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TG Therapeutics, Inc. (TGTX): Business Model Canvas [Dec-2025 Updated] |
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You're digging into the mechanics of a biotech that's hitting its stride, and honestly, the core engine for TG Therapeutics, Inc. (TGTX) right now is laser-focused: the drug Briumvi. After another guidance raise, the story is simple-they are driving toward a $600 million global revenue target for 2025, largely powered by the U.S. market and a smart partnership with Neuraxpharm overseas. I've seen plenty of these growth curves, and understanding how they convert a single approved therapy into that kind of top-line performance-from their high-touch sales force to managing R&D costs like the subcutaneous formulation-is key to seeing where the next dollar comes from. Dive into the Canvas below to see the nine blocks that make this near-term success tick.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Key Partnerships
You're looking at how TG Therapeutics, Inc. gets its product, BRIUMVI, to patients and how it manages the complex process of making that drug. Partnerships are defintely key here, especially as U.S. net product revenue hit $152.9 million in the third quarter of 2025, leading to a raised full-year 2025 global revenue target of approximately $600 million.
Neuraxpharm for ex-U.S. commercialization and distribution in Europe/UK
The agreement with Neuraxpharm Group for ex-U.S. commercialization of BRIUMVI is a major component of the international strategy. This deal, originally structured in August 2023, provides significant upfront cash flow and future upside.
The financial structure of this partnership includes:
- Upfront payment received: $140 million.
- Additional payment upon first EU launch: $12.5 million.
- Total potential upfront and milestone payments: Up to $645 million.
- Maximum milestone payments available: Up to $492.5 million.
- Royalty structure: Tiered double-digit royalties on net product sales up to 30%.
Neuraxpharm holds exclusive rights in territories outside the U.S., Canada, and Mexico, excluding certain Asian countries. As of late 2025, BRIUMVI has secured approvals in several key international markets through this partnership, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates.
Contract Manufacturing Organizations (CMOs) for drug production
TG Therapeutics, Inc. relies on established external partners to handle the large-scale manufacturing of its commercial product, BRIUMVI, and pipeline assets. This outsourcing helps manage capital expenditure and scale production to meet growing demand.
Known manufacturing agreements include:
| Partner Name | Agreement Type/Product Focus | Date Context |
| FUJIFILM Diosynth Biotechnologies | Development and Manufacturing Services Agreement | Filed in 2025 |
| Samsung BioLogics | Expanded large-scale contract manufacturing for ublituximab | Original deal expanded in 2021 |
| Confidential Service Provider | Master Services Agreement for Biologics Manufacturing Services | Details in filings |
The company acknowledges that its reliance on CMOs means that any failure to comply with regulations by these organizations could delay regulatory approval and lead to enforcement action.
Academic Medical Centers for clinical trial execution
The development of the pipeline, including trials for subcutaneous ublituximab and simplified IV dosing, depends on collaboration with leading clinical sites. The prior ULTIMATE I & II Phase 3 trials for BRIUMVI involved significant international collaboration.
Key statistics from past and ongoing trial structures:
- Total patients enrolled in ULTIMATE I & II trials: 1,094 patients.
- Countries involved in ULTIMATE I & II trials: 10 countries.
- Key clinical investigators/centers mentioned in 2025 data presentations include Dr. Bruce Cree of the Weill Institute for Neurosciences, University of California, San Francisco, CA, and Dr. John Foley of Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah.
TG Therapeutics, Inc. actively seeks collaborations for preclinical or clinical research programs via sponsoredresearch@tgtxinc.com.
Specialty pharmacies and distributors for U.S. logistics
Getting BRIUMVI to U.S. patients requires a network of authorized specialty distributors. The company maintains a list of these Authorized Distributors of Record (ADRs) to ensure product availability.
The ADR list as of October 1, 2025, includes several major players in specialty distribution:
- MCKESSON SPECIALTY
- CuraScript SD (PRIORITY HEALTHCARE DISTRIBUTION)
- CARDINAL HEALTH SPECIALTY
- ASD HEALTHCARE
- ONCOLOGY SUPPLY
- BESSE MEDICAL
- MCKESSON PLASMA & BIOLOGICS
You can find the current list of authorized specialty distributors at www.briumvi.com.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Key Activities
You're looking at the core engine driving TG Therapeutics, Inc. right now-the day-to-day execution required to turn their lead asset, BRIUMVI, into a market leader while simultaneously building out the next generation of treatments. These aren't just tasks; they are the high-stakes activities that define the company's near-term financial reality.
