Karyopharm Therapeutics Inc
For the period ended Dec 31, 2024. Filed Feb 19, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 19, 2025
KPTI$0.05-8.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-02-29.
0000950170-24-022650
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-02-19.
0000950170-25-022765
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 75 previous paragraphs and 80 current paragraphs.
31 unchanged; 29 reworded; 19 added; 14 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
In May 2024, we entered into a series of transactions (the “Refinancing Transactions”) to limit our aggregate indebtedness, extend the maturity of certain of our indebtedness and provide us with additional working capital. Pursuant to these transactions, we borrowed $100.0 million from existing lenders and certain entities managed by HealthCare Royalty Management, LLC (“HCRx”) under a $100.0 million senior secured term loan facility (the “Term Loan”) and used a portion of the proceeds of the Term Loan to repay obligations under our existing financing arrangement with HCRx pursuant to an amendment that made other changes to our existing financing arrangement with HCRx. We also exchanged, pursuant to privately negotiated agreements, an aggregate principal amount of $148.0 million of our existing 3.00% unsecured convertible senior notes due 2025 (the “2025 Notes”) for (i) $111.0 million aggregate principal amount of new 6.00% secured convertible senior notes due 2029 (the “2029 Notes”) and (ii) warrants to purchase up to 45.8 million shares of our common stock. In addition, HCRx purchased $5.0 million aggregate principal amount of the 2029 Notes through satisfaction of $5.0 million of our existing obligations to HCRx. Please refer to Note 10 “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for additional details of the Refinancing Transactions.
Current report
License Agreements
Current report
Refinancing Transactions
Current report
Our estimated value of the gain on extinguishment of debt, the embedded derivatives in the 2029 Notes (as defined above) and the liability-classified common stock warrants related to the Refinancing Transactions, were valued using methodologies that incorporate certain unobservable inputs including (i) the volatility of our common stock price, (ii) our estimated credit spread and (iii) an estimate of when the warrants will be exercised based on an option pricing model. See Note 6, “Fair Value Measurements”, and Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for additional information.
Current report
Net product revenue from U.S. commercial sales of XPOVIO for the year ended December 31, 2024 was relatively consistent as compared to the year ended December 31, 2023. XPOVIO net product revenue was adversely impacted year-over-year by higher gross-to-net adjustments in 2024, driven primarily by 340B discounts and Medicare rebates. We expect net product revenue to increase in 2025 as compared to 2024 due to demand growth.
Current report
Operating Expenses (in thousands, except for percentages)
Current report
At any one time, we have a number of ongoing clinical development programs that we are conducting independently or in collaboration with third parties. We track our external clinical trial and related costs on a program-by-program basis. Our major programs include our lead clinical programs in myelofibrosis and our other late-stage clinical programs in endometrial cancer and multiple myeloma. To the extent that external clinical trial and related costs are not attributable to a major program, they are included in “Other programs” and to the extent external clinical trial and related costs cannot be allocated to a specific program, they are included in “Non-program specific clinical trial and related costs.” We also have unallocated research and development costs, which we do not track on a program-by-program basis. These costs represent expenses incurred across multiple programs or to support our general research and development operations.
Current report
We expect our research and development expenses to decrease in 2025 as compared to 2024 due primarily to full enrollment in mid-2024 of our Phase 3 multiple myeloma study and decreased headcount costs, partially offset by an increase in expenses in connection with our ongoing Phase 3 trials in myelofibrosis and endometrial cancer.
Current report
Other income (expense), net for the year ended December 31, 2024 increased by $56.3 million as compared to the year ended December 31, 2023, primarily due to a $44.7 million gain on extinguishment of debt from the Refinancing Transactions and a $28.7 million gain from the remeasurement of embedded derivatives and liability-classified common stock warrants, both of which are non-cash items. These gains were partially offset by an increase in interest expense related to the Term Loan and the 2029 Notes and a decrease in interest income resulting from lower investment balances in 2024 as compared to 2023.
