On May 1, 2024 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the first quarter of 2024, along with recent company developments (Press release, TG Therapeutics, MAY 1, 2024, View Source [SID1234642529]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We were extremely pleased with the strong sales of just over $50 million in BRIUMVI U.S. net revenue for the first quarter of 2024, which was ahead of our guidance. We believe this strong momentum will continue to build throughout 2024 and are pleased to update our yearly guidance to $270 to $290 million in BRIUMVI U.S. net revenue in 2024." Mr. Weiss continued, "We are also pleased to be making strides towards our clinical goals for the year which include enhancing the convenient dosing of IV BRIUMVI, developing a subcutaneous form of BRIUMVI, moving BRIUMVI into additional indications beyond MS, and advancing our recent pipeline addition, azer-cel, an allogeneic CAR T, into clinical development."

Recent Highlights & Developments

United States (U.S.) Commercialization of BRIUMVI(ublituximab-xiiy)

BRIUMVI U.S. net product revenue of $50.5 million for the first quarter of 2024, representing >25% quarter over quarter growth
Approximately 4,450 BRIUMVI new patient prescriptions received by the TG Therapeutics hub since launch, including more than 1,250 in the first quarter of 2024, from approximately 800 healthcare providers at approximately 450 centers
Awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI to be the preferred agent listed on the VA National Formulary for anti-CD20 antibody indications for patients with relapsing forms of multiple sclerosis
European Commercialization of BRIUMVI

Launched BRIUMVI in the first European country, Germany, with our partner, Neuraxpharm Group (Neuraxpharm)
General Business

Presented updated data from the ENHANCE Phase 3b trial evaluating patients who switch from another CD20 antibody to BRIUMVI at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum
Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042
Entered into a global license agreement with Precision BioSciences, Inc. (Precision) for the development and commercialization of Precision’s allogeneic CD19 CAR T therapy program, azercabtagene zapreleucel (azer-cel), for the treatment of autoimmune disorders and all other non-oncology indications
2024 Updated Target U.S. BRIUMVI Guidance

Q2 2024 target BRIUMVI U.S. net product revenue of approximately $65 million
Updating BRIUMVI U.S. net product revenue target to approximately $270 million to $290 million for the full year 2024 (prior guidance of $220 to $260 million for full year 2024)
2024 Development Pipeline Anticipated Milestones

Commence clinical development of subcutaneous BRIUMVI
Commence a clinical trial evaluating BRIUMVI in an additional autoimmune disease outside of multiple sclerosis (MS)
Commence a clinical trial evaluating azer-cel in autoimmune disease
Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
Financial Results for First Quarter 2024

Product Revenue, Net: Product revenue, net was approximately $50.5 million for the three months ended March 31, 2024, compared to $7.8 million for the three months ended March 31, 2023. Product revenue, net for both the three months ended March 31, 2024 and March 31, 2023, consisted of net product sales of BRIUMVI in the United States.
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $13.0 million and less than $0.1 million for the three months ended March 31, 2024 and March 31, 2023, respectively. License, milestone, royalty and other revenue for the three months ended March 31, 2024 is predominantly comprised of a $12.5 milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union.
R&D Expenses: Total research and development (R&D) expense was $32.7 million for the three months ended March 31, 2024, compared to $15.9 million for the three months ended March 31, 2023. The increase in R&D expense during the three months ended March 31, 2024, was primarily attributable to license and milestone expense of $8.8 million related to the license agreement with Precision, as well as additional manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work during the period.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $34.6 million for the three months ended March 31, 2024, compared to $28.1 million during the three months ended March 31, 2023. The increase was primarily due to the scale-up of the BRIUMVI commercial launch, including personnel and consultants, during the three months ended March 31, 2024.
Net Loss: Net loss was $10.7 million for the three months ended March 31, 2024, compared to a net loss of $39.2 million for the three months ended March 31, 2023.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $209.8 million as of March 31, 2024. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2024, combined with the projected revenues from BRIUMVI, will be sufficient to fund our planned operations to cash flow positivity based on our current operating plan.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, May 1, 2024, at 8:30 AM ET, to discuss the Company’s financial results from the first quarter, ended March 31, 2024.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.