Soleno posts 2025 profit on $190M VYKAT XR sales
Soleno Therapeutics reported a rapid shift to commercial growth driven by its first product, VYKAT XR for Prader‑Willi syndrome.
Rhea-AI Filing Summary
Soleno Therapeutics reported a rapid shift to commercial growth driven by its first product, VYKAT XR for Prader‑Willi syndrome. Product revenue, net, reached $91.7 million in the fourth quarter and $190.4 million for 2025, compared to no product revenue in 2024.
For 2025, the company generated net income of $20.9 million, or $0.40 per basic share, reversing a $175.9 million net loss in 2024. Operating income was $9.4 million for the year as higher sales offset commercialization costs.
Research and development expense fell to $40.6 million for 2025 from $78.6 million, mainly as pre‑launch and clinical costs declined. Selling, general and administrative expense increased to $132.1 million, reflecting commercial hiring, launch programs and international expansion.
Soleno reported strong launch momentum, noting patient start forms representing over 12% of the U.S. VYKAT XR addressable market in nine months. Total assets were $563.8 million and stockholders’ equity was $450.1 million as of December 31, 2025.
Positive
- Commercial launch drives profitability: 2025 product revenue, net, of $190.4 million from VYKAT XR enabled Soleno to swing from a $175.9 million net loss in 2024 to $20.9 million in net income.
- Strong early market uptake: Within nine months, patient start forms represented over 12% of the U.S. VYKAT XR addressable market, signaling robust initial demand in Prader‑Willi syndrome.
- Solid balance sheet growth: Total assets increased to $563.8 million and stockholders’ equity to $450.1 million as of December 31, 2025, providing a stronger financial base for ongoing commercialization and expansion.
Negative
- None.
Insights
First commercial year delivers rapid revenue ramp and a swing to profitability.
Soleno Therapeutics posted 2025 product revenue, net, of $190.4 million from VYKAT XR, after having no product revenue in 2024. This underpinned a move from a $175.9 million net loss in 2024 to $20.9 million net income in 2025.
Operating leverage came from sharply lower research and development spending, which declined to $40.6 million for 2025 from $78.6 million, as pre‑commercial and clinical costs eased. At the same time, selling, general and administrative expense rose to $132.1 million to support commercialization, new programs, and international expansion.
Launch indicators appear strong: management reported patient start forms covering over 12% of the U.S. VYKAT XR addressable market within nine months. The company also surpassed a $100 million commercial revenue milestone in Q4 2025, triggering a $7.0 million payment in Q1 2026. Future filings will clarify whether revenue growth continues to offset rising commercial and milestone obligations.
8-K Event Classification
FAQ
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| ITEM 2.02 | Results of Operations and Financial Conditions |
On February 25, 2026, Soleno Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2025. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This information is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| ITEM 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Soleno Therapeutics, Inc. dated February 25, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SOLENO THERAPEUTICS, INC. | ||||||
| Date: February 25, 2026 | ||||||
| By: | /s/ Anish Bhatnagar | |||||
| Anish Bhatnagar | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT(TM) XR
REDWOOD CITY, Calif., February 25, 2026 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKATTM XR (diazoxide choline) extended-release tablets.
Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights
| • | Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was $91.7 million and $190.4 million, respectively. |
| • | From approval on March 26, 2025 through December 31, 2025, Soleno reports: |
| • | 1,250 patient start forms received, including 207 in the fourth quarter |
| • | 630 unique prescribers, including 136 new prescribers in the fourth quarter |
| • | 859 active patients on drug as of December 31, 2025 |
| • | Over 185 million lives covered |
| • | Achieved profitability with positive net income of $20.9 million for the year. |
| • | Generated $48.7 million of cash flow from operating activities in the fourth quarter. |
| • | Invested $100 million in accelerated share repurchase program announced in November 2025 and ended the year with $506.1 million of cash, cash equivalents and marketable securities. |
“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market, reflecting both the strength of our world-class commercial team as well as the substantial disease burden that is addressed by VYKAT XR. We are very pleased with the positive trajectory of our other leading indicators, including patient start forms, patients on active therapy, unique prescribers, and lives covered.”
“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”
Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results
Product revenue, net, was $91.7 million and $190.4 million for the three and twelve months ended December 31, 2025, respectively. VYKAT XR had not been approved or commercially launched in the three and twelve months ended December 31, 2024, and accordingly, generated no revenue during those periods.
