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01/11 11:51
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals several negative indicators: increased operating loss guidance due to Sage acquisition costs, cash reserves depletion, and unresolved supply constraints for Onapgo. Although revenue guidance was raised, the uncertainty surrounding Q4 sales and evasive management responses in the Q&A suggest potential risks. The stock is likely to react negatively, especially given the small-cap market cap, which typically shows higher volatility.
Onapgo net sales $6.8 million in Q3 2025, up from $1.6 million in Q2 2025. The increase is attributed to stronger-than-expected demand and positive feedback from prescribers.
Zurzuvae collaboration revenue $20.2 million in Q3 2025, representing approximately 2 months of collaboration revenue since the Sage acquisition. U.S. sales of Zurzuvae increased approximately 150% year-over-year and 19% quarter-over-quarter, driven by the Sage acquisition and integration.
Qelbree net sales 31% growth in Q3 2025 compared to Q3 2024, driven by a 23% increase in prescriptions and strong back-to-school season performance.
GOCOVRI net sales 15% growth in Q3 2025 compared to Q3 2024, supported by growth in prescriptions and the number of prescribers.
Total revenue $192.1 million in Q3 2025, up from $175.7 million in Q3 2024. The 30% increase (excluding Trokendi XR and Oxtellar XR) was driven by growth in Qelbree, GOCOVRI, Onapgo, and Zurzuvae collaboration revenues.
R&D and SG&A expenses $209 million in Q3 2025, up from $98.8 million in Q3 2024. The increase was primarily due to $70 million in acquisition-related costs, $30 million in Sage operating costs, and intangible asset amortization.
Operating loss (GAAP) $60.2 million in Q3 2025, compared to operating earnings of $40.9 million in Q3 2024. The change was driven by higher SG&A expenses and acquisition-related costs.
Net loss (GAAP) $45.1 million in Q3 2025, compared to net earnings of $38.5 million in Q3 2024. The loss was due to increased SG&A expenses and acquisition-related costs.
Cash, cash equivalents, and marketable securities $281 million as of September 30, 2025, down from $454 million as of December 31, 2024. The decrease was due to the funding of the Sage acquisition, partially offset by cash generated from operations.
Onapgo: Generated net sales of $6.8 million in Q3 2025, up from $1.6 million in Q2. Over 1,300 enrollment forms submitted by 450+ prescribers. Positive feedback from prescribers, but supply constraints are limiting new patient initiations.
Zurzuvae: Collaboration revenue of $20.2 million in Q3 2025. U.S. sales increased 150% YoY and 19% QoQ. Integration of Sage acquisition expected to complete by year-end, with potential synergies of $200 million annually by mid-2026.
Qelbree: 23% growth in prescriptions and 31% growth in net sales YoY in Q3 2025. Strong back-to-school season with 19% growth in pediatric prescriptions and 32% growth in adult prescriptions. Prescriber base grew by 18% YoY.
GOCOVRI: Net sales grew by 15% YoY in Q3 2025, driven by increased prescriptions and prescribers.
ADHD Market: Total ADHD market grew 12% in prescriptions YoY in Q3 2025. Adult segment grew 16%, outpacing pediatric segment growth of 5%.
Revenue Growth: Total revenue for Q3 2025 was $192.1 million, up from $175.7 million YoY. Excluding Trokendi XR and Oxtellar XR, revenue increased 30% YoY.
Financial Guidance Update: Full-year 2025 revenue guidance increased to $685-$705 million from $670-$700 million. Non-GAAP operating earnings guidance raised to $125-$145 million from $105-$135 million.
R&D and SG&A Expenses: Combined R&D and SG&A expenses for Q3 2025 were $209 million, up from $98.8 million YoY, primarily due to Sage acquisition-related costs.
Sage Acquisition: Integration on track to complete by year-end 2025. Expected synergies of up to $200 million annually by mid-2026.
