Karyopharm Therapeutics(KPTI)

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Karyopharm Therapeutics(KPTI) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:32
Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $30 million, down from $33.1 million in Q1 2024 [46] - U.S. XPOVIO net product revenue decreased to $21.1 million from $26 million year-over-year, attributed to a $5 million increase in product return reserves [47] - Gross to net provisions for XPOVIO were 45% in Q1 2025 compared to 29.3% in the same period in 2024 [47] - Cash, cash equivalents, and investments at the end of Q1 2025 were $70.3 million, down from $109.1 million at the end of 2024 [48] Business Line Data and Key Metrics Changes - Demand growth for Q1 was 5% year-over-year, with net product revenue impacted by atypical returns of expired products [40] - Royalty revenue increased by 57% to $1.7 million in Q1 2025 compared to Q1 2024, reflecting growing global demand for XPOVIO [42] Market Data and Key Metrics Changes - The multiple myeloma market remains highly competitive, with expectations of additional new entrants this year [41] - The company anticipates a peak revenue potential of approximately $1 billion in the U.S. for selinexor in myelofibrosis if approved [10] Company Strategy and Development Direction - The company is focused on completing enrollment in the Phase III SENTRY trial for myelofibrosis and advancing the Phase III trial in endometrial cancer [7][38] - The strategy includes leveraging a profitable commercial organization in multiple myeloma to drive rapid commercialization in new disease areas [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of selinexor to redefine the standard of care in myelofibrosis, with encouraging clinical data supporting its efficacy [8][10] - The company is exploring various opportunities to extend its cash runway while focusing on advancing clinical trials and commercial performance [51][53] Other Important Information - The Phase III SENTRY trial successfully passed its pre-specified futility analysis, allowing the study to continue as planned [35] - The company expects to complete enrollment in the SENTRY trial by June-July 2025 [35][67] Q&A Session Summary Question: Can you talk about the futility analysis and its basis? - The futility analysis was based on efficacy and safety data from the first 61 patients, with thresholds for no worsening compared to ruxolitinib alone [55][56] Question: What are the assumptions for achieving full enrollment in June and July? - The company is currently 80% enrolled and expects to complete enrollment in the June-July timeframe, with a press release to follow [67] Question: What is driving utilization in multiple myeloma? - The company reported 5% growth in demand, with utilization driven by its flexible combination therapy positioning in both community and academic settings [82] Question: What is the normal run rate of return product? - The atypical returns of $5 million were related to high-dose products, and the company does not expect this to continue into future quarters [89] Question: How confident is the company in reaching its revenue guidance? - The company believes it can deliver at the lower end of its revenue guidance due to strong demand growth and global partner revenue [97]
Karyopharm Therapeutics(KPTI) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:30
Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $30 million, down from $33.1 million in Q1 2024 [44] - U.S. XPOVIO net product revenue decreased to $21.1 million from $26 million year-over-year, attributed to a $5 million increase in product return reserves [45] - Gross to net provisions for XPOVIO increased to 45% from 29.3% in the same period in 2024 [45] - Cash, cash equivalents, and investments at the end of Q1 2025 were $70.3 million, down from $109.1 million at the end of 2024 [46] Business Line Data and Key Metrics Changes - Demand growth for Q1 was 5% year-over-year, with net product revenue impacted by atypical returns of expired products [38] - Royalty revenue increased by 57% to $1.7 million in Q1 2025 compared to Q1 2024, reflecting growing global demand for XPOVIO [40] Market Data and Key Metrics Changes - The multiple myeloma market remains highly competitive, with expectations of additional new entrants this year [39] - The company anticipates a peak revenue potential of approximately $1 billion in the U.S. for selinexor in myelofibrosis if approved [8] Company Strategy and Development Direction - The company is focused on completing enrollment in the Phase III SENTRY trial for myelofibrosis and advancing the Phase III trial in endometrial cancer [5][36] - The strategy includes leveraging a profitable commercial organization in multiple myeloma to drive rapid commercialization in new disease areas [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of selinexor to redefine the standard of care in