TG THERAPEUTICS INC
For the period ended Mar 31, 2025. Filed May 9, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 9, 2025
TGTX$59.83+3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001437749-24-033948
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0001437749-25-015804
Item 2. 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 60 previous paragraphs and 45 current paragraphs.
20 unchanged; 20 reworded; 5 added; 15 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 7 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 (5)
Current report
Subcutaneous Ublituximab Overview
Current report
In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab.
Current report
Azercabtagene Zapreleucel (azer-cel)
Current report
Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by the Company for autoimmune diseases. Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in several B-cell cancers and autoimmune diseases. Azer-cel is designed to avoid graft-versus-host disease (GvHD), a significant complication associated with other donor-derived, cell-based therapies. In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS.
Current report
While we recently began generating net income, we have incurred significant operating losses since our inception. BRIUMVI first became commercially available in the United States in January of 2023, and ex-US through our partner Neuraxpharm, in November 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability. During the three months ended March 31, 2025, we generated $119.7 million in product revenue from product sales of BRIUMVI. Historically, substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities to date. Our future operating results, profitability and other financial results may fluctuate from period to period, and we will need to generate significant revenues to maintain profitability and/or positive cash flow on a sustained basis. As of March 31, 2025, we have an accumulated deficit of approximately $1.5 billion.
Removed paragraphs (15)
Previous report
Recent Business Update Highlights
Previous report
BRIUMVI Five-Year Data Update
Previous report
In September 2024 we presented new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with RMS, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. These data demonstrate that 92% of patients with RMS were free from disability progression after five years of BRIUVI treatment, the annualized relapse rate during year five of treatment was 0.02 (equivalent to one relapse occurring every fifty years of patient treatment), and the overall safety profile remained consistent over five years of continuous treatment, with no new safety signals emerging with prolonged treatment.
Previous report
Ublituximab Development
Previous report
Pipeline
Previous report
In August 2024, we announced FDA clearance of the Investigational New Drug Application (IND) for azercabtagene zapreleucel (azer-cel) for the treatment of progressive forms of multiple sclerosis. Previously, in January 2024, we entered into an agreement with Precision BioSciences, Inc. (Precision) to acquire a worldwide license to Precision’s azer-cel, for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic (off the shelf) CAR T program, and the Company has near term plans to evaluate the program in multiple autoimmune indications.
Previous report
BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, that can be administered in a twice yearly, one-hour infusion following the starting dose.
Previous report
Product Revenue, Net*.*Product revenue, net was approximately $206.4 million for the nine months ended September 30, 2024, compared to $48.9 million for the nine months ended September 30, 2023. Product revenue, net for both the nine months ended September 30, 2024 and September 30, 2023, consisted of net product sales of BRIUMVI in the United States. In January 2023, we began commercial sales of BRIUMVI within the U.S. following FDA approval.
Previous report
Cost of Revenue. Cost of revenue for the nine months ended September 30, 2024 was $23.1 million compared to approximately $6.3 million for the nine months ended September 30, 2023. Cost of revenue for both the nine months ended September 30, 2024 and September 30, 2023 consists primarily of third-party manufacturing, distribution, overhead costs and royalties owed to our licensing partner for BRIUMVI sales. A portion of the costs of producing BRIUMVI sold to date was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories. We expect to use the remaining pre-commercialization inventory for product sales through the first quarter of 2025, after which our product gross margin is anticipated to decrease modestly. The cost of revenue for the nine months ended September 30, 2024 and the nine months ended September 30. 2023 includes $1.4 million and $0.7 million, respectively, of costs related to delivering regulatory support and development services to Neuraxpharm in accordance with the Commercialization Agreement.
Previous report
Other Research and Development Expense*.*Other research and development expense increased for the nine months ended September 30, 2024, by approximately $13.8 million to $62.4 million, as compared to $48.6 million during the comparable period ended September 30, 2023. The increase in other research and development expense during the nine months ended September 30, 2024 was primarily attributable to the Precision License Agreement, as well as manufacturing related expenses during the period, offset by a decrease in clinical trial expenses.
