Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended March 31, 2024, and highlighted select corporate milestones and progress on its key clinical development programs.
“We have taken a significant step that improves our capital structure, strengthening our opportunity to realize the full value of three potential new indications for selinexor. We are strongly positioned for our next stage of growth, driven by our focused and rapidly advancing late-stage pipeline with expected data readouts from our three ongoing Phase 3 trials next year,” said Richard Paulson, President and Chief Executive Officer of Karyopharm.
First Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
- Achieved U.S. net product revenue of $26.0 million for the first quarter of 2024, compared to $25.1 million for the fourth quarter of 2023 and $28.3 million for the first quarter 2023.
- XPOVIO net product revenue was supported by quarter-over-quarter growth in new patient starts amidst increased competition, while being adversely impacted by softness in refills following lower new prescriptions in the fourth quarter of 2023 and higher gross to net driven by increased Medicare rebates and 340B discounts.
- Approximately 60% of XPOVIO net product revenue came from the community setting, with a vast majority of XPOVIO patient mix continuing to be in earlier lines of therapy. In the academic setting, demand for XPOVIO grew quarter-over-quarter despite competitive pressures, driven by the expanding use of XPOVIO immediately preceding and following T-cell therapies in later lines.
- Effective January 1, 2024, XPOVIO was added to Mainland China’s National Reimbursement Drug List for the treatment of adult patients with relapsed or refractory multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody.
- In April 2024, the National Institute for Health and Care Excellence (NICE) in the United Kingdom recommended the expanded use of NEXPOVIO in combination with bortezomib and dexamethasone, as a treatment for multiple myeloma patients who have received one or two prior treatments.
R&D Highlights
Endometrial Cancer
- Invited to present updated long-term follow-up data of selinexor in patients with TP53 wild-type advanced or recurrent endometrial cancer – a pre-specified exploratory subgroup analysis from the Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study – during the “ASCO Plenary Series: Rapid Abstract Updates” session in June 2024.
- 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) was presented as an encore oral presentation at the 25th European Gynaecological Oncology Congress (ESGO) in March 2024.
Myelofibrosis
- Initiated the Phase 2 SENTRY-2 trial (XPORT-MF-044; NCT05980806), evaluating the efficacy and safety of selinexor monotherapy at 60 mg QW or 40 mg QW in subjects (n=58) with JAK inhibitor-naïve myelofibrosis with platelet counts of 50 to less than (<) 100 x 10^9/L. The Company expects to present preliminary results from this trial by the end of 2024.
Financing Transactions
- The Company announced certain financing transactions which extended the vast majority of its debt maturities into 2028 and 2029 and further strengthened its balance sheet. Karyopharm also amended its royalty agreement with HealthCare Royalty (HCRx) to address the remaining principal portion of HCRx’s $135.0 million investment, and, among other things, reduce the royalty rate on the Company’s net revenue from 12.5% to 7.0%. For the details of these transactions, please refer to Karyopharm’s press release issued earlier this morning and the Form 8-K filed on May 8, 2024 with the U.S. Securities and Exchange Commission.
First Quarter 2024 Financial Results
Total Revenues: Total revenue for the first quarter of 2024 was $33.1 million, compared to $38.7 million for the first quarter of 2023.
Net product revenue: Net product revenue for the first quarter of 2024 was $26.0 million, compared to $28.3 million for the first quarter of 2023.
License and other revenue: License and other revenue for the first quarter of 2024 was $7.1 million, compared to $10.4 million for the first quarter of 2023. The decrease was primarily due to $3.5 million of license-related revenue recognized from the Menarini Group (Menarini) during the three months ended March 31, 2023, partially offset by a $1.0 million increase in revenue for the reimbursement of development-related expenses from Menarini due to a corresponding increase in the underlying expenses during the three months ended March 31, 2024.
Cost of sales: Cost of sales for the first quarter of 2024 was $1.9 million, compared to $1.4 million for the first quarter of 2023. Cost of sales reflects the costs of XPOVIO units sold and the costs of products sold to our partners.
Research and development (R&D) expenses: R&D expenses for the first quarter of 2024 were $35.4 million, compared to $32.3 million for the first quarter of 2023. The increase was primarily due to higher clinical trial costs related to the advancement of our three pivotal Phase 3 programs during the three months ended March 31, 2024.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the first quarter of 2024 were $29.5 million, compared to $35.9 million for the first quarter of 2023. The decrease was primarily due to our ongoing cost reduction initiatives and lower headcount.
Interest income: Interest income for the first quarter of 2024 was $2.2 million, compared to $2.8 million for the first quarter of 2023.
Interest expense: Interest expense for the first quarter of 2024 was $5.9 million, compared to $5.8 million for the first quarter of 2023.
Net loss: Karyopharm reported a net loss of $37.4 million, or $0.32 per share, for the first quarter of 2024, compared to a net loss of $34.1 million, or $0.30 per share, for the first quarter of 2023.
Cash position: Cash, cash equivalents, restricted cash and investments as of March 31, 2024 totaled $149.3 million, compared to $192.4 million as of December 31, 2023.
2024 Financial Outlook
Based on its current operating plans, Karyopharm reaffirms the following for full year 2024:
- Total revenue to be in the range of $140.0 million to $160.0 million. Total revenue consists of 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 $100.0 million to $120.0 million.
- R&D and SG&A expenses to be in the range of $260.0 million to $280.0 million, which includes approximately $20.0 million to $25.0 million of estimated non-cash stock-based compensation expense.
- 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 end of 20251.
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 U.S. and marketed by the Company in three oncology indications. It has also received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline targeting indications in multiple high unmet need cancers, including in multiple myeloma, endometrial cancer, myelofibrosis, and diffuse large B-cell lymphoma (DLBCL). For more information about our people, science and pipeline, please visit www.karyopharm.com, and follow us on LinkedIn and on X at @Karyopharm.
