TG Therapeutics Q1 Earnings Call Highlights

TG Therapeutics NASDAQ: TGTX reported first-quarter 2026 results that management characterized as “record-setting” across most of its commercial metrics, led by sales of multiple sclerosis therapy BRIUMVI. The company posted U.S. BRIUMVI net product revenue of approximately $195 million, exceeding its prior guidance range of $185 million to $190 million, and said total net product revenue reached $201 million when including product sales to its ex-U.S. partner Neuraxpharm.

BRIUMVI sales beat guidance as company raises full-year outlook

Chairman and CEO Michael Weiss said the quarter reflected “consistency and durability” across the business, noting that global revenue exceeded $200 million and that the company expects to approach a $1 billion annualized run rate before year-end.

Chief Commercial Officer Adam Waldman said U.S. net revenue grew 63% year-over-year and represented the “12th consecutive quarter of sequential growth since launch.” He added that the company saw record new patient enrollments, with March described as its highest month ever.

Following the stronger quarter, Waldman said TG Therapeutics is raising full-year 2026 U.S. revenue guidance to $885 million to $900 million and is providing second-quarter guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. CFO Sean Power also said the company raised its full-year total global revenue guidance to approximately $925 million.

Installed patient base grows; persistence and DTC efforts highlighted

Waldman said more than 25,000 patients have been prescribed BRIUMVI globally, framing the milestone as evidence the company is moving beyond “early adoption” and building an “installed base” in a recurring, twice-yearly dosing model. He said persistence has been “strong,” and later added in Q&A that trends have been “better than expected” as patients move into their second year of treatment, though he emphasized it is still early and the company will continue to monitor as data matures.

Waldman also pointed to direct-to-consumer (DTC) outreach as a contributor to awareness, saying the company has been investing over the last year and is encouraged by “markers and indicators of success,” with more patients arriving at physicians’ offices already informed about BRIUMVI.

On competition, Waldman said the company continued to grow sequentially while outpacing competitors and the broader MS market. He stated TG Therapeutics is “now the number one CD20 by dynamic share in private practices with infusion capabilities,” attributing uptake to a combination of clinical profile, operational simplicity, one-hour infusion, and twice-yearly dosing. He also said the share of treatment-naive patients in BRIUMVI’s mix continues to rise, which he called a key leading indicator of long-term positioning.

Clinical and real-world data emphasized; “wearing off” switch data presented

Weiss said the company’s five-year follow-up data from the ULTIMATE I and II open-label extension were published in JAMA Neurology, which he said reinforced sustained efficacy and a consistent safety and tolerability profile over time. He also cited presentations at the American Academy of Neurology (AAN) meeting highlighting real-world data on rapid and sustained B-cell depletion, low annualized relapse rates maintained over time, and infusion experience/tolerability.

Weiss said TG Therapeutics presented prospective data for the first time in patients who switched from a prior anti-CD20 therapy to BRIUMVI, showing improvement in patient-reported “wearing off” symptoms—sometimes referred to as the “crap gap”—after switching.

Pipeline updates: ENHANCE, subcutaneous BRIUMVI, and new indications

Weiss outlined two key lifecycle programs aimed at extending the BRIUMVI franchise:

• ENHANCE (Phase III): The trial evaluates initiating BRIUMVI with a single 600 mg IV infusion versus the currently approved split dosing (day 1 and day 15). Weiss said the company expects top-line data “in the coming weeks” and, if positive and approved, believes it could launch a consolidated dosing schedule next year.
• Subcutaneous (sub-Q) BRIUMVI: TG Therapeutics is developing a self-administered, at-home formulation delivered via an auto-injector and pen-like device. Weiss said the Phase III program is evaluating dosing every two months and quarterly dosing, with a primary endpoint of non-inferiority to IV based on drug exposure over 24 weeks. He said the Phase III study is fully enrolled, with top-line data expected around year-end or early next year, and a potential launch targeted for 2028, assuming positive outcomes and regulatory approval.

Weiss also said the company expects to share Phase I bioavailability results for sub-Q BRIUMVI “in the coming weeks,” though he said during Q&A that TG Therapeutics did not have exact timing on whether ENHANCE or Phase I sub-Q data would come first.

On the commercial rationale for sub-Q, Waldman said the patient-administered subcutaneous segment represents roughly 35% of the anti-CD20 market, which TG Therapeutics does not currently participate in. He described sub-Q as an opportunity to enter a “new segment of the market,” rather than shifting existing IV patients. When asked about the importance of dosing frequency, management said quarterly dosing would be incrementally better than every two months, but both schedules could represent a strong profile depending on the data.

Beyond relapsing MS, Weiss said TG Therapeutics plans to expand BRIUMVI into additional autoimmune indications. He said Phase I work in myasthenia gravis is complete and the company expects to initiate a Phase II, potentially registration-directed study this quarter. He also said the company is initiating an exploratory study in treatment-resistant schizophrenia, citing emerging evidence of an autoimmune component in a subset of patients.

Weiss also provided an update on azer-cel, the company’s allogeneic anti-CD19 CAR T program in progressive MS. He said it remains early, the study is challenging logistically, and safety is the most important focus, followed by biomarkers such as B-cell depletion and oligoclonal bands in the CNS. He added the team is moving up in dose escalation and expects to start the “penultimate dose” in the next one to two weeks, with additional updates later this year.

Profitability improves; Blue Owl refinancing and share repurchases

Power said total revenue in the quarter was $205 million, including $3.6 million of license, royalty, and other revenue. Operating expenses (R&D and SG&A excluding stock-based compensation) were approximately $117 million, reflecting investment across the business, including a milestone expense under the company’s Precision BioSciences agreement, higher clinical costs, and expanded marketing and media spending.

Operating income was $34.8 million, compared with an operating loss of $8.6 million in the year-ago quarter. Power noted a one-time $9.2 million charge tied to refinancing the company’s Blue Owl facility, approximately half of which was non-cash. Net income was $19.8 million, or $0.12 per diluted share, compared with $5.1 million, or $0.03 per diluted share, a year earlier.

On the balance sheet, Power said the company ended the quarter with approximately $573 million in cash, cash equivalents, and investment securities, up from roughly $200 million at year-end, primarily due to proceeds from the expanded Blue Owl Capital facility. During the quarter, the company repurchased over 3 million shares at an average price of roughly $30, bringing total repurchases since program launch to about 6.8 million shares at an average price of approximately $29—nearly 5% of shares outstanding—leaving 153 million shares outstanding.

Asked about capital allocation and business development, Weiss said the company remains “highly selective” and “disciplined” on pricing for external opportunities while continuing to repurchase shares, reiterating management’s view that the stock is undervalued. On gross-to-net, Waldman said dynamics were largely in line with expectations and can vary quarterly, with an expectation that it averages around 65% for the year.

About TG Therapeutics NASDAQ: TGTX

TG Therapeutics, Inc is a clinical‐stage biopharmaceutical company headquartered in New York City that specializes in developing targeted therapies for hematological malignancies and autoimmune diseases. The company's research strategy focuses on the modulation of B-cell biology through novel antibody and small‐molecule agents. Since its founding in 2003, TG Therapeutics has built a diversified portfolio aimed at addressing unmet medical needs in oncology and immunology.

In December 2022, TG Therapeutics achieved its first commercial milestone when ublituximab-xiiy (marketed as Briumvi® in collaboration with Biogen) received U.S.

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