On May 10, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ending March 31, 2021 and recent company developments, along with a business outlook for 2021 (Press release, TG Therapeutics, MAY 10, 2021, View Source [SID1234579593]).
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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2021 has been an incredibly impactful year, kicking off with our first approval coming ahead of schedule for UKONIQ to treat both relapsed or refractory Marginal Zone Lymphoma and Follicular Lymphoma. That was followed by the completion of a BLA submission for ublituximab in combination with UKONIQ (U2) to treat patients with CLL, and the full presentation of positive results from the ULTIMATE I & II Phase 3 trials in relapsing forms of MS. As a fully integrated commercial organization we are pleased with our progress thus far with the UKONIQ launch and we look forward to continuing to build our commercial infrastructure to support the potential approval and commercialization of U2 in CLL and ublituximab in RMS."
2021 Highlights & Recent Developments
UKONIQTM (umbralisib) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma
Received accelerated approval from the U.S. Food and Drug Administration (FDA) on February 5, 2021 for UKONIQ to treat 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.
Launch efforts underway across the U.S. UKONIQ has payor coverage for 85-90% of Medicare and commercial lives and is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL, consistent with the FDA-approved indications.
Published results from the UKONIQ monotherapy cohorts of the UNITY-NHL Phase 2b trial in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia
Completed 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, based on the positive results from the UNITY-CLL Phase 3 trial.
Completed enrollment in the ULTRA-V Phase 2 trial, and launched the ULTRA-V Phase 3 randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment naïve and relapsed or refractory CLL.
Ublituximab in Multiple Sclerosis
Presented positive results from the ULTIMATE I & II Phase 3 trials at the American Academy of Neurology 2021 Annual Meeting. 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 relapsing forms of multiple sclerosis (RMS).
TG-1701 in B-cell Malignancies
Updated data from TG-1701, our BTK inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held in June 2021.
Remaining Key Objectives for 2021
Focus on the commercialization of UKONIQ in relapsed/refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 for CLL and ublituximab in MS
Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I & II Phase 3 trials
Receive notification from the FDA that the BLA for U2 in CLL has been accepted for filing and work closely with the Agency on its review of the application
Enroll into the newly launched ULTRA-V 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 Three Months Ended March 31, 2021
Product Revenue, net: Product revenue, net was approximately $0.8 million for the three months ended March 31, 2021, compared to zero during the comparable period in 2020. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021, with launch later in the month.
R&D Expenses: Total research and development (R&D) expense was $63.1 million for the three months ended March 31, 2021, compared to $36.0 million for the three months ended March 31, 2020. The increase was due primarily to licensing milestone fees of approximately $14.0 million incurred during the first quarter of 2021 and an increase of approximately $5.5 million in non-cash compensation R&D expenses over the comparable quarter in 2020.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $26.8 million for the three months ended March 31, 2021 and $14.3 million for the three months ended March 31, 2020. The increase was due primarily to increased personnel and other selling, general and administrative costs associated with preparations for, and now execution of, the commercial launch of UKONIQ. We expect our selling, general and administrative expenses to increase for the remainder of 2021 in preparation for the potential launch of ublituximab as part of the U2 combination for CLL and as a monotherapy in MS.
Net Loss: Net loss was $90.6 million for the three months ended March 31, 2021 compared to $51.1 million for the three months ended March 31, 2020. Excluding non-cash compensation, the net loss for the three months ended March 31, 2021 was approximately $74.0 million, compared to a net loss of $40.0 million for the three months ended March 31, 2020.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $523.8 million as of March 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, May 10, 2021, at 8:30 AM ET, to discuss the Company’s first quarter ended March 31, 2021 financial results and provide a business outlook for the remainder of 2021.
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.