Research and development expense was $9.6 million, which includes $2.8 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, research and development expense was $40.6 million, which includes $11.7 million of non-cash stock-based compensation, a decrease of $38.0 million compared to $78.6 million, which includes $33.7 million non-cash stock-based compensation, in the same period of 2024.
For the year, the $15.9 million decrease in expense not related to stock-based compensation was due to a reduction in pre-commercial launch costs in support of the Company’s 2024 NDA submission, supply chain, and clinical activities. These expenses decreased $7.5 million, $6.0 million, and $3.8 million, respectively. These decreases were partially offset by the Company incurring an additional $1.4 million of expense towards its MAA submission in Europe, which was submitted in the second quarter of 2025. The cadence of the Company’s research and development expenditures will fluctuate depending upon the state of its research activities, clinical programs, and the timing of manufacturing and other projects necessary to support the submission of its regulatory filings.
Selling, general and administrative expense was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, selling, general and administrative expense was $132.1 million, which includes $34.1 million of non-cash stock-based compensation, an increase of $26.2 million compared to $105.9 million, which includes $66.2 million of non-cash stock-based compensation, in the same period of 2024.
For the year, personnel costs, including hiring expense and other associated headcount costs, increased $31.3 million as the Company hired additional employees in support of its commercial launch and increased business activities. New program costs associated with commercial launch activities, including disease state education, analytics, other marketing programs, medical affairs and patient advocacy activities, increased $23.4 million. Costs for international expansion increased $3.5 million. These increases were offset by the $32.1 million reduction in stock-based compensation. Selling, general and administrative expenses are anticipated to increase as the Company continues commercialization of VYKAT XR.
The Company is obligated to make cash payments of up to a maximum of $21.2 million to the former Essentialis stockholders upon the achievement of certain commercial milestones associated with the sales of DCCR in accordance with the terms of the Company’s 2017 merger agreement with Essentialis. The fair value of the liability for the contingent consideration payable by the Company upon the achievement of commercial sales milestones of $100 million and $200 million in aggregate revenue, respectively, was estimated to be $20.3 million as of December 31, 2025, a $5.5 million increase from the estimate as of December 31, 2024. The first commercial milestone was achieved in the fourth quarter 2025 and $7.0 million will be paid in the first quarter 2026.
Total other income, net, was $3.8 million for the three months ended December 31, 2025, compared to total other income, net, of $3.1 million in the same period of 2024. For the year, total other income, net, was $11.5 million for 2025, compared to $11.8 million for 2024.
For the year ended December 31, 2025, net income was approximately $20.9 million, or $0.40 per basic and $0.39 per diluted share, compared to a net loss of $(175.9) million, or $(4.38) per basic and diluted share, for the same period of 2024.
Conference Call and Webcast Information
Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:
| Conference call details: | Toll-free: 800-717-1738 | |
| International: 646-307-1865 | ||
| Conference ID: 55257 | ||
| Call me™ (avoids waiting for an operator): |
Here | |
| Webcast: |
Here |
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
IMPORTANT SAFETY INFORMATION
Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.
Warnings and Precautions
Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.
Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.
