10q10k10q10k.net

What changed in TG THERAPEUTICS, INC.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of TG THERAPEUTICS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+872 added−799 removedSource: 10-K (2026-02-27) vs 10-K (2025-03-03)

Top changes in TG THERAPEUTICS, INC.'s 2025 10-K

872 paragraphs added · 799 removed · 598 edited across 3 sections

Item 1. Business

Business — how the company describes what it does

67 edited+22 added−33 removed154 unchanged
Biggest changeSTRATEGY As a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include: ● Successfully commercializing BRIUMVI in the U.S. for RMS; ● Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases; ● Continuing to expand our pipeline with mechanisms of importance to B-cell mediated diseases; ● Evaluating potential strategic collaborations to maximize the value of our programs and B-cell directed platform; and ● Maintaining our “patient first” culture as we grow our business. ​ Our Approach and Platform ​ Our approach to drug development is centered on developing therapies for B-cell mediated diseases.
Biggest changeSTRATEGY As a fully-integrated, commercial stage biotechnology company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include: ● Successfully commercializing BRIUMVI in the U.S. for RMS and submitting for FDA approval a simplified dosing schedule for IV BRIUMVI in the U.S.; ● Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases; ● Developing and seeking FDA approval of subcutaneous form of BRIUMVI (ublituximab); ● Identifying additional areas to expand the use of BRIUMVI beyond MS; ● Continuing to expand our pipeline with mechanisms of importance to B-cell mediated diseases; ● Evaluating the potential of azer-cel to treat patients with B-cell mediated diseases, including progressive forms of multiple sclerosis; and ● Maintaining our “patient first” culture as we grow our business. ​ Our Approach and Platform ​ Our approach to drug development is centered on developing therapies for B-cell mediated diseases.
If our manufacturing partners are inspected and deemed out of compliance with cGMPs, product recalls could result, inventory could be destroyed, production could be stopped, and supplies could be delayed or otherwise disrupted. ​ If we need to change manufacturers after commercialization, the FDA and corresponding foreign regulatory agencies may need to approve these new manufacturers in advance, which will involve testing, regulatory submissions, and additional inspections to ensure compliance with FDA regulations and standards and may require significant lead times and delay.
If our manufacturing partners are inspected and deemed out of compliance with cGMPs, product recalls could result, inventory could be destroyed, production could be stopped, and supplies could be delayed or otherwise disrupted. ​ If we need to change or add manufacturers after commercialization, the FDA and corresponding foreign regulatory agencies will need to approve these new manufacturers in advance, which will involve testing, regulatory submissions, and additional inspections to ensure compliance with FDA regulations and standards and may require significant lead times and delay.
BRIUMVI received approval by the FDA on December 28, 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.
BRIUMVI received approval by the FDA in December 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.
The FTC's guidance for appropriately securing consumers' personal information is similar to what is required under HIPAA. ​ 22 Table of Contents In addition, we may be subject to state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts.
The FTC's guidance for appropriately securing consumers' personal information is similar to what is required under HIPAA. 16 Table of Contents In addition, we may be subject to state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts.
The procedures and requirements for BTD are similar to those required for Fast Track such that the Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases, however, with BTD, there is a further requirement that the sponsor present “preliminary clinical evidence” which “indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. ​ Sponsors of drugs granted Fast Track or breakthrough therapy designation also may seek approval under the FDA’s accelerated approval regulations.
The procedures and requirements for BTD are similar to those required for Fast Track such that the Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases, however, with BTD, there is a further requirement that the sponsor present “preliminary clinical evidence” which “indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. ​ 13 Table of Contents Sponsors of drugs granted Fast Track or breakthrough therapy designation also may seek approval under the FDA’s accelerated approval regulations.
We have a number of issued patents and pending patent applications related to our compounds and other technology, but we cannot guarantee the scope of protection of the issued patents, or that such patents will survive a validity or enforceability challenge, or that any of the pending patent applications will issue as patents. 9 Table of Contents Generally, patent applications in the U.S. are maintained in secrecy for a period of 18 months or more.
We have a number of issued patents and pending patent applications related to our compounds and other technology, but we cannot guarantee the scope of protection of the issued patents, or that such patents will survive a validity or enforceability challenge, or that any of the pending patent applications will issue as patents. 8 Table of Contents Generally, patent applications in the U.S. are maintained in secrecy for a period of 18 months or more.
Our telephone number is 1-877-575-TGTX(8489), and our e-mail address is info@tgtxinc.com. We maintain a website with the address www.tgtherapeutics.com and maintain various social media accounts, including but not limited to X (formerly Twitter) and LinkedIn. We also maintain websites related to BRIUMVI, including but not limited to www.BRIUMVI.com, and www.BRIUMVIPATIENTSUPPORT.com.
Our telephone number is 1-877-575-TGTX(8489), and our e-mail address is info@tgtxinc.com. We maintain a corporate website with the address www.tgtherapeutics.com, a website with the address www.NextinMS, and various social media accounts, including but not limited to X (formerly Twitter) and LinkedIn. We also maintain websites related to BRIUMVI, including but not limited to www.BRIUMVI.com, and www.BRIUMVIPATIENTSUPPORT.com.
Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. We commercially launched BRIUMVI in the U.S. on January 26, 2023, making it available to physicians and patients. In August 2023, we entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.
Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. We commercially launched BRIUMVI in the U.S. in January 2023, making it available to physicians and patients. In August 2023, we entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.
Commercialization of BRIUMVI (ublituximab-xiiy) ​ On December 28, 2022, BRIUMVI received approval by the FDA for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
Commercialization of BRIUMVI (ublituximab-xiiy) ​ In December 2022, BRIUMVI received approval by the FDA for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. ​ 16 Table of Contents Product Development and Applications for Marketing Authorization ​ The regulatory review and approval process is lengthy, expensive, and uncertain.
The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. ​ 12 Table of Contents Product Development and Applications for Marketing Authorization ​ The regulatory review and approval process is lengthy, expensive, and uncertain.
The majority of states also have anti-kickback laws, which establish similar prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers. ​ 21 Table of Contents In addition, the civil False Claims Act prohibits, among other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S. government.
The majority of states also have anti-kickback laws, which establish similar prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers. In addition, the civil False Claims Act prohibits, among other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S. government.
BRIUMVI received approval by the FDA on December 28, 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
BRIUMVI received approval by the FDA in December 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and may require the implementation of other risk management measures. ​ From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA.
Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and may require the implementation of other risk management measures. ​ 14 Table of Contents From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA.
Both studies met their primary endpoint of significantly reducing ARR over a 96-week period (p ​On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.
Both studies met their primary endpoint of significantly reducing ARR over a 96-week period (p ​In August 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.
Our earliest in time patent family relates to compositions of matter for ublituximab, which have issued in the U.S., Europe and other jurisdictions, including Australia, Canada, China, Japan, Korea and India.
Our earliest in time patent family relates to compositions of matter for ublituximab, which have issued in the U.S., Europe and other jurisdictions, including Australia, Brazil, Canada, China, Israel, Japan, Korea and India.
Our commercial manufacturing partners have a limited number of facilities in which our product candidates can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Our third-party manufacturers will have other clients and may have other priorities that could affect their ability to perform the work satisfactorily and/or on a timely basis.
Our third-party manufacturing partners operate a limited number of facilities in which our product can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Additionally, our third-party manufacturers will have other clients and may have other priorities that could affect their ability to perform the work satisfactorily and/or on a timely basis.
It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be. ​ 19 Table of Contents Should we wish to market our products outside the U.S., we must receive marketing authorization from the appropriate foreign regulatory authorities.
It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be. ​ Should we wish to market our products outside the U.S., we must receive marketing authorization from the appropriate foreign regulatory authorities.
Both of these occurrences would be beyond our control. ​ We expect to similarly rely on contract manufacturing relationships for any products that we may in-license or acquire in the future.
All of these occurrences would be beyond our control. ​ We expect to similarly rely on contract manufacturing relationships for any products that we may in-license or acquire in the future.
It is estimated that nearly 1 million people are living with MS in the United States and over 2.3 million people world-wide are living with MS. ​​ OUR PRODUCTS We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development.
It is estimated that nearly 1 million people are living with MS in the United States and over 2.3 million people world-wide are living with MS. ​​ 6 Table of Contents OUR PRODUCTS We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development.
The expected expiration for the composition of matter patent in the U.S. is 2029 and in Europe and other non-U.S. jurisdictions, exclusive of patent term extensions which could result in later expiration dates, is 2025.
The expected expiration for the composition of matter patent in the U.S. is 2029, exclusive of patent term extension, which could result in later expiration date, and in Europe and other non-U.S. jurisdictions, exclusive of patent term extensions which could result in later expiration dates, is 2025.
To receive Fast Track designation, an applicant must demonstrate: ● that the drug is intended to treat a serious or life-threatening condition; and ● that nonclinical or clinical data demonstrate the potential to address an unmet medical need. ​ 17 Table of Contents The FDA must respond to a request for Fast Track designation within 60 calendar days of receipt of the request.
To receive Fast Track designation, an applicant must demonstrate: ● that the drug is intended to treat a serious or life-threatening condition; and ● that nonclinical or clinical data demonstrate the potential to address an unmet medical need. The FDA must respond to a request for Fast Track designation within 60 calendar days of receipt of the request.
To attract qualified candidates, the Company offers an attractive total rewards package, consisting of base salary, cash bonus, a comprehensive benefit package, equity compensation, and 401(k) plan. Bonus opportunities and equity compensation increase as a percentage of total compensation based on level of responsibility, and actual bonus awards are based on performance. ​ 23 Table of Contents
To attract qualified candidates, the Company offers an attractive total rewards package, consisting of base salary, cash bonus, a comprehensive benefit package, equity compensation, and 401(k) plan. Bonus opportunities and equity compensation increase as a percentage of total compensation based on level of responsibility, and actual bonus awards are based on performance.
Late-Stage Clinical Development of Ublituximab-xiiy ULTIMATE I & II Trials Evaluating Single Agent Ublituximab in RMS ULTIMATE I and ULTIMATE II are two independent Phase 3 trials.
Late-Stage Clinical Development of Ublituximab-xiiy ULTIMATE I & II Trials Evaluating Single Agent Ublituximab in RMS ULTIMATE I and ULTIMATE II were two independent Phase 3 trials.
Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study evaluating the efficacy and safety/tolerability of ublituximab-xiiy (450mg dose administered by one hour intravenous infusion every six months, following a Day 1 infusion of 150mg over four hours, and a Day 15 infusion of 450mg over one hour) to teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.
Each trial was a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study that evaluated the efficacy and safety/tolerability of ublituximab-xiiy (450mg dose administered by one hour intravenous infusion every six months, following a day 1 infusion of 150mg over four hours, and a day 15 infusion of 450mg over one hour) to teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.
We expect that additional state healthcare reform measures will be adopted in the future, which could limit the amounts that state governments will pay for healthcare products and services and result in additional pricing pressures. In addition, in some foreign countries, the proposed pricing for a prescription drug must be approved before the drug may be lawfully marketed.
We expect that additional state healthcare reform measures will be adopted in the future, which could limit the amounts that state governments will pay for healthcare products and services and result in additional pricing pressures. 15 Table of Contents In addition, in some foreign countries, the proposed pricing for a prescription drug must be approved before the drug may be lawfully marketed.
As with any supply program, obtaining materials of sufficient quality and quantity to meet the requirements of the market demand for BRIUMVI and our ublituximab development programs cannot be guaranteed and we cannot ensure that we will be successful in this endeavor. ​ To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products.
As with any supply program, obtaining materials of sufficient quality and quantity to meet the requirements of the market demand for BRIUMVI and our development programs cannot be guaranteed and we cannot ensure that we will be successful in these endeavors. ​ To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products.
On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.
In February 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.
(Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, for the ex-U.S. commercialization of BRIUMVI. On February 26, 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries in the European Union and the United Kingdom.
(Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, for the ex-U.S. commercialization of BRIUMVI. In February 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries outside of the U.S.
The following table summarizes the current status for our lead drug candidates as of February 2025.
The following table summarizes the current status for our lead drug candidates as of February 2026.
Furthermore, European data protection authorities may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in or from the European Union or United Kingdom. ​ Human Capital ​ As of February 25, 2025, we had 338 employees.
Furthermore, European data protection authorities may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in or from the European Union or United Kingdom. ​ Human Capital ​ As of February 20, 2026, we had 399 employees.
ITEM 1. BUSINESS. OVERVIEW TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases. TG has received approval from the U.S.
ITEM 1. BUSINESS. OVERVIEW TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S.
