Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress
- None.
- None.
Insights
The reported full-year revenue of $146 million aligns with the company's guidance, indicating a level of financial predictability and operational execution that is crucial for investor confidence. The specific mention of U.S. XPOVIO net product revenue of $112 million underscores the significance of this product to the company's portfolio. Looking ahead, the provided guidance for 2024, with total revenue expected to be between $140 million and $160 million, suggests a stable to modest growth outlook. The forecasted revenue figures are particularly noteworthy for stakeholders as they reflect the company's expectations for product performance and market conditions. Additionally, the cash runway projection to late 2025 implies that the company has sufficient liquidity to support its operations and development programs without the immediate need for additional financing, which can be dilutive to current shareholders.
The anticipation of top-line data from the pivotal Phase 3 trials in endometrial cancer, myelofibrosis and multiple myeloma by 2025 is of substantial interest. These trials are critical milestones for Karyopharm and positive results could significantly expand the therapeutic applications of Selinexor. From a medical research perspective, the success in these trials could lead to increased adoption in treatment protocols and potentially improve patient outcomes in these indications. The multi-year timeline before data readouts also suggests a rigorous, long-term study period that is typical for Phase 3 trials, which are designed to confirm efficacy and monitor adverse effects in a larger patient population. The outcome of these trials will be a key driver of the company's future growth and could have a profound impact on its valuation.
The company's focus on the competitive multiple myeloma space, where it aims to build on its foundation, indicates a strategic commitment to a market with high unmet medical needs and significant commercial potential. The competitive landscape in oncology, particularly for multiple myeloma, is dynamic, with several players investing heavily in research and development. The company's ability to maintain and grow its market share with XPOVIO will depend on the drug's clinical benefits compared to existing treatments, as well as its pricing and reimbursement strategy. The reference to 'significant progress' in the clinical pipeline suggests that the company is advancing its research and development efforts, which could lead to pipeline diversification and reduce dependency on a single product. For investors, the performance of XPOVIO and the progression of the pipeline are crucial indicators of long-term sustainability and potential market expansion.
– Total Revenue of
– Top-Line Data Readouts from Three Pivotal Phase 3 Trials Evaluating Selinexor in Endometrial Cancer, Myelofibrosis and Multiple Myeloma Expected in 2025 –
– Company Provides Full-Year 2024 Total Revenue Guidance of
– Conference Call Scheduled for Today at 8:00 a.m. ET —
"We made significant progress in 2023 across our clinical pipeline and continued to build on our foundation in the highly competitive multiple myeloma space. The encouraging clinical results that we presented last year reinforce the potential of our three ongoing pivotal Phase 3 trials in addressing critical unmet needs of cancer patients," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Our drive for innovation and progress will continue into 2024, by focusing our resources to advance our Phase 3 trials. We are enthusiastic about the upcoming top-line read-outs from these trials and what they could mean for patients and selinexor's growth potential."
Fourth Quarter 2023 and Recent Highlights
Research and Development (R&D) Highlights
- Long-term exploratory analysis of the pre-specified subgroup of patients with advanced or recurrent TP53 wild-type endometrial cancer (EC) from the Phase 3 SIENDO trial (NCT03555422) was presented at the International Gynecological Cancer Society Annual Global Meeting in
Seoul, South Korea , with updated progression-free survival (PFS). As of the September 1, 2023 data cut-off date, median PFS was 27.4 months in the selinexor treatment arm (n=77) as compared to 5.2 months (n=36) in the placebo arm. Immature overall survival data showed an encouraging signal and corroborated the PFS results. - Oral presentation at the 65th American Society of Hematology 2023 Annual Meeting of the updated results from the Phase 1 trial (XPORT-MF-034) evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (MF) showed encouraging long-term durability.
