical practice.

A few things stand out when we look at with being treated and Suez first Friday well.

While most patients are between four six year H. We are also seeing meaningful utilization and adults, particularly house 27 45.

This speaks to by cats relevance across the U S.

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Sorry, it's actually recorded in the real World study have been consistent with the comparison of our clinical trials and with the FDA approved right bulk.

Operator 2: As patients settle into their optimal target dose, adherence has remained high, with a launch-to-date discontinuation rate related to adverse events of approximately 12% at the end of the quarter. We are also leaning into real-world experience to support demand. We are systematically capturing success stories with VYKAT XR to highlight its impact on hyperphagia and to support more proactive treatment discussions. Through community outreach, including patient webinars and live events where families hear directly from others treated with VYKAT XR, we are sustaining strong interest and supporting ongoing launch momentum. Our January patient webinar attracted over 200 registrants, nearly 60 more than our November event, underscoring growing interest in VYKAT XR.

Meredith Manning: As patients settle into their optimal target dose, adherence has remained high, with a launch-to-date discontinuation rate related to adverse events of approximately 12% at the end of the quarter. We are also leaning into real-world experience to support demand. We are systematically capturing success stories with VYKAT XR to highlight its impact on hyperphagia and to support more proactive treatment discussions. Through community outreach, including patient webinars and live events where families hear directly from others treated with VYKAT XR, we are sustaining strong interest and supporting ongoing launch momentum. Our January patient webinar attracted over 200 registrants, nearly 60 more than our November event, underscoring growing interest in VYKAT XR.

And as patients settle into their optimal target.

Darren has remained high with our launch to date this continuation rate related to adverse events of approximately 12% at the end of the client.

We're also leaning into real world experience to support demand, we are systematically capture tax sorry, with <unk> XR to highlight impact on tanker paycheck.

CT more proactive treatment discussion.

Community outreach, including patient Webinars and live events, where families Karen correctly from other accretive with <unk> XR.

The strong interest and support ongoing launch momentum.

Our January patient webinar attracted over 200 registrants nearly 60 more than our November event underscoring growing interest in <unk>.

Operator 2: We are also collecting feedback from families who have attended these programs, and while still early, we have already heard of families who, after attending these events, have proactively asked their physicians about VYKAT XR, encouraging signals that our education efforts are helping to drive appropriate demand and convert interest into active treatment. Looking ahead to 2026, our priority is to deepen experience and adoption across leading academic and endocrine centers, specifically among PWS experts who shape practice patterns, while further broadening the prescriber base in the community, where many people with PWS are treated.

Meredith Manning: We are also collecting feedback from families who have attended these programs, and while still early, we have already heard of families who, after attending these events, have proactively asked their physicians about VYKAT XR, encouraging signals that our education efforts are helping to drive appropriate demand and convert interest into active treatment. Looking ahead to 2026, our priority is to deepen experience and adoption across leading academic and endocrine centers, specifically among PWS experts who shape practice patterns, while further broadening the prescriber base in the community, where many people with PWS are treated.

We are also collecting feedback from families who are they tend to take programs.

While still early we have already heard of families who are accurate attending these events have proactively ask their physicians about <unk> XR incurred.

We encourage you to take note that our education efforts are helping to drive our corporate demand and convert interest into asset treatment.

Looking ahead to 2020, our priority is to see and experience and adoption across leading academic and interfaith center.

Specifically, among gws expert to shape practice patterns, while further broadening the prescriber base in the community.

Where many people with gws are treated.

Operator 2: We are seeing growing confidence among these key experts in utilizing VYKAT XR, and we have made important strides in creating champions among both HCPs and PWS families, which we believe will continue to support wider uptake over time and advance our goal of making VYKAT XR the standard of care for appropriate patients with PWS-related hyperphagia. We continue to secure broad coverage for VYKAT XR across all channels, commercial, Medicaid, and Medicare, resulting in policies that covered over 180 million lives at the end of Q4. Additionally, we have strong coverage or reimbursed claims from approximately 45 state Medicaid programs through Q4. Payers continue to recognize the seriousness of PWS, understand the true unmet need in treating hyperphagia, and appreciate the meaningful value VYKAT XR can deliver. We are seeing this clearly play out in the reauthorization process.

Meredith Manning: We are seeing growing confidence among these key experts in utilizing VYKAT XR, and we have made important strides in creating champions among both HCPs and PWS families, which we believe will continue to support wider uptake over time and advance our goal of making VYKAT XR the standard of care for appropriate patients with PWS-related hyperphagia. We continue to secure broad coverage for VYKAT XR across all channels, commercial, Medicaid, and Medicare, resulting in policies that covered over 180 million lives at the end of Q4. Additionally, we have strong coverage or reimbursed claims from approximately 45 state Medicaid programs through Q4. Payers continue to recognize the seriousness of PWS, understand the true unmet need in treating hyperphagia, and appreciate the meaningful value VYKAT XR can deliver. We are seeing this clearly play out in the reauthorization process.

We're seeing growing confidence among the key expert and utilizing biotech.

We have made important strides in creating champions among both HPT and PWM family, which we believe will continue to support flatter uptake overtime and then advance our goal of making mechanics are the standard of care for appropriate patients with PWM related expectation.

We continue to sit here Raj coverage for biotech power across all channels commercial Medicaid and Medicare, resulting in policies that covered over 180 million lives at the end of the fourth quarter.

Additionally, we have strong coverage are reimbursed place from approximately 45 state Medicaid programs through Q4.

Payers continue to recognize the seriousness of gws understand that true unmet need in treating hyperplasia and appreciate the meaningful value biotechs are tens in liver.

And we our team is clearly play out and the reauthorization process.

Operator 2: As a reminder, payers typically require reauthorization every 6 to 12 months for rare disease medicines. We are pleased to see the overwhelming majority of claims for patients have been quickly processed and continued on paid products. In summary, we believe 2025 has established a solid foundation with patients, prescribers, and payers for VYKAT XR. Looking ahead, we are committed to deepening adoption and expanding our prescriber base in both the KOL and community settings, while keeping families and individuals with PWS experiencing hyperphagia at the forefront as we realize the full potential of the first approved treatment for this condition. I will now turn the call over to Jim for a review of the company's financial statements for the Q4.

Meredith Manning: As a reminder, payers typically require reauthorization every six to 12 months for rare disease medicines. We are pleased to see the overwhelming majority of claims for patients have been quickly processed and continued on paid products. In summary, we believe 2025 has established a solid foundation with patients, prescribers, and payers for VYKAT XR. Looking ahead, we are committed to deepening adoption and expanding our prescriber base in both the KOL and community settings, while keeping families and individuals with PWS experiencing hyperphagia at the forefront as we realize the full potential of the first approved treatment for this condition. I will now turn the call over to Jim for a review of the company's financial statements for the Q4.

As a reminder, payers typically require a reauthorization every six to 12 months for rare disease medicines.

And we are pleased to see overwhelming the overwhelming majority of claims or patients have been quickly process and continued on pain product.

In summary, we believe 2025 has established a solid foundation with patients prescribers and payers for <unk>.

Looking ahead, we are committed to deepening adoption and expanding our prescriber base in both the Kols and community settings.

Keeping families and individuals with gws experiencing hyper payback at the forefront as we realize the full potential of the first approved treatment for this condition.

I will now turn the call over to Jim for a review of the company's financial statements for the fourth quarter.

David Brown: Thanks, Meredith. Total net revenue for Q4 ended 31 December 2025 was $91.7 million, representing sequential growth of nearly 40% from $66 million in Q3. For the full year 2025, which, as a reminder, represents less than 9 months of commercial availability, total net revenue was $190.4 million. VYKAT XR was approved in March of this year. Therefore, the company generated no revenue for the 3 or 12 months ending 31 December 2024. We generated $48.7 million of cash from operating activities for Q4 and achieved profitability with positive net income of $20.9 million for the full year 2025. At the end of the year, we had $506.1 million of cash equivalents, and marketable securities.

Jim Mackaness: Thanks, Meredith. Total net revenue for Q4 ended 31 December 2025 was $91.7 million, representing sequential growth of nearly 40% from $66 million in Q3. For the full year 2025, which, as a reminder, represents less than nine months of commercial availability, total net revenue was $190.4 million. VYKAT XR was approved in March of this year. Therefore, the company generated no revenue for the three or 12 months ending 31 December 2024. We generated $48.7 million of cash from operating activities for Q4 and achieved profitability with positive net income of $20.9 million for the full year 2025. At the end of the year, we had $506.1 million of cash equivalents, and marketable securities.

Thanks Meredith.

Net revenue for the fourth quarter ended December 31, 2025 was 91 7 million represents a sequential growth of nearly 40% from $66 million in Q3.

For the full year 2020, which as a reminder.

And you Rick says that the nine months of commercial availability.

Revenue was $190 4 million.

<unk> was approved in March of this year and therefore, the company generated no revenue for three or 12 months ended December 31 2020.

We generated $48 $7 million of cash from operating activities for the fourth quarter and achieved profitability with positive net income of $29 million for the full year 2025 at the end of the year, we had $506 1 million of cash cash equivalents amongst will securities.

David Brown: Please note, this is after our investment of $100 million in the accelerated share repurchase program that we announced in November. Our strong balance sheet ensures that we are sufficiently capitalized to continue to execute an effective US launch of VYKAT XR, while in parallel progressing towards regulatory approvals and commercialization, either on a standalone basis or with partners in the EU and other geographies, and to begin investments in possible new indications. Cost of goods sold was $0.9 million for Q4 and $2.7 million for the full year. As a reminder, prior to FDA approval, costs associated with manufacturing VYKAT XR were expensed as research and development expenses. As such, a portion of the Cost of goods sold during these periods included inventory at 0 cost.

Jim Mackaness: Please note, this is after our investment of $100 million in the accelerated share repurchase program that we announced in November. Our strong balance sheet ensures that we are sufficiently capitalized to continue to execute an effective US launch of VYKAT XR, while in parallel progressing towards regulatory approvals and commercialization, either on a standalone basis or with partners in the EU and other geographies, and to begin investments in possible new indications. Cost of goods sold was $0.9 million for Q4 and $2.7 million for the full year. As a reminder, prior to FDA approval, costs associated with manufacturing VYKAT XR were expensed as research and development expenses. As such, a portion of the cost of goods sold during these periods included inventory at zero cost.

