Karyopharm Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Company Progress
Karyopharm Therapeutics reported total revenue of $157.1 million for 2022, with U.S. XPOVIO® net product revenue of $120.4 million, meeting company guidance. The fourth quarter saw a 4% increase in net product revenue year-over-year. For 2023, the company anticipates total revenue between $160 million and $175 million, including U.S. XPOVIO projections of $125 million to $140 million. Cash reserves are expected to sustain operations until late 2025. The company also revealed advancements in its clinical pipeline, including key studies in myelofibrosis and myelodysplastic neoplasms, with interim data expected in the first half of 2023.
- Achieved U.S. XPOVIO net product revenue of $120.4 million for 2022, up 22% YoY.
- Provided 2023 revenue guidance of $160 million to $175 million, indicating growth potential.
- Solid cash position of $279.7 million, extending runway to late 2025.
- Total revenue decreased from $209.8 million in 2021 to $157.1 million in 2022.
- Net loss of $165.3 million for 2022 compared to a $124.1 million loss in 2021.
- License and other revenue dropped significantly, from $111.4 million in 2021 to $36.6 million in 2022.
-- Total Revenue of
-- Updated Results from the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis and Interim Data from the Phase 2 Study Evaluating Eltanexor in Relapsed/Refractory Myelodysplastic Neoplasms Expected in 1H 2023 --
-- Company Provides Full Year 2023 Total Revenue Guidance of
-- Conference Call Scheduled for Today at
"In 2022, Karyopharm delivered strong financial performance with a
Fourth Quarter 2022 and Recent Highlights
XPOVIO Commercial Performance
- Achieved
U.S. net product revenue for the year endedDecember 31, 2022 of , up$120.4 million 22% compared to for the year ended$98.4 million December 31, 2021 .U.S. net product revenue for the fourth quarter of 2022 was , up$31.1 million 4% from the fourth quarter of 2021. - Continued progress in shifting selinexor use into earlier lines of therapy, with strong growth in the community setting, offsetting increased pressure in the academic setting due to intensifying late-line competition and ongoing trials.
R&D Highlights
- Initiated pivotal Phase 3 study of selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer. Entered into a global collaboration with
Foundation Medicine, Inc. , a pioneer in molecular profiling for cancer, to develop FoundationOne®CDx, a TP53 wild-type companion diagnostic for selinexor. - Presented encouraging preliminary data from the Phase 1 study (XPORT-MF-034) evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (MF) at the
American Society of Hematology 2022 Annual Meeting. Initial data from the study were also presented at theEuropean Hematology Association 2022Hybrid Congress and theAmerican Society of Clinical Oncology 2022 Annual Meeting. - Orphan medicinal product designation granted by the
European Commission for selinexor for the treatment of MF.
Corporate and Business Highlights
- Completed a
private placement of common stock to new and existing shareholders, extending cash runway into late 2025.$165 million
Anticipated Near-Term Catalysts and Operational Objectives in 2023
- Continue to grow the Company's commercial foundation in the competitive multiple myeloma marketplace, driving increased XPOVIO sales.
- Additional global launches of selinexor by partners in ex-
U.S. territories. - Present data supporting optimization of selinexor dose in multiple myeloma and other key programs.
- Continue to generate data demonstrating selinexor's efficacy, combinability and tolerability in patients with multiple myeloma.
- Report interim data from the Phase 2 study evaluating eltanexor in relapsed/refractory myelodysplastic neoplasms in 1H 2023.
- Report updated results from the Phase 1 study of selinexor in combination with ruxolitinib in patients with treatment-naïve MF in 1H 2023. Initiate pivotal Phase 3 study in front-line MF in 1H 2023, subject to regulatory feedback.
- Present updated subgroup analysis results in patients with TP53 wild-type endometrial cancer from the SIENDO study of selinexor versus placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer at a medical conference in 2023.
- Further exploration of biomarker subsets to identify patient populations who may best respond to SINE compounds.
2023 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2023:
- Total revenue to be in the range of
to$160 million . Total revenue consists of$175 million U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from our partners. U.S XPOVIO net product revenue to be in the range of to$125 million .$140 million - Non-GAAP R&D and SG&A expenses, which exclude stock-based compensation expense, to be in the range of
to$260 million . 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.$280 million - 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 2025.
