– Achieved Second Quarter 2023 Total Revenue
of $37.6 Million and U.S. XPOVIO®
(selinexor) Net Product Revenue of $28.5
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
–
– Announces ~20% Workforce Reduction Enhancing
Financial Strength; Further Reduces Full Year 2023 Non-GAAP R&D
and SG&A Expense Guidance to $240
Million to $255 Million; Cash
Runway into Late 2025 –
–Initiated Pivotal Phase 3 Study of
XPO1 Inhibitor Selinexor and Ruxolitinib in JAK Inhibitor (JAKi)
Naïve Myelofibrosis in June 2023 and
Received Fast Track Designation from US FDA –
– Announced Long-Term Exploratory Subgroup
Analyses Presented at ASCO Plenary Providing Further Rationale for
XPORT-EC-042, the Company's Ongoing Pivotal Phase 3 Study in
Endometrial Cancer –
– Conference Call Scheduled for Today at
8:00 a.m. ET –
NEWTON,
Mass., Aug. 2, 2023 /PRNewswire/ -- Karyopharm
Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical
company pioneering novel cancer therapies, today reported financial
results for the quarter ended June 30,
2023. In addition, Karyopharm highlighted select corporate
milestones and progress on its key clinical development programs
and announced further optimization of its organization and cost
structure aimed at prioritizing focus on advancing its late-stage
clinical pipeline and positioning the Company for sustained
growth.
"We had a strong second quarter executing against our key
priorities with our late-stage clinical pipeline and XPOVIO
commercial performance. We achieved an important milestone this
quarter with the initiation of our pivotal Phase 3 study evaluating
selinexor in combination with ruxolitinib in JAKi-naïve patients
with myelofibrosis. We are highly encouraged by the updated
exploratory subgroup analyses from SIENDO presented at the ASCO
Plenary in July, which further strengthen the rationale of and our
growing confidence in our ongoing XPORT-EC-042 study in patients
with TP53 wild-type advanced or recurrent endometrial
cancer. Finally, in multiple myeloma, we are pleased to see
continued growth in patients treated with XPOVIO, in both the
community and academic settings despite increased competition."
"As we continue to focus on our near-term Phase 3 clinical
programs, driving benefit for our patients and creating value for
our shareholders, we've also taken further actions to streamline
our operations and optimize our cost structure and workforce to
maximize the potential of these programs. We truly appreciate the
hard work and dedication of all our employees, past and present,"
said Richard Paulson, President and
Chief Executive Officer of Karyopharm.
Second Quarter 2023 and Recent Highlights
XPOVIO Commercial Performance
- Achieved U.S. net product revenue for the second quarter of
2023 of $28.5 million, compared to
$29.0 million U.S. net product
revenue in the second quarter of 2022.
- Total demand1 growth for XPOVIO was 9% in
the second quarter year over year, amidst increasing competition in
the late line setting, with total demand growth of 11% and 6% in
the community and academic settings, respectively. Growth in the
community setting was driven by increased use of XPOVIO in earlier
lines as a novel mechanism of action and a convenient oral therapy,
while expansion of use in the academic setting was driven by the
use of XPOVIO pre and post T-cell therapies. The use of XPOVIO
in the second to fourth lines grew to greater than 60%
of XPOVIO new starts in these settings, up from 49% in the
second quarter of 2022, with continued improvement in perception of
XPOVIO in the third line setting according to Intent to Prescribe
data2.
- U.S. net product revenue in the second quarter of 2023 was
adversely impacted by approximately $3.0
million due to continued higher utilization of
the KaryForward Patient Assistance Program (PAP) (free drug)
resulting from ongoing funding constraints at certain multiple
myeloma foundations.3 US net product revenues were also
impacted by higher gross-to-net driven by increased 340B discounts and Medicare and Medicaid rebates
year over year.
R&D Highlights
Myelofibrosis
- Initiated pivotal Phase 3 portion of the XPORT-MF-034 clinical
trial (NCT04562389) to assess the efficacy and safety of
once-weekly selinexor 60mg in combination with ruxolitinib in
JAKi-naïve patients with myelofibrosis. The randomized,
double-blind, placebo-controlled study is expected to enroll 306
JAKi-naive patients with intermediate or high-risk myelofibrosis.
