Full Press Release Details
Karyopharm Announces Preliminary Unaudited Fourth Quarter and Full Year 2022 Revenue and Outlines 2023
Preliminary Unaudited Full Year 2022 Total Revenue and U.S.
XPOVIO (selinexor) Net Product Revenue Expected to be Approximately $157.7 Million and $120.4 Million, Respectively, Meeting Company s Guidance
Initiated Pivotal Phase 3 Study Evaluating Selinexor as a Maintenance Therapy in Women with Advanced or Recurrent TP53 Wild-Type
Endometrial Cancer; Encouraging Updated Exploratory Subgroup Analysis in Patients with TP53 Wild-Type Endometrial Cancer Continues to Support Study Rationale; Partnership with Foundation Medicine to Develop TP53 Companion Diagnostic
Planning to Initiate Pivotal Phase 3 Study in Front-Line Myelofibrosis in 1H 2023; Report Updated Results from the Phase 1 study of
Selinexor in Combination with Ruxolitinib in Patients with Treatment-Na ve MF in 1H 2023
Anticipate Multiple Data Catalysts and Progress Across Multiple Myeloma, Myelofibrosis, Endometrial Cancer and Myelodysplastic
Extended Cash Runway to Late 2025
NEWTON, Mass. January 9, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel
cancer therapies, today announced 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.
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)
Selinexor in Endometrial Cancer (EC)
Eltanexor in Myelodysplastic Neoplasms (MDS)
Selinexor in Myelofibrosis
Corporate and Financial Highlights for 2022
Anticipated Near-Term Catalysts and Operational Objectives in 2023
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, http://investors.karyopharm.com/events-presentations. 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.
About XPOVIO (selinexor)
XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of
Karyopharm s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and
marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least
one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large
B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO
in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom,
China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.
Please refer to the local Prescribing Information for full details.
Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet
need cancer indications, including in endometrial cancer and myelofibrosis.
For more information about Karyopharm s products or clinical trials,
please contact the Medical Information department at:
Tel: +1 (888) 209-9326
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Use In Specific Populations
Lactation: Advise not to
For additional product information, including full prescribing information, please visit www.XPOVIO.com.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Karyopharm Therapeutics
Karyopharm Therapeutics
Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was
developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm s lead SINE compound and first-in-class, oral exportin 1
(XPO1) inhibitor, XPOVIO (selinexor), is approved in the U.S. and marketed by the Company in three oncology
indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the
United Kingdom (as NEXPOVIO ) and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer,
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm s preliminary financial information for the fourth quarter and full year
2022; guidance on its expected cash runway; the ability of selinexor to treat patients with multiple myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma, solid tumors and other diseases;
expectations with respect to commercialization efforts; and expectations with respect to the clinical development plans and potential regulatory submissions of selinexor and eltanexor. 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 Karyopharm s current expectations. For example, there can be no guarantee that Karyopharm will successfully
commercialize XPOVIO or that any of Karyopharm s drug candidates, including selinexor and eltanexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm s drug candidates will continue.
Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm s drug candidate portfolio will result in stock price appreciation. Management s expectations and, therefore, any
forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could
disrupt Karyopharm s business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the
development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption
of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm s drug candidates that receive regulatory approval; the ability to obtain and retain regulatory approval of XPOVIO or any of
Karyopharm s drug candidates that receive regulatory approval; Karyopharm s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the
content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional
clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement;
Karyopharm s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm s competitors for products or product candidates in which
Karyopharm is currently commercializing or developing; and Karyopharm s ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. These and other risks are described
under the caption Risk Factors in Karyopharm s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on
November 3, 2022, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly
disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
XPOVIO and NEXPOVIO are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.
Senior Vice President, Investor Relations
617.658.0600 | elhan.webb@karyopharm.com
Vice President, Corporate Communications
617.658.0600 | sarah.connors@karyopharm.com