Previous report
Interest Expense.*** ***Interest expense increased by $6.8 million to $17.0 million for the nine months ended September 30, 2024, as compared to $10.2 million for the nine months ended September 30, 2023. Interest expense for the nine months ended September 30, 2024 is comprised of approximately $4.6 million of debt extinguishment costs pertaining to the First Amendment with Hercules, as well as increased interest expense pertaining to the Initial Term Loan with Blue Owl during the same period (see Note 7 for details).
Previous report
Other Income.*** ***Other income increased by $1.0 million to $5.1 million for the nine months ended September 30, 2024, as compared to $4.1 million during the nine months ended September 30, 2023. The increase is mainly due to greater accretion income earned from short-term investment securities during the nine months ended September 30, 2024, compared to the comparable period ending September 30, 2023.
Previous report
Historically, we have incurred operating losses; however, during the three and nine months ended September 30, 2024 the Company generated net income. Additionally, during the twelve months ended December 31, 2023, the Company experienced a net profit due to a $140.0 million non-refundable upfront payment recognized as license revenue in the third quarter of 2023 as part of our ex-U.S. commercialization agreement (the Commercialization Agreement) with Neuraxpharm (see Note 2 for more information). We may incur operating losses in the near term and may never become profitable. As of September 30, 2024, we have an accumulated deficit of $1.6 billion.
Previous report
Our major sources of cash have been proceeds from private placements and public offerings of equity securities, from our loan and security agreements, the upfront payment from the Commercialization Agreement (see Note 2 for more information), and from product revenue from drug sales of BRIUMVI. During the nine months ended September 30, 2024, we generated $206.4 million in product revenue from drug sales of BRIUMVI. BRIUMVI is currently our only marketed product. Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. We expect to continue to incur significant research and development expenses, as well as significant commercialization and outsourced manufacturing expenses as we continue to commercialize BRIUMVI. Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products, we are unable to predict the extent of any future losses, or for how long we may continue to experience a net profit. We may not be able to sustain or increase our profitability on a quarterly or annual basis. Our ability to become profitable depends upon our ability to generate substantial revenue.
Previous report
As of September 30, 2024, we had $341.0 million in cash, cash equivalents, and investment securities. The Company believes its existing cash, cash equivalents, and investment securities, combined with projected revenues associated with the sale of BRIUMVI in the U.S. and ex-U.S., will be sufficient to fund our anticipated operating cash requirements for at least twelve months following the date of this filing.
Reworded paragraphs (20)
Previous wording
You should read the following discussion and analysis in conjunction with the unaudited condensed consolidated financial statements and the related footnotes thereto appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
You should read the following discussion and analysis in conjunction with the condensed consolidated financial statements and the related footnotes thereto appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG also received approval for BRIUMVI by the European Commission (EC) in the European Union (EU), and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK), for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG continues to actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
Current wording
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
Previous wording
The BRIUMVI approvals were primarily based on the ULTIMATE I and ULTIMATE II Phase 3 trials. Each trial was an independent global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a day 1 infusion of 150mg over four hours and a day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with RMS. These trials were conducted under a special protocol assessment (SPA) with the FDA. The ULTIMATE I and II trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University. Full enrollment was completed in October 2018, with approximately 1,100 subjects enrolled in both studies combined.
Current wording
BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose. BRIUMVI received approval from the FDA primarily based on results from the ULTIMATE I and ULTIMATE II Phase 3 trials. Each trial was an independent global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a day 1 infusion of 150mg over four hours and a day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.
Previous wording
On February 26, 2024, we announced the commercial launch of BRIUMVI in the EU by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany, with additional EU markets expected to follow.
Current wording
On February 26, 2024, we announced the commercial launch of BRIUMVI in the EU by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany, and is now commercially available in several other countries in the European Union, United Kingdom and Switzerland.
Previous wording
In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab in patients with RMS and that patients have been dosed.
