– Total Revenue of $145
Million and U.S. XPOVIO® (selinexor) Net Product Revenue of
$113 Million for Full Year 2024
–
– Top-Line Data Readout from Phase 3
SENTRY Trial Evaluating Selinexor in Combination with Ruxolitinib
in Patients with JAKi-Naïve Myelofibrosis Anticipated in 2H 2025;
Company on Track to Complete Enrollment in 1H 2025 –
– Company Announces Update to Phase 3
XPORT-EC-042 Trial of Selinexor as Maintenance Therapy in Advanced
or Recurrent TP53 Wild-Type Endometrial Cancer. Following Dialogue
with the FDA Regarding the Evolving Treatment Landscape, Trial to
Focus Enrollment on Patients with Either pMMR Tumors or Patients
with dMMR Tumors that are Medically Ineligible for Checkpoint
Inhibitors. Increasing Sample Size to 276; Top-Line Data Now
Expected in Mid-2026 –
– Company Provides Full-Year 2025 Total
Revenue Guidance of $140 Million to
$155 Million, Including U.S. XPOVIO
Net Product Revenue Guidance of $115
Million to $130 Million
–
– Conference Call Scheduled for Today at
8:00 a.m. ET –
NEWTON,
Mass., Feb. 19, 2025 /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, 2024. In addition, Karyopharm
highlighted select corporate milestones and provided an overview of
its key clinical development programs.
"In 2025, our teams remain focused on the transformative
opportunity to redefine the standard of care in myelofibrosis, with
top-line data from our Phase 3 SENTRY trial evaluating selinexor in
combination with ruxolitinib on-track for the second half of 2025.
We look forward to completing enrollment of our SENTRY trial in the
first half of this year and leveraging our demonstrated
commercialization capabilities in multiple myeloma to support a
rapid launch, subject to approval," said Richard Paulson,
President and Chief Executive Officer of Karyopharm. "In
endometrial cancer, today we announced our updated plans for our
Phase 3 trial and intend to primarily focus on the TP53
wild-type pMMR population, which represents approximately 50% of
all women with endometrial cancer, and expect to share top-line
data in mid-2026."
Fourth Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
- Achieved U.S. net product revenue for the year ended
December 31, 2024 of $113 million, compared to $112 million for the year ended December 31, 2023. U.S. net product revenue for
the fourth quarter of 2024 was $29
million, compared to $25
million for the fourth quarter of 2023.
- Demand for XPOVIO was consistent in 2024 versus 2023, with
demand growth in the second half of 2024 in both the community
setting, which represents approximately 60% of XPOVIO net product
revenue, and the academic setting, offsetting a decline in demand
in the first half of the year due to an intensified competitive
landscape.
- XPOVIO net product revenue was impacted year-over-year by
higher gross-to-net adjustments in 2024, driven primarily by
increased 340B discounts and Medicare
rebates.
- Expanded global patient access for selinexor in 2024 with
favorable reimbursement decisions in the United Kingdom, France, Italy, China
and South Korea and additional
regulatory approvals in UAE, Kuwait, China, Malaysia, Turkey, Thailand, and South
Korea in various indications, increasing the number of
countries where selinexor is now approved in more than 45
countries.
Research and Development (R&D) Highlights
Myelofibrosis
- Updated the co-primary endpoint in the Phase 3 SENTRY trial
(XPORT-MF-034; NCT04562389) to absolute mean change in total
symptom score (Abs-TSS) following alignment with the U.S. Food and
Drug Administration (FDA) and proactively increased the total
sample size to approximately 350 patients to further increase the
statistical powering. Abs-TSS measures the average improvement in
symptom scores over 24 weeks relative to the baseline symptom
score. Abs-TSS is viewed by many key opinion leaders (KOLs) and
patient advocacy organizations as a more accurate assessment of
symptom improvement in head-to-head clinical trials, such as SENTRY
which is evaluating selinexor in combination with ruxolitinib in
patients with JAK inhibitor (JAKi) naïve myelofibrosis versus
ruxolitinib alone. Spleen volume reduction ≥35% (SVR35) at week 24
remains the other co-primary endpoint. These two co-primary
endpoints will be tested sequentially starting with SVR35 followed
by Abs-TSS.