Patients are randomized 2:1 to ruxolitinib plus selinexor 60mg or
ruxolitinib plus placebo. The ruxolitinib dose is determined by the
investigators based on the patients' baseline platelet count per
the drug's prescribing information. The co-primary endpoints are
spleen volume response rate of ≥ 35% (SVR35) and symptom
improvement of ≥ 50% (TSS50) at week 24, with a key secondary
endpoint of anemia response at week 24. Top-line data from this
study are expected in 2025.
- Updated results from the Phase 1 portion of this study were
presented at the American Society of Clinical Oncology (ASCO) and
European Hematology Association (EHA) conferences. As of the
April 10, 2023 data cut-off date,
78.6% (11/14) of the intent to treat (ITT) patients who were
treated with the 60mg dose of selinexor in combination with
ruxolitinib, achieved SVR35 and 58.3% (7/12) of the ITT patients
achieved TSS50, at week 24. SVR35 responses were consistent across
all subgroups, including males and patients treated with low dose
ruxolitinib. The most common treatment emergent grade ≥3 adverse
events (AE) experienced with the 60mg selinexor dose, in
combination with ruxolitinib were anemia (42.9%), thrombocytopenia
(28.6%) and back pain (14.3%). Further details can be found
here.
- The Company received Fast Track Designation from the U.S. Food
and Drug Administration (FDA) for selinexor for the treatment
of patients with myelofibrosis, including primary myelofibrosis,
post-essential thrombocythemia myelofibrosis, and post-polycythemia
vera myelofibrosis.
Endometrial Cancer (EC)
- Long term exploratory subgroup analysis was presented from
the SIENDO (NCT03555422) study in patients with advanced or
recurrent TP53 wild-type endometrial cancer at the virtual
American Society of Clinical Oncology (ASCO) July 2023 Plenary Series. The primary analysis of
the Phase 3 SIENDO study of selinexor maintenance therapy in
advanced or recurrent endometrial cancer in 2022 showed
improvements in progression-free survival (PFS) for the ITT
population but were not clinically meaningful. However, an
exploratory analysis of a pre-specified subgroup of patients with
TP53 wild-type endometrial cancer showed a promising
efficacy signal. As of the March 30,
2023 data cut-off date, median PFS was 27.4 months in the
selinexor treatment arm (n=77) as compared to 5.2 months (n=36) in
the placebo arm. In the TP53 wild-type/ Microsatellite
Stable (MSS/pMMR) population, the median PFS has not been reached.
The most common AEs in the TP53 wild-type subgroup were
nausea (91%), vomiting (61%) and diarrhea (40%), the majority of
which were grades 1-2. The most common reported grade 3-4
treatment-emergent AEs (TEAEs) included neutropenia (18%), nausea
(12%), and thrombocytopenia (9%). TEAEs leading to discontinuations
were reported in 16% of patients.
- Following the primary analysis of the SIENDO study,
Karyopharm initiated the pivotal Phase 3 study (XPORT-EC-042;
NCT05611931) of selinexor specifically in patients with TP53
wild-type advanced or recurrent endometrial cancer, and entered
into a global collaboration with Foundation Medicine, Inc. to
develop FoundationOne®CDx, a tissue-based comprehensive genomic
profiling test to identify and enroll patients whose tumors are
TP53 wild type in this study. Top-line data from this study are
expected in late 2024 to early 2025.
Update on Intellectual Property
- The United States Patent and Trademark Office issued a
certificate extending the term of the patent covering the
composition of matter of XPOVIO® (selinexor) (U.S. patent
8,999,996) by 342 days to July 3,
2033.
Optimization of Corporate Organization, Financial
Position and Cost Structure
- Karyopharm has further positioned its organization to focus on
its late-stage core programs by taking steps to optimize its cost
structure to further strengthen its financial position to invest in
its three ongoing Phase 3 studies. As a result, there has been a
~20% reduction of the Company's workforce, including full time
employees and contractors.