Current wording
In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS. In January 2025, at the Annual J.P. Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating subcutaneous ublituximab with an expected dosing frequency of at least every other month.
Previous wording
Product Revenue, Net*.*Product revenue, net was approximately $83.3 million for the three months ended September 30, 2024, compared to $25.1 million for the three months ended September 30, 2023. Product revenue, net for both the three months ended September 30, 2024 and September 30, 2023 consisted of net product sales of BRIUMVI in the United States. In January 2023, we began commercial sales of BRIUMVI within the U.S. following FDA approval.
Current wording
Product Revenue, Net*.*Product revenue, net was approximately $119.7 million for the three months ended March 31, 2025, compared to $50.5 million for the three months ended March 31, 2024. Product revenue, net for both the three months ended March 31, 2025 and March 31, 2024 consisted of net product sales of BRIUMVI in the United States. The increase in product revenue, net is a result of greater market penetration.
Previous wording
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $0.6 million for the three months ended September 30, 2024 and $140.7 million for the three months ended September 30, 2023. License, milestone, royalty and other revenue for the three months ended September 30, 2024 is primarily comprised of consideration received for development and regulatory activities performed on behalf of Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm) in accordance with the Commercialization Agreement with Neuraxpharm (see Note 2 for more information). License, milestone, royalty and other revenue for the three months ended September 30, 2023 is predominantly comprised of recognition of the one-time $140.0 million non-refundable upfront payment under the Commercialization Agreement with Neuraxpharm.
Current wording
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $1.2 million for the three months ended March 31, 2025 and $13.0 million for the three months ended March 31, 2024. License, milestone, royalty and other revenue for the three months ended March 31, 2025 is primarily comprised of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the three months ended March 31, 2024 is predominantly comprised of recognition of the one-time $12.5 million milestone payment under the Commercialization Agreement for the first key market commercial launch of BRIUMVI in the EU.
Previous wording
Cost of Revenue. Cost of revenue for the three months ended September 30, 2024 was $9.3 million compared to approximately $3.5 million for the three months ended September 30, 2023. Cost of revenue for both the three months ended September 30, 2024 and September 30, 2023 consists primarily of third-party manufacturing, distribution, overhead costs and royalties owed to our licensing partner for BRIUMVI sales. A portion of the costs of producing BRIUMVI sold to date was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories. We expect to use the remaining pre-commercialization inventory for product sales through the first quarter of 2025, after which our product gross margin is anticipated to decrease modestly. The cost of revenue for both the three months ended September 30, 2024 and September 30, 2023 includes $0.3 million and $0.7 million, respectively, of costs related to delivering regulatory support and development services to Neuraxpharm in accordance with the Commercialization Agreement.
Current wording
Cost of Revenue. Cost of revenue for the three months ended March 31, 2025 was $15.5 million compared to approximately $5.4 million for the three months ended March 31, 2024. Cost of revenue for both the three months ended March 31, 2025 and March 31, 2024 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold through the middle of the quarter ending March 31, 2025 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We expect the cost of revenue for BRIUMVI to increase modestly in relation to product revenues now that we have depleted these inventories. As a result, we expect that beginning in the second quarter of 2025 our product gross margin as a percentage of product revenue, net is anticipated to decrease modestly by approximately one to two percentage points.
Previous wording
Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $8.0 million for the nine months ended September 30, 2024, as compared to $10.2 million during the comparable period ended September 30, 2023. The decrease in noncash compensation expense was primarily due to decreased vesting of milestone-based grants during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023.
Current wording
Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $3.3 million for the three months ended March 31, 2025, as compared to $2.5 million during the comparable period ended March 31, 2024. The modest increase in noncash compensation expense was primarily due to an increase in headcount and stock price at which equity awards were granted during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024.
Previous wording
Other Research and Development Expense*.*Other research and development expense increased for the three months ended September 30, 2024, by approximately $5.3 million to $17.1 million as compared to the period ended September 30, 2023. The increase in research and development expense during the three months ended September 30, 2024 was primarily due to increased personnel, clinical trial related expenses and manufacturing costs incurred during the period.