- Hosted an investor event with leading KOLs in October 2024 to discuss the change in the
co-primary endpoint in the Phase 3 SENTRY trial to Abs-TSS and
highlight the strength of the data from the Company's Phase 1 trial
in myelofibrosis. Data from the Company's Phase 1 trial, evaluating
the combination of selinexor 60 mg plus ruxolitinib in JAKi naïve
myelofibrosis patients, demonstrated that 79% of patients in the
intent to treat population (n=14) achieved SVR35 and an average
Abs-TSS improvement of 18.5 points in the efficacy evaluable
population (n=9), at week 24 relative to baseline. Acknowledging
the small sample size, these data suggest that the combination is
favorable compared to historical ruxolitinib monotherapy data which
indicates that less than half of patients achieve SVR35 and an
Abs-TSS improvement of 11 to 14 points1. As of the most
recent data cut off, the safety profile remained consistent and no
new safety signals were identified.
- The Company continues to enroll patients into the 60 mg cohort
of the Phase 2 SENTRY-2 trial of selinexor monotherapy in JAKi
naïve patients with moderate thrombocytopenia (XPORT-MF-044;
NCT05980806).
1Phase 3 MANIFEST trial. Rampal R, et al. ASH 2023.
Oral 628; Phase 3 TRANSFORM-1 trial Pemmaraju N, et al. ASH 2023
abstract 620.
Endometrial Cancer
- The Company is modifying the design of its Phase 3 XPORT-EC-042
trial evaluating selinexor as a maintenance-only therapy following
systemic therapy versus placebo in patients with TP53
wild-type advanced or recurrent endometrial cancer. In late 2024
and early 2025, the Company engaged in communications with the FDA
regarding the design adequacy of XPORT-EC-042 given the changing
standard of care in endometrial cancer, particularly the approval
of checkpoint inhibitors for patients with advanced or recurrent
endometrial cancer regardless of mismatch repair status. In light
of the FDA's acknowledgement that the magnitude of benefit achieved
from checkpoint inhibitors is less for patients with pMMR tumors
than patients with dMMR tumors, consistent with the biology and
mechanism of action of checkpoint inhibitors, the Company's
modifications include defining two patient populations for which
the primary endpoint of progression free survival (PFS), tested
sequentially, and key secondary endpoint of overall survival (OS)
will be evaluated:
- a modified intent to treat population (mITT) that will include
patients with:
- TP53 wild-type tumors with proficient mismatch repair
status (pMMR); or,
- TP53 wild-type tumors with deficient mismatch repair
status (dMMR), who are medically ineligible to receive checkpoint
inhibitors.
- the trial's original intent to treat (ITT) population, which
will include all patients enrolled in the trial whose tumors are
TP53 wild-type, regardless of MMR status.
- The Company is increasing the trial sample size from 220
patients to approximately 276 patients, to ensure that the mITT
population includes approximately 220 patients who are either: a)
TP53 wild-type pMMR or b) TP53 wild-type dMMR and
medically ineligible to receive a checkpoint inhibitor. The
increase in sample size maintains sufficient power for the primary
endpoint of PFS in the mITT population. To date, approximately 80%
of patients enrolled meet the new eligibility definition for the
mITT population.
- The proposed modifications are intended to address certain of
the FDA's feedback regarding the evolving treatment landscape,
including the approval of multiple checkpoint inhibitors for
advanced/recurrent endometrial cancer patients with pMMR and/or
dMMR tumors in 2023 and 2024.
- Enrollment continues in the XPORT-EC-042 trial and, depending
on the strength of the data, the Company intends to pursue
regulatory approval. As a result of the proposed modifications, the
Company now expects topline data in mid-2026.
Multiple Myeloma
- Completed enrollment of the Phase 3 XPORT-MM-031 trial (EMN29;
NCT05028348) of approximately 120 patients, leveraging the data
published on selinexor 40 mg, pomalidomide and dexamethasone
(SPd40) in 2024. The Phase 3 XPORT-MM-031 trial is being conducted
in collaboration with the European Myeloma Network and is
evaluating the all-oral combination SPd40 in patients with
previously treated multiple myeloma who received an anti-CD38 in
their immediate prior line of therapy. Pending ongoing engagement
with regulatory agencies on the updated protocol and statistical
plan, the Company intends to provide an update on this trial.
