Full Press Release Details
Karyopharm Reports Business Highlights and Second Quarter 2021 Financial Results
Achieved Second Quarter 2021 XPOVIO (selinexor) Net Product Revenues
of $20.2 Million and $41.9 Million YTD, Up 8% Versus Second Quarter 2020 and Up 21% Versus First Half of 2020
Forward to a Milestone-Driven Second Half of 2021, Including Top-Line Data from Phase 3 SIENDO Study in Endometrial Cancer and Initiations and Expansions of Key Clinical Trials in Myelodysplastic Syndrome,
Myelofibrosis, Multiple Myeloma & Colorectal Cancer
Company to Host Investor Day in Fourth Quarter 2021 to
Outline Commercial and Pipeline Priorities and Objectives
NEWTON, Mass. August 5, 2021 Karyopharm Therapeutics Inc.
(Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported business highlights and financial results for the quarter ended June 30, 2021.
Richard Paulson, President and Chief Executive Officer of Karyopharm, commented, We are encouraged by the commercial performance of XPOVIO during the
first half of 2021, which reflected meaningful year-over-year growth, up 21% compared to the first half of 2020, driven by rising confidence and demand from both academic and community-based oncologists. XPOVIO continues to move earlier in the
treatment paradigm following U.S. Food and Drug Administration (FDA) approval in the second-line plus treatment setting for multiple myeloma in December 2020. In my first 100 days as CEO, my top priorities have been executional excellence in our
multiple myeloma launch and prioritizing and advancing our pipeline. With respect to the launch, we ve strengthened our organization and execution while solidifying our positioning in the multiple myeloma treatment landscape. XPOVIO is a new
and effective modality that can become a standard of care in second-line plus, where utilizing new mechanisms is critical to continue improving patient outcomes. With respect to the pipeline, we have initiated a comprehensive portfolio review and
continue to move forward with key new trials.
Looking ahead to the remainder of 2021, there are several important events and milestones on
the horizon. First, we plan to host an investor day in the fourth quarter to outline Karyopharm s commercial and pipeline priorities and objectives for the upcoming quarters and years. Next, along with continued commercial growth in hematologic
cancers, we are expecting top-line data from the Phase 3 SIENDO study in endometrial cancer, also around the end of this year. Endometrial cancer is the most common gynecologic cancer and has the potential to
be our first XPOVIO approval in solid tumors. And finally, we expect to initiate or expand several key clinical studies across our pipeline, including in myelodysplastic syndrome, myelofibrosis, multiple myeloma and colorectal cancer,
concluded Mr. Paulson.
Second Quarter 2021 & Recent Highlights
XPOVIO Commercial Performance
Hematologic Malignancies:
Karyopharm is actively building its hematologic oncology franchise through several key initiatives, including pursuing NEXPOVIO 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 and myelodysplastic syndrome.
XPOVIO in Solid Tumors:
In 2020, Karyopharm established proof-of-concept for XPOVIO in solid tumors in advanced liposarcoma. The Company is actively pursuing additional 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 cancer.
Corporate & Business Highlights
Second Quarter 2021 Financial Results
Our balance sheet remains strong, and based on our current operating plans, we believe our cash, cash equivalents and investments, together with growing
XPOVIO revenues, license revenues and the recent capital secured through our amended agreement with HCR, provide us with a cash runway into mid-2023, said Michael P. Mason, Chief Financial Officer of
Karyopharm. Through steady topline growth, driven by both increased physician adoption as well as adding new patient groups and indications over time, our goal is to become a self-sustaining organization for our stakeholders.
Net product revenue: Net product revenue for the second quarter of 2021 was $20.2 million, compared to $18.6 million for the
second quarter of 2020.
License and other revenue: License and other revenue for the second quarter of 2021 was $2.4 million,
compared to $14.9 million for the second quarter of 2020. During the three months ended June 30, 2021, Karyopharm recognized $1.0 million pursuant to its license agreement with Anivive Lifesciences, Inc. and $1.4 million of
revenue associated with named patient programs. During the three months ended June 30, 2020, Karyopharm recognized $12.7 million pursuant to its license agreement with Antengene Therapeutics Limited and $2.2 million upon reacquisition
of the exclusive development and commercial rights from Ono Pharmaceutical Co., Ltd.
Cost of sales: Cost of sales for the second quarter of 2021 were $1.1 million, compared to
$0.4 million for the second 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 second quarter of 2021 were $34.0 million, compared to
$42.6 million for the second quarter of 2020. The decrease in R&D expenses in the second quarter of 2021 compared to the second quarter of 2020 was primarily attributable to the COVID-19 trial
activity in the second quarter of 2020 that did not occur in 2021.
Selling, general and administrative (SG&A)
expenses: SG&A expenses for the second quarter of 2021 were $36.5 million, compared to $30.8 million for the second quarter of 2020. The increase in SG&A expenses in the second quarter of 2021 compared to the
second 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.
expense: Interest expense for the second quarter of 2021 was $5.0 million, compared to $6.8 million for the second quarter of 2020. The decrease in interest expense was primarily attributable to the 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. Post adoption, Karyopharm is no longer required to amortize the debt discount to
non-cash interest expense, as the debt discount component of $50.6 million has now been reclassified out of equity into the convertible senior notes line on its balance sheet.
Net loss: Karyopharm reported a net loss of $53.6 million, or $0.71 per share, for the second quarter of 2021, compared to a net loss
of $46.4 million, or $0.63 per share, for the second quarter of 2020. Net loss included non-cash stock-based compensation expense of $8.1 million and $6.4 million for the second quarters of 2021
and 2020, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2021 totaled
$239.3 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, Thursday, August 5, 2021, at 8:30 a.m. Eastern Time, to discuss the second quarter 2021
financial results and other company updates. To access the conference call, please dial (888) 437-3179 (local) or (862) 298-0702 (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 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.