Full Press Release Details
Karyopharm Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress
Achieved First Quarter 2023 Total Revenues of $38.7 Million, including
XPOVIO (selinexor) Net Product Revenue of $28.3 Million, Adversely Impacted by Increased Utilization of Patient Assistant Programs (PAP) and Higher Gross to Net; YoY Growth in Total Demand1
Rapid, Deep and Sustained Spleen and Symptom Responses Observed in
the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Na ve Myelofibrosis; Planning to Initiate Pivotal Phase 3 Study in Front-Line Myelofibrosis in 1H 2023
Single-Agent Eltanexor Showed Encouraging Results with a Median Overall Survival of 8.7 Months in Patients with Higher Risk
Relapsed/Refractory Myelodysplastic Neoplasms (MDS) in the Interim Analysis of the Phase 2 Study
Company Revises Full
Year 2023 Total Revenue Guidance to $145 Million to $160 Million, Including Revised XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million, Reflecting Increased Use of PAP
Non-GAAP R&D and SG&A Expense Guidance Revised to $245 Million to $260 Million;
Company Re-iterates Cash Runway to Late 2025
Conference Call Scheduled for
Today at 8:00 a.m. ET
NEWTON, Mass. May 4, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage
pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended March 31, 2023. In addition, Karyopharm highlighted select corporate milestones and provided an overview of its key clinical development
We are very excited to continue advancing our pipeline in areas of high unmet need, including the rapid advancement of our myelofibrosis
program. We are encouraged by the growing body of data that demonstrates the potential importance of XPO1 inhibition in patients with hard-to-treat cancers, said
Richard Paulson, President and Chief Executive Officer of Karyopharm. In patients with treatment-na ve myelofibrosis, the combination of selinexor plus ruxolitinib produced rapid, deep and sustained
spleen responses and robust symptom improvement, with response rates well above what is typically achieved with the current standard of care. Likewise, in patients with myelodysplastic neoplasms, we are encouraged with the median overall survival of
8.7 months observed with eltanexor, which is a meaningful improvement compared to the four-to-six months that is traditionally seen in patients with higher-risk relapsed or refractory MDS. Finally, in multiple
myeloma, during the first quarter of 2023, we are encouraged by the year-over-year uptake of XPOVIO despite increased competition and expanded use of our patient assistance program as we continue to help additional patients gain access to
First Quarter 2023 and Recent Highlights
XPOVIO Commercial Performance
Myelodysplastic Neoplasms (MDS)
First Quarter 2023 Financial Results
Revenues: Total revenue for the first quarter of 2023 was $38.7 million, compared to $47.7 million for the first quarter of 2022. The decrease was due to a decline in license and other revenue.
Net product revenue: Net product revenue for the first quarter of 2023 was $28.3 million, consistent with the first quarter of 2022.
License and other revenue: License and other revenue for the first quarter of 2023 was
$10.4 million, compared to $19.4 million for the first quarter of 2022. The decrease in license and other revenue in the first quarter of 2023 compared to the first quarter of 2022 was primarily due to the recognition of $7.8 million
of milestone-related revenue from Antengene in the first quarter of 2022, partially offset by the recognition of $3.5 million of license- related revenue from Menarini in the first quarter of 2023. There was also a $2.3 million decrease in
revenue for the reimbursement of development-related expenses from Menarini, due to a corresponding decrease in the underlying expenses.
sales: Cost of sales for the first quarter of 2023 was $1.4 million, consistent with the first 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 first quarter of 2023 were $32.3 million, compared to $42.1 million for
the first quarter of 2022. The decrease in R&D expenses in the first quarter of 2023 compared to the first quarter of 2022 was primarily attributable to a decrease in clinical trial costs resulting from the prioritization of the Company s
core programs in its clinical pipeline.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the first quarter of 2023
were $35.9 million, compared to $38.8 million for the first quarter of 2022.
Interest income: Interest income for the first quarter of
2023 was $2.8 million, compared to $0.1 million for the first quarter of 2022 due to higher average interest rates on investments.
expense: Interest expense for the first quarter of 2023 was $5.8 million, compared to $6.7 million for the first quarter of 2022.
loss: Karyopharm reported a net loss of $34.1 million, or $0.30 per share, for the first quarter of 2023, compared to a net loss of $41.4 million, or $0.53 per share, for the first quarter of 2022.
Cash position: Cash, cash equivalents, restricted cash and investments as of March 31, 2023 totaled $261.9 million, compared to
$279.7 million as of December 31, 2022.
2023 Financial Outlook
Based on its current operating plans, Karyopharm is updating its guidance for full year 2023:
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
Conference Call Information
will host a conference call today, May 4, 2023, at 8:00 a.m. Eastern Time, to discuss the first 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)
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 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 breastfeed.
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
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 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 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 Annual Report on Form 10-K for the year ended
December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on February 17, 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.