On March 1, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2021, and recent company developments, along with a business outlook for 2022 (Press release, TG Therapeutics, MAR 1, 2022, View Source [SID1234609214]).
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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "While we’ve faced numerous challenges over the last several months, we continued to progress our programs forward toward commercialization. With both MS and CLL BLA/sNDA submissions pending at the FDA, we continue to see 2022 as potentially the most transformative year in the Company’s history." Mr. Weiss continued, "We are looking forward to the upcoming ODAC meeting where we can showcase the clinical profile of UKONIQ monotherapy in its approved indications and in combination with ublituximab in CLL. We are also very excited about the evolving profile of ublituximab and its potential role in the treatment of RMS. We continue to receive positive feedback from the MS community about the safety, efficacy and one hour infusion offered by ublituximab."
2021 Highlights & Recent Developments
Ublituximab in Multiple Sclerosis
U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for ublituximab, as a treatment for patients with relapsing forms of multiple sclerosis (RMS) and set a Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022.
Presented positive results, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 2021 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and at the 2022 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum. As previously reported, both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with RMS. Additional secondary, tertiary and post-hoc sensitivity analyses were also presented, including T1 and T2 lesions, no evidence of disease activity (NEDA), brain volume, multiple sclerosis functional composite (MSFC) score, neutralizing antibodies and antidrug antibodies, and pharmacodynamics of B-cell depletion.
Ublituximab plus UKONIQ (umbralisib) (U2) in Chronic Lymphocytic Leukemia
FDA accepted a BLA for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ, both submissions requesting approval of U2 as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These applications were based on results from the UNITY-CLL Phase 3 trial, which included both treatment-naïve and relapsed or refractory (R/R) CLL patients. FDA notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC), in connection with its review of the pending BLA/sNDA for U2, in the March/April 2022 timeframe. Due to the pending ODAC meeting, the Company does not expect a decision on the BLA/sNDA by the current PDUFA goal date of March 25, 2022.
Related to the concerns giving rise to the ODAC, FDA imposed a partial clinical hold on studies of U2 and its components in CLL and NHL.
UKONIQ in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma
Launched UKONIQ in the U.S. for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Generated $6.5 million in total net UKONIQ revenue from launch through the end of Q4 2021, approximately ten months.
Achieved broad U.S. payor coverage for more than 95% of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL.
TG-1701 in B-cell Malignancies
Presented updated data on TG-1701, our investigational bruton tyrosine kinase (BTK) inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
Strengthened Cash Position
Ended the year with more than $350 million in cash, cash equivalents and investment securities.
Key Objectives for 2022
Obtain a favorable outcome at the upcoming ODAC meeting.
Obtain FDA approval of U2 in CLL and SLL.
Obtain FDA approval of ublituximab in RMS.
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), our PDL1 inhibitor, TG-1701, our BTK inhibitor and TG-1801 our CD47/CD19 bispecific antibody.
Financial Results for the Fourth Quarter and Full Year 2021
Product Revenue, net: Product revenue, net was approximately $2.3 million and $6.5 million for the three and twelve months ended December 31, 2021. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021.
R&D Expenses: Total research and development (R&D) expense was $62.6 million and $222.6 million for the three and twelve months ended December 31, 2021, compared to $43.0 million and $165.9 million for the three and twelve months ended December 31, 2020. The increase was due primarily to an increase in manufacturing expenses, as well as an increase in non-cash compensation R&D expense during the twelve months ended December 31, 2021 over the comparable period in 2020.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $32.4 million and $128.1 million for the three and twelve months ended December 31, 2021, and $43.9 million and $107.9 million for the three and twelve months ended December 31, 2020. The increase during the twelve months ended December 31, 2021 was primarily attributable to increased personnel and other selling, general and administrative costs associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL/SLL and ublituximab in RMS. The decrease during the three months ended December 31, 2021 was primarily related to non-cash compensation expense related to milestone-based vesting of restricted stock grants during the comparable period in 2020.
Net Loss: Net loss was $93.3 million and $348.1 million for the three and twelve months ended December 31, 2021, compared to $88.2 million and $279.4 million for the three and twelve months ended December 31, 2020. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2021 was approximately $79.0 million and $286.8 million, compared to a net loss of $54.7 million and $199.1 million for the three and twelve months ended December 31, 2020.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $350.3 million as of December 31, 2021, which the Company believes will be sufficient to fund the Company’s planned operations into 2023.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, March 1, 2022, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2021 financial results and provide a business outlook for 2022.
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.