Karyopharm Therapeutics(KPTI) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Highlights Karyopharm's Q2 2025 financial and operational highlights, including revenue, guidance, and strategic efforts, are presented alongside CEO commentary Q2 2025 Financial & Operational Overview Karyopharm reported Q2 2025 total revenue of $37.9 million, with U.S. XPOVIO net product revenue up 6% to $29.7 million, reaffirming full-year guidance while exploring strategic alternatives | Metric | Q2 2025 | YoY Change | | :----------------------------- | :-------- | :--------- | | Total Revenue | $37.9 Million | N/A | | U.S. XPOVIO Net Product Revenue | $29.7 Million | +6% | - Reaffirms Full-Year 2025 Total Revenue Guidance: $140 Million to $155 Million[1] - Updates U.S. XPOVIO Net Product Revenue Guidance: $110 Million to $120 Million[1] - The Company is exploring financing transactions and strategic alternatives to extend its cash runway and maximize value[1] CEO Commentary CEO Richard Paulson discussed financing efforts and the nearing completion of Phase 3 SENTRY trial enrollment, with top-line data expected March 2026 - Company is seeking potential financing and strategic alternatives to extend cash runway and enhance liquidity[2] - Phase 3 SENTRY trial in myelofibrosis is in its final weeks of enrollment, with top-line data anticipated in March 2026[2] XPOVIO Commercial Performance This section details XPOVIO's Q2 2025 commercial performance, including U.S. net product revenue growth and demand drivers XPOVIO Commercial Performance Overview Karyopharm reported a 6% increase in U.S. XPOVIO net product revenue to $29.7 million in Q2 2025 compared to Q2 2024, with consistent demand driven primarily by the community setting (approximately 60% of revenue) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :----------------------- | :-------- | :-------- | :--------- | | U.S. Net Product Revenue | $29.7 million | $28.0 million | +6.1% | | Royalty Revenue | $1.6 million | N/A | +28% | - Demand for XPOVIO was consistent year-over-year, with the community setting contributing approximately 60% of overall net product revenue[3] Research and Development (R&D) Highlights Key updates on Karyopharm's clinical development programs for myelofibrosis, endometrial cancer, and multiple myeloma are provided Myelofibrosis Program The Phase 3 SENTRY trial is nearing full enrollment, with new patient screening expected to close this week, and preliminary safety data suggests potential improvements in adverse events - Phase 3 SENTRY trial (XPORT-MF-034) is nearing full enrollment, with new patient screening expected to close this week, and top-line data anticipated in March 2026[6][8] - Preliminary blinded aggregate safety data from the first 61 patients in SENTRY may suggest improvements in both hematologic and non-hematologic treatment emergent adverse events[6] - Phase 2 SENTRY-2 trial (XPORT-MF-044) continues enrollment for JAKi-naïve myelofibrosis patients with moderate thrombocytopenia and plans to amend the protocol to include patients with platelet counts above 100,000[6] Endometrial Cancer Program Enrollment is ongoing for the Phase 3 XPORT-EC-042 trial, evaluating selinexor as a maintenance monotherapy in patients with TP53 wild-type advanced or recurrent endometrial cancer, with top-line data expected in mid-2026 - Enrollment continues in the Phase 3 XPORT-EC-042 trial for selinexor as maintenance-only therapy in TP53 wild-type advanced or recurrent endometrial cancer[5][9] - Top-line data from the event-driven XPORT-EC-042 trial is expected in mid-2026[9] Multiple Myeloma Program Enrollment for the Phase 3 XPORT-MM-031 trial was completed in Q4 2024, evaluating an all-oral combination of selinexor, pomalidomide, and dexamethasone, with top-line data expected in the first half of 2026 - Enrollment of approximately 120 patients in the Phase 3 XPORT-MM-031 trial was completed in the fourth quarter of 2024[7] - The trial evaluates the all-oral combination of selinexor 40 mg, pomalidomide, and dexamethasone (SPd40) in patients with previously treated multiple myeloma[7] - Top-line data from the event-driven XPORT-MM-031 trial is expected in the first half of 2026[10] Anticipated Catalysts and Operational Objectives This section outlines key upcoming milestones and operational objectives for Karyopharm's myelofibrosis, endometrial cancer, and multiple myeloma programs Myelofibrosis Milestones The company expects to close new patient screening for the Phase 3 SENTRY trial this week, with top-line data