Pipeline Development: SPN-443 program to focus on ADHD with Phase I trials in 2026. SPN-820 Phase IIb trial for major depressive disorder to start by end of 2025. SPN-817 Phase IIb trial for treatment-resistant focal seizures ongoing.
Supply Chain Constraints: Due to stronger-than-expected demand for Onapgo, supplier constraints are impacting the company's ability to fully meet this demand. This has led to prioritizing care for existing patients and pausing delivery to new patients.
Increased Operating Expenses: The company reported significantly higher SG&A expenses, including $70 million of acquisition-related costs and $30 million of Sage operating costs, contributing to an operating loss of $60.2 million in Q3 2025.
Integration Risks: The integration of Sage Therapeutics is ongoing and expected to be completed by year-end. Potential risks include delays or challenges in achieving the anticipated synergies of up to $200 million annually by mid-2026.
R&D and Clinical Trial Risks: The company is conducting multiple clinical trials, including SPN-443, SPN-820, and SPN-817. These trials carry inherent risks such as delays, failure to meet endpoints, or safety concerns.
Financial Liquidity Concerns: Cash reserves decreased significantly from $454 million at the end of 2024 to $281 million as of September 30, 2025, primarily due to the Sage acquisition. This could limit financial flexibility for future growth opportunities.
Revenue Guidance: The company updated its full-year 2025 revenue guidance to range from $685 million to $705 million, up from the previous range of $670 million to $700 million. This includes net product sales, Zurzuvae collaboration revenues, and royalty and licensing revenues.
Product Sales Expectations: Full-year 2025 guidance assumes approximately $75 million to $85 million of combined net sales of Trokendi XR and Oxtellar XR, up from the previous estimate of $65 million to $75 million.
Operating Loss: The company expects a full-year 2025 operating loss in the range of $65 million to $75 million, compared to the previous range of $70 million to $80 million.
Non-GAAP Operating Earnings: Non-GAAP operating earnings for full-year 2025 are expected to range from $125 million to $145 million, up from the previous guidance of $105 million to $135 million.
R&D and SG&A Expenses: For full-year 2025, combined R&D and SG&A expenses are expected to range from $505 million to $530 million, unchanged from the previous guidance.
Sage Integration and Synergies: The integration of Sage is expected to be substantially completed by the end of 2025, with potential synergies of up to $200 million annually by mid-2026.
SPN-443 Program: A Phase I study for SPN-443 in adult healthy volunteers is expected to begin in 2026, focusing on ADHD as the lead indication.
SPN-820 Program: A Phase IIb trial for SPN-820 in adults with major depressive disorder is on track to begin by the end of 2025.
SPN-817 Program: A Phase IIb trial for SPN-817 in adults with treatment-resistant focal seizures is ongoing, targeting enrollment of approximately 258 patients.
The selected topic was not discussed during the call.
The earnings call reveals several negative indicators: increased operating loss guidance due to Sage acquisition costs, cash reserves depletion, and unresolved supply constraints for Onapgo. Although revenue guidance was raised, the uncertainty surrounding Q4 sales and evasive management responses in the Q&A suggest potential risks. The stock is likely to react negatively, especially given the small-cap market cap, which typically shows higher volatility.
The earnings call reflects strong financial performance with increased net earnings and a healthy cash position. Product launches, particularly ONAPGO and Qelbree, show promising growth and market acceptance. The company’s optimistic guidance, strategic focus on CNS and women's health, and successful reimbursement processes are positive indicators. Despite some concerns about operating earnings and management's lack of specific details on ZURZUVAE, the overall sentiment is positive, especially with new product momentum and strategic partnerships. Given the market cap, a positive stock price movement between 2% to 8% is expected.
The earnings call shows mixed results. Financial performance is slightly positive with revenue and sales growth, but the GAAP net loss and operating loss raise concerns. The Q&A section highlights management's positive outlook on growth drivers and product differentiation, yet lacks clarity on certain operational aspects. No new partnerships or share repurchase programs were announced. The market cap suggests limited volatility, leading to a neutral prediction for stock price movement.
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