Current report
Liquidity, Capital Resources and Going Concern
Current report
We have historically financed our operations primarily through a combination of proceeds from (i) product revenue sales, (ii) public and private placements of equity securities, (iii) the issuance of convertible debt, (iv) a term loan, (v) our deferred royalty obligation, (vi) at the market offerings and (vii) business development activities. As of December 31, 2024, our principal source of liquidity was $108.7 million of cash, cash equivalents and investments. We have had recurring losses since inception and incurred a loss of $76.4 million for the year ended December 31, 2024.
Current report
We anticipate that we will continue to incur significant operating losses in the foreseeable future. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding and considering our debt obligations, including a requirement to maintain cash, cash equivalents and investments of at least $25.0 million at all times, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. We expect that our cash, cash equivalents and investments as of December 31, 2024 will be sufficient to fund our current operating plans and debt obligation requirements into the fourth quarter of 2025. See “Liquidity, Capital Resources and Going Concern – Funding Requirements” below and Note 1 “Organization and Operations” to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
Current report
The $40.5 million increase in net cash provided by financing activities during the year ended December 31, 2024 as compared to the year ended December 31, 2023 was primarily driven by $83.3 million of proceeds from the Term Loan, partially offset by a $40.5 million payment of our deferred royalty obligation to HCRx and a $2.6 million payment of debt issuance costs related to the Refinancing Transactions.
Current report
On May 8, 2024, we entered into a credit and guaranty agreement (the “Credit Agreement”) with certain existing lenders and HCRx, which provides for a senior secured term loan facility of $100.0 million. For additional information, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Current report
We are party to an operating lease of office and research space in Newton, Massachusetts, which was amended in November 2024 and under which we currently lease a total of 98,502 square feet of research and office space through September 30, 2025, which will be reduced to 52,224 square feet of solely office space from October 1, 2025 through September 30, 2030. We expect to incur total lease costs of $10.9 million from January 1, 2025 to September 30, 2030.
Current report
Future obligations related to the 2025 Notes of $25.2 million through October 2025;
Current report
Future obligations related to the 2029 Notes of $146.4 million through May 2029;
Current report
Future obligations related to the Credit Agreement of $142.7 million through May 2028 in addition to our requirement to maintain cash, cash equivalents and investments of at least $25.0 million at all times; and
Current report
Item 7A. Quantitat
Removed paragraphs (14)
Previous report
License and Asset Purchase Agreements
Previous report
Net product revenue from U.S. commercial sales of XPOVIO for the year ended December 31, 2023 decreased 7% as compared to the year ended December 31, 2022. A number of myeloma foundations that help support Medicare Part D patients with their out-of-pocket costs for multiple myeloma oral oncolytics, including XPOVIO, closed during the first quarter of 2023 and some remained closed throughout 2023. During the foundation closures, we provided XPOVIO to these patients at no charge through our Patient Assistance Program (“PAP”), which adversely impacted our 2023 revenues by approximately $5.8 million as patients who entered our PAP earlier in the year remained in the program through the calendar year and received their refills during the course of their treatment. We believe this trend will be mainly limited to 2023 since, beginning in 2024, changes in the design of Medicare Part D under the Inflation Reduction Act eliminated the patient burden of the 5% Beneficiary Coinsurance requirement and we expect less need for Medicare Part D patients to utilize PAP for co-pay assistance in 2024 compared to 2023.
Previous report
Operating Costs and Expenses (in thousands, except for percentages)
Previous report
We expect our research and development expenses to increase slightly in 2024 as compared to 2023 as we continue to advance our three pivotal Phase 3 trials.
Previous report
Other expense, net for the year ended December 31, 2023 decreased by $9.5 million as compared to the year ended December 31, 2022, primarily due to an increase in interest income resulting from higher interest rates on our investments.
Previous report
Liquidity and Capital Resources
Previous report
To date, we have financed our operations primarily through a combination of product revenue sales, private placements of our common stock, proceeds from public offerings of our common stock, proceeds from the issuance of convertible debt, proceeds pursuant to the deferred royalty obligation, and cash generated from our business development activities.
