Karyopharm Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress
Karyopharm Therapeutics reported Q3 2024 financial results with total revenue of $38.8 million, including U.S. XPOVIO net product revenue of $29.5 million. The company narrowed its full-year 2024 guidance, projecting total revenue of $145.0-155.0 million and U.S. XPOVIO net product revenue of $110.0-115.0 million. Following FDA alignment, the Phase 3 SENTRY trial in myelofibrosis will use Absolute Change in Total Symptom Score as a co-primary endpoint, with top-line data expected in 2H 2025. The company reported a net loss of $32.1 million for Q3 2024 and had cash reserves of $133.9 million as of September 30, 2024.
Karyopharm Therapeutics ha riportato i risultati finanziari del terzo trimestre del 2024 con un fatturato totale di $38,8 milioni, inclusi i ricavi netti del prodotto XPOVIO negli Stati Uniti pari a $29,5 milioni. L'azienda ha ristretto le previsioni per l'intero anno 2024, prevedendo un fatturato totale compreso tra $145,0 e $155,0 milioni e ricavi netti del prodotto XPOVIO negli Stati Uniti tra $110,0 e $115,0 milioni. Dopo l'allineamento con la FDA, il trial di Fase 3 SENTRY nella mielofibrosi utilizzerà il Cambiamento Assoluto nel Puntee Totale dei Sintomi come endpoint co-primario, con dati preliminari attesi nella seconda metà del 2025. L'azienda ha riportato una perdita netta di $32,1 milioni per il terzo trimestre del 2024 e disponeva di riserve di cassa di $133,9 milioni al 30 settembre 2024.
Karyopharm Therapeutics informó los resultados financieros del tercer trimestre de 2024, con ingresos totales de $38.8 millones, incluidos los ingresos netos del producto XPOVIO en EE. UU. de $29.5 millones. La compañía ha ajustado su orientación para el año completo 2024, proyectando ingresos totales entre $145.0 y $155.0 millones y ingresos netos del producto XPOVIO en EE. UU. entre $110.0 y $115.0 millones. Tras la alineación con la FDA, el ensayo de Fase 3 SENTRY en mielofibrosis utilizará el Cambio Absoluto en el Puntaje Total de Síntomas como un endpoint co-principal, con datos preliminares esperados para la segunda mitad de 2025. La compañía reportó una pérdida neta de $32.1 millones en el tercer trimestre de 2024 y tenía reservas de efectivo de $133.9 millones al 30 de septiembre de 2024.
Karyopharm Therapeutics는 2024년 3분기 재무 결과를 보고하며 총 수익이 $38.8백만에 달하고, 이 중 미국 XPOVIO의 순 제품 수익은 $29.5백만이라고 전했습니다. 이 회사는 2024년 전체 연도 지침을 조정하여 총 수익이 $145.0 ~ $155.0백만, 미국 XPOVIO의 순 제품 수익이 $110.0 ~ $115.0백만이 될 것으로 예상하고 있습니다. FDA와의 일치에 따라, 골수섬유증에 대한 3상 SENTRY 시험은 총 증상 점수의 절대 변화를 공동 주요 평가 지표로 사용할 것이며, 주요 데이터는 2025년 하반기에 예상됩니다. 이 회사는 2024년 3분기에 $32.1백만의 순손실을 보고했으며, 2024년 9월 30일 기준으로 현금 잔고가 $133.9백만입니다.
Karyopharm Therapeutics a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus totaux de $38,8 millions, y compris les revenus nets de produit XPOVIO aux États-Unis de $29,5 millions. L'entreprise a réduit ses prévisions pour l'ensemble de l'année 2024, projetant des revenus totaux entre $145,0 et $155,0 millions et des revenus nets de produit XPOVIO aux États-Unis entre $110,0 et $115,0 millions. Suite à l'alignement avec la FDA, l'essai de Phase 3 SENTRY dans la myélofibrose utilisera le Changement Absolu dans le Score Total des Symptômes comme un critère d'évaluation co-principal, avec des données préliminaires attendues dans la seconde moitié de 2025. L'entreprise a déclaré une perte nette de $32,1 millions pour le troisième trimestre 2024 et disposait de réserves de liquidités de $133,9 millions au 30 septembre 2024.
Karyopharm Therapeutics hat die finanziellen Ergebnisse des 3. Quartals 2024 veröffentlicht, mit einem Gesamtumsatz von $38,8 Millionen, einschließlich der Nettoprodukterlöse von XPOVIO in den USA von $29,5 Millionen. Das Unternehmen hat die Prognose für das Gesamtjahr 2024 eingegrenzt und erwartet einen Gesamtumsatz zwischen $145,0 und $155,0 Millionen sowie Nettoprodukterlöse von XPOVIO in den USA zwischen $110,0 und $115,0 Millionen. Nach der Abstimmung mit der FDA wird die Phase-3-Studie SENTRY bei Myelofibrose den absoluten Veränderungswert im Gesamtsymptom-Score als co-primären Endpunkt verwenden, mit den wichtigsten Ergebnissen, die in der zweiten Hälfte von 2025 erwartet werden. Das Unternehmen berichtete über einen Nettoverlust von $32,1 Millionen für das 3. Quartal 2024 und hatte am 30. September 2024 Barreserven von $133,9 Millionen.
- Quarter-over-quarter double-digit growth in XPOVIO demand
- Expanded global access with new reimbursement approvals in France and Italy
- Additional regulatory approvals in multiple countries including South Korea and Thailand
- Cash runway expected to fund operations into Q1 2026
- Net loss of $32.1 million in Q3 2024
- Decreased cash position from $192.4M to $133.9M since December 2023
- Increased interest expense to $11.4M from $6.1M year-over-year
- Narrowed down revenue guidance range, reducing upper limit from $160M to $155M
Insights
Q3 2024 shows mixed financial performance with total revenue of
The cash position of
The FDA endpoint modification in the Phase 3 SENTRY trial from TSS50 to Absolute Change in Total Symptom Score (Abs-TSS) represents a significant positive development. This change, coupled with maintaining SVR35 as a co-primary endpoint, aligns better with current clinical trial standards for combination therapies in myelofibrosis.
Early data showing
– Achieves Third Quarter 2024 Total Revenue of
– Following FDA Alignment, Absolute Change in Total Symptom Score (Abs-TSS) Will Replace TSS50 as a Co-Primary Endpoint in Phase 3 SENTRY Trial in JAKi Naïve Myelofibrosis (MF); Expected Top-line Data Read-out Remains on Track for 2H 2025 –
– Narrows Full-Year 2024 Total Revenue Guidance Range to
"This quarter, we delivered our third consecutive quarter of
"A significant unmet need in myelofibrosis remains, as less than half of patients achieve SVR35 with each of the approved JAKi inhibitors. I am encouraged by the Phase 1 trial which evaluated the combination of selinexor and ruxolitinib, as it shows an approximate doubling of SVR35 to
Third Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
- Achieved
U.S. net product revenue of for the third quarter of 2024, compared to$29.5 million for the second quarter of 2024 and$28.0 million for the third quarter of 2023.$30.2 million - XPOVIO net product revenue was supported by quarter-over-quarter double digit growth in demand, partially offset by higher gross-to-net quarter-over-quarter largely due to higher proportion of 340B book of business.
- Continued quarter-over-quarter demand growth with strong demand growth in the community setting, which represents approximately
60% of overall net product revenues. In the academic setting, demand for XPOVIO grew quarter-over-quarter amidst ongoing competitive pressures with continued use of XPOVIO preceding and following T-cell therapies in later lines. - Expanded global patient access for selinexor in the third quarter of 2024 with favorable reimbursement decisions in
France andItaly and additional regulatory approvals in Turkiye,South Korea ,Thailand andMalaysia .
Research and Development (R&D) Highlights
Myelofibrosis
- Following recent alignment with the FDA, absolute change in total symptom score (Abs-TSS) at Week 24 will replace total symptom improvement of ≥
50% (TSS50) as a co-primary endpoint in the pivotal Phase 3 SENTRY trial of selinexor in combination with ruxolitinib in JAKi naive myelofibrosis. Abs-TSS measures the average improvement in patient symptom scores over 24 weeks relative to the patient's baseline symptom score and is an accepted measure that has been used in other Phase 3 clinical trials in myelofibrosis to evaluate the benefit/risk of an add-on treatment, such as selinexor, to the current standard of care. Spleen volume reduction ≥35% (SVR35) at Week 24 will remain as a co-primary endpoint. These two co-primary endpoints will be tested sequentially starting with SVR35 followed by Abs-TSS. - Proactively increasing the total sample size of the SENTRY trial to approximately 350 patients to further increase the statistical powering. The trial continues to enroll patients with strong momentum with expected top-line data read-out remaining in the second half of 2025.
- SENTRY-2 Phase 2 trial of selinexor monotherapy in JAKi naïve patients with moderate thrombocytopenia continues to enroll patients. The Company expects to present preliminary data from this trial in late 2024 or early 2025.
Endometrial Cancer
- Long-term follow-up data from a pre-specified exploratory subgroup analysis of patients with advanced or recurrent TP53 wild-type endometrial cancer from the SIENDO study (NCT03555422) were presented with expanded exploratory quality-adjusted time without symptoms or toxicity analysis (Q-TWiST) for the proficient mismatched repair status (pMMR) TP53 wild-type subgroup at the International Gynecological Cancer Society (IGCS) conference in October 2024. These data showed the restricted mean Q-TWiST for selinexor to be 30 months compared to 17 months for placebo, resulting in a difference of 13 months.
- Pivotal XPORT-EC-042 Phase 3 trial in TP53 wild-type endometrial cancer continues to enroll patients and is expected to read-out top-line data in early 2026.
Multiple Myeloma
- Pivotal XPORT-MM-031 (EMN29) Phase 3 trial, in collaboration with the European Myeloma Network, evaluating an oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd) in patients with previously treated multiple myeloma now has a targeted enrollment of approximately 120 patients which leverages the positively evolving data observed with SPd 40 mg. Pending regulatory agency feedback on the updated protocol, the Company will provide guidance on the top-line data readout timeline from this trial.
2024 Financial Outlook
Based on its current operating plans, Karyopharm has further narrowed its guidance for full year 2024 as follows:
- Total revenue to be in the range of
to$145.0 million as compared to the Company's prior guidance of$155.0 million to$145.0 million . Total revenue consists of$160.0 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 to$110.0 million as compared to the Company's prior guidance of$115.0 million to$105.0 million .$120.0 million - R&D and selling, general and administrative (SG&A) expenses to be in the range of
to$255.0 million , which includes approximately$265.0 million estimated non-cash stock-based compensation expense, as compared to the Company's prior guidance of$20.0 million to$250.0 million .$265.0 million - The Company expects that its existing cash, cash equivalents and investments, the revenue it expects to generate from XPOVIO net product sales and its license agreements and ongoing disciplined expense management and cost saving measures, will be sufficient to fund its planned operations into the first quarter of 2026.1
1Excluding re-payment of
Third Quarter 2024 Financial Results
Total revenue: Total revenue for the third quarter of 2024 was
Net product revenue: Net product revenue for the third quarter of 2024 was
License and other revenue: License and other revenue for the third quarter of 2024 was
Cost of sales: Cost of sales for the third quarter of 2024 was
R&D expenses: R&D expenses for the third quarter of 2024 were
SG&A expenses: SG&A expenses for the third quarter of 2024 were
Interest income: Interest income for the third quarter of 2024 was
Interest expense: Interest expense for the third quarter of 2024 was
Other income: Other income for the third quarter of 2024 was
Net loss: Karyopharm reported a net loss of
Cash position: Cash, cash equivalents, restricted cash and investments as of September 30, 2024 totaled
Conference Call Information
Karyopharm will host a conference call today, November 5, 2024, at 8:00 a.m. Eastern Time, to discuss the third quarter 2024 financial results and provide business highlights. 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 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 whose dedication to pioneering novel cancer therapies is fueled by a belief in the extraordinary strength and courage of patients with cancer. Since its founding, Karyopharm has been an industry leader in oral compounds that address nuclear export dysregulation, a fundamental mechanism of oncogenesis. Karyopharm's lead 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. 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, 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.
KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited); (in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 29,516 | $ | 30,207 | $ | 83,554 | $ | 86,955 | ||||||||
License and other revenue | 9,267 | 5,802 | 31,141 | 25,331 | ||||||||||||
Total revenue | 38,783 | 36,009 | 114,695 | 112,286 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 1,300 | 911 | 4,676 | 3,456 | ||||||||||||
Research and development | 36,134 | 35,553 | 109,930 | 99,369 | ||||||||||||
Selling, general and administrative | 27,632 | 30,805 | 88,251 | 101,193 | ||||||||||||
Total operating expenses | 65,066 | 67,269 | 202,857 | 204,018 | ||||||||||||
Loss from operations | (26,283) | (31,260) | (88,162) | (91,732) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,832 | 2,750 | 5,918 | 8,423 | ||||||||||||
Interest expense | (11,385) | (6,073) | (26,218) | (17,615) | ||||||||||||
Gain on extinguishment of debt | — | — | 44,702 | — | ||||||||||||
Other income (expense), net | 3,792 | 89 | 18,284 | (145) | ||||||||||||
Total other income (expense), net | (5,761) | (3,234) | 42,686 | (9,337) | ||||||||||||
Loss before income taxes | (32,044) | (34,494) | (45,476) | (101,069) | ||||||||||||
Income tax provision | (28) | (12) | (166) | (193) | ||||||||||||
Net loss | $ | (32,072) | $ | (34,506) | $ | (45,642) | $ | (101,262) | ||||||||
Basic net loss per share | $ | (0.26) | $ | (0.30) | $ | (0.38) | $ | (0.89) | ||||||||
Diluted net loss per share | $ | (0.26) | $ | (0.30) | $ | (0.69) | $ | (0.89) | ||||||||
Weighted-average number of common shares | 125,010 | 114,401 | 120,513 | 114,033 | ||||||||||||
Weighted-average number of common shares | 125,010 | 114,401 | 126,606 | 114,033 |
KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited); (in thousands) | |||||||
September 30, | December 31, | ||||||
Assets | |||||||
Cash, cash equivalents and investments | $ | 133,526 | $ | 191,443 | |||
Restricted cash | 339 | 961 | |||||
Accounts receivable | 31,778 | 26,962 | |||||
Other assets | 23,833 | 21,072 | |||||
Total assets | $ | 189,476 | $ | 240,438 | |||
Liabilities and stockholders' deficit | |||||||
Convertible senior notes due 2025 | $ | 24,392 | $ | 170,919 | |||
Convertible senior notes due 2029 | 72,091 | — | |||||
Senior secured term loan | 94,109 | — | |||||
Deferred royalty obligation | 73,499 | 132,479 | |||||
Other liabilities | 85,032 | 73,246 | |||||
Total liabilities | 349,123 | 376,644 | |||||
Total stockholders' deficit | (159,647) | (136,206) | |||||
Total liabilities and stockholders' deficit; 125,303 and 114,915 shares issued and | $ | 189,476 | $ | 240,438 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/karyopharm-reports-third-quarter-2024-financial-results-and-highlights-recent-company-progress-302296090.html
SOURCE Karyopharm Therapeutics Inc.
FAQ
What was Karyopharm's (KPTI) Q3 2024 revenue?
What is KPTI's updated revenue guidance for 2024?
When will KPTI's SENTRY trial in myelofibrosis report top-line data?