Current wording
Other Research and Development Expense*.*Other research and development expense was $43.0 million for the three months ended March 31, 2025, as compared to $30.3 million during the three months ended March 31, 2024. The increase in research and development expense during the three months ended March 31, 2025 was primarily due to an increase in manufacturing expense in connection with our ublituximab subcutaneous development work during the period ended March 31, 2025.
Previous wording
Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $8.7 million for the three months ended September 30, 2024, as compared to $6.3 million during the comparable period ended September 30, 2023. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for grants to executives during the three months ended September 30, 2024.
Current wording
Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $11.7 million for the three months ended March 31, 2025, as compared to $6.9 million during the comparable period ended March 31, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for market based awards during the three months ended March 31, 2025.
Previous wording
Other Selling, General and Administrative Expenses.*** ***Other selling, general and administrative expenses totaled $33.2 million for the three months ended September 30, 2024, as compared to $26.5 million during the comparable period ended September 30, 2023. The increase was primarily due to other selling, general and administrative costs, including personnel, consultants, and third parties associated with the commercialization of BRIUMVI during the three months ended September 30, 2024.
Current wording
Other Selling, General and Administrative Expenses.*** ***Other selling, general and administrative expenses totaled $38.7 million for the three months ended March 31, 2025, as compared to $27.7 million during the comparable period ended March 31, 2024. The increase was primarily due to other selling, general and administrative costs, including personnel, consultants, and third parties associated with the commercialization of BRIUMVI during the three months ended March 31, 2025.
Previous wording
Interest Expense.*** ***Interest expense increased by $7.1 million to $10.8 million for the three months ended September 30, 2024, as compared to $3.7 million for the three months ended September 30, 2023. Interest expense for the three months ended September 30, 2024 is comprised of approximately $4.6 million of debt extinguishment costs pertaining to the First Amendment with Hercules, as well as $4.4 million in interest expense pertaining to the Initial Term Loan with Blue Owl during the same period (see Note 7 for more information).
Current wording
Interest Expense.*** ***Interest expense totaled $6.8 million for the three months ended March 31, 2025, as compared to $2.3 million for the three months ended March 31, 2024. The increase is mainly due to increased interest expense pertaining to the Initial Term Loan with Blue Owl during the period ended March 31, 2025 (see Note 7 - Loan Payable for more information).
Previous wording
Other Income.*** ***Other income totaled $2.7 million for the three months ended September 30, 2024, as compared to $2.9 million during the comparable period ended September 30, 2023.
Current wording
Other Income.*** ***Other income totaled $3.6 million for the three months ended March 31, 2025, as compared to $0.9 million during the comparable period ended March 31, 2024. The increase is mainly due to higher interest income received from our investments during the period.
Previous wording
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates. We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any of our drug candidates.
Current wording
As of March 31, 2025, we had $276.2 million in cash and cash equivalents, and short-term investment securities. We anticipate that our cash, cash equivalents, and investment securities, combined with projected revenues from BRIUMVI in the U.S. and ex-U.S., will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates. We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations.
Previous wording
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:
Current wording
The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:
Previous wording
Cash used in operating activities for the nine months ended September 30, 2024 was $14.9 million as compared to cash used in operating activities of $18.2 million for the nine months ended September 30, 2023. The decrease in net cash used in operating activities was due to greater revenue during the nine months ended September 30, 2024, offset by higher operating expenditures and an increase in cash used for inventory purchases during the same period.
Current wording
Cash used in operating activities for the three months ended March 31, 2025 was $28.7 million as compared to cash used in operating activities of $8.2 million for the three months ended March 31, 2024. The increase in net cash used in operating activities was due to an increase in accounts receivable during the three months ended March 31, 2025, and an increase in cash used for inventory purchases during the same period, partially offset by lower operating expenditures.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2024 was $16.8 million as compared to $5.9 million used in investing activities for the nine months ended September 30, 2023. The increase in net cash used in investing activities was primarily due to increased investment in short-term securities during the nine months ended September 30, 2024.