Previous report
As of December 31, 2023, our principal source of liquidity was $191.4 million of cash, cash equivalents and investments. We have had recurring losses since inception and incurred a loss of $143.1 million for the year ended December 31, 2023. We expect that our cash, cash equivalents and investments at December 31, 2023 will be sufficient to fund our current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of the financial statements contained in this Annual Report on Form 10-K.
Previous report
Net Cash Provided by (Used in) Investing Activities
Previous report
The $192.6 million decrease in net cash provided by financing activities during the year ended December 31, 2023 as compared to the year ended December 31, 2022 was primarily driven by net proceeds of approximately $154.7 million from a private placement offering of our common stock in 2022 and $35.1 million in net proceeds received from the sale of common stock under our “at the market offering” program in 2022.
Previous report
On December 5, 2022, we entered into a securities purchase agreement with certain institutional investors pursuant to which we issued and sold, in a private placement offering of securities, an aggregate of (i) 31,791,908 shares of common stock and (ii) accompanying warrants to purchase up to 9,537,563 shares of common stock at an exercise price of $6.36 per share. We received aggregate net proceeds of approximately $154.7 million.
Previous report
We are party to an operating lease of 98,502 square feet of office and research space in Newton, Massachusetts with a term through September 30, 2025 (the “Newton, MA Lease”). Pursuant to the Newton, MA Lease, we have provided a security deposit in the form of a cash-collateralized letter of credit in the amount of $0.3 million which is classified in long-term restricted cash on our consolidated balance sheets. We expect to incur total lease costs of $6.7 million from December 31, 2023 to September 30, 2025.
Previous report
In addition, we are party to certain short-term leases having a term of twelve months or less at the commencement date. We recognize short-term lease expense on a straight-line basis and do not record a related right-of use asset or lease liability for such leases. These costs were insignificant for the years ended December 31, 2023, 2022 and 2021.
Previous report
Future long-term debt obligations related to the 3.00% Convertible Senior Notes due 2025 of $182.9 million over the next three years; and
Reworded paragraphs (29)
Previous wording
We are a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Our scientific expertise is based upon an understanding of the regulation of intracellular communication between the nucleus and the cytoplasm. We have discovered and are developing and commercializing novel, small molecule Selective Inhibitor of Nuclear Export (“SINE”) compounds that inhibit the nuclear export protein exportin 1 (“XPO1”). These SINE compounds represent a new class of drug candidates with a novel mechanism of action that have the potential to treat a variety of diseases with high unmet medical need. Our lead asset, XPOVIO®(selinexor), was the first oral XPO1 inhibitor to receive marketing approval, receiving its initial U.S. approval from the U.S. Food and Drug Administration (“FDA”) in July 2019, and is currently approved and marketed in the U.S. for the following indications:
Current wording
We are a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer. Our scientific expertise is based upon an understanding of the regulation of intracellular communication between the nucleus and the cytoplasm. We have discovered and are developing and commercializing novel, small molecule Selective Inhibitor of Nuclear Export (“SINE”) compounds that inhibit the nuclear export protein exportin 1 (“XPO1”). These SINE compounds represent a new class of drug candidates with a novel mechanism of action that have the potential to treat a variety of diseases with high unmet medical need. Our lead asset, XPOVIO®(selinexor), was the first oral XPO1 inhibitor to receive marketing approval, receiving its initial U.S. approval from the U.S. Food and Drug Administration (“FDA”) in July 2019, and is currently approved and marketed in the U.S. for the following indications:
Previous wording
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Approval in this indication was based on the results from the BOSTON (Bortezomib, Selinexor and Dexamethasone) study;
Current wording
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Approval in this indication was based on the results from the BOSTON (Bortezomib, Selinexor and Dexamethasone) trial;
Previous wording
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. Approval in this indication was based on the results from the STORM (Selinexor Treatment of Refractory Myeloma) study; and
Current wording
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. Approval in this indication was based on the results from the STORM (Selinexor Treatment of Refractory Myeloma) trial; and
Previous wording
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 was approved under accelerated approval based on response rate and was based on the results from the SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Current wording
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 was approved under accelerated approval based on response rate and was based on the results from the SADAL (Selinexor Against Diffuse Aggressive Lymphoma) trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Previous wording
The commercialization of XPOVIO and NEXPOVIO® (selinexor) (the brand name for selinexor in Europe and the United Kingdom (“UK”)) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory approval in various indications in over 40 countries outside the U.S. and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.
Current wording
The commercialization of XPOVIO and NEXPOVIO® (selinexor) (the brand name for selinexor in Europe and the United Kingdom) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory approval in various indications in over 45 countries outside the U.S. and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.
Previous wording
Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking the regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our core programs in endometrial cancer, multiple myeloma, and myelofibrosis. We plan to continue to conduct clinical trials and to seek additional approvals for the use of selinexor as a single agent or in combination with other oncology therapies to expand the patient populations that are eligible for treatment with selinexor. In January 2024, we announced that further clinical development of our eltanexor program is on hold in an effort to focus our resources on our prioritized late-stage programs.
Current wording
Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking the regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosis and our other late-stage clinical programs in endometrial cancer and multiple myeloma. We plan to continue to conduct clinical trials and to seek additional approvals for the use of selinexor as a single agent or in combination with other oncology therapies to expand the patient populations that are eligible for treatment with selinexor. As announced in January 2024, further clinical development of our eltanexor program continues to remain on hold in an effort to focus our resources on our prioritized late-stage programs.
Previous wording
As of December 31, 2023, we had an accumulated deficit of $1.5 billion. We had net losses of $143.1 million, $165.3 million, and $124.1 million for the years ended December 31, 2023, 2022 and 2021, respectively. We recognized total revenue of $146.0 million in 2023, including $112.0 million of XPOVIO net product revenue and $34.0 million of license revenue. License revenue included $15.0 million of revenue for the reimbursement of development related expenses from the Menarini Group (“Menarini”). As of December 31, 2023, we had $191.4 million in cash, cash equivalents and investments.
Current wording
As of December 31, 2024, we had an accumulated deficit of $1.6 billion. We had net losses of $76.4 million, $143.1 million, and $165.3 million for the years ended December 31, 2024, 2023 and 2022, respectively. We recognized total revenue of $145.2 million in 2024, including $112.8 million of XPOVIO net product revenue and $32.4 million of license revenue. License revenue included $15.0 million of revenue for the reimbursement of development related expenses from the Menarini Group (“Menarini”). As of December 31, 2024, we had $108.7 million in cash, cash equivalents and investments. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding and considering our debt obligations, including a requirement to maintain cash, cash equivalents and investments of at least $25.0 million at all times, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See “Liquidity, Capital Resources, and Going Concern” below for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
Previous wording
We recognize product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are reported. These reserves are based on the amounts earned, or to be claimed on the related sales, and are generally classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Certain amounts are known at the time of sale based on contractual terms and are recorded pursuant to the most likely amount method, which is the single most likely amount in a range of possible considerations. Other amounts are estimated pursuant to the expected value method, which is the sum of probability-weighted amounts in a range of possible considerations. Relevant factors used in the expected value method include: current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. These reserves reflect our best estimates of the variable consideration based on the terms of the respective underlying contracts.
Current wording
We recognize product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is upon delivery to the customer. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are reported. These reserves are based on the amounts earned, or to be claimed on the related sales, and are generally classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Certain amounts are known at the time of sale based on contractual terms and are recorded pursuant to the most likely amount method, which is the single most likely amount in a range of possible considerations. Other amounts are estimated pursuant to the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. Relevant factors used in the expected value method include: current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. These reserves reflect our best estimates of the variable consideration based on the terms of the respective underlying contracts.
Previous wording
A 10% increase or decrease in these estimates would impact net product revenue by a corresponding increase or decrease of less than $3.0 million.
Current wording
A 10% increase or decrease in these estimates would impact net product revenue by a corresponding increase or decrease of approximately $4.0 million.
