Full Press Release Details
Karyopharm Reports Second Quarter 2022 Financial Results and Highlights Recent Company Progress
Achieved Second Quarter 2022 Total Revenue of $39.7 Million, Up 76% Versus Second Quarter 2021;
XPOVIO (selinexor) Net Product Revenue of $29.0 Million, a 44% Increase Over Q2
Received Full Marketing Authorization from the European Commission Expanding Indication for NEXPOVIO (selinexor) for Treatment of Adults with Multiple Myeloma Who Have Received at Least One Prior Therapy
Clinical Updates from Phase 1/2 Study of Selinexor in Combination with Ruxolitinib in
Treatment-Na ve Myelofibrosis and Interim Data from Phase 2 Study Evaluating Eltanexor in Relapsed/Refractory MDS Expected in 2H 2022
Company Provides Full Year 2022 Total Revenue Guidance of $155 Million to $165 Million Including Revised XPOVIO Net Product Revenue of $120 Million
to $130 Million and non-GAAP R&D and SG&A Expense Guidance of $250 Million to $265 Million; Re-iterates Cash Runway to Early 2024
Conference Call Scheduled for Today at 8:00 a.m. ET
NEWTON, Mass. August 4, 2022 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 June 30, 2022.
I m pleased with our
team s ongoing commitment to successfully execute against key priorities in the second quarter, achieving more than 75% year-over-year revenue growth and further expanding patient access for selinexor globally following full marketing
authorization from the European Commission and recent launches in China and Canada, said Richard Paulson, President and Chief Executive Officer of Karyopharm. Despite headwinds caused by COVID-19
at the beginning of the year and increased competition for later lines of multiple myeloma treatment, we continue to see increased use of XPOVIO in earlier lines with growth in the community setting. Looking ahead to the remainder of the year, we
have several key upcoming milestones, including reporting additional data from our studies of selinexor in front-line myelofibrosis and eltanexor in relapsing/refractory myelodysplastic syndromes.
Second Quarter 2022 and Recent Highlights
Commercial Performance
Research & Development (R&D) Highlights for Selinexor and Eltanexor
2022 Financial Guidance
its current operating plans, Karyopharm is updating its guidance for full year 2022:
Karyopharm has not reconciled the full year 2022 outlook for non-GAAP R&D and SG&A expenses to
full year 2022 outlook for GAAP R&D and SG&A expenses because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense,
which is excluded from the full year 2022 outlook for non-GAAP R&D and SG&A expenses.
Second Quarter 2022 Financial Results
Revenues: Total revenue for the second quarter of 2022 was $39.7 million, up 76% compared to $22.6 million for the second quarter of 2021.
Net product revenue: Net product revenue for the second quarter of 2022 was $29.0 million, up 44% compared to $20.2 million for the second
License and other revenue: License and other revenue for the second quarter of 2022 was $10.7 million, compared to
$2.4 million for the second quarter of 2021. The increase was primarily attributable to $6.5 million earned in reimbursement of development expenses from the Menarini Group.
Cost of sales: Cost of sales for the second quarter of 2022 were $0.9 million, compared to $1.1 million for the second quarter of 2021. Cost
of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.
R&D expenses: R&D expenses for the
second quarter of 2022 were $44.3 million, compared to $34.0 million for the second quarter of 2021. The increase was primarily driven by an increase in personnel costs and stock-based compensation, including $3.8 million of
severance-related stock-based compensation expense incurred during the three months ended June 30, 2022.
SG&A expenses: SG&A expenses
for the second quarter of 2022 were $37.3 million, compared to $36.5 million for the second quarter of 2021. The increase in SG&A expenses was primarily due to an increase in stock-based compensation as a result of $3.5 million of
severance-related stock-based compensation expense incurred during the three months ended June 30, 2022.
Interest expense: Interest expense
for the second quarter of 2022 was $6.3 million, compared to $5.0 million for the second quarter of 2021.
Net loss: Karyopharm reported a net loss of $49.1 million, or $0.62 per share, for the second
quarter of 2022, compared to a net loss of $53.6 million, or $0.71 per share, for the second quarter of 2021. Net loss included non-cash stock-based compensation expense of $15.1 million and
$8.1 million for the second quarters of 2022 and 2021, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments
as of June 30, 2022, totaled $172.6 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, August 4, 2022, at 8:00 a.m. Eastern Time, to discuss the second 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)
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 and Israel, and is marketed in those areas by Karyopharm s global
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
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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 syndromes and myelofibrosis. For more information about our people, science and pipeline, please visit www.karyopharm.com, and
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, 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 March 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on May 5, 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