As growth evolves across channels, are there meaningful changes in gross-to-net assumptions, or does the prior framework still hold?

Gross-to-net can vary quarter-to-quarter, especially in Q1 due to deductible resets and co-pay programs. This is a Q1 dynamic consistent with historical trends and fully incorporated into the full-year guidance, not a structural change. “It is a Q1 dynamic that seems to be consistent with what we see across the CD20 space, also other specialty products, and it's fully baked into our full year guidance.”

Given strong new patient starts, why is guidance conservative? What is the proportion of new vs. switch patients, and how much revenue comes from repeat patients? Are new patient starts still growing?

The company is being somewhat conservative with guidance early in the year, but new patient enrollments are at record levels and persistence is strong. The business is becoming more predictable with a growing proportion of repeat patients. Q1 faces headwinds from gross-to-net and benefit reverification, which are distinct from underlying demand. “We're being somewhat conservative here. But so far, the year is starting are strong, but we're -- again, we're only in February. So we'll see how that goes.”

How much incremental investment is needed for the subcu launch, and what are the plans for commercializing subcu BRIUMVI ex-U.S.?

There will not be a huge incremental investment for the U.S. subcu launch, as there is about 80% overlap with the current IV field force, plus some marketing costs. For ex-U.S., the partner Neuraxpharm is expected to opt into the program. “overlap between our current field force for IV to subcu is, I think, about 80%. So I don't -- there's not a huge incremental cost.”

TGTX

TG Therapeutics (TGTX) Q4 FY25 earnings call: guidance and Q&A

Earnings call· Dec 2025 (Q4 FY25)· Health Care· Feb 26, 2026

Source: earnings call transcript

Executive summary

TG Therapeutics Q4 FY25 — BRIUMVI Drives Strong Growth, Pipeline Advances

TG Therapeutics delivered a strong Q4 and full-year 2025, driven by robust BRIUMVI sales and market share gains in the relapsing multiple sclerosis (RMS) market. The company is advancing its pipeline with ENHANCE and subcutaneous BRIUMVI programs, aiming to simplify treatment and expand market opportunity. Management reaffirmed its full-year 2026 revenue guidance, balancing strong demand with typical Q1 seasonal headwinds, and emphasized a flexible capital allocation strategy focused on maximizing BRIUMVI, judicious pipeline expansion, and share repurchases.

Highlights

Total global revenue reached approximately $616 million for FY25.
BRIUMVI U.S. net sales were $594 million for FY25, with Q4 sales of $183 million.
Q4 FY25 U.S. net sales grew approximately 92% year-over-year and 20% sequentially.
6-year open-label extension data for BRIUMVI showed nearly 90% of patients free from 24-week confirmed disability progression.
The company expects to continue generating positive cash flow in 2026 and beyond.

Concerns

Q1 FY26 U.S. revenue is expected to be $185 million to $190 million, reflecting typical seasonal headwinds like benefit reverifications and gross-to-net variability due to deductible resets.
Gross margin for Q4 FY25 was slightly below typical due to timing of sales to an ex-U.S. partner and a one-time inventory reserve.

Guidance & targets

Category	Target	Timeline	Confidence
Positive cash flow	Continue generating positive cash flow high materiality	FY26 and beyond	High
Full year U.S. BRIUMVI net revenue	$825 million to $850 million high materiality	Full year 2026 · FY26	High
Total global revenue	$875 million to $900 million high materiality	Full year 2026 · FY26	High
U.S. revenue	$185 million to $190 million medium materiality	Q1 · FY26	High
Ex-U.S. revenue	$5 million to $10 million medium materiality	Q1 · FY26	High
Full year operating expenses (excluding noncash comp)	approximately $350 million medium materiality	Full year 2026 · FY26	High
Subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up expenses	approximately $100 million medium materiality	Full year 2026 · FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
U.S. BRIUMVI Strong performance in the fourth quarter, showing significant year-over-year and sequential growth, contributing the vast majority of global revenue. Full year 2025 net revenue: $594 million	$183 million	92%	20%	—
Ex-U.S. (Neuraxpharm) Revenue from sales to partner Neuraxpharm for ex-U.S. commercialization. Full year 2025 revenue from products supplied to Neuraxpharm: $12.8 million	$6.4 million	—	—	—
Global Total Total net product revenue for the quarter, including U.S. and ex-U.S. sales. Full year 2025 global revenue: $616 million	$189.1 million	—	—	—

Deals & partnerships

Neuraxpharm Ex-U.S. commercialization of BRIUMVI

Partner for commercialization of BRIUMVI outside the U.S. Expected to opt into the subcutaneous program when offered.

