On February 28, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2022, and recent company developments (Press release, TG Therapeutics, FEB 28, 2023, View Source [SID1234627857]).
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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "2022 was a pivotal year for TG with the approval of BRIUMVI for relapsing forms of Multiple Sclerosis, and 2023 is off to an exciting start with the commercial launch of BRIUMVI. Our teams are hard at work introducing BRIUMVI to the MS community and while we are only 4 weeks into the launch, we are encouraged by the early feedback from providers, payors and advocates." Mr. Weiss continued, "Our highest priority is our commitment to patients and to ensure that patients who want BRIUMVI will have access to BRIUMVI. We look forward to building on the foundation we are developing in this early launch phase and extending it throughout 2023 and beyond."
2022 Highlights & Recent Developments
● U.S. Food and Drug Administration (FDA) approved BRIUMVI (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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Commercially launched BRIUMVI making it available for patients and physicians.
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Presented additional data, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 2022 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and at the 2023 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum.
Key Objectives for 2023
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Execute a strong commercial launch of BRIUMVI in RMS
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Obtain broad payor coverage for BRIUMVI
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Continue to present additional data from the ULTIMATE I & II Phase 3 trials of BRIUMVI in RMS
Financial Results for the Fourth Quarter and Full Year 2022
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Product Revenue, net: Product revenue, net was approximately zero and $2.6 million for the three and twelve months ended December 31, 2022. Net product revenues during the year represent U.S. sales of UKONIQ, which received approval in February of 2021 and was withdrawn from the U.S. market effective May 31, 2022.
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R&D Expenses: Total research and development (R&D) expense was $29.6 million and $125.4 million for the three and twelve months ended December 31, 2022, compared to $62.6 million and $222.6 million for the three and twelve months ended December 31, 2021. The decrease in R&D expense is primarily attributable to reduced clinical trial related expenses, license milestones and manufacturing expense, decreased headcount and lower fees paid to consultants and outside service providers, as well as a decrease in non-cash compensation R&D expense during the twelve months ended December 31, 2022 over the comparable period in 2021.
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SG&A Expenses: Total selling, general and administrative (SG&A) expense was $22.5 million and $70.0 million for the three and twelve months ended December 31, 2022, and $32.4 million and $128.1 million for the three and twelve months ended December 31, 2021. The decrease was primarily attributable to reduced other selling, general and administrative costs as a result of our withdrawal of UKONIQ and decreased headcount during the period ended December 31, 2022, as well as decreased non-cash compensation G&A expense during the twelve months ended December 31, 2022 over the comparable period in 2021.
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Net Loss: Net loss was $53.0 million and $198.3 million for the three and twelve months ended December 31, 2022, compared to $93.3 million and $348.1 million for the three and twelve months ended December 31, 2021. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2022 was approximately $41.9 million and $179.2 million, compared to a net loss of $79.0 million and $286.8 million for the three and twelve months ended December 31, 2021.
● Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $174.1 million as of December 31, 2022. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2022, combined with the $45.0 million of available capacity under our existing term loan facility and projected revenues, will be sufficient to fund the Company’s planned operations into mid-2024.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, February 28, 2023, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2022 financial results.
In order 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 replay at www.tgtherapeutics.com, for a period of 30 days after the call.