What changed in this filing

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Item 1. Business

2025-03-03 compared with 2024-02-29 · 72 added, 92 removed, 430 unchanged (28% of the section changed)

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.

In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S.

TG has received approval from the U.S.

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.

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Business Highlights

FDA Approval and U.S.

Launch of BRIUMVI

On December 28, 2022, we announced that the FDA granted approval of ublituximab, now referred to as BRIUMVI, for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

BRIUMVI is an anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose.

Approval was granted for this indication 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.

Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine.

On January 26, 2023, we announced the commercial launch of BRIUMVI, making it available to physicians and patients.

We are committed to helping patients access BRIUMVI through the BRIUMVI Patient Support Program, which we launched following the approval, additional information can be found at www.briumvi.com.

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.

On August 1, 2023, we announced an agreement with Neuraxpharm Pharmaceuticals, S.L.

BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose.

BRIUMVI received approval 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.

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.

(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 November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK.

On February 26, 2024, we announced the commercial launch of BRIUMVI in the European Union (EU) by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany, with additional EU markets expected to follow.

Pipeline Expansion

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.

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, and the Company has near term plans to evaluate the program in multiple autoimmune indications.

Azer-cel is an allogeneic (off the shelf) CAR T program.

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.

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.

In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab.

CORPORATE INFORMATION

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It is possible that the information we post on social media could be deemed to be material information.

Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to review the information we post on the U.S.

social media channels listed on our website.

Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to also review the information we post on the social media channels listed on our website.

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 relapsing forms of multiple sclerosis;

Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases;

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Initial Target Disease

Stage of Development (trial name)

Ublituximab (anti-CD20 mAb)

Relapsing Forms of Multiple Sclerosis (RMS)

TG-1701 (BTK inhibitor)

B-cell disorders

Phase 1 trial

TG-1801 (anti-CD47/CD19 bispecific mAb)

B-cell disorders

Stage of Development

Ublituximab IV (anti-CD20 mAb)

Ublituximab Subcutaneous (anti-CD20 mAb)

Phase 1 trial

Auto-immune disorders

Phase 1 (pending)

BRIUMVI (ublituximab-xiiy) Overview

BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, that can be administered in a twice a year one-hour infusion following the starting dose.

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.

Late-Stage Clinical Development of Ublituximab-xiiy

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The primary endpoint for each study was ARR following 96 weeks of treatment.

This program was led by Lawrence Steinman, MD, George A.

Zimmermann Professor and Professor of Pediatrics, Neurology and Neurological Sciences at Stanford University.

In December 2020, we announced positive topline results from the ULTIMATE I & II trials.

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On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.

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 September 2024 we presented new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with RMS, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting.

These data demonstrate that 92% of patients with RMS were free from disability progression after five years of 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.

ENHANCE Phase 3b Trial

On October 11, 2023, we presented the first data from the ENHANCE Phase 3b trial evaluating BRIUMVI in patients with RMS who switch from another anti-CD20 therapy to BRIUMVI.

The presentation occurred at the 2023 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting.

In this study, patients with low levels of B-cells as pre-specified in the protocol are eligible to proceed directly to a full dose of BRIUMVI 450mg without receiving a 150 mg loading dose.

As of the presentation, 13 patients switched from Ocrevus to BRIUMVI 450mg as a 2-hour infusion with no infusion related reactions reported and no unexpected side effects.

An additional 2 patients switched from Ocrevus to BRIUMVI 450mg as a 1-hour infusion again with no infusion related reactions reported and no unexpected side effects.

The study has continued to enroll patients at 450mg as a 1-hour infusion and additional data is expected to be reported during the course of 2024.

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.

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.

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.

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.

Commercialization of BRIUMVI (ublituximab-xiiy)

On December 28, 2022, we announced the FDA approval of BRIUMVI (ublituximab-xiiy) for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, primarily based on results from the ULTIMATE I & II Phase 3 trials, and on January 26, 2023, we announced the U.S.

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.

In January 26, 2023, we announced the U.S.

commercial launch of BRIUMVI, making it available to physicians and patients.

On July 1, 2023, the permanent J-Code for BRIUMVI (J2329) became effective.

Commercialization of BRIUMVI

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With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein.

On August 1, 2023, we announced an agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-US commercialization of BRIUMVI.

Under the terms of the commercialization agreement, we received an upfront payment of $140 million, and are eligible to receive an additional $12.5 million upon launch in the first EU country and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.

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.

Under the terms of the commercialization agreement, we received an upfront payment of $140 million and $12.5 million upon launch in the first EU country.

We are eligible to receive up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.

The total deal is valued at up to $645 million in upfront and milestone payments.

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On November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK.

On February 26, 2024, we announced the commercial launch of BRIUMVI in the European Union (EU).

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.

Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating subcutaneous ublituximab with an expected dosing frequency of at least every other month.