anticipated in March 2026 - New patient screening for the Phase 3 SENTRY trial is expected to close this week[8] - Top-line data from the Phase 3 SENTRY trial is expected in March 2026[8] Endometrial Cancer Milestones Karyopharm plans to continue enrolling patients in the Phase 3 XPORT-EC-042 trial, with top-line data from this event-driven trial expected in mid-2026 - Continue to enroll patients into the Phase 3 XPORT-EC-042 trial[9] - Top-line data from the event-driven XPORT-EC-042 trial is expected in mid-2026[9] Multiple Myeloma Milestones The company will continue to follow patients enrolled in the Phase 3 XPORT-MM-031 trial, with top-line data from this event-driven trial expected in the first half of 2026 - Continue to follow patients that are enrolled in the Phase 3 XPORT-MM-031 (EMN29) trial[10] - Top-line data from the event-driven XPORT-MM-031 trial is expected in the first half of 2026[10] 2025 Financial Outlook & Liquidity Karyopharm's full-year 2025 financial guidance and liquidity position are discussed, including ongoing efforts to explore strategic alternatives Full-Year 2025 Guidance For full-year 2025, Karyopharm projects total revenue of $140 million to $155 million, with U.S. XPOVIO net product revenue contributing $110 million to $120 million, and combined R&D and SG&A expenses estimated between $240 million and $250 million | Metric | 2025 Guidance Range | | :----------------------------- | :------------------ | | Total Revenue | $140 million to $155 million | | U.S. XPOVIO Net Product Revenue | $110 million to $120 million | | R&D and SG&A Expenses | $240 million to $250 million | - Maintain the Company's commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues[10] - Continue to support global launches by partners following regulatory and reimbursement approvals for selinexor in ex-U.S. territories[10] Liquidity and Strategic Alternatives Karyopharm anticipates its current liquidity will fund operations until October 2025, or into January 2026 excluding certain obligations, while actively exploring financing and strategic alternatives - Existing liquidity is expected to fund planned operations to the maturity of its senior convertible notes due October 2025[12] - Excluding the $24.5 million Remaining 2025 Notes maturity and its $25.0 million minimum liquidity covenant, the Company expects it would have sufficient liquidity to fund planned operations into January 2026[12] - The Company, with the assistance of its advisors, is exploring potential financing and strategic alternatives to enhance liquidity and maximize value[12] Second Quarter 2025 Financial Results A detailed analysis of Karyopharm's Q2 2025 financial performance, covering revenue, operating expenses, net loss, and cash position Revenue Analysis Total revenue for Q2 2025 was $37.9 million, down from $42.8 million in Q2 2024, primarily due to a non-recurring license-related revenue recognized in Q2 2024, while U.S. net product revenue increased to $29.7 million | Revenue Type | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :---------------------- | :----------------- | :----------------- | :--------- | | Total Revenue | $37.9 | $42.8 | -$4.9 (-11.4%) | | Net Product Revenue | $29.7 | $28.0 | +$1.7 (+6.1%) | | License and Other Revenue | $8.2 | $14.8 | -$6.6 (-44.6%) | - The decrease in license and other revenue was primarily attributable to $6.0 million of non-recurring license-related revenue recognized during the second quarter of 2024[14] Operating Expenses Operating expenses decreased in Q2 2025 compared to Q2 2024, with reductions in cost of sales, R&D expenses due to lower personnel and clinical trial costs, and SG&A expenses from cost reduction initiatives | Expense Type | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :---------------- | :----------------- | :----------------- | :--------- | | Cost of Sales | $1.1 | $1.5 | -$0.4 (-26.7%) | | R&D Expenses | $32.8 | $38.4 | -$5.6 (-14.6%) | | SG&A Expenses | $28.5 | $31.1 | -$2.6 (-8.4%) | - R&D expense decrease was due to a reduction in personnel costs and stock-based compensation, coupled with lower clinical trial and related costs[16] - SG&A expense decrease was primarily due to the realization of previously implemented cost reduction initiatives[17] Other Income (Expense) & Net Loss Karyopharm reported a net loss of $37.3 million in Q2 2025, a significant shift from net income in Q2 2024, largely due to changes in interest income/expense and the absence of a prior year gain on debt extinguishment | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :------------------------------ | :----------------- | :----------------- | :--------- | | Net (Loss) Income | -$37.3 | $23.8 | -$61.1 | | Basic Net (Loss) Income Per Share | -$4.32 | $2.26 | -$6.58 | | Diluted Net Loss Per Share | -$4.32 | -$2.97 | -$1.35 | | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :------------------------------ | :----------------- | :----------------- | :--------- | | Interest Income | $0.6 | $1.9 | -$1.3 (-68.4%) | | Interest Expense | $11.2 | $8.9 | +$2.3 (+25.8%) | | Gain on Extinguishment of Debt | $0.0 | $44.7 | -$44.7 | | Other (expense) income, net | -$2.2 | $14.3 | -$16.5 | - Interest expense increased due to a full quarter of interest on the term loan and convertible debt issued in the second quarter of 2024[18] - The change in other (expense) income, net, is attributable to recurring non-cash fair value remeasurements related to 2024 refinancing transactions, and the absence of a $44.7 million gain on extinguishment of debt from Q2 2024[19] Cash Position As of June 30, 2025, Karyopharm's cash, cash equivalents, restricted cash, and investments totaled $52.0 million, a decrease from $109.1 million as of December 31, 2024 | Metric | June 30, 2025 (Millions) | December 31, 2024 (Millions) | Change | | :---------------------------------------------- | :----------------------- | :--------------------------- | :----- | | Cash, Cash Equivalents, Restricted Cash & Investments | $52.0 | $109.1 | -$57.1 | Conference Call Information Details regarding Karyopharm's conference call to discuss Q2 2025 financial results and business updates are provided Conference Call Details Karyopharm hosted a conference call on August 11, 2025, at 8:00 a.m. ET to discuss Q2 2025 financial results, the 2025 financial outlook, and other business updates - Conference call held on August 11, 2025, at 8:00 a.m. Eastern Time, to discuss Q2 2025 financial results, 2025 financial outlook, and business updates[22] - Access details for dial-in and live audio webcast, along with accompanying slides, were provided[22] About XPOVIO (selinexor) This section provides a description of XPOVIO (selinexor), its approved indications, and important safety information Product Description and Indications XPOVIO is a first-in-class, oral XPO1 inhibitor approved in the U.S. for multiple myeloma and DLBCL, with international approvals in over 50 territories - XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer, functioning by selectively binding to and inhibiting the nuclear export protein XPO1[23][30] - Approved in the U.S. for multiple myeloma: (i) in combination with VELCADE® (bortezomib) and dexamethasone (XVd) after at least one prior therapy; (ii) in combination with dexamethasone (Xd) in adult patients with heavily pre-treated multiple myeloma[23][24] - Approved under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy[23][25] - Received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada, marketed by partners[23][30] Important Safety Information Important safety information for XPOVIO includes common adverse reactions such as fatigue and nausea, significant Grade 3-4 laboratory abnormalities like thrombocytopenia, and warnings for various toxicities - Most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting[27] - Grade 3-4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia[27] - Most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection[32] - Warnings and Precautions include monitoring for thrombocytopenia, neutropenia, gastrointestinal toxicity, hyponatremia, serious infection, neurological toxicity, embryo-fetal toxicity, and cataract[28] - Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception[28] - For specific populations, advise not to breastfeed during lactation[29] About Karyopharm Therapeutics An overview of Karyopharm Therapeutics Inc., its mission, lead compound XPOVIO, and focused pipeline Company Overview Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company focused on pioneering novel cancer therapies by addressing nuclear export dysregulation, with its lead compound XPOVIO approved in the U.S. for three oncology indications and globally in over 50 territories - Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company dedicated to pioneering novel cancer therapies by addressing nuclear export dysregulation, a fundamental mechanism of oncogenesis[30] - Karyopharm's lead compound, XPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, is approved in the U.S. for three oncology indications