myelofibrosis, with encouraging clinical data supporting its efficacy [6][34] - The company is exploring various opportunities to extend its cash runway while focusing on advancing clinical trials and commercial performance [49] Other Important Information - The Phase III SENTRY trial passed its pre-specified futility analysis, allowing the study to continue as planned [33] - The company expects to complete enrollment in the SENTRY trial by June-July 2025 [67] Q&A Session Summary Question: Can you talk about the futility analysis and what it was based on? - The futility analysis was based on efficacy and safety data from the first 61 patients, focusing on SVR35 and absolute TSS [53][54] Question: What are the assumptions for reaching full enrollment in June and July? - The company is currently 80% enrolled and expects to complete enrollment in the June-July timeframe, with a press release to follow [67][68] Question: What is driving utilization in multiple myeloma? - The company reported 5% growth in demand, with strong performance in both community and academic settings, leveraging its differentiated mechanism of action [82] Question: What is the normal run rate of return product? - The atypical returns of $5 million were related to high-dose products and are not expected to continue into future quarters [88][89] Question: How confident is the company in reaching its revenue guidance? - The company believes it can deliver at the lower end of its revenue guidance due to strong demand growth and global partner performance [96]
Karyopharm Therapeutics(KPTI) - 2025 Q1 - Earnings Call Presentation
2025-05-12 20:21
First Quarter 2025 Financial Results & Business Update May 12, 2025 On Today's Call • Welcome Brendan Strong, SVP, Investor Relations and Corporate Communications • Overview Richard Paulson, President and Chief Executive Officer • Pipeline Update Dr. Reshma Rangwala, Chief Medical Officer and Head of Research Sohanya Cheng, Chief Commercial Officer and Head of Business Development • Financial Results and Guidance Lori Macomber, Chief Financial Officer and Treasurer • Closing Remarks Richard Paulson, Preside ...
Karyopharm Therapeutics(KPTI) - 2025 Q1 - Quarterly Report
2025-05-12 20:14
Revenue Performance - For the three months ended March 31, 2025, product revenue decreased by $4.95 million (19%) to $21.05 million compared to $26.01 million in the same period of 2024, primarily due to an increase in the gross-to-net provision[105]. - License and other revenue increased by $1.84 million (26%) to $8.96 million for the three months ended March 31, 2025, driven by a $1.2 million revenue recognition for reimbursement of development-related expenses from Menarini[108]. - Total revenue for the three months ended March 31, 2025, was $30.02 million, a decrease of $3.11 million (9%) from $33.13 million in the same period of 2024[105]. Operating Expenses - Operating expenses decreased by $3.61 million (5%) to $63.27 million for the three months ended March 31, 2025, compared to $66.89 million in 2024[110]. - Selling, general and administrative expenses decreased by $2.2 million to $27.4 million in Q1 2025 compared to Q1 2024[115]. - Research and development expenses for Q1 2025 decreased by $0.8 million to $34.6 million compared to Q1 2024[113]. Net Loss and Financial Position - The net loss for the three months ended March 31, 2025, was $23.46 million, a reduction of $13.90 million (37%) from a net loss of $37.36 million in the same period of 2024[105]. - As of March 31, 2025, the company had an accumulated deficit of $1.6 billion and substantial doubt regarding its ability to continue as a going concern within one year[101]. - The company expects to incur significant operating losses in the foreseeable future, raising substantial doubt about its ability to continue as a going concern[120]. Cash and Investments - As of March 31, 2025, the company had $69.9 million in cash, cash equivalents, and investments, with a loss of $23.5 million for the quarter[119]. - Cash, cash equivalents, and investments amount to $69.9 million as of March 31, 2025[132]. - The company has a requirement to maintain at least $25.0 million in cash and equivalents at all times due to debt obligations[130]. Future Obligations - Headquarters lease costs amount to $10.9 million through September 30, 2030[131]. - Future obligations related to the 2025 Notes total $25.2 million through October 2025[131]. - Future obligations related to the 2029 Notes are $144.7 million through May 2029[131]. - Future obligations under the Credit Agreement are $141.9 million through May 2028, with a requirement to maintain at least $25.0 million in cash and equivalents[131]. - Future royalty obligations to HCRx under the Amended Revenue Interest Agreement total $117.8 million by October 1, 2031[131]. Clinical Development and Strategy - The company plans to continue clinical trials and seek additional approvals for selinexor