On January 9, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported preliminary unaudited fourth quarter and full year 2022 total revenue and U.S. XPOVIO net product revenue estimates and outlined its 2022 achievements and 2023 objectives (Press release, Karyopharm, JAN 9, 2023, View Source [SID1234626077]).
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Based on preliminary unaudited financial information, Karyopharm expects total revenue, which includes license and royalty revenue from partners, to be approximately $34.2 million for the fourth quarter 2022 and approximately $157.7 million for the full year 2022, and net product revenue for XPOVIO in the U.S. to be approximately $31.1 million for the fourth quarter 2022 and approximately $120.4 million for the full year 2022, representing growth of 22% over 2021.
"In 2022, we delivered solid revenue growth with XPOVIO and made meaningful progress with our pipeline, achieving several clinical and regulatory milestones. Importantly, we solidified our financial runway to late 2025, enabling us to be well positioned to deliver the next stages of the company’s growth. Moving forward in 2023, we look to continue growing our foundation in multiple myeloma, progressing our focused clinical pipeline through several important milestones, and leveraging both our commercialization and mid to late-stage clinical development expertise to deliver value for our shareholders and patients," said Richard Paulson, President and Chief Executive Officer of Karyopharm.
Key Program Highlights in 2022
Selinexor in Multiple Myeloma (MM)
Over 20% U.S. revenue growth driven by continued progress in shifting selinexor use into earlier lines of therapy and strong growth in the community setting, accounting for approximately 70% of selinexor revenues, offsetting increased pressure in the academic setting due to intensifying late-line competition and ongoing trials.
Selinexor is now approved in 40 countries globally, following full marketing authorization from the European Commission for NEXPOVIO (selinexor) in combination with bortezomib (Velcade) and dexamethasone (SVd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, expanding the indication to 2L+.
First patient dosed in pivotal Phase 3 study, in collaboration with and sponsored by the European Myeloma Network (EMN), evaluating an all-oral regimen of selinexor in combination with pomalidomide and dexamethasone post anti-CD38 therapy in relapsed/refractory MM.
Selinexor in Endometrial Cancer (EC)
Initiated pivotal Phase 3 study of selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (EC-042; NCT03555422).
Entered into a global collaboration with Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, to develop FoundationOneCDx as a companion diagnostic for selinexor and to identify and enroll patients whose tumors are TP53 wild-type in the EC-042 Phase 3 study.
Eltanexor in Myelodysplastic Neoplasms (MDS)
Completed recruitment for the interim analysis of the Phase 2 study evaluating eltanexor in relapsed/refractory MDS.
Received orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission for eltanexor for the treatment of MDS. The FDA also granted Fast Track Designation for eltanexor in MDS.
Selinexor in Myelofibrosis (MF)
Presented encouraging preliminary data results from the Phase 1 study (XPORT-MF-034) evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve MF at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Initial data from this study were also presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress and ASCO (Free ASCO Whitepaper).
Received orphan drug designations from the FDA and the European Commission for selinexor for the treatment of MF.
Corporate and Financial Highlights for 2022
Based on preliminary unaudited financial information, expect total revenue to be approximately $157.7 million, including estimated U.S. XPOVIO net product revenue of approximately $120.4 million, an increase of 22% from 2021.
Cash, cash equivalents, restricted cash and investments as of December 31, 2022 was approximately $279.0 million, following the completion of a $165 million private placement in December 2022, extending cash runway to late 2025.
Strengthened leadership team with several key appointments, including Reshma Rangwala, MD, PhD as Chief Medical Officer and Stuart Poulton as Chief Development Officer.
Anticipated Near-Term Catalysts and Operational Objectives in 2023
Continue to grow our commercial foundation in the competitive multiple myeloma marketplace, driving increased XPOVIO sales.
Additional global launches of selinexor by partners in ex-U.S. territories.
Present data supporting optimization of selinexor dose in multiple myeloma and other key programs.
Continue to generate data demonstrating selinexor’s efficacy, combinability and tolerability in patients with multiple myeloma.
Report interim data from the Phase 2 study evaluating eltanexor in relapsed/refractory MDS in 1Q.
Report updated results from the Phase 1 study of selinexor in combination with ruxolitinib in patients with treatment-naïve MF in 1H. Initiate pivotal Phase 3 study in front-line myelofibrosis in 1H 2023, subject to regulatory feedback.
Present updated subgroup analysis results in patients with TP53 wild-type endometrial cancer from the SIENDO study at a medical conference in 2023 further supporting rationale for EC-042 pivotal Phase 3 study.
Further exploration of biomarker subsets to identify patient populations who best respond to SINE compounds.
The financial information presented in this press release may be adjusted as a result of the completion of customary quarterly and annual review and audit procedures.
Listen to the Webcast
These achievements and updates will be discussed during a webcast presentation at the 41st Annual J.P. Morgan Healthcare Conference to be held on January 11, 2023, at 1:30 p.m. Eastern Time/10:30 a.m. Pacific Time. A live webcast of the presentation and breakout session, along with accompanying slides, can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived replay will be available for 30 days following the event. The presentation slides will also be available on the Company’s website following the event.