On March 2, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2020 and recent company developments, along with a business outlook for 2021 (Press release, Manhattan Pharmaceuticals, MAR 2, 2021, View Source [SID1234575905]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2020 was a year of data and regulatory execution for us as we delivered results from our UNITY-NHL study that led to the approval of UKONIQ in relapsed/refractory MZL and FL and from UNITY-CLL that will be used to support the current rolling BLA submission for ublituximab in combination with umbralisib for patients with CLL. We also announced the top line results from our ULTIMATE MS Phase 3 trials that will be used to support a BLA submission for ublituximab in MS. These successful outcomes were made possible by the hard work of everyone at TG over many years and has positioned us for an exciting 2021." Mr. Weiss continued, "With the UKONIQ launch underway, we are excited to keep the momentum going and expect this year to complete our BLA submission for U2 in CLL, present final results from the ULTIMATE trials and then submit a BLA for ublituximab in MS, and continue to advance our triple therapy combination trials and our early pipeline."

2020 Highlights & Recent Developments

FDA Accelerated Approval of UKONIQ (umbralisib) in Relapsed/Refractory MZL & FL
Received accelerated approval from the U.S. Food and Drug Administration (FDA) for UKONIQ 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.
Presented umbralisib monotherapy results from the UNITY-NHL Phase 2b trial in patients with relapsed or refractory MZL, FL and small lymphocytic lymphoma (SLL) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
Received orphan drug designation (ODD) from the FDA for umbralisib for the treatment of FL.
Chronic Lymphocytic Leukemia
Presented results from the UNITY-CLL Phase 3 trial at the 62nd ASH (Free ASH Whitepaper) annual meeting showing the trial met its primary endpoint of ublituximab and umbralisib (U2) significantly improving progression-free survival (PFS) over obinutuzumab plus chlorambucil.
Initiated a rolling submission of a Biologics License Application (BLA) to the FDA requesting approval of U2, as a treatment for patients with chronic lymphocytic leukemia (CLL), including both previously untreated and relapsed/refractory patients.
Granted Fast Track Designation by the FDA for the combination of U2 for the treatment of adult patients with CLL.
Presented data from the triple combination of U2 plus venetoclax in patients with relapsed or refractory (R/R) CLL and data from the combination of U2 plus TG-1701, the Company’s BTK inhibitor, in patients with R/R CLL or B-cell lymphoma, at the 62nd ASH (Free ASH Whitepaper) annual meeting.
Published final results from the Phase 3 GENUINE trial evaluating ublituximab in combination with ibrutinib, in patients with relapsed or refractory high-risk CLL, in The Lancet Haematology.
Multiple Sclerosis
Announced that the Phase 3 ULTIMATE I & II 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 relapsing forms of multiple sclerosis (RMS).
Published results from the multicenter Phase 2 trial evaluating ublituximab in RMS, in the Multiple Sclerosis Journal.
Strengthened Cash Position
Ended the year with more than $600 million in cash, cash equivalents and investment securities.
Key Objectives for 2021

Continue the commercialization of UKONIQ in relapsed/refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of ublituximab
Present results from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in RMS and prepare a BLA submission
Complete the rolling BLA submission of ublituximab, in combination with umbralisib, for the treatment of patients with CLL
Complete enrollment in the ULTRA-V Phase 2b trial and begin a Phase 3 trial evaluating the triple combination of U2 plus venetoclax
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801
Financial Results for the Fourth Quarter and Full Year 2020

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $37.1 million and $151.9 million for the three and twelve months ended December 31, 2020, respectively, compared to $29.5 million and $148.3 million for the three and twelve months ended December 31, 2019, respectively. The increase in R&D expense during the year ended December 31, 2020 is primarily attributable to an increase in licensing milestones as well as clinical trial and personnel expense of approximately $34.4 million, partially offset by a decrease in manufacturing expense of approximately $30.6 million. We expect our other research and development costs to remain at consistent levels throughout 2021.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $16.2 million and $41.5 million for the three and twelve months ended December 31, 2020, respectively, as compared to $2.9 million and $9.5 million for the three and twelve months ended December 31, 2019, respectively. The increase during the three and twelve months ended December 31, 2020 was due primarily to commercialization costs, including personnel, incurred in preparation for the U.S. launch of UKONIQ. We expect our other general and administrative expenses to increase modestly during 2021 in preparation for our launch of ublituximab.

Net Loss: Net loss was $88.2 million and $279.4 million for the three and twelve months ended December 31, 2020, respectively, compared to a net loss of $39.6 million and $172.9 million for the three and twelve months ended December 31, 2019, respectively. The net loss for the twelve months ended December 31, 2020 included approximately $21.0 million of one-time milestone expenses related to our license agreements. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2020 was approximately $54.7 million and $199.1 million, respectively, compared to a net loss of $34.0 million and $161.5 million for the three and twelve months ended December 31, 2019, respectively.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $605.4 million as of December 31, 2020, 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 2, 2021, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2020 financial results and provide a business outlook for 2021.

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.