Anticipated Catalysts and Operational Objectives in
2025
Myelofibrosis
- Announce completion of enrollment of the Phase 3 SENTRY trial
evaluating selinexor in combination with ruxolitinib in JAKi naive
myelofibrosis patients in 1H 2025.
- Report preliminary data on a subset of participants in the 60
mg cohort from the Phase 2 SENTRY-2 trial evaluating selinexor as a
monotherapy in patients with JAKi naïve myelofibrosis with moderate
thrombocytopenia in 1H 2025.
- Report top-line results from the Phase 3 SENTRY trial in 2H
2025.
Multiple Myeloma
- Maintain the Company's commercial foundation in the competitive
multiple myeloma marketplace and drive increased XPOVIO
revenues.
- Continue global launches and reimbursement approvals for
selinexor by partners in ex-U.S. territories.
- Continue to follow patients that are enrolled in the Phase 3
XPORT-MM-031 (EMN29) trial. Pending ongoing engagement with
regulatory agencies on the updated protocol and statistical plan,
the Company intends to provide an update on this trial.
Endometrial Cancer
- Continue to enroll patients into the Phase 3 XPORT-EC-042 trial
of selinexor as a maintenance monotherapy for patients with
TP53 wild-type advanced or recurrent endometrial
cancer.
2025 Financial Outlook
Based on its current operating plans, Karyopharm expects the
following for full year 2025:
- Total revenue to be in the range of $140
million to $155 million. Total
revenue consists of U.S. XPOVIO net product revenue and license,
royalty and milestone revenue earned from partners.
- U.S. XPOVIO net product revenue to be in the range of
$115 million to $130 million.
- R&D and selling, general and administrative (SG&A)
expenses to be in the range of $240
million to $255 million, which
includes approximately $20 million of
estimated non-cash stock-based compensation expense.
- The Company expects that its existing cash, cash equivalents
and investments, and the revenue it expects to generate from XPOVIO
net product sales, as well as revenue generated from its license
agreements, will be sufficient to fund its planned operations into
the first quarter of 2026.2
2Excluding re-payment of $24.5
million aggregate principal amount of the Company's
remaining senior convertible notes due October 2025 (the 2025 Notes) and $25.0 million minimum liquidity covenant under
the Company's senior secured term loan due 2028. Taking into
account the repayment of the 2025 Notes and the minimum liquidity
covenant, Karyopharm expects its cash, cash equivalents and
investments will be sufficient to fund its operations into the
fourth quarter of 2025.
Full Year and Fourth Quarter 2024 Financial Results
Total revenue: Total revenue for the fourth quarter
of 2024 was $30.5 million, compared
to $33.7 million for the fourth
quarter of 2023. Total revenue for the year ended December 31, 2024 was $145.2 million, compared to $146.0 million for the year ended December 31, 2023.
Net product revenue: Net product revenue for the
fourth quarter of 2024 was $29.3
million, compared to $25.1
million for the fourth quarter of 2023. Net product revenue
for the year ended December 31, 2024
was $112.8 million, compared to
$112.0 million for the year ended
December 31, 2023.
License and other revenue: License and other revenue for
the fourth quarter of 2024 was $1.3
million, compared to $8.7
million for the fourth quarter of 2023. License and other
revenue for the year ended December 31,
2024 was $32.4 million,
compared to $34.0 million for the
year ended December 31, 2023.
Cost of sales: Cost of sales for the fourth quarter
of 2024 was $1.3 million, compared to
$1.5 million for the fourth quarter
of 2023. Cost of sales for the year ended December 31, 2024 was $6.0
million, compared to $4.9
million for the year ended December
31, 2023. 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 fourth
quarter of 2024 were $33.3 million,
compared to $39.4 million for the
fourth quarter of 2023. R&D expenses for the year ended
December 31, 2024 were $143.2 million, compared to $138.8 million for the year ended December 31, 2023. The increase in both periods
was primarily due to increased clinical trial activity, partially
offset by a reduction in headcount and contractors.
