Full Press Release Details
Karyopharm Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress
Achieved Second Quarter 2023 Total Revenue of $37.6 Million and U.S. XPOVIO
(selinexor) Net Product Revenue of $28.5 Million
Maintains Full Year 2023 Total Revenue Guidance of $145 Million to
$160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million
Workforce Reduction Enhancing Financial Strength; Further Reduces Full Year 2023 Non-GAAP R&D and SG&A Expense Guidance to $240 Million to $255 Million; Cash Runway into Late 2025
Initiated Pivotal Phase 3 Study of XPO1 Inhibitor Selinexor and Ruxolitinib in JAK Inhibitor (JAKi) Na ve Myelofibrosis in June
2023 and Received Fast Track Designation from US FDA
Announced Long-Term Exploratory Subgroup Analyses Presented at
ASCO Plenary Providing Further Rationale for XPORT-EC-042, the Company s Ongoing Pivotal Phase 3 Study in Endometrial Cancer
Conference Call Scheduled for Today at 8:00 a.m. ET
NEWTON, Mass. August 2, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel
cancer therapies, today reported financial results for the quarter ended June 30, 2023. In addition, Karyopharm highlighted select corporate milestones and progress on its key clinical development programs and announced further optimization of
its organization and cost structure aimed at prioritizing focus on advancing its late-stage clinical pipeline and positioning the Company for sustained growth.
We had a strong second quarter executing against our key priorities with our late-stage clinical pipeline and XPOVIO commercial performance. We achieved
an important milestone this quarter with the initiation of our pivotal Phase 3 study evaluating selinexor in combination with ruxolitinib in JAKi-na ve patients with myelofibrosis. We are highly encouraged by the updated exploratory subgroup
analyses from SIENDO presented at the ASCO Plenary in July, which further strengthen the rationale of and our growing confidence in our ongoing XPORT-EC-042 study in patients with TP53 wild-type advanced or recurrent endometrial cancer. Finally, in
multiple myeloma, we are pleased to see continued growth in patients treated with XPOVIO, in both the community and academic settings despite increased competition.
As we continue to focus on our near-term Phase 3 clinical programs, driving benefit for our patients and creating value for our shareholders, we ve
also taken further actions to streamline our operations and optimize our cost structure and workforce to maximize the potential of these programs. We truly appreciate the hard work and dedication of all our employees, past and present, said
Richard Paulson, President and Chief Executive Officer of Karyopharm.
Second Quarter 2023 and Recent Highlights
Endometrial Cancer (EC)
Update on Intellectual
Optimization of Corporate Organization, Financial Position and Cost Structure
Second Quarter 2023 Financial Results
Revenues: Total revenue for the second quarter of 2023 was $37.6 million, compared to $39.7 million for the second quarter of 2022. The slight decrease was due primarily to a decline in license and other revenue.
Net product revenue: Net product revenue for the second quarter of 2023 was $28.5 million, compared with $29.0 million for the second quarter
License and other revenue: License and other revenue for the second quarter of 2023 was $9.1 million, compared to $10.7 million
for the second quarter of 2022. The decrease was primarily attributable to a decrease in revenue for the reimbursement of development-related expenses from the Menarini Group due to a corresponding decrease in the underlying expenses.
Cost of sales: Cost of sales for the second quarter of 2023 was $1.2 million, compared to $0.9 million for the second quarter of 2022. Cost
of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.
Research and development (R&D) expenses:
R&D expenses for the second quarter of 2023 were $31.5 million, compared to $44.3 million for the second quarter of 2022. The decrease was attributable to a decrease in personnel costs, stock-based compensation and clinical trial costs
related to our non-core programs, partially offset by costs incurred in 2023 related to our Phase 3 EC-042 study. The decrease in stock-based compensation is primarily
due to $3.8 million of severance-related stock-based compensation expenses incurred during the quarter ended June 30, 2022, in connection with the departure of our former Chief Scientific Officer.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the second quarter of 2023 were $34.5 million, compared to
$37.3 million for the second quarter of 2022. The decrease is primarily due to severance-related stock-based compensation expenses incurred during the quarter ended June 30, 2022, in connection with the departure of our former Chief
Interest income: Interest income for the second quarter of 2023 was $2.8 million, compared to $0.3 million for the
second quarter of 2022 due to higher average interest rates on our investments.
Interest expense: Interest expense for the second quarter of 2023
was $5.8 million, compared to $6.3 million for the second quarter of 2022.
Net loss: Karyopharm reported a net loss of
$32.6 million, or $0.29 per share, for the second quarter of 2023, compared to a net loss of $49.1 million, or $0.62 per share, for the second quarter of 2022.
Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2023, totaled $237.7 million, compared to
$279.7 million as of December 31, 2022.
2023 Financial Outlook
Based on its current operating plans, Karyopharm s guidance for full year 2023 is as follows:
Non-GAAP Financial Information
Karyopharm uses a non-GAAP financial measure, non-GAAP R&D and SG&A expenses, to provide operating expense guidance. Non-GAAP R&D and SG&A
expenses exclude stock-based compensation expense. Karyopharm believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Karyopharm s operating performance as it excludes non-cash stock
compensation expense. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP R&D and SG&A expenses and should not be considered a measure of Karyopharm s liquidity. Instead, non-GAAP R&D and
SG&A expenses should only be used to supplement an understanding of Karyopharm s operating results as reported under GAAP.
Karyopharm will host a conference call today, August 2, 2023, at 8:00 a.m. Eastern Time, to discuss the second quarter 2023 financial
results and financial outlook for 2023 and to provide other business highlights. To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (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,
http://investors.karyopharm.com/events-presentations. 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, China, South Korea and Israel, 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
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 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, myelodysplastic neoplasms 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 2023 total revenue, 2023 U.S. net product revenue and 2023 non-GAAP R&D and SG&A expenses; Karyopharm s expected cash runway;
expectations with respect to future savings from current optimization efforts and reduction in the Company s workforce; expectations with respect to commercialization efforts; the ability of selinexor or eltanexor to treat patients with
multiple myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma, myelodysplastic neoplasms 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 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; 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 March 31, 2023, which was filed with the Securities and Exchange Commission
(SEC) on May 4, 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