Please note this is after our <unk>.

<unk> $100 million accelerated share repurchase program that we announced in November.

Strong balance sheet that shows that we are sufficiently capitalized to continue to execute an effective U S launch if I could ask while in parallel progressing towards regulatory approvals and commercialization either on a standalone basis or with partners in the EU.

Since the beginning of the essence and possible indications.

Cost of goods sold was <unk> 9 million for the fourth quarter and $2 7 million for the full year as a reminder, prior to FDA approval costs associated with manufacturing blanket X where expense this research and development expenses at such a portion of the cost of goods sold during these periods included inventory this year.

David Brown: Going forward, as we continue to sell VYKAT XR, we will deplete our zero-cost inventory and replenish it with at-cost inventory. Consequently, cost of goods sold as a percentage of revenue will increase. Research and development expenses for the Q4 was $9.6 million, which included $2.8 million of non-cash stock-based compensation, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation for the same period of 2024. The cadence of our research and development expenditures fluctuates depending upon the state of our research activities, clinical programs, and the timing of manufacturing and other projects necessary to support submission of regulatory filings. For the full year 2025, research and development expenses were $40.6 million, as compared to $78.6 million for the full year 2024.

Jim Mackaness: Going forward, as we continue to sell VYKAT XR, we will deplete our zero-cost inventory and replenish it with at-cost inventory. Consequently, cost of goods sold as a percentage of revenue will increase. Research and development expenses for the Q4 was $9.6 million, which included $2.8 million of non-cash stock-based compensation, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation for the same period of 2024. The cadence of our research and development expenditures fluctuates depending upon the state of our research activities, clinical programs, and the timing of manufacturing and other projects necessary to support submission of regulatory filings. For the full year 2025, research and development expenses were $40.6 million, as compared to $78.6 million for the full year 2024.

Going forward as we continue to tell us like Alexa, we will deplete a zero cost inventory to replenish it with <unk> and consequently cost of goods sold as a percentage of revenue will increase.

Research and development expense for the fourth quarter was $9 6 million, which included $2 8 million of noncash stock based compensation compared to $21 5 million, which includes $2 1 billion of those noncash stock based compensation for the same period of 2000.

The cadence of our research and development expenditures fluctuate depending upon the states on research activities clinical programs and the timing of manufacturing and other projects necessary to support submission for Greg.

Pilot.

For the full year 2025 research and development expenses were $40 6 million this compared to $78 6 million for the full year 2020.

David Brown: Selling, general, and administrative expense for the Q4 ended 31 December 2025, was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation for the same period of 2024. The increase in expense, after removing stock-based compensation, reflects our ongoing investment in additional personnel and new programs to support the VYKAT XR commercial launch and in support of our increased business activities. For the full year 2025, SG&A expenses were $132.1 million, as compared to $105.9 million for the full year 2024.

Jim Mackaness: Selling, general, and administrative expense for the Q4 ended 31 December 2025, was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation for the same period of 2024. The increase in expense, after removing stock-based compensation, reflects our ongoing investment in additional personnel and new programs to support the VYKAT XR commercial launch and in support of our increased business activities. For the full year 2025, SG&A expenses were $132.1 million, as compared to $105.9 million for the full year 2024.

Selling general and administrative expense for the fourth quarter ended December 31, 2025 was $14 9 million, which includes $8 7 million of noncash.

When compared to $37 3 million Teus $19 7 million of noncash stock based compensation for the same period.

Cool.

The increase in expense after removing stock based compensation reflects our ongoing investment in additional personnel and new programs to support the <unk> commercial launch and is supported by increased business activities.

For the full year 2025, SG&A expense grew $132 1 million as compared to $105 9 million for the full year 2024.

David Brown: Total other income net was $3.8 million for the 3 months ended 31 December 2025, compared to total other income net of $3.1 million in the same period of 2024. For the full year 2025, total other income net was $11.5 million, as compared to $11.8 million for the full year 2024. Net income for Q4 was approximately $43.4 million, or $0.82 per basic and $0.80 per diluted share, compared to a net loss of $56.0 million, or $1.27 per basic and diluted share for the same period in 2024. For the full year 2025, net income was $20.9 million, or $0.40 per basic and $0.39 per diluted share....

Jim Mackaness: Total other income net was $3.8 million for the three months ended 31 December 2025, compared to total other income net of $3.1 million in the same period of 2024. For the full year 2025, total other income net was $11.5 million, as compared to $11.8 million for the full year 2024. Net income for Q4 was approximately $43.4 million, or $0.82 per basic and $0.80 per diluted share, compared to a net loss of $56.0 million, or $1.27 per basic and diluted share for the same period in 2024. For the full year 2025, net income was $20.9 million, or $0.40 per basic and $0.39 per diluted share....

Other income net was $3 8 million for the three months ended December 31, two decline compared to total other income net $3 1 million in the same period of 2024.

For the full year 2025 total other income net was $11 5 million as compared to 11 8 million for the fourth.

Net income for the fourth quarter was approximately $43 4 million or <unk> 82 cents per basic and diluted.

Diluted share.

Got it to a net loss of 56 million or $1 27 per basic and diluted share for the same period in 2024.

For the full year 2025, net income was $20 9 billion or <unk> 40 per basic and <unk> 39 per diluted share.

David Brown: as compared to a net loss of $175.9 million, or $4.38 per basic and diluted share for 2024. Please note, with regards to KPIs, we intend to share patient start forms, number of unique prescribers, and lives covered in our Q1 2026 earnings call, which will mark 12 months of results. Our intention is to retire these metrics at that time. This concludes the financial overview. On a personal note, I would like to let everyone know that I am retiring at the end of March. It's been my great pleasure to work with Anish and the team over the last 6 years. It's been a fantastic journey. We've accomplished so much, and I feel the company is in an excellent position to ensure future success.

Jim Mackaness: as compared to a net loss of $175.9 million, or $4.38 per basic and diluted share for 2024. Please note, with regards to KPIs, we intend to share patient start forms, number of unique prescribers, and lives covered in our Q1 2026 earnings call, which will mark 12 months of results. Our intention is to retire these metrics at that time. This concludes the financial overview. On a personal note, I would like to let everyone know that I am retiring at the end of March. It's been my great pleasure to work with Anish and the team over the last six years. It's been a fantastic journey. We've accomplished so much, and I feel the company is in an excellent position to ensure future success.

As compared to a net loss of $135 9 million or <unk>.

$4 with 38 cents per basic and diluted share for 2020.

Okay.

Please note with regards to Kpis retention shares patient start forms number of unique prescribers and lives covered in our Q1 2026 earnings call, which will Mark 12 months of results.

And our orientation is to retire these metrics.

Okay.

This concludes the financial review, but on a personal note I would like to later you will note that I am retiring at the end of March has been my great pleasure to work with the <unk> team over the last six years discrete a fantastic journey, we've accomplished so much and I feel the company is in an excellent position to ensure future success.

David Brown: We have an outstanding replacement, Jennifer Volk, who will take over as CFO in the coming weeks, and I will move into a consulting role to ensure a smooth transition. I now turn the call back over to Anish for additional thoughts. Anish?

Jim Mackaness: We have an outstanding replacement, Jennifer Volk, who will take over as CFO in the coming weeks, and I will move into a consulting role to ensure a smooth transition. I now turn the call back over to Anish for additional thoughts. Anish?

We have an outstanding replacement Joseph bulk will take over as CFO in the coming weeks that will move into a consulting role to ensure a smooth transition for.

I'll now turn the call back over to Denise traditional niche. Thanks.

Anish Bhatnagar: Thank you, Jim, for the incredible work over the last six years to get us to where we are today. With the launch of VYKAT XR well underway, we turn our attention to what's next for the company and to begin with, what's next for DCCR. We continue to pursue additional metabolic rare disease indications with high unmet needs, where the probability of success is high and the mechanism of action directly applies. The first of these indications is Glycogen storage disease type I, or GSD I, which is a rare metabolic condition characterized by the accumulation of fat in the liver and kidneys, resulting in extremely low levels of blood glucose. It impacts approximately one in every 100,000 live births, resulting in a prevalence of greater than 7,000 patients globally and approximately 3,000 to 4,000 of the patients residing in the US.

Anish Bhatnagar: Thank you, Jim, for the incredible work over the last six years to get us to where we are today. With the launch of VYKAT XR well underway, we turn our attention to what's next for the company and to begin with, what's next for DCCR. We continue to pursue additional metabolic rare disease indications with high unmet needs, where the probability of success is high and the mechanism of action directly applies. The first of these indications is Glycogen Storage Disease Type I, or GSD I, which is a rare metabolic condition characterized by the accumulation of fat in the liver and kidneys, resulting in extremely low levels of blood glucose. It impacts approximately one in every 100,000 live births, resulting in a prevalence of greater than 7,000 patients globally and approximately 3,000 to 4,000 of the patients residing in the US.

Thank you Jim for the incredible work over the last six years to get us to where we are today.

With the launch of <unk>, well underway, we turn our attention to what's next for the company and to begin with let's say for the CCR.

We continue to pursue additional metabolic rare disease indications with high end with Windows, where the probability of success is high and the mechanism of action directly applies.

The first of these indications with glycogen storage disease type, one or <unk>, one which is a rare metabolic condition characterized by the accumulation of fat in the liver and kidney, resulting in extremely low levels of blood glucose.

<unk> approximately one in every 100000 lives but.

The other thing in the prevalence of greater than 7000 patients globally, and approximately three to 4000 observations residing in the U S.

Anish Bhatnagar: There are currently no FDA-approved therapies. GSD I represents a natural and logical extension of our VYKAT XR franchise beyond PWS. The predominant physician standpoint for GSD I, namely pediatric endocrinologist, is the same for PWS. The mechanism of action of VYKAT XR uniquely addresses the severe clinical manifestations of GSD I. People affected by GSD I lack the ability to convert stored glycogen into glucose and live at the constant risk of life-threatening hypoglycemia. They are dependent upon external sources of glucose, in this case, daily consumption of cornstarch multiple times a day, in order to survive. The precise timing of cornstarch consumption is critical, especially during periods of fasting between meals and during the night, as missed doses can lead to potentially fatal hypoglycemia. Long-term use of cornstarch can lead to severe GI issues, metabolic dysfunction, and very poor quality of life.