TG-1701 (BTK inhibitor) Overview

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B-cell receptor (BCR) signaling is crucial for normal B-cell development and supports the survival and growth of B-cells.

We are currently evaluating TG-1701 in a Phase 1, multi-center, dose-escalation clinical trial in patients with B-cell malignancies.

Data from this trial was last presented at the 2021 American Society of Hematology (ASH) annual meeting.

TG-1801 (anti-CD47/anti-CD19 bispecific monoclonal antibody) Overview

TG-1801 is a potentially first-in-class, bispecific CD47 and CD19 antibody.

It is the first therapy to target both CD19, a B-cell specific marker widely expressed across B-cell malignancies, and CD47, the "don’t eat me" signal used by both healthy and tumor cells to evade macrophage mediated phagocytosis.

In the first quarter of 2019, we commenced a Phase 1 first-in-human, dose-escalation study of TG-1801 in patients with B-cell lymphoma.

In December 2022, preliminary results from this first-in-human Phase 1 study were presented at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition.

TG-1801 was well tolerated as monotherapy and in combination with ublituximab with no maximum tolerable dose (MTD) identified and exhibited preliminary signs of efficacy in a variety of relapsed or refractory B-cell lymphomas.

In the first half of 2021, we commenced a second Phase 1 study of TG-1801 in the U.S.

to continue dose optimization as monotherapy.

We evaluated TG-1701 in a Phase 1, multi-center, dose-escalation clinical trial in patients with B-cell malignancies, which is now closed.

Data from this trial were presented at the 2021 American Society of Hematology (ASH) annual meeting.

Azercabtagene Zapreleucel (azer-cel)

Azer-cel is an allogeneic (off-the-shelf) CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by the Company for autoimmune diseases.

Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in several B-cell cancers and autoimmune diseases.

Azer-cel is designed to avoid graft-versus-host disease (GvHD), a significant complication associated with other donor-derived, cell-based therapies.

The Company has near term plans to evaluate the program in autoimmune indications.

In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS.

INTELLECTUAL PROPERTY AND PATENTS

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patents covering our product and/or their methods of use.

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 in certain European Patent (EP) countries.

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.

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.

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BLA supplements are not eligible for any additional exclusivity.

The objectives of the BPCIA are conceptually similar to those of the Hatch-Waxman Act described above.

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.

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These patents and patent applications include composition of matter patents relating to the structure and mechanism of action for ublituximab, as well as method of use patents which cover use of ublituximab in combination with various agents and for various therapeutic indications.

Our earliest in time patent families relate to compositions of matter for ublituximab , which has been issued in the U.S., Europe and other jurisdictions, including Australia, Canada, China, Japan, Korea and India.

The expected expiration for the composition of matter patent is 2029 in the U.S.

and 2025 in Europe and other non-U.S.

jurisdictions, exclusive of patent term extensions, which could result in later expiration dates.

We also have a method of use patent on the combination of UKONIQ and ublituximab, which has been issued in the U.S., Europe, and other jurisdictions, including Australia, China, Korea, and Japan, and is pending in other territories.

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.

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.

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 three issued U.S.

patents and one recently allowed U.S.

We also have patent applications pending in this family in the U.S., Argentina, the EU and Taiwan.

The Patent Cooperation Treaty application , from which further national phase applications may be filed, is also pending.

Patents issuing from this family may first begin to expire as early as 2042.

This family includes four issued U.S.

patents and two pending U.S.

applications.

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.

Any patents issuing from this family may first begin to expire as early as 2042, not accounting for any patent term adjustment or extensions or terminal disclaimers, and assuming that all applicable annuity and/or maintenance fees are paid timely .

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.

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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, 2022 , we have incurred expenses of approximately $ 25.0 million related to milestones in accordance with the terms of the LFB License Agreement, $ 12 .0 million of which was incurred in December of 2022 related to a milestone associated with receiving approval of BRIUMVI by the FDA .

LFB Group is eligible to receive future payments of approximately $6.0 million, upon our successful achievement of certain regulatory milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate in the high-single digits.

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.

LFB Group is eligible to receive royalty payments on net sales of ublituximab at a royalty rate in the high-single digits.

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.

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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 Ildong 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 August 2023, we entered into an agreement with Neuraxpharm, for the ex-U.S.

In August 2023, we entered into a Commercialization Agreement with Neuraxpharm, for the ex-U.S.

commercialization of BRIUMVI.

Under the terms of the commercialization agreement, we received an upfront payment of $140 million and are eligible to receive an additional $12.5 million upon launch in the first EU country and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.

Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million and an additional $12.5 million upon launch in the first EU country.

We are eligible to receive up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.

The total deal is valued at up to $645 million in upfront and milestone payments.

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Pursuant to such 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 as an equity investment.

The Company will make an additional deferred payment of $2.5 million to Precision as an equity investment to Precision within 12 months at a pre-specified premium.