79% of intent-to-treat (ITT) patients (11 out of 14) treated with 60mg selinexor achieved ≥35% reduction in spleen volume (SVR35) at week 24, and continued to remain in radiographic response as of the August 1, 2023 data cut-off date. In addition,58% of the ITT patients (7 out of 12) who achieved symptom improvement of ≥50% (TSS50) at week 24 also remained in response as of the data cut-off. In general, early cytokine reduction at week 4 was associated with spleen volume reduction at week 24, was sustained until the end of treatment, and is a potential sign of disease modification. - Clinical trial collaboration agreement executed with Bristol Myers Squibb (BMS) to evaluate selinexor in combination with BMS' proprietary investigational cereblon E3 ligase modulator (CELMoD™) agent mezigdomide in patients with relapsed/refractory multiple myeloma (MM) progressing after T-cell immunotherapies, potentially adding to the growing body of evidence that selinexor has the potential to show meaningful benefit in combination with MM therapies with differing mechanisms of action; the study of selinexor/mezigdomide enables further evaluation of selinexor's role in maintaining an optimal T-cell environment.
XPOVIO Commercial Performance
- Achieved
U.S. net product revenue for the year ended December 31, 2023 of$112 million $120 million U.S. net product revenue for the fourth quarter of 2023 was$25 million $31 million - Continued progress in shifting selinexor use into earlier lines of therapy, with patient mix approaching
70% in the second to fourth lines in 2023 versus55% in 20221. - XPOVIO net product revenue was adversely impacted year-over-year by increased utilization of the KaryForward Patient Assistance Program (PAP), due to MM foundation closures2, contributing to ~
10% of total demand in 2023 as compared to ~5% in 2022, leading to an estimated impact of~ . Additionally, increased competition and higher gross-to-net, driven by increased 340B discounts and Medicaid rebates during the year, adversely impacted XPOVIO net product revenue in 2023.$6 million
Intellectual Property
- The
U.S. Patent and Trademark Office issued patents directed toward the polymorphic form of selinexor present in XPOVIO, pharmaceutical compositions comprising the polymorphic form and methods of treatment using the polymorphic form and the pharmaceutical compositions. The newly issued patents will expire in August 2035.
Anticipated Catalysts and Operational Objectives in 2024 and 2025
- Present updated exploratory subgroup analysis results in patients with TP53 wild-type EC from the Phase 3 SIENDO trial in 2024.
- Complete enrollment in pivotal XPORT-EC-042 Phase 3 trial in TP53 wild-type EC in 2H 2024 and report top-line results in 1H 2025.
- Report updated results from the Phase 1 trial of selinexor in combination with ruxolitinib in patients with treatment-naïve MF in 2024.
- Report preliminary results from the Phase 2 trial evaluating the efficacy and safety of selinexor monotherapy in subjects with JAK inhibitor-naïve MF and moderate thrombocytopenia in 2H 2024.
- Report top-line results from pivotal Phase 3 trial of selinexor in combination with ruxolitinib in treatment-naïve MF in 2H 2025.
- Publish and present efficacy and safety data on selinexor 40mg in combination with pomalidomide and dexamethasone from ongoing STOMP/028 Phase 2 trials in patients with MM in 2024.
- Report additional data on selinexor's impact on T-cell fitness and potential combinability with multiple agents pre- or post-T-cell therapy in patients with MM in 2024.
- Complete enrollment in pivotal Phase 3 trial evaluating an oral combination of 40mg selinexor, pomalidomide and dexamethasone in patients with previously treated MM in 2H 2024 and report top-line results in 1H 2025.
- Maintain the Company's commercial foundation in the competitive MM marketplace, driving increased XPOVIO revenues.
- Continue global launches and reimbursement approvals for selinexor by partners in ex-
U.S. territories.
2024 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2024:
- Total revenue to be in the range of
$140 million $160 million U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners. U.S. XPOVIO net product revenue to be in the range of$100 million $120 million - R&D and SG&A expenses to be in the range of
$260 million $280 million $20 million $25 million - The Company expects that its existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO net 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 2023 Financial Results
Total revenue: Total revenue for the fourth quarter of 2023 was
Net product revenue: Net product revenue for the fourth quarter of 2023 was
License and other revenue: License and other revenue for the fourth quarter of 2023 was
Cost of sales: Cost of sales for the fourth quarter of 2023 was
R&D expenses: R&D expenses for the fourth quarter of 2023 were
SG&A expenses: SG&A expenses for the fourth quarter of 2023 were
Interest expense: Interest expense for the fourth quarter of 2023 was
Net loss: Karyopharm reported a net loss of
Cash position: Cash, cash equivalents, restricted cash and investments as of December 31, 2023 totaled
Conference Call Information
Karyopharm will host a conference call today, February 29, 2024, at 8:00 a.m. Eastern Time, to discuss the fourth quarter and full year 2023 financial results and the financial outlook for 2024 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (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, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website. 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 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 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. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm's lead SINE compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is approved in the
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 2024 total revenue, 2024 U.S. net product revenue and 2024 R&D and SG&A expenses; Karyopharm's expected cash runway; expectations with respect to commercialization efforts; the ability of selinexor to treat patients with multiple myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma, 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 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 trials, including subsequent analysis of existing data and new data received from ongoing and future trials; the content and timing of decisions made by the
XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.
