TG THERAPEUTICS, INC. Q4 FY2024 earnings call

• Commercial Performance: BRIUMVI had strong Q4 2024 U.S. net sales of $103.6 million (24% QoQ growth) and full year 2024 revenues of $310 million (250% growth vs 2023). Internationally, partnered with Neuraxpharm for BRIUMVI launch in EU countries.
• Clinical Developments: ENHANCE study updates included 30-minute infusion safety and switching from other anti-CD20 therapies. Subcutaneous BRIUMVI bioavailability studies suggest potential for every other month dosing. Started treating Myasthenia Gravis patients with BRIUMVI. Partnered with Precision BioSciences for azer-cel in autoimmune diseases, with Phase 1 study for progressive MS ready to enroll.
• Patents: Three new patents issued for BRIUMVI, protecting it until 2042, including a composition of matter covering glyco engineered attributes.

In the fourth quarter of 2024, U.S. BRIUMVI net product revenue was $103.6 million. For the full year 2024, total global revenue was approximately $329 million, with $310 million coming from U.S. BRIUMVI net product sales and a $12.5 million milestone from the ex U.S. commercial launch partner. BRIUMVI's U.S. revenues in full year 2024 represented a 250% growth versus 2023, with Q4 2024 U.S. net sales showing 24% quarter-over-quarter growth.

• Q1 2025 U.S. BRIUMVI net revenue estimated at $115 million. Expect to meet or exceed full year U.S. guidance of $525 million for 2025.
• Operating expenses for 2025 guided at approximately $300 million.

Forward-looking statements are subject to risks in SEC filings, including factors affecting operations such as competitive landscape, clinical trial outcomes, and regulatory changes.

Q: Prakhar Agrawal asked about growth drivers and Ocrevus high dose.

A: Adam and Mike discussed growth from academic and private clinics, noting academic hospitals now account for majority of enrollments; Ocrevus high dose details unknown until more information is available.

Q: Michael DiFiore asked about subcu trial design and gross to net.

A: Adam said gross to net is expected to be in the 70% to 75% range with quarter-to-quarter fluctuations; Mike discussed subcu trial design not yet finalized, with target to start mid-year and potential study of two doses.

Q: Ed White asked about OpEx and sales force.

A: Adam discussed strategically adding to the sales force slowly where opportunity exists; Sean mentioned no material changes to OpEx related to marketing schemes at this time.

Q: Eric Joseph asked about ENHANCE trial reception and subcu BLA.

A: Michael discussed ENHANCE trial reception with most physicians already comfortable switching patients without the introductory dose; BLA for consolidated shortened infusion regimen expected by mid-2027.

Q: Mayank Mamtani asked about revenue split and pipeline.

A: Adam discussed expectation of repeat prescriptions being majority in early 2025; Michael talked about azer-cel study for progressive MS not yet enrolling first patient, focusing on dose finding and biomarkers in the study.