SG&A expenses: SG&A expenses for the fourth
quarter of 2024 were $27.2 million,
compared to $30.7 million for the
fourth quarter of 2023. SG&A expenses for the year ended
December 31, 2024 were $115.4 million, compared to $131.9 million for the year ended December 31, 2023. The decrease in both periods
was primarily due to a reduction in headcount and contractors as
well as lower commercial-related activities in connection with cost
optimization efforts.
Interest income: Interest income for the fourth
quarter of 2024 was $1.5 million,
compared to $2.5 million for the
fourth quarter of 2023. Interest income for the year ended
December 31, 2024 was $7.4 million compared to $10.9 million for the year ended December 31, 2023, due to lower investment
balances in 2024 as compared to 2023.
Interest expense: Interest expense for the fourth
quarter of 2024 was $11.2 million,
compared to $6.2 million for the
fourth quarter of 2023. Interest expense for the year ended
December 31, 2024 was $37.4 million, compared to $23.8 million for the year ended December 31, 2023. The increase in both periods
was primarily due to the term loan and convertible debt that were
issued in 2024.
Gain on extinguishment of debt and other income: Other
income for the fourth quarter of 2024 was $10.1 million due to non-cash fair value
remeasurements. The Company had immaterial other expense in the
fourth quarter of 2023. Gain on extinguishment of debt and other
income for the year ended December 31,
2024 was $73.1 million
primarily due to the recognition of a $44.7
million non-cash gain on extinguishment of debt and
$28.7 million non-cash fair value
remeasurements, both of which related to the refinancing
transactions that were completed in mid-2024. The Company had
immaterial other expense for the year ended December 31, 2023.
Net loss: Karyopharm reported a net loss of
$30.8 million, or $0.24 per basic and diluted share, for the fourth
quarter of 2024, compared to a net loss of $41.8 million, or $0.36 per basic and diluted share, for the fourth
quarter of 2023. Net loss included non-cash stock-based
compensation expense of $3.9 million
and $5.2 million for the fourth
quarters of 2024 and 2023, respectively. Karyopharm reported a net
loss of $76.4 million, or
$0.63 per basic share and
$0.93 per diluted share, for the year
ended December 31, 2024, compared to
a net loss of $143.1 million, or
$1.25 per basic and diluted share,
for the year ended December 31, 2023.
Net loss included non-cash stock-based compensation expense of
$18.4 million and $21.7 million for the years ended December 31, 2024 and 2023, respectively.
Cash position: Cash, cash equivalents, restricted
cash and investments as of December 31,
2024 totaled $109.1 million,
compared to $192.4 million as of
December 31, 2023.
Conference Call Information
Karyopharm will host a conference call today, February 19, 2025, at 8:00
a.m. Eastern Time, to discuss the fourth quarter and
full year 2024 financial results, the financial outlook for 2025
and to provide other business updates. To access the conference
call, please dial (800) 836-8184 (local) or (646) 357-8785
(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. 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 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) under accelerated approval 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, Mainland China, Taiwan, Hong
Kong, Australia,
South Korea, Singapore, Israel, and Canada. XPOVIO®/NEXPOVIO® is marketed in these
respective ex-U.S. territories by Karyopharm's partners: Antengene,
Menarini, Neopharm, and FORUS. 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:
- In combination with bortezomib and dexamethasone for the
treatment of adult patients with multiple myeloma who have received
at least one prior therapy (XVd).
- In combination with dexamethasone for the treatment of adult
patients with relapsed or refractory multiple myeloma who have
received at least four prior therapies and whose disease is
refractory to at least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti‐CD38 monoclonal antibody
(Xd).
- For the treatment of adult patients with relapsed or refractory
diffuse large B‐cell lymphoma (DLBCL), not otherwise specified,
including DLBCL arising from follicular lymphoma, after at least
two lines of systemic therapy. This indication is approved under
accelerated approval based on response rate. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Thrombocytopenia: Monitor platelet counts throughout treatment.
Manage with dose interruption and/or reduction and supportive
care.
- Neutropenia: Monitor neutrophil counts throughout treatment.
Manage with dose interruption and/or reduction and granulocyte
colony‐stimulating factors.
- Gastrointestinal Toxicity: Nausea, vomiting, diarrhea,
anorexia, and weight loss may occur. Provide antiemetic
prophylaxis. Manage with dose interruption and/or reduction,
antiemetics, and supportive care.