Previous wording
The following table summarizes our results of operations (in thousands):
Current wording
The following table summarizes our results of operations (in thousands, except for percentages):
Previous wording
License and other revenue for the year ended December 31, 2023 decreased by $2.6 million as compared to the year ended December 31, 2022 primarily due to a decrease in milestone-related revenue and royalty revenue from Antengene Therapeutics Limited (“Antengene”), partially offset by an increase in milestone-related revenue, license-related revenue, and royalty revenue from Menarini. The license agreements with Menarini and Antengene are each defined and described in Note 5 “License and Asset Purchase Agreements”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Current wording
License and other revenue for the year ended December 31, 2024 decreased by $1.6 million as compared to the year ended December 31, 2023 primarily due to a decrease in milestone-related revenue from our other license agreements, offset by an increase in milestone-related and royalty revenue from Menarini. The license agreements with Menarini and Antengene Therapeutics Limited (“Antengene”) are each defined and described in Note 5, “License Agreements”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Previous wording
We expect license and other revenue to increase in 2024 as compared to 2023 primarily due to expected milestone achievements.
Current wording
We expect license and other revenue to slightly decrease in 2025 as compared to 2024 primarily due to a decrease in milestone-related revenue from our partners.
Previous wording
We expect cost of sales to remain relatively consistent in 2024 as compared to 2023.
Current wording
Cost of sales for the year ended December 31, 2024 was relatively consistent with the year ended December 31, 2023. We expect cost of sales to remain relatively consistent in 2025 as compared to 2024.
Previous wording
Research and development expenses for the year ended December 31, 2023 decreased by $9.9 million as compared to the year ended December 31, 2022, primarily due to a decrease in personnel costs of $9.2 million and a decrease in stock-based compensation of $7.8 million, which was primarily because of a reduction in headcount and contractors, including severance-related expenses incurred in 2022. These decreases were partially offset by an increase in clinical trial and related costs of $9.2 million, primarily due to the advancement of our three pivotal Phase 3 trials and the timing of purchases of comparator drug used in our clinical trials.
Current wording
Research and development expenses for the year ended December 31, 2024 increased by $4.5 million as compared to the year ended December 31, 2023. The $9.8 million increase in clinical trial and related costs was primarily due to increased activity in each of our ongoing Phase 3 trials, including increased purchases of comparator drugs. These increases were partially offset by a $9.8 million decrease in clinical trial and related costs in other programs. The decrease in personnel costs of $5.7 million was primarily due to a reduction in headcount and contractors for the year ended December 31, 2024 as compared to the year ended December 31, 2023 due to the realization of previously implemented cost reduction initiatives.
Previous wording
Selling, general and administrative expenses for the year ended December 31, 2023 decreased by $13.5 million as compared to the year ended December 31, 2022, primarily due to a decrease in stock-based compensation and a decrease in consulting, professional and other costs. The decrease in stock-based compensation of $6.0 million was primarily due to severance-related expenses incurred during 2022. The decrease in consulting, professional and other costs was primarily due to lower commercial-related activities.
Current wording
Selling, general and administrative expenses for the year ended December 31, 2024 decreased by $16.4 million as compared to the year ended December 31, 2023. The decrease in personnel costs of $8.8 million and the decrease in stock-based compensation of $1.5 million were primarily due to a reduction in headcount and contractors for the year ended December 31, 2024 as compared to the year ended December 31, 2023 due to our ongoing cost reduction initiatives. The decrease in consulting, professional and other costs of $6.2 million was primarily due to lower commercial-related activities in connection with cost optimization efforts during 2024.
Previous wording
We expect our selling, general and administrative expenses to decrease slightly in 2024 as compared to 2023 due to cost optimization efforts.
Current wording
We expect our selling, general and administrative expenses to slightly decrease in 2025 as compared to 2024 due to continued realization of previously implemented cost reduction initiatives.
Previous wording
Other Expense, net (in thousands, except for percentages)
Current wording
Other Income (Expense), net (in thousands, except for percentages)
Previous wording
We expect other expense, net to remain relatively consistent in 2024 as compared to 2023.