Currently no FDA approved therapies.

GSE, one represents a natural and logical extension of our <unk> franchise beyond PWM.

The predominant physician Paul but.

GSE, one, namely pediatric endocrinologists is the same for PWM.

The mechanism of action of <unk> XR uniquely addresses the suggest clinical manifestations of GSE one.

People affected by GSE, one lastly ability to convert stored glycogen into glucose and live at the concert risk of life threatening hypoglycemia.

Centered upon external sources of glucose in this case daily consumption of corn starch multiple times a day in order to survive.

However, the precise timing of cornstarch consumption is critical especially during periods of crossing between meals and during the night as missed doses can lead to potentially fatal hyperglycemia.

In addition, long term use of corn starch can lead to severe gi issues metabolic dysfunction and very positively.

Anish Bhatnagar: VYKAT XR's ability to innovate insulin secretion with its fast onset and repeatable and tailored dosing, could maintain proper levels of glucose throughout the day and night and reduce the person's dependency on cornstarch. DCCR has orphan designation for GSD I in the US as well as in the EU. Our plan is to file an IND in the first half of this year and to initiate a clinical program later in 2026. More detail will be provided during the year as we approach the start of the trial. We look forward to sharing future updates on these programs as they emerge. In closing, we are very pleased with the success and trajectory of VYKAT XR, we will continue to work tirelessly to make this safe and effective therapy available to as many patients living with PWS-related hyperphagia as possible.

So I got excited ability to innovate incident depletion with its fast onset and repeatable and tailored dosing, but maintain proper levels of glucose throughout the day and night and reduce the burden dependency on search <unk> has orphan designation for <unk> in the U S as well as in the EU.

Our plan is to file an IND in the first half of this year and to initiate the clinical program. Later in 2000 purchases more details will be provided during the year as we of course to start off the cloud.

We look forward to shed a future update on these programs as they emerge.

In closing, we have any fees with the success and trajectory of <unk> XR and we will continue to work tirelessly to make the safe and effective therapy available to as many patients living with Pwc's related hyperphagia as possible.

Anish Bhatnagar: We're excited about expanding into new indications, leveraging our existing knowledge and skills. With that, we'll now open the call for your questions. Operator?

We're excited about expanding into new indications, leveraging our existing knowledge and skills and with that we'll now open the call for your questions operator.

Okay.

Brian Ritchie: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. If you would like to withdraw from the polling process, please press star, then the number two. If you are using a speakerphone, please make sure to lift your handset before pressing any keys. Your first question comes from the line of Paul Choi from Goldman Sachs. Please go ahead.

Operator: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. If you would like to withdraw from the polling process, please press star, then the number two. If you are using a speakerphone, please make sure to lift your handset before pressing any keys. Your first question comes from the line of Paul Choi from Goldman Sachs. Please go ahead.

Ladies and gentlemen, we will now begin the question and answer session.

If you have a question. Please press star followed by the number one on your Touchtone phone you will hear a prompt that your hand has been raised.

If you would like to withdraw from the polling process. Please press Star then the number two.

You are using a speaker phone please make sure to lift your handset before pressing any case.

Your first question comes from the line of Paul Choi from Goldman Sachs. Please go ahead.

[Analyst] (Goldman Sachs): Hi, Jim and Anish. This is Khalil calling in for Paul. Thank you so much, and for taking the question and congrats on the quarter. I suppose I just wanted to start quick on the 1,000 patient start forms that you guided for the next 9 to 12 months. Can you remind us what the cadence of that is expected to look like? Is there going to be a bolus in the start of the year? Is it going to be later in the year due to the adjustment, seasonal adjustment in Q1? Just helps understand the cadence there.

Khalil Fenina: Hi, Jim and Anish. This is Khalil calling in for Paul. Thank you so much, and for taking the question and congrats on the quarter. I suppose I just wanted to start quick on the 1,000 patient start forms that you guided for the next nine to 12 months. Can you remind us what the cadence of that is expected to look like? Is there going to be a bolus in the start of the year? Is it going to be later in the year due to the adjustment, seasonal adjustment in Q1? Just helps understand the cadence there.

Hi, Jeremy this is <unk>, calling in for Paul. Thank you so much.

And for taking the question and congrats on the quarter.

I suppose I just wanted to start a quick one with us for on the 1000 patient start forms that you got it for the next nine to 12 months can you remind us what the cadence of that.

If I could look like is there going to be a bolus in the start of the year is it going to be.

It going to be later in the year due to the adjustment seasonal adjustment in <unk>, just help us understand the cadence there.

Anish Bhatnagar: Thanks for the question, Khalil. I think it's fair to say that we want you to think of this as over the 9 to 12 months, not necessarily on a quarter-to-quarter basis. It's hard to, you know, think of a bolus at this time. I think it's fair to say that the start forms will come in over the year. I'll let Meredith address it further in terms of how she thinks the cadence is likely to be.

Anish Bhatnagar: Thanks for the question, Khalil. I think it's fair to say that we want you to think of this as over the nine to 12 months, not necessarily on a quarter-to-quarter basis. It's hard to, you know, think of a bolus at this time. I think it's fair to say that the start forms will come in over the year. I'll let Meredith address it further in terms of how she thinks the cadence is likely to be.

Thanks for the question.

I think it's fair to say that we want you to think of this as over the nine to 12 months not necessarily on a quarter to quarter basis.

So it's hard to think of a bolus at this time I think it's fair to say that to start forms will come in over the year like Meredith address it further in terms of how she thinks the cadence is likely to be yes. Thank you I agree with the niche that obviously, we're looking at a thousand over the next nine to 12 months.

Meredith Manning: Yeah. Thank you, Anish. I agree with Anish that obviously we're looking at 1,000 over the next 9 to 12 months. That's our goal in order to continue to sustain momentum of the very strong launch. As I mentioned in the script, you know, we're really doubling down on broadening our experience with KOLs, getting out into the community setting, and also activating the caregiver population.

Meredith Manning: Yeah. Thank you, Anish. I agree with Anish that obviously we're looking at 1,000 over the next nine to 12 months. That's our goal in order to continue to sustain momentum of the very strong launch. As I mentioned in the script, you know, we're really doubling down on broadening our experience with KOLs, getting out into the community setting, and also activating the caregiver population.

Our goal in order to continue the sustained momentum momentum of the of the very strong launch.

And as I mentioned in the script, we're really doubling down on broadening our experience with kols getting out into the community setting and also activating the caregiver population.

[Analyst] (Goldman Sachs): Got it. Thank you so much. Jim, congrats on your retirement. We're sorry to see you go.

Khalil Fenina: Got it. Thank you so much. Jim, congrats on your retirement. We're sorry to see you go.

Got it. Thank you so much and Jim Congrats on your retirement, we're sorry to see you go.

David Brown: Thank you very much. Appreciate it, Khalil.

Jim Mackaness: Thank you very much. Appreciate it, Khalil.

Thank you very much I appreciate it.

Brian Ritchie: Your next question comes from the line of Etzer Darout from Guggenheim Securities. Please go ahead.

Operator: Your next question comes from the line of Moritz Reiterer from Guggenheim Securities. Please go ahead.

Your next question comes from the line of Marez retrieved from Guggenheim Securities. Please go ahead.

[Analyst] (Guggenheim Securities): Hi, this is Mohit Bansal for Debjit Chattopadhyay. I got first a question on PWS. At peak, what percent of the market do you think could be accessible in the US at this point? Then a second one about GSD I. What do you think about dosing in GSD I? Do you think the dose will be similar or lower? How do you think tolerability of the drug would impact adoption in that disease? Thank you.

Moritz Reiterer: Hi, this is Moritz for Debjit. I got first a question on PWS. At peak, what percent of the market do you think could be accessible in the US at this point? Then a second one about GSD I. What do you think about dosing in GSD I? Do you think the dose will be similar or lower? How do you think tolerability of the drug would impact adoption in that disease? Thank you.

This is mark on for Doug.

First a question on <unk>.

Ws peak what percent of the market do you think could be accessible in the U S. At this point and then a second one about just the one what do you think about dosing and just see one do you think the dose will be similar or lower and how do you think.

Tolerability of the drug with impacted adoption in that disease. Thank you.

Anish Bhatnagar: Sure. Your first question was about what is the likely peak penetration in PWS? It's a good question, and I think you have to put it in the context of the fact that no other treatments exist today. You know, many of these treatments, you look at 40%, 50% penetration in these larger rare diseases. I think if we are, you know, 3, 4 years out and the competitive landscape looks like the way it does today, I don't think it's unreasonable to expect a higher penetration than that. In terms of GSD, your question around dosing, part of our first trial is going to be looking at dosing in these patients.

Sure. So your first question was about.

What are the likely peak penetration and PWM. It's a good question and I think you have to put it in the context of the.

The fact that no other treatments exists today. So many of these treatments you look at 40%, 50% penetration in these larger rare diseases, but I think if we are three or four years out in the competitive landscape looks like the way. It does today I don't think it's unreasonable to expect a higher penetration than that.

In terms of.

<unk> D youre.

Your question around dosing, we have to as a part of our first trial is going to be looking at dosing in these patients. We do know that it's a pretty sensitive insulin is pretty sensitive to die oxide. So we expect the dosing to be likely in the range of where we are today. It is important to know though that even though.

Anish Bhatnagar: We do know that it's a pretty sensitive insulin is pretty sensitive to diazoxide, so we expect the dosing to be likely in the range of where we are today. It is important to know, though, that even though the unmet need is really great here, it's really about the precise dosing to increase blood glucose levels enough. These patients don't have the sort of comorbidities that you see in PWS patients, so they're unlikely to be significantly obese, they're unlikely to be significantly diabetic, et cetera. I think there will be more room to do to dose in that patient population, but that remains to be seen, be the subject of the first trial.

The unmet need is really great here, it's really about the precise dosing to increase blood glucose levels enough.

And.

These patients don't have the sort of comorbidities that youll see and PWM patients so they're unlikely to be significantly obese, they're unlikely to be significantly diabetic et cetera. So I think there will be more room to dose to dose in that patient population, but that remains to be seen really the subject of the first trial.