Commercialization and marketing of Briumvi in the U.S.
The primary activity is pushing BRIUMVI (ublituximab-xiiy) adoption in the U.S. for relapsing forms of multiple sclerosis (RMS). The results show this is working, as they keep raising guidance. For the third quarter of 2025, U.S. net product revenue hit $152.9 million. That's an 84% growth over the same period in 2024, and a 10% sequential increase from Q2 2025's $138.8 million. Based on this momentum, TG Therapeutics, Inc. raised the full-year 2025 U.S. net revenue target to approximately $585 million, up from the earlier projection of $560 million. This commercial push is supported by international expansion, with BRIUMVI approved in the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates as of the third quarter of 2025.
Here's a quick look at the revenue trajectory:
| Period Ending | BRIUMVI U.S. Net Revenue | Year-over-Year Growth |
| March 31, 2025 (Q1) | $119.7 million | 137% |
| June 30, 2025 (Q2) | $138.8 million | 91% |
| September 30, 2025 (Q3) | $152.9 million | 84% |
Research and development (R&D) for subcutaneous Briumvi formulation
A major R&D focus is developing a subcutaneous (SC) formulation of BRIUMVI, aiming for a more convenient, self-administered product dosed at least every other month. This work directly impacts R&D spending. For the first quarter of 2025, total R&D expense was $46.4 million, an increase from $32.7 million in Q1 2024, primarily due to manufacturing expenses for the SC development. By Q3 2025, R&D expenses continued to reflect these manufacturing and development costs, alongside clinical trial expenses. The company's goal for 2025 included commencing the Phase 3 pivotal program for this subcutaneous BRIUMVI.
Running pivotal clinical trials (e.g., ENHANCE, azer-cel)
TG Therapeutics, Inc. is actively running trials to optimize the current IV product and test new modalities. The key activity here involves advancing two main programs:
- Enrollment into the Phase 3 ENHANCE trial, evaluating a consolidated IV dosing regimen.
- Advancing azer-cel (an allogeneic CD19 CAR-T) in a Phase 1 trial for progressive MS.
The ENHANCE trial reached a significant milestone: enrollment completion in the randomized cohort on October 28, 2025. This trial is testing streamlined dosing, specifically comparing a single 600 mg BRIUMVI infusion on Day 1 against the standard 150 mg on Day 1 followed by 450 mg on Day 15. Separately, the azer-cel program saw its first patient dosed with progressive multiple sclerosis in the Phase 1 clinical trial during the second quarter of 2025.
Regulatory affairs and compliance (FDA, EMA)
Maintaining compliance and securing global market access are constant key activities. BRIUMVI already has U.S. Food and Drug Administration (FDA) approval for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Beyond the FDA, regulatory teams secured approvals from:
- The European Commission (EC) in Europe.
- The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
- Swissmedic in Switzerland.
- The Therapeutic Goods Administration (TGA) in Australia.
The company is also focused on presenting data to regulatory bodies and the broader scientific community, with updates shared at the 2025 ECTRIMS annual meeting in Barcelona, Spain, held September 24-26.
Finance: draft 13-week cash view by Friday.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Key Resources
You're looking at the core assets TG Therapeutics, Inc. (TGTX) relies on to drive its business as of late 2025. These aren't just abstract concepts; they are concrete, measurable resources that underpin their market position.
Regulatory and Intellectual Property Assets
The foundation of the Key Resources is the regulatory standing and the legal protection around its lead product, Briumvi (ublituximab-xiiy).
- Briumvi (ublituximab-xiiy) Regulatory Approvals:
- U.S. Food and Drug Administration (FDA) approval received on December 28, 2022, for relapsing forms of multiple sclerosis (RMS).
- Approval granted by the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) for adult patients with RMS who have active disease defined by clinical or imaging features in the European Union and the United Kingdom, respectively.
- Intellectual Property (IP) Protection:
- Issuance of additional U.S. patents extends patent protection covering the composition of matter and methods of treatment utilizing ublituximab through 2042.
- In the U.S., Briumvi is eligible for 12 years of market exclusivity from the date of U.S. approval under the Biologics Price Competition and Innovation Act.
Financial and Operational Capacity
The firm's current financial health and its dedicated commercial infrastructure are vital for scaling Briumvi.
Here's a quick look at the balance sheet strength as of the third quarter close:
| Financial Metric | Amount as of September 30, 2025 |
| Cash, Cash Equivalents, and Investment Securities | $178.3 million |
| Cash, Cash Equivalents, and Investment Securities as of June 30, 2025 | $278.9 million |
| Three-Month Net Income (Q3 2025) | $390.9 million |
The specialized field organization is a significant operational asset, built out to support the commercial launch that began in Q1 2023.
- Specialized Commercial and Medical Affairs Field Organization:
- Total employees across TG Therapeutics, Inc. was reported at 352.
- Selling, General and Administrative (SG&A) expense for the three months ended September 30, 2025, was approximately $63.4 million, driven by marketing and personnel costs for Briumvi commercialization.
- U.S. net product revenue for Briumvi in the third quarter of 2025 reached $152.9 million.
This structure is designed to support the ongoing commercialization of Briumvi following its U.S. launch on January 26, 2023.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Value Propositions
You're looking at the core reasons why prescribers and patients choose TG Therapeutics, Inc.'s lead product, Briumvi, over established options in the relapsing multiple sclerosis (RMS) market. The value here isn't just efficacy; it's about convenience and the underlying science.
Briumvi: Treatment for relapsing multiple sclerosis (RMS)
Briumvi (ublituximab-xiiy) is a key value driver for TG Therapeutics, Inc., targeting adult patients with RMS, which includes relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). The commercial uptake has been strong, reflecting market acceptance of this anti-CD20 therapy. For the third quarter of 2025, U.S. net product revenue for Briumvi hit $152.9 million, marking an 84% growth year-over-year. This momentum led TG Therapeutics, Inc. to raise its full-year 2025 U.S. BRIUMVI net revenue target to approximately $585 million, with the global revenue target set at $600 million. The clinical profile supports this adoption, showing that in Phase 3 trials, Briumvi reduced the annualized relapse rate (ARR) by 80% compared to placebo after 96 weeks. Furthermore, long-term data shows sustained benefit, with nearly 89.9% of patients remaining free from confirmed disability progression after six years of continuous treatment.
The core product value can be summarized:
- Targeting CD20-expressing B-cells for autoimmune disorder management.
- Sustained efficacy, with an ARR of 0.012 in Year 6 of continuous treatment.
- Low rate of IgM reduction, reported in 0.6% of treated patients.
Shorter infusion time than competitors, improving clinic efficiency
A major point of differentiation is the potential to reduce the time patients spend in the clinic for their infusion. The standard approved intravenous (IV) regimen for Briumvi involves an initial 150 mg dose over four hours, followed by a 450 mg dose over one hour two weeks later, with subsequent maintenance infusions at one hour every six months. To enhance clinic throughput, TG Therapeutics, Inc. is actively exploring faster options. Data from the ENHANCE Phase 3b trial demonstrated that rapid 30-minute BRIUMVI infusions were well tolerated in over 80 patients with RMS. Moreover, patients switching from a prior anti-CD20 therapy could receive a full 450 mg dose in just 1 hour, with 97% of those infusions completing without interruption or slowing. This focus on efficiency is a clear value proposition against therapies that might require longer or more frequent visits.
Here's a quick comparison of the maintenance infusion convenience:
| Attribute | Briumvi (Subsequent Maintenance IV) | Competitor Ocrevus (Maintenance SubQ) |
| Infusion/Injection Time | 1 hour (IV) | 10 minutes (SubQ) |
| Frequency | Every six months | Every six months |
| Potential Future Briumvi Time | Potential for 30-minute maintenance infusions | N/A |
Glycoengineered anti-CD20 antibody for efficient B-cell depletion
The underlying technology provides a value proposition rooted in molecular design. BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody. This means TG Therapeutics, Inc. specifically designed the molecule to lack certain sugar molecules normally found on antibodies. This structural modification translates directly into clinical benefit: it allows for efficient B-cell depletion at low doses. This mechanism is central to its efficacy profile in B-cell mediated diseases.
Pipeline expansion into other B-cell mediated autoimmune diseases
The value proposition extends beyond the current RMS indication through a clear pipeline strategy focused on leveraging the B-cell depletion platform. TG Therapeutics, Inc. is advancing several programs to capture value in adjacent markets. You can see this commitment in the pipeline milestones:
- Commenced patient enrollment into the Phase 3 pivotal program for subcutaneous ublituximab.
- Enrollment is ongoing for the trial evaluating BRIUMVI in autoimmune diseases outside of Multiple Sclerosis (MS).
- Phase 1 clinical trial enrollment continues for azer-cel, an allogeneic CD19 CAR T-cell therapy, targeting autoimmune diseases, starting with progressive forms of MS.
- Pivotal programs are being planned to evaluate 30 minute BRIUMVI maintenance infusions, further optimizing the patient experience.
Finance: draft 13-week cash view by Friday.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Customer Relationships
You're managing a commercial launch for a novel therapy like BRIUMVI, so the relationship strategy with prescribers and patients is everything. TG Therapeutics, Inc. (TGTX) is clearly investing heavily in making sure neurologists are educated and patients can access and stay on therapy. This focus on the customer journey is directly reflected in their financial outlay; for instance, Selling, General and Administrative (SG&A) expense in the first quarter of 2025 was $50.3 million, a notable increase from $34.6 million in the first quarter of 2024, driven by costs including marketing and personnel for BRIUMVI commercialization.
High-touch engagement with neurologists and Key Opinion Leaders (KOLs)
The strategy centers on deep, scientific engagement, which requires a highly specialized field force. This is not a 'drop-by' sales model; it's about clinical partnership. The company's structure relies on field-based Medical Science Liaisons (MSLs) who must possess deep scientific knowledge and actively maintain relationships with top thought leaders in the Multiple Sclerosis (MS) community. This high-touch approach is designed to build confidence among prescribers, which is clearly working given the raised revenue guidance.
Patient support programs (Hub services) for access and adherence
For a complex treatment, patient support is non-negotiable for adherence. TG Therapeutics, Inc. (TGTX) runs the BRIUMVI Patient Support program, which they describe as flexible and designed to support U.S. patients through their entire treatment journey in a way that works best for them. This hub service directly addresses access hurdles and helps maintain patient persistence, a key driver behind the raised full-year 2025 BRIUMVI U.S. net revenue target to approximately $585 million.
- BRIUMVI Patient Support offers flexible support for U.S. patients.
- Supports patients through the treatment journey.
Direct-to-Consumer (DTC) national television advertising campaigns
While the primary focus is on the healthcare provider, brand awareness is clearly being driven through direct-to-consumer efforts. TG Therapeutics, Inc. (TGTX) explicitly cites a 'Nationwide TV + digital campaign driving brand awareness' as a factor in BRIUMVI's strong performance. To put this in industry context, the total U.S. spending on prescription drug TV ads in the third quarter of 2025 was approximately $1.25 billion. The top 10 pharma TV ad spenders combined for $544.8 million in that same third quarter.
Medical Science Liaisons (MSLs) for clinical education
The MSL team serves as the scientific bridge between TG Therapeutics, Inc. (TGTX) and the medical community. These roles are critical for providing clinical education and support compliantly. The requirements for these roles define the high standard of relationship management:
The MSL role demands specific qualifications to ensure credibility when engaging Key Opinion Leaders (KOLs) and other healthcare professionals (HCPs):
| Requirement Type | Detail/Metric |
| Experience (Minimum) | 2 years in an MSL or similar role (MS/Neurology preferred) |
| Experience (Alternative) | > 5 years clinical experience in Multiple Sclerosis |
| Travel Expectation | Approximately 75% field-based travel |
| Key Relationship Mandate | Must have well-established networks and active relationships with KOLs |
MSLs are expected to collaborate with cross-functional teams, including Sales, Marketing, and Market Access, to deliver clinical support. One example territory assignment mentioned for an MSL role covers MN, SD, ND, IA, NE, and MO.