We also file patent applications directed to novel combinations of our drugs together and with drugs developed by others. The intellectual property portfolios for our most advanced drug candidates as of February 2025 are summarized below. Each of these portfolios contains one or more pending patent applications covering our products and product candidates and uses and combinations thereof.
We also file patent applications directed to novel combinations of our drugs together and with drugs developed by others. A summary of our intellectual property portfolios for our most advanced drug candidates is included below. Each of these portfolios contains one or more pending patent applications covering our products and product candidates and uses and combinations thereof.
In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada and Mexico, the commercialization rights for which had been previously retained by TG, thus excluding certain Asian countries subject to previously existing partnerships.
In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada and Mexico, the commercialization rights for which had been previously retained by TG, thus excluding certain Asian countries subject to previously existing partnerships. In February 2024, we announced the commercial launch of BRIUMVI in the European Union (EU).
This may be the case with respect to our pending patent applications referred to below. ​ 11 Table of Contents BRIUMVI (ublituximab-xiiy) Pursuant to our license for ublituximab with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusive commercial rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as a non-exclusive license to additional background patent rights.
BRIUMVI (ublituximab-xiiy) Pursuant to our license for ublituximab with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusive commercial rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as a non-exclusive license to additional background patent rights.
Clinical Drug Candidate: (molecular target) Initial Target Disease Stage of Development Ublituximab IV (anti-CD20 mAb) RMS APPROVED Ublituximab Subcutaneous (anti-CD20 mAb) RMS Phase 1 trial Azer-cel Auto-immune disorders Phase 1 ​BRIUMVI (ublituximab-xiiy) Overview 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.
Clinical Drug Candidate: (molecular target) Initial Target Disease Stage of Development Ublituximab IV (anti-CD20 mAb) RMS APPROVED Ublituximab IV Simplified Dosing Schedule RMS Phase 3 completed enrollment Ublituximab Subcutaneous (anti-CD20 mAb) RMS Phase 3 enrolling Azer-cel Progressive Forms of Multiple Sclerosis Phase 1 enrolling ​BRIUMVI (ublituximab-xiiy) Overview 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 was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries in the European Union and the United Kingdom. Subcutaneous Ublituximab Overview 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.
BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries outside the U.S. Subcutaneous Ublituximab Overview In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS.
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. As of December 31, 2024, we have incurred expenses of approximately $31.0 million related to milestones in accordance with the terms of the LFB License Agreement.
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. From the inception of the LFB License Agreement, we incurred expenses of approximately $31.0 million related to the achievement of certain milestones under the LFB License Agreement.
We also have patent applications pending in this family in the U.S., Argentina, the EU, Taiwan, United Arab Emirates, Australia, Brazil, Canada, China, Hong Kong, Israel, India, Japan, Korea, Kuwait, Mexico, and Saudi Arabia.
We also have patent applications pending in this family in the U.S., Argentina, the EU, Taiwan, United Arab Emirates, Australia, Brazil, Canada, China, Hong Kong, Israel, India, Japan, Korea, Kuwait, Mexico, and Saudi Arabia. A further family of patents, presently in the PCT phase, relates to formulations for subcutaneous administration.
If we were to experience any such delay that would negatively impact our business and timeline to commercialization of any of our drug candidates affected by such manufacturing issue. ​ 18 Table of Contents Post-Approval Requirements ​ Any products for which we receive FDA approval are subject to continuing regulation by the FDA and other federal and state regulators on a wide range of matters, including, among other things cGMPs and product quality, pharmacovigilance and reporting of adverse events, product distribution requirements, fulfilling post-marketing or confirmatory study or REMS commitments, and complying with FDA promotion and advertising requirements.
Post-Approval Requirements ​ Any products for which we receive FDA approval are subject to continuing regulation by the FDA and other federal and state regulators on a wide range of matters, including, among other things cGMPs and product quality, pharmacovigilance and reporting of adverse events, product distribution requirements, fulfilling post-marketing or confirmatory study or REMS commitments, and complying with FDA promotion and advertising requirements.
The license agreement includes non-exclusive rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as non-exclusive rights to additional background patent rights.
The license agreement includes non-exclusive rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as non-exclusive rights to additional background patent rights. These patents and patent applications include composition of matter patents relating to azer-cel, as well as method of use patents which cover use of azer-cel.
For those patents, prosecution is in progress. Prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO is often significantly narrowed by the time they issue, if they issue at all.
For those patents, prosecution is in progress. Prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO is often significantly narrowed by the time they issue, if they issue at all. This may be the case with respect to our pending patent applications referred to below.
These patents and patent applications include composition of matter patents relating to azer-cel, as well as method of use patents which cover use of azer-cel. ​ 12 Table of Contents Limitations on Patent Rights and Trade Secrets ​ The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third parties from competing against us if we obtain regulatory approval to market these product candidates.
Limitations on Patent Rights and Trade Secrets ​ The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third parties from competing against us if we obtain regulatory approval to market these product candidates.
These data demonstrate that 92% of patients with RMS were free from disability progression after five years of BRIUMVI 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. 7 Table of Contents ENHANCE Phase 3b Trial The ENHANCE Phase 3b trial is an ongoing, multi-center, open-label study designed to evaluate alternative dosing regimens for BRIUMVI in patients with RMS.
These data demonstrate that 92% of patients with RMS were free from disability progression after five years of BRIUMVI 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.
Litigation and legislation over the Affordable Care Act are likely to continue, with unpredictable and uncertain results, and the new U.S. administration and recent congressional seat turnover may result in increased regulatory and economic uncertainty with respect to the Affordable Care Act. ​ 20 Table of Contents The Inflation Reduction Act of 2022 (the IRA) includes, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms, such as requiring manufacturers of certain drugs to engage in price negotiations with Medicare beginning in 2026, imposing rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replacing the Part D coverage gap discount program with a new discounting program beginning in 2025.
The Inflation Reduction Act of 2022 (the IRA) includes, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms, such as requiring manufacturers of certain drugs to engage in price negotiations with Medicare beginning in 2026, imposing rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replacing the Part D coverage gap discount program with a new discounting program beginning in 2025.
Azer-Cel (allogeneic CD19 CAR T) Pursuant to our license agreement with Precision, we have an exclusive license to develop and commercialize Precision’s azer-cel for the treatment of autoimmune and other non-oncology diseases and conditions as well as a non-exclusive license to manufacture azer-cel.
During this 12-year period, which extends until December 2034, a biosimilar product that references our BRIUMVI product cannot be approved. ​ Azer-Cel (allogeneic CD19 CAR T) Pursuant to our license agreement with Precision, we have an exclusive license to develop and commercialize Precision’s azer-cel for the treatment of autoimmune and other non-oncology diseases and conditions as well as a non-exclusive license to manufacture azer-cel.
Additionally, proof that a competitor contributes to or induces infringement of a patented method of use by another can also prove difficult because an off-label use of a product could prohibit a finding of contributory infringement, and inducement of infringement requires proof of intent by the competitor.
Additionally, proof that a competitor contributes to or induces infringement of a patented method of use by another can also prove difficult because an off-label use of a product could prohibit a finding of contributory infringement, and inducement of infringement requires proof of intent by the competitor. 10 Table of Contents LICENSING AGREEMENTS AND COLLABORATIONS We have formed strategic alliances with a number of companies for the manufacture and commercialization of our products.
We currently do not have any manufacturing capabilities of our own. We have established a contract manufacturing relationship for the commercial supply of BRIUMVI with Samsung Biologics.
SUPPLY AND MANUFACTURING ​ We currently do not have any manufacturing capabilities of our own and we rely on third-party contract manufacturers for the clinical and commercial supply of our products. We have established a contract manufacturing relationship with Samsung Biologics for our primary clinical and commercial supply of BRIUMVI, and a secondary contract manufacturing relationship with FUJIFILM Diosynth Biotechnologies.
Food and Drug Administration (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 in Europe and the United Kingdom (UK), respectively.
Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. 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. Business Highlights Commercialization of BRIUMVI 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.
Commercialization of BRIUMVI 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.
Given the long lead times and cost of establishing additional commercial manufacturing sites we expect that we will rely on single contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for many years.
However, due to the long lead times and costs associated with establishing and qualifying additional commercial manufacturing sites, we expect to rely on a limited number of contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for the foreseeable future.
Our most recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions. This family includes four issued U.S. patents and two pending U.S. applications.
More recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions.
Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug and have been filed for and granted in certain European Patent (EP) countries. 10 Table of Contents Also, under the Hatch-Waxman Act, drugs that are new chemical entities (NCEs) are eligible for a five-year period of marketing exclusivity in the United States.
Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug and have been filed for and granted in certain European Patent (EP) countries.
The objectives of the BPCIA are conceptually similar to those of the Hatch-Waxman Act. The implementation of an abbreviated approval pathway for biosimilar products is under the direction of the FDA. Since the enactment of the BPCIA, the FDA has issued guidance on biosimilars, addressing scientific, quality and procedural issues relevant to an abbreviated application for a biosimilar product.
The objectives of the BPCIA are conceptually similar to those of the Hatch-Waxman Act. The implementation of an abbreviated approval pathway for biosimilar products is under the direction of the FDA.
In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS.
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 had been dosed with azer-cel in a Phase 1 trial.
Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA). ​The Company’s current focus is on MS. 6 Table of Contents Multiple Sclerosis Overview RMS is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses.
Multiple Sclerosis Overview RMS is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses.
The resulting changes in standard of care can impact the likelihood of regulatory accelerated approval opportunities for our drug candidates. ​ For BRIUMVI, there are a number of established therapies with which we will compete: ● We expect BRIUMVI will primarily compete against other iv CD20-targeted agents, while the group of CD20-targeted agents will also compete broadly against a number of already approved MS therapies.
The resulting changes in standard of care can impact the likelihood of regulatory accelerated approval opportunities for our drug candidates. ​ 11 Table of Contents ​ For BRIUMVI, there are a number of established therapies with which we compete: ● Currently, BRIUMVI directly competes with ocrelizumab, the only other approved intravenously administered anti-CD20 monoclonal antibody (Roche Holdings AG).
Many of our competitors have significantly greater capital resources, larger research and development staffs and facilities and greater experience in drug development, regulation, manufacturing and marketing than we do. These organizations also compete with us to recruit qualified personnel, attract partners for joint ventures or other collaborations, and license technologies that are competitive with ours.
These organizations also compete with us to recruit qualified personnel, attract partners for joint ventures or other collaborations, and license technologies that are competitive with ours.
In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab. 5 Table of Contents ​ CORPORATE INFORMATION We were incorporated in Delaware in 1993. Our executive offices are located at 3020 Carrington Mill Blvd, Suite 475, Morrisville, North Carolina, 27560.
There were no repurchases under the 2025 Share Repurchase Program during the three and twelve months ended December 31, 2025. 5 Table of Contents ​ CORPORATE INFORMATION We were incorporated in Delaware in 1993. Our executive offices are located at 3020 Carrington Mill Blvd, Suite 475, Morrisville, North Carolina, 27560.
With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein. On August 1, 2023, we entered into a Commercialization Agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the ex-US commercialization of BRIUMVI.
In January 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients. Ex-U.S. Commercialization of BRIUMVI In August 2023, we entered into a Commercialization Agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the ex-U.S. commercialization of BRIUMVI.
Data from this trial were presented at the 2021 American Society of Hematology (ASH) annual meeting. 8 Table of Contents Azercabtagene Zapreleucel (azer-cel) Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by the Company for autoimmune diseases.
In February 2026, we announced the trial is more than approximately 75% enrolled. Azercabtagene Zapreleucel (azer-cel) Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by the Company for autoimmune diseases.
In the U.S., the Biologics Price Competition and Innovation Act provides that BRIUMVI is eligible for 12 years of market exclusivity from the date of BRIUMVI’s U.S. approval. During this 12-year period a biosimilar product that references our BRIUMVI product cannot be approved. ​ TG-1701 (BTK inhibitor) ​ Pursuant to our license agreement with Jiangsu Hengrui Medicine Co.
In the U.S., the Biologics Price Competition and Innovation Act provides that BRIUMVI is eligible for 12 years of market exclusivity from the date of BRIUMVI’s U.S. approval, which was granted in December 2022.
Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies that are active in different but related fields represent substantial competition for us.
In addition, companies that are active in different but related fields represent substantial competition for us. Many of our competitors have significantly greater capital resources, larger research and development staffs and facilities and greater experience in drug development, regulation, manufacturing and marketing than we do.
In August 2024, we announced FDA clearance of the Investigational New Drug Application (IND) for azer-cel for the treatment of progressive forms of multiple sclerosis. In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS and in January 2025, at the Annual J.P.
Pipeline Development In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab. In August 2025, we announced the first patient with progressive multiple sclerosis has been dosed with azer-cel in a Phase 1 trial.