Brian Ritchie: Your next question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead.

Operator: Your next question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead.

Your next question comes from the line of <unk> Rahimi from Piper Sandler. Please go ahead.

[Analyst] (Piper Sandler): Hi, this is Shannon on for Yas. Congrats on the progress, guys, and thank you so much for taking our question. Just 2 from us. Could you help us understand a little bit more about the refill rates that you're seeing now that you have a larger proportion of patients who have been on the drug for several months? The second question is, how do you expect the average weight of new patients coming in to change over time? If you're seeing more older patients, do you expect the average weight to increase? Thank you.

Hi, This is Shannon on for yes, congrats on the progress guys and thank you so much for taking our question.

Just two from us.

Could you help us understand a little bit more about the refill rates that youre seeing now that you have a larger proportion of patients.

<unk> been on the drug for several months.

And then the second question is how do you expect the average weight of new patients coming into changeover time, Inc.

Being more older patients do you expect that the average rate to increase thank.

Thank you.

Anish Bhatnagar: Sure. Shannon, I'll take the second question, Meredith will take the first one. In terms of the weight over time, as you know, our clinical trial average weight was 61 kg. The age was about 13 years. What we have said more recently is that the predominant number of patients coming in are in the 4 to 26 year age group, and in general, likely heavier than what we are seeing in the clinical trial population. The average whack for a clinical trial patient would be about 488. We have said publicly that we're looking at averages in the higher than 500 range. We are also seeing more older patients coming on at this time, and we expect that over time, therefore, the total weight will be going up as well.

Sure Shannon I'll take the second question Meredith will take the first one.

In terms of the weight over time as you know our clinical trial average weight was 61 kilograms. The age was about 13 years.

We have said more recently is that.

The predominant number of patients coming in are in the 4% to 26 year age group and in general likely heavier than what we're seeing in the clinical trial population. So the average WAC for a clinical trial patients would be about 488, we have said publicly that we're looking at averages and the higher than 500 range.

We are also seeing more order patients coming on at this time and we expect that over time. Therefore, the total weight will be going up as well.

Anish Bhatnagar: Again, these are not likely to be large stepwise inflections, but think of it more as sort of gentle increases over time. Meredith, you want to talk about refill rates, realizing that it's early and we don't really.

So again these are not likely to be large step wise inflections, but think of it more as sort of gentle drink skus overtime.

<unk> you want to talk about refill rates realizing that its early and we don't really have that much data, yes. Thank you and similar to what I said in my prepared remarks, if you look at as the patients are settling in to their optimal dose we're very pleased with the high.

[Analyst] (Guggenheim Securities): Yeah.

Meredith Manning: Yeah.

Anish Bhatnagar: have that much data?

[Analyst] (Guggenheim Securities): Thank you. Similar to what I said in my prepared remarks, if you look at as the patients are settling into their optimal dose, we're very pleased with the high adherence rates and seeing that we are, you know, nine months in at the end of Q4, we're seeing patients who are able to stay on therapy and reach longer time frames. We're very pleased with the refill rates.

Moritz Reiterer: Thank you. Similar to what I said in my prepared remarks, if you look at as the patients are settling into their optimal dose, we're very pleased with the high adherence rates and seeing that we are, you know, nine months in at the end of Q4, we're seeing patients who are able to stay on therapy and reach longer time frames. We're very pleased with the refill rates.

Adherence rates and seen that we are nine months in at the end of Q4.

We're seeing patients who are able to.

Stay on therapy and reach longer timeframe. So we're very pleased with what the refill rate.

[Analyst] (Piper Sandler): Great. Thank you so much.

Great. Thank you so much.

Brian Ritchie: Your next question comes from the line of Kristen Kluska from Cantor Fitzgerald. Please go ahead.

Operator: Your next question comes from the line of Kristen Kluska from Cantor Fitzgerald. Please go ahead.

Your next question comes from the line of question <unk> from Cantor. Please go ahead.

Yeah.

Kristen Kluska: Hi, thanks for taking the questions. Congrats, Jim. It's been an absolute pleasure working with you and always wishing you the best. You talked about longer term, maybe factoring in a 15% to 20% discontinuation rate. I'm wondering how you're thinking, how efficacy will ultimately play into this. At what point in the launch do you think you'll have a good sense of % of patients that are dropping out due to lack of efficacy? I'm curious, as you are collecting some of these real-world anecdotes, if the efficacy looks similar or different amongst patients, meaning are there some that are responding to hyperphagia? Are there some that are responding on behavior? What's really the factor that will keep somebody on the therapy longer term from efficacy standpoint?

Hi, Thanks for taking the questions and congrats Jim it's been an absolute pleasure working with you and always wishing you. The best So you talked about longer term, maybe factoring in a 15% to 20% in discontinuation rate I am wondering how youre thinking how efficacy will ultimately play into this at what point in the launch.

Youll have a good sense of.

The percent of patients that are dropping out due to lack of efficacy and then I'm curious as you are collecting some of these real world anecdotes.

The efficacy looks similar or different amongst patients meaning are there. Some that are responding to hyperkinesia are there. Some that are responding on behavior and what's really the factor that will keep somebody on the therapy longer terms from an efficacy standpoint.

Anish Bhatnagar: Thanks, Kristen. I think it's fair to say that when you look at our experience in the clinical trials, which, as you know, lasted for many years, if you stay on therapy, you are likely to see benefits. As you can imagine, you're unlikely to stay on therapy if you have significant adverse events. What we have seen to date is that patients who have stayed on drug for some time are seeing efficacy. I think it's fair to say that discontinuations for lack of efficacy are few at this time, and I would not expect that to change too much, because if you stay on drug, we expect you to have some levels of efficacy.

Thanks, Kristen I think it's fair to say that when you look at our experience in the clinical trials, which as you know lasted for many years.

Stay on therapy, you are likely to see benefits and as you can imagine you are unlikely to stay on therapy. If you have a significant adverse events. So what we have seen to date is that patients who have stayed on drug for some time are seeing efficacy.

Think of it is fair to say that discontinuation for lack of efficacy are few at this time and I would not expect that to change too much because if you stay on drug we expect you to have some levels of efficacy.

James MacInnis: Okay, just on what that efficacy actually is in the real world, is it looking different in patients? Meaning, are some responding to hyperphagia, are some responding to behavior, or is it like a mix?

Kristen Kluska: Okay, just on what that efficacy actually is in the real world, is it looking different in patients? Meaning, are some responding to hyperphagia, are some responding to behavior, or is it like a mix?

Okay, and then just on what that efficacy actually is in the real world is it looking different in patients, meaning are some responding to hyperphagia or some responding to behavior or is it like a mix.

Anish Bhatnagar: Yeah, it's a good question. As you know, we don't have the same precise gauge on efficacy in the real world as we do in the clinical trials. We're not, you know, doing efficacy analyses per se. The anecdotes that we're hearing certainly primarily relate to changes in hyperphagia and the downstream effects of it. As you know, hyperphagia itself gets mixed up with, you know, anxiety related to food, behaviors, and aggressive behaviors around food. As long as you're targeting something around hyperphagia, we think that is the primary effect. I think the other effects time will tell. It's hard for us to measure those, even in the trials. We do hear anecdotes, you know, that talk about, you know, being more calm, having better social interactions, having less anxiety, and things like that.

Yes, it's a good question and as you know we don't have the same precise gauge on efficacy in the real world as we do in the clinical trials. So we're not doing efficacy analyses per se, but the anecdotes that we're hearing thirdly, primarily related to changes in hyperphagia and the downstream effects of it so as you know <unk>.

Jay itself gets mixed up with anxiety related to food behaviors aggressive behaviors around food. So as long as you were targeting something around hyperphagia. We think that is the primary effect I think the other effects will time will tell it's hard for us to measure those even in the trials, but we do hear anecdotes.

They talk about.

Being more com, having better social interactions, having listened xiety and things like that so yes, there is an element of that as well.

Anish Bhatnagar: Yes, there is an element of that as well.

James MacInnis: Thank you.

Kristen Kluska: Thank you.

Thank you.

Brian Ritchie: Your next question comes from the line of Tyler Van Buren from TD Cowen. Please go ahead.

Operator: Your next question comes from the line of Tyler Van Buren from TD Cowen. Please go ahead.

Your next question comes from the line of Tyler Van Buren from TD Cowen. Please go ahead.

Tyler Van Buren: Great, thanks, guys. I'll add my congratulations to you, Jim, on your retirement and the success you've experienced at Soleno. You'll be missed. Wanted to just follow up on the 1,000 start forms over the next 9 to 12 months that you guys reiterated, which is, of course, encouraging. Earlier, you spoke about the cadence in response to a question, but wanted to maybe hear you elaborate specifically on what has been observed so far during January and February in the new year with the launch. Then as a follow-up, are you expecting any meaningful level of Q1 seasonality?

Great. Thanks, guys I'll add my congratulations to you Jim on your retirement and the success we've experienced so I know you'll be missed.

Hmm.

Wanted to just follow up on the <unk>.

Start forms over the next nine to 12 months that you guys reiterated which is of course encouraging and.

Earlier, you spoke about the cadence.

In response to a question, but wanted to maybe hear you elaborate specifically on what has been observed so far during January and February in the new year with the launch.

And then as a follow up.

Are you expecting any meaningful level of Q1 seasonality.

Anish Bhatnagar: Tyler, as you know, we're not able to comment on Q1, but we can tell you that it is interesting to launch a drug into a completely new indication, and we are learning as we go. You know, the Thanksgiving/Christmas was interesting. It was interesting to see some of the summer, you know, camp-related things that happened, people going away to camp. We'll have to see what the cadence is like. I'm gonna let Meredith answer.

So Tyler as you know we were not able to comment on Q1, but we can tell you that it is interesting to launch a drug into a completely new indication and we're learning as we go.

Thanks, giving Christmas was interesting it was interesting to see some of the summer.

Caf related things that happen people going away to camp.

So we'll have to see what the cadence is like.

Im going to let Meredith answer the yes.

Meredith Manning: Yeah

Anish Bhatnagar: rest of the question.

Rest of the question, Thanks finished and I concur, 100% with you that.