Current wording
We expect other income (expense), net to decrease in 2025 as compared to 2024 due to the $44.7 million gain on extinguishment of debt being a one-time, non-recurring item. We also expect increased interest expense in 2025 as compared to 2024 on the Term Loan and the 2029 Notes, as both of these instruments were issued in May 2024, and 2025 will include a full year of interest expense on these instruments. The future impact from remeasurements of the embedded derivatives and liability-classified common stock warrants will depend on a variety of factors, including movements in our stock price, and cannot be forecasted.
Previous wording
The $56.8 million decrease in net cash used in operating activities during the year ended December 31, 2023 as compared to the year ended December 31, 2022 was primarily driven by a decrease in expenses and $27.3 million of milestone payments we received from Antengene in 2023.
Current wording
The $34.8 million increase in net cash used in operating activities during the year ended December 31, 2024 as compared to the year ended December 31, 2023 was primarily driven by working capital changes, including the collection of $27.3 million of milestone payments from Antengene in 2023.
Previous wording
The $112.2 million increase in net cash provided by investing activities during the year ended December 31, 2023 as compared to the year ended December 31, 2022 was primarily driven by a $66.9 million decrease in purchases of investments and a $45.2 million increase in proceeds from the sales and maturities of investments.
Current wording
Net cash provided by investing activities increased by $87.5 million during the year ended December 31, 2024 as compared to the year ended December 31,2023. Proceeds from the maturities of investments decreased by $12.7 million in 2024, which was significantly offset by a decrease of $100.3 million in purchases of investments in 2024, due to liquidity needs to fund our operations.
Previous wording
In September 2019, we entered into the Revenue Interest Financing Agreement (the “Revenue Interest Agreement”) with HealthCare Royalty Partners III, L.P. and HealthCare Royalty Partners IV, L.P. (“HCR”) which was amended in June 2021 (the “Amended Revenue Interest Agreement”). Pursuant to the Revenue Interest Agreement, HCR paid us $75.0 million, less certain transaction expenses, on September 27, 2019 and pursuant to the Amended Revenue Interest Agreement, HCR paid us $60.0 million on June 23, 2021. For additional information on the Amended Revenue Interest Agreement, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Current wording
On September 14, 2019, we and certain of our subsidiaries entered into the Revenue Interest Financing Agreement with HCRx, which was subsequently amended on June 23, 2021, August 1, 2023 and May 8, 2024 (the “Revenue Interest Agreement” and, as amended, the “Amended Revenue Interest Agreement”), pursuant to which, HCRx paid us a total of $135.0 million, less certain transaction expenses. For additional information on the Amended Revenue Interest Agreement, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Previous wording
On February 17, 2023, we entered into an Open Market Sale Agreement (the “2023 Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”). Under the 2023 Open Market Sale Agreement, we may issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million (the “Shares”) from time to time through Jefferies (the “2023 Open Market Offering”). Upon entry into the 2023 Open Market Sale Agreement, we terminated our previous Open Market Sale Agreement with Jefferies, as agent, which we had entered into in August 2018 (the “2018 Open Market Sale Agreement”), pursuant to which we could issue and sell shares of our common stock having an aggregate offering price of up to $175.0 million (the “Open Market Shares”). During the year ended December 31, 2022, we sold an aggregate of 3,991,652 Open Market Shares under the 2018 Open Market Sale Agreement, for net proceeds of approximately $35.1 million.
Current wording
On February 17, 2023, we entered into an Open Market Sale Agreement (the “2023 Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”). Under the 2023 Open Market Sale Agreement, we may issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million (the “Shares”) from time to time through Jefferies. We did not sell any Shares under the 2023 Open Market Sales Agreement during the year ended December 31, 2024. As of December 31, 2024, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.
