Full Press Release Details
Karyopharm Reports First Quarter 2022 Financial Results and Highlights Recent Company
Achieved First Quarter 2022 Net Revenues of $47.7 Million, Up 105% Versus First Quarter 2021,
Including $19.4 Million License Revenues from Partners
XPOVIO (selinexor) Net Product Revenue of $28.3 Million, with a 30%
Increase Over Q1 2021
Preliminary Data from Phase 1/2 Trial Evaluating Selinexor in Combination with
Ruxolitinib in Patients with Treatment-Na ve Myelofibrosis to Be Presented at ASCO 2022
Promising Results from Pre-Specified Exploratory Subgroup Analysis in Patients with p53
Wild-Type Endometrial Cancer from the SIENDO Study; Planning Registration-Enabling Study Targeting Initiation in 2H 2022
Recent Approvals Received by Partner Antengene Continues to Expand XPOVIO s Global Reach
Conference Call Scheduled for Today at 8:30 a.m. ET
NEWTON, Mass. May 5, 2022 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel
cancer therapies, today reported financial results for the quarter ended March 31, 2022. In addition, Karyopharm highlighted select corporate milestones, including details regarding the ongoing U.S. commercialization of XPOVIO (selinexor) and provided an overview of its key clinical development programs.
first quarter of 2022, we continued to drive further patient benefit by expanding the use of XPOVIO in the 2nd to 4th line setting and, despite
headwinds caused by the Omicron variant, we achieved strong XPOVIO sales of 30% year-over-year growth, said Richard Paulson, President and Chief Executive Officer of Karyopharm. As we advance our clinical pipeline across four core
priority areas, we look forward to presenting the preliminary results from our Phase 1/2 frontline myelofibrosis study and initiating our Phase 3 study in the p53 wild-type endometrial cancer patient population in the second half of 2022, both areas
with significant unmet need.
First Quarter 2022 and Recent Highlights
XPOVIO Commercial Performance
Highlights for Selinexor and Eltanexor
Corporate and Business Highlights
First Quarter 2022 Financial Results
Total Revenues: Total revenue for the first quarter of 2022 was $47.7 million, up 105% compared to $23.3 million for the first
Net product revenue: Net product revenue for the first quarter of 2022 was $28.3 million, up 30% compared to
$21.7 million for the first quarter of 2021.
License and other revenue: License and other revenue for the first quarter of
2022 was $19.4 million, compared to $1.5 million for the first quarter of 2021. The increase in license and other revenue in the first quarter of 2022 compared to the first quarter of 2021 was primarily attributable to $8.6 million in
revenue recognized related to milestones earned in connection with our license agreements with Antengene Therapeutics Limited and Promedico Ltd., coupled with $7.1 million earned in reimbursement of development expenses from the Menarini Group.
Cost of sales: Cost of sales for the first quarter of 2022 were $1.4 million, compared to $0.9 million for the first
quarter of 2021. Cost of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.
development (R&D) expenses: R&D expenses for the first quarter of 2022 were $42.1 million, compared to $37.1 million for the first quarter of 2021. The increase in R&D expenses in the first quarter of 2022 compared to the
first quarter of 2021 was primarily attributable to higher clinical trial expenses.
Selling, general and administrative
(SG&A) expenses: SG&A expenses for the first quarter of 2022 were $38.8 million, compared to $37.7 million for the first quarter of 2021.
Interest expense: Interest expense for the first quarter of 2022 was $6.7 million, compared to $5.1 million for the first
quarter of 2021. The increase in interest expense in the first quarter of 2022 compared to the first quarter of 2021 was related to the deferred royalty obligation following Karyopharm s June 2021 amendment of its Revenue Interest
Agreement with HealthCare Royalty Management, LLC.
Net loss: Karyopharm reported a net loss of $41.4 million, or $0.53 per
share, for the first quarter of 2022, compared to a net loss of $57.4 million, or $0.77 per share, for the first quarter of 2021. Net loss included non-cash stock-based compensation expense of
$7.3 million and $7.4 million for the first quarters of 2022 and 2021, respectively.
Cash position: Cash, cash
equivalents, restricted cash and investments as of March 31, 2022 totaled $207.0 million, compared to $235.6 million as of December 31, 2021.
2022 Financial Outlook
Based on its current operating
plans, Karyopharm reaffirms the following for full year 2022:
Non-GAAP Financial Information
Karyopharm uses a non-GAAP financial measure, including 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, May 5, 2022, at 8:30 a.m. Eastern Time, to discuss the first quarter 2022 financial
results and 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
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
Twitter at @Karyopharm and LinkedIn.
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 2022 net product revenue and 2022 non-GAAP research and development and selling, general and administrative expenses; Karyopharm s
expected cash runway; the ability of selinexor or eltanexor to treat patients with multiple myeloma, diffuse large B-cell lymphoma, solid tumors and other diseases; and expectations related to future
clinical development and potential regulatory submissions of selinexor or 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, 2021, which was filed with the Securities and Exchange Commission (SEC) on March 1, 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.