Upon achievement of certain near-term clinical or time-based milestones, the Company will make a further $7.5 million payment to Precision, a portion of which will also be an equity investment in Precision’s common stock at a pre-specified premium.

The Company made an additional payment of $2.5 million as an equity investment to Precision in January 2025.

Upon the achievement of certain near-term clinical or time-based milestones, the Company will make a further $7.5 million payment to Precision, a portion of which will also be an equity investment in Precision’s common stock at a pre-specified premium.

Precision will be eligible to receive up to $288 million in additional milestone payments based on the achievement of certain clinical, regulatory and commercial milestones.

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The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, or (ii) by either party due to a breach of the agreement.

In March 2015, we entered into a global collaboration (the Collaboration Agreement) with Checkpoint Therapeutics, Inc.

(Checkpoint) for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies with an option to acquire rights in autoimmune diseases.

In September 2023, we terminated this agreement and have no remaining obligations or commitments under the Collaboration Agreement.

Competition in the pharmaceutical and biotechnology industries is intense.

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In addition, while we believe not directly competitive, there is also a subcutaneous anti-CD20 monoclonal antibody approved for MS, ofatumumab (Novartis AG).

TG-1701, TG-1801 and azer-cel, if approved will also face competition from drugs on the market and under development in the same therapeutic class as each of those drugs.

Azer-cel, if approved will also face competition from drugs on the market and under development in the same therapeutic class as each of those drugs.

Additional information can be found under Item “1A - Risk Factors – Other Risks Related to Our Business” within this report.

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ineffectiveness of the drug candidates.

In December 2022, with the passage of Food and Drug Omnibus Reform Act, Congress required sponsors to develop and submit a diversity action plan (DAP) for each Phase 3 clinical trial or any other “pivotal study” of a new drug or biological product.

These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products.

Specifically, DAPs must include the sponsor’s goals for enrollment, the underlying rationale for those goals and an explanation of how the sponsor intends to meet them.

In addition to these requirements, the legislation directs the FDA to issue new guidance on diversity action plans.

For clinical trials that are intended to form the basis of a new drug or biologics license application for approval, sponsors of drugs may apply for a Special Protocol Assessment (SPA) from the FDA, by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols.

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Decreases in third-party reimbursement for our drug candidates, if approved, or a decision by a third-party payor to not cover our drug candidates could reduce physician usage of such drugs and have a material adverse effect on our sales, results of operations and financial condition.

In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the Affordable Care Act, enacted in March 2010, has had a significant impact on the health care industry.

In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the Affordable Care Act, has had a significant impact on the health care industry.

The Affordable Care Act expanded coverage for the uninsured while at the same time containing overall healthcare costs.

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Since the enactment of the Affordable Care Act, certain provisions of the Affordable Care Act have been subject to judicial challenges as well as efforts to repeal or replace them or to alter their interpretation or implementation.

For example, the Tax Cuts and Jobs Act enacted on December 22, 2017, eliminated the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the individual mandate, effective January 1, 2019.

Although litigation and legislation over the Affordable Care Act are likely to continue, with unpredictable and uncertain results, we expect that the Biden administration may seek to expand and strengthen the Affordable Care Act.

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (the Act), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically, the Act authorizes and directs the Department of Health and Human Services (the DHHS) to set drug price caps for certain high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs selected on August 29, 2023, and the first year of maximum price applicability to begin in 2026.

The Act further authorizes the DHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation.

Finally, the Act creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.

For example, the Tax Cuts and Jobs Act of 2017 eliminated the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the individual mandate.

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.

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.

We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

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The Affordable Care Act, among other things, imposes reporting requirements on drug manufacturers for payments made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.

Drug manufacturers are required to submit annual reports to the Centers for Medicare & Medicaid Services, which publicly posts the data on its website.

Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners.

Failure to submit required information may result in civil monetary penalties for payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.

Drug manufacturers are required to submit annual reports to the Centers for Medicare & Medicaid Services (CMS), which publicly posts the data on its website.

These reporting obligations include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners.

Certain states also mandate implementation of compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians.

We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information Technology and Clinical Health Act, (HITECH), and their respective implementing regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.

HIPAA, as amended by the Health Information Technology and Clinical Health Act, (HITECH), and their respective implementing regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity.

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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.

For example, the California Consumer Protection Act, (CCPA), which went into effect on January 1, 2020, established a privacy framework for covered businesses by creating an expanded definition of personal information, data privacy rights for consumers in California, and a potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.

For example, the California Consumer Protection Act, (CCPA) established a privacy framework for covered businesses by creating an expanded definition of personal information, data privacy rights for consumers in California, and a potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.

The CCPA was recently amended by the California Privacy Rights Act (CPRA), expanding certain consumer rights such as the right to know.

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Human Capital

As of February 26, 2024, we had 264 full-time employees.

As of February 25, 2025, we had 338 employees.

None of our employees are represented by a collective bargaining agreement, and we have never experienced a work stoppage.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business