Full Press Release Details
Karyopharm Reports Fourth Quarter and Full Year 2019 Financial Results and
Highlights Recent Company Progress
XPOVIO Net Product Sales of $17.7 Million for Fourth Quarter and $30.5 Million for Full Year 2019
XPOVIO Prescription Demand Increased by 65% in Fourth Quarter 2019 Compared to
sNDA for Selinexor in DLBCL Submitted to FDA
Phase 3 BOSTON Top-Line Data Expected Before End of April 2020
Conference Call Scheduled for Today at 8:30 a.m. ET
NEWTON, Mass. February 13, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today
reported financial results for the fourth quarter and full year ended December 31, 2019. In addition, Karyopharm highlighted select corporate milestones, including details regarding the ongoing U.S. commercial launch of XPOVIO (selinexor), and provided an overview of its key clinical development programs.
year of significant progress for Karyopharm as we successfully transitioned into an integrated commercial organization following the accelerated approval of oral XPOVIO, the first and only nuclear export inhibitor approved in the U.S., indicated for
patients with heavily pretreated multiple myeloma. Our XPOVIO commercial launch efforts have yielded a strong positive reception from prescribing physicians and patients, with approximately 1,400 prescriptions filled in 2019, said Michael G.
Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. Our pipeline efforts also continued to advance with the top-line Phase 3 BOSTON study results expected before the end of April, which if
positive, could support future regulatory submissions and dramatically increase the eligible multiple myeloma patient population for XPOVIO. And importantly, we ended the year with the submission of our supplemental New Drug Application (sNDA) in
the U.S. based on our SADAL study for selinexor requesting accelerated approval for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a disease with significant patient unmet
Fourth Quarter 2019 Highlights and Recent Progress
XPOVIO (selinexor) in Multiple Myeloma
Increased fourth quarter net revenues were primarily driven by a combination of new patient
starts and prescription refills. Broad insurance coverage for XPOVIO has been a key contributor to its commercial success with XPOVIO being added to numerous national commercial and Medicare formularies and coverage policies. Based on prescription
fulfillment data through the specialty pharmacy channel, Karyopharm estimates that approximately 55% of XPOVIO prescriptions have been dispensed to patients with Medicare coverage, 40% to patients with commercial insurance, and the remaining
patients having either Medicaid or another form of prescription coverage.
Selinexor in Diffuse Large B-Cell Lymphoma (DLBCL)
Selinexor in Solid Tumors
Other Pipeline Updates
Full Year and Fourth Quarter 2019 Financial Results
Net product revenue: Net product revenue for the fourth quarter of 2019 was $17.7 million and $30.5 million for the year ended
December 31, 2019. Karyopharm did not have net product revenue during the year ended December 31, 2018.
License and other revenue:
License and other revenue for the fourth quarter of 2019 was $0.4 million, compared to $0.2 million for the fourth quarter of 2018. License and other revenue for the year ended 2019 was $10.4 million, compared to
$30.3 million for the year ended 2018.
Cost of sales: Karyopharm began U.S. sales of XPOVIO in the third quarter of 2019. Cost of sales were
$1.4 million for the fourth quarter of 2019, and $2.4 million for the year ended December 31, 2019. Cost of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.
Research and development expenses: Research and development expense for the fourth quarter of 2019 was $31.6 million, compared to
$38.9 million for the fourth quarter of 2018. Research and development expense for the year ended 2019 was $122.3 million, compared to $161.4 million for the year ended 2018.
Selling, general and administrative expenses: For the fourth quarter 2019, selling, general and administrative expense was $28.4 million, compared
to $18.8 million for the fourth quarter 2018. For the year ended December 31, 2019, selling, general and administrative expense was $105.4 million, compared to $48.8 million for the year ended December 31, 2018. The increase
in selling, general and administrative expenses compared to the prior year was due primarily to the hiring of the Karyopharm commercial team and related activities to support the U.S. commercial launch of XPOVIO.
