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Soleno Therapeutics Inc (SLNO)
NASDAQ:SLNO
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Soleno Therapeutics
(NASDAQ:SLNO)
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Rating:66Neutral
Price Target:
$36.00
▲(9.76% Upside)
Action:ReiteratedDate:03/17/26
The score is driven primarily by the sharp 2025 financial inflection (revenue scale, profitability, positive free cash flow) and positive earnings-call momentum on launch execution and liquidity. These strengths are tempered by weak technicals (price below key moving averages with negative MACD) and a high P/E with no dividend support, which increases sensitivity to any slowdown or regulatory/commercial setbacks.
Positive Factors
2025 financial inflection
The company achieved a durable operational inflection in 2025: substantial revenue scale, full‑year profitability and free cash flow roughly matching net income. That combination improves earnings quality, supports reinvestment and reduces reliance on external financing over the next 2–6 months.
Very strong balance sheet
Exceptionally low leverage and a large cash/asset base provide flexibility to fund continued U.S. launch, EU activities and pipeline work without meaningful refinancing risk. This capital buffer materially lowers short- to medium-term solvency and execution risk for commercialization and R&D.
Successful commercial launch and coverage
Early adoption metrics and broad payer coverage indicate durable market access and distribution strength. A sizeable base of prescribers and reimbursed claims across Medicaid programs supports steady patient uptake and repeat dosing, underpinning sustainable revenue growth as launch scales.
Negative Factors
EU regulatory uncertainty
Regulatory uncertainty in the EU is a structural risk to international revenue diversification and patient access. A delayed or negative EMA outcome would constrain geographic expansion, slow incremental top‑line growth and complicate long‑term commercial planning outside the U.S.
Rising COGS pressure
Margins may compress as pre‑approval inventory (expensed at zero cost) is replaced by at‑cost production. A structural increase in COGS percent reduces free cash flow margins and makes profitability more sensitive to volume and pricing, affecting multi‑period margin sustainability.
Sustained elevated SG&A
Ongoing high commercial spend to support launch sustains elevated SG&A, which can cap near‑term operating leverage. If revenue growth moderates or unit economics worsen, persistent SG&A creates structural pressure on margins and free cash flow conversion over the next several quarters.
Soleno Therapeutics (SLNO) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.69B
Dividend YieldN/A
Average Volume (3M)1.49M
Price to Earnings (P/E)117.9
Beta (1Y)0.50
Revenue GrowthN/A
EPS Growth44.84%
CountryUS
Employees115
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)0.80
Shares Outstanding51,624,386
10 Day Avg. Volume1,705,929
30 Day Avg. Volume1,493,100
Financial Highlights & Ratios
PEG Ratio-1.08
Price to Book (P/B)5.47
Price to Sales (P/S)12.93
P/FCF Ratio52.69
Enterprise Value/Market Cap1.01
Enterprise Value/Revenue9.00
Enterprise Value/Gross Profit9.12
Enterprise Value/Ebitda60.34
Forecast
1Y Price Target
$101.09Price Target Upside208.20% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
EPS Forecast (FY)4.04
Revenue Forecast (FY)$478.71M
Soleno Therapeutics Business Overview & Revenue Model
Company DescriptionSoleno Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutics for the treatment of rare diseases. Its lead candidate is Diazoxide Choline Controlled-Release, a once-daily oral tablet for the treatment of Prader-Willi Syndrome, which is being evaluated in an ongoing Phase III clinical development program. The company was formerly known as Capnia, Inc. and changed its name to Soleno Therapeutics, Inc. in May 2017. Soleno Therapeutics, Inc. was incorporated in 1999 and is based in Redwood City, California.
How the Company Makes Moneynull
Soleno Therapeutics Earnings Call Summary
Earnings Call Date:Feb 25, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 12, 2026
Earnings Call Sentiment Positive
The call communicated a strong commercial launch and material financial progress — meaningful sequential revenue growth (~40% Q/Q), positive operating cash flow and full-year profitability — alongside encouraging commercial metrics (1,250 start forms, 859 active patients, 630 prescribers and coverage of >180M lives). Key near-term risks flagged include EU regulatory uncertainty, anticipated increases in COGS as inventory normalizes, seasonality-driven Q1 gross-to-net effects, elevated SG&A for continued launch investment, and an expected long-term discontinuation range of 15%–20%. On balance, the positive financial and commercial momentum and ample cash runway outweigh the outlined challenges.Q4-2025 Updates
Positive Updates
Strong Revenue Growth and Profitability
Q4 net revenue of $91.7M, representing sequential growth of nearly 40% from $66.0M in Q3; full-year 2025 net revenue of $190.4M (note: <9 months of commercial sales). Achieved profitability with full-year net income of $20.9M and Q4 net income of ~$43.4M compared to a net loss in the prior-year periods.
Robust Cash Generation and Balance Sheet
Generated $48.7M of cash from operating activities in Q4 and ended the year with $506.1M of cash, cash equivalents and marketable securities (after a $100M accelerated share repurchase), providing strong capital to support U.S. launch, EU activities and new indications.
Successful Commercial Launch Metrics
Since launch through Dec 31, 2025: 1,250 patient start forms (≈12.5% of the U.S. addressable market) and 859 active patients on treatment (up from 764 at end of Q3, a ~12.4% increase quarter-over-quarter). Added 136 new prescribers in Q4 to reach 630 unique prescribers.
Broad Payer Coverage
Secured coverage across commercial, Medicaid and Medicare channels covering over 180 million lives at the end of Q4, and reimbursed claims from ~45 state Medicaid programs through Q4, supporting rapid access and reauthorization success.
Real-World Safety and Adherence
Real-world safety profile mirrors clinical expectations; launch-to-date discontinuation related to adverse events ~12% and total discontinuation ~15%, consistent with management’s long-term expectation of 15%–20%. High adherence observed as patients settle into optimal doses.
Pipeline Expansion Plans — EU and GSD1
EMA MAA validated; Day 120 questions answered and Day 180 questions expected by end of Feb; decision anticipated mid-2026. Pursuing glycogen storage disease type 1 (GSD1) with orphan designation in U.S. and EU, IND planned in H1 2026 and trial initiation later in 2026.
Negative Updates
EU Regulatory Uncertainty
EMA questions focus on adequacy of efficacy data derived primarily from a randomized withdrawal study; Day 180 questions imminent and decision uncertain — EU approval remains unresolved and could impact near-term international expansion plans.
Seasonal and Gross-to-Net Headwinds in Q1
Potential Q1 seasonality: co-pay resets and plan churn can increase gross-to-net discounts (Soleno ONE reimburses co-pays, increasing discounts) and cause temporary free-drug periods when patients change plans, which may depress reported Q1 revenue despite underlying patient growth.
Rising Commercial Spend and Ongoing Launch Costs
Full-year SG&A increased to $132.1M from $105.9M prior year (+~24.7%) reflecting launch investments; Q4 SG&A $40.9M (includes $8.7M stock comp). Continued commercialization investment will sustain elevated SG&A in the near term.
Cost of Goods Sold to Increase as Inventory Turns
COGS was low ($0.9M in Q4; $2.7M full year) due to pre-approval inventory expensed to R&D at $0 cost; management expects COGS as a % of revenue to rise (anticipate mid-single-digit gross cost levels) as zero-cost inventory is depleted and replaced with at-cost inventory.
Discontinuation and Adherence Uncertainty
Launch-to-date AE-related discontinuation (~12%) and total discontinuation (~15%) are meaningful; management expects long-term 15%–20% discontinuation. While current signals are acceptable, sustained adherence and future discontinuation trends remain a risk to penetration forecasts.
Visibility Changes to KPIs
Company intends to share certain KPIs (patient start forms, unique prescribers, lives covered) through Q1 2026 and then retire these metrics, which could reduce granularity/visibility for investors on ongoing launch performance after that point.
