Full Press Release Details
Karyopharm Reports Strong Third Quarter 2021 Financial Results and Provides Business
Quarter 2021 XPOVIO (selinexor) Net Product Revenues of $26.7 Million, Up 32% Sequential
Quarter-Over-Quarter and 25% Year-Over-Year
Milestone-Driven Q4 with Top-Line Data From Phase 3 SIENDO Study in Endometrial Cancer and
Initiation and Expansion of Key Clinical Trials in Multiple Myeloma, Myelodysplastic Syndromes and
Conference Call Scheduled for Today at 8:30 a.m. ET
Company to Host Virtual Investor Day on December 8, 2021 to Outline Commercial and Pipeline Priorities and Objectives
NEWTON, Mass. November 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company
pioneering novel cancer therapies, today reported financial results for the quarter ended September 30, 2021 and provided business highlights.
Driven by acceleration in demand growth for XPOVIO, Karyopharm delivered a strong third quarter, which saw a significant increase in net product
revenues versus the second quarter of 2021. XPOVIO continues to move into earlier lines of therapy in multiple myeloma as a new and effective modality that can become the standard of care in second line plus where utilizing new mechanisms is
critical to improve patient outcomes, said Richard Paulson, President and Chief Executive Officer of Karyopharm. With respect to the pipeline, we remain focused on expanding key clinical trials in multiple myeloma, as well as in
additional cancer indications such as endometrial cancer, myelodysplastic syndromes and myelofibrosis, as emerging data continue to guide our clinical programs. Looking ahead, we have several key upcoming milestones including reporting top-line data from the Phase 3 SIENDO study in endometrial cancer where recruitment remains on track. Finally, we look forward to hosting an Investor Day in early December to present further details on our
commercial and pipeline priorities.
Third Quarter 2021 and Recent Highlights
XPOVIO Commercial Performance
R&D Highlights for Selinexor and Eltanexor
Hematologic Malignancies: Karyopharm is actively building its hematologic oncology franchise through several key initiatives, including pursuing NEXPOVIO (selinexor) marketing approval in Europe in the second-line plus treatment setting for multiple myeloma, expanding approved multiple myeloma indications in the U.S. to include combinations with
certain approved therapies, and pursuing additional high unmet need indications beyond multiple myeloma, such as myelofibrosis (MF) and myelodysplastic syndromes (MDS).
XPOVIO in Solid Tumors:
The Company is exploring solid tumor indications for XPOVIO, either alone or in combination with other agents, including in endometrial cancer, glioblastoma, melanoma, colorectal cancer and non-small cell lung
Corporate and Business Highlights
Third Quarter 2021 Financial Results
We are pleased with the continued expansion of our international program in the third quarter, which was highlighted by our progressing partnership with
Antengene in South Korea and the subsequent milestone payment received by Karyopharm, said Michael P. Mason, Chief Financial Officer of Karyopharm. Based on our current operating plans, we believe our cash, cash equivalents and
investments, together with growing XPOVIO sales and revenues from existing collaborators, provide us with a cash runway that extends into mid-2023.
Net product revenue: Net product revenue for the third quarter of 2021 was $26.7 million, compared to $21.3 million for the third
License and other revenue: License and other revenue for the third quarter of 2021 was $11.0 million. During the
third quarter of 2021, Karyopharm recognized $9.8 million pursuant to its agreement with Antengene, following the July 2021 approval of selinexor for the treatment of patients with multiple myeloma and DLBCL in South Korea and $1.2 million
of revenue associated with named patient programs.
Cost of sales: Cost of sales for the third quarter of 2021 were $0.6 million, compared to
$0.4 million for the third quarter of 2020. Cost of sales reflect 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 third quarter of 2021 were $45.8 million, compared to
$37.0 million for the third quarter of 2020. The increase in R&D expenses in the third quarter of 2021 compared to the third quarter of 2020 was primarily attributable to the acquisition of certain assets from Neumedicines Inc., which
closed in the third quarter of 2021.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the third
quarter of 2021 were $35.1 million, compared to $31.0 million for the third quarter of 2020. The increase in SG&A expenses in the third quarter of 2021 compared to the third quarter of 2020 was due primarily to increased personnel
Interest expense: Interest expense for the third quarter of 2021 was $8.0 million, compared to $6.8 million
for the third quarter of 2020. The increase in interest expense was primarily attributable to a $3.0 million increase in interest expense due to the increased deferred royalty obligation following Karyopharm s June 2021 amendment of its
Revenue Interest Agreement with HealthCare Royalty Management, LLC, partially offset by a $1.8 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
Net loss: Karyopharm reported a net loss of $51.8 million, or $0.69 per share, for the third quarter of 2021,
compared to a net loss of $53.5 million, or $0.73 per share, for the third quarter of 2020. Net loss included non-cash stock-based compensation expense of $7.4 million and $6.5 million for the
third quarters of 2021 and 2020, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of
September 30, 2021 totaled $209.3 million, compared to $276.7 million as of December 31, 2020.
2021 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2021:
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, Wednesday, November 3, 2021, at 8:30 a.m. Eastern Time, to discuss the third quarter
2021 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 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 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 approved:
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 hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple
myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult
patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration,
inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
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 2021 non-GAAP
research and development and selling, general and administrative expenses; Karyopharm s expected cash runway; expectations and plans relating to XPOVIO for the treatment of adult patients with relapsed or refractory multiple
myeloma or relapsed or refractory diffuse large B-cell lymphoma and other hematologic malignancies and solid tumors; commercialization of XPOVIO or any of
Karyopharm s drug candidates and the commercial performance of XPOVIO; submissions to, and the review and potential approval of selinexor or eltanexor by, regulatory authorities, including the Company s regulatory strategy, the anticipated
availability of data to support such submissions, timing of such submissions and actions by regulatory authorities and the potential availability of accelerated approval pathways; the expected design of the Company s clinical trials; and the
therapeutic potential of and potential clinical development plans for Karyopharm s drug candidates, especially 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; 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