Karyopharm Therapeutics(KPTI)

Search documents
Karyopharm to Report Second Quarter 2024 Financial Results on August 6, 2024
Prnewswire· 2024-07-31 20:05
-- Conference Call Scheduled for Tuesday, August 6, 2024, at 8:00 a.m. ET -- NEWTON, Mass., July 31, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced it will report second quarter 2024 financial results on Tuesday, August 6, 2024. Karyopharm's management team will host a conference call and audio webcast at 8:00 a.m. ET on Tuesday, August 6, 2024, to discuss the financial results and other company u ...
Antengene Announces XPOVIO® (selinexor) National Health Insurance Service Approval for Reimbursement in South Korea
Prnewswire· 2024-06-26 08:42
- Additional reimbursements of XPOVIO® in APAC markets are expected. MM, the second most common hematologic malignancy, is caused by the dysregulated proliferation of plasma cells. Patients with MM face a range of challenges including a high relapse rate, short survival, and limited treatment options. According to market data, the global MM market has exceeded US$17 billion in 2023 and is expected to reach US$ 26 billion by 2028, with a compound annual growth rate (CAGR) of 8.7%[1]. Antengene has already su ...
Karyopharm Therapeutics(KPTI) - 2024 Q1 - Quarterly Report
2024-05-08 20:13
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36167 Karyopharm Therapeutics Inc. (Exact name of registrant as specified in its charter) (State or other jur ...
Karyopharm Therapeutics(KPTI) - 2024 Q1 - Quarterly Results
2024-05-08 11:47
Exhibit 99.1 Targeting Disease at the Nuclear Pore "We have taken a significant step that improves our capital structure, strengthening our opportunity to realize the full value of three potential new indications for selinexor. We are strongly positioned for our next stage of growth, driven by our focused and rapidly advancing late-stage pipeline with expected data readouts from our three ongoing Phase 3 trials next year," said Richard Paulson, President and Chief Executive Officer of Karyopharm. First Quar ...
Karyopharm Announces Significant Refinancing Transactions and Amended Royalty Agreement Extending Vast Majority of Its Debt Maturities into 2028 and 2029
Prnewswire· 2024-05-08 11:30
– $148.0 Million (86%) of Existing Convertible Notes due in 2025 to be Exchanged for $111.0 Million of New Convertible Notes due in 2029 and Warrants – – Issues New $100.0 Million Senior Secured Term Loan due in 2028 – – Repays Principal Portion and Amends Royalty Agreement with HealthCare Royalty – NEWTON, Mass., May 8, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, announced today that it has entered into a ser ...
Karyopharm Therapeutics: Spiraling Despite Upcoming Catalysts
Seeking Alpha· 2024-04-30 18:28
Thomas Barwick Topline Summary and Update Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a long-struggling commercial-stage biotech working on developing the market for their nuclear exportin 1 inhibitor selinexor. While it is currently approved to treat multiple myeloma in later lines of therapy, KPTI is on track to potentially expand the label into endometrial cancer, with a phase 3 trial eagerly anticipated (though still a ways away). Now that we know the abstracts being presented at the American Society ...
Karyopharm Therapeutics(KPTI) - 2023 Q4 - Earnings Call Transcript
2024-02-29 16:26
Financial Data and Key Metrics Changes - Total revenue for Q4 2023 was $33.7 million, consistent with Q4 2022, while total revenue for the full year 2023 was $146 million, down from $157.1 million in 2022 [55][56] - Net product revenue from US commercial sales of XPOVIO for Q4 2023 was $25.1 million, compared to $31.1 million in Q4 2022, and for the full year 2023, it was $112 million, down from $120.4 million in 2022 [56][60] - The gross-to-net discount for XPOVIO in Q4 2023 was 23.5%, and for the full year 2023, it was 22%, with expectations for 2024 to be in the 25% to 30% range [68] Business Line Data and Key Metrics Changes - XPOVIO's new patient share in the community setting approached 70% in the second to fourth line, representing double-digit growth year-over-year [44] - The community setting now accounts for two-thirds of the business, with a 20% year-over-year increase in prescribing sites [51][52] - The company expects US XPOVIO net product revenue for 2024 to be in the range of $100 million to $120 million, reflecting a balance of growth conviction and competitive market recognition [60][71] Market Data and Key Metrics Changes - The competitive landscape in the multiple myeloma market has intensified, particularly with the introduction of bispecific therapies in the second half of 2023, impacting demand in the academic setting [12][44] - Despite competition, the company achieved total demand growth year-on-year in the community setting in 2023, which is a key growth driver for 2024 [84] Company Strategy and Development Direction - The company is focused on advancing its late-stage pipeline, particularly in myelofibrosis and endometrial cancer, with three pivotal Phase 3 trials expected to read out results in 2025 [5][17] - The strategy includes shifting the use of selinexor into earlier lines of therapy, where patients tend to stay on treatment longer, thus increasing duration of therapy [95] - The company aims to leverage its existing commercial infrastructure to support rapid launches of selinexor in new indications, with a potential peak annual revenue of approximately $2 billion in the US alone [13][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase 3 studies and the potential for selinexor to address high unmet needs in cancer treatment [67][73] - The company anticipates a cash runway into late 2025, supported by expected revenues from XPOVIO and partnerships [66][71] - Management highlighted the importance of evolving the regulatory landscape and potential changes in study design to enhance the value proposition of