Some of these diseases may not be antibody mediated but may still result from aberrant activity of B-cells.
Some of these diseases may not be antibody mediated but may still result from aberrant activity of B-cells. Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA). ​The Company’s primary focus is on MS.
Many drug approvals have been delayed due to issues at contract manufacturing facilities.
Many drug approvals have been delayed due to issues at contract manufacturing facilities. If we were to experience any such delay that would negatively impact our business and timeline to commercialization of any of our drug candidates affected by such manufacturing issue.
As of December 2024, the FDA had approved 60 biosimilar products. ​ Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.
Since the enactment of the BPCIA, the FDA has issued guidance on biosimilars, addressing scientific, quality and procedural issues relevant to an abbreviated application for a biosimilar product. ​ 9 Table of Contents Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.
The Company has also agreed to make certain payments to Precision’s licensors during the term of our license agreement with Precision. UKONIQ (umbralisib) In September 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the Umbralisib License) with Rhizen Pharmaceuticals, S A (Rhizen) for the development and commercialization of umbralisib.
The Company has also agreed to make certain payments to Precision’s licensors during the term of our license agreement with Precision. COMPETITION ​ Competition in the pharmaceutical and biotechnology industries is intense. Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions.
Removed
Pipeline Expansion and Development On January 9, 2024, we entered into an agreement with Precision BioSciences, Inc. (Precision) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic (off the shelf) CAR T program.
Added
We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
Removed
Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating a subcutaneous ublituximab with an expected dosing frequency of at least every other month.
Added
Business Highlights Next In MS ™ Platform Launch in Collaboration with Christina Applegate ● Announced collaboration with Christina Applegate to raise awareness of multiple sclerosis (MS) via a Super Bowl LX commercial ● Launched, Next In MS™, a platform designed to foster honest, real-world conversations about life with MS—featuring unfiltered dialogue, including discussions with Christina Applegate—and to support people living with MS in continuing those conversations with family, friends, and healthcare professionals on their own terms.
Removed
The first data from the ENHANCE trial were presented at the 2023 ECTRIMS annual meeting and updated data were also presented at the 2024 ECTRIMS annual meeting and most recently at the Americas Committee for Treatment and Research (ACTRIMS) annual meeting held in February of 2025.
Added
In September 2025, we announced enrollment commenced in the Phase 3 pivotal program evaluating subcutaneous ublituximab. The Phase 3 pivotal program is a randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous ublituximab compared to IV BRIUMVI in adult participants with RMS.
Removed
These data showed rapid 30-minute infusions of BRIUMVI were well tolerated in patients with RMS and infusion related reactions in these patients were generally mild and resolved completely.
Added
Participants will be randomized into one of three arms: 8-week regimen of subcutaneous ublituximab, 12-week regimen of subcutaneous ublituximab or the currently approved IV BRIUMVI dosing schedule. The primary endpoint of the trial is non inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI with respect to area under the curve (AUC) at week 24.
Removed
The data also demonstrated that RMS patients who are already B-cell depleted were able to switch from a prior anti-CD20 therapy directly to a full 450 mg dose of BRIUMVI administered in 1 hour as an initial infusion, without a 150 mg initial dose. U.S.
Added
In February 2026, we announced that the Phase 3 trial was more than approximately 75% enrolled. In October 2025, we announced completion of enrollment in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated day 1 and day 15 dosing schedule for IV BRIUMVI® in people with RMS.
Removed
In January 26, 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients. Ex-U.S. Commercialization of BRIUMVI 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.
Added
The primary endpoint of this trial is non inferior exposure with respect to area under the curve (AUC) at week 16. Share Repurchase Program In September 2025, we announced the completion of our previously authorized $100 million share repurchase program, which was initially announced in August 2024 (the Prior Share Repurchase Program).
Removed
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.

… 42 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

238 edited+119 added−49 removed428 unchanged
Biggest changeHITECH created new tiers of civil monetary penalties, made civil and criminal penalties directly applicable to business associates, and gave state attorneys authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs; ● a wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers including those related to privacy; ● the FDCA and its implementing regulations, which among other things, strictly regulate drug product marketing and prohibit manufacturers from promotion and marketing of products prior to approval or for uses inconsistent with the FDA-required labeling; ● federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; ● the Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S.; and ● state law equivalents of some of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, marketing restrictions and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
Biggest changeHITECH created new tiers of civil monetary penalties, made civil and criminal penalties directly applicable to business associates, and gave state attorneys authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs; ● a wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers including those related to privacy; ● the FDCA and its implementing regulations, which among other things, strictly regulate drug product marketing and prohibit manufacturers from promotion and marketing of products prior to approval or for uses inconsistent with the FDA-required labeling; ● federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; ● the Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S.; and ● state law equivalents of some of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, state laws that require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the applicable guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; marketing restrictions and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. 34 Table of Contents As we continue commercialization of BRIUMVI, we are taking steps to provide patient support services to help patients access the product.
To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials and manufacturing and testing services for our commercial products.
To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products.
If we or others identify unexpected side effects caused by BRIUMVI or other products or product candidates within the RMS space following introduction into the market, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw approval or limit the approved indications for use of such products; ● regulatory authorities may require the addition of new or different labeling statements, including warnings or boxed warnings, precautions, or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product; ● we may be required to change the way such drug candidates are distributed or administered, or to conduct additional clinical trials; ● regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS), a plan to mitigate risks, which could include a Medication Guide, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; ● we may be subject to regulatory investigations and government enforcement actions; ● we may decide to remove such drug candidates from the marketplace; ● we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model; ● we could be sued and held liable for injury caused to individuals exposed to or taking our products; and ● our reputation may suffer.
If we or others identify unexpected side effects or adverse events caused by BRIUMVI or other products or product candidates within the RMS space following introduction into the market, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw approval or limit the approved indications for use of such products; ● regulatory authorities may require the addition of new or different labeling statements, including warnings or boxed warnings, precautions, or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product; ● we may be required to change the way such drug candidates are distributed or administered, or to conduct additional clinical trials; ● regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS), a plan to mitigate risks, which could include a Medication Guide, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; ● we may be subject to regulatory investigations and government enforcement actions; ● we may decide to remove such drug candidates from the marketplace; ● we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model; ● we could be sued and held liable for injury caused to individuals exposed to or taking our products; and ● our reputation may suffer.
All obligations under the Financing Agreement are secured by a lien on substantially all of assets of the Company and certain of our subsidiaries as guarantors. This indebtedness may create additional financing risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing its outstanding debt obligations at maturity.
All obligations under the Financing Agreement are secured by a lien on substantially all of assets of our and certain of our subsidiaries as guarantors. This indebtedness may create additional financing risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing its outstanding debt obligations at maturity.
Later discovery of previously unknown problems with a product or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things, restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, mandatory safety labeling changes or product recalls, suspension or revocation of product approvals, product seizure or detention, refusal to permit the import or export of products, and injunctions or the imposition of civil or criminal penalties, all of which would adversely affect our business, prospects and ability to achieve or sustain profitability. 25 Table of Contents BRIUMVI, and any of our product candidates for which we in the future obtain approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization.
Later discovery of previously unknown problems with a product or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things, restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, mandatory safety labeling changes or product recalls, suspension or revocation of product approvals, product seizure or detention, refusal to permit the import or export of products, and injunctions or the imposition of civil or criminal penalties, all of which would adversely affect our business, prospects and ability to achieve or sustain profitability. 18 Table of Contents BRIUMVI, and any of our product candidates for which we in the future obtain marketing approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization.
Top-line or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the topline, interim, or preliminary data we previously published. When providing top-line results, we may disclose the primary endpoint of a study before all secondary endpoints have been fully analyzed.
Top-line or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the top-line, interim, or preliminary data we previously published. When providing top-line results, we may disclose the primary endpoint of a study before all secondary endpoints have been fully analyzed.
We expect prescription drug pricing and other healthcare costs to continue to be subject to intense political and social pressures on a global basis. In the United States, the President, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of healthcare and addressing public concern over access and affordability of prescription drugs.
We expect prescription drug pricing and other healthcare costs to continue to be subject to intense political and social pressures on a global basis. In the United States, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of healthcare and addressing public concern over access and affordability of prescription drugs.
The Affordable Care Act, made significant changes to the U.S. healthcare system, which included expanding healthcare coverage through Medicaid and implementation of the individual health insurance mandate; changing coverage and reimbursement of drug products under Medicare, Medicaid and 340B government programs; imposing an annual fee on manufacturers of branded drugs; and expanding government enforcement authority.
The Affordable Care Act (ACA) made significant changes to the U.S. healthcare system, which included expanding healthcare coverage through Medicaid and implementation of the individual health insurance mandate; changing coverage and reimbursement of drug products under Medicare, Medicaid and 340B government programs; imposing an annual fee on manufacturers of branded drugs; and expanding government enforcement authority.
Many of the results reported in our early clinical trials rely on local investigator-assessed efficacy outcomes which may be subject to greater variability or subjectivity than results assessed in a blinded, independent, centrally reviewed manner, often required of later phase, adequate and well-controlled registration-directed clinical trials.
Many of the results reported in our early-stage clinical trials rely on local investigator-assessed efficacy outcomes which may be subject to greater variability or subjectivity than results assessed in a blinded, independent, centrally reviewed manner, often required of later phase, adequate and well-controlled registration-directed clinical trials.
The Initial Term Loan is governed by the Financing Agreement, which provides for (i) a single draw of the Initial Term Loan on the Closing Date and (ii) an uncommitted additional facility in an aggregate principal amount of $100 million ( see Note 7 to our consolidated financial statements for more information).
The Initial Term Loan is governed by the Financing Agreement, which provides for (i) a single draw of the Initial Term Loan on the Closing Date and (ii) an uncommitted additional facility in an aggregate principal amount of $100 million (see Note 7 – Loan Payable to our consolidated financial statements for more information).
Security breaches can also include phishing attempts or e-mail fraud to cause unauthorized payments or information to be transmitted to an unintended recipient, or to permit unauthorized access to systems. Although we have experienced security breaches in the past, the impact on our operations and financial condition has not been material.
Security breaches can also include phishing attempts or e-mail fraud to cause unauthorized payments or information to be transmitted to an unintended recipient, or to permit unauthorized access to systems. Although we have experienced security events in the past, the impact on our operations and financial condition has not been material.
Loss of access to the facilities of our manufacturing partners may result in increased costs, delays in the development of our products or interruption of our business operations. Any disaster recovery and business continuity plans that our we or our third-party manufacturers have in place may prove inadequate in the event of a serious natural disaster or similar event.
Loss of access to the facilities of our manufacturing partners may result in increased costs, delays in the development of our products or interruption of our business operations. Any disaster recovery and business continuity plans that our or our third-party manufacturers have in place may prove inadequate in the event of a serious natural disaster or similar event.
Any action against us for violation of these laws, rules or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business, as well as damage our business or reputation.
Any action against us for violation or perceived violation of these laws, rules or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business, as well as damage our business or reputation.
To become and remain profitable, we must succeed in developing (or in-licensing) and commercializing our products or product candidates, and continue to successfully commercialize BRIUMVI. It is uncertain when and if we will generate or continue to generate any significant revenue from the sale of our product or any product candidates, if approved, in the future.
To remain profitable, we must succeed in developing (or in-licensing) and commercializing our products or product candidates, and continue to successfully commercialize BRIUMVI. It is uncertain when and if we will generate or continue to generate any significant revenue from the sale of our product or any product candidates, if approved, in the future.
Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. 44 Table of Contents Some of our relationships with customers and third-party payors are subject to applicable fraud and abuse laws, false claims laws, transparency and disclosure laws, health information and security laws, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. 33 Table of Contents Some of our relationships with customers and third-party payors are subject to applicable fraud and abuse laws, false claims laws, transparency and disclosure laws, health information and security laws, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with products.
Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.
We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market.
We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements or commitments to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market.
Further, we cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.
We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others and the compliance concerns cannot be resolved, remediated, or otherwise addressed to the FDA’s or others’ satisfaction in a timely manner during the review of any marketing applications that we submit, it may negatively impact our ability to obtain regulatory approval for our drug candidates or obtain approval within projected timelines.
If our contract manufacturers do not successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others and the compliance concerns cannot be resolved, remediated, or otherwise addressed to the FDA’s or others’ satisfaction in a timely manner during the review of any marketing applications that we submit, it may negatively impact our ability to obtain regulatory approval for our drug candidates or obtain approval within projected timelines.
