On November 1, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2023, along with recent company developments (Press release, TG Therapeutics, NOV 1, 2023, View Source [SID1234636642]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "The team has executed very well in the third quarter, making significant progress on our corporate goals and continuing to build a solid foundation for the BRIUMVI launch. We showed strong net quarterly revenue of approximately $166 million, including an upfront milestone payment from our ex-U.S. partner, Neuraxpharm, as well as $25.1 million in BRIUMVI net sales in the U.S., which again exceeded our expectations." Mr. Weiss continued, "The adoption of BRIUMVI from both healthcare providers and centers continues to grow, which I believe positions us to close out the year on a positive note and I am excited for 2024 and for the future of BRIUMVI and TG."

Recent Highlights & Developments

General Business

●

Total net quarterly revenue of $165.8 million, with a current cash position of $229.2 million

●

Presented the first data from the ENHANCE Phase 3b trial evaluating patients with relapsing forms of multiple sclerosis (RMS) who switch from an IV anti-CD20 therapy to BRIUMVI, as well as additional exploratory data from the ULTIMATE I and II Phase 3 trials at the 2023 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting.

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

●

Achieved $25.1 million in BRIUMVI net sales for the third quarter 2023; total net product revenue of approximately $48.9 million since launch.

●

Secured payor coverage policies for approximately 95% of covered lives across the U.S.

●

Over 900 BRIUMVI prescriptions in the third quarter of 2023, marking approximately 2,200 prescriptions since launch, from more than 500 healthcare providers at more than 250 centers.

●

Received a permanent J-Code (J2329) for BRIUMVI from the U.S. Centers for Medicare & Medicaid Services (CMS), which became effective July 1, 2023.

European Commercialization of BRIUMVI
●

Received European Commission (EC) approval of BRIUMVI, for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features, on June 1, 2023.

●

Announced an agreement with Neuraxpharm for the ex-U.S. commercialization of BRIUMVI in RMS on August 1, 2023.

● Received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the United Kingdom (UK).

Financial Results for the Three and Nine Months Ended September 30, 2023

●

Product Revenue, Net: Product revenue, net was approximately $25.1 million and $48.9 million for the three and nine months ended September 30, 2023, compared to $0.1 million and $2.6 million for the three and nine months ended September 30, 2022. Product revenue, net for the three and nine months ended September 30, 2023, consisted of net product sales of BRIUMVI in the U.S., which was commercially launched in late January 2023. Product revenue, net for the three and nine months ended September 30, 2022, consisted of net product sales of UKONIQ (umbralisib), which was withdrawn from the U.S. market in May of 2022.
●

License revenue: License revenue was approximately $140.0 million and $140.1 million for the three and nine months ended September 30, 2023, compared to less than $0.1 million and $0.1 million for the three and nine months ended September 30, 2022. License revenue for the three and nine months ended September 30, 2023, is primarily related to the $140.0 million one-time payment received from Neuraxpharm in July 2023 upon execution of the agreement for the ex-U.S. commercialization of BRIUMVI in RMS.
●

R&D Expenses: Total research and development (R&D) expense was $14.8 million and $58.7 million for the three and nine months ended September 30, 2023, compared to $20.8 million and $95.7 million for the three and nine months ended September 30, 2022. The decrease in R&D expense during the nine months ended September 30, 2023, was primarily attributable to reduced manufacturing expense and clinical trial related expenses, offset by an increase in license milestone expense of approximately $6.0 million during the nine months ended September 30, 2023. Prior to the approval of BRIUMVI, manufacturing costs pertaining to BRIUMVI were expensed to R&D expense in the period incurred, and following approval are reflected in inventory.
●

SG&A Expenses: Total selling, general and administrative (SG&A) expense was $32.8 million and $91.6 million for the three and nine months ended September 30, 2023, compared to $14.3 million and $47.5 million for the three and nine months ended September 30, 2022. The increase was primarily due to non-cash compensation SG&A expenses incurred, and other costs, including personnel, associated with the commercialization of BRIUMVI during the three and nine months ended September 30, 2023.
●

Net Income (Loss): Net income was $113.9 million and $27.1 million for the three and nine months ended September 30, 2023, compared to a net loss of $35.8 million and $145.3 million for the three and nine months ended September 30, 2022.

●

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $229.2 million as of September 30, 2023. We anticipate that our cash, cash equivalents and investment securities as of September 30, 2023, combined with the projected revenues from BRIUMVI, will be sufficient to fund our planned operations into cash flow positivity based on the current operating plan.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, November 1, 2023, at 8:30 AM ET, to discuss the Company’s financial results from the third quarter, ended September 30, 2023.

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.