Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAnish Bhatnagar - Chairman and CEOBrian Ritchie - Managing DirectorBrian Skorney - Managing Director of BiotechnologyJim Mackaness - CFOKhalil Fenina - Equity Research Associate of BiotechnologyMeredith Manning - Chief Commercial OfficerMoritz Reiterer - Biotechnology Equity Research AssociateShannon Duffy - Biotech Equity Research AssociateConference Call ParticipantsDerek Archila - Managing Director ...

Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAnish Bhatnagar - Chairman and CEOBrian Ritchie - Managing DirectorBrian Skorney - Managing Director of BiotechnologyJim Mackaness - CFOKhalil Fenina - Equity Research Associate of BiotechnologyMeredith Manning - Chief Commercial OfficerMoritz Reiterer - Biotechnology Equity Research AssociateRam Selvaraju - Managing Director of Healthcare Equity ResearchShannon Duffy - Biotech Equity Research Associa ...

Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Speaker1Good afternoon, thank you for standing by. Welcome to Soleno Therapeutics' fourth quarter 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. ...

Core Viewpoint - Soleno Therapeutics (NASDAQ:SLNO) is identified as a promising biotechnology stock with significant upside potential, supported by positive analyst ratings and strong sales performance. Group 1: Analyst Ratings and Price Targets - Ram Selvaraju from H.C. Wainwright increased the price target for Soleno Therapeutics from $110 to $120, indicating an upside potential of nearly 211% and reaffirming a Buy rating [1] - Wells Fargo analyst Derek Archila maintained an Overweight rating and raised the price target from $106 to $114, suggesting a revised upside potential of 195% [3] Group 2: Financial Performance and Product Development - The fourth-quarter earnings for Vykat extended-release exceeded expectations, although new PSFs did not meet targets; management aims for approximately 250 new starts per quarter, excluding seasonal effects [4] - Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases, with its leading product being Diazoxide Choline Extended-Release tablets, VYKAT XR, which began commercialization in April 2025 following FDA approval [5]

Core Viewpoint - Soleno Therapeutics is currently not providing full-year guidance as it seeks to better understand its business dynamics, but management indicates that guidance may be offered in the future when more comfortable with the data [1] Group 1: Company Overview - Soleno Therapeutics is a commercial-stage company focused on rare diseases, specifically with an approved product for Prader-Willi syndrome (PWS), which is characterized by hyperphagia [3][18] - The company has been marketing its product for approximately three quarters [3] Group 2: Launch and Market Dynamics - The company expects to capture about 10% of the total addressable market (TAM), translating to approximately 1,000 start forms over a 9 to 12-month period, with variability from quarter to quarter [2][6] - The first-quarter report will be the last to disclose start-form metrics, after which the focus will shift to revenue and active patient reporting [2][6] Group 3: Reimbursement and Coverage - Reimbursement has exceeded expectations, with coverage through nearly 48 Medicaid programs and Medicare being a strong payer [5][14] - The prescriber base has grown to over 600, although many prescribers are new to PWS and require education on the drug [15] Group 4: Patient Conversion and Revenue - Start forms typically convert to active patients within 30 to 45 days, with a single-digit cancellation rate and overall discontinuation around 15% to 20% [6][8] - Revenue is primarily driven by active paid patients, adherence, wholesale acquisition cost (WAC), and gross-to-net dynamics [8] Group 5: International Regulatory Progress - The company is progressing with its European regulatory review, expecting Day 180 questions by the end of February for a patient pool of approximately 9,500 in the EU4 plus the UK [5][16] - Soleno is building its European team and is considering direct market engagement while also exploring partnerships [16] Group 6: Future Plans and Capital Deployment - Capital deployment priorities include supporting U.S. and international launches, pursuing additional indications for its product, and evaluating inorganic growth opportunities, though significant deals are not anticipated in the short term [17]

Summary of Soleno Therapeutics Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM:SLNO) - **Industry**: Rare Disease Biopharmaceuticals - **Product**: First approved treatment for Prader-Willi syndrome (PWS), a genetic disorder characterized by hyperphagia, with no prior treatments available [5][38] Key Points and Arguments Market Position and Growth Expectations - Soleno currently holds approximately **10%** of the total addressable market (TAM) with a target of reaching another **10%** over the next **9-12 months**, equating to about **250 Start Forms** per quarter [7][12] - The company anticipates moving from Start Forms to traditional metrics of revenue and active patients after the first quarter of 2026 [10] - The expectation is that the holiday variability seen in the previous quarter will not recur, as there are no major holidays in the current quarter [8] Patient Flow and Revenue Generation - The process for Start Forms involves a **30-45 day** assessment period through their specialty pharmacy partner, Panther, with a small percentage of forms being canceled [14] - The discontinuation rate for patients is expected to stabilize between **15%-20%**, which is considered healthy for a rare disease context [15][24] - Active patient revenue is driven by a combination of paid and free patients, with adherence impacting overall revenue [17][18] Financial Guidance and Revenue Trends - Soleno is not providing full-year guidance for 2026 as the business is still maturing [11] - The company expects a **seasonal increase** in Gross to Net discounts in the first quarter due to resets in copay and potential changes in patient coverage [20][21] - The overall discontinuation rate as of the fourth quarter was approximately **15%**, with **12%** being adverse event-related [23] Clinical and Market Insights - Adverse events (AEs) reported in the real-world setting are consistent with those observed in clinical trials, primarily non-serious [26] - Most patients are titrating to their prescribed doses, with a few exceptions due to comorbidities [27][28] - The average wholesale acquisition cost (WAC) is currently in the **$500,000s**, with expectations of gradual increases over the next few years [31][32] Market Expansion and Reimbursement - Soleno has coverage for approximately **185 million lives**, with expectations for this number to increase as reimbursement policies improve [42] - The company is experiencing a favorable reimbursement environment, with no significant issues reported regarding prior authorizations [44] - There is a growing number of prescribers, with over **600** currently, which exceeds initial expectations [41] International Opportunities - The company is preparing for potential CHMP approval in Europe, with an estimated patient population of **9,500** in the EU and UK [47] - Soleno is considering launching the product independently in Europe while also exploring partnership opportunities [49] Capital Deployment Strategy - Soleno plans to focus on sustaining the success of its launch and exploring other indications, while also considering inorganic growth opportunities [50] Additional Important Insights - The company acknowledges the challenges of educating prescribers unfamiliar with PWS and the drug, which is crucial for improving treatment outcomes [45] - There is a noted social aspect influencing patient adherence and return to treatment, as positive patient experiences are shared within the community [34] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting Soleno Therapeutics' current market position, growth expectations, and operational strategies in the rare disease sector.