and has received regulatory approvals in various indications in 50 ex-U.S. territories and countries[30] - Karyopharm has a focused pipeline targeting indications in multiple high unmet need cancers, including multiple myeloma, endometrial cancer, myelofibrosis, and diffuse large B-cell lymphoma (DLBCL)[30] Forward-Looking Statements This section outlines Karyopharm's forward-looking statements and the inherent risks and uncertainties that may impact future results Forward-Looking Statements and Risks Karyopharm's forward-looking statements regarding 2025 financial guidance, cash runway, strategic alternatives, commercialization, and clinical development are subject to numerous risks and uncertainties that may cause actual results to differ materially - Forward-looking statements include guidance on 2025 total revenue, U.S. net product revenue, R&D and SG&A expenses; expected cash runway and liquidity; exploration of strategic alternatives and financing transactions; expectations for commercialization efforts; and expectations for clinical development plans and potential regulatory submissions of selinexor[31] - Such statements are subject to numerous important factors, risks, and uncertainties, many of which are beyond Karyopharm's control, that may cause actual events or results to differ materially from current expectations[31] - Risks include the ability to successfully commercialize XPOVIO, successful completion of clinical development phases, regulatory approval, stock price appreciation, adoption of XPOVIO, timing and costs of commercialization, clinical trial results, FDA decisions, ability to enroll patients, unplanned expenditures, going concern doubt, competitor development, COVID-19 impact, and intellectual property protection[31][33] Condensed Consolidated Financial Statements Presents Karyopharm's condensed consolidated statements of operations and balance sheets for Q2 2025 and comparative periods Condensed Consolidated Statements of Operations The Condensed Consolidated Statements of Operations show a net loss of $37.3 million for Q2 2025, compared to a net income of $23.8 million for Q2 2024, with total revenue and operating expenses both decreasing | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | | Product revenue, net | $29,681 | $28,032 | | License and other revenue | $8,248 | $14,754 | | Total revenue | $37,929 | $42,786 | | Cost of sales | $1,051 | $1,465 | | Research and development | $32,788 | $38,371 | | Selling, general and administrative | $28,477 | $31,070 | | Total operating expenses | $62,316 | $70,906 | | Loss from operations | $(24,387) | $(28,120) | | Interest income | $613 | $1,930 | | Interest expense | $(11,228) | $(8,949) | | Gain on extinguishment of debt | — | $44,702 | | Other (expense) income, net | $(2,210) | $14,296 | | Net (loss) income | $(37,252) | $23,792 | | Basic net (loss) income per share | $(4.32) | $2.26 | | Diluted net loss per share | $(4.32) | $(2.97) | | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $50,735 | $54,038 | | License and other revenue | $17,209 | $21,874 | | Total revenue | $67,944 | $75,912 | | Cost of sales | $2,352 | $3,376 | | Research and development | $67,406 | $73,796 | | Selling, general and administrative | $55,829 | $60,619 | | Total operating expenses | $125,587 | $137,791 | | Loss from operations | $(57,643) | $(61,879) | | Interest income | $1,613 | $4,086 | | Interest expense | $(22,222) | $(14,833) | | Gain on extinguishment of debt | — | $44,702 | | Other (expense) income, net | $17,614 | $14,492 | | Net (loss) income | $(60,714) | $(13,570) | | Basic net (loss) income per share | $(7.11) | $(1.72) | | Diluted net loss per share | $(7.11) | $(7.16) | Condensed Consolidated Balance Sheets The Condensed Consolidated Balance Sheets show total assets of $104.9 million as of June 30, 2025, a decrease from $164.4 million at December 31, 2024, with total stockholders' deficit increasing to $(238.9) million | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $51,697 | $108,712 | | Restricted cash | $350 | $338 | | Accounts receivable | $32,932 | $30,766 | | Other assets | $19,900 | $24,602 | | Total assets | $104,879 | $164,418 | | Convertible senior notes due 2025 | $24,484 | $24,426 | | Convertible senior notes due 2029 | $62,684 | $68,345 | | Senior secured term loan | $95,816 | $94,603 | | Deferred royalty obligation | $73,499 | $73,499 | | Other liabilities | $87,322 | $89,562 | | Total liabilities | $343,805 | $350,435 | | Total stockholders' deficit | $(238,926)| $(186,017) |