Please see the full Prescribing Information, including Medication Guide.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Corporate Contact: Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
Soleno Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands except share and per share data)
| December 31, 2025 |
December 31, 2024 |
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| Assets |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 70,106 | $ | 87,928 | ||||
| Marketable securities |
235,366 | 203,509 | ||||||
| Accounts receivable, net |
28,208 | — | ||||||
| Inventory, net |
15,024 | — | ||||||
| Prepaid expenses and other current assets |
7,110 | 2,452 | ||||||
|
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|
|
|
|||||
| Total current assets |
355,814 | 293,889 | ||||||
| Long-term assets |
||||||||
| Property and equipment, net |
185 | 186 | ||||||
| Operating lease right-of-use assets |
2,191 | 2,798 | ||||||
| Intangible assets, net |
4,861 | 6,805 | ||||||
| Long-term marketable securities |
200,616 | 27,211 | ||||||
| Other long-term assets |
163 | 83 | ||||||
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| Total assets |
$ | 563,830 | $ | 330,972 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities |
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| Accounts payable |
$ | 12,435 | $ | 8,882 | ||||
| Accrued compensation |
9,677 | 4,776 | ||||||
| Operating lease liabilities |
726 | 526 | ||||||
| Contingent liability for Essentialis purchase price |
20,327 | — | ||||||
| Other current liabilities |
18,198 | 4,563 | ||||||
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| Total current liabilities |
61,363 | 18,747 | ||||||
| Long-term liabilities |
||||||||
| Contingent liability for Essentialis purchase price |
— | 14,791 | ||||||
| Long-term debt, net |
49,863 | 49,828 | ||||||
| Long-term lease liabilities |
1,964 | 2,472 | ||||||
| Other long-term liabilities |
525 | 21 | ||||||
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| Total liabilities |
113,715 | 85,859 | ||||||
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| Commitments and contingencies (Note 6) |
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| Stockholders’ equity |
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| Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding |
— | — | ||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized, |
52 | 46 | ||||||
| Additional paid-in-capital |
881,018 | 696,966 | ||||||
| Accumulated other comprehensive income |
415 | 361 | ||||||
| Accumulated deficit |
(431,370 | ) | (452,260 | ) | ||||
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| Total stockholders’ equity |
450,115 | 245,113 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 563,830 | $ | 330,972 | ||||
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Soleno Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands except share and per share data)
| Three Months Ended December 31, |
Years Ended December 31, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product revenue, net |
$ | 91,730 | $ | — | $ | 190,405 | $ | — | ||||||||
| Operating expenses |
||||||||||||||||
| Cost of goods sold |
863 | — | 2,700 | — | ||||||||||||
| Research and development |
9,558 | 21,486 | 40,627 | 78,568 | ||||||||||||
| Selling, general and administrative |
40,878 | 37,303 | 132,128 | 105,861 | ||||||||||||
| Change in fair value of contingent consideration |
854 | 327 | 5,536 | 3,242 | ||||||||||||
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| Total operating expenses |
52,153 | 59,116 | 180,991 | 187,671 | ||||||||||||
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| Operating income (loss) |
39,577 | (59,116 | ) | 9,414 | (187,671 | ) | ||||||||||
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| Other income (expense), net |
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| Interest income, net |
5,130 | 3,365 | 16,952 | 12,052 | ||||||||||||
| Interest expense |
(1,349 | ) | (231 | ) | (5,476 | ) | (231 | ) | ||||||||
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| Total other income (expense), net |
3,781 | 3,134 | 11,476 | 11,821 | ||||||||||||
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| Net income (loss) |
$ | 43,358 | $ | (55,982 | ) | $ | 20,890 | $ | (175,850 | ) | ||||||
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| Other comprehensive income (loss) |
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| Net unrealized gain (loss) on marketable securities |
68 | (537 | ) | 37 | 361 | |||||||||||
| Foreign currency translation adjustment |
(13 | ) | 3 | 17 | — | |||||||||||
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| Total comprehensive income (loss) |
$ | 43,413 | $ | (56,516 | ) | $ | 20,944 | $ | (175,489 | ) | ||||||
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| Net income (loss) |
43,358 | (55,982 | ) | 20,890 | (175,850 | ) | ||||||||||
| Less: Undistributed earnings attributable to participating securities |
(1 | ) | — | (415 | ) | — | ||||||||||
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| Net income (loss) attributable to common stockholders - basic and diluted |
$ | 43,357 | $ | (55,982 | ) | $ | 20,475 | $ | (175,850 | ) | ||||||
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| Net income (loss) per share - basic |
$ | 0.82 | $ | (1.27 | ) | $ | 0.40 | $ | (4.38 | ) | ||||||
| Net income (loss) per share - diluted |
$ | 0.80 | $ | (1.27 | ) | $ | 0.39 | $ | (4.38 | ) | ||||||
| Weighted-average common shares outstanding - basic |
53,175,700 | 43,924,831 | 50,817,586 | 40,175,926 | ||||||||||||
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| Weighted-average common shares outstanding - diluted |
54,331,407 | 43,924,831 | 52,384,886 | 40,175,926 | ||||||||||||
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Soleno Therapeutics, Inc.
Stock-based Compensation Expense
(In thousands)
| Three Months Ended December 31, |
Years Ended December 31, |
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| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development |
$ | 2,821 | $ | 10,061 | $ | 11,722 | $ | 33,743 | ||||||||
| Selling, general and administrative |
8,650 | 19,694 | 34,124 | 66,215 | ||||||||||||
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| Total |
$ | 11,471 | $ | 29,755 | $ | 45,846 | $ | 99,958 | ||||||||
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