TG THERAPEUTICS INC

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, 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.

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), the Medicines and Healthcare Products Regulatory Agency (MHRA), Swissmedic, and Australia’s Therapeutic Goods Administration (TGA) 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

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.

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 BRIUMVI (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 December 28, 2022, we announced the FDA approval of BRIUMVI for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, primarily based on results from the ULTIMATE I & II Phase 3 trials. On January 26, 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients and the first RMS patient received a BRIUMVI infusion on February 1, 2023.

Current wording

In December 2022, we announced the FDA approval of BRIUMVI for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, primarily based on results from the ULTIMATE I & II Phase 3 trials. On January 26, 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients.

Previous wording

On June 1, 2023, we announced that the EC granted approval of BRIUMVI for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein.

Current wording

In June 2023, we announced that the EC granted approval of BRIUMVI for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein.

Previous wording

On August 1, 2023, we announced an agreement with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-U.S. commercialization of BRIUMVI (Commercialization Agreement). Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million, and $12.5 million upon launch in the first EU country (February 2024) and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%. In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in territories outside the U.S., Canada and Mexico, which are retained by TG, and excluding certain Asian countries of which the Company previously partnered. We retain an option to buy back all rights under the Commercialization Agreement for a period of two years in the event of a change in control of TG.

Current wording

In August 2023, we announced an agreement with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-U.S. commercialization of BRIUMVI (Commercialization Agreement). Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million, and $12.5 million upon launch in the first EU country (February 2024) and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%. In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in territories outside the U.S., Canada and Mexico, which are retained by TG, and excluding certain Asian countries of which the Company previously partnered.

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, and is now commercially available in several other countries in the European Union, United Kingdom and Switzerland.

Current wording

In February 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, and United Kingdom. BRIUMVI is now also approved in Switzerland and Australia.

Previous 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.

Current wording

In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous BRIUMVI (ublituximab) in patients with RMS.

Previous wording

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 wording

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 minimize 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. In August 2025, we announced the first patient with progressive multiple sclerosis has been dosed with azer-cel in a Phase 1 trial.

Previous 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.

Current wording

Product Revenue, Net*.*Product revenue, net was approximately $138.8 million for the three months ended June 30, 2025, compared to $72.6 million for the three months ended June 30, 2024. Product revenue, net for both the three months ended June 30, 2025 and June 30, 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

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.

Current wording

Cost of Revenue. Cost of revenue for the three months ended June 30, 2025 was $18.9 million compared to approximately $8.3 million for the three months ended June 30, 2024. Cost of revenue for both the three months ended June 30, 2025 and June 30, 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 during the quarter ending June 30, 2024 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 depleted these inventories during the quarter ending March 31, 2025; therefore, the cost of revenue for BRIUMVI increased modestly in relation to product revenues during the three months ended June 30, 2025.

Previous 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.

Current wording

Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $4.3 million for the three months ended June 30, 2025, as compared to $2.5 million during the comparable period ended June 30, 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 June 30, 2025, as compared to the three months ended June 30, 2024.

Previous 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.

Current wording

Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $12.0 million for the three months ended June 30, 2025, as compared to $7.0 million during the comparable period ended June 30, 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 June 30, 2025.

Previous 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.

Current wording

Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $43.5 million for the three months ended June 30, 2025, as compared to $31.8 million during the comparable period ended June 30, 2024. The increase was primarily due to other selling, general and administrative costs, including marketing personnel and external costs associated with the commercialization of BRIUMVI during the three months ended June 30, 2025.

Previous 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).

Current wording

Interest Expense. Interest expense totaled $6.7 million for the three months ended June 30, 2025, as compared to $4.0 million for the three months ended June 30, 2025. The increase is mainly due to increased interest expense pertaining to the Initial Term Loan with Blue Owl during the period ended June 30, 2025 (see Note 7 - Loan Payable for more information).

Previous 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.

Current wording

Other Income.*** ***Other income totaled $2.8 million for the three months ended June 30, 2025, as compared to $1.7 million during the comparable period ended June 30, 2024. The increase is mainly due to higher interest income received from our investments during the period.

Previous 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.

Current wording

License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $3.5 million for the six months ended June 30, 2025 and $13.9 million for the six months ended June 30, 2024. License, milestone, royalty and other revenue for the six months ended June 30, 2025 is primarily comprised $1.8 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $1.7 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the six months ended June 30, 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

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.

Current wording

Other Research and Development Expense*.*Other research and development expense was $70.5 million for the six months ended June 30, 2025, as compared to $45.3 million during the six months ended June 30, 2024. The increase in research and development expense during the six months ended June 30, 2025 was primarily due to an increase in manufacturing expense in connection with our ublituximab subcutaneous development work during the period ended June 30, 2025.

Previous wording

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.

Current wording

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 February 2024. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability. During the six months ended June 30, 2025, we generated $262.0 million in revenue. 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 June 30, 2025, we have an accumulated deficit of approximately $1.5 billion.

Previous 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.

Current wording

As of June 30, 2025, we had $278.9 million in cash and cash equivalents, and investment securities. We anticipate that our cash, cash equivalents, and investment securities, combined with projected future revenues 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 three months ended March 31, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:

Previous 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.

Current wording

Cash used in operating activities for the six months ended June 30, 2025 was $21.3 million as compared to cash used in operating activities of $2.7 million for the six months ended June 30, 2024. The increase in net cash used in operating activities was due to an increase in accounts receivable during the six months ended June 30, 2025 and inventory purchases during the same period, partially offset by increase in accounts payable.

Previous 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.

Current wording

Net cash used in investing activities for the six months ended June 30, 2025 was $16.9 million as compared to $7.5 million used in investing activities for the six months ended June 30, 2024. The increase in net cash used in investing activities was primarily due to lower maturities of short-term securities during the six months ended June 30, 2025.

Previous 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.

Current wording

Net cash used in financing activities for the six months ended June 30, 2025 was approximately $12.5 million as compared to net cash provided by financing activities of $0.1 million for the six months ended June 30, 2024. The increase in net cash used in financing activities during the six months ended June 30, 2025 is mainly due to the repurchase of stock under our share repurchase program.