- The Company entered into an amendment to its Revenue Interest
Financing Agreement with affiliates of Healthcare Royalty Partners
in August 2023. The amendment
extended the minimum aggregate payment amount date by six months
from December 31, 2024 to
June 30, 2025 and increased the
payment cap from 185% to 195% of the investment amount. In
addition, the Company agreed to issue to Healthcare Royalty
Partners warrants exercisable for 250,000 shares of common stock
with a termination date of August 1,
2030 and an exercise price of $2.25 per share.
- These initiatives further position the Company to enhance its
financial strength and are expected to provide a cash runway into
late 2025, with the capital needed to deliver top-line readouts
from its three Phase 3 studies.
Second Quarter 2023 Financial Results
Total Revenues: Total revenue for the second quarter of
2023 was $37.6 million, compared to
$39.7 million for the second quarter
of 2022. The slight decrease was due primarily to a decline in
license and other revenue.
Net product revenue: Net product revenue for the
second quarter of 2023 was $28.5
million, compared with $29.0
million for the second quarter of 2022.
License and other revenue: License and other revenue for
the second quarter of 2023 was $9.1
million, compared to $10.7
million for the second quarter of 2022. The decrease was
primarily attributable to a decrease in revenue for the
reimbursement of development-related expenses from the Menarini
Group due to a corresponding decrease in the underlying
expenses.
Cost of sales: Cost of sales for the second quarter
of 2023 was $1.2 million, compared to
$0.9 million for the second 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 second quarter of 2023 were $31.5 million, compared to $44.3 million for the second quarter of 2022. The
decrease was attributable to a decrease in personnel costs,
stock-based compensation and clinical trial costs related to
our non-core programs, partially offset by costs incurred in 2023
related to our Phase 3 EC-042 study. The decrease in stock-based
compensation is primarily due to $3.8
million of severance-related stock-based compensation
expenses incurred during the quarter ended June 30, 2022, in connection with the departure
of our former Chief Scientific Officer.
Selling, general and administrative (SG&A) expenses:
SG&A expenses for the second quarter of 2023 were $34.5 million, compared to $37.3 million for the second quarter of 2022. The
decrease is primarily due to severance-related stock-based
compensation expenses incurred during the quarter ended
June 30, 2022, in connection with the
departure of our former Chief Executive Officer.
Interest income: Interest income for the second quarter
of 2023 was $2.8 million, compared to
$0.3 million for the second quarter
of 2022 due to higher average interest rates on our
investments.
Interest expense: Interest expense for the second quarter
of 2023 was $5.8 million, compared to
$6.3 million for the second quarter
of 2022.
Net loss: Karyopharm reported a net loss of
$32.6 million, or $0.29 per share, for the second quarter of 2023,
compared to a net loss of $49.1
million, or $0.62 per share,
for the second quarter of 2022.
Cash position: Cash, cash equivalents, restricted cash
and investments as of June 30, 2023,
totaled $237.7 million, compared to
$279.7 million as of December 31, 2022.
2023 Financial Outlook
Based on its current operating plans, Karyopharm's guidance for
full year 2023 is as follows:
- Total revenue to be in the range of $145
million to $160 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
$110 million to $125 million, driven by the expectation that the
increased use of PAP will continue in 2023, including a cumulative
effect from refills.
- Non-GAAP R&D and SG&A expenses*, which exclude
stock-based compensation expense, to be in the range of
$240 million to $255 million, as a result of cost savings from
further optimization of infrastructure and cost structure and
workforce reduction of approximately 20%.
- The Company continues to expect 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 late 2025.
* Karyopharm has not reconciled the full year 2023 outlook for
non-GAAP R&D and SG&A expenses to full year 2023 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
2023 outlook for non-GAAP R&D and SG&A expenses.
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 2, 2023, at 8:00
a.m. Eastern Time, to discuss the second 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:
- 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 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 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 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
future savings from current optimization efforts and reduction in
the Company's workforce; 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 March 31,
2023, which was filed with the Securities and Exchange
Commission (SEC) on May 4, 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.
