Full Press Release Details
Karyopharm Reports First Quarter 2021 Financial Results and Highlights Recent Company Progress
Total Revenues of $23.3 Million for the First Quarter of 2021; XPOVIO
(selinexor) Net Product Sales of $21.7 Million
Conditional Marketing Authorization Granted by the European
Commission for NEXPOVIO (selinexor) in Penta-Refractory Multiple Myeloma; European Decision for Expanded Multiple Myeloma Indication Expected in the Fourth Quarter of 2021
Richard Paulson Appointed Next President and Chief Executive Officer of Karyopharm
Conference Call Scheduled for Today at 8:30 a.m. ET
NEWTON, Mass. May 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel
cancer therapies, today reported financial results for the quarter ended March 31, 2021. In addition, Karyopharm highlighted select corporate milestones, including details regarding the appointment of its next President and Chief Executive
Officer, the ongoing U.S. commercialization of XPOVIO, and regulatory progress in Europe, and provided an overview of its key clinical development programs.
We are encouraged to see patient demand for XPOVIO return to growth in the first quarter of 2021, and we remain confident in its long-term commercial
potential and our ability to further increase utilization and expand into additional cancer indications, said Richard Paulson, MBA, a member of the Board of Directors and the newly appointed President and Chief Executive Officer of Karyopharm.
As the Company is now at a pivotal point in its commercialization efforts, I am excited to lead Karyopharm in its next chapter as we seek to expand XPOVIO s impact across indications and geographies. Looking ahead to the remainder of the
year, we expect to report top-line data from the Phase 3 SIENDO study in endometrial cancer before the end of the year, and we anticipate receiving a decision from the European Commission regarding our request
for an expansion of the currently authorized indication for NEXPOVIO in Europe in the fourth quarter of 2021.
Mr. Paulson went on to say,
On behalf of the entire Board of Directors, I can t thank Dr. Kauffman enough for his vision, leadership, and immense contributions to the scientific and initial commercial success achieved by Karyopharm. I look forward to our
progress and continued partnership on behalf of the patients we aim to serve, and the support of all of our employees, partners, and shareholders who share in our commitment to improve the lives of patients battling cancer.
First Quarter 2021 and Recent Highlights
Dr. Kauffman will continue to advance the
Company s mission and remain a member of Karyopharm s Board of Directors. In addition, he will also take on a new role as Senior Clinical Advisor. In this capacity, he will help guide the clinical development for Karyopharm s robust
pipeline of programs, with a focus on solid tumor indications. Dr. Shacham will continue in her role as Chief Scientific Officer, overseeing research, development and regulatory affairs.
XPOVIO in Hematologic Malignancies
During the first quarter of 2021, XPOVIO generated net product sales of $21.7 million, representing a 7% increase as compared to the
fourth quarter of 2020 and a 35% increase as compared to the first quarter of 2020. Net sales for the first quarter of 2021 were largely driven by prescription demand from both academic and community-based oncologists for patients with multiple
myeloma. Approximately 1,170 XPOVIO prescriptions were filled in the first quarter of 2021 as compared to approximately 1,000 prescriptions in the fourth quarter of 2020, representing a 17% increase in patient demand from the prior quarter. Further,
over 160 new physician prescribing accounts were added in the first quarter of 2021, which included physicians treating both myeloma and diffuse large B-cell lymphoma (DLBCL). Additionally, prescription demand
in the first quarter of 2021 was the highest generated since XPOVIO s initial accelerated FDA approval in July 2019.
Nine abstracts highlighting data from hematologic malignancy studies will be presented at the upcoming 2021 ASCO Annual
Meeting taking place June 4-8, 2021.
XPOVIO in Development for Solid Tumors
Seven abstracts highlighting data from solid tumor studies will be presented at the upcoming 2021 ASCO Annual Meeting taking place June 4-8, 2021. These data will include XPOVIO studies in advanced colorectal cancer, endometrial cancer, and dedifferentiated liposarcoma.
First Quarter 2021 Financial Results
revenue: Net product revenue for the first quarter of 2021 was $21.7 million, compared to $16.1 million for the first quarter of 2020.
License and other revenue: License and other revenue for the first quarter of 2021 was $1.5 million, compared to $2.1 million for
the first quarter of 2020.
Cost of sales: Cost of sales for the first quarter of 2021 were $0.9 million, compared to
$0.8 million for the first quarter of 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 first quarter of 2021 were $37.1 million, compared to
$34.0 million for the first quarter of 2020. The increase in R&D expenses in the first quarter of 2021 compared to the first quarter of 2020 was primarily attributable to continued clinical trial activity and clinical development of
selinexor in Karyopharm s lead indications.
Selling, general and administrative (SG&A) expenses: SG&A expenses for
the first quarter of 2021 were $37.7 million, compared to $30.7 million for the first quarter of 2020. The increase in SG&A expenses compared to the first quarter of 2020 was due primarily to activities to support the U.S.
commercialization of XPOVIO, including the launch of XPOVIO in combination with once-weekly Velcade and dexamethasone for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy.
Interest expense: Interest expense for the first quarter of 2021 was $5.1 million, compared
to $6.5 million for the first quarter of 2020. The decrease in interest expense was primarily attributable to the decrease in non-cash interest expense related to our 3.00% senior convertible notes due
2025, as a result of the adoption of ASU No. 2020-06, Debt Debt with Conversion and Other Options and Derivatives and Hedging Contracts in Entity s Own Equity, on
January 1, 2021. Post adoption, we are no longer required to amortize the debt discount to non-cash interest expense, as that component of $50.6 million has now been reclassified out of equity
into the convertible senior notes line on our Balance Sheet.
Net loss: Karyopharm reported a net loss of $57.4 million, or $0.77
per share, for the first quarter of 2021, compared to a net loss of $52.9 million, or $0.78 per share, for the first quarter of 2020. Net loss included non-cash stock-based compensation expense of $7.4 million and $5.2 million for the
first quarters of 2021 and 2020, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of
March 31, 2021 totaled $233.6 million, compared to $276.7 million as of December 31, 2020.
2021 Financial Outlook
Based on its current operating plans, Karyopharm expects its non-GAAP R&D and SG&A expenses, excluding
stock-based compensation expense, for the full-year 2021 to be in the range of $[280] to $[300] million. Karyopharm has not reconciled the full year 2021 outlook for non-GAAP R&D and SG&A
expenses to full year 2021 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 2021 outlook for non-GAAP R&D and SG&A expenses.
The Company expects that its existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO product sales, as well as
revenue generated from its license agreements, will be sufficient to fund its planned operations into late 2022.
Non-GAAP Financial Information
Karyopharm uses a non-GAAP financial measure, including 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.
Karyopharm will host a conference call today, Monday, May 3, 2021, at 8:30 a.m. Eastern Time, to discuss the first quarter 2021
financial results, recent accomplishments, clinical developments and business plans. 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 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 Selective Inhibitor of Nuclear Export (SINE)
compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to
accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe
DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with
relapsed refractory multiple myeloma (RRMM) 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. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm s supplemental New
Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received
accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from
follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a
potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in
combination with approved therapies in a variety of tumor types to further inform Karyopharm s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.
For more information about Karyopharm s products or clinical trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326
XPOVIO (selinexor) is a prescription medicine
SELECT IMPORTANT SAFETY INFORMATION
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 and dedicated to the discovery, development, and commercialization of
first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm s Selective Inhibitor of Nuclear Export (SINE)
compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm s lead compound, XPOVIO (selinexor), is approved in the U.S. in multiple