- Hyponatremia: Monitor serum sodium levels throughout treatment.
Correct for concurrent hyperglycemia and high serum paraprotein
levels. Manage with dose interruption, reduction, or
discontinuation, and supportive care.
- Serious Infection: Monitor for infection and treat
promptly.
- Neurological Toxicity: Advise patients to refrain from driving
and engaging in hazardous occupations or activities until
neurological toxicity resolves. Optimize hydration status and
concomitant medications to avoid dizziness or mental status
changes.
- Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential and males with a female partner of
reproductive potential, of the potential risk to a fetus and use of
effective contraception.
- Cataract: Cataracts may develop or progress. Treatment of
cataracts usually requires surgical removal of the cataract.
Adverse Reactions
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive XVd are fatigue, nausea, decreased
appetite, diarrhea, peripheral neuropathy, upper respiratory tract
infection, decreased weight, cataract and vomiting. Grade 3‐4
laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia,
hypophosphatemia, anemia, hyponatremia and neutropenia. In the
BOSTON trial, fatal adverse
reactions occurred in 6% of patients within 30 days of last
treatment. Serious adverse reactions occurred in 52% of patients.
Treatment discontinuation rate due to adverse reactions was
19%.
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive Xd are thrombocytopenia, fatigue,
nausea, anemia, decreased appetite, decreased weight, diarrhea,
vomiting, hyponatremia, neutropenia, leukopenia, constipation,
dyspnea and upper respiratory tract infection. In the STORM trial,
fatal adverse reactions occurred in 9% of patients. Serious adverse
reactions occurred in 58% of patients. Treatment discontinuation
rate due to adverse reactions was 27%.
- The most common adverse reactions (incidence ≥20%) in patients
with DLBCL, excluding laboratory abnormalities, are fatigue,
nausea, diarrhea, appetite decrease, weight decrease, constipation,
vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%)
are thrombocytopenia, lymphopenia, neutropenia, anemia, and
hyponatremia. In the SADAL trial, fatal adverse reactions occurred
in 3.7% of patients within 30 days, and 5% of patients within 60
days of last treatment; the most frequent fatal adverse reactions
was infection (4.5% of patients). Serious adverse reactions
occurred in 46% of patients; the most frequent serious adverse
reaction was infection (21% of patients). Discontinuation due to
adverse reactions occurred in 17% of patients.
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 whose dedication to
pioneering novel cancer therapies is fueled by a belief in the
extraordinary strength and courage of patients with cancer. Since
its founding, Karyopharm has been an industry leader in oral
compounds that address nuclear export dysregulation, a fundamental
mechanism of oncogenesis. Karyopharm's lead 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. It has also 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 indications in multiple high unmet need cancers,
including in multiple myeloma, endometrial cancer, myelofibrosis,
and diffuse large B-cell lymphoma (DLBCL). For more information
about our people, science and pipeline, please visit
www.karyopharm.com, and follow us on LinkedIn and on X at
@Karyopharm.
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 2025 total revenue,
2025 U.S. net product revenue and 2025 R&D and SG&A
expenses; expected cash runway; expectations with respect to
commercialization efforts; the ability of selinexor to treat
patients with multiple myeloma, endometrial cancer, myelofibrosis,
diffuse large B-cell lymphoma and other diseases; and
expectations with respect to the clinical development plans and
potential regulatory submissions of selinexor. 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, 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 trials, including subsequent analysis of
existing data and new data received from ongoing and future trials;
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
trials; 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; substantial doubt exists regarding Karyopharm's
ability to continue as a going concern; 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 September 30, 2024,
which was filed with the Securities and Exchange Commission (SEC)
on November 5, 2024, 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.
