Full Press Release Details
Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company
Total Revenue of $146 Million and U.S. XPOVIO (selinexor)
Net Product Revenue of $112 Million for Full Year 2023, Meeting Company s Guidance
Top-Line Data Readouts from Three Pivotal Phase 3 Trials Evaluating Selinexor in Endometrial Cancer, Myelofibrosis and Multiple Myeloma Expected in 2025
Company Provides Full-Year 2024 Total Revenue Guidance of $140 Million to $160 Million, Including U.S. XPOVIO Net Product Revenue
Guidance of $100 Million to $120 Million; Cash Runway to Late 2025
Conference Call Scheduled for Today at 8:00 a.m.
NEWTON, Mass. February 29, 2024 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a
commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the fourth quarter and full year ended December 31, 2023. In addition, Karyopharm highlighted select corporate milestones and
provided an overview of its key clinical development programs.
We made significant progress in 2023 across our clinical pipeline and continued to
build on our foundation in the highly competitive multiple myeloma space. The encouraging clinical results that we presented last year reinforce the potential of our three ongoing pivotal Phase 3 trials in addressing critical unmet needs of cancer
patients, said Richard Paulson, President and Chief Executive Officer of Karyopharm. Our drive for innovation and progress will continue into 2024, by focusing our resources to advance our Phase 3 trials. We are enthusiastic about
the upcoming top-line read-outs from these trials and what they could mean for patients and selinexor s growth potential.
Fourth Quarter 2023 and Recent Highlights
and Development (R&D) Highlights
XPOVIO Commercial Performance
Intellectual Property
Anticipated Catalysts and Operational Objectives in 2024 and 2025
2024 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2024:
Full Year and Fourth Quarter 2023 Financial Results
Total revenue: Total revenue for the fourth quarter of 2023 was $33.7 million, compared to $33.6 million for the fourth quarter of 2022. Total
revenue for the year ended December 31, 2023 was $146.0 million, compared to $157.1 million for the year ended December 31, 2022.
Net product revenue: Net product revenue for the fourth quarter of 2023 was $25.1 million, compared to $31.1 million for the fourth quarter
of 2022. Net product revenue for the year ended December 31, 2023 was $112.0 million, compared to $120.4 million for the year ended December 31, 2022.
License and other revenue: License and other revenue for the fourth quarter of 2023 was
$8.7 million, compared to $2.5 million for the fourth quarter of 2022. License and other revenue for the year ended December 31, 2023 was $34.0 million, compared to $36.6 million for the year ended December 31, 2022.
Cost of sales: Cost of sales for the fourth quarter of 2023 was $1.5 million, compared to $1.9 million for the fourth quarter of 2022.
Cost of sales for the year ended December 31, 2023 was $4.9 million, compared to $5.2 million for the year ended December 31, 2022. Cost of sales reflects the costs of XPOVIO units sold and third-party royalties on net product
R&D expenses: R&D expenses for the fourth quarter of 2023 were $39.4 million, compared to $30.9 million for the fourth
quarter of 2022. R&D expenses for the year ended December 31, 2023 were $138.8 million, compared to $148.7 million for the year ended December 31, 2022. The decrease in R&D expenses in 2023 compared to 2022 was primarily
due to a decrease in personnel costs and stock-based compensation attributable to a reduction in headcount and contractors, including severance-related expenses incurred in 2022. These decreases were partially offset by an increase in clinical trial
and related costs primarily due to the advancement of the Company s three pivotal Phase 3 trials and the timing of purchases of comparator drug used in the Company s clinical trials.
SG&A expenses: SG&A expenses for the fourth quarter of 2023 were $30.7 million, compared to $34.6 million for the fourth quarter of
2022. SG&A expenses for the year ended December 31, 2023 were $131.9 million, compared to $145.4 million for the year ended December 31, 2022. The decrease in SG&A expenses in 2023 compared to 2022 was primarily due to a
decrease in stock-based compensation because of severance-related expenses incurred in 2022.
Interest expense: Interest expense for the fourth
quarter of 2023 was $6.2 million, compared to $5.9 million for the fourth quarter of 2022. Interest expense for the year ended December 31, 2023 was $23.8 million, compared to $25.0 million for the year ended
Net loss: Karyopharm reported a net loss of $41.8 million, or $0.36 per basic and diluted share, for the fourth
quarter of 2023, compared to a net loss of $38.5 million, or $0.43 per basic and diluted share, for the fourth quarter of 2022. Net loss includes non-cash stock-based compensation expense of
$5.2 million and $6.2 million for the fourth quarters of 2023 and 2022, respectively. Karyopharm reported a net loss of $143.1 million, or $1.25 per basic and diluted share, for the year ended December 31, 2023, compared to a net
loss of $165.3 million, or $2.02 per basic and diluted share, for the year ended December 31, 2022. Net loss includes non-cash stock-based compensation expense of $21.7 million and
$35.4 million for the years ended December 31, 2023 and 2022, respectively.
Cash position: Cash, cash equivalents, restricted cash and
investments as of December 31, 2023 totaled $192.4 million, compared to $279.7 million as of December 31, 2022.
Karyopharm will host a conference call today, February 29, 2024, at 8:00 a.m. Eastern Time, to discuss the fourth quarter and full
year 2023 financial results and the financial outlook for 2024 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and
ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under Events & Presentations in the Investor section of the Company s website. An
archived webcast will be available on the Company s website approximately two hours after 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 a growing number of ex-U.S. territories and countries, including Europe, the United Kingdom, South Korea, Israel, Singapore, Hong Kong, Mainland
China, Australia, Canada, Taiwan and Macau and is marketed in those areas by Karyopharm s global partners. 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,
XPOVIO (selinexor) is a prescription medicine approved:
SELECT IMPORTANT SAFETY INFORMATION
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 a growing number of ex-U.S. territories and countries, including Europe,
the United Kingdom, China, South Korea, Israel, Singapore, Hong Kong, Mainland China, Australia, Canada, Taiwan and Macau, and is marketed in those areas by Karyopharm s global partners.
Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer and myelofibrosis. For more information about our people, science and pipeline, please visit
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 guidance on its 2024 total revenue, 2024 U.S. net product revenue and 2024 R&D and SG&A expenses; Karyopharm s expected cash runway; expectations with respect to commercialization
efforts; the ability of selinexor to treat patients with multiple myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma, and other diseases; 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 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 trials, including
subsequent analysis of existing data and new data received from ongoing and future trials; 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 trials; 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; the direct or indirect impact of the COVID-19 pandemic or any
future pandemic on Karyopharm s business, results of operations and financial condition; 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, 2023, which was filed with
the Securities and Exchange Commission (SEC) on November 2, 2023, 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
Head of Corporate Communications
617.658.0540 |stacy.nobles@karyopharm.com