The commercial success funding these relationship efforts is substantial; Q3 2025 U.S. BRIUMVI net revenue hit $152.9 million, leading to a raised full-year 2025 global revenue target of approximately $600 million.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Channels
You're looking at how TG Therapeutics, Inc. gets its product, BRIUMVI, into the hands of neurologists and patients as of late 2025. It's a multi-pronged approach centered on specialty care, so let's break down the specific avenues they use to reach their customer segments.
Direct U.S. Sales Force to Neurology Clinics and Infusion Centers
The direct sales force is your primary engine for driving adoption in the U.S. market. When TG Therapeutics, Inc. launched BRIUMVI in early 2023, the sales team covered about half of the 550 centers they estimate account for 70-80% of the total U.S. Multiple Sclerosis (MS) market. By 2024, they had doubled that sales force to cover all 550 targeted centers and increase the frequency of interactions with healthcare providers. This investment in personnel is reflected in the Selling, General and Administrative (SG&A) expenses, which totaled $55.6 million for the three months ended June 30, 2025, and $169.3 million for the nine months ended September 30, 2025. The effort is paying off, as management noted in Q2 2025 that roughly one-third of new Intravenous (IV) anti-CD20 starts were choosing BRIUMVI. For the third quarter of 2025, U.S. net product revenue for BRIUMVI hit $152.9 million, leading to a raised full-year 2025 U.S. guidance of approximately $585 million. That's the goal for the direct channel this year.
Specialty Distributors and Wholesalers for Product Delivery
For the physical delivery of BRIUMVI, TG Therapeutics, Inc. relies on established specialty distribution networks. This is the logistical backbone that ensures the product gets from the manufacturer to the infusion center after a prescription is written. While the exact number of partners isn't public, you can find a list of authorized specialty distributors on their product website. The cost of getting the product to market is part of the Cost of Revenue, which was $38.5 million for the year ended December 31, 2024. The efficiency of this channel is key to hitting the raised full-year 2025 global revenue target of $600 million.
Here's a snapshot of the U.S. commercial performance driving these channel activities:
| Metric | Q3 2025 Amount | Year-over-Year Growth (Q3 2024 vs Q3 2025) | Sequential Growth (Q2 2025 vs Q3 2025) |
| BRIUMVI U.S. Net Product Revenue | $152.9 million | 84% | 10% |
| Total Revenue | $161.7 million | 92.7% (Based on $83.9M Q3 2024 preliminary) | 14.6% (Based on $141.1M Q2 2025) |
| Full Year 2025 U.S. Revenue Guidance | ~$585 million | N/A | N/A |
Ex-U.S. Commercial Partner, Neuraxpharm, for International Markets
For markets outside the U.S., TG Therapeutics, Inc. uses a strategic partnership with Neuraxpharm Pharmaceuticals, S.L., which focuses on Central Nervous System (CNS) disorders. They signed the Commercialization Agreement in August 2023. This deal is structured to provide significant upside for TG Therapeutics, Inc. through milestones and royalties. The total potential value of the deal is up to $645 million. The upfront payment was $140 million, plus an additional $12.5 million upon the first key market commercial launch in the European Union (EU), which happened in Germany on February 26, 2024. TG Therapeutics, Inc. is eligible to receive up to $492.5 million in future launch and commercialization milestones, along with tiered double-digit royalties on net product sales up to 30%. As of Q3 2025, BRIUMVI is approved in several territories via this channel, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates. The milestone payment of $12.5 million from the first EU launch was recorded in the nine months ended September 30, 2024.
Digital and Social Media for Patient and Physician Awareness
Awareness campaigns are crucial for driving the high volume of new patient starts needed to meet guidance. Management noted in January 2025 that sustained new patient growth was expected to be bolstered by upcoming advertisements and increased visibility among key opinion leaders. While specific digital ad spend figures aren't itemized in the same way as SG&A, the focus is clearly on digital and conference presence. You can track their public-facing communications through their official channels:
- X (formerly Twitter) handle: @TGTherapeutics
- Professional networking: LinkedIn presence
- Patient support access: www.briumvipatientsupport.com
- Product information: www.briumvi.com
They also presented data at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, which is a key channel for physician education.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Customer Segments
You're looking at the core groups TG Therapeutics, Inc. (TGTX) serves or aims to serve with its commercial and pipeline products as of late 2025. It's a focused approach, centered heavily on the multiple sclerosis (MS) market right now.