Core Viewpoint - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is identified as a promising investment opportunity with significant upside potential, supported by recent positive financial results and analyst upgrades [1][2][3]. Financial Performance - Soleno Therapeutics announced preliminary unaudited full-year 2025 net revenue for its VYKAT XR offering, exceeding estimates by $16.5 million to $18.5 million [2] - The anticipated preliminary fourth-quarter 2025 net revenue is projected to be between $90 million and $92 million, significantly higher than the analyst guidance of $73.8 million [2]. Analyst Ratings and Price Targets - H.C. Wainwright raised the price target for Soleno Therapeutics to $120 from $110, indicating an upside potential of 177% [1] - Wells Fargo also increased its price target to $114 from $106 and maintained an Overweight rating, citing the strong fourth-quarter revenue performance [3]. Company Overview - Soleno Therapeutics is a California-based clinical-stage biopharmaceutical company founded in 1999, specializing in novel therapeutics for serious illnesses, including Diazoxide Choline Extended-Release tablets [4].

Core Insights - Soleno Therapeutics has reported strong preliminary financial results for Q4 and full-year 2025, driven by the successful launch of VYKAT XR for treating Prader-Willi syndrome (PWS) [1][5] - The company has achieved significant market penetration, with over 10% of the addressable U.S. PWS patient population having initiated treatment with VYKAT XR within nine months of its launch [1][5] - Soleno is well-funded with approximately $500 million in cash and equivalents at year-end 2025, and has achieved profitability and positive cash flow [5] Financial Performance - Preliminary unaudited net revenue for full-year 2025 from U.S. sales of VYKAT XR is expected to be between $189 million and $191 million [5] - Preliminary unaudited net revenue for Q4 2025 is anticipated to be between $90 million and $92 million [5] - The company reported a total of 1,250 new patient start forms since the launch, with 207 forms submitted in Q4 2025 [5] Market and Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in patients aged 4 years and older with PWS [4][6] - The discontinuation rate of VYKAT XR due to adverse events was approximately 12% by the end of Q4 2025 [5] - The product has been prescribed by 630 unique prescribers, including 136 new prescribers in Q4 2025 [5] Patient Demographics and Impact - The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, highlighting the significant unmet medical need for effective treatments [3] - Hyperphagia, the defining symptom of PWS, poses serious health risks, including mortality and long-term co-morbidities such as diabetes and obesity [3]

Group 1 - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is recognized by Wall Street analysts as one of the stocks expected to bounce back, with LifeSci Capital reiterating a Buy rating and a price target of $110 [1] - Piper Sandler has identified Soleno Therapeutics as a commercial-stage biotech company poised for transformational growth in 2026, following insights gained from discussions at a Healthcare Conference [2][3] - The company has a solid plan for drug launches and progress, which has led to improved confidence from analysts [3] Group 2 - On January 5, Soleno Therapeutics announced pivotal study results for VYKAT XR, published in the Journal of Clinical Endocrinology and Metabolism, which established the drug's efficacy and safety [4] - The study supports VYKAT XR's approval by the FDA as the first and only treatment for hyperphagia in individuals with Prader-Willi syndrome [4] - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, indicating a specialized market approach [5]

Core Insights - Soleno Therapeutics has achieved profitability for the first time, coinciding with a significant investment from Braidwell, which acquired 1.3 million shares valued at approximately $86.7 million [1][2][6] Company Overview - Soleno Therapeutics specializes in developing therapeutics for rare diseases, with its lead product candidate being Diazoxide Choline Controlled-Release for Prader-Willi Syndrome [5] - As of the latest report, Soleno's market capitalization stands at $2.7 billion, with a trailing twelve months (TTM) revenue of $98.7 million and a net income of ($78.5 million) [4] Financial Performance - In the third quarter, Soleno reported $66 million in product revenue, more than doubling from the previous quarter, and achieved a net income of $26 million, marking its first profitable quarter [7] - The company ended the quarter with $556.1 million in cash and securities, supported by a $230 million equity offering [7] Investment Insights - Braidwell's new position in Soleno represents 3.5% of its reportable U.S. equity assets, indicating confidence in Soleno's transition from a clinical-stage to a commercial-stage company [2][9] - Despite recent gains, Soleno's shares remain down 90% from 2015 levels, highlighting the ongoing risk profile associated with the investment [9]