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What were the key takeaways from Soleno Therapeutics’s earnings call?

- **Revenue milestone**: Q3 2025 net revenue doubles to $66 million, marking first profitable quarter.
- **Market adoption**: 764 active patients on VYKAT XR, 494 prescribers, and 132 million lives covered by payers.
- **Discontinuation management**: 8% AE-related discontinuations, with efforts to restart therapy through patient education.
- **Global expansion**: EU regulatory progress for 9,500 PWS patients, despite ongoing U.S. launch.
- **Financial strength**: $556 million cash balance supports commercialization and international expansion.

**【CEO Summary Section】**
- Total net revenue doubled to $66 million in Q3 2025, achieving profitability with a net income of $26 million.
- VYKAT XR launch momentum continued despite a mid-August short seller report causing temporary disruption in patient start forms and discontinuations.
- 764 active patients on therapy at quarter-end, with 1,043 cumulative patient start forms and 494 unique prescribers.
- Discontinuation rate due to adverse events (AEs) was 8%, below long-term expectations, with most AEs being nonserious (e.g., edema, hyperglycemia).
- EU regulatory progress: EMA Day 120 questions received, similar to FDA discussions, with potential market expansion for 9,500 PWS patients in key European countries.

**【CFO Financial Commentary】**
- Q3 2025 revenue: $66.0 million (vs. $32.7 million in Q2 2025), net income: $26.0 million (vs. -$76.6 million in Q3 2024).
- Cash from operations: $43.5 million; ending cash balance: $556.1 million (including $230 million from July equity offering).
- Cost of goods sold: $1.1 million (low due to 0-cost inventory from pre-launch manufacturing).
- R&D expenses: $8.4 million (down 92% YoY due to reduced clinical trial activity post-approval).
- SG&A expenses: $33.8 million (up 25% YoY due to commercial launch investments).

**【Q&A Key Highlights】**
- **Discontinuation trends**: 8% AE-related discontinuations, with 10% total discontinuation rate. Anecdotal evidence shows patients restarting therapy after AE resolution.
- **Launch momentum**: Q3 start forms (+397) slower than Q2 (+646), but October activity similar to September, suggesting stabilization.
- **Payer access**: 132 million lives covered, including top 3 PBMs, with 40 state Medicaid programs reimbursing claims.
- **EU timeline**: No specific approval timeline, but regulatory process progressing with responses to EMA questions.
- **Competitor dynamics**: Rhythm's setmelanotide in PWS Phase II trial failed, but open-label data pending; potential for synergistic use with VYKAT XR if efficacy shown.

Soleno Therapeutics, Inc. (SLNO) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

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Basic EPS from Discontinued Operations

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Diluted EPS from Discontinued Operations

SLNO

SLNO fundamentals

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