Current wording
Net cash used in investing activities for the three months ended March 31, 2025 was $12.9 million as compared to $9.3 million used in investing activities for the three months ended March 31, 2024. The increase in net cash used in investing activities was primarily due to increased investment in short-term securities during the three months ended March 31, 2025.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $134.6 million as compared to net cash provided by financing activities of $72.7 million for the nine months ended September 30, 2023. The increase in net cash provided by financing activities during the nine months ended September 30, 2024 is mainly due to the proceeds from the new loan with Blue Owl, offset by the payoff of our prior loan with Hercules.
Current wording
Net cash used in financing activities for the three months ended March 31, 2025 was approximately $6.1 million as compared to net cash provided by financing activities of approximately zero for the three months ended March 31, 2024. The increase in net cash used in financing activities during the three months ended March 31, 2025 is mainly due to the repurchase of stock under our share repurchase program.
Previous wording
A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a description of our significant accounting policies, refer to “Part II, Item 8. Financial Statements and Supplementary Data, Note 1 – Organization and Summary of Significant Accounting Policies”** **in our Annual Report on Form 10-K for the year ended December 31, 2023, and refer to Note 1 in this Quarterly Report on Form 10-Q for significant accounting policies due to commercialization for revenue recognition, gross-to-net sales adjustments, accounts receivable, inventory, and cost of revenue. Of these policies, the following are considered critical to an understanding of our Unaudited Condensed Consolidated Financial Statements as they require the application of the most difficult, subjective and complex judgments: stock-based compensation expenses, and fair value measurement of financial liabilities. Refer to “Note 2 – Revenue”, “Note 5 – Fair Value Measurements” and “Note 6 – Stockholders’ Equity” respectively, for more information.
Current wording
A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a description of our significant accounting policies, refer to “Part II, Item 8. Financial Statements and Supplementary Data, Note 1 – Organization and Summary of Significant Accounting Policies”** **in our Annual Report on Form 10-K for the year ended December 31, 2024, and refer to Note 1 - Organization and Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q for significant accounting policies due to commercialization for revenue recognition, gross-to-net sales adjustments, accounts receivable, inventory, and cost of revenue. Of these policies, the following are considered critical to an understanding of our condensed consolidated financial statements as they require the application of the most difficult, subjective and complex judgments: revenue recognition and stock-based compensation expenses. Refer to Note 2 – Revenue and Note 6 – Stockholders’ Equity respectively, in this Quarterly Report on Form 10-Q for more information.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $3.0 million for the three months ended September 30, 2024, as compared to $2.9 million during the comparable period ended September 30, 2023.
Previous report — wording carried elsewhere
The following table summarizes the results of operations for the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $14.4 million for the nine months ended September 30, 2024 compared to approximately $140.8 million for the nine months ended September 30, 2023. License, milestone, royalty and other revenue for the nine months ended September 30, 2024 is comprised of a $12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the EU, as well as consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. License, milestone, royalty and other revenue for the nine months ended September 30, 2023 is predominantly comprised of recognition of the one-time $140.0 million non-refundable upfront payment under the Commercialization Agreement with Neuraxpharm (see Note 2 for more information).
Previous report — wording carried elsewhere
Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $22.6 million for the nine months ended September 30, 2024, as compared to $18.4 million during the comparable period ended September 30, 2023. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for grants to executives during the nine months ended September 30, 2024.
Previous report — wording carried elsewhere
Other Selling, General and Administrative Expenses.*** ***Other selling, general and administrative expenses totaled $92.7 million for the nine months ended September 30, 2024, as compared to $73.2 million during the comparable period ended September 30, 2023. The increase was primarily due to other selling, general and administrative costs, including personnel, consultants, and third parties associated with the commercialization of BRIUMVI during the nine months ended September 30, 2024.