On August 2, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ending June 30, 2021 and recent company developments, along with a business outlook for the remainder 2021 (Press release, TG Therapeutics, AUG 2, 2021, View Source [SID1234585521]).
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, "We are pleased with the progress made throughout the second quarter, including our ongoing launch of UKONIQ in relapsed or refractory MZL and FL, FDA’s acceptance of our BLA/sNDA for the combination of ublituximab and UKONIQ (U2) to treat CLL and SLL, and the continued advancement of our clinical programs. We have built a strong commercialization infrastructure to launch UKONIQ and have received positive feedback from healthcare providers on their experiences with the product and with the TG team. We believe this solid commercialization foundation will support, if approved, the launch of U2 in CLL and ublituximab in relapsing forms of multiple sclerosis."
Mr. Weiss continued, "We look forward to an exciting second half of 2021, during which we plan to submit a BLA for ublituximab to treat patients with relapsing forms of multiple sclerosis, continue executing on the launch of UKONIQ in MZL and FL, and continue preparations for potential commercialization of U2 in CLL and ublituximab in RMS."
2021 Highlights & Recent Developments
UKONIQ (umbralisib) 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 $2.3M in total net UKONIQ revenue from launch through the end of Q2 2021, approximately 4 months.
Achieved broad U.S. payor coverage for more than 90% of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia
Received FDA acceptance of a Biologics License Application (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 primarily based on results from the UNITY-CLL Phase 3 trial, which included both treatment-naïve and relapsed or refractory (R/R) patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022 for both applications.
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 R/R CLL.
Ublituximab in Multiple Sclerosis
Presented positive results from the ULTIMATE I and II Phase 3 trials at the 2021 American Academy of Neurology (AAN) annual meeting and the 7th Congress of the European Academy of Neurology (EAN). 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
Presented updated data from TG-1701, our BTK inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) virtual congress and the 16th International Congress on Malignant Lymphoma (ICML).
Remaining Key Objectives for 2021 and Early 2022
Focus on the commercialization of UKONIQ in R/R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS
Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I and II Phase 3 trials
Obtain approval for U2 in CLL and SLL by the PDUFA goal date of March 25, 2022
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 and Six Months Ended June 30, 2021
Product Revenue, net: Product revenue, net was approximately $1.5 million and $2.3 million for the three and six months ended June 30, 2021, compared to zero during the comparable periods 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.
R&D Expenses: Total research and development (R&D) expense was $44.9 million and $108.0 million for the three and six months ended June 30, 2021, compared to $36.5 million and $72.5 million for the three and six months ended June 30, 2020. The increase was due primarily to licensing milestone fees of approximately $4.0 million and $18.0 million incurred during the three and six months ended June 30, 2021, and an increase in non-cash compensation R&D expense over the comparable periods in 2020.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $34.0 million and $60.8 million for the three and six months ended June 30, 2021, and $14.4 million and $28.7 million for the three and six months ended June 30, 2020. The increase was due primarily 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 and ublituximab in RMS. We expect our selling, general and administrative expenses to increase for the remainder of 2021 as we continue to prepare for those potential 2022 launches.
Net Loss: Net loss was $78.5 million and $169.1 million for the three and six months ended June 30, 2021, compared to $52.9 million and $104.0 million for the three and six months ended June 30, 2020. Excluding non-cash compensation, the net loss for the three and six months ended June 30, 2021 was approximately $62.2 million and $136.2 million, compared to a net loss of $45.5 million and $85.6 million for the three and six months ended June 30, 2020.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $456.2 million as of June 30, 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, August 2, 2021, at 8:30 AM ET, to discuss the Company’s second quarter ended June 30, 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.