Interest expense: Interest expense for the fourth quarter and for the year ended December 31, 2019 was $6.5 million and $15.6 million,
respectively, compared to $2.5 million for both the fourth quarter 2018 and the year ended December 31, 2018. The increase in interest expense is attributable to the imputed interest on the deferred royalty obligation Karyopharm has with
HealthCare Royalty Partners (HCR).
Net loss: Karyopharm reported a net loss of $48.6 million, or $0.76 per share, for the fourth
quarter 2019, compared to a net loss of $58.2 million, or $0.96 per share, for the fourth quarter 2018. Net loss includes non-cash stock-based compensation expense of $3.6 million and
$3.9 million for the 2019 and 2018 quarters, respectively. Karyopharm reported a net loss of $199.6 million, or $3.22 per share, for the year ended 2019, compared to a net loss of $178.4 million, or $3.14 per share, for the year ended
2018. Net loss includes non-cash stock-based compensation expense of $15.3 million and $17.3 million for the years ended 2019 and 2018, respectively.
Cash position: Cash, cash equivalents, restricted cash and investments as of December 31, 2019 totaled $265.8 million, compared to
$330.9 million as of December 31, 2018.
2020 Financial Outlook
Based on its current operating plans, Karyopharm expects its non-GAAP R&D and SG&A expenses, which excludes
stock-based compensation expense, for the full year 2020 to be in the range of $240 million to $260 million.
The Company expects that its
existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO product sales, will be sufficient to fund its planned operations into the middle of 2021.
Non-GAAP Financial Information
Karyopharm uses a non-GAAP financial measure, non-GAAP operating expense, to
provide operating expense guidance. Non-GAAP operating expense excludes 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. Karyopharm has not reconciled the full year 2020
outlook for non-GAAP operating expenses to full year 2020 outlook for GAAP operating 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 2020 outlook for non-GAAP operating expenses. This
non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Karyopharm s liquidity. Instead, non-GAAP operating expense 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, Thursday, February 13, 2020, at 8:30 a.m. Eastern Time, to discuss the fourth quarter and full year 2019 financial results, recent accomplishments, clinical developments and business plans. To access the conference call,
please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 4367549. 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.
IMPORTANT SAFETY INFORMATION
XPOVIO can cause thrombocytopenia,
leading to potentially fatal hemorrhage. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3-4) thrombocytopenia occurred in 61% of patients treated with XPOVIO. The
median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia and fatal hemorrhage occurred in <1% of patients.
Monitor platelet counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment.
Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse
XPOVIO can cause neutropenia,
potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3-4) neutropenia occurred in 21% of patients treated with XPOVIO. The median
time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.
Obtain neutrophil counts at baseline, during treatment,
and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of
infection and use of growth factors (e.g., G-CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Gastrointestinal Toxicity
Gastrointestinal toxicities
occurred in patients treated with XPOVIO.
Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with XPOVIO. The median time to onset of
the first nausea event was 3 days.
Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with XPOVIO. The
median time to onset of the first vomiting event was 5 days.
Provide prophylactic 5-HT3 antagonists and/or other
anti-nausea agents, prior to and during treatment with XPOVIO. Manage nausea/vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use
additional anti-nausea medications as clinically indicated.
Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with XPOVIO. The median time to onset
of diarrhea was 15 days.
Manage diarrhea by dose modifications and/or standard anti-diarrheal agents; administer intravenous fluids to
prevent dehydration in patients at risk.
Anorexia/Weight Loss
Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with XPOVIO. The median time to onset
of anorexia was 8 days.
Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated
with XPOVIO. The median time to onset of weight loss was 15 days.
Monitor patient weight at baseline, during treatment, and as clinically indicated.
Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.
XPOVIO can cause hyponatremia; 39% of
patients treated with XPOVIO experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days.
Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct
sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose,