Karyopharm Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) reported financial results for Q2 2024, achieving total revenue of $42.8 million and U.S. XPOVIO® net product revenue of $28.0 million. The company highlighted:
1. Updated clinical results from the SIENDO study showing promising PFS in endometrial cancer subgroups.
2. Completion of refinancing transactions extending debt maturities to 2028 and 2029.
3. Raised lower end of 2024 revenue guidance to $145.0-$160.0 million.
4. Lowered 2024 R&D and SG&A expense guidance to $250.0-$265.0 million.
5. Reported net income of $23.8 million for Q2 2024.
6. Cash position of $152.5 million as of June 30, 2024.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) ha riportato i risultati finanziari per il secondo trimestre del 2024, registrando entrate totali di 42,8 milioni di dollari e ricavi netti da prodotto XPOVIO® negli Stati Uniti di 28,0 milioni di dollari. L'azienda ha evidenziato:
1. Risultati clinici aggiornati dallo studio SIENDO che mostrano un PFS promettente nei sottogruppi di cancro endometriale.
2. Completamento delle operazioni di rifinanziamento che estendono le scadenze del debito al 2028 e al 2029.
3. Aumento della fine inferiore della previsione di entrate per il 2024 a 145,0-160,0 milioni di dollari.
4. Riduzione della guida per le spese in ricerca e sviluppo e SG&A per il 2024 a 250,0-265,0 milioni di dollari.
5. Reddito netto riportato di 23,8 milioni di dollari per il secondo trimestre del 2024.
6. Posizione di cassa di 152,5 milioni di dollari al 30 giugno 2024.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) reportó resultados financieros para el segundo trimestre de 2024, alcanzando ingresos totales de 42.8 millones de dólares y un ingreso neto del producto XPOVIO® en EE. UU. de 28.0 millones de dólares. La compañía destacó:
1. Resultados clínicos actualizados del estudio SIENDO que muestran PFS prometedor en subgrupos de cáncer endometrial.
2. Finalización de transacciones de refinanciamiento que extienden los vencimientos de deuda hasta 2028 y 2029.
3. Aumento del extremo inferior de la guía de ingresos para 2024 a 145.0-160.0 millones de dólares.
4. Reducción de la guía de gastos de I+D y SG&A para 2024 a 250.0-265.0 millones de dólares.
5. Ingreso neto reportado de 23.8 millones de dólares para el segundo trimestre de 2024.
6. Posición de efectivo de 152.5 millones de dólares al 30 de junio de 2024.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI)는 2024년 2분기 재무 결과를 보고하며 총 수익 4,280만 달러와 미국 XPOVIO®의 순 제품 수익 2,800만 달러를 기록했다고 전했습니다. 회사는 다음 사항을 강조했습니다:
1. 자궁내막암 하위 그룹에서 유망한 PFS를 보여주는 SIENDO 연구의 업데이트된 임상 결과.
2. 2028년 및 2029년으로 부채 만기를 연장하는 재융자 거래 완료.
3. 2024년 수익 지침의 하단을 1억 4,500만-1억 6,000만 달러로 상향 조정.
4. 2024년 R&D 및 SG&A 비용 가이드를 2억 5,000만-2억 6,500만 달러로 하향 조정.
5. 2024년 2분기 동안 2,380만 달러의 순이익 보고.
6. 2024년 6월 30일 기준 현금 보유액 1억 5,250만 달러.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) a publié les résultats financiers pour le deuxième trimestre 2024, atteignant des revenus totaux de 42,8 millions de dollars et un revenu net de produit XPOVIO® aux États-Unis de 28,0 millions de dollars. La société a souligné :
1. Des résultats cliniques mis à jour de l'étude SIENDO montrant un PFS prometteur dans les sous-groupes de cancer endométrial.
2. L'achèvement des transactions de refinancement prolongeant les échéances de la dette jusqu'en 2028 et 2029.
3. Élévation de la limite inférieure de la prévision de revenus pour 2024 à 145,0-160,0 millions de dollars.
4. Baisse de l'estimation des dépenses R&D et SG&A pour 2024 à 250,0-265,0 millions de dollars.
5. Un revenu net de 23,8 millions de dollars pour le deuxième trimestre 2024.
6. Position de liquidités de 152,5 millions de dollars au 30 juin 2024.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) berichtete über die Finanzresultate für das zweite Quartal 2024 und erzielte Gesamteinnahmen von 42,8 Millionen USD sowie einen Nettoumsatz aus dem Produkt XPOVIO® in den USA von 28,0 Millionen USD. Das Unternehmen hob hervor:
1. Aktualisierte klinische Ergebnisse der SIENDO-Studie, die vielversprechende PFS in Subgruppen von Endometriumkarzinomen zeigen.
2. Abschluss von Refinanzierungsmaßnahmen, die die Fälligkeiten der Schulden bis 2028 und 2029 verlängern.
3. Anhebung der unteren Grenze der Umsatzprognose für 2024 auf 145,0–160,0 Millionen USD.
4. Senkung der Prognose für F&E- und SG&A-Ausgaben für 2024 auf 250,0–265,0 Millionen USD.
5. Berichtetes Nettoergebnis von 23,8 Millionen USD für das zweite Quartal 2024.
6. Bargeldposition von 152,5 Millionen USD zum 30. Juni 2024.
- Achieved total revenue of $42.8 million in Q2 2024, up from $37.6 million in Q2 2023
- U.S. XPOVIO net product revenue grew to $28.0 million in Q2 2024 from $26.0 million in Q1 2024
- Raised lower end of 2024 total revenue guidance to $145.0-$160.0 million
- Completed refinancing transactions extending debt maturities to 2028 and 2029
- Reported net income of $23.8 million for Q2 2024, compared to a net loss of $32.6 million in Q2 2023
- Lowered 2024 R&D and SG&A expense guidance to $250.0-$265.0 million
- Cash position decreased to $152.5 million as of June 30, 2024, from $192.4 million as of December 31, 2023
- R&D expenses increased to $38.4 million in Q2 2024 from $31.5 million in Q2 2023
- Interest expense increased to $8.9 million in Q2 2024 from $5.8 million in Q2 2023
- Delayed top-line data readout for XPORT-EC-042 Phase 3 trial to early 2026
- Slower than expected enrollment in XPORT-MM-031 Phase 3 trial
Insights
Karyopharm's Q2 2024 results show mixed performance. Total revenue increased to
The company's financial outlook has improved, with raised guidance for total revenue (
The debt refinancing has strengthened Karyopharm's balance sheet, extending most debt maturities to 2028 and 2029. This provides financial stability beyond expected data readouts from three Phase 3 trials. However, investors should note the
The clinical updates for Karyopharm's lead drug, selinexor, are encouraging. In endometrial cancer, the SIENDO study showed impressive median PFS of 28.4 months in TP53 wild-type patients and 39.5 months in the pMMR TP53 wild-type subgroup. These results suggest potential efficacy in specific patient populations.
In multiple myeloma, the SPd regimen demonstrated a median PFS of 18.4 months with a manageable safety profile. This data supports the ongoing Phase 3 trial, although enrollment challenges have led to study design amendments.
The preclinical data in myelofibrosis is intriguing, showing selinexor's potential to target multiple oncogenic pathways beyond JAK/STAT. This could provide a rationale for both monotherapy and combination approaches. However, it's important to note that these are early-stage findings and need validation in clinical trials.
Karyopharm faces a competitive landscape in multiple myeloma, evidenced by the
The global expansion of XPOVIO is progressing well, with favorable reimbursement decisions in the UK and South Korea and additional approvals in China and other markets. This international growth could become a significant revenue driver in the future.
However, challenges in clinical trial enrollment for the XPORT-MM-031 study in multiple myeloma highlight the intensifying competition in this space. The company's decision to amend the trial design reflects the need for adaptability in a rapidly evolving market.
The Rare Pediatric Disease and Orphan Drug Designations for KPT-9274 in rare pediatric cancers open up new potential markets, but the company's decision to seek partnerships for this program suggests a focus on core assets.
– Achieves Second Quarter 2024 Total Revenue of
– Updated Clinical Results at ASCO Annual Meeting Showed Median Progression-Free Survival (PFS) of 28.4 Months in the TP53 Wild-Type Exploratory Subgroup and 39.5 Months in the Proficient Mismatched Repair Status (pMMR) TP53 Wild-Type Exploratory Subgroup from Phase 3 SIENDO Study of Selinexor Maintenance Treatment in Advanced/Recurrent Endometrial Cancer –
– Pre-Clinical Data Presented at the June 2024 European Hematology Association Meeting Support Selinexor's Mechanism of Action Targeting Multiple Oncogenic Pathways beyond JAK/STAT and Builds on the Compelling Clinical Data in Myelofibrosis –
– Completed Significant Refinancing Transactions and Amended Royalty Agreement with HealthCare Royalty Extending Vast Majority of Its Debt Maturities into 2028 and 2029, Well Beyond Expected Data Readouts and Potential Approvals from the Company's Three Phase 3 Trials, Strengthening the Company for its Next Stage of Growth –
– Raises the Lower End of Full-Year 2024 Total Revenue Guidance to
"We are pleased with the strength of our commercial performance with consecutive quarter-over-quarter growth in the highly competitive multiple myeloma marketplace and look forward to leveraging the foundation that we have built in this indication to serve additional patients. Looking ahead with our improved capital structure following our debt refinancing and disciplined expense management, we are strongly positioned for our next stage of growth, to redefine the standard of care for patients with myelofibrosis and endometrial cancer, driven by selinexor's growing body of compelling clinical and preclinical data in these indications," said Richard Paulson, President and Chief Executive Officer of Karyopharm.
Second Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
- Achieved
U.S. net product revenue of$28.0 million $26.0 million $28.5 million - XPOVIO net product revenue was supported by quarter-over-quarter growth in both new patient starts and refills.
- Continued quarter-over-quarter growth with >
10% growth in the community setting, which represents ~60% of overall net product revenues. In the academic setting, demand for XPOVIO was consistent quarter-over-quarter amidst ongoing competitive pressures, driven by the expanding use of XPOVIO immediately preceding and following T-cell therapies in later lines. The vast majority of XPOVIO new patient mix continues to be in the second to fourth lines of therapy. - Continued global momentum in the second quarter of 2024 with favorable reimbursement decisions in the
United Kingdom andSouth Korea , and additional regulatory approvals in relapsed/refractory (R/R) DLBCL in mainlandChina and R/R multiple myeloma in multiple international markets.
Research and Development (R&D) Highlights
Myelofibrosis
- Pre-clinical data were presented on the mechanism of action for XPO1 inhibition in myelofibrosis targeting multiple oncogenic pathways beyond JAK/STAT, including inhibition of NF-κB-driven proinflammatory cytokines and p53-mediated cell cycle regulation, at the June 2024 European Hematology Association meeting. These data suggest that XPO1 may be fundamental in myelofibrosis, providing the mechanistic rationale for both monotherapy as well as additive, if not synergistic, activity in combination with ruxolitinib, which we believe further supports the promising clinical results, including durable spleen volume reduction and symptom improvement, observed to date from the Phase 1 trial.
- Pivotal SENTRY Phase 3 trial of selinexor in combination with ruxolitinib in JAK-naive myelofibrosis continues to enroll with strong momentum, supported by high interest from investigators and minimal competition from other therapies in the JAK-naïve setting; expected top-line data readout on track for 2H 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 at "ASCO Plenary Series: Rapid Abstract Updates" oral session at the ASCO Annual Meeting in June 2024.
- In the exploratory subgroup analysis from the Phase 3 SIENDO Study, 113 patients with TP53 wild-type advanced/recurrent endometrial cancer were randomized to receive selinexor (n=77) vs placebo (n=36) as maintenance therapy after 1L platinum-based chemotherapy. As of the April 1, 2024 data cut-off date, and a median duration of follow-up of 36.8 months, selinexor-treated patients had a median PFS of 28.4 months compared to 5.2 months for patients receiving placebo. In selinexor-treated patients with TP53 wild-type/pMMR and TP53 wild-type/dMMR endometrial cancer, the median PFS was 39.5 months and 13.1 months compared to 4.9 months and 3.7 months in those treated with placebo, respectively. Although immature, overall survival (OS) in the TP53 wild-type subgroup was promising, with a hazard ratio of 0.65; median OS for selinexor has not been reached as of the data cut-off date. No new safety signals were identified as of the data cut-off date of April 1, 2024. The most common treatment-emergent adverse events in selinexor treated TP53 wild-type patients were nausea (
90% ), vomiting (60% ) and diarrhea (45% ), the majority of which were grades 1-2. - The updated SIENDO analysis also highlighted findings from an exploratory quality-adjusted time without symptoms or toxicity analysis (Q-TWiST) used to assess quality and toxicity-adjusted PFS. The findings showed the restricted mean Q-TWiST for selinexor to be 26 months compared to 15 months for placebo, resulting in a difference of nearly 11 months.
- Pivotal XPORT-EC-042 Phase 3 trial in TP53 wild-type endometrial cancer is now expected to read-out top-line data in early 2026, primarily due to higher-than-expected screen failure rates.
Multiple Myeloma
- Updated clinical data on SPd (selinexor in combination with pomalidomide and dexamethasone) regimen from STOMP and MM-028 trials were published in the Frontiers of Oncology Journal in May 2024. Both the Phase 1b/2 Selinexor and Backbone Treatments of Myeloma Patients (STOMP) trial (NCT02343042) and the Phase 2b XPORT-MM-028 (NCT04414475) trials are evaluating multiple selinexor combinations, including SPd, in patients with relapsed or refractory multiple myeloma (RRMM). The updated results for SPd 40 mg from these studies showed a median PFS of 18.4 months and a manageable safety profile with no new safety signals.
- Pivotal XPORT-MM-031 (EMN29) Phase 3 trial, an oral combination of selinexor 40 mg, pomalidomide and dexamethasone in patients with previously treated multiple myeloma, is enrolling patients at a lower rate than expected in an increasingly global competitive clinical trial environment targeting a similar patient population. Given this evolving environment and the positive SPd 40 mg PFS data published from the STOMP and MM-028 trials, Karyopharm intends to work with the trial's sponsor, the European Myeloma Network, to amend certain aspects of the design for this trial, including a reduction in the number of patients that are targeted for enrollment, and the statistical plan. With these updates, Karyopharm expects top-line data readout in 1H 2025; there remains a potential to seek regulatory approval pending the outcome of the study results.
KPT-9274 (Padnarsertib)
- KPT-9274, a first-in-class, oral small molecule and a dual inhibitor of PAK4 and NAMPT that was discovered at Karyopharm, was granted two Rare Pediatric Disease Designations (RPDD) by the
U.S. Food and Drug Administration (FDA) for the treatment of Rhabdomyosarcoma (RMS) and for the treatment of Ewing sarcoma (EWS) in June 2024. The FDA further granted KPT-9274 two Orphan Drug Designations in July 2024 for the treatment of soft tissue sarcoma, which includes RMS, and for the treatment of EWS. RMS and EWS are rare cancers of the bone or soft tissue, primarily diagnosed in pediatric patients, with poor survival outcomes and high unmet need for new therapies. KPT-9274 showed tumor regressions and decreased metastatic properties in pediatric RMS and EWS pre-clinical models. Karyopharm is evaluating out-licensing and/or partnership opportunities for further advancement of this program.
Financing Transactions and 2024 Financial Outlook
- In May 2024, the Company completed certain financing transactions which extended the vast majority of its debt maturities into 2028 and 2029 and amended its royalty agreement with HealthCare Royalty, further strengthening its balance sheet.
Based on its current operating plans, Karyopharm has updated its guidance for full year 2024 as follows:
- Total revenue to be in the range of
$145.0 million $160.0 million $140.0 million $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$105.0 million $120.0 million $100.0 million $120.0 million - R&D and selling, general and administrative (SG&A) expenses to be in the range of
$250.0 million $265.0 million $20.0 million $260.0 million $280.0 million $20.0 million $25.0 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 the first quarter of 20261 aided by ongoing disciplined expense management and initiated cost saving measures.
1 Excluding re-payment of
Second Quarter 2024 Financial Results
Total revenue: Total revenue for the second quarter of 2024 was
Net product revenue: Net product revenue for the second quarter of 2024 was
License and other revenue: License and other revenue for the second quarter of 2024 was
Cost of sales: Cost of sales for the second quarter of 2024 was
R&D expenses: R&D expenses for the second quarter of 2024 were
SG&A expenses: SG&A expenses for the second quarter of 2024 were
Interest income: Interest income for the second quarter of 2024 was
Interest expense: Interest expense for the second quarter of 2024 was
Gain on extinguishment of debt and other income: The Company recognized a non-cash gain on extinguishment of debt of
Net income (loss): Karyopharm reported net income of
Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2024 totaled
Conference Call Information
Karyopharm will host a conference call today, August 6, 2024, at 8:00 a.m. Eastern Time, to discuss the second 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.
References:
1 Excluding re-payment
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 | Six Months Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 28,032 | $ | 28,460 | $ | 54,038 | $ | 56,748 | ||||||||
License and other revenue | 14,754 | 9,119 | 21,874 | 19,529 | ||||||||||||
Total revenue | 42,786 | 37,579 | 75,912 | 76,277 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 1,465 | 1,194 | 3,376 | 2,545 | ||||||||||||
Research and development | 38,371 | 31,477 | 73,796 | 63,816 | ||||||||||||
Selling, general and administrative | 31,070 | 34,481 | 60,619 | 70,388 | ||||||||||||
Total operating expenses | 70,906 | 67,152 | 137,791 | 136,749 | ||||||||||||
Loss from operations | (28,120) | (29,573) | (61,879) | (60,472) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,930 | 2,824 | 4,086 | 5,673 | ||||||||||||
Interest expense | (8,949) | (5,784) | (14,833) | (11,542) | ||||||||||||
Gain on extinguishment of debt | 44,702 | — | 44,702 | — | ||||||||||||
Other income (expense), net | 14,296 | 30 | 14,492 | (234) | ||||||||||||
Total other income (expense), net | 51,979 | (2,930) | 48,447 | (6,103) | ||||||||||||
Income (loss) before income taxes | 23,859 | (32,503) | (13,432) | (66,575) | ||||||||||||
Income tax provision | (67) | (127) | (138) | (181) | ||||||||||||
Net income (loss) | $ | 23,792 | $ | (32,630) | $ | (13,570) | $ | (66,756) | ||||||||
Basic net income (loss) per share | $ | 0.15 | $ | (0.29) | $ | (0.11) | $ | (0.59) | ||||||||
Diluted net loss per share | $ | (0.20) | $ | (0.29) | $ | (0.48) | $ | (0.59) | ||||||||
Weighted-average number of common shares outstanding | 121,027 | 114,207 | 118,240 | 113,846 | ||||||||||||
Weighted-average number of common shares outstanding | 154,425 | 114,207 | 127,066 | 113,846 | ||||||||||||
KARYOPHARM THERAPEUTICS INC. | |||||||
June 30, | December 31, | ||||||
Assets | |||||||
Cash, cash equivalents and investments | $ | 152,124 | $ | 191,443 | |||
Restricted cash | 336 | 961 | |||||
Accounts receivable | 37,995 | 26,962 | |||||
Other assets | 23,522 | 21,072 | |||||
Total assets | $ | 213,977 | $ | 240,438 | |||
Liabilities and stockholders' deficit | |||||||
Convertible senior notes due 2025 | $ | 24,359 | $ | 170,919 | |||
Convertible senior notes due 2029 | 73,255 | — | |||||
Senior secured term loan | 93,517 | — | |||||
Deferred royalty obligation | 73,499 | 132,479 | |||||
Other liabilities | 81,487 | 73,246 | |||||
Total liabilities | 346,117 | 376,644 | |||||
Total stockholders' deficit | (132,140) | (136,206) | |||||
Total liabilities and stockholders' deficit; 124,635 and 114,915 shares issued | $ | 213,977 | $ | 240,438 | |||
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SOURCE Karyopharm Therapeutics Inc.
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