Adult patients with relapsing forms of multiple sclerosis (RMS)
This is the primary market for the flagship product, BRIUMVI (ublituximab-xiiy). The total addressable market in the US is substantial, though TGTX is competing for share within it.
- Estimated nearly 1 million people living with MS in the United States.
- Approximately 85% of those diagnosed in the US are initially diagnosed with RRMS.
- Worldwide, more than 2.3 million people have a diagnosis of MS.
- BRIUMVI U.S. net product revenue for Q3 2025 was $152.9 million.
- Full year 2025 BRIUMVI U.S. net revenue target is approximately $585 million.
- Data from the ULTIMATE I & II Phase 3 trials showed 89.9% of patients were free from 24-week confirmed disability progression after 6 years of continuous BRIUMVI treatment.
Neurologists and MS treatment specialists/prescribers
These are the key decision-makers who write the prescriptions for BRIUMVI. Their confidence and adoption drive the revenue figures we see.
- BRIUMVI U.S. net product revenue for Q2 2025 was $138.8 million.
- BRIUMVI U.S. net product revenue for Q3 2025 represented 10% growth over Q2 2025.
- The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries.
Healthcare Payers (insurance companies, government programs)
Payer coverage dictates patient access, which is a critical risk factor mentioned in their disclosures. The commercial success hinges on favorable formulary placement.
Here's a quick look at the scale of the commercial operation supporting these segments as of late 2025:
| Metric | Value as of Q3 2025 or Latest Guidance | Date/Period |
| Total Global Revenue Target (FY 2025) | $600 million | FY 2025 Guidance |
| Q3 2025 Total Revenue | $161.7 million | Three months ended September 30, 2025 |
| Cash, Cash Equivalents, and Investment Securities | $178.3 million | September 30, 2025 |
| Gross Margin | 86.96% | Q3 2025 Data |
Clinical trial participants for pipeline products (e.g., azer-cel)
This segment represents future customers, specifically patients with progressive forms of MS who are not currently addressed by the approved indication for BRIUMVI.
- Azer-cel, an allogeneic CD19 CAR T, is in Phase 1 for progressive MS (PPMS and SPMS).
- The early-stage azer-cel trial is expected to recruit up to a total of 32 patients.
- The company continued enrollment for patients with progressive MS into the ongoing Phase 1 clinical trial evaluating azer-cel as of Q3 2025.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Cost Structure
You're looking at where TG Therapeutics, Inc. is putting its cash to work to drive the commercial success of Briumvi and advance its pipeline. The cost structure is heavily weighted toward getting Briumvi into more hands and developing the next generation of treatments.
R&D Expenses, Including Subcutaneous Briumvi Development
Research and Development (R&D) is a major cost center, reflecting the ongoing commitment to pipeline advancement, especially the subcutaneous version of Briumvi. For the third quarter ended September 30, 2025, total R&D expense was approximately $40.9 million. This was up from $20.1 million for the same period in 2024. For the first nine months of 2025, R&D spend totaled $119.0 million, compared to $70.4 million for the first nine months of 2024.
Honestly, that increase in R&D spend during the third quarter was mainly due to manufacturing and development costs tied directly to the subcutaneous ublituximab development work. This is a critical investment, as management noted that a successful subcutaneous launch could potentially double the total addressable market for Briumvi.
Selling, General, and Administrative (SG&A) for Commercial Expansion
SG&A costs are climbing to support the commercial rollout and expansion of Briumvi. For the third quarter of 2025, SG&A expense hit approximately $63.4 million. That compares to $42.0 million in the third quarter of 2024. On a nine-month basis through September 30, 2025, total SG&A was $169.3 million, up from $115.3 million for the same period in 2024.
This higher spend reflects increased marketing, personnel, and external costs associated with scaling the Briumvi commercial footprint. The company is definitely investing in the field organization and marketing initiatives, like national television campaigns, to drive adoption.
Manufacturing and Supply Chain Costs for Briumvi Production
Specific, standalone figures for manufacturing and supply chain costs for the currently marketed intravenous Briumvi aren't broken out separately in the top-line reporting you see here. What we do know is that manufacturing expenses are bundled into the R&D line item when they relate to the development of new formulations, like the subcutaneous version. The overall gross margin remains robust at 86.96%, which suggests the cost of goods sold (COGS) for the existing product is well-managed.