Meredith Manning: Thanks, Anish, I concur 100% with you that it is interesting to launch. This is the first-ever FDA-approved medicine for the treatment of hyperphagia. We're learning a lot around some of the aspects in the home or the family or what will bring them into the office to get seen by the practitioner. Also, I think I've mentioned several times on our last earnings calls, that we also are looking at some of the physicians who are increasingly more interested and excited to treat PWS because there actually is a treatment for hyperphagia now. They're opening up clinical practices or PWS-specific clinics. We're hoping to see some of the availability of clinicians improving as we go forward and really strengthening the care that's being delivered out there. It's exciting.

It is interesting to launch this is the first ever FDA approved medicine for the treatment of hyperplasia, and so we're learning a lot around some of the aspects in the home or the family or what will bring them into the office.

To get seen by the practitioner also I think Ive mentioned several times on our last earnings calls that we also are looking at some.

Some of the physicians, who are increasingly more interested and excited to treat PWM because there actually is a treatment for hyperphagia now and so they're opening up clinical practices or PWM specific clinic.

So we're hoping to see some of the availability of clinicians improving as we go forward and really strengthening the care that's being delivered out there. So it's exciting well hopefully be able to provide you more details as we go along but.

Meredith Manning: We'll hopefully be able to provide you more details as we go along, but, you know, strong interest out there.

Wrong interest out there I will say that on the seasonality front.

Anish Bhatnagar: I will say that on the seasonality front, Jim, would you like to add something?

Jim would you like to add something sure China. Thank you for the good wishes.

James MacInnis: Sure. Tyler, thank you for the good wishes. I, yes, I never like to miss an opportunity on the revenue side of Q1 to point out seasonality that impacts all commercial drugs, and it shows up in the gross to net. Tyler, as you're aware, but just to communicate again, what tends to happen with folks on, particularly on commercial plans, is they'll reset their copays. That means that's more out-of-pocket that they would incur, except that we offer Soleno One, and we will effectively reimburse them for those copays. That increases the discount, if you like, on the gross to net. The other phenomenon that can happen is in the disruption of changing plans, your employer might change plans, you may choose a different plan.

Jim Mackaness: Sure. Tyler, thank you for the good wishes. I, yes, I never like to miss an opportunity on the revenue side of Q1 to point out seasonality that impacts all commercial drugs, and it shows up in the gross to net. Tyler, as you're aware, but just to communicate again, what tends to happen with folks on, particularly on commercial plans, is they'll reset their copays. That means that's more out-of-pocket that they would incur, except that we offer Soleno One, and we will effectively reimburse them for those copays. That increases the discount, if you like, on the gross to net. The other phenomenon that can happen is in the disruption of changing plans, your employer might change plans, you may choose a different plan.

I never like to visit opportunity on the revenue side of Q1 to point out seasonality that impacts all commercial drugs.

And it shows up in the gross to net so China as Youre aware, but just to communicate again, what tends to happen with folks on particularly on commercial plans as they will reset the co pays so that means that's more out of pocket that they would incur exit that we offer cylinder one and we will effectively reimbursement for those co pays so that increases the discount if you like on the gross to net.

And then the other phenomenon that can happen is in the disruption of changing plans from your employer might change plans you may choose a different plan. There is an opportunity where you move may move from what we would call a paid bucket of active patients into the free bucket.

James MacInnis: There's an opportunity where you may move from what we would call our paid bucket of active patients into the free bucket of active patients. Maybe you'll receive four to six weeks of free drug before you move back to paid. It's a seasonality. It doesn't change the underlying growth in active patients, but it's just something that does impact the revenue because it will impact the gross to net discount for Q1. We'll obviously be able to give you better color once we get through Q1, and we'll be able to size it at that stage.

Jim Mackaness: There's an opportunity where you may move from what we would call our paid bucket of active patients into the free bucket of active patients. Maybe you'll receive four to six weeks of free drug before you move back to paid. It's a seasonality. It doesn't change the underlying growth in active patients, but it's just something that does impact the revenue because it will impact the gross to net discount for Q1. We'll obviously be able to give you better color once we get through Q1, and we'll be able to size it at that stage.

So maybe you will receive four to six weeks of free drug before you move back to paid is the seasonality it doesn't change the underlying growth in active patients, but it's just something that does impact the revenue because it will impact the gross to net discount for Q1, and we'll obviously be able to give you better color. Once we get through Q1 and will be at a size of that stage.

Brian Ritchie: Your next question comes from the line of Leland Gershell from Oppenheimer. Please go ahead.

Operator: Your next question comes from the line of Leland Gershell from Oppenheimer. Please go ahead.

Your next question comes from the line of Leland <unk> from Oppenheimer. Please go ahead.

[Analyst] (Oppenheimer & Co. Inc.): Thanks. Good afternoon. Thank you for this update. Jim, just wanted to add my sentiments as well. Wish you all the best as you move on. Wanted to ask, you know, at the time of approval, as you were entering the initial launch, I guess this is a question directed at Meredith. You had said, I think, that, you know, you'd identified that there are about 300 physicians who were direct treaters of about 20% of PWS patients, and who also influenced the care of another 20%. I think there were, you know, about 80% of pediatric endocrinologists who had expressed willingness to prescribe VYKAT XR.

Leland Gershell: Thanks. Good afternoon. Thank you for this update. Jim, just wanted to add my sentiments as well. Wish you all the best as you move on. Wanted to ask, you know, at the time of approval, as you were entering the initial launch, I guess this is a question directed at Meredith. You had said, I think, that, you know, you'd identified that there are about 300 physicians who were direct treaters of about 20% of PWS patients, and who also influenced the care of another 20%. I think there were, you know, about 80% of pediatric endocrinologists who had expressed willingness to prescribe VYKAT XR.

Thanks, Good afternoon.

Thank you for this update and Jim just wanted to add my sentiments as well wish you all the best as you move on.

Wanted to ask.

The time of approval as you were entering the initial launch I guess this is a question directed at Meredith.

You had said I think that you would identify that there are about 300 physicians who are directly reserve of about 20%.

Gws patients.

We will also influence the care of another 20% and I think there were about 80% of <unk>.

For career colleges to IDEXX.

This willingness to prescribe if I could ask or just wondering if you could provide us a picture of.

[Analyst] (Oppenheimer & Co. Inc.): Just wondering if you could provide us a picture of the, where that landscape is today with respect to, physicians' uptake of Vykat in their practices. Thank you.

Leland Gershell: Just wondering if you could provide us a picture of the, where that landscape is today with respect to, physicians' uptake of Vykat in their practices. Thank you.

Where that landscape is today with respect to.

Physicians uptake of <unk> in their practices. Thank you.

Meredith Manning: Yeah, thank you very much for the question. I appreciate that. The phenomena is still there. As we look at the top 300, we think that's the best way to focus on the market and target where we can have deeper penetration. We are seeing strong uptake among the top 300, and the majority of them have more than 1 patient, so they're repeat writers, which is very exciting to see. We're continuing to see that those individuals are influencing the treatment patterns across the country. I've mentioned before that we have peer-to-peer programs, so we're doubling down on that.

Yes. Thank you very much for the question I appreciate that.

The phenomena is still there as we look at the top 300, we think thats the best way to focus on the market and target where we can have deeper penetration. We are seeing strong uptake among the top 300 and the majority of them have.

More than one patient so their repeat writers, which is very exciting to see.

And we're continuing to see that those individuals are influencing the treatment patterns across the country.

I've mentioned before that we have peer to peer programs. So we're doubling down on that we also have an expert on demand.

Meredith Manning: We also have an expert on demand, where many community physicians can reach out to those top practitioners and get guidance on patient selection and what to look for with regard to setting expectations on efficacy and dosing and monitoring, et cetera. That's been very exciting. As we look at moving forward on focusing in on the caregiver aspect, as I mentioned, we're doubling down on webinars and live events and hoping to see that that will drive caregivers to come in and ask for VYKAT XR.

Where many community physicians can reach out to those top practitioners and get guidance on patient selection and what to look for with regard to setting expectations on efficacy and dosing and monitoring et cetera.

So that's been very exciting and then as we look at.

Moving forward on focusing in on the caregiver aspect as I mentioned, we are doubling down on Webinars and live events and hoping to see that that will drive caregivers to come in and ask for <unk> XR.

[Analyst] (Oppenheimer & Co. Inc.): That's very helpful. Then just, you know, kind of a higher level question on company's philosophy going forward in terms of the expansion, maybe with, through business development and the like. You obviously have a continuing and growing stream of cash coming in. It may, you know, cost you some to commercialize elsewhere and also advance your next program, but seems like you'll have firepower to do, you know, beyond that. Just wondering if you could give us any some thoughts, as Soleno continues to evolve and develop its footprint. Thank you.

Leland Gershell: That's very helpful. Then just, you know, kind of a higher level question on company's philosophy going forward in terms of the expansion, maybe with, through business development and the like. You obviously have a continuing and growing stream of cash coming in. It may, you know, cost you some to commercialize elsewhere and also advance your next program, but seems like you'll have firepower to do, you know, beyond that. Just wondering if you could give us any some thoughts, as Soleno continues to evolve and develop its footprint. Thank you.

That's very helpful and then just.

Kind of a higher level question on company's philosophy going forward in terms of.

<unk>.

Expansion, maybe with through business development and the like you obviously have a <unk>.

And growing stream of cash coming in it may cost you some to commercialize elsewhere and also advance your next program but.

It seems like Youll have firepower to do.

Just wondering if you could give us a niche some thoughts.

Solana continues to evolve and develop it.

Its footprint. Thank you.

Anish Bhatnagar: Yep. Thanks, Leland. I think the most important thing remains successful commercialization of VYKAT. I think it starts with the US, but the next step is outside the US, EU, other geographies, et cetera. The next thing is, I'd say, the lower-hanging fruit of using VYKAT itself for other things which are high likelihood of success situations like GSD I. Those are our primary targets, and we obviously continue to look at things on the outside. I don't expect imminent activity on that front, but we certainly will, in the longer term, look at doing that too.

Yes, Thanks, Leland I think the most important thing remains successful commercialization of <unk> and I think it starts with the U S. But the next step is outside the U S. EU other geographies et cetera, and then the next thing is I'd say, the lower hanging fruit of using <unk> itself or other things, which are high likelihood of success.

