Full Press Release Details
Karyopharm Reports Strong Fourth Quarter and Full Year 2021 Financial Results and Highlights Recent Company
XPOVIO Achieves Net Product Revenue of $98.4 Million for
Full Year 2021; Company Provides Full Year 2022 XPOVIO Net Product Revenue Guidance of $135 to $145 Million -
of $209.8 Million for Full Year 2021, Including a $75 Million Up-front Payment Related to the Exclusive XPOVIO Licensing Agreement with the Menarini Group
Phase 3 SIENDO Study Meets Primary Endpoint with Statistically Significant Increase in Progression-Free Survival in Patients with
Advanced or Recurrent Endometrial Cancer
Conference Call Scheduled for Today at 8:30 a.m. ET
NEWTON, Mass. February 8, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI) ( Karyopharm, the Company,
we and our ), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the fourth quarter and full year ended December 31, 2021. 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.
I am exceptionally proud of the Karyopharm team s performance in 2021 as we advanced all aspects of our business, including securing a
commercialization partnership with Menarini for Europe and other key global territories, said Richard Paulson, President and Chief Executive Officer of Karyopharm. We delivered consecutive quarters of double-digit growth driven by
XPOVIO s strong commercial performance in the second half of the year and head into 2022 with momentum as we continue to prioritize driving sales and the adoption of XPOVIO in multiple myeloma. Our momentum is accelerating as we reported
positive top-line data from the SIENDO study evaluating selinexor as a maintenance therapy following front-line chemotherapy in patients with advanced or recurrent endometrial cancer. Based on these findings, Karyopharm intends to submit a
supplemental New Drug Application to the U.S. Food and Drug Administration in the first half of this year. We are also progressing our pipeline in key indications of multiple myeloma, myelodysplastic syndromes and myelofibrosis to improve survival
and outcomes for patients with cancer.
Fourth Quarter 2021 and Recent Highlights
XPOVIO Commercial Performance
R&D Highlights for Selinexor and Eltanexor
Corporate and Business Highlights
Full Year and Fourth Quarter 2021 Financial Results
Net product revenue: Net product revenue for the fourth quarter of 2021 was $29.8 million, up 47% as compared to $20.2 million for
the fourth quarter of 2020. Net product revenue for the year ended December 31, 2021, was $98.4 million, up 29% compared to $76.2 million for the year ended December 31, 2020.
License and other revenue: License and other revenue for the fourth quarter of 2021 was $96.5 million, compared to $14.9 million for
the fourth quarter of 2020. This increase was driven by $75.0 million of revenue recognized related to the upfront payment that Karyopharm received from Menarini in connection with the license agreement entered into during the fourth
quarter of 2021. In addition, Karyopharm recognized $19.5 million for a milestone payment related to commercial launch within the Antengene Therapeutics Limited territory following regulatory approval received for selinexor for the
treatment of patients with multiple myeloma and diffuse large B-cell lymphoma. License and other revenue for the year ended December 31, 2021 was $111.4 million, compared to $31.9 million for the year ended
Cost of sales: Cost of sales for the fourth quarter of 2021 was $0.7 million, compared to
$1.1 million for the fourth quarter of 2020. Cost of sales for the year ended December 31, 2021 was $3.4 million, compared to $2.7 million for the year ended December 31, 2020. 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 2021 were $44.0 million, compared to $37.2 million for the fourth quarter of 2020. R&D expenses for the year ended December 31, 2021 were $160.8 million,
compared to $150.8 million for the year ended December 31, 2020. The increase in R&D
expenses in 2021 compared to 2020 was primarily attributable to $7.4 million related to the acquisition of certain assets from Neumedicines Inc., which closed in the third quarter of 2021,
coupled with costs for key clinical trials in 2021, including costs incurred in preparation for a Phase 3 study evaluating selinexor in combination with pomalidomide in patients with relapsed or refractory multiple myeloma.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the fourth quarter of 2021 were $34.6 million, compared to
$33.9 million for the fourth quarter of 2020. SG&A expenses for the year ended December 31, 2021, were $143.8 million, compared to $126.4 million for the year ended December 31, 2020.
The increase in SG&A expenses compared to the prior year was due primarily to increased personnel costs.
Interest expense: Interest expense
for the fourth quarter of 2021 was $7.9 million, compared to $7.1 million for the fourth quarter of 2020. Interest expense for the year ended December 31, 2021 was $26.0 million, compared to
$27.1 million for the year ended December 31, 2020. The decrease in interest expense year over year was primarily attributable to a $7.3 million decrease in non-cash interest expense
related to Karyopharm s 3.00% senior convertible notes due 2025, as a result of the January 1, 2021 adoption of
ASU No. 2020-06, Debt Debt with Conversion and Other Options and Derivatives and Hedging Contracts in Entity s
Own Equity, partially offset by a $6.2 million increase in interest expense related to the deferred royalty obligation following Karyopharm s June 2021 amendment of its Revenue Interest Agreement with HealthCare Royalty
Net income (loss): Karyopharm reported net income of $38.7 million, or $0.51 per basic share and $0.46 per diluted share,
for the fourth quarter of 2021, compared to a net loss of $43.4 million, or $0.59 per basic and diluted share, for the fourth quarter of 2020. Net income (loss) includes non-cash stock-based compensation expense of
$6.9 million and $6.3 million for the fourth quarters of 2021 and 2020, respectively. Karyopharm reported a net loss of $124.1 million, or $1.65 per basic and diluted share, for the year ended
December 31, 2021, compared to a net loss of $196.3 million, or $2.72 per basic and diluted share, for the year ended December 31, 2020. Net loss includes non-cash stock-based compensation expense of $29.8
million and $24.4 million for the years ended December 31, 2021 and 2020, respectively.
Cash position: Cash, cash equivalents,
restricted cash and investments as of December 31, 2021 totaled $235.6 million, compared to $276.7 million as of December 31, 2020.
2022 Financial Outlook
Based on its current operating
plans, Karyopharm expects the following for full year 2022:
Non-GAAP Financial Information
Karyopharm uses a non-GAAP financial measure, including 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 8, 2022, at 8:30 a.m. Eastern Time, to discuss the fourth quarter and full year 2021 financial results and financial outlook for 2022 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
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 endometrial cancer, myelodysplastic syndromes and myelofibrosis. For more
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 revenues 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; that regulators will grant confirmatory approval in the European Union based on the BOSTON study in adult patients with multiple myeloma; 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,