as a single agent or in combination with other therapies to expand treatment options[100]. - The company expects net product revenue to increase in the second quarter of 2025 due to improved gross-to-net favorability with product returns aligning with historical averages[107]. - Clinical trial costs for Selinexor in myelofibrosis increased by $5.0 million to $11.4 million, while costs for multiple myeloma decreased by $2.1 million to $1.9 million[113]. - The company anticipates research and development expenses to remain consistent in Q2 2025 as it continues to invest in clinical trials[114]. Other Financial Information - Other income increased by $13.4 million to $9.8 million in Q1 2025, primarily due to a $20.0 million non-cash gain from remeasurement of derivatives[117]. - Net cash used in operating activities decreased by $4.7 million to $39.0 million in Q1 2025 compared to Q1 2024[121]. - The company entered into refinancing transactions in May 2024, borrowing $100 million and exchanging $148 million of existing notes for new secured convertible senior notes[102]. Risk Factors - Company is exposed to interest rate sensitivity, but a 100 basis point shift would not materially affect the investment portfolio's fair market value[132]. - Company does not hedge foreign currency exchange rate risk, exposing it to fluctuations in foreign currency rates[134]. - Contracts with organizations in Canada, the UK, and Europe are denominated in foreign currencies, impacting budget stability[134]. - Company cannot provide assurance against potential losses on deposits and investments due to financial institution instability[133].
Karyopharm Therapeutics(KPTI) - 2025 Q1 - Quarterly Results
2025-05-12 20:06
Exhibit 99.1 Karyopharm Reports First Quarter 2025 Financial Results and Announces New Data in Myelofibrosis that Further Suggests Selinexor May Lead to Meaningful Spleen Volume Reduction, Symptom Improvement, Hemoglobin Stabilization and Disease Modification – New Randomized Phase 2 Monotherapy Data from XPORT-MF-035 Trial in a Hard-to-Treat Patient Population Further Strengthens Conviction in Selinexor's Potential in Combination with Ruxolitinib in JAKi-Naïve Myelofibrosis in Ongoing Phase 3 SENTRY Trial ...
Karyopharm Reports First Quarter 2025 Financial Results and Announces New Data in Myelofibrosis that Further Suggests Selinexor May Lead to Meaningful Spleen Volume Reduction, Symptom Improvement, Hemoglobin Stabilization and Disease Modification
Prnewswire· 2025-05-12 20:05
Core Insights - Karyopharm Therapeutics reported positive developments in its Phase 3 SENTRY trial for selinexor in JAKi-naïve myelofibrosis, which has passed a planned futility analysis and is approximately 80% enrolled [2][4] - The company experienced a 5% increase in demand for XPOVIO® (selinexor) in Q1 2025 compared to Q1 2024, with total revenue of $30.0 million [5][15] - Karyopharm reaffirmed its full-year 2025 revenue guidance of $140 million to $155 million, including U.S. net product revenue guidance of $115 million to $130 million [21] Financial Performance - Total revenue for Q1 2025 was $30.0 million, down from $33.1 million in Q1 2024 [15] - U.S. net product revenue was $21.1 million in Q1 2025, compared to $26.0 million in Q1 2024, impacted by a $5.0 million increase in product return reserves [16] - License and other revenue increased to $9.0 million in Q1 2025 from $7.1 million in Q1 2024, attributed to timing of revenue recognition from Menarini [17] Research and Development Highlights - The Phase 3 SENTRY trial is evaluating the combination of selinexor and ruxolitinib, targeting 350 patients for enrollment [4] - The Phase 2 XPORT-MF-035 trial showed promising results for selinexor monotherapy in hard-to-treat myelofibrosis patients, with 67% achieving spleen volume reduction of 25% or more [10] - Enrollment continues in the Phase 3 XPORT-EC-042 trial for selinexor as maintenance therapy in advanced endometrial cancer [6] Operational Objectives - Karyopharm aims to complete target enrollment for the Phase 3 SENTRY trial by June/July 2025 and report top-line results in late 2025/early 2026 [11] - The company is exploring alternatives to extend its cash runway, with cash and investments totaling $70.3 million as of March 31, 2025 [25][14] - R&D expenses for Q1 2025 were $34.6 million, slightly down from $35.4 million in Q1 2024, reflecting reduced personnel costs [19]
Karyopharm to Report First Quarter 2025 Financial Results on May 12, 2025
Prnewswire· 2025-05-08 20:05
-- Conference Call Scheduled for Monday, May 12, 2025, at 4:30 p.m. ET --NEWTON, Mass., May 8, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced it will report first quarter 2025 financial results on Monday, May 12, 2025. Karyopharm's management team will host a conference call and audio webcast at 4:30 p.m. ET on Monday, May 12, 2025, to discuss the financial results and other company updates.To acc ...
XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC
Prnewswire· 2025-03-05 05:00
Core Viewpoint - Antengene Corporation Limited has successfully expanded the approval and commercial presence of its drug XPOVIO® (selinexor) in multiple APAC markets, including Indonesia, enhancing its position in the biopharmaceutical industry focused on innovative cancer treatments [2][4]. Group 1: Product Approval and Indications - XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia, with its New Drug Application (NDA) approved for three indications related to multiple myeloma and diffuse large B-cell lymphoma [1][2]. - The drug has been approved for multiple indications in ten markets across the APAC region, including health insurance coverage in China, Taiwan, Australia, Singapore, and South Korea [1][3]. Group 2: Market Potential and Expansion - The ASEAN region, with a population exceeding 600 million and steady economic growth, presents significant potential for biomedical development, driven by an aging population and increasing disease burden [4]. - Antengene is actively working to expand its presence in APAC markets to introduce more innovative medicines, aiming to improve healthcare levels and benefit patients in need [4]. Group 3: Mechanism of Action and Development - XPOVIO® is the world's first orally-available, selective XPO1 inhibitor, which promotes the accumulation of tumor suppressor proteins and down-regulates oncogenic proteins, delivering antitumor effects through multiple pathways [6][7]. - Antengene is developing various combination regimens of XPOVIO® for additional indications, including myelofibrosis and endometrial cancer, and is conducting multiple clinical studies in China [5][7]. Group 4: Company Overview and Pipeline - Antengene is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative therapeutics for hematologic malignancies and solid tumors, with a vision of "Treating Patients Beyond Borders" [9]. - Since 2017, Antengene has built a pipeline of 9 oncology assets, obtained 31 investigational new drug (IND) approvals, and submitted 10 NDAs in various Asia Pacific markets [10].
Karyopharm Announces 1-for-15 Reverse Stock Split
Prnewswire· 2025-02-24 13:40
Core Viewpoint - Karyopharm Therapeutics Inc. will implement a 1-for-15 reverse stock split to increase the per-share market price of its common stock, aiming to regain compliance with Nasdaq listing requirements [1][9]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 5:00 p.m. Eastern Time on February 25, 2025, and trading on a split-adjusted basis will begin on February 26, 2025 [1][2]. - The number of issued and outstanding shares will decrease from approximately 126.2 million to approximately 8.4 million shares, and authorized shares will reduce from 800 million to 53.33 million [3]. - Proportional adjustments will be made to equity incentive plans, outstanding equity awards, and convertible notes in accordance with their terms [3]. Group 2: Shareholder Impact - No fractional shares will be issued; instead, stockholders entitled to a fractional share will receive a cash payment [4]. - Stockholders holding shares electronically will not need to take action to receive post-split shares, while those with shares through banks or brokers will have their positions adjusted accordingly [5]. Group 3: Company Overview - Karyopharm Therapeutics is a commercial-stage pharmaceutical company focused on novel cancer therapies, particularly oral compounds addressing nuclear export dysregulation [7]. - The company's lead product, XPOVIO® (selinexor), is approved in the U.S. and marketed in multiple oncology indications, with regulatory approvals in various international markets [7].