Situations like GSD, one so those are our primary targets and we obviously continue to look at things on the outside I don't expect.

Imminent activity on that front, but we certainly will in the longer term look at doing that too.

[Analyst] (Oppenheimer & Co. Inc.): All right, that's helpful. Thanks so much.

Leland Gershell: All right, that's helpful. Thanks so much.

Alright thats helpful. Thanks, so much.

Brian Ritchie: Your next question comes from the line of Brian Scorney from Baird. Please go ahead.

Operator: Your next question comes from the line of Brian Scorney from Baird. Please go ahead.

Your next question comes from the line of Brian <unk> Corny from Baronet. Please go ahead.

Brian Scorney: Hey, good afternoon, guys. Thanks for taking the question, and Jim, congrats on the retirement as well. Sorry to see you go. You have six patents listed in the Orange Book for VYKAT, with the four longest duration ones going out to 2035. I think when you got approval last year, we talked a little bit, you know, in vagaries about the label, creating some opportunity for even longer dated IP. Just wondering if you could give us your current thoughts on exclusivity of VYKAT based on where you are across patent prosecution? Just real quick on COGS, just wanted to get guidance if what we're seeing is product that was already expressed through R&D, and if there will be sort of a true up this year in terms of the gross margin. Thanks.

Brian Skorney: Hey, good afternoon, guys. Thanks for taking the question, and Jim, congrats on the retirement as well. Sorry to see you go. You have six patents listed in the Orange Book for VYKAT, with the four longest duration ones going out to 2035. I think when you got approval last year, we talked a little bit, you know, in vagaries about the label, creating some opportunity for even longer dated IP. Just wondering if you could give us your current thoughts on exclusivity of VYKAT based on where you are across patent prosecution? Just real quick on COGS, just wanted to get guidance if what we're seeing is product that was already expressed through R&D, and if there will be sort of a true up this year in terms of the gross margin. Thanks.

Hey, good afternoon, guys. Thanks for taking my question, Jim Congrats on the environment as well sorry to see you go.

You have six patents listed in the Orange book provides for longest duration ones going out to 2035, I think when you got approval last year, we talked a little bit.

Bakeries about the label, creating some opportunity for even longer data. So just wondering if you could give us your current thoughts on exclusivity of by job based on where you are across patent prosecution and just real quick on Cogs I just wanted to get guidance of what we're seeing is product that was already spreads through R&D and there will be sort of a true up this year in terms of the.

Gross margin thanks.

Anish Bhatnagar: Sure. Let me take the first part, and Jim can take the second part of it. On the exclusivity front, you're right. When we got approved, we had talked about the possibility of extension of IP beyond where we are today. I think what you saw with the listing of the 2035 patent is a step in that direction. It's a patent that's specific to methods of treating hyperphagia and food-related behaviors. That particular family, the related patents, have the ability to be extended into the late 2030s. We have also stated that we have filed additional IP, although we have not discussed the details of that, so stay tuned on that. Yes, that's the plan on exclusivity. Jim?

Sure Let me take the first part and Jim can take the second part of it so on the exclusivity front Youre right. When we got approved we had talked about the possibility of extension of IP beyond where we are today and I think what you saw with the lifting of the 2035 patents is a step in that direction. So it's a pattern.

Is that specific to methods of treating hyperphagia and food related behaviors.

That particular family related patents have the ability to be extended into the late 2000 <unk>. We have also stated that we have filed additional IP. Although we have not discussed the details of that so stay tuned on that.

So yes, that's the plan on exclusivity Jim Yes, so Brian thanks for the wishes.

Meredith Manning: Yeah, Brian, to your point, and thanks for your wishes. To your specific point, we still do have a little bit of, if you like, the zero cost inventory flowing through, so inventory that was in the supply chain prior to approval. Anticipate that COGS will just gently nudge up. They should stay in mid-single digits, so they'll just nudge up as we get full cost through the supply chain.

Jim Mackaness: Yeah, Brian, to your point, and thanks for your wishes. To your specific point, we still do have a little bit of, if you like, the zero cost inventory flowing through, so inventory that was in the supply chain prior to approval. Anticipate that COGS will just gently nudge up. They should stay in mid-single digits, so they'll just nudge up as we get full cost through the supply chain.

Specific point, we still do have a little bit of if you like the zero cost inventory flowing through so inventory that was in the supply chain prior to approval.

So anticipate that Cogs will just Jenny nudge up they should stay in mid single digit. So so they'll just nudge up as we get full cost through the supply chain.

Brian Scorney: Great. Thank you.

Brian Skorney: Great. Thank you.

Alright, thank you.

Brian Ritchie: Your next question comes from the line of Annabel Samimy from Stifel. Please go ahead.

Operator: Your next question comes from the line of Annabel Samimy from Stifel. Please go ahead.

Your next question comes from the line of James <unk> from Stifel. Please go ahead.

[Analyst] (Oppenheimer & Co. Inc.): Hey, thanks for taking our question. It's Mark on for James. I guess as it relates to the EU side of things, I think it's interesting, we've now seen SKYCLARYS get approval and trofinetide trending in the negative direction with the votes. I guess in the context of that, how are you thinking about, you know, these as potential analogs and EMA's overall comfort with perhaps maybe imperfect clinical data in the rare disease space? Just kind of your overall broader comfort with the EU approval. The second question also on the EU is, you know, when do you think you'll kinda have the 180-day questions in hand for the filing? Thank you.

[Analyst] (Stifel): Hey, thanks for taking our question. It's Mark on for James. I guess as it relates to the EU side of things, I think it's interesting, we've now seen SKYCLARYS get approval and trofinetide trending in the negative direction with the votes. I guess in the context of that, how are you thinking about, you know, these as potential analogs and EMA's overall comfort with perhaps maybe imperfect clinical data in the rare disease space? Just kind of your overall broader comfort with the EU approval. The second question also on the EU is, you know, when do you think you'll kinda have the 180-day questions in hand for the filing? Thank you.

Hey, Thanks for taking a question it's mark on for James.

Yes, yes, as it relates to the EU side of things I think it's interesting we've now seen sky Claris get approval and for credits on its running in the negative direction with the vote I guess in the context to that how are you thinking about these as potential analogs in the amaze overall comfort with perhaps maybe imperfect clinical data in the rare disease space and just kind of your overall brought.

Her comfort with EU approval and then the second question also on <unk>. When do you think youll kind of have the 180 day questions in hand for the filing thank you.

Anish Bhatnagar: Yeah. On the EU approval, you're right. I think it's fair to say that decisions on the rare disease side go in one direction or the other. You know, we've seen other examples. You know, Translarna is another example, which was approved in Europe for a long time, did not see an approval here. These things are always custom. Rare disease data sets are never perfect, so we have to just play out the process and see. We have day 120 questions. We responded to day 120 questions in a timely manner, expecting the day 120 questions by the end of this month, so imminently, and we'll see what they say.

Yes on the EU approval.

Youre right I think it's fair to say that decisions on the rare disease side go in one direction or the other and we've seen other examples trans lateral as another example, which was approved in Europe for a long time did not see an approval here. So these things are always custom rare disease datasets are never perfect. So we have to just play out the process in <unk>.

So we have de 120 questions. We've responded to de 120 questions in a timely manner expecting the day 120 questions by the end of this month are imminently and we will see what they say so I think as.

Anish Bhatnagar: I think, as we have said in the past, the nature of the key questions were around the proof of efficacy using randomized withdrawal as the key trial, the fact that the same patients were in the early as well as the late part of the study, and does that create potential for bias, et cetera. Clearly, you know, these are questions that the FDA asked us as well, and we were able to prevail. We will attempt to do the same here. Hard to predict the outcome, though. In terms of timing of the 180 day, I would say imminently. I think they're supposed to be 26 February.

We have said in the past.

The nature of the key questions were around the proof of efficacy using randomized withdrawal as the key trial. The fact that the same patients were in the early as well as the late part of the study and does that create potential for bias et cetera. So clearly these are questions that the FDA asked us as well and we were able to prevail. So we will attempt to do it.

Same here hard to predict the outcome, though in.

In terms of timing of the 180 day I would say imminently I think they're supposed to be.

<unk> 2006.

Meredith Manning: Thanks.

[Analyst] (Stifel): Thanks.

Thanks.

Brian Ritchie: The next question comes from the line of Katherine DeLaRusso from LifeSci Capital. Please go ahead.

And your next question comes from the line of Catherine <unk> Russo from lifestyle capital. Please go ahead.

Kate Dellorusso: Hi, congrats on the strong quarter, and congrats, Jim, on the retirement and for taking our questions. Yeah, I guess, just a few more follows on Europe, just given it's possibly around the corner. Yeah, just thinking about the potential launch trajectory in Europe versus US, are there anything, you know, key learnings that can be had from the US experience that could accelerate the uptake? I guess, if you were to commercialize on your own, any comments on the sales force that you think you would need there?

Katherine Dellorusso: Hi, congrats on the strong quarter, and congrats, Jim, on the retirement and for taking our questions. Yeah, I guess, just a few more follows on Europe, just given it's possibly around the corner. Yeah, just thinking about the potential launch trajectory in Europe versus US, are there anything, you know, key learnings that can be had from the US experience that could accelerate the uptake? I guess, if you were to commercialize on your own, any comments on the sales force that you think you would need there?

Hi, Congrats on the strong quarter and congrats Jim on the retirement and for taking our questions.

Yes, I guess that just a few more follow up on Europe.

Given that.

It's possibly around the corner.

Yeah, just thinking about the potential launch trajectory in Europe versus U S are there anything no key learnings that can be had in the U S experienced that could accelerate the uptake and I guess, if you were to commercialize on your own.

Any comment on the sales force that you would think you would need there.

Anish Bhatnagar: Meredith, would you like to take that?

Meredith would you like to take that sure happy to take that so we're still.

Meredith Manning: Sure. Happy to take that. We're still looking at what the size of the field force would look like. Most specifically, we're focusing in on potentially Germany and Austria, the first to launch, so we're looking at what the marketplace looks like there. Additionally.

Looking at what the size of the field force would look like.

Most specifically we're focusing in on.

Potentially Germany and Austria.

First to launch so we're.

