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01/11 07:57
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents a mixed outlook. While financial performance shows improvements in cost management and revenue growth, the company's guidance and liquidity concerns raise uncertainties. The Q&A section highlights potential growth in myelofibrosis treatment but lacks clarity on financing and market positioning. The absence of a strong catalyst like a new partnership or record revenue tempers expectations, resulting in a neutral sentiment.
Total Revenue $44 million, an increase of 13.4% year-over-year. This growth was driven by higher milestone revenue from partners and increased U.S. net product revenue.
U.S. XPOVIO Net Product Revenue $32 million, an increase of 8.5% year-over-year. This growth reflects the continued strength of XPOVIO in multiple myeloma and disciplined execution of commercial and operational teams.
Gross to Net Provisions for XPOVIO 27% in Q3 2025, down from 31% in Q3 2024. This reduction reflects improved pricing and reimbursement strategies.
License and Other Revenue $12 million, up nearly 30% from Q3 2024. This increase was primarily driven by higher milestone revenue from the partner Menarini.
Research and Development Expenses $30.5 million, down 16% year-over-year. The decrease was driven by lower clinical trial costs for selinexor in multiple myeloma and reduced personnel and stock-based compensation expenses.
Selling, General, and Administrative Expenses $26.6 million, down 4% year-over-year. This decrease was due to cost reduction initiatives.
Loss from Operations Improved by approximately 42% year-over-year. This improvement reflects disciplined expense management and increased revenue.
Interest Expense $11 million in Q3 2025, compared to $11.4 million in Q3 2024. This slight decrease reflects refinancing efforts.
Other Expense $7.4 million in Q3 2025, compared to $3.8 million of other income in Q3 2024. This change was driven by noncash fair value remeasurements of embedded derivatives and liability-classified common stock warrants.
Net Loss $33.1 million or $3.82 per share on a GAAP basis. More than half of this loss is driven by below-the-line items, including interest expense and noncash mark-to-market adjustments.
Phase III SENTRY trial completion: Enrollment completed for the Phase III SENTRY trial in frontline myelofibrosis, focusing on selinexor plus ruxolitinib as a potential all-oral treatment option. Top-line results expected in March 2026.
XPO1 inhibition mechanism: XPO1 inhibition targets multiple pathways, potentially overcoming limitations of current JAK inhibitors like ruxolitinib.
Myelofibrosis market opportunity: Potential peak revenue of $1 billion annually in the U.S. for selinexor plus ruxolitinib combination therapy. Target market includes 4,000 newly diagnosed intermediate to high-risk myelofibrosis patients annually in the U.S.
XPOVIO revenue growth: U.S. net product revenue grew 8.5% year-over-year to $32 million in Q3 2025, driven by its use in multiple myeloma.
Financial flexibility: Secured approximately $100 million through refinancing and capital restructuring, extending cash runway into Q2 2026.
Cost management: Reduced R&D and SG&A expenses, improving operational efficiency and lowering operating loss by 42% year-over-year in Q3 2025.
Focus on late-stage clinical programs: Prioritizing SENTRY and EC-042 trials, aiming for transformative outcomes in myelofibrosis and endometrial cancer.
Commercial readiness for myelofibrosis: Preparing for a potential launch of selinexor plus ruxolitinib combination therapy, leveraging existing commercial infrastructure.
Market Competition: The multiple myeloma market is highly competitive, with XPOVIO facing challenges in maintaining and growing its market share. The company must contend with established therapies and new entrants, which could impact revenue growth.
Regulatory Risks: The success of the Phase III SENTRY trial and subsequent regulatory approval for selinexor in combination with ruxolitinib is critical. Any delays or negative outcomes in the trial could significantly impact the company's strategic plans and financial performance.
Financial Sustainability: While the company has extended its cash runway into Q2 2026, it remains reliant on successful commercialization of selinexor and other products to sustain operations. Failure to achieve projected revenues could lead to financial strain.
Clinical Trial Risks: The ongoing Phase III SENTRY trial carries inherent risks, including the possibility of not meeting primary endpoints or encountering unforeseen safety issues, which could derail the company's plans for selinexor in myelofibrosis.
Supply Chain and Operational Risks: The company must ensure a reliable supply chain and operational efficiency to support the potential launch of selinexor in combination with ruxolitinib. Any disruptions could delay commercialization and impact revenue.
Economic and Market Conditions: Broader economic uncertainties and market conditions could affect the company's ability to secure funding, maintain profitability, and achieve its strategic objectives.
Phase III SENTRY trial in frontline myelofibrosis: Enrollment completed with top-line results expected in March 2026. The trial aims to redefine the standard of care for myelofibrosis through the combination of selinexor and ruxolitinib, potentially establishing a new paradigm for treatment.
Financial guidance: The company expects total revenue for 2025 to be between $140 million and $155 million, with U.S. XPOVIO net product revenue projected at $110 million to $120 million. Existing liquidity is expected to fund operations into Q2 2026.
Commercial opportunity in myelofibrosis: The potential peak revenue opportunity for selinexor in combination with ruxolitinib is estimated at $1 billion annually in the U.S. The target market includes approximately 4,000 newly diagnosed intermediate to high-risk myelofibrosis patients annually.
Selinexor's potential in myelofibrosis: The combination therapy with ruxolitinib is expected to improve spleen volume reduction, symptom improvement, and lower rates of Grade 3+ anemia. Preliminary data suggests meaningful efficacy and a manageable safety profile.
Strategic focus areas: The company is prioritizing advancing late-stage clinical programs (SENTRY and EC-042), driving growth in the XPOVIO franchise, and maintaining financial discipline to position for sustained success.
The selected topic was not discussed during the call.
The earnings call presents a mixed outlook. While financial performance shows improvements in cost management and revenue growth, the company's guidance and liquidity concerns raise uncertainties. The Q&A section highlights potential growth in myelofibrosis treatment but lacks clarity on financing and market positioning. The absence of a strong catalyst like a new partnership or record revenue tempers expectations, resulting in a neutral sentiment.
The earnings call reflects a mixed sentiment. While the company reports decreased R&D and SG&A expenses, an increase in interest expense and a significant net loss raise concerns. The Q&A highlights management's optimism about future trials, yet lacks specifics on enrollment and liquidity strategies. The positive outlook on new data readouts and potential market opportunities is tempered by financial challenges. These mixed signals suggest a neutral impact on stock price, with no strong catalysts for a significant move in either direction.
The earnings call presents a concerning picture with declining revenues, increased product returns, and cash flow risks. Despite passing a futility analysis, clinical trials face enrollment challenges. The lack of a shareholder return plan adds to the negative sentiment. While there is some growth in multiple myeloma, competitive pressures and supply chain issues pose risks. Management's vague responses on cash runway and future risks further contribute to uncertainty. Overall, the sentiment leans negative due to financial instability and competitive market pressures.
The earnings call reveals mixed financial performance with a slight revenue increase but declining cash reserves. Regulatory risks, competitive pressures, and supply chain challenges pose significant threats. The Q&A section indicates some positive clinical trial progress but lacks clarity on key metrics. Guidance remains unchanged, and no new partnerships were announced. These factors, combined with the absence of strong catalysts, suggest a negative stock price movement in the short term, particularly with financial stability concerns and competitive pressures in key markets.
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