Full Year and Fourth Quarter 2022 Financial Results
Total revenue: Total revenue for the fourth quarter of 2022 was
Net product revenue: Net product revenue for the fourth quarter of 2022 was
License and other revenue: License and other revenue for the fourth quarter of 2022 was
Cost of sales: Cost of sales for the fourth quarter of 2022 was
Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2022 were
Selling, general and administrative (SG&A) expenses: SG&A expenses for both the fourth quarters of 2022 and 2021 were
Interest expense: Interest expense for the fourth quarter of 2022 was
Net income (loss): Karyopharm reported net loss of
Cash position: Cash, cash equivalents, restricted cash and investments as of
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,
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
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 theBOSTON trial, fatal adverse reactions occurred in6% of patients within 30 days of last treatment. Serious adverse reactions occurred in52% of patients. Treatment discontinuation rate due to adverse reactions was19% . - 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 in9% of patients. Serious adverse reactions occurred in58% of patients. Treatment discontinuation rate due to adverse reactions was27% . - 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 in3.7% of patients within 30 days, and5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in17% 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
About
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 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 risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; 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
XPOVIO® and NEXPOVIO® are registered trademarks of
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 31,126 | $ | 29,803 | $ | 120,445 | $ | 98,436 | ||||||||
License and other revenue | 2,454 | 96,466 | 36,629 | 111,383 | ||||||||||||
Total revenues | 33,580 | 126,269 | 157,074 | 209,819 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 1,868 | 742 | 5,213 | 3,402 | ||||||||||||
Research and development | 30,932 | 44,003 | 148,662 | 160,842 | ||||||||||||
Selling, general and administrative | 34,649 | 34,562 | 145,401 | 143,846 | ||||||||||||
Total operating expenses | 67,449 | 79,307 | 299,276 | 308,090 | ||||||||||||
(Loss) income from operations | (33,869) | 46,962 | (142,202) | (98,271) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,334 | 55 | 2,359 | 582 | ||||||||||||
Interest expense | (5,885) | (7,940) | (24,996) | (26,046) | ||||||||||||
Other expense, net | (13) | (478) | (83) | (85) | ||||||||||||
Total other expense, net | (4,564) | (8,363) | (22,720) | (25,549) | ||||||||||||
(Loss) income before income taxes | (38,433) | 38,599 | (164,922) | (123,820) | ||||||||||||
Income tax (provision) benefit | (73) | 121 | (369) | (268) | ||||||||||||
Net (loss) income | $ | (38,506) | $ | 38,720 | $ | (165,291) | $ | (124,088) | ||||||||
Net (loss) income per basic common share | $ | (0.43) | $ | 0.51 | $ | (2.02) | $ | (1.65) | ||||||||
Weighted-average number of basic common shares | 89,934 | 75,671 | 81,871 | 75,218 | ||||||||||||
Net (loss) income per diluted common share | $ | (0.43) | $ | 0.46 | $ | (2.02) | $ | (1.65) | ||||||||
Weighted-average number of diluted common shares | 89,934 | 86,875 | 81,871 | 75,218 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands) | |||||||
|
| ||||||
Assets | |||||||
Cash, cash equivalents and investments | $ | 277,967 | $ | 228,615 | |||
Restricted cash | 1,697 | 6,986 | |||||
Accounts receivable | 47,086 | 22,497 | |||||
Other assets | 31,422 | 47,207 | |||||
Total assets | $ | 358,172 | $ | 305,305 | |||
Liabilities and stockholders' deficit | |||||||
Convertible senior notes | $ | 170,105 | $ | 169,293 | |||
Deferred royalty obligation | 132,718 | 132,998 | |||||
Other liabilities | 72,005 | 82,687 | |||||
Total liabilities | 374,828 | 384,978 | |||||
Total stockholders' deficit | (16,656) | (79,673) | |||||
Total liabilities and stockholders' deficit; 113,213 and 75,746 shares | $ | 358,172 | $ | 305,305 |
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