Looking at what the marketplace looks like there.

Additionally.

Anish Bhatnagar: US launch experience.

Hi, Thanks launch experience.

Meredith Manning: Oh, yeah, US launch experience. Yeah, I think the one other thing that Anish had mentioned in his comments, though, about Europe is one of the phenomena is that there are more centers of excellence and tighter treatment over in Europe. That's a little bit different than here in the US. With regard to launch success, obviously, it's making sure that there's strong education of the treaters and making sure that they understand exactly the patient population that they'll be treating. The selection of that patient population has been really key in the United States.

<unk> U S launch experience, yes, I think the one other thing that are niche had mentioned in his comments, though about Europe is one of the phenomena is that there are more centers of excellence and tighter treatment over in Europe, and so that's a little bit different than here in the U S.

But with regard to launch success, obviously is making sure that there's strong education.

The treaters and.

Making sure that they understand exactly the.

The patient population that there'll be treating in the selection of that patient population has been really key in the United States.

Kate Dellorusso: Great. Thanks again.

Katherine Dellorusso: Great. Thanks again.

Great. Thanks again.

Brian Ritchie: The next question comes from the line of Yale Jen from Ladenburg Thalmann. Please go ahead.

Operator: The next question comes from the line of Yale Jen from Ladenburg Thalmann. Please go ahead.

Our next question comes from the line of Yale Jen from Laidlaw <unk> Company. Please go ahead.

Operator: Good afternoon, and thanks for taking the question. The first, Jim, congratulations on your retirement, and hopefully you enjoy the good life going forward. My first question is that, given that the drug has a great start for the first year, and do you guys feel that for the next... To getting the next wave of patients, is that more difficult or just a different approach to accomplish that? I have a follow-up.

Yale Jen: Good afternoon, and thanks for taking the question. The first, Jim, congratulations on your retirement, and hopefully you enjoy the good life going forward. My first question is that, given that the drug has a great start for the first year, and do you guys feel that for the next... To getting the next wave of patients, is that more difficult or just a different approach to accomplish that? I have a follow-up.

Good afternoon. Thanks for taking the question in the first Jim Congratulations on all.

Retirement and hopefully.

Thank God.

The good life going forward.

My first question is.

Good.

Given that.

The drug has.

<unk> for the first year and do you guys feel that for the next two getting the next wave of patients is therefore difficult or just defer.

<unk> approach to accomplish.

Accomplish that and I have a follow up.

Anish Bhatnagar: Sure, Meredith, you want to take that?

Sure Meredith soon but I'm happy to take that yes. So I think what we're pleased to see is that we're getting a spectrum across the patient population I mentioned that the majority of patients are coming in.

Meredith Manning: Yeah, I'm happy to take that. I think what we're pleased to see is that we're getting a spectrum across the patient population. I mentioned that the majority of patients are coming in, ages 4 to 26, but we're also really pleased that we've reached greater penetration in the younger adult, I'll say, even though up to 45. That population definitely has more comorbidities, if you will, as they get older. We're seeing a broad spectrum. We believe we'll see a broad spectrum as we move into 2026.

<unk> four to 26, but we're also really pleased that we've reached greater penetration and the younger adults I'll say, even now up to 45.

That population definitely has more karma <unk>, if you will as they get older.

But we're seeing a broad spectrum and so we continue to see a broad we believe we will see a broad spectrum as we move into 2026.

Operator: Okay, great. That's very helpful. Maybe just one in the product development or life cycle management questions, which is that, are you guys also thinking about maybe the next gen product follow the DCCR? If so, what sort of attribute you think that may you want to have?

Yale Jen: Okay, great. That's very helpful. Maybe just one in the product development or life cycle management questions, which is that, are you guys also thinking about maybe the next gen product follow the DCCR? If so, what sort of attribute you think that may you want to have?

Okay, Great. That's very helpful. Maybe just one in the product development lifecycle management questions.

Is that the.

You guys are also thinking about maybe the next gen product.

Following the CCR and <unk>.

If so what sort of.

Attributed to think that me.

You want to have.

Anish Bhatnagar: That's a good question, Yale. As you know, this, what we are doing is a once-a-day pill. There are limits to what you can do with regards to improving upon that. That said, we do have some internal programs on life cycle management, which I'm not able to discuss today, but we do hope to discuss later this year.

That's a good question Yale as you know what we are doing is the once a day pills. So there are limits to what you can do with regards to improving upon that that said, we do have some internal programs on lifecycle management, which I'm not able to discuss today, but we do hope to discuss later this year.

Operator: Oh, okay, maybe last question here. In terms of DCCR, the mechanism actions for GSD, could you elaborate a little bit more? Thanks.

Yale Jen: Oh, okay, maybe last question here. In terms of DCCR, the mechanism actions for GSD, could you elaborate a little bit more? Thanks.

Okay. Maybe last question here in terms of D. C. Our the mechanism of actions or GSP could you elaborate a little bit more.

Anish Bhatnagar: As you know, the critical problem in GSD is life-threatening hypoglycemia. We know that when you target certain channels in the beta cells of the pancreas, you can suppress the secretion of insulin, which means that you can elevate levels of glucose. The problem that occurs in GSD is that in order to keep glucose levels higher, these patients are required to take very regular feedings of cornstarch all day, including through the night. What is very desirable is to be able to elevate those blood glucose levels enough that they don't get hypoglycemic. There is actually interesting information and published data using the parent molecule, and we've spoken with KOLs who have tried it.

Yes, as you know the critical problem in GSD is life threatening hypoglycemia.

And we know that when you Chad when you target certain channels on the beta cells of the pancreas, you can suppress the secretion of insulin, which means that you can elevate levels of glucose.

So the problem that occurs in GSD is that in order to keep glucose higher. These patients are required to take very regular feeding the cornstarch all day, including through the night.

And what is very desirable is to be.

To be able to elevate those blood glucose levels enough that they don't get hypoglycemic. So there is actually interesting information and publish data using the parent molecule and we've spoken with Kols, who have tried it it works, but as we know in situations like CACI as well the side effect profile is such that it's.

Anish Bhatnagar: It works, but as we know, in situations like CHI as well, the side effect profile is such that it's difficult to tolerate. When we're looking at VYKAT XR, VCCR, and the low, stable levels that we will have in the blood, we expect a very different side effect profile and should have the ability to elevate levels of glucose very precisely.

Difficult to tolerate but when we're looking at <unk> XR, the CCR and the low stable level that we will have in the blood. We expect a very different side effect profile and should have the ability to elevated levels of glucose very precisely.

Operator: Okay, great. Thanks a lot, and again, congrats on the progress.

Yale Jen: Okay, great. Thanks a lot, and again, congrats on the progress.

Okay, great. Thanks, a lot and again congrats on the progress.

Hello, Chris.

Anish Bhatnagar: Thanks, Yale.

Thanks Neil.

Brian Ritchie: Your next question comes from the line of Derek Archila from Wells Fargo. Please go ahead.

Operator: Your next question comes from the line of Derek Archila from Wells Fargo. Please go ahead.

Your next question comes from the line of Eric Our Chilean from Wells Fargo. Please go ahead.

Derek Archila: Hey, good afternoon, and thanks for taking the questions. And Jim, congrats, wishing you well, and great working with you. Yeah, just two brief ones. I just wanted to clarify. On the seasonality component, you talked about kind of impact of price and kind of free drug rate, but, you know, how much of an impact do you expect in terms of the patient visits and scripts in Q1?

Hey, good afternoon, thanks for taking the questions and Jim Congrats wishing you well and great working with you. So.

Yeah, just two brief ones I just wanted to clarify so on the seasonality component.

You talked about kind of impact of price and kind of free drug right, but how much of an impact do you expect in terms of the patient visits and scripts in the first quarter.

Anish Bhatnagar: Meredith?

Meredith.

Meredith Manning: Yeah, I think what we were saying is that we're not really commenting on the Q1 numbers as of right now. With regard to seasonality and the gross to net, I think Jim talked about it. As you know, a lot of patients are coming in. What we didn't see, we launched in March 2023. Now we're going into January, where the copay will re-up for a lot of the commercial payment patients. As Jim mentioned, with Soleno One, we offer copay support for commercial patients, and we pay down to zero on the copay. That's a potential what we'll see in the gross to net.

Yeah, I think what we were saying is that we're not really commenting on the first quarter numbers as of right now, but with regard to seasonality in the gross to net I think Jim talked about it as you know a lot of <unk>.

Patients are coming in so what we didn't see we launched in March of last year now we're going into January where the co pay will re up.

There are a lot of the commercial pay.

And so.

As Jim mentioned with Solana, one we offer.

Offer co pay support for commercial patients and we pay down to zero on the co pay so that's one.

Potential.

What we'll see in the gross to net.

Derek Archila: Yeah, let me ask this a different way. I guess for typical Prader-Willi patients, do they tend to have, you know, seasonality in terms of their patient visits with their physicians?

Yeah, Let me ask this a different way so I guess for typical greater Willi patients do they tend to have.

And Ali in terms of their patient visits with their physicians.

Anish Bhatnagar: Derek, I think, again, I'll point you back to the fact that we're launching the first hyperphagia drug in this space, and we're learning as we go. What we know about visits that patients have, based on claims data, is that the younger patient population, which is a 4 to 26-year-old age group, has about 4 to 6 touch points with healthcare providers over the year. What we know from conversations with KOLs, people who run these top 300 practices or, you know, top 10 practices, is that their practices are pretty crowded, and you schedule your appointments a year out or more. The visits do happen, and there is this particular cadence of visits. Whether it's different in Q1 or not, we'll find out.

So Derek I think again I'll point, you back to the fact that we are launching the first hyperphagia a drug in this space and we're learning as we go what we know about visits that patients have based on claims data is that the younger patient population, which is a 402006 year old age group has about four to six.

Touch points with health care providers over the year.

What we know from conversations with Kols people, who run these top 300 practices or top 10 practices is that their practices are pretty crowded and youre scheduled appointments a year out or more so the visits do happen and there is this particular cadence of visits whether it's different in the first quarter or not.

We'll find out.

Derek Archila: Got it. Just to follow up, just wanted to know in terms of inventory and stocking in Q4, if there's any comments there. Thanks. Jim?