Christina Applegate Launch of NextInMS.com educational platform

Partnership to launch an educational platform for individuals living with RMS and their caregivers, focusing on education, empowerment, and informed dialogue.

Risks & headwinds

Seasonal headwinds impacting Q1 revenue Q1 FY26

Q1 FY26 U.S. revenue expected to be $185 million to $190 million, reflecting typical seasonal headwinds.

Mitigation:These dynamics are consistent with historical trends and fully incorporated into full-year guidance.

Gross margin impact from ex-U.S. sales timing and inventory reserve Q4 FY25

Gross margin for Q4 FY25 was slightly below typical.

Mitigation:Caused by timing of sales to ex-U.S. partner and a one-time inventory reserve, implying it is not a structural issue.

What to watch in Q1 FY26

ENHANCE trial top-line data

Midyear 2026

Current Enrollment complete

Target Top-line data release

Why it matters

Successful data could simplify BRIUMVI treatment, potentially increasing market share and convenience for patients and centers.

Enrollment is complete. We expect top line data midyear with the potential 2027 launch of this consolidated treatment schedule.

Find out whether TGTX delivers this. Inve re-checks your case every morning.

Q&A highlights

How do dynamics of accelerating subcu uptake by competitors in community practices fit with BRIUMVI's broad momentum across academic and community settings in the HCP administered segment? Where is the strongest incremental momentum?

BRIUMVI continues to gain share in the IV segment, with de novo business primarily from Ocrevus IV. Growth is seen across both private practice and academic centers, driven by clinical data, 6-year safety data, and operational advantages. New patient enrollments are at their highest since launch, and persistence is strong.

“It seems like the majority of the de novo business seems to be coming from Ocrevus IV. But importantly, we're also -- we're not seeing any decreases in the switches from Ocrevus to BRIUMVI.”

asked by Michael DiFiore · answered by Adam Waldman

2 min read 5 chapters

Detailed narrative

BRIUMVI Performance and Market Position

BRIUMVI achieved approximately $616 million in total global revenue for FY25, with U.S. net sales of $594 million. Q4 FY25 U.S. net sales were $183 million, marking 92% year-over-year and 20% sequential growth. The drug continues to gain dynamic share in the IV anti-CD20 segment, driven by its clinical profile, 6-year safety data, and operational advantages like a 1-hour twice-yearly maintenance infusion.

Growth is broad-based across academic and community settings, with record new patient enrollments and strong persistence on therapy.

Pipeline Advancement: ENHANCE and Subcutaneous BRIUMVI

The Phase III ENHANCE study, evaluating a single 600mg dose of BRIUMVI (consolidating day 1 and day 15 infusions), has completed enrollment with top-line data expected midyear 2026 and a potential 2027 launch. The subcutaneous BRIUMVI program, a self-administered at-home auto-injector, is approximately 75% enrolled in its Phase III study, with pivotal top-line data targeted for late 2026 or early 2027 and a potential 2028 launch.

This subcu formulation is expected to significantly expand the total addressable market.

Capital Allocation Strategy

TG Therapeutics expects to generate positive cash flow in 2026 and beyond, providing financial flexibility. Capital priorities include maximizing the BRIUMVI opportunity, judiciously expanding the pipeline, and repurchasing shares when undervalued. The company completed a $100 million share repurchase program and authorized an additional $100 million, viewing shares as significantly undervalued relative to expected cash flow.

Commercial Strategy and Field Expansion

The company expanded its field organization in 2025 to deepen coverage in high-opportunity geographies and broaden reach among community neurologists and independent infusion centers. This expanded footprint is driving increased prescriber engagement and is expected to accelerate penetration in 2026. Direct-to-patient engagement efforts also expanded, including a partnership with Christina Applegate for the Next In MS educational platform, which has exceeded engagement expectations.

Q1 FY26 Outlook and Gross-to-Net Dynamics

For Q1 FY26, U.S. revenue is projected to be $185 million to $190 million, showing sequential growth over Q4 despite typical seasonal headwinds. These headwinds include benefit reverifications and gross-to-net variability driven by deductible resets, which are consistent with historical trends in the specialty product category and fully incorporated into the full-year guidance.

Ex-U.S. revenue for Q1 is expected to be $5 million to $10 million.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.