TG THERAPEUTICS, INC. Q1 FY2025 earnings call

• Mike Weiss highlighted the strong performance of BRIUMVI with Q1 net sales exceeding expectations, driven by increasing adoption by healthcare providers and patient confidence. - Adam Waldman discussed commercial execution, noting the highest three months of patient enrollments ever, strong repeat prescriber activity, and growth drivers including community neurologist uptake and direct-to-patient campaigns. - Sean Power provided financial overview, mentioning US net product revenue of $119.7 million for Q1 2025, OpEx of approximately $82 million for the quarter, and a balance sheet with $276 million in cash, cash equivalents, and investment securities. - Pipeline updates included an enhanced clinical trial for BRIUMVI showing positive results on infusion simplification, progress on self-administered subcu BRIUMVI with ongoing Phase 1 study, and azer-cel Phase 1 in progressive forms of MS.

BRIUMVI US net sales reached nearly $120 million in the first quarter of 2025, representing a 137% year-over-year growth and a 16% sequential quarter-over-quarter increase. BRIUMVI contributed US net product revenue of $119.7 million for the first quarter of 2025, reflecting strong demand for the product.

• Raised full-year 2025 US net revenue guidance from $525 million to $560 million. - Q2 2025 target for US net revenue is $135 million.

• Potential impact of tariffs on manufacturing in South Korea, though currently not anticipated to materially affect gross margins or overall financial performance.

Q: Please provide more color on competitive dynamics, especially with Ocrevus Zunovo, and new patient share.

A: Adam Waldman stated that BRIUMVI saw the highest three months ever on patient enrollments, with strong traction in the marketplace and no impact from Zunovo.

Q: Any update on gross-to-net trends this quarter and comments on gross margin depletion?

A: Adam Waldman noted no material change in gross-to-net in the quarter, and Sean Power mentioned pre-commercial inventory reserves in gross margin have been fully depleted.

Q: Update on subcu BRIUMVI pivotal trial timeline and Myasthenia Gravis investment?

A: Michael Weiss stated subcu pivotal trial is on track, and the company is evaluating Myasthenia Gravis cautiously with a moderate pace.

Q: Tariff impact and North Carolina plant status?

A: Michael Weiss said moving manufacturing to North Carolina will take several years, and tariffs are not expected to materially impact the company.

Q: BRIUMVI adherence metric?

A: Adam Waldman noted persistence trends remain positive.

Q: Subcu BRIUMVI pivotal trial start and MG investment?

A: Michael Weiss said subcu trial is on track, and the company is evaluating Myasthenia Gravis cautiously.

Q: Percentage of BRIUMVI patients switching from Ocrevus?

A: Adam Waldman stated there is a consistent amount of switches from Ocrevus, with no material change.