Full Press Release Details
Karyopharm Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress
Achieves Second Quarter 2024 Total Revenue of $42.8 Million and U.S. XPOVIO
(selinexor) Net Product Revenue of $28.0 Million; Positive Momentum ex-US with Continued Regulatory and Reimbursement Approvals
Updated Clinical Results at ASCO Annual Meeting Showed Median Progression-Free Survival (PFS) of 28.4 Months in the TP53 Wild-Type Exploratory
Subgroup and 39.5 Months in the Proficient Mismatched Repair Status (pMMR) TP53 Wild-Type Exploratory Subgroup from Phase 3 SIENDO Study of Selinexor Maintenance Treatment in Advanced/Recurrent Endometrial Cancer
Pre-Clinical Data Presented at the June 2024 European Hematology Association Meeting Support
Selinexor s Mechanism of Action Targeting Multiple Oncogenic Pathways beyond JAK/STAT and Builds on the Compelling Clinical Data in Myelofibrosis
Completed Significant Refinancing Transactions and Amended Royalty Agreement with HealthCare Royalty Extending Vast Majority of Its Debt
Maturities into 2028 and 2029, Well Beyond Expected Data Readouts and Potential Approvals from the Company s Three Phase 3 Trials, Strengthening the Company for its Next Stage of Growth
Raises the Lower End of Full-Year 2024 Total Revenue Guidance to $145.0 Million to $160.0 Million and U.S. XPOVIO Net Product Revenue Guidance
to $105.0 Million to $120.0 Million; Lowers Full Year 2024 R&D and SG&A Expense Guidance to $250.0 Million to $265.0 Million
NEWTON, Mass. August 6, 2024 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering
novel cancer therapies, today reported financial results for the quarter ended June 30, 2024, and highlighted select corporate milestones and progress on its key clinical development programs.
We are pleased with the strength of our commercial performance with consecutive quarter-over-quarter growth in the highly competitive multiple myeloma marketplace
and look forward to leveraging the foundation that we have built in this indication to serve additional patients. Looking ahead with our improved capital structure following our debt refinancing and disciplined expense management, we are strongly
positioned for our next stage of growth, to redefine the standard of care for patients with myelofibrosis and endometrial cancer, driven by selinexor s growing body of compelling clinical and preclinical data in these indications, said
Richard Paulson, President and Chief Executive Officer of Karyopharm.
Second Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
Research and Development (R&D) Highlights
KPT-9274 (Padnarsertib)
Transactions and 2024 Financial Outlook
Based on its current operating plans, Karyopharm has updated its guidance for full year 2024 as follows:
Excluding re-payment of $24.5 million aggregate principal amount of the Company s remaining senior convertible notes due 2025 and $25.0 million minimum liquidity covenant under the senior
secured term loan due 2028.
Second Quarter 2024 Financial Results
Total revenue: Total revenue for the second quarter of 2024 was $42.8 million, compared to $37.6 million for the second quarter of
Net product revenue: Net product revenue for the second quarter of 2024 was $28.0 million, compared to $28.5 million for the
second quarter of 2023.
License and other revenue: License and other revenue for the second quarter of 2024 was $14.8 million, compared to
$9.1 million for the second quarter of 2023. The increase was primarily due to $4.0 million of milestone-related revenue recognized from Menarini in 2024 and a $2.3 million increase in revenue for the reimbursement of
development-related expenses from Menarini due to an increase in the corresponding expenses.
Cost of sales: Cost of sales for the second
quarter of 2024 was $1.5 million, compared to $1.2 million for the second quarter of 2023. Cost of sales reflects the costs of XPOVIO units sold and the costs of products sold to our partners.
R&D expenses: R&D expenses for the second quarter of 2024 were $38.4 million, compared to $31.5 million for the second quarter of 2023. The
increase was primarily due to an increase in clinical trial and related costs,
related mainly to increased activity in our ongoing pivotal Phase 3 trials in myelofibrosis and multiple myeloma, including increased purchases of comparator drugs.
SG&A expenses: SG&A expenses for the second quarter of 2024 were $31.1 million, compared to $34.5 million for the second
quarter of 2023. The decrease was primarily due to our ongoing cost reduction initiatives and lower headcount.
Interest income: Interest
income for the second quarter of 2024 was $1.9 million, compared to $2.8 million for the second quarter of 2023.
Interest expense for the second quarter of 2024 was $8.9 million, compared to $5.8 million for the second quarter of 2023. The increase in interest expense was due to the Company s new term loan and new secured convertible senior
Gain on extinguishment of debt and other income: The Company recognized a non-cash gain on
extinguishment of debt of $44.7 million and other income of $14.3 million during the second quarter of 2024, which related to the refinancing transactions that were completed during the second quarter of 2024.
Net income (loss): Karyopharm reported net income of $23.8 million, or $0.15 income per basic share and $0.20 loss per diluted share, for
the second quarter of 2024, compared to a net loss of $32.6 million, or $0.29 loss per basic and diluted share, for the second quarter of 2023.
Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2024 totaled $152.5 million, compared to
$192.4 million as of December 31, 2023.
Conference Call Information
Karyopharm will host a conference call today, August 6, 2024, at 8:00 a.m. Eastern Time, to discuss the second quarter 2024 financial results and
provide business highlights. 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.
1 Excluding re-payment $24.5 million aggregate principal amount of the
Company s remaining senior convertible notes due 2025 and $25.0 million minimum liquidity covenant under the senior secured term loan due 2028.
XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm s Selective Inhibitor of Nuclear Export (SINE) compounds 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; Email: medicalinformation@karyopharm.com
XPOVIO (selinexor) is a prescription medicine approved:
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Use In Specific Populations
Lactation: Advise not to breastfeed.
For additional product information, including full prescribing information, please visit
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 whose dedication to pioneering novel cancer
therapies is fueled by a belief in the extraordinary strength and courage of patients with cancer. Since its founding, Karyopharm has been an industry leader in oral compounds that address nuclear export dysregulation, a fundamental mechanism of
oncogenesis. Karyopharm s lead 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. It has also 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 indications in multiple high unmet need cancers, including in multiple
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. 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, 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 March 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on May 8, 2024, 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