Karyopharm Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Company Progress
-- Total Revenue of $157.1 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $120.4 Million for Full Year 2022, Meeting Company's Guidance --
-- Updated Results from the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis and Interim Data from the Phase 2 Study Evaluating Eltanexor in Relapsed/Refractory Myelodysplastic Neoplasms Expected in 1H 2023 --
-- Company Provides Full Year 2023 Total Revenue Guidance of $160 Million to $175 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $125 Million to $140 Million; Cash Runway to Late 2025 --
-- Conference Call Scheduled for Today at 8:00 a.m. ET--
NEWTON, Mass., Feb. 15, 2023 /PRNewswire/ -- 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, 2022. In addition, Karyopharm highlighted select corporate milestones and provided an overview of its key clinical development programs.
"In 2022, Karyopharm delivered strong financial performance with a 22% increase in U.S. XPOVIO net product revenue, coupled with significant progress across our clinical pipeline and the achievement of several key regulatory milestones. Importantly, we solidified our financial runway to late 2025, enabling us to be well positioned to deliver the next stages of the company's growth," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Moving forward in 2023, we are excited to advance our mid-late stage pipeline and anticipate multiple data catalysts and robust progress across our programs in multiple myeloma, endometrial cancer, myelofibrosis and myelodysplastic neoplasms. We are passionate in our pursuit to bring forward innovative treatments that address critical unmet needs and positively impact the lives of people living with cancer."
Fourth Quarter 2022 and Recent Highlights
XPOVIO Commercial Performance
Corporate and Business Highlights
Anticipated Near-Term Catalysts and Operational Objectives in 2023
2023 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2023:
Full Year and Fourth Quarter 2022 Financial Results
Total revenue: Total revenue for the fourth quarter of 2022 was $33.6 million, compared to $126.3 million for the fourth quarter of 2021. Total revenue for the year ended December 31, 2022, was $157.1 million, compared to $209.8 million for the year ended December 31, 2021.
Net product revenue: Net product revenue for the fourth quarter of 2022 was $31.1 million, up 4% compared to $29.8 million for the fourth quarter of 2021. Net product revenue for the year ended December 31, 2022, was $120.4 million, up 22% compared to $98.4 million for the year ended December 31, 2021.
License and other revenue: License and other revenue for the fourth quarter of 2022 was $2.5 million, compared to $96.5 million for the fourth quarter of 2021. License and other revenue for the year ended December 31, 2022 was $36.6 million, compared to $111.4 million for the year ended December 31, 2021. This decrease in license and other revenue in both the fourth quarter and full year 2022 was primarily driven by $75.0 million of revenue recognized in the fourth quarter of 2021 related to the upfront payment that Karyopharm received from the Menarini Group in connection with execution of a license agreement in December 2021.
Cost of sales: Cost of sales for the fourth quarter of 2022 was $1.9 million, compared to $0.7 million for the fourth quarter of 2021. Cost of sales for the year ended December 31, 2022 was $5.2 million, compared to $3.4 million for the year ended December 31, 2021. 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 fourth quarter of 2022 were $30.9 million, compared to $44.0 million for the fourth quarter of 2021. R&D expenses for the year ended December 31, 2022 were $148.7 million, compared to $160.8 million for the year ended December 31, 2021. The decrease in R&D expenses in 2022 compared to 2021 was primarily attributable to decreased clinical trial and related costs in 2022 due to the prioritization of the Company's core programs and the purchase of certain assets in 2021, partially offset by an increase in personnel costs and stock-based compensation, largely due to severance-related expenses incurred in 2022 in connection with the departure of certain executive officers.
Selling, general and administrative (SG&A) expenses: SG&A expenses for both the fourth quarters of 2022 and 2021 were $34.6 million. SG&A expenses for the year ended December 31, 2022 were $145.4 million, compared to $143.8 million for the year ended December 31, 2021. The slight increase in SG&A expenses compared to the prior year was due primarily to an increase in personnel costs and stock-based compensation, including severance-related expenses incurred in 2022 in connection with the departure of our former chief executive officer, partially offset by decreased consulting and professional fees.
Interest expense: Interest expense for the fourth quarter of 2022 was $5.9 million, compared to $7.9 million for the fourth quarter of 2021. Interest expense for the year ended December 31, 2022 was $25.0 million, compared to $26.0 million for the year ended December 31, 2021.
Net income (loss): Karyopharm reported net loss of $38.5 million, or $0.43 per basic and diluted share, for the fourth quarter of 2022, compared to a net income of $38.7 million, or $0.51 per basic and $0.46 per diluted share, for the fourth quarter of 2021. Net income (loss) includes non-cash stock-based compensation expense of $6.2 million and $6.9 million for the fourth quarters of 2022 and 2021, respectively. Karyopharm reported a net loss of $165.3 million, or $2.02 per basic and diluted share, for the year ended December 31, 2022, compared to a net loss of $124.1 million, or $1.65 per basic and diluted share, for the year ended December 31, 2021. Net loss includes non-cash stock-based compensation expense of $35.4 million and $29.8 million for the years ended December 31, 2022 and 2021, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of December 31, 2022 totaled $279.7 million, compared to $235.6 million as of December 31, 2021.
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.
Conference Call Information
Karyopharm will host a conference call today, February 15, 2023, at 8:00 a.m. Eastern Time, to discuss the fourth quarter and full year 2022 financial results and the 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 department at:
Tel: +1 (888) 209-9326
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 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 www.karyopharm.com, and follow us on Twitter at @Karyopharm and LinkedIn.
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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on November 3, 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.
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.
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SOURCE Karyopharm Therapeutics Inc.
Company Codes: NASDAQ-NMS:KPTI