Previous wording
During the year ended December 31, 2023, we received $32.0 million in milestone and upfront payments under our license and distribution arrangements pursuant to which we are entitled to receive additional milestone payments, if certain development goals and sales milestones are achieved, as well as royalties on future net sales of the licensed and sold products in the territories under such arrangements. In addition, under the Menarini Agreement, Menarini will reimburse us for 25% of all development related expenses we incur for selinexor from 2022 through 2025, provided that such reimbursements shall not exceed $15.0 million per calendar year. We received $15.0 million of reimbursements for development related expenses under the Menarini Agreement during the year ended December 31, 2023.
Current wording
During the year ended December 31, 2024, we received $19.6 million in milestone and upfront payments under our license and distribution arrangements pursuant to which we are entitled to receive additional milestone payments, if certain development goals and sales milestones are achieved, as well as royalties on future net sales of the licensed and sold products in the territories under such arrangements. In addition, under the Menarini Agreement, Menarini will reimburse us for 25% of all development related expenses we incur for selinexor from 2022 through 2025, provided that such reimbursements shall not exceed $15.0 million per calendar year. We received $15.0 million of reimbursements for development related expenses under the Menarini Agreement during the year ended December 31, 2024.
Previous wording
We have contractual obligations under our 3.00% Convertible Senior Notes due 2025 and under our Revenue Interest Financing Agreement as disclosed in Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Current wording
We have contractual obligations under our (i) 2025 Notes; (ii) Credit Agreement, (iii) 2029 Notes, and (iv) Amended Revenue Interest Agreement as disclosed in Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
Previous wording
We expect our expenses to remain relatively consistent in 2024 as compared to 2023. We expect to continue to incur costs related to our clinical development programs as we rapidly advance three pivotal Phase 3 trials, as well as commercialization expenses related to sales, marketing, manufacturing and distribution of any of our products, to the extent that these functions are not the responsibility of our collaborators.
Current wording
We expect to continue to incur costs related to our clinical development programs as we continue to advance our lead clinical programs in myelofibrosis and our other late-stage clinical programs in endometrial cancer and multiple myeloma, as well as commercialization expenses related to sales, marketing, manufacturing and distribution of our approved products, to the extent that these functions are not the responsibility of our collaborators.
Previous wording
We currently expect that cash, cash equivalents and investments at December 31, 2023 will be sufficient to fund our current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of the financial statements contained in this Annual Report on Form 10-K while we continue to commercialize XPOVIO in the U.S. and continue the clinical trials of our product candidates. Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “We will need additional funding to achieve our business objectives. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts,” under the heading “Risk Factors” in this Annual Report on Form 10-K.
Current wording
Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding and considering our debt obligations, including a requirement to maintain cash, cash equivalents and investments of at least $25.0 million at all times, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See Note 1, “Organization and Operations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of the conditions that raise substantial doubt regarding our ability to continue as a going concern. We currently expect that cash, cash equivalents and investments as of December 31, 2024 will be sufficient to fund our current operating plans and debt obligation requirements into the fourth quarter of 2025 while we continue to commercialize XPOVIO in the U.S. and continue the clinical trials of our product candidates. Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “We will need additional funding to achieve our business objectives. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts,” under the heading “Risk Factors” in this Annual Report on Form 10-K.
Previous wording
In addition to the expenses required to fund our operations described above, our funding requirements also include the following:
Current wording
In addition to the expenses required to fund our operations described above, our funding requirements as of December 31, 2024 also include the following:
Previous wording
Lease costs for our headquarters in Newton, Massachusetts with a term through September 30, 2025, which totaled $3.7 million in 2023 and increase annually; we expect total future lease costs to be approximately $6.7 million;
Current wording
Lease costs for our headquarters in Newton, Massachusetts of $10.9 million through September 30, 2030;
Previous wording
Future royalty obligations to HCR under our Revenue Interest Financing Agreement of approximately $201.6 million.
Current wording
Future royalty obligations to HCRx under the Amended Revenue Interest Agreement of $119.9 million by October 1, 2031.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Net Cash Provided by Investing Activities
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We did not sell any Open Market Shares under the 2018 Open Market Sale Agreement nor any Shares under the 2023 Open Market Sales Agreement during the year ended December 31, 2023. As of December 31, 2023, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.