TG Therapeutics (TGTX) Q1 2025: Briomvy Revenue Jumps 137% as Repeat Prescriptions Surpass New Starts
Briomvy’s accelerating adoption and rising repeat prescriptions mark a critical inflection point for TG Therapeutics’ commercial strategy. Commercial execution outpaced expectations, with notable traction among both new and switching MS patients, while pipeline innovation and lifecycle investments signal management’s intent to deepen the franchise. With repeat prescriptions now overtaking new starts, TG’s focus shifts to sustaining momentum and broadening indications amid a competitive landscape.
Summary
- Inflection in Persistence: Repeat prescriptions for Briomvy now exceed new starts, underscoring deepening patient and prescriber confidence.
- Pipeline Expansion: Subcutaneous and simplified dosing regimens advance, aiming to further differentiate Briomvy’s profile and access.
- Revenue Guidance Raised: Management lifts full-year outlook, citing robust Q1 demand and ongoing commercial tailwinds.
Performance Analysis
Q1 marked a step-change in Briomvy’s commercial trajectory, with U.S. net sales reaching $119.7 million, reflecting 137% year-over-year and 16% sequential growth. This performance exceeded internal expectations and was driven by both new patient enrollments and, for the first time, a higher volume of repeat prescriptions than new starts. The company highlighted that March was its highest month ever for repeat prescribers, a signal of growing prescriber satisfaction and patient persistence.
Hospital channel penetration deepened, with institutional accounts representing approximately 60% of enrollments in March, the highest to date. The company also reported strong financial discipline, with operating expenses (OpEx) at $82 million, tracking modestly ahead of full-year guidance due to manufacturing investments for the subcutaneous Briomvy formulation. Importantly, TG Therapeutics delivered positive net income, supported by robust sales and a stable gross-to-net profile.
- Persistence Trend Shift: The crossover where repeat prescriptions now outnumber new starts highlights durable patient retention and therapy stickiness.
- Institutional Channel Growth: Hospital enrollments surged, reflecting effective targeting of high-volume infusion centers and academic partners.
- OpEx Moderation: Despite increased R&D for new formulations, management reaffirmed its $300 million annual operating expense target, supporting margin stability.
With these dynamics, TG raised full-year Briomvy revenue guidance to $560 million (from $525 million), and set Q2 expectations at $135 million, indicating confidence in continued demand acceleration.
Executive Commentary
"Over the past month, I spent a significant amount of time in the field, meeting with prescribers, and it's energizing to see firsthand how Briomvy is becoming the go-to anti-CD20 therapy for many of them... Word of mouth within the MS community is powerful, and we believe these success stories are helping to drive continued growth and enthusiasm."
Michael Weiss, Chairman and CEO
"Importantly, we're seeing both an expansion of the CD20 market overall and continued dynamic market share gains for Briomvy in the anti-CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switched patients."
Adam Waldman, Chief Commercialization Officer
Strategic Positioning
1. Commercial Execution and Market Share Capture
TG’s commercial team executed a multi-phase launch strategy, targeting high-volume infusion centers and community neurologists, which resulted in record new patient enrollments and repeat prescriber activity. The company reports dynamic market share gains in the IV anti-CD20 segment, with Briomvy now estimated at over 25% share, and signals that this figure continues to rise. Targeted hospital engagement and repeat prescriber growth are reinforcing Briomvy’s position as a preferred therapy among both new and switch patients.
2. Lifecycle Innovation and Pipeline Advancements
Lifecycle management is central to TG’s strategy, with several pipeline initiatives designed to sustain differentiation. The company is advancing a registration-directed trial for a simplified 600mg day-one dosing regimen, eliminating the need for a day 15 dose and streamlining patient onboarding. Additionally, a self-administered subcutaneous (sub-Q) Briomvy formulation is progressing, with pivotal trials planned and early data supporting potential every-other-month or quarterly dosing. These innovations aim to expand patient access and address evolving preferences in the MS community.
3. Broadening Indications and Pipeline Optionality
Beyond relapsing MS, TG is evaluating Briomvy’s sub-Q formulation in myasthenia gravis (MG), and is also advancing Azercel, an allogeneic CD19 CAR-T cell therapy, into early trials for progressive MS. While the company remains cautious in expanding into MG, it is positioned to accelerate if market dynamics warrant. These pipeline moves reflect a commitment to building a multi-product autoimmune portfolio, leveraging platform assets for long-term growth.
4. Financial Discipline and Manufacturing Flexibility
Despite R&D investments in new formulations, management reaffirmed its $300 million annual OpEx guidance and highlighted a strong balance sheet with $276 million in cash and equivalents. The company is also progressing a North Carolina manufacturing facility as a long-term risk mitigation measure, though near-term production remains in South Korea. Management does not expect proposed tariffs to materially impact gross margins, citing low cost of goods and ongoing monitoring of policy changes.
Key Considerations
This quarter’s results underscore a pivotal shift toward durable revenue growth and pipeline-driven optionality, but also surface new considerations as Briomvy’s lifecycle matures:
- Persistence Inflection: The transition to repeat prescriptions outpacing new starts signals maturing product adoption, but sustaining high persistence rates will be critical as the base grows.
- Competitive Dynamics: Despite new entrants (e.g., Zenovo), management reports “zero impact” on Briomvy’s trajectory, though ongoing competitive launches could pressure future share gains.
- Lifecycle Innovation Execution: Timely execution of simplified dosing and sub-Q pivotal trials will be essential to maintain differentiation as the market evolves.
- OpEx and Margin Management: Manufacturing and R&D investments are front-loaded, but management’s disciplined guidance implies confidence in margin preservation as revenue scales.
- Indication Expansion Optionality: Cautious approach to new indications like MG could limit near-term upside but preserves capital flexibility and risk management.
Risks
Key risks include intensifying competition in the anti-CD20 MS segment, particularly as new IV and sub-Q options launch, potentially eroding Briomvy’s dynamic share gains. Regulatory and policy changes, such as tariffs or Medicare reimbursement shifts, could affect cost structure, though management currently expects minimal impact. Execution risk around pipeline trials and lifecycle innovation remains, and any delays could narrow TG’s competitive window. Finally, expansion into new indications brings development and commercial uncertainty, especially in crowded autoimmune markets.
Forward Outlook
For Q2 2025, TG Therapeutics guided to:
- $135 million in Briomvy U.S. net revenue
For full-year 2025, management raised guidance:
- Briomvy U.S. net revenue: $560 million (up from $525 million)
- Total OpEx: $300 million (unchanged)
Management highlighted several factors that support the outlook:
- Record April enrollments and persistent demand momentum
- Strong hospital channel expansion and repeat prescriber trends
- Continued investment in direct-to-patient campaigns and real-world evidence generation
Takeaways
Investors should view Q1 as a validation of Briomvy’s commercial durability and TG’s operational discipline, but also as a juncture where future growth will increasingly depend on successful lifecycle and pipeline execution.
- Commercial Inflection: Repeat prescriptions overtaking new starts marks a critical maturity milestone, but future growth will require continued share capture and high persistence.
- Pipeline Differentiation: The pace and success of simplified dosing and sub-Q launches will determine Briomvy’s ability to fend off competition and expand its addressable market.
- Strategic Optionality: Prudent investment in new indications and manufacturing flexibility position TG for long-term resilience, but execution risks remain as the business scales.
Conclusion
Briomvy’s Q1 performance demonstrates robust commercial momentum and deepening market penetration, with repeat prescriptions now driving the franchise. TG Therapeutics’ focus on lifecycle innovation and pipeline expansion provides multiple levers for future growth, though execution and competitive dynamics will be key watchpoints for investors in the coming quarters.
Industry Read-Through
TG’s results reinforce the ongoing expansion and segmentation of the anti-CD20 MS therapy market, with product differentiation increasingly driven by dosing convenience, persistence, and patient experience. The rapid uptake of sub-Q formulations and simplified regimens highlights a broader shift toward patient-centric innovation in neurology and autoimmune therapeutics. For competitors and adjacent players, the inflection in repeat prescriptions underscores the importance of lifecycle management and real-world evidence in sustaining market leadership as biologic therapies mature. Investors should monitor how new entrants and evolving reimbursement dynamics reshape share trajectories and margin structures across the specialty pharma landscape.