We do not have any committed external source of funds, other than funds already borrowed under our term loan facility of $250 million pursuant to the financing agreement, dated August 2, 2024, that we entered into with Blue Owl Capital Corporation, as administrative agent, HealthCare Royalty and Blue Owl Capital (the Financing Agreement) ( see Note 7 to our consolidated financial statements for more information).
We do not have any committed external source of funds, other than funds already borrowed under our term loan facility of $250 million (the Initial Term Loan) pursuant to the financing agreement, dated August 2, 2024, that we entered into with Blue Owl Capital Corporation, as administrative agent, HealthCare Royalty and Blue Owl Capital (the Financing Agreement) ( see Note 7 – Loan Payable to our consolidated financial statements for more information).
A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs, or integrity oversight and reporting obligations to resolve allegations of non-compliance; 45 Table of Contents ● the Physician Payments Sunshine Act under section 6002 of the Affordable Care Act requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to monitor and report certain information related to payments and other transfers of value to and the ownership and investment interests of physicians and certain other healthcare providers as well as teaching hospitals to the federal government for redisclosure to the public.
A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs, or integrity oversight and reporting obligations to resolve allegations of non-compliance; ● the Physician Payments Sunshine Act under section 6002 of the Affordable Care Act requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to monitor and report certain information related to payments and other transfers of value to and the ownership and investment interests of physicians and certain other healthcare providers as well as teaching hospitals to the federal government for redisclosure to the public.
We may experience unforeseen events that could delay or prevent our ability to complete current clinical trials, initiate new trials, receive marketing approval or commercialize our product candidates, including: ● the FDA or other regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial; ● the FDA or other regulatory authorities or institutional review boards (IRBs) or Data Safety Monitoring Boards (DSMBs) or ethics committees (ECs) may not authorize us or our investigators to commence or continue a clinical trial or conduct a clinical trial at a prospective trial site or in a country; we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective clinical research organizations (CROs), the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulatory authorities may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon drug development programs; ● the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, and enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our third-party contractors, including our clinical trial sites, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; ● we may elect to or regulatory authorities or IRBs, DSMBs or ECs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our product candidates may be greater than we anticipate; ● any shifts in the regulatory focus of the U.S. government as a reflection of changing administrations; ● the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including, without limitation, as a result of disruptions to our supply chains caused by global health crises, international conflicts in Russia and Ukraine and the Middle East, economic instability, or natural disasters; ● regulatory authorities may revise the requirements applicable to our product candidates, or such requirements may not be as we anticipate; and ● our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulatory authorities, IRBs, DSMBs or ECs to suspend or terminate the trials, or reports may arise from preclinical or clinical testing of other therapies in the same or a similar class that raise safety or efficacy concerns about our product candidates.
We may experience unforeseen events that could delay or prevent our ability to complete current clinical trials, initiate new trials, receive marketing approval or commercialize our product candidates, including: ● the FDA or other regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial; ● the FDA or other regulatory authorities or institutional review boards (IRBs) or Data Safety Monitoring Boards (DSMBs) or ethics committees (ECs) may not authorize us or our investigators to commence or continue a clinical trial or conduct a clinical trial at a prospective trial site or in a country; we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective clinical research organizations (CROs), the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulatory authorities may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon drug development programs; ● the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, and enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our third-party contractors, including our clinical trial sites, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; ● we may elect to or regulatory authorities or IRBs, DSMBs or ECs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our product candidates may be greater than we anticipate; ● any shifts in the regulatory focus of government agencies; ● the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including, without limitation, as a result of disruptions to our supply chains caused by global health crises, international conflicts in Russia and Ukraine, the Middle East, and South America, economic instability, or natural disasters; ● regulatory authorities may revise the requirements applicable to our product candidates, or such requirements may not be as we anticipate; and ● our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulatory authorities, IRBs, DSMBs or ECs to suspend or terminate the trials, or reports may arise from preclinical or clinical testing of other therapies in the same or a similar class that raise safety or efficacy concerns about our product candidates.
Among other things, these state-specific laws create new data privacy obligations for covered companies and provide new privacy rights to state residents, including the right to opt out of certain disclosures of their information. Draft regulations implementing certain of the state statutes have been published, but many questions remain as to how all of the new statutes will be interpreted.
Among other things, new state-specific laws create additional data privacy obligations for covered companies and provide new privacy rights to state residents, including the right to opt out of certain disclosures of their information. Draft regulations implementing certain of the state statutes have been published, but many questions remain as to how all of the new statutes will be interpreted.
There can be no assurance that any repurchases will enhance shareholder value, because the market price of our common stock may decline below the levels at which we repurchased our common stock. Although our share repurchase program is intended to enhance long-term shareholder value, short-term stock price fluctuations could reduce the share repurchase program’s effectiveness. 73 Table of Contents
There can be no assurance that any repurchases will enhance shareholder value, because the market price of our common stock may decline below the levels at which we repurchased our common stock. Although our share repurchase program is intended to enhance long-term shareholder value, short-term stock price fluctuations could reduce the share repurchase program’s effectiveness. 53 Table of Contents
Even for established companies with existing infrastructure and significantly greater resources than we have, challenges have occurred. We have made and continue to make significant investments in our commercial organization and infrastructure. We have developed and expanded our processes and systems to support the ongoing commercialization of BRIUMVI following its commercial launch in the U.S. on January 26, 2023.
Even for established companies with existing infrastructure and significantly greater resources than we have, challenges have occurred. We have made and continue to make significant investments in our commercial organization and infrastructure. We have developed and expanded our processes and systems to support the ongoing commercialization of BRIUMVI following its commercial launch in the U.S. in January 2023.
In addition, the long-term effects of climate change on general economic conditions and the pharmaceutical industry in particular are unclear and may heighten or intensify the existing risk of natural disasters. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for our business.
In addition, the long-term effects of climate changes on general economic conditions and the pharmaceutical industry in particular are unclear and may heighten or intensify the existing risk of natural disasters. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for our business.
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.
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 profitability. We may not be able to sustain or increase our profitability on a quarterly or annual basis.
Investors should also refer to the other information contained or incorporated by reference in this Annual Report on Form 10-K, including our financial statements and related notes, and our other filings from time to time with the SEC. Risks Related to Commercialization If we obtain U.S.
Investors should also refer to the other information contained or incorporated by reference in this Annual Report on Form 10-K, including our financial statements and related notes, and our other filings from time to time with the SEC. Risks Related to Commercialization If we obtain marketing approval from the U.S.
An adverse result in any litigation or defense proceedings could put one or more of our pending patents at risk of being invalidated, held unenforceable, or interpreted narrowly. 61 Table of Contents In patent litigation in the United States, defendant counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace.
An adverse result in any litigation or defense proceedings could put one or more of our pending patents at risk of being invalidated, held unenforceable, or interpreted narrowly. 45 Table of Contents In patent litigation in the United States, defendant counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace.
Privacy Shield framework, one of the mechanisms used to legitimize the transfer of personal data from the EEA to the U.S., which may lead to increased scrutiny on data transfers from the EEA to the U.S. generally and increase our costs of compliance with data privacy legislation. 47 Table of Contents If we experience a reportable data breach that is subject to any data privacy and security laws or if our operations are found to otherwise be in violation of any data privacy and security laws, rules or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, litigation and the curtailment or restructuring of our operations, which could adversely affect our ability to operate our business, our reputation and our financial results.
Privacy Shield framework, one of the mechanisms used to legitimize the transfer of personal data from the EEA to the U.S., which may lead to increased scrutiny on data transfers from the EEA to the U.S. generally and increase our costs of compliance with data privacy legislation. 35 Table of Contents If we experience a reportable cybersecurity incident or data breach that is subject to any data privacy and security laws or if our operations are found to otherwise be in violation of any data privacy and security laws, rules or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, litigation and the curtailment or restructuring of our operations, which could adversely affect our ability to operate our business, our reputation and our financial results.
In addition to the Commercialization Agreement, we may enter into collaboration arrangements with other collaboration and commercialization partners. 55 Table of Contents We are subject to a number of risks associated with our dependence on our relationships with our collaboration and commercialization partners, including: ● decisions by our collaboration and commercialization partners to terminate their collaboration or commercialization agreements with us for reasons specified in the collaboration or commercialization agreements, including our breach; ● the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities, including development and commercialization activities, currently performed by our collaboration or commercialization partners in the event that a collaboration or commercialization partner terminates its agreement with us; ● adverse decisions by a collaboration or commercialization partner regarding the amount and timing of resource expenditures for the commercialization, distribution, and sale of our drug products; ● failure by a collaboration or commercialization partner to perform its duties under its agreement with us (e.g., its failure to comply with regulatory requirements which may disrupt its performance of its obligations under the agreement with us); ● failure by a collaboration or commercialization partner to timely deliver accurate and complete financial information to us or to maintain adequate and effective internal control over its financial reporting may negatively affect our ability to meet our financial reporting obligations as required by the SEC; ● failure by a collaboration or commercialization partner to timely deliver accurate and complete medical or clinical information to us or to maintain adequate and effective internal control over its pharmacovigilance activities and reporting may negatively affect our ability to meet our reporting obligations as required by the FDA and other regulatory bodies; ● collaboration or commercialization partners’ and their affiliates’ development and commercialization of products that compete directly or indirectly with our products or product candidates; ● decisions by a collaboration or commercialization partner to prioritize others of its current or future products more highly than our drug products or our product candidates when it performs its duties; ● possible disagreements with a collaboration or commercialization partner as to the timing, nature and extent of our development plans or distribution and sales and marketing plans; and ● the fact that financial returns to us, if any, under our collaboration agreement with Neuraxpharm depends in large part on the achievement of milestones and generation of product sales, and if Neuraxpharm fails to perform or satisfy its obligations under the collaboration agreements, the development and commercialization of our drug products could be delayed, hindered or may not occur, and our business and prospects could be materially and adversely affected.
We are subject to a number of risks associated with our dependence on our relationships with our collaboration and commercialization partners, including: ● decisions by our collaboration and commercialization partners to terminate their collaboration or commercialization agreements with us for reasons specified in the collaboration or commercialization agreements, including our breach; ● the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities, including development and commercialization activities, currently performed by our collaboration or commercialization partners in the event that a collaboration or commercialization partner terminates its agreement with us; ● adverse decisions by a collaboration or commercialization partner regarding the amount and timing of resource expenditures for the commercialization, distribution, and sale of our drug products; 41 Table of Contents ● failure by a collaboration or commercialization partner to perform its duties under its agreement with us, including failure to comply with regulatory requirements which may disrupt its performance of its obligations under the agreement with us; ● failure by a collaboration or commercialization partner to timely deliver accurate and complete financial information to us or to maintain adequate and effective internal control over its financial reporting may negatively affect our ability to meet our financial reporting obligations as required by the SEC; ● failure by a collaboration or commercialization partner to timely deliver accurate and complete medical or clinical information to us or to maintain adequate and effective internal control over its pharmacovigilance activities and reporting may negatively affect our ability to meet our reporting obligations as required by the FDA and other regulatory bodies; ● collaboration or commercialization partners’ and their affiliates’ development and commercialization of products that compete directly or indirectly with our products or product candidates; ● decisions by a collaboration or commercialization partner to prioritize others of its current or future products more highly than our drug products or our product candidates when it performs its duties; ● possible disagreements with a collaboration or commercialization partner as to the timing, nature and extent of our development plans or distribution and sales and marketing plans; and ● the fact that financial returns to us, if any, under our collaboration agreement with Neuraxpharm depends in large part on the achievement of milestones and generation of product sales, and if Neuraxpharm fails to perform or satisfy its obligations under the collaboration agreements, the development and commercialization of our drug products could be delayed, hindered or may not occur, and our business and prospects could be materially and adversely affected.
A positive primary endpoint does not translate to all, or any, secondary endpoints being met. As a result, top-line and preliminary data should be viewed with caution until the final data are available, including data from the full safety analysis and the final analysis of all endpoints.
A positive primary endpoint may not translate to all, or any, secondary endpoints being met. As a result, top-line and preliminary data should be viewed with caution until the final data are available, including data from the full safety analysis and the final analysis of all endpoints.
Despite the implementation of security measures, our internal information technology systems and those of our third-party CROs, CMOs, and other contractors and consultants are vulnerable to damage from unauthorized access, security breach or incidents, natural disasters, terrorism, war and telecommunication and electrical failures.
Despite the implementation of security measures, our internal information technology systems and those of our third-party CROs, CMOs, and other contractors, vendors, and consultants are vulnerable to damage from viruses, unauthorized access, security breach or incidents, natural disasters, terrorism, war and telecommunication and electrical failures.
As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. 69 Table of Contents We are subject to risks related to corporate social responsibility and reputational matters.
As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. 51 Table of Contents We are subject to risks related to corporate social responsibility and reputational matters.