selinexor [105] Other Important Information - The company reported a decrease in R&D expenses due to reduced personnel costs, while SG&A expenses also decreased, reflecting cost optimization efforts [64][69] - The existing cash and investments as of December 31, 2023, totaled $192.4 million, down from $279.7 million in 2022 [70] Q&A Session Summary Question: Can you quantify the community versus academic setting growth in 2023? - The company achieved total demand growth year-on-year in the community setting, with a 20% increase in prescriber base, which is a significant growth driver for 2024 [84][85] Question: What is the impact of BCMA therapies moving into 2024? - The introduction of bispecific therapies posed a significant competitive threat in the academic setting, but the community setting has not seen a major impact yet [78] Question: Can you comment on the enrollment experience of the Phase 3 SPD triplet study in multiple myeloma? - Enrollment is progressing well, with significant interest in the study both in the US and EU, and completion of enrollment is expected later this year [115] Question: What is the company's cash position and runway? - The company finished 2023 with $192 million in cash, with a projected cash runway into late 2025, considering expected revenues and expenditures [119]
Karyopharm Therapeutics(KPTI) - 2023 Q4 - Earnings Call Presentation
2024-02-29 16:00
Fourth Quarter and Full Year 2023 Financial Results & Business Update • Welcome Elhan Webb, CFA, Senior Vice President, Investor Relations • Overview Dr. Reshma Rangwala, Chief Medical Officer • Commercial Highlights Richard Paulson, President and Chief Executive Officer • Q&A Session XPOVIO® (selinexor) and NEXPOVIO® (selinexor) are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this presentation are the property of their respective owners. All rights reserved. 3 ...
Karyopharm Therapeutics(KPTI) - 2023 Q4 - Annual Report
2024-02-29 12:43
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36167 KARYOPHARM THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 26-3931704 (State ...
Karyopharm Therapeutics(KPTI) - 2023 Q3 - Earnings Call Transcript
2023-11-02 18:25
Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $36 million, slightly down from $36.1 million in Q3 2022 [36] - Net product revenue from U.S. sales of XPOVIO was $30.2 million in Q3 2023, compared to $32 million in Q3 2022, impacted by higher patient assistance program utilization and increased gross to net discounts [37] - Cash and cash equivalents totaled $209.2 million as of September 30, 2023, down from $279.7 million at the end of 2022, with a cash runway expected through late 2025 [39][40] Business Line Data and Key Metrics Changes - XPOVIO delivered $30.2 million in net sales in Q3 2023, with total demand year-over-year declining 3% compared to Q3 2022, primarily due to increased competition in late lines [17][32] - The utilization of the patient assistance program (PAP) contributed to 9% of total demand in Q3 2023, up from 4% in Q3 2022, reflecting higher patient engagement [18] - The NCCN has updated guidelines to recommend switching classes of therapy, enhancing XPOVIO's positioning in the treatment landscape [20] Market Data and Key Metrics Changes - The company expects total revenues in 2023 to be between $145 million and $160 million, with XPOVIO net U.S. product revenue projected between $110 million and $125 million [40] - The new patient share mix for XPOVIO in the second to fourth line was over 60%, representing approximately 20% growth year-over-year [49] Company Strategy and Development Direction - The company is focused on advancing its mid and late-stage pipeline, with three pivotal Phase 3 trials expected to read out data through 2024 and 2025 [4][90] - There is a strong emphasis on cost management, with a 12% reduction in R&D and SG&A expenses year-over-year for the first nine months of 2023 [38] - The company aims to leverage its commercialization capabilities and relationships in the community to drive growth across multiple indications [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for selinexor to change treatment paradigms in multiple myeloma and endometrial cancer [42][90] - The company is optimistic about the upcoming data readouts and the impact of recent guideline updates on XPOVIO's market positioning [60][76] Other Important Information - The company has reduced its workforce by approximately 20% to strengthen its financial position for ongoing Phase 3 studies [36] - The collaboration with BMS to evaluate selinexor in combination with mezigdomide is expected to enhance treatment options for multiple myeloma patients [93] Q&A Session Summary Question: Contextualizing new IMF data and Phase 3 top line data expectations - Management highlighted the impressive efficacy of the combination of selinexor and ruxolitinib in JAK naive patients, with a focus on the durability of responses [46] Question: Update on eltanexor development plans - Management remains enthusiastic about eltanexor's data in hard-to-treat patient populations, with encouraging survival rates observed [47] Question: Enrollment progress and repo rates in early line patients - Enrollment is proceeding well, driven by enthusiasm around new data, with a noted increase in new patient starts in earlier lines [57] Question: Impact of NCCN guideline updates on XPOVIO - The elevation of XPOVIO to category one in NCCN guidelines is expected to strengthen its position in the community and drive steady growth [60] Question: Overall survival data from the SIENDO Phase 3 study - Initial overall survival data is anticipated to be presented later this year, with ongoing monitoring of patient populations [71] Question: Impact of foundation closures on PAP - The impact of PAP is expected to remain similar in Q4 as in Q3, with anticipated changes in Medicare Part D design expected to reduce reliance on PAP in 2024 [85]