References:
1 Based on Komodo claims data analysis, accessed in November 2023
2 Four multiple myeloma foundations provide financial support to Medicare patients with multiple myeloma
KARYOPHARM THERAPEUTICS INC. | ||||||||||||||||
Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 25,056 | $ | 31,126 | $ | 112,011 | $ | 120,445 | ||||||||
License and other revenue | 8,691 | 2,454 | 34,022 | 36,629 | ||||||||||||
Total revenue | 33,747 | 33,580 | 146,033 | 157,074 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 1,486 | 1,868 | 4,942 | 5,213 | ||||||||||||
Research and development | 39,381 | 30,932 | 138,750 | 148,662 | ||||||||||||
Selling, general and administrative | 30,688 | 34,649 | 131,881 | 145,401 | ||||||||||||
Total operating expenses | 71,555 | 67,449 | 275,573 | 299,276 | ||||||||||||
Loss from operations | (37,808) | (33,869) | (129,540) | (142,202) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 2,520 | 1,334 | 10,943 | 2,359 | ||||||||||||
Interest expense | (6,208) | (5,885) | (23,823) | (24,996) | ||||||||||||
Other expense, net | (211) | (13) | (356) | (83) | ||||||||||||
Total other expense, net | (3,899) | (4,564) | (13,236) | (22,720) | ||||||||||||
Loss before income taxes | (41,707) | (38,433) | (142,776) | (164,922) | ||||||||||||
Income tax provision | (130) | (73) | (323) | (369) | ||||||||||||
Net loss | $ | (41,837) | $ | (38,506) | $ | (143,099) | $ | (165,291) | ||||||||
Net loss per share—basic and diluted | $ | (0.36) | $ | (0.43) | $ | (1.25) | $ | (2.02) | ||||||||
Weighted-average number of common shares | 114,778 | 89,934 | 114,221 | 81,871 | ||||||||||||
KARYOPHARM THERAPEUTICS INC. | |||||||
December 31, 2023 | December 31, 2022 | ||||||
Assets | |||||||
Cash, cash equivalents and investments | $ | 191,443 | $ | 277,967 | |||
Restricted cash | 961 | 1,697 | |||||
Accounts receivable | 26,962 | 47,086 | |||||
Other assets | 21,072 | 31,422 | |||||
Total assets | $ | 240,438 | $ | 358,172 | |||
Liabilities and stockholders' deficit | |||||||
Convertible senior notes | $ | 170,919 | $ | 170,105 | |||
Deferred royalty obligation | 132,479 | 132,718 | |||||
Other liabilities | 73,246 | 72,005 | |||||
Total liabilities | 376,644 | 374,828 | |||||
Total stockholders' deficit | (136,206) | (16,656) | |||||
Total liabilities and stockholders' deficit; 114,915 and 113,213 | $ | 240,438 | $ | 358,172 | |||
View original content to download multimedia:https://www.prnewswire.com/news-releases/karyopharm-reports-fourth-quarter-and-full-year-2023-financial-results-and-highlights-recent-company-progress-302074918.html
SOURCE Karyopharm Therapeutics Inc.
FAQ
What was Karyopharm Therapeutics Inc.'s total revenue for 2023?
What was the U.S. XPOVIO® net product revenue for Karyopharm in 2023?
What are the expected top-line data readouts from Karyopharm's Phase 3 trials in 2025?
What is Karyopharm's full-year 2024 total revenue guidance?
When is the conference call scheduled for Karyopharm?