If we are unable to generate significant and sustained revenues, we will not become or remain profitable and we will be unable to continue our operations without continued funding. 30 Table of Contents While we do not expect to need to raise additional capital, we may need to do so.
If we are unable to generate significant and sustained revenues, we will not become or remain profitable and we will be unable to continue our operations without continued funding. 22 Table of Contents While we do not expect to need to raise additional capital, we may need to do so.
We may not be able to generate the data within the time period necessary to obtain approval within the established regulatory review timelines, such as by a Prescription Drug User Fee Act (PDUFA) goal date or at all to satisfy the FDA or foreign regulatory authorities; ● the approval processes of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; or ● interruptions or delays in the operations of the FDA and foreign regulatory authorities as a result of global health crises, inadequate government funding, political conditions or economic crises, international conflict, or natural disasters may negatively impact review, inspection, and approval timelines.
We may not be able to generate the data within the time period necessary to obtain approval within the established regulatory review timelines, such as by a Prescription Drug User Fee Act (PDUFA) goal date or at all to satisfy the FDA or regulatory authorities outside of the U.S.; ● the approval processes of the FDA or comparable regulatory authorities outside of the U.S. may significantly change in a manner rendering our clinical data insufficient for approval; or ● interruptions or delays in the operations of the FDA and regulatory authorities outside of the U.S. as a result of global health crises, inadequate government funding, political conditions or economic crises, international conflict, or natural disasters may negatively impact review, inspection, and approval timelines.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors when needed, we may be unable to successfully implement the tasks necessary to achieve our research, development and commercialization goals. 65 Table of Contents Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors when needed, we may be unable to successfully implement the tasks necessary to achieve our research, development and commercialization goals. Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult.
We do not know whether any of our ongoing or future clinical trials for our product candidates will be completed on schedule, if at all.​ 35 Table of Contents Whether or not, and if so, how quickly, we complete clinical trials depends in part upon the rate at which we are able to engage clinical research/trial sites and, thereafter, the rate of enrollment of patients, and the rate at which we collect, clean, lock and analyze the clinical trial database.
We do not know whether any of our ongoing or future clinical trials for our product candidates will be completed on schedule, if at all.​ Whether or not, and if so, how quickly, we complete clinical trials depends in part upon the rate at which we are able to engage clinical research/trial sites and, thereafter, the rate of enrollment of patients, and the rate at which we collect, clean, lock and analyze the clinical trial database.
These laws are rapidly changing, and tracking, analyzing and complying with such laws require significant time and expenses and can materially impact our business. We cannot predict where new legislation might arise, the scope of such legislation, or the potential impact to our business and operations.
These laws are rapidly changing, and tracking, analyzing and complying with such laws require significant time and expenses and can materially impact our business. We cannot predict where new legislation might arise, the scope of such legislation, or the potential impact on our business and operations.
Our ability to become profitable depends upon our ability to generate substantial revenue. Our prior losses have had and will continue to have an adverse effect on our stockholders’ deficit and working capital should we be unable to maintain profitability in future periods.
Our ability to maintain profitability depends upon our ability to generate substantial revenue. Our prior losses have had and will continue to have an adverse effect on our stockholders’ deficit and working capital should we be unable to maintain profitability in future periods.
In addition, if the breadth or strength of protection provided by patents and patent applications for our drug candidates is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products or product candidates. 59 Table of Contents The issuance of a patent does not foreclose challenges to its inventorship, scope, validity or enforceability.
In addition, if the breadth or strength of protection provided by patents and patent applications for our drug candidates is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products or product candidates. The issuance of a patent does not foreclose challenges to its inventorship, scope, validity or enforceability.
Once a product candidate has displayed sufficient preclinical data to warrant clinical investigation, we will be required to demonstrate, through adequate and well-controlled clinical trials, that our product candidates are effective with a favorable benefit-risk profile for use in populations for their target indications before we can seek regulatory approvals for their commercial sale.
Once a product candidate has displayed sufficient preclinical data to warrant clinical investigation, we will be required to demonstrate, through adequate and well-controlled clinical trials, that our product candidate is effective with a favorable benefit-risk profile for use in populations for their target indications before we can seek regulatory approvals for their commercial sale.
Moreover, success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing. Companies frequently experience significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.
Moreover, success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through earlier stages of clinical testing. Companies frequently experience significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.
Our commercial manufacturing partners have a limited number of facilities in which our product candidates can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Our third-party manufacturers will have other clients and may have other priorities that could affect their ability to perform the work satisfactorily and/or on a timely basis.
Our third-party manufacturing partners operate a limited number of facilities in which our product can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Additionally, our third-party manufacturers will have other clients and may have other priorities that could affect their ability to perform the work satisfactorily and/or on a timely basis.
In addition, larger scale Phase 3 studies, which are often conducted internationally, are inherently subject to increased operational risks compared to earlier stage studies, including the risk that the results could vary on a region to region or country to country basis, which could materially adversely affect the outcome of the study or the opinion of the validity of the study results by applicable regulatory agencies. ​ 34 Table of Contents From time to time, we may publicly disclose top-line or preliminary data from our clinical trials, which is based on a preliminary analysis of available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
In addition, larger scale Phase 3 studies, which are often conducted internationally, are inherently subject to increased operational risks compared to earlier stage studies, including the risk that the results could vary on a region to region or country to country basis, which could materially adversely affect the outcome of the study or the assessment of the validity of the study results by applicable regulatory agencies. ​ From time to time, we may publicly disclose top-line or preliminary data from our clinical trials, which is based on a preliminary analysis of available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
Our business, financial condition and results of operations could be materially adversely affected as a result of any of these events. In addition, the Financing Agreement imposes operating and other restrictions on the Company.
Our business, financial condition and results of operations could be materially adversely affected as a result of any of these events. In addition, the Financing Agreement imposes operating and other restrictions on us.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that may have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval.
A Breakthrough Therapy or Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process. We may seek Breakthrough Therapy or Fast Track designation for some of our drug candidates.
A Breakthrough Therapy or Fast Track designation by the FDA ma y not actually lead to a faster development or regulatory review or approval process. We may seek Breakthrough Therapy or Fast Track designation for some of our drug candidates.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. ​ 36 Table of Contents Negative or inconclusive results from the clinical trials we conduct, unanticipated adverse medical events, or changes in regulatory policy could cause us to have to delay, repeat or terminate the clinical trials.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. ​ Negative or inconclusive results from the clinical trials we conduct, unanticipated adverse medical events, or changes in regulatory policy could cause us to have to delay, repeat or terminate the clinical trials.
Therefore, such patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation.
Therefore, such patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. 43 Table of Contents The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation.
The degree of market acceptance of BRIUMVI, as well as any future product candidates for which we may receive marketing approval, will depend on a number of factors, including: ● the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained; ● the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments; ● the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products; ● the indications for which our products are approved, and other aspects of the approved labeling for such products; ● acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments; ● the potential and perceived advantages or disadvantages of our products compared to alternative treatments; ● our ability to offer our products for sale at competitive prices; ● the availability of adequate reimbursement by third-party payors and government authorities; ● the extent of patient cost-sharing obligations, including copays and deductibles; ● changes in regulatory requirements by government authorities for our products; ● relative convenience and ease of administration; ● the prevalence and severity of side effects and adverse events; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the effectiveness of our sales and marketing efforts, as well as those of any current or future partners; ● protecting our rights in our intellectual property portfolio; ● our ability to maintain a reliable supply of our products that meets market demand; and ● favorable or unfavorable publicity relating to our products or relating to the Company. 24 Table of Contents In addition, global health concerns could impact commercialization of BRIUMVI.
The degree of market acceptance of BRIUMVI, as well as any future product candidates for which we may receive marketing approval, will depend on a number of factors, including: ● the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained; ● the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments; ● the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products; ● the indications for which our products are approved, and other aspects of the approved labeling for such products; ● acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments; ● the potential and perceived advantages or disadvantages of our products compared to alternative treatments; ● our ability to offer our products for sale at competitive prices; ● the availability of adequate reimbursement by third-party payors and government authorities; ● the extent of patient cost-sharing obligations, including copays and deductibles; ● changes in regulatory requirements by government authorities for our products; ● relative convenience and ease of administration; ● the prevalence and severity of side effects and adverse events; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the effectiveness of our sales and marketing efforts, as well as those of any current or future partners; ● protecting our rights in our intellectual property portfolio; ● our ability to maintain a reliable supply of our products that meets market demand; and ● favorable or unfavorable publicity relating to our products or relating to the Company.
Our ability to generate sustained revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete clinical trials that meet their clinical endpoints; ● initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and foreign marketing approval for our product and product candidates; ● obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA, MHRA and EMA approvals of BRIUMVI for RMS; ● establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates; ● expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties; ● obtain, develop, maintain, protect, and defend our intellectual property portfolio; and ● achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.
Our ability to generate sustained revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete clinical trials that meet their clinical endpoints; ● initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and non-U.S. marketing approval for our product and product candidates; ● obtain approval from the FDA and comparable regulatory authorities outside of the U.S. to market and sell our product and product candidates, and maintain FDA and other global approvals of BRIUMVI for RMS; ● establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates; ● expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties; ● obtain, develop, maintain, protect, and defend our intellectual property portfolio; and ● achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.
In a competitive environment, a company’s communications may also be subject to heightened scrutiny from regulators and competitors under laws, regulations, and guidance about promotional communications (advertising and promotional labeling) and non-promotional communications (e.g., certain educational and scientific exchange), and with regard to potential competitor actions under federal law (such as the Lanham Act) and congruous state law, which protect businesses against the unfair competition of misleading advertising or labeling.
In a competitive environment, a company’s communications may also be subject to heightened scrutiny from regulators and competitors under laws, regulations, and guidance about promotional communications (advertising and promotional labeling), direct-to-consumer advertising and non-promotional communications (certain educational and scientific exchange), and with regard to potential competitor actions under federal law (such as the Lanham Act) and congruous state law, which protect businesses against the unfair competition of misleading advertising or labeling.
Large pharmaceutical companies have extensive experience commercializing products and may have significant existing relationships with customers and more resources available to them to promote their products. Many are active in the same diseases that we are, including within the neurological and immunological fields, some in direct competition with us.
Large pharmaceutical companies have extensive experience commercializing products and may have significant existing relationships with customers and more resources available to them to promote their products. Many are active in the same disease areas that we are, including within the neurological and immunological fields, some in direct competition with us.
While the Commercialization Agreement contains provisions that allow for dispute resolution, arbitration, and/or termination of the agreement by the Company in the event of a breach by Neuraxpharm, there can be no assurance that the Company and Neuraxpharm will agree on a cure for such a breach, and in the event of termination, there can be no assurance that the Company would be appropriately compensated and/or recover any losses sustained.
While the Commercialization Agreement contains provisions that allow for dispute resolution, arbitration, and/or termination of the agreement by us in the event of a breach by Neuraxpharm, there can be no assurance that we and Neuraxpharm will agree on a cure for such a breach, and in the event of termination, there can be no assurance that we would be appropriately compensated and/or recover any losses sustained.
Should we fail to adequately secure a license to any newly generated intellectual property, our ability to successfully develop or commercialize our products may be hindered, possibly materially. 63 Table of Contents If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
Should we fail to adequately secure a license to any newly generated intellectual property, our ability to successfully develop or commercialize our products may be hindered, possibly materially. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare beginning in 2026, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replaces the Part D coverage gap discount program with a new discounting program beginning in 2025.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replaces the Part D coverage gap discount program with a new discounting program.
The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authorities from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions, which may include conditions related to the applicability and verifiability of the data and cooperation with foreign regulatory agencies.
The acceptance of study data by the FDA or other comparable regulatory authorities outside of the U.S. from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions, which may include conditions related to the applicability and verifiability of the data and cooperation with foreign regulatory agencies.
This could create a situation where we are spending more than required and could impact our ongoing operations and entail curtailing other important research and development or commercialization efforts, all of which could have a material adverse effect on the Company.
This could create a situation where we are spending more than required and could impact our ongoing operations and entail curtailing other important research and development or commercialization efforts, all of which could have a material adverse effect on us.
In addition, the laws of foreign countries may not protect our patent rights to the same extent as the patent laws of the United States. 57 Table of Contents Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed.
In addition, the laws of foreign countries may not protect our patent rights to the same extent as the patent laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed.
If the interim, top-line or preliminary data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions we have reached, our ability to obtain approval for, or successfully commercialize, our product or product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
If the interim, top-line or preliminary data that we report differ from final results, or if others, including regulatory authorities, disagree with the scope of disclosure we have made or the conclusions we have reached, our ability to obtain approval for, or successfully commercialize, our product or product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
Our product or product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval.
