TG Therapeutics, Inc. — FY 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a standalone fourth-quarter report; the supplied filing text does not provide a clear Q4-only financial breakdown. TG Therapeutics is a commercial-stage biopharmaceutical company focused on B-cell malignancies and autoimmune diseases. UKONIQ (umbralisib) was its only marketed product during 2021.
Financial performance and liquidity
| Metric | 2021 | 2020 |
|---|---|---|
| Total revenue | $6.7 million | $0.2 million |
| UKONIQ net product revenue | $6.5 million | None |
| Operating loss | $344.8 million | $273.6 million |
| Net loss | $348.1 million | $279.4 million |
| Basic and diluted net loss per share | $2.63 | $2.42 |
| Cash used in operating activities | $295.6 million | $214.5 million |
- Research and development expense was $222.6 million, up from $165.9 million; selling, general and administrative expense was $128.1 million, up from $107.9 million. Management attributed the increases chiefly to manufacturing and clinical development, UKONIQ’s launch, and preparation for potential launches.
- At year-end, cash and cash equivalents were $298.9 million, short- and long-term investment securities totaled $51.4 million, and current assets were $331.0 million against current liabilities of $65.4 million. The company stated that cash and investments were expected to fund operations for more than 12 months from the filing date, while also warning that significant future financing would be needed.
- Year-end loan payable, net of unamortized financing costs, was $67.8 million. In December 2021, the company amended its Hercules facility to provide up to $200 million in total borrowing capacity and drew $70 million; further advances are subject to conditions. Maturity was extended to January 2026, with an interest rate of at least 5.40% and financial covenants. Substantially all assets other than intellectual property secure the loan.
- Reported product cost was $0.8 million, but much of the UKONIQ inventory sold had been expensed as R&D before FDA approval. Accordingly, the reported product cost and gross margin do not represent a steady-state commercial margin.
Material developments and outlook
- UKONIQ received accelerated FDA approval in February 2021 for certain relapsed or refractory MZL and FL patients and launched in the U.S. Continued approval depends on confirming clinical benefit.
- The UNITY-CLL Phase 3 trial met its primary progression-free-survival endpoint for U2 (ublituximab plus umbralisib). However, a preliminary overall-survival analysis raised FDA concern about a possible higher risk of death versus the control arm. The FDA