Got it and then just a follow up just wanted to know in terms of inventory and stocking and <unk>. If there is any comments there. Thanks.

Okay.

James MacInnis: Yeah, we work with PANTHERx Rare, you know, one specialty pharmacy. You know, they just went through the holiday period. We'll have to sort of be able to do a deep dive to really understand anything. Nothing untoward that we're aware of.

Jim Mackaness: Yeah, we work with PANTHERx Rare, you know, one specialty pharmacy. You know, they just went through the holiday period. We'll have to sort of be able to do a deep dive to really understand anything. Nothing untoward that we're aware of.

Yes, we were Panthers, you know one specialty pharmacy.

They just went through the holiday period.

We'll have to sort of do a deep dive to really understand anything but nothing untoward that we're aware of.

Derek Archila: Got it. Excellent. Thanks, guys.

Got it excellent thanks, guys.

Anish Bhatnagar: Thanks, Derek.

Thanks Derek.

Brian Ritchie: Your next question comes from the line of Kalpit Patel from Wolfe Research. Please go ahead.

Your next question comes from the line of coffee at all from Wolfe Research. Please go ahead.

Kalpit Patel: Hey, thank you for taking our question. Just on the active patients, number that you gave, the growth in quarter-over-quarter is not keeping pace with the growth in new patient start forms. Is that mainly driven by insurance-related delays, or is that more of a function of the discontinuation rate, or is it a mix of both factors? How should we think about this gap moving forward?

Hey, Thank you for taking our question just on the active patient number that you gave the growth in quarter.

Quarter over quarter is not keeping pace with the growth in new patients start forms is that mainly driven by insurance related delays or is that more of a function of the discontinuation rate or is it a mix of both factors and how should we think about this gap.

Sure.

Anish Bhatnagar: I think a very important consideration is the time it takes for benefits assessment. When we get a start form, you don't instantly start someone on drug, so they go into a benefits assessment time, which, you know, will take 30-ish days, give or take. We don't think there's any issues with reimbursement that have been encountered that are significant. There will always be a lag between the number of new patient start forms and the number of patients who will be active for that quarter. Meredith, anything to add to that?

I think a very important consideration is the time it takes for benefits assessment. So when we get a start form you don't instantly start somewhere on drug. So they go into a benefits assessment time, which will take 30 ish days give or take and we don't think there's any issues with reimbursement there have been encountered.

Our significant and there will always be a lag between the number of new patients start forms and the number of patients who will be active for that quarter. So meredith anything to add to that.

Meredith Manning: No, I think that was a perfect answer. I think that we're looking at a little bit of a mix of all of the above, but we're pleased with, as I mentioned, the ability to convert start forms into patients and reimburse claims. We're gonna continue to do that and double down on that in 2026 and believe that we'll be very successful.

No I think that was perfect answer I think that we're looking at.

Bit of a mix of all of the above but we're pleased with as I mentioned the ability to convert start forms into.

Patients and reimburse claims so we're going to continue to do that and double down on that in 2026 and believe that will be very successful.

Kalpit Patel: Got it. One more on our end. I know you mentioned the long-term discontinuation rate, do you forecast the discontinuation rate meaningfully fluctuating between now and the end of the year? How might that affect the active patient growth in 2026? Thank you.

Got it and one more on our end.

I know you mentioned the long term discontinuation rate.

But do you forecast the discontinuation rate, meaning meaningfully fluctuating between now and the ended the year and how might that affect the active patient growth in 2026.

Okay.

Anish Bhatnagar: Good question. We have to see. I mean, what we have seen so far, I think, is very acceptable for a drug that's treating such a significantly comorbid condition. If we remain in this zone of 15 to 20, thereabout, I think that's a really good outcome. It's difficult for us to predict if it changes between now and the end of the year. I'm sure it'll go up and down, or it'll fluctuate, but I don't see a reason why there would be major changes during the year. Not sure if that answers your question.

Good question I mean, we have to see I mean, what we have seen so far I think is very acceptable for a drug that's treating such a significantly comorbid conditions.

So if we remain in this zone of 15 to 20 thereabouts.

I think thats, a really good outcome, it's difficult for us to predict if it changes between now and the end of the year I am sure. It will go up and down it will fluctuate, but I don't see a reason why they would be major changes during the year.

I'm not sure of that answer that question.

Kalpit Patel: Yeah, that answers it. Thank you. Congrats, Jim, on the retirement.

Yes that answers it thank you and congrats Jim on the retirement.

James MacInnis: Thank you.

Jim Mackaness: Thank you.

Thank you.

Brian Ritchie: Ladies and gentlemen, as a reminder, if you would like to ask a question, please press Star followed by the number one on your touch-tone phone. If you are using a speakerphone, please make sure to lift your handsets before pressing any case. Your next question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead.

Ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star followed by the number one on your Touchtone phone and if you are using a speaker phone. Please make sure to lift your handset before pressing any case.

Your next question comes from the line of Gram Silver Jorge from H C. Wainwright. Please go ahead.

Ram Selvaraju: Thanks so much for taking our questions. I just wanted to ask about whether you are evaluating other disease indications in which to explore VYKAT XR beyond Glycogen storage disease, and if so, what some of these indications might be. If, for example, there's any plan to potentially revisit the utility of the drug in Smith-Magenis syndrome, or other conditions of that ilk. Secondly, I just wanted to clarify whether you anticipate any potential pricing flexibility impact if you were to launch the drug yourself in Europe or through a partner, if there might potentially be any spillover to the US pricing paradigm, or if ultimately this is a non-factor, given the rarity of Prader-Willi syndrome.

Thanks, so much for taking our questions I just wanted to ask about whether you are evaluating other disease indications in which to explore <unk> XR beyond glycogen storage disease and if so what some of these indications might be if for example, there's any plan to potentially revisit the utility of the drug in Smith <unk>.

Syndrome or other conditions of that Bill Secondly, I just wanted to clarify whether you anticipate any potential pricing flexibility impact.

If you were to launch the drug yourself in Europe or through a partner.

If there might potentially be any spillover to the U S pricing paradigm or if ultimately this is a non factor given the rarity of product Willi syndrome, and lastly, I don't know if you can comment on any underlying dynamics with respect to the discontinuation rates that we're seeing if it's plateauing. If you are seeing any evidence.

Ram Selvaraju: Lastly, I don't know if you can comment on any underlying dynamics with respect to the discontinuation rate that you're seeing, if it's plateauing, if you are seeing any evidence that it is in fact declining as there is more experience with the drug over time in the PWS population, or if you're seeing the actual percentage rate increase. If it is increasing, by how much? Thank you.

That it is in fact declining as there is more experience with the drug over time and the PWM population.

Or if you are seeing the actual percentage rate increase and if it is increasing by how much. Thank you.

Yes.

Anish Bhatnagar: Lots of questions, Ram. Okay, I think I got those. The first one is other indications. What we've said in the past, just to remind you, is that there's two categories of rare diseases that we think DCCR could be useful. One is conditions like PWS, where things like hyperphagia and food-related behaviors are a problem. You're right, Smith-Magenis syndrome is one of them. You know, Fragile X, about 10% of Fragile X has a PWS phenotype. Some patients with Angelman have it. There's SIM1 obesity. There's various other indications where we definitely continue to think that it could be useful, and we are continuing to evaluate it. In terms of the pricing impact of self-launch versus not, I think the challenge right now is that it's a moving target.

Two questions.

Yes.

I think I think I got those so the first one is other indications.

Well, we have said in the past just to remind you is that there is two categories of rare diseases that we think <unk> could be useful one as conditions like gws, where things like hyperphagia and food related behaviors are a problem. You arrived Smith <unk> syndrome is one of them fragile X about 10% of fragile X.

PWM phenotype, some patients with Angelman have at their same one obesity. So there is various other indications where we definitely continue to think that it could be useful and we are continuing to evaluate it.

In terms of the pricing impact of self launch versus not.

I think the challenge right now is that it's a moving target I think if we had to make a decision today. It would probably say that pricing flexibility is optimal if we control it both here as well as in Europe or outside the country.

Anish Bhatnagar: I think if we had to make a decision today, it would probably say that pricing flexibility is optimal if we control it, both here as well as in Europe or outside the country. I'm not sure that it's a non-factor due to the rarity, because even though there has been some conversation about an orphan exclusion in MFN, we haven't seen that actually become reality yet. In terms of the discontinuation rates and are they plateauing? The one phenomenon that we're following very closely is to see if the cadence of discontinuations is going to be like what we saw in the clinical trials. Which is to say that if you stay on drug, you know, through titration and some period of time after, you are very likely to stay on drug.

I am not sure that it's a non factor due to the rarity because even though there has been some conversation about an orphan exclusion and MSN.

We haven't seen that actually becomes reality yet.

In terms of the discontinuation rates and are they plateauing. The one phenomenon that we're following very closely is to see if the cadence of discontinuation is going to be like what we saw in the clinical trials, which is to say that if you stay on drug through titration in some period of time. After you are very likely to stay on drug and I would see.

Anish Bhatnagar: I would say that the early indicators are that that is indeed the case. We think that's very encouraging, but it's something that we're following very carefully, and we'll continue to update you all.

The early indicators are that that is indeed the case. So we think that's very encouraging but it's something that we are following very carefully and we will continue to update you on.

Okay.

David Brown: Thank you very much.

Ram Selvaraju: Thank you very much.

Thank you very much.

Brian Ritchie: Thank you. We have no further questions at this time. I'm going to turn the call over back to Anish Bhatnagar for closing comments. Sir, please go ahead.

Operator: Thank you. We have no further questions at this time. I'm going to turn the call over back to Anish Bhatnagar for closing comments. Sir, please go ahead.

Thank you we have no further questions at this time, so I'm going to turn the call over back to initial but Nagar for closing comments. Sir. Please go ahead.

Anish Bhatnagar: Well, thank you all for dialing in today, and we look forward to continuing the conversation with you all. Have a good evening.

Well. Thank you all for dialing in today and we look forward to continuing the conversation with you all have a good evening.

Brian Ritchie: Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.

Ladies and gentlemen. This concludes today's conference call. Thank you very much for your participation you may now disconnect.

Okay.

Yeah.

Q4 2025 Soleno Therapeutics Inc Earnings Call

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