Our product or product candidates may cause undesirable side effects or adverse events that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval.
We do not control these analysts. If one or more of the analysts covering our business downgrade their evaluations of our common stock, the price of our common stock could decline.
We do not control these analysts. If one or more of the analysts covering our business downgrade their valuations of our common stock, the price of our common stock could decline.
In all interactions with foreign regulatory authorities and other government agencies, we are exposed to liability risks under the Foreign Corrupt Practices Act (FCPA) or similar anti-bribery laws. We may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA, or local anti-corruption laws.
In all interactions with regulatory authorities outside of the U.S. and other government agencies, we are exposed to liability risks under the Foreign Corrupt Practices Act (FCPA) or similar anti-bribery laws. We may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA, or local anti-corruption laws.
We expect that health care reform measures that may be adopted in the future, may result in increased manufactured financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved.
We expect that healthcare reform measures that may be adopted in the future may result in increased manufactured financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved.
In addition, with respect to BRIUMVI and any product candidate that the FDA or a comparable foreign regulatory authority approves, the manufacturing processes, testing, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements.
In addition, with respect to BRIUMVI and any product candidate that the FDA or a comparable regulatory authority outside the U.S. approves, the manufacturing processes, testing, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements.
The clinical development, manufacturing, labeling, packaging, storage, record-keeping, advertising, promotion, import, export, marketing and distribution, and pharmacovigilance and adverse event reporting of our product or product candidates or any future product candidates are subject to extensive regulation by the FDA in the United States and by comparable regulatory authorities worldwide.
The research, nonclinical and clinical development, manufacturing, labeling, packaging, storage, record-keeping, advertising, promotion, import, export, marketing and distribution, compliant handling, and pharmacovigilance and adverse event reporting of our product or product candidates or any future product candidates are subject to extensive regulation by the FDA in the United States and by comparable regulatory authorities worldwide.
We expect such cybersecurity threats to continue and become more sophisticated. Threat actors, including nation state attackers, could also use artificial intelligence for malicious purposes, increasing the frequency and complexity of their attacks.
We expect such cybersecurity threats to continue and become more sophisticated. Threat actors, including nation state attackers, could also use AI for malicious purposes, increasing the frequency and complexity of their attacks.
These regulations are enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities for any drug candidates in clinical development. The FDA enforces GCP regulations through periodic inspections of clinical trial sponsors, clinical investigators, CROs, institutional review boards, and non-clinical laboratories.
These regulations are enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable regulatory authorities outside of the U.S. for any drug candidates in clinical development. The FDA enforces GCP regulations through periodic inspections of clinical trial sponsors, clinical investigators, CROs, institutional review boards, and non-clinical laboratories.
If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and we may ultimately not be able to generate revenue from their sales. Risks Related to Our Intellectual Property Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies.
If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and we may ultimately not be able to generate revenue from their sales. 42 Table of Contents Risks Related to Our Intellectual Property Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies.
Any additional sources of financing may involve the issuance of our equity securities, which would have a dilutive effect to stockholders. Currently, other than BRIUMVI, our products are investigational and have not been approved by the FDA or any foreign regulatory authority for sale.
Any additional sources of financing may involve the issuance of our equity securities, which would have a dilutive effect to stockholders. Currently, other than BRIUMVI, our products are investigational and have not been approved by the FDA or any regulatory authority outside of the U.S. for sale.
In addition, any product for which we obtain marketing approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of, and review by, the FDA, EMA and comparable regulatory authorities.
In addition, any product for which we obtain marketing approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of, and review by, the FDA and comparable regulatory authorities outside of the U.S.
To the extent additional debt is added to our current debt levels, the risks described above could increase. 32 Table of Contents We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
To the extent additional debt is added to our current debt levels, the risks described above could increase. We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
There is an extremely high rate of failure of pharmaceutical candidates proceeding through clinical trials. Individually reported outcomes of patients treated in clinical trials may not be representative of the entire population of treated patients in such studies.
There is a high rate of failure of pharmaceutical candidates proceeding through clinical trials. Individually reported outcomes of patients treated in clinical trials may not be representative of the entire population of treated patients in such studies.
If we do not accurately evaluate the commercial potential or target markets for BRIUMVI and azer-cel, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate(s) or program(s).
If we do not accurately evaluate the commercial potential or target markets for BRIUMVI and our other product candidates, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing, or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidates or programs.
These factors include, among others: ● reception and success of BRIUMVI in the U.S. market; ● reception and success of BRIUMVI in the German market and the anticipated launch of BRIUMVI in additional European markets; ● publicity regarding actual or potential clinical results relating to our product or products under development by our competitors or us; ● delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials; ● achievement or rejection of regulatory approvals by us or our competitors; ● any delay in our regulatory review for products and product candidates we may develop, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation a change to the projected approval date, scheduling of an advisory committee meeting or issuance of a “refusal to file” letter; ● announcements of technological innovations or new commercial products by our competitors or us; ● developments concerning proprietary rights, including patents; ● developments concerning our collaborations; ● announcements of technological innovations by us or our competitors; ● actual or anticipated variations in our operating results due to the level of development expenses and other factors; ● conditions and trends in the pharmaceutical, biotechnology and other industries; ● regulatory developments in the United States and foreign countries; ● litigation or arbitration; ● economic, political and market conditions or other crises and other external factors such as the disruptions in the global economy caused by global health crises and geopolitical conflicts in Russia and Ukraine and the Middle East; ● period-to-period fluctuations in our revenues and other results of operations; ● failure to meet our revenue projections or guidance; ● changes in financial estimates by securities analysts; ● our repurchase of shares of our common stock pursuant to our share repurchase program; ● sales of our common stock by us; and ● the occurrences of any of the other risks described in this Annual Report on Form 10-K.
These factors include, among others: ● reception and success of BRIUMVI in the U.S. market; ● reception and success of BRIUMVI in any jurisdiction outside of the U.S. in which it is currently approved, or in any other jurisdiction in which it might be approved or launched; ● publicity regarding actual or potential clinical results relating to our product or products under development by our competitors or us; ● delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials; ● achievement or rejection of regulatory approvals by us or our competitors; ● any delay in our regulatory review for products and product candidates we may develop, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation a change to the projected approval date, scheduling of an advisory committee meeting or issuance of a “refusal to file” letter; ● announcements of technological innovations or new commercial products by our competitors or us; ● developments concerning proprietary rights, including patents; ● developments concerning our collaborations; ● announcements of technological innovations by us or our competitors; ● actual or anticipated variations in our operating results due to the level of development expenses and other factors; ● conditions and trends in the pharmaceutical, biotechnology and other industries; ● regulatory developments in the United States and foreign countries; ● litigation or arbitration; ● economic, political and market conditions or other crises and other external factors such as the disruptions in the global economy caused by global health crises and geopolitical conflicts in Russia and Ukraine, the Middle East, and South America; ● period-to-period fluctuations in our revenues and other results of operations; ● failure to meet our revenue projections or guidance; ● changes in financial estimates by securities analysts; ● our repurchase of shares of our common stock pursuant to our share repurchase program; ● sales of our common stock by us; and ● the occurrences of any of the other risks described in this Annual Report on Form 10-K.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. 64 Table of Contents Recruiting and retaining qualified scientific, clinical, manufacturing and medical affairs, and commercial personnel, particularly in MS, will be critical to our success.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. Recruiting and retaining qualified scientific, clinical, manufacturing and medical affairs, and commercial personnel, particularly in MS, will be critical to our success.
If we are unable to effectively manage real or perceived issues, including concerns about product quality, safety, corporate social responsibility or other matters, sentiments toward the Company or our products could be negatively impacted, and our financial results could suffer.
If we are unable to effectively manage real or perceived issues, including concerns about product quality, safety, corporate social responsibility or other ESG matters, sentiments toward us or our products could be negatively impacted, and our financial results could suffer.
For the foreseeable future, we will have to fund all our operations and capital expenditures from sales of BRIUMVI, cash on hand and amounts raised in future offerings or financings.
For the foreseeable future, we will fund our operations and capital expenditures from sales of BRIUMVI, cash on hand and amounts raised in future offerings or financings.
The occurrence of any of these risks could harm our reputation and might have a materially adverse impact on our business operations, financial position and/or results of operations. 29 Table of Contents Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant operating losses since our inception, and we may incur losses in the future.
The occurrence of any of these risks could harm our reputation and might have a materially adverse impact on our business operations, financial position and/or results of operations. Risks Related to Our Financial Position and Need for Additional Capital We have incurred substantial operating losses since our inception, and we may incur losses in the future.

… 326 more changes not shown on this page.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

293 edited+133 added−119 removed71 unchanged
Biggest changeIncome tax expense differed from amounts computed by applying the US federal income tax rate of 21% for the years ending December 31, 2024, 2023 and 2022 , to pretax income (loss) as follows: ​ ​ For the year ended December 31, (in thousands) 2024 2023 2022 Income (loss) before income taxes, as reported in the consolidated statements of operations $ 25,594 $ 13,062 $ (223,812 ) ​ ​ ​ ​ Computed “expected” tax benefit $ 5,375 $ 2,743 $ (47,000 ) ​ Increase (decrease) in income taxes resulting from: State and local taxes 780 (700 ) (8,457 ) Research and development credits (4,637 ) (3,402 ) (6,366 ) Officer Compensation Limitation 2,164 (740 ) 20,580 Provision-to-return 11,733 (9,235 ) 60 Prior period state tax benefit (3,508 ) — — Other 646 245 358 Stock options (1,602 ) (10,616 ) 7,908 Change in state tax rates (4,970 ) 4,141 — Change in the balance of the valuation allowance for deferred tax assets (3,770 ) 17,954 32,917 ​ $ 2,211 $ 390 $ — We file income tax returns in the U.S Federal and various state and local jurisdictions.
Biggest changeA reconciliation of the U.S. federal statutory income tax rate to our effective tax rate for the year ending December 31, 2025 is as follows: For the Year Ended December 31, 2025 (in thousands) Tax Effect Effective Tax Rate U.S. federal statutory income tax rate $ 22,552 21.0 % State and local income tax, net of federal income tax effect (6,440 ) (6.0 )% Tax credits: Research and development (R&D) tax credit (7,352 ) (6.8 )% Changes in valuation allowance (357,904 ) (333.3 )% Nontaxable or nondeductible items: Officer compensation limit 6,213 5.8 % Excess tax benefit on stock-based compensation (8,118 ) (7.6 )% Other 324 0.3 % Other adjustments: Limitation to tax attribute utilization 9,477 8.8 % Other 1,459 1.4 % Tax effect and effective tax rate $ (339,789 ) (316.4 )% Income tax expense differed from amounts computed by applying the US federal income tax rate of 21% for the years ending December 31, 2024 and 2023, to pretax income as follows: For the year ended December 31, (in thousands) 2024 2023 Income before income taxes, as reported in the consolidated statements of operations $ 25,594 $ 13,062 ​ ​ ​ Computed “expected” tax benefit $ 5,375 $ 2,743 ​ Increase (decrease) in income taxes resulting from: State and local taxes 780 (700 ) Research and development credits (4,637 ) (3,402 ) Officer Compensation Limitation 2,164 (740 ) Provision-to-return 11,733 (9,235 ) Prior period state tax benefit (3,508 ) — Other 646 245 Stock options (1,602 ) (10,616 ) Change in state tax rates (4,970 ) 4,141 Change in the balance of the valuation allowance for deferred tax assets (3,770 ) 17,954 ​ $ 2,211 $ 390 Cash paid for income taxes, net of refunds received, by jurisdiction for the years ended December 31, 2025 are as follows: For the year ended December 31, (in thousands) 2025 Federal $ 300 State: California 710 Kentucky 1,100 Mississippi 500 Tennessee 4,519 Other 750 Foreign — Cash paid for income taxes, net of refunds received $ 7,879 F- 21 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements Our deferred tax assets (liabilities) are as follows: ​ (in thousands) 2025 2024 Deferred tax assets: Net operating loss carryforwards $275,710 $294,046 Research and development credit 58,045 50,693 Noncash compensation 15,400 12,267 Capitalized R&D Expenses 14,753 49,681 Other 27,966 10,335 Gross deferred tax assets 391,874 417,022 Deferred tax liabilities: Other (3,897 ) (2,408 ) Net deferred tax assets, excluding valuation allowance 387,977 414,614 Less valuation allowance (39,977 ) (414,614 ) Net deferred tax assets $ 348,000 $ — As of December 31, 2025, the Company has U.S. federal net operating loss (NOL) carryforwards of approximately $1.1 billion and research and development credit carryforwards (R&D credits) of approximately $58.0 million.