Clinical Trial Costs and Regulatory Filing Fees
Clinical trial costs are a significant, though integrated, part of the overall R&D spend. The increase in R&D expense for the first nine months of 2025 included increased clinical trial expenses related to the clinical pipeline. You should know that these costs cover fees paid to trial sites and vendors associated with managing clinical studies. Regulatory filing fees are also part of this overall investment in pipeline progression, though specific fee amounts aren't itemized in the quarterly releases.
Here's a quick look at the main operating expense drivers for the third quarter of 2025:
| Expense Category | Q3 2025 Amount (Millions USD) | Nine Months Ended 9/30/2025 Amount (Millions USD) |
| Research & Development (R&D) | $40.9 | $119.0 |
| Selling, General & Administrative (SG&A) | $63.4 | $169.3 |
| Total Operating Expenses (R&D + SG&A, excluding noncash comp) | $86.6 | $239 |
The combined operating expenses, excluding noncash compensation, totaled approximately $86.6 million for the third quarter. Management reiterated the full-year operating expense guidance to be in the range of approximately $300 million to $320 million.
The pipeline activities driving these R&D costs include key milestones:
- Commenced patient enrollment into the Phase 3 pivotal program for subcutaneous ublituximab.
- Completed patient enrollment into the randomized Phase 3 ENHANCE trial for simplified IV dosing.
- Continued enrollment for the Phase 1 clinical trial evaluating azer-cel for autoimmune diseases.
Finance: draft 13-week cash view by Friday.
TG Therapeutics, Inc. (TGTX) - Canvas Business Model: Revenue Streams
You're looking at the core engine driving TG Therapeutics, Inc.'s current financial performance, which is almost entirely centered on the commercial success of BRIUMVI (ublituximab-xiiy). As a seasoned analyst, I can tell you that seeing a company raise guidance mid-year, as TG Therapeutics did after Q3 2025, is a strong signal of market acceptance and execution. Here's the quick math on where the money is coming from as we head into the final quarter of 2025.
Product Sales: BRIUMVI Dominance
The primary revenue driver is the net product sales of BRIUMVI in the United States for relapsing forms of multiple sclerosis (RMS). The market demand has been strong enough that TG Therapeutics has repeatedly increased its expectations for the year. The full-year 2025 target for U.S. net product sales of Briumvi has been raised to approximately $585 million. This reflects continued strong sequential and year-over-year growth, with Q3 2025 U.S. net product revenue alone hitting $152.9 million.
This revenue stream is supported by the international expansion, which flows through the licensing agreement. For the third quarter of 2025, sales of BRIUMVI to the ex-U.S. licensing partner, Neuraxpharm, accounted for $6.4 million. This figure is derived from the reported total product revenue of $159.3 million for Q3 2025, less the U.S. net sales of $152.9 million. It's defintely a key component of the global picture.
Here's a snapshot of the key revenue components for the third quarter of 2025:
| Revenue Component | Q3 2025 Amount (Millions USD) |
| U.S. BRIUMVI Net Product Sales | 152.9 |
| Sales to Ex-U.S. Partner (Neuraxpharm) | 6.4 |
| Total Product Revenue, net | 159.3 |
Ancillary and Partnership Revenue
Beyond the direct sales of the drug product, TG Therapeutics, Inc. also captures revenue from its intellectual property and commercial partnerships. This category is smaller but important for showing the value embedded in their agreements.
For the third quarter of 2025, the revenue recognized from license, milestone, royalty, and other revenue was approximately $2.4 million. This is calculated by taking the total reported revenue for the quarter and subtracting the total product revenue.
The overall commercial success is summarized in the updated full-year outlook. The total global revenue target for 2025 has been increased to approximately $600 million. That's a significant upward revision, showing management's confidence in the fourth quarter performance to close the gap from the Q3 figures to the full-year goal.
You should keep an eye on these revenue sources as they evolve:
- U.S. BRIUMVI net sales growth rate.
- Milestone achievement triggers with Neuraxpharm.
- Progress on pipeline assets that could generate future royalties.
- The ongoing commercial uptake outside the United States.
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