Latest News by Industry
– Achieved Third Quarter 2022 Total Revenue of $36.1 Million, Including XPOVIO® (selinexor) Net Product Revenue of $32.0 Million, a 20 % Increase Over Third Quarter 2021–
– Initiated Phase 3 Study Evaluating Selinexor as a Maintenance Therapy in Women with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer –
–Encouraging Data Observed in Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Activity Across Three Key Efficacy Endpoints, and a Generally Manageable Safety Profile with No Dose Limiting Toxicities. Updated Results to Be Presented at ASH –
– Company Re-Affirms Full Year 2022 XPOVIO Net Product Revenue Guidance of $120 Million to $130 Million, Total Revenue Guidance of $155 Million to $165 Million and Cash Runway into Early 2024 –
– Conference Call Scheduled for Today at 4:30 p.m. ET –
NEWTON, Mass., Nov. 3, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported business highlights and financial results for the quarter ended September 30, 2022.
"We had a highly productive third quarter executing against our key priorities which delivered strong growth in patient demand and product revenues. We also achieved an important milestone this quarter with the initiation of the pivotal Phase 3 study evaluating selinexor as a maintenance therapy in women with TP53 wild-type endometrial cancer and anticipate sharing topline results in 2024," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Today, our abstracts were released for the American Society of Hematology (ASH) Annual Meeting, including encouraging data from the Phase 1 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis, which continues to demonstrate promising activity in key efficacy endpoints. We look forward to sharing further updated results from this study at the ASH meeting in December."
Third Quarter 2022 and Recent Highlights
XPOVIO Commercial Performance
Research & Development (R&D) Highlights for Selinexor and Eltanexor
2022 Financial Guidance
Based on its current operating plans, Karyopharm is maintaining its guidance for the full year 2022:
Third Quarter 2022 Financial Results
Total Revenue: Total revenue for the third quarter of 2022 was $36.1 million, down 4% compared to $37.7 million for the third quarter of 2021.
Net product revenue: Net product revenue for the third quarter of 2022 was $32.0 million, up 20% compared to $26.7 million for the third quarter of 2021.
License and other revenue: License and other revenue for the third quarter of 2022 was $4.1 million, compared to $11.0 million for the third quarter of 2021. The decrease was primarily attributable to the recognition of $9.8 million in milestone-related revenue from Antengene Therapeutics Limited (Antengene) in the third quarter of 2021, compared to $2.4 million in royalty revenue and $1.4 million in reimbursement revenue from Menarini recognized in the third quarter of 2022.
Cost of sales: Cost of sales for the third quarter of 2022 were $1.0 million, compared to $0.6 million for the third quarter of 2021. Cost of sales includes the costs of producing and distributing XPOVIO units sold and third-party royalties on net product revenue.
R&D expense: R&D expense for the third quarter of 2022 were $31.4 million, compared to $45.8 million for the third quarter of 2021. The decrease was primarily driven by the recognition of $7.4 million of costs in connection with the acquisition of certain assets from Neumedicines Inc. in the third quarter of 2021, for which there were no similar costs in 2022. Additionally, clinical trial and related costs decreased primarily due to the prioritization of the Company's core programs in its clinical pipeline and the timing of the purchases of comparator drug used in clinical trials.
SG&A expense: SG&A expense for the third quarter of 2022 were $34.6 million, compared to $35.1 million for the third quarter of 2021.
Interest expense: Interest expense for the third quarter of 2022 was $6.1 million, compared to $8.0 million for the third quarter of 2021.
Net loss: Karyopharm reported a net loss of $36.3 million, or $0.45 per share, for the third quarter of 2022, compared to a net loss of $51.8 million, or $0.69 per share, for the third quarter of 2021. Net loss included non-cash stock-based compensation expense of $6.8 million and $7.4 million for the third quarters ended September 30, 2022 and 2021, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of September 30, 2022, totaled $150.1 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, November 3, 2022, at 4:30 p.m. Eastern Time, to discuss the third 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 various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm's partners, Antengene, Menarini, Neopharm and FORUS in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.
Please refer to the local Prescribing Information for full details.
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
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Adverse Reactions
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 syndromes 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.
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 financial guidance for full year 2022; Karyopharm's expected cash runway; the ability of selinexor or eltanexor to treat patients with multiple myeloma, myelofibrosis, myelodysplastic syndromes, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on August 4, 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.
KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 32,009 | $ | 26,723 | $ | 89,319 | $ | 68,633 | ||||||||
License and other revenue | 4,136 | 10,966 | 34,175 | 14,917 | ||||||||||||
Total revenues | 36,145 | 37,689 | 123,494 | 83,550 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 980 | 589 | 3,345 | 2,660 | ||||||||||||
Research and development | 31,359 | 45,808 | 117,730 | 116,839 | ||||||||||||
Selling, general and administrative | 34,645 | 35,104 | 110,752 | 109,284 | ||||||||||||
Total operating expenses | 66,984 | 81,501 | 231,827 | 228,783 | ||||||||||||
Loss from operations | (30,839) | (43,812) | (108,333) | (145,233) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 658 | 98 | 1,025 | 527 | ||||||||||||
Interest expense | (6,114) | (8,010) | (19,111) | (18,106) | ||||||||||||
Other income (expense), net | 16 | 18 | (70) | 393 | ||||||||||||
Total other expense, net | (5,440) | (7,894) | (18,156) | (17,186) | ||||||||||||
Loss before income taxes | (36,279) | (51,706) | (126,489) | (162,419) | ||||||||||||
Income tax provision | (45) | (106) | (296) | (389) | ||||||||||||
Net loss | $ | (36,324) | $ | (51,812) | $ | (126,785) | $ | (162,808) | ||||||||
Net loss per share—basic and diluted | $ | (0.45) | $ | (0.69) | $ | (1.60) | $ | (2.17) | ||||||||
Weighted-average number of common shares outstanding | 80,210 | 75,461 | 79,153 | 75,065 | ||||||||||||
KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands) | |||||||
September 30, | December 31, | ||||||
Assets | |||||||
Cash, cash equivalents and investments | $ | 148,381 | $ | 228,615 | |||
Restricted cash | 1,706 | 6,986 | |||||
Accounts receivable | 27,446 | 22,497 | |||||
Other assets | 53,703 | 47,207 | |||||
Total assets | $ | 231,236 | $ | 305,305 | |||
Liabilities and stockholders' deficit | |||||||
Convertible senior notes | 169,894 | 169,293 | |||||
Deferred royalty obligation | 132,998 | 132,998 | |||||
Other liabilities | 68,624 | 82,687 | |||||
Total liabilities | 371,516 | 384,978 | |||||
Total stockholders' deficit | (140,280) | (79,673) | |||||
Total liabilities and stockholders' deficit; 81,027 and 75,746 shares issued and | $ | 231,236 | $ | 305,305 |
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SOURCE Karyopharm Therapeutics Inc.