Other Selling, General and Administrative. Other selling, general and administrative expenses increased for the year ended December 31, 2024, by approximately $25.1 million to $122.9 million as compared to the prior year ended December 31, 2023.
Other selling, general and administrative expenses increased for the year ended December 31, 2024, by approximately $25.1 million to $122.9 million as compared to the prior year ended December 31, 2023.
The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at the Company’s option, either (a) at a base rate determined by reference to the highest of (1) the prime rate published by the Wall Street Journal, (2) the federal funds effective rate plus 0.50% and (3) Term SOFR, plus 1.00% or (b) Term SOFR, which, shall be no less than 1.00%.
The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at the Company’s option, either (a) a base rate determined by reference to the highest of ( 1 ) the prime rate published by the Wall Street Journal, ( 2 ) the federal funds effective rate plus 0.50% and ( 3 ) Term SOFR, plus 1.00% or (b) Term SOFR, which shall be no less than 1.00%.
The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
The amount of variable consideration included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
To achieve this core principle, Topic 606 includes provisions within a five -step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation.
To achieve this core principle, Topic 606 includes provisions within a five -step model that includes (i) identifying the contract with a customer, (ii) identifying the performance obligations in the contract, (iii) determining the transaction price, (iv) allocating the transaction price to the performance obligations, and (v) recognizing revenue when, or as, an entity satisfies a performance obligation.
The Company estimates the amount of its product sales that may be returned by its customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel.
The Company estimates the amount of its product sales that may be returned by customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel.
Stock-based compensation expense for awards that vest upon the achievement of milestones is recognized over the requisite service period when the achievement of such milestones becomes probable. Stock-based compensation expense for an award that has a market condition is recognized over the requisite service period, which is derived from the valuation model, even if the market condition is never satisfied.
Stock-based compensation expense for awards that vest upon the achievement of milestones is recognized over the requisite service period when the achievement of such milestones becomes probable. Stock-based compensation expense for an award that has a market condition is recognized over the requisite service period, which is derived from the valuation model, even if the market condition is never satisfied.
The Initial Term Loan will mature on August 2, 2029 ( the Term Loan Maturity Date).
The Initial Term Loan will mature on August 2, 2029 ( the Term Loan Maturity Date).
Clawback Policy (incorporated by reference to Exhibit 97.1 to the Registrant’s Form 10-K for the year ended December 31, 2023). 101 The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated Financial Statements. ​ ​ 104 Cover Page Interactive Data File (embedded within inline XBRL included as Exhibit 101). # Filed Herewith. † Indicates management contract or compensatory plan or arrangement. * Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. ​ ​ TG Therapeutics, Inc.
Clawback Policy (incorporated by reference to Exhibit 97.1 to the Registrant’s Form 10-K for the year ended December 31, 2023). 101 The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2025, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated Financial Statements. ​ ​ 104 Cover Page Interactive Data File (embedded within inline XBRL included as Exhibit 101). # Filed Herewith. † Indicates management contract or compensatory plan or arrangement. * Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. ​ ​ TG Therapeutics, Inc.
Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the approval of BRIUMVI, all manufacturing and other potential costs related to the commercial launch of BRIUMVI were expensed to research and development expense in the period incurred.
Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the approval of BRIUMVI, all manufacturing and other potential costs related to the commercial launch of BRIUMVI were expensed to research and development in the period incurred.
We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements. Forfeitures are recognized as they occur. Accrued Research and Development Expenses. As part of the process of preparing our financial statements, we are required to estimate our accrued expenses.
We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements. We recognize forfeitures as they occur. Accrued Research and Development Expenses . As part of the process of preparing our financial statements, we are required to estimate our accrued expenses.
BRIUMVI, was commercially launched in the U.S. in January 2023, following FDA approval. License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $15.3 million for the year ended December 30, 2024 compared to approximately $141.7 million for the year ended December 31, 2023.
BRIUMVI, was commercially launched in the U.S. in January 2023, following FDA approval. License Revenue . License, milestone, royalty and other revenue was $15.3 million for the year ended December 31, 2024 compared to approximately $141.7 million for the year ended December 31, 2023.
The Company incurred total financing and upfront costs of $6.0 million related to the Initial Term Loan which are recorded as debt issuance costs and debt discount costs and as an offset to loan payable on the Company’s consolidated balance sheet.
The Company incurred total financing and upfront costs of $6.0 million related to the Initial Term Loan, which are recorded as debt issuance costs and debt discount costs and presented as an offset to loan payable on the Company’s consolidated balance sheet.
(incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.31 Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Funding IV, LLC.
(incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.28 Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Funding IV, LLC.
(incorporated by reference to Exhibit 10.5 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.34 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Capital Inc.
(incorporated by reference to Exhibit 10.5 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.31 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Capital Inc.
The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at the Company’s option, either (a) at a base rate determined by reference to the highest of ( 1 ) the prime rate published by the Wall Street Journal, ( 2 ) the federal funds effective rate plus 0.50% and ( 3 ) Term SOFR, plus 1.00% or (b) Term SOFR, which, shall be no less than 1.00%.
The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at our option, either (a) a base rate determined by reference to the highest of (1) the prime rate published by the Wall Street Journal, (2) the federal funds effective rate plus 0.50% and (3) Term SOFR, plus 1.00% or (b) Term SOFR, which shall be no less than 1.00%.
During the year ended December 31, 2023, we sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $47.1 million at an average selling price of $34.01 per share, resulting in net proceeds of approximately $46.3 million after deducting commissions and other transactions costs.
During the year ended December 31, 2023, the Company sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $47.1 million at an average selling price of $34.01 per share, resulting in net proceeds of approximately $46.3 million after deducting commissions and other transactions costs.
Securities Trading Plans of Directors and Executive Officers ​During the three months ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5 - 1 trading arrangement (as defined in Item 408 (a)( 1 )(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5 - 1 trading arrangement (as defined in Item 408 (c) of Regulation S-K) for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c).
Securities Trading Plans of Directors and Executive Officers ​During the three months ended December 31, 2025 , none of our directors or executive officers adopted or terminated a Rule 10b5 - 1 trading arrangement (as defined in Item 408 (a)( 1 )(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5 - 1 trading arrangement (as defined in Item 408 (c) of Regulation S-K) for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c).
Contents ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) ​ F-1 ​ ​ ​ Consolidated Balance Sheets as of December 31, 2024 and 2023 ​ F-4 ​ ​ ​ Consolidated Statements of Operations for the years ended December 31, 2024, 2023 and 2022 ​ F-5 ​ ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023 and 2022 ​ F-6 ​ ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023 and 2022 ​ F-7 ​ ​ ​ Notes to Consolidated Financial Statements ​ F-8 2.
Contents ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) ​ F-1 ​ ​ ​ Consolidated Balance Sheets as of December 31, 2025 and 2024 ​ F-4 ​ ​ ​ Consolidated Statements of Operations for the years ended December 31, 2025, 2024 and 2023 ​ F-5 ​ ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025, 2024 and 2023 ​ F-6 ​ ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2025, 2024 and 2023 ​ F-7 ​ ​ ​ Notes to Consolidated Financial Statements ​ F-8 2.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or fifteen years after the first commercial sale of a product in such country, unless the agreement is earlier terminated (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Form 10-K for the year ended December 31, 2023). 21.1 Subsidiaries of TG Therapeutics, Inc. # ​ ​ 23.1 Consent of Independent Registered Public Accounting Firm (KPMG, LLP). # ​ ​ 24.1 Power of Attorney (included in signature page). ​ ​ 31.1 Certification of Principal Executive Officer. # ​ ​ 31.2 Certification of Principal Financial Officer. # ​ ​ 32.1 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. # ​ ​ 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. # 95 Table of Contents 97.1 TG Therapeutics, Inc.
Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Form 10-K for the year ended December 31, 2023). 21.1 Subsidiaries of TG Therapeutics, Inc. # ​ ​ 23.1 Consent of Independent Registered Public Accounting Firm (KPMG, LLP). # ​ ​ 24.1 Power of Attorney (included in signature page). ​ ​ 31.1 Certification of Principal Executive Officer. # ​ ​ 31.2 Certification of Principal Financial Officer. # ​ ​ 32.1 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. # ​ ​ 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. # 97.1 TG Therapeutics, Inc.
In making this assessment, our management used the criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management has concluded that, as of December 31, 2024, our internal control over financial reporting was effective based on these criteria.
In making this assessment, our management used the criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management has concluded that, as of December 31, 2025, our internal control over financial reporting was effective based on these criteria.
License Revenue - Revenue recognized from license agreements will include royalties on sales, upfront, milestone and other payments, if any, under any current or future licensing agreements, including revenues related to the supply of our drug candidates or approved drugs to our various licensing partners under these types of contracts.
Revenue recognized from license agreements may include royalties on sales, upfront, milestone and other payments, if any, under any current or future licensing agreements, including revenues related to the supply of our drug candidates or approved drugs to our various licensing partners under these types of contracts.
As of December 31, 2024, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act)).
As of December 31, 2025, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act)).
Product revenue, net was approximately $313.7 million for the year ended December 31, 2024 compared to $92.0 million for the year ended December 31, 2023. The increase in product revenue, net is driven by an increase in product shipments for BRIUMVI as a result of greater market penetration.
P roduct revenue, net was approximately $313.7 million for the year ended December 31, 2024 compared to $92.0 million for the year ended December 31, 2023. The increase in product revenue, net is driven by an increase in product shipments for BRIUMVI as a result of greater market penetration.
(incorporated by reference to the Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019). ​ ​ 10.21 Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Technology III, L.P.
(incorporated by reference to the Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019). ​ ​ 10.19 Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Technology III, L.P.
(incorporated by reference to Exhibit 10.3 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.32 Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P.
(incorporated by reference to Exhibit 10.3 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.29 Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P.
(incorporated by reference to Exhibit 10.7 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.36 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Global Venture Growth Fund I L.P.
(incorporated by reference to Exhibit 10.7 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.33 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Global Venture Growth Fund I L.P.
Consolidated Financial Statements ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) F-1 ​ ​ Consolidated Balance Sheets as of December 31, 2024 and 2023 F-4 ​ ​ Consolidated Statements of Operations for the years ended December 31, 2024, 2023 and 2022 F-5 ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023 and 2022 F-6 ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023 and 2022 F-7 ​ ​ Notes to Consolidated Financial Statements F-8 ​ 96 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements).
Consolidated Financial Statements ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) F-1 ​ ​ Consolidated Balance Sheets as of December 31, 2025 and 2024 F-4 ​ ​ Consolidated Statements of Operations for the years ended December 31, 2025, 2024 and 2023 F-5 ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025, 2024 and 2023 F-6 ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2025, 2024 and 2023 F-7 ​ ​ Notes to Consolidated Financial Statements F-8 ​ 68 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2025, and the related notes (collectively, the consolidated financial statements).
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025.
And TG Therapeutics, Inc., effective February 21, 2018 (incorporated by reference to the Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). * ​ ​ 10.20 Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Capital, Inc.
And TG Therapeutics, Inc., effective February 21, 2018 (incorporated by reference to the Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). * ​ ​ 10.17 Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Capital, Inc.
(incorporated by reference to Exhibit 10.6 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).* 10.35 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P.
(incorporated by reference to Exhibit 10.6 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).* 10.32 Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P.
The Company paid a premium for the shares which was recorded in research and development expense as part of the cost of the Precision License Agreement. Precision subsequently had a 30-to- 1 reverse stock split in February 2024.
The Company paid a premium for the shares, which was recorded in research and development expense as part of the cost of the Precision License Agreement. Precision subsequently implemented a 30-to- 1 reverse stock split in February 2024.
Weiss ​ ​ Michael S. Weiss ​ ​ Chairman and Chief Executive Officer F-33 Table of Contents POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S. Weiss and Sean A.
Weiss ​ ​ Chairman and Chief Executive Officer F-25 Table of Contents POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S. Weiss and Sean A.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our financial statements and the reported amounts of revenues and expenses during the applicable period.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities and the related disclosures of contingent assets and liabilities at the date of our financial statements and the reported amounts of revenues and expenses during the applicable period.
Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and procedures were effective. Management ’ s Annual Report on Internal Control over Financial Reporting.
Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2025, our disclosure controls and procedures were effective. Management ’ s Annual Report on Internal Control over Financial Reporting.
(incorporated by reference to Exhibit 4.5 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020). ​ 93 Table of Contents 10.2 Restricted Stock Subscription Agreement, effective December 29, 2011, by and between TG Therapeutics, Inc. and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † ​ ​ 10.3 Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S.