References:
1 Includes patient assistant
program and commercial demand
2 Based on claims data analysis, accessed in
June 2023
3 Four Multiple myeloma foundations provide
financial support to Medicare patients with multiple myeloma
KARYOPHARM
THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (unaudited); (in thousands, except
per share amounts)
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
|
28,460
|
|
|
$
|
29,010
|
|
|
$
|
56,748
|
|
|
$
|
57,310
|
|
License and other
revenue
|
|
|
9,119
|
|
|
|
10,669
|
|
|
|
19,529
|
|
|
|
30,039
|
|
Total
revenue
|
|
|
37,579
|
|
|
|
39,679
|
|
|
|
76,277
|
|
|
|
87,349
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
1,194
|
|
|
|
939
|
|
|
|
2,545
|
|
|
|
2,365
|
|
Research and
development
|
|
|
31,477
|
|
|
|
44,309
|
|
|
|
63,816
|
|
|
|
86,371
|
|
Selling, general and
administrative
|
|
|
34,481
|
|
|
|
37,339
|
|
|
|
70,388
|
|
|
|
76,107
|
|
Total operating
expenses
|
|
|
67,152
|
|
|
|
82,587
|
|
|
|
136,749
|
|
|
|
164,843
|
|
Loss from
operations
|
|
|
(29,573)
|
|
|
|
(42,908)
|
|
|
|
(60,472)
|
|
|
|
(77,494)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
2,824
|
|
|
|
293
|
|
|
|
5,673
|
|
|
|
367
|
|
Interest
expense
|
|
|
(5,784)
|
|
|
|
(6,313)
|
|
|
|
(11,542)
|
|
|
|
(12,997)
|
|
Other income
(expense), net
|
|
|
30
|
|
|
|
(13)
|
|
|
|
(234)
|
|
|
|
(86)
|
|
Total other expense,
net
|
|
|
(2,930)
|
|
|
|
(6,033)
|
|
|
|
(6,103)
|
|
|
|
(12,716)
|
|
Loss before income
taxes
|
|
|
(32,503)
|
|
|
|
(48,941)
|
|
|
|
(66,575)
|
|
|
|
(90,210)
|
|
Income tax
provision
|
|
|
(127)
|
|
|
|
(121)
|
|
|
|
(181)
|
|
|
|
(251)
|
|
Net loss
|
|
$
|
(32,630)
|
|
|
$
|
(49,062)
|
|
|
$
|
(66,756)
|
|
|
$
|
(90,461)
|
|
Net loss per
share—basic and diluted
|
|
$
|
(0.29)
|
|
|
$
|
(0.62)
|
|
|
$
|
(0.59)
|
|
|
$
|
(1.15)
|
|
Weighted-average number
of common shares
outstanding used in net loss per share—basic and
diluted
|
|
|
114,207
|
|
|
|
79,651
|
|
|
|
113,846
|
|
|
|
78,616
|
|
KARYOPHARM
THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (unaudited); (in thousands)
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
Assets
|
|
|
|
|
|
Cash, cash equivalents
and investments
|
$
|
236,765
|
|
|
$
|
277,967
|
|
Restricted
cash
|
|
954
|
|
|
|
1,697
|
|
Accounts
receivable
|
|
32,280
|
|
|
|
47,086
|
|
Other assets
|
|
27,831
|
|
|
|
31,422
|
|
Total
assets
|
$
|
297,830
|
|
|
$
|
358,172
|
|
Liabilities and
stockholders' deficit
|
|
|
|
|
|
Convertible senior
notes
|
$
|
170,497
|
|
|
$
|
170,105
|
|
Deferred royalty
obligation
|
|
132,718
|
|
|
|
132,718
|
|
Other
liabilities
|
|
65,863
|
|
|
|
72,005
|
|
Total
liabilities
|
|
369,078
|
|
|
|
374,828
|
|
Total stockholders'
deficit
|
|
(71,248)
|
|
|
|
(16,656)
|
|
Total liabilities and
stockholders' deficit; 114,340 and 113,213 shares issued and
outstanding at June 30, 2023 and December 31, 2022,
respectively
|
$
|
297,830
|
|
|
$
|
358,172
|
|
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SOURCE Karyopharm Therapeutics Inc.