KARYOPHARM
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
December 31,
|
|
|
Years Ended
December 31,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
|
29,252
|
|
|
$
|
25,056
|
|
|
$
|
112,806
|
|
|
$
|
112,011
|
|
License and other
revenue
|
|
|
1,290
|
|
|
|
8,691
|
|
|
|
32,431
|
|
|
|
34,022
|
|
Total
revenue
|
|
|
30,542
|
|
|
|
33,747
|
|
|
|
145,237
|
|
|
|
146,033
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
1,331
|
|
|
|
1,486
|
|
|
|
6,007
|
|
|
|
4,942
|
|
Research and
development
|
|
|
33,302
|
|
|
|
39,381
|
|
|
|
143,232
|
|
|
|
138,750
|
|
Selling, general and
administrative
|
|
|
27,190
|
|
|
|
30,688
|
|
|
|
115,441
|
|
|
|
131,881
|
|
Total operating
expenses
|
|
|
61,823
|
|
|
|
71,555
|
|
|
|
264,680
|
|
|
|
275,573
|
|
Loss from
operations
|
|
|
(31,281)
|
|
|
|
(37,808)
|
|
|
|
(119,443)
|
|
|
|
(129,540)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,482
|
|
|
|
2,520
|
|
|
|
7,400
|
|
|
|
10,943
|
|
Interest
expense
|
|
|
(11,204)
|
|
|
|
(6,208)
|
|
|
|
(37,422)
|
|
|
|
(23,823)
|
|
Gain on extinguishment
of debt
|
|
|
—
|
|
|
|
—
|
|
|
|
44,702
|
|
|
|
—
|
|
Other income
(expense), net
|
|
|
10,114
|
|
|
|
(211)
|
|
|
|
28,398
|
|
|
|
(356)
|
|
Total other income
(expense), net
|
|
|
392
|
|
|
|
(3,899)
|
|
|
|
43,078
|
|
|
|
(13,236)
|
|
Loss before income
taxes
|
|
|
(30,889)
|
|
|
|
(41,707)
|
|
|
|
(76,365)
|
|
|
|
(142,776)
|
|
Income tax
provision
|
|
|
109
|
|
|
|
(130)
|
|
|
|
(57)
|
|
|
|
(323)
|
|
Net loss
|
|
$
|
(30,780)
|
|
|
$
|
(41,837)
|
|
|
$
|
(76,422)
|
|
|
$
|
(143,099)
|
|
Basic net loss per
share
|
|
$
|
(0.24)
|
|
|
$
|
(0.36)
|
|
|
$
|
(0.63)
|
|
|
$
|
(1.25)
|
|
Diluted net loss per
share
|
|
$
|
(0.24)
|
|
|
$
|
(0.36)
|
|
|
$
|
(0.93)
|
|
|
$
|
(1.25)
|
|
Weighted-average number
of common shares
outstanding used to compute basic net loss per share
|
|
|
125,881
|
|
|
|
114,778
|
|
|
|
121,863
|
|
|
|
114,221
|
|
Weighted-average number
of common shares
outstanding used to compute diluted net loss per share
|
|
|
125,881
|
|
|
|
114,778
|
|
|
|
126,809
|
|
|
|
114,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KARYOPHARM
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in
thousands)
|
|
|
December 31,
2024
|
|
|
December 31,
2023
|
|
Assets
|
|
|
|
|
|
Cash, cash equivalents
and investments
|
$
|
108,712
|
|
|
$
|
191,443
|
|
Restricted
cash
|
|
338
|
|
|
|
961
|
|
Accounts
receivable
|
|
30,766
|
|
|
|
26,962
|
|
Other assets
|
|
24,602
|
|
|
|
21,072
|
|
Total
assets
|
$
|
164,418
|
|
|
$
|
240,438
|
|
Liabilities and
stockholders' deficit
|
|
|
|
|
|
Convertible senior
notes due 2025
|
$
|
24,426
|
|
|
$
|
170,919
|
|
Convertible senior
notes due 2029
|
|
68,345
|
|
|
|
—
|
|
Senior secured term
loan
|
|
94,603
|
|
|
|
—
|
|
Deferred royalty
obligation
|
|
73,499
|
|
|
|
132,479
|
|
Other
liabilities
|
|
89,562
|
|
|
|
73,246
|
|
Total
liabilities
|
|
350,435
|
|
|
|
376,644
|
|
Total stockholders'
deficit
|
|
(186,017)
|
|
|
|
(136,206)
|
|
Total liabilities and
stockholders' deficit; 126,201 and 114,915 shares issued and
outstanding at December 31, 2024 and December 31, 2023,
respectively
|
$
|
164,418
|
|
|
$
|
240,438
|
|

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SOURCE Karyopharm Therapeutics Inc.