(incorporated by reference to Exhibit 4.5 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020). 10.2 Restricted Stock Subscription Agreement, effective December 29, 2011, by and between TG Therapeutics, Inc. and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † ​ ​ 10.3 Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S.
(incorporated by reference to Exhibit 10.38 to the Registrant’s Form 10-K for the year ended December 31, 2023).* 10.39 Financing Agreement, dated August 2, 2024, by and among TG Therapeutics, Inc., certain subsidiaries of TG Therapeutics, Inc., various lenders from time to time party thereto, and Blue Owl Capital Corporation (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2024).* 10.40 Master Services Agreement, effective October 8, 2024, by and among TG Therapeutics, Inc., Fujifilm Diosynth Biotechnologies North Carolina, Inc. and Fujifilm Diosynth Biotechnologies Denmark Aps (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended September 30, 2024).* 19.1 TG Therapeutics, Inc.
(incorporated by reference to Exhibit 10.38 to the Registrant’s Form 10-K for the year ended December 31, 2023).* 10.36 Financing Agreement, dated August 2, 2024, by and among TG Therapeutics, Inc., certain subsidiaries of TG Therapeutics, Inc., various lenders from time to time party thereto, and Blue Owl Capital Corporation (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2024).* 10.37 Master Services Agreement, effective October 8, 2024, by and among TG Therapeutics, Inc., Fujifilm Diosynth Biotechnologies North Carolina, Inc. and Fujifilm Diosynth Biotechnologies Denmark Aps (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended September 30, 2024).* 19.1 TG Therapeutics, Inc.
For time-based or performance-based restricted stock, the fair value is based on the market value of our common stock on the date of grant. Stock-based compensation expense for time-based restricted stock and options is recognized on a straight-line basis over the requisite service period.
For time-based or performance-based restricted stock, the fair value is based on the market value of the Company's common stock on the date of grant. Stock-based compensation expense for time-based restricted stock and options is recognized on a straight-line basis over the requisite service period.
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards.
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as operating losses and tax credit carryforwards.
The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and will be included in interest expense in the Company’s consolidated statements of operations.
The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and are included in interest expense in the Company’s consolidated statements of operations.
Our consolidated financial statements and the notes thereto, included in Part IV, Item 14(a), part 1, are incorporated by reference into this Item 8. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES. Not applicable. 89 Table of Contents ITEM 9A. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures.
Our consolidated financial statements and the notes thereto, included in Part IV, Item 14(a), part 1, are incorporated by reference into this Item 8. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES. Not applicable. ITEM 9A. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures.
Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
Any such adjustments are recorded on a cumulative catch-up basis, which may affect license and other revenue, as well as earnings, in the period of adjustment.
The Company capitalized third party fees from the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.
We capitalized third party fees from the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.
Equity securities are recognized at their fair value in accordance with ASC 321, Investments – Equity Securities. Forward contracts to purchase equity securities that do not qualify as derivatives under ASC 815 are accounted for in accordance with ASC 321. These forward contracts are recorded at fair value at the balance sheet date. See Note 5 for further details.
Forward contracts to purchase equity securities that do not qualify as derivatives under ASC 815 are accounted for in accordance with ASC 321. These forward contracts are recorded at fair value at the balance sheet date. See Note 5 for further details.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. 90 Table of Contents ITEM 9B. OTHER INFORMATION.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. ITEM 9B. OTHER INFORMATION.
(incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.37 Commercialization Agreement by and between TG Therapeutics, Inc. and Neuraxpharm Pharmaceuticals, S.L., dated as of July 28, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2023). * 10.38 License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc.
(incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.34 Commercialization Agreement by and between TG Therapeutics, Inc. and Neuraxpharm Pharmaceuticals, S.L., dated as of July 28, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2023). * 10.35 License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc.
Optional Purchases : The Company’s arrangements may provide the licensee the right to make optional purchases of the licensed product. These optional purchases are accounted for as separate contracts when the licensee determines that it will make such a purchase, unless the option conveys a material right.
Optional Purchases : The Company’s arrangements may provide the licensee the right to make optional purchases of the licensed product. These optional purchases are accounted for as separate contracts when the licensee determines that it will make such a purchase, unless the option conveys a material right. Optional purchases are recorded as product revenue, net.
Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar.
Under the terms of the sublicense agreement, Ildong was granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar.
(incorporated by reference to the Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019). ​ ​ 10.22 Amended and Restated Collaboration Agreement by and between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated June 19, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). * ​ ​ 10.23 Amended and Restated Employment Agreement by and between TG Therapeutics, Inc. and Michael S.
(incorporated by reference to the Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019). ​ ​ 10.20 Amended and Restated Collaboration Agreement by and between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated June 19, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). * ​ ​ 10.21 Amended and Restated Employment Agreement by and between TG Therapeutics, Inc. and Michael S.
The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25-basis point step-down upon achievement of a specified US Net Sales threshold.
The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25 basis point step-down upon achievement of a specified U.S. Net Sales threshold.
The work in process materials consist primarily of bulk drug substance, which has a multi-year shelf life. When the bulk drug substance is manufactured into BRIUMVI finished goods, those finished goods have a shelf life of three years from the date of manufacture. Our expectation is to sell finished goods at least twelve months prior to expiration.
The work in process materials consist primarily of bulk drug substance, which has a multi-year shelf life. When the bulk drug substance is manufactured into BRIUMVI finished goods, those finished goods have a shelf life of three years from the date of manufacture. The Company expects to sell finished goods at least twelve months prior to expiration.
The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25 basis point step-down upon achievement of a specified US Net Sales threshold.
The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25 basis point step-down upon achievement of a specified U.S. Net Sales threshold.
Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance. 87 Table of Contents These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).
Variable consideration includes the following components, which are described below: chargebacks, government rebates, commercial payer rebates, trade discounts and allowances, product returns, and co-payment assistance. 63 Table of Contents These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against our customer account) or a liability (if the amount is expected to be settled with a cash payment).
The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied.
The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, and the Company recognizes revenue as or when the performance obligations under the contract are satisfied.
We used the incremental borrowing rate of 10.25% on February 28, 2019, for leases that commenced prior to that date through December 31, 2021. We used an incremental borrowing rate of 5.65% for the NC lease.
The Company used the incremental borrowing rate of 10.25% on February 28, 2019, for operating leases that commenced prior to that date through December 31, 2021. The Company used an incremental borrowing rate of 5.65% for the NC lease.
We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 9 for further information. STOCK-BASED COMPENSATION Stock-based compensation costs related to equity awards granted to employees and non-employees are measured at the date of grant based on the fair value of the award.
The Company recognizes interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 9 for further information. STOCK-BASED COMPENSATION Stock-based compensation costs related to equity awards granted to employees and non-employees are measured at the date of grant based on the fair value of the award.
Our future minimum lease commitments include our office leases in New York and North Carolina as of December 31, 2024.
Our future minimum lease commitments include our office leases in New York and North Carolina as of December 31, 2025.
Weiss (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). † ​ ​ 10.4 Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Michael S.
Weiss (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). † 66 Table of Contents 10.4 Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Michael S.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements), and our report dated March 3, 2025 expressed an unqualified opinion on those consolidated financial statements.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2025 and 2024, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2025, and the related notes (collectively, the consolidated financial statements), and our report dated February 27, 2026 expressed an unqualified opinion on those consolidated financial statements.
New York, New York March 3, 2025 F-2 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: ​ Opinion on Internal Control Over Financial Reporting ​ We have audited TG Therapeutics, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
New York, New York February 27, 2026 F-2 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: ​ Opinion on Internal Control Over Financial Reporting ​ We have audited TG Therapeutics, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated March 3, 2025 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 27, 2026 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination.
The Company has tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination.
Other Revenue Revenue is also generated from service-based fees recognized for providing regulatory support and development services to customers. Service fee revenue is recognized overtime as the services are transferred to the customer.
Other Revenue Revenue is also generated from service-based fees recognized for providing regulatory support and development services to customers. Service fee revenue is recognized over time as the services are transferred to the customer.
RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Research and development expenses consist primarily of costs incurred to third -party service providers for the conduct of research, preclinical and clinical studies, contract manufacturing costs, license milestone fees, personnel costs for our research and development employees, consulting, and other related expenses.
RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Research and development expenses consist primarily of costs incurred with third -party service providers for the conduct of research, preclinical and clinical studies, contract manufacturing costs, license milestone fees, personnel costs for the Company's research and development employees, consulting, and other related expenses.
The Company's estimates of reserves established for variable consideration are calculated based on the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company's current contractual requirements, customer channel mix, changes to product price, government pricing calculations, and industry data.
The Company's estimate of reserves for variable consideration are calculated using the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company's current contractual requirements, customer channel mix, changes to product price, government pricing calculations, and industry data.
The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: ● Level 1 – quoted prices in active markets for identical assets and liabilities; ● Level 2 – inputs other than Level 1 quoted prices that are directly or indirectly observable; and ● Level 3 – unobservable inputs that are not corroborated by market data.
The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used to determine fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: ● Level 1 – quoted prices in active markets for identical assets and liabilities; ● Level 2 – inputs other than Level 1 quoted prices that are directly or indirectly observable; and ● Level 3 – unobservable inputs for which market data are not available.
We estimate the grant date fair value of options, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model. Equity awards with market conditions are valued using advanced option-pricing models, such as a Monte Carlo simulation. The effect of a market condition is reflected in the award’s fair value on the grant date.
The Company estimates the grant date fair value of options, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model. Equity awards with market conditions are valued using advanced option-pricing models, such as a Monte Carlo simulation, with the effect of a market condition reflected in the award’s fair value on the grant date.
The Company capitalized third party fees from the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.
The Company capitalized third party fees incurred in connection with the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.
Pursuant to the Precision License Agreement, the Company made an upfront payment to Precision of $7.5 million, consisting of (i) $5.25 million in cash and (ii) $2.25 million (the Upfront Precision Stock Payment), as an equity investment, for the purchase of 2,920,816 shares of Precision’s common stock at a price of $0.77 per share.
Upon execution of the Precision License Agreement, the Company made an upfront payment to Precision of $7.5 million, comprised of (i) $5.25 million in cash and (ii) $2.25 million (the Upfront Precision Stock Payment), as an equity investment, for the purchase of 2,920,816 shares of Precision’s common stock at a price of $0.77 per share.
The $11.4 million increase is mainly due to $4.6 million of debt extinguishments costs incurred pertaining to the First Amendment with Hercules as well as increased interest expense pertaining to the Initial Term Loan with Blue during the same period (see Note 7 for more information). Other Income.
The $11.4 million increase is mainly due to $4.6 million of debt extinguishments costs incurred pertaining to the prior loan agreement 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 more information). Other Income.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. Not applicable. 91 Table of Contents PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. Not applicable. PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2026 Annual Meeting of Stockholders.
(Manhattan)) with Ariston Pharmaceuticals, Inc. (Ariston) in March 2010, Ariston issued $15.5 million of five -year 5% notes payable (the 5% Notes) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share.
(Ariston) in March 2010, Ariston issued $15.5 million of five -year 5% notes payable (the 5% Notes) in satisfaction of several prior note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share.
An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement.
An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings, is recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or fifteen years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which the Company has certain ongoing responsibilities under the sublicense agreement.
NOTE 12 – COMMITMENTS AND CONTINGENCIES Purchase Commitments We contract with various third parties to conduct certain activities including clinical operations and contract manufacturing, and for the clinical and commercial supply of BRIUMVI. Certain contracts contain non-cancellable features or require us to make binding forecasts for future purchases.
NOTE 12 – COMMITMENTS AND CONTINGENCIES Purchase Commitments The Company contracts with various third parties to conduct certain activities including clinical operations and contract manufacturing, and for the clinical and commercial supply of BRIUMVI. Certain contracts contain non-cancelable features or require the Company to make binding forecasts for future purchases.
Leases with an initial term of 12 months or less are not recorded on the balance sheet and we recognize lease expense for these leases on a straight-line basis over the term of the lease.
Leases with an initial term of 12 months or less are not recorded on the balance sheet, and the Company recognizes lease expense for these leases on a straight-line basis over the lease term.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on March 3, 2025, and in the capacities indicated: Signatures Title /s/ Michael S. Weiss Michael S. Weiss ​ Chairman, Chief Executive Officer and President ​ ​ ​ /s/ Sean A.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on February 27, 2026, and in the capacities indicated: Signatures Title /s/ Michael S. Weiss Michael S. Weiss ​ Chairman, Chief Executive Officer and President ​ ​ ​ /s/ Sean A.
The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and will be included in interest expense in the Company’s consolidated statements of operations.
The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and are included in interest expense in our consolidated statements of operations.

… 465 more changes not shown on this page.

Other TGTX 10-K year-over-year comparisons