Full Press Release Details
Karyopharm Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress
Achieved Third Quarter 2023 Total Revenue of $36.0 Million and U.S. XPOVIO
(selinexor) Net Product Revenue of $30.2 Million
Maintains Full Year 2023 Total Revenue Guidance of $145 Million to
$160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million
Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Na ve Myelofibrosis Patients, with No SVR or TSS Progressions Observed 1
Announced Clinical Trial Collaboration with Bristol Myers Squibb to
Evaluate Novel CELMoD Agent CC- 92480, Mezigdomide in Combination with Selinexor in Patients with R/R Multiple Myeloma Progressing After T-cell Immunotherapies
Conference Call Scheduled for Today at 8:00 a.m. ET
NEWTON, Mass. November 2, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage
pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended September 30, 2023, and highlighted select corporate milestones and progress on its key clinical development programs.
We are strongly positioned for our next stage of growth driven by our focused and rapidly advancing late-stage pipeline with evolving data including
impressive durability data observed with selinexor 60mg in combination with ruxolitinib in patients with myelofibrosis as well as the substantial progression-free survival observed in patients with TP53 wild-type endometrial cancer,
said Richard Paulson, President and Chief Executive Officer of Karyopharm. Our commercial organization continues to perform with resilience amidst an increasingly competitive multiple myeloma landscape, focusing on fueling growth in the
community and expanding use of selinexor in the earlier lines.
Third Quarter 2023 and Recent Highlights
XPOVIO Commercial Performance
Third Quarter 2023 Financial Results
Total Revenues: Total revenue for the third quarter of 2023 was $36.0 million, compared to $36.1 million for the third quarter of 2022.
Net product revenue: Net product revenue for the third quarter of 2023 was $30.2 million, compared to $32.0 million for the third quarter of
License and other revenue: License and other revenue for the third quarter of 2023 was $5.8 million, compared to $4.1 million for
the third quarter of 2022. The increase was primarily due to an increase in revenue for the reimbursement of development-related expenses from the Menarini Group.
Cost of sales: Cost of sales for the third quarter of 2023 was $0.9 million, compared to $1.0 million for the third 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 third quarter of 2023 were $35.6 million, compared to $31.4 million for the third quarter of 2022. The increase was primarily due to higher clinical trial costs related to the advancement of our three pivotal Phase
Selling, general and administrative (SG&A) expenses: SG&A expenses for the third quarter of 2023 were $30.8 million,
compared to $34.6 million for the third quarter of 2022. The decrease was primarily due to a decrease in consulting, professional and other costs as a result of more focused commercial-related activities due to lower headcount.
Interest income: Interest income for the third quarter of 2023 was $2.8 million, compared to $0.7 million for the third quarter of 2022, due
to higher average interest rates on investments.
Interest expense: Interest expense for the third quarters of both 2023 and 2022 was
Net loss: Karyopharm reported a net loss of $34.5 million, or $0.30 per share, for the third quarter of 2023, compared to
a net loss of $36.3 million, or $0.45 per share, for the third quarter of 2022.
Cash position: Cash, cash equivalents, restricted cash and
investments as of September 30, 2023 totaled $209.2 million, compared to $279.7 million as of December 31, 2022.
Based on its current operating plans, Karyopharm reiterates its guidance for full year 2023 as follows:
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 2, 2023, at 8:00 a.m. Eastern Time, to discuss the third 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)
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; Email: medicalinformation@karyopharm.com
XPOVIO (selinexor) is a prescription medicine approved:
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
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
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 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; 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 June 30, 2023, which was filed with the Securities and Exchange Commission (SEC) on August 2, 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.
Senior Vice President, Investor Relations
617.658.0600 | elhan.webb@karyopharm.com
Head of Corporate Communications
617.658.0540 |stacy.nobles@karyopharm.com
KARYOPHARM THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited); (in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 30,207 | $ | 32,009 | $ | 86,955 | $ | 89,319 | ||||||||
| License and other revenue | 5,802 | 4,136 | 25,331 | 34,175 | ||||||||||||
| Total revenue | 36,009 | 36,145 | 112,286 | 123,494 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 911 | 980 | 3,456 | 3,345 | ||||||||||||
| Research and development | 35,553 | 31,359 | 99,369 | 117,730 | ||||||||||||
| Selling, general and administrative | 30,805 | 34,645 | 101,193 | 110,752 | ||||||||||||
| Total operating expenses | 67,269 | 66,984 | 204,018 | 231,827 | ||||||||||||
| Loss from operations | (31,260 | ) | (30,839 | ) | (91,732 | ) | (108,333 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 2,750 | 658 | 8,423 | 1,025 | ||||||||||||
| Interest expense | (6,073 | ) | (6,114 | ) | (17,615 | ) | (19,111 | ) | ||||||||
| Other income (expense), net | 89 | 16 | (145 | ) | (70 | ) | ||||||||||
| Total other expense, net | (3,234 | ) | (5,440 | ) | (9,337 | ) | (18,156 | ) | ||||||||
| Loss before income taxes | (34,494 | ) | (36,279 | ) | (101,069 | ) | (126,489 | ) | ||||||||
| Income tax provision | (12 | ) | (45 | ) | (193 | ) | (296 | ) | ||||||||
| Net loss | $ | (34,506 | ) | $ | (36,324 | ) | $ | (101,262 | ) | $ | (126,785 | ) | ||||
| Net loss per share basic and diluted | $ | (0.30 | ) | $ | (0.45 | ) | $ | (0.89 | ) | $ | (1.60 | ) | ||||
| Weighted-average number of common shares outstanding used in net loss per share basic and diluted | 114,401 | 80,210 | 114,033 | 79,153 |