Karyopharm Therapeutics(KPTI) - 2024 Q4 - Earnings Call Transcript
2025-02-19 16:05
Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $30.5 million, down from $33.7 million in Q4 2023, primarily due to lower milestone-related revenue from licensing agreements [51] - Total revenue for the full year was $145.2 million, compared to $146 million in 2023 [52] - U.S. XPOVIO net product revenue for Q4 2024 was $29.3 million, up from $25.1 million in Q4 2023, and for the full year, it was $112.8 million compared to $112 million in 2023 [52] - The gross-to-net discount for XPOVIO was 33.3% for Q4 2024 and 30.9% for the full year, compared to 23.5% and 22.3% in the same periods in 2023 [52] - R&D expenses for Q4 2024 were $33.3 million, down from $39.4 million in Q4 2023, while for the full year, R&D expenses were $143.2 million compared to $138.8 million in 2023 [53] - SG&A expenses for Q4 2024 were $27.2 million, down from $30.7 million in Q4 2023, and for the full year, SG&A expenses were $115.4 million compared to $131.9 million in 2023 [54] Business Line Data and Key Metrics Changes - XPOVIO net product revenue for Q4 2024 was $29.3 million, consistent with Q3 2024 and up 16% compared to Q4 2023 [40] - For the year, XPOVIO net product revenue was $112.8 million, up from $112 million in 2023, despite increased competition [41] - 60% of XPOVIO sales came from the community setting, indicating strong demand despite competition [42] Market Data and Key Metrics Changes - The company expects to grow XPOVIO net product revenue in 2025 and reduce expenses while advancing clinical programs [9] - The peak revenue potential for Selinexor in myelofibrosis is estimated at approximately $1 billion in the U.S. alone if approved [15] Company Strategy and Development Direction - The company aims to redefine the standard of care in myelofibrosis and endometrial cancer, focusing on advancing Phase 3 clinical trials [9][60] - The strategy includes cost reduction initiatives and resource allocation towards pivotal clinical trials [8][55] - The company is preparing for a potential launch of Selinexor in combination with Ruxolitinib in myelofibrosis, targeting a rapid market entry [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase 3 trial data for myelofibrosis and endometrial cancer, viewing these as transformative opportunities [60] - The company remains focused on maintaining a profitable commercial organization while navigating a competitive landscape [41][58] - Management highlighted the importance of being well-capitalized to support ongoing operations and clinical trials [110] Other Important Information - The company exited 2024 with cash and investments of $109.1 million, down from $192.4 million at the end of 2023 [56] - Guidance for 2025 includes total revenue of $140 million to $155 million, with U.S. XPOVIO net product revenue projected between $115 million and $130 million [56] Q&A Session Summary Question: Can you provide insights on the myelofibrosis Phase 3 trial and the expected TSS reduction for statistical significance? - Management indicated that a delta of three to four points in TSS would be meaningful, with previous trials showing statistical significance with smaller differences [64][66] Question: What drove the recent FDA discussions regarding the endometrial cancer study? - The FDA recommended focusing on the pMMR patient population due to the evolving standard of care with new therapies, which led to modifications in the trial design [70][73] Question: How is enrollment progressing in the endometrial cancer trial? - Enrollment is on track with approximately 276 patients expected, and top-line results are anticipated in mid-2026 [105] Question: Can you elaborate on the cash runway guidance relative to the Phase 3 studies? - The company is exploring various financing options to extend its cash runway while maintaining a profitable revenue-generating business [110][111] Question: What are the characteristics of the dMMR population not eligible for checkpoint inhibitors? - The dMMR patients are typically excluded due to comorbidities rather than tumor characteristics, and no unique features were identified [115]