Earnings Call Insights: TG Therapeutics (TGTX) Q3 2025
Management View
- CEO Michael Weiss reported, “Our flagship product, BRIUMVI for relapsing MS continues to outperform, exemplifying what happens when innovation meets execution. We’ve always believed BRIUMVI had a best-in-class profile, and we’ve built what we believe is the best-in-class team around it.” Weiss detailed the launch and progress of two pivotal studies: ENHANCE, which seeks to consolidate BRIUMVI’s dosing into a single infusion, and a Phase III trial of subcutaneous ublituximab, with enrollment progressing well and data expected by late 2026 or early 2027. Weiss stated these could lead to “meaningful new launches in ’27, ’28 and ’29, each with the potential to drive continued growth into the next decade.”
- Weiss emphasized a disciplined approach to capital allocation, noting, “During the quarter, we completed our initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50. The Board has now authorized another $100 million program, giving us flexibility to keep doing what makes sense.”
- Chief Commercialization Officer Adam Waldman highlighted, “U.S. net sales for BRIUMVI in Q3 totaled approximately $153 million, extending our track record of strong sequential and year-over-year growth. BRIUMVI’s performance once again exceeded both our internal targets and the Street’s expectation, underscoring the depth and consistency of demand we continue to see across the marketplace.” Waldman attributed growth to strong demand, favorable commercial indicators, and strategic expansion of the field organization. He also referenced the first full quarter of national television campaigns as an early success in brand awareness.
- CFO Sean Power stated, “Our third quarter results reflect sustained commercial strength with total revenue reaching $161.7 million, an increase of 93% compared to Q3 ’24 and 15% over Q2 ’25. Product revenue totaled $159.3 million, driven primarily by $152.9 million in U.S. BRIUMVI net sales.”
Outlook
- Waldman announced, “Based on the strong year-to-date performance, continued new patient growth and positive persistence trends, we are again raising our full year 2025 U.S. BRIUMVI net revenue guidance from $570 million to $575 million to now approximately $585 million for the full year 2025.”
- Management reiterated confidence in BRIUMVI’s long-term potential, describing it as “on track to become a multibillion-dollar brand in RMS.”
Financial Results
- Power detailed that total operating expenses, defined as R&D and SG&A excluding noncash compensation, were approximately $86.6 million in Q3 and approximately $239 million for the nine months ended September 30. He explained, “The quarter-over-quarter increase in OpEx was primarily driven by continued investment in R&D for subcutaneous BRIUMVI as well as higher SG&A spend to support the continued expansion of the BRIUMVI commercial footprint.”
- The company ended the quarter with approximately $178 million in cash, cash equivalents and investment securities.
- GAAP net income was $390.9 million or $2.43 per diluted share, which included a nonrecurring income tax benefit of approximately $365 million from the release of the deferred tax asset valuation allowance. Power clarified, “While this release impacts reported GAAP net income and earnings per share, it does not affect our cash position or our day-to-day operating performance.”
Q&A
- Tara Bancroft, TD Cowen, asked about the updated revenue guidance and implied Q4 growth deceleration. Waldman responded that growth assumptions are “quite good, 14% quarter-over-quarter in the third year here,” driven by patient retention and field expansion, with hopes that media investments will further support demand.
- Lut Ming Cheng, JPMorgan, inquired about demand from the J-code and field force expansion. Waldman clarified, “We’ve had a J-code for several years at this point,” and said hospital demand growth outpaced private practice, driven by new sales reps and account additions.
- Corinne Jenkins, Goldman Sachs, sought details on the subcutaneous product’s market opportunity. Weiss responded, “Subcu — self-administered subcu is approximately 35% closer probably to 40% at this point, potentially growing… 50% of new starts, that would double the opportunity.”
- Michael DiFiore, Evercore ISI, questioned inventory and competitive dynamics. Waldman stated, “No inventory changes or gross to net changes in the quarter. Gross to net is still within the range that we’ve provided.” Regarding competition, he noted the subcutaneous segment has stabilized around a 65-35 or 60-40 IV to subcu split.
- Prakhar Agrawal, Cantor Fitzgerald, asked about 2026 trends and business development. Waldman emphasized patient persistence and new patient growth, while Weiss reiterated a high ROI standard for deals, saying, “It’s all about ROI and risk reward.”
- William Wood, B. Riley Securities, asked about 2026 expectations and maintenance drop-offs. Waldman said patient persistence is “above expectations” and remains a key growth driver, with DTC investments being refined for better targeting.
- Cha Cha Yang, Jefferies, asked about the simplified dosing regimen’s market impact. Weiss said, “This one doesn’t have a clearly different addressable market,” but cited customer excitement and rapid enrollment as positive indicators.
Sentiment Analysis
- Analysts expressed moderate optimism, focusing on sustainability of growth, competitive pressures, and market expansion, but pressed for clarity on growth drivers and the impact of new initiatives.
- Management maintained a confident tone in both prepared remarks and Q&A, consistently emphasizing growth, operational strength, and discipline, with Weiss stating, “Our progress to date, I believe, speaks volumes to the value BRIUMVI delivers.”
- Compared to the previous quarter, the management tone remains confident, but analysts showed increased focus on sustainability of current growth rates and competitive market dynamics.
Quarter-over-Quarter Comparison
- Revenue guidance was raised from a previous $575 million to approximately $585 million for 2025, reflecting stronger-than-expected demand and persistence.
- Product revenue for BRIUMVI increased from $139 million in Q2 to approximately $153 million in Q3.
- Operating expenses increased to $86.6 million from the Q2 figure of $71 million, attributable to R&D and commercial expansion.
- Management’s confidence in subcutaneous BRIUMVI and pipeline progress remained strong, with more specificity on timelines and addressable market potential compared to last quarter.
- Analysts’ questions shifted more toward the long-term sustainability of growth and the competitive landscape, compared to previous quarters where initial launch momentum was a primary focus.
Risks and Concerns
- Management cited the potential for temporary changes in profitability due to future business development moves.
- Weiss highlighted, “Some [deals] look tempting, but we’ve chosen to stay patient and true to our principles,” signaling caution in external investments.
- Analysts raised concerns about deceleration in sequential growth, the impact of competition in the subcutaneous segment, and the translation of DTC investments into sustained demand.
Final Takeaway
TG Therapeutics delivered another quarter of commercial strength, raising full-year BRIUMVI revenue guidance as demand and patient retention remain robust. The company advanced key pipeline milestones, progressing pivotal studies for both simplified dosing and subcutaneous BRIUMVI, which management believes could significantly expand the addressable market. With disciplined capital allocation, a focus on operational excellence, and a strong financial position, TG Therapeutics is positioning itself for sustained growth and leadership in the MS market.