Company Guidance
Management guided to a strong ongoing launch: Q4 net revenue was $91.7M (nearly 40% sequential growth from $66M), full‑year revenue $190.4M (from <9 months of sales), Q4 cash from operations $48.7M, full‑year net income $20.9M, and year‑end cash, cash equivalents and marketable securities of $506.1M (after a $100M accelerated share repurchase). Commercial KPIs through 12/31 included 1,250 patient start forms (~12.5% of the U.S. addressable market), 859 active patients (up from 764 in Q3), 630 unique prescribers (136 added in Q4), coverage for >180 million lives and reimbursed claims from ~45 state Medicaid programs; they expect to capture ~1,000 additional start forms over the next 9–12 months. Safety and retention guidance: launch‑to‑date AE‑related discontinuation ≈12%, total discontinuation ≈15%, and an anticipated long‑term discontinuation rate of 15–20%. Financial and operational notes: Q4 COGS $0.9M (FY $2.7M) with COGS% expected to rise as zero‑cost inventory depletes; Q4 R&D $9.6M (FY $40.6M), Q4 SG&A $40.9M (FY $132.1M); Net income per share Q4 ~$0.82 basic/$0.80 diluted and FY $0.40 basic/$0.39 diluted. Regulatory and pipeline milestones: EMA Day‑180 questions expected end of Feb with a mid‑2026 EU decision window (UK/EU PWS population ~9,500), six Orange Book patents listed (four longest to 2035 with potential extension into the late‑2030s), and GSD‑1 plans (prevalence ~1/100,000 → >7,000 globally, 3–4k in U.S.), with an IND planned in H1 2026 and a clinical program to start later in 2026; the company will share 12‑month KPI updates on the Q1 2026 call and intends to retire those metrics then.Soleno Therapeutics Financial Statement Overview
Summary
Strong 2025 inflection with meaningful revenue ($190.4M), profitability (net income $20.9M), and positive free cash flow (~$46.7M) plus an exceptionally low-debt balance sheet. The main constraint is limited multi-year proof of durable profitability and prior years of heavy losses and cash burn, making results appear early and potentially volatile.Income Statement
The company shows a major inflection in 2025, with revenue rising to $190.4M and turning profitable (net income $20.9M, ~11.0% net margin; EBITDA margin ~4.9%). This is a sharp improvement versus 2020–2024, when revenue was effectively zero and losses were sizable (e.g., 2024 net loss of $175.9M). Key weakness is limited multi-year evidence of sustainable commercial profitability given the very recent revenue ramp and historically loss-making profile.70
Positive
Balance Sheet
Balance sheet strength is a clear positive: very low leverage in 2025 with total debt of ~$2.7M against ~$450.1M of equity (debt-to-equity ~0.006), and a much larger asset base (~$563.8M). Return on equity turned positive in 2025 (~4.6%) after deeply negative levels in prior years (notably 2024), highlighting improving economics. Main watch-out is the volatility in profitability across years, which can pressure equity over time if losses re-emerge.86
Very Positive
Cash Flow
Cash generation improved meaningfully in 2025 with operating cash flow of ~$46.8M and free cash flow of ~$46.7M, roughly matching reported net income (free cash flow to net income ~1.0), which supports earnings quality. However, cash flow was negative and cash-consuming in 2020–2024, and 2025 free cash flow growth is sharply negative versus the prior period in the dataset, indicating volatility and potential lumpiness as the business transitions.64
Positive
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Mar 2022 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 190.41M | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 187.71M | 0.00 | -1.96M | 0.00 | 0.00 |
| EBITDA | 28.38M | -173.63M | -37.03M | -22.10M | -30.30M |
| Net Income | 20.89M | -175.85M | -38.99M | -24.07M | -30.91M |
Balance Sheet | |||||
| Total Assets | 563.83M | 330.97M | 180.69M | 26.50M | 35.55M |
| Cash, Cash Equivalents and Short-Term Investments | 305.47M | 291.44M | 169.68M | 14.60M | 21.30M |
| Total Debt | 2.69M | 52.83M | 403.00K | 155.00K | 457.00K |
| Total Liabilities | 113.72M | 85.86M | 23.18M | 16.15M | 17.76M |
| Stockholders Equity | 450.12M | 245.11M | 157.51M | 10.35M | 17.79M |
Cash Flow | |||||
| Free Cash Flow | 46.73M | -69.31M | -24.94M | -20.79M | -27.79M |
| Operating Cash Flow | 46.80M | -69.10M | -24.94M | -20.78M | -27.77M |
| Investing Cash Flow | -201.78M | -225.68M | 0.00 | -13.00K | -22.00K |
| Financing Cash Flow | 137.16M | 213.03M | 180.02M | 14.09M | -128.00K |
Soleno Therapeutics Technical Analysis
Negative
32.80
Price Trends
40.23
Negative
45.95
Negative
59.76
Negative
Market Momentum
-1.83
Positive
30.80
Neutral
7.45
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SLNO, the sentiment is Negative. The current price of 32.8 is below the 20-day moving average (MA) of 37.93, below the 50-day MA of 40.23, and below the 200-day MA of 59.76, indicating a bearish trend. The MACD of -1.83 indicates Positive momentum. The RSI at 30.80 is Neutral, neither overbought nor oversold. The STOCH value of 7.45 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for SLNO.
Soleno Therapeutics Risk Analysis
Soleno Therapeutics disclosed 64 risk factors in its most recent earnings report. Soleno Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Soleno Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
SLNO
Soleno Therapeutics
32.80
-15.98
-32.76%
ADMA
ADMA Biologics
14.87
-5.74
-27.85%
KRYS
Krystal Biotech
250.83
61.65
32.59%
Soleno Therapeutics Corporate Events
Business Operations and StrategyRegulatory Filings and Compliance
Soleno Therapeutics Updates Bylaws, Tightens Governance Framework
Positive
Mar 16, 2026
On March 16, 2026, Soleno Therapeutics’ Board of Directors approved amended and restated bylaws, acting on recommendations from its Nominating and Corporate Governance Committee. The changes update advance notice requirements for shareholder proposals and director nominations, incorporate recent Delaware law developments, refine governance practices, add a forum selection clause, and make technical clarifications, signaling a tightening of the company’s corporate governance framework and shareholder engagement protocols.
These bylaw revisions could streamline how shareholder business is brought before the company, reduce legal uncertainty, and concentrate dispute resolution in specified courts. For investors and other stakeholders, the move suggests an effort to modernize Soleno’s governance structure, potentially improving predictability in corporate processes while also shaping how activist or dissident shareholders can interact with the company in future proxy seasons.
The most recent analyst rating on (SLNO) stock is a Hold with a $37.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Announces New Chief Financial Officer Appointment
Positive
Feb 26, 2026
On its February 25, 2026 earnings call, Soleno announced that veteran pharmaceutical finance executive Jennifer Fulk will become chief financial officer on March 2, 2026, succeeding long-time CFO James Mackaness, who plans to retire by the end of March. Fulk’s compensation package includes a $525,000 base salary, performance-based bonus eligibility, and equity grants, underscoring her strategic role as Soleno scales its rare-disease franchise.
Mackaness will remain with the company as an at-will employee until March 31, 2026 and then as a consultant through year-end, providing continuity in financial leadership as Soleno navigates its commercial expansion and ongoing capital markets engagement. The leadership transition pairs Fulk’s extensive experience at Eli Lilly, Talkspace and 120Water with Soleno’s growth trajectory following the U.S. launch of VYKAT XR, aiming to support operational efficiency and long-term value creation for stakeholders.
The most recent analyst rating on (SLNO) stock is a Buy with a $85.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Updates Executive Compensation and Severance Plans
Positive
Jan 23, 2026
On January 21, 2026, Soleno Therapeutics’ board, following a review by its independent compensation consultant and Compensation Committee, approved higher base salaries for fiscal 2026, cash bonuses for fiscal 2025, and new stock option and restricted stock unit grants for its named executive officers, with CEO Anish Bhatnagar, CFO James Mackaness, CCO Meredith Manning and SVP of Regulatory Affairs Patricia Hirano all receiving increased pay and equity awards that vest over time. On the same date, the board also adopted a Key Executive Change in Control and Severance Plan covering vice presidents and above, including the named executive officers, which standardizes severance, bonus eligibility, COBRA coverage and equity-vesting acceleration terms in the event of involuntary termination, particularly around a corporate change in control, aligning Soleno’s executive compensation and severance practices more closely with market norms and potentially strengthening leadership retention and stability during strategic transactions.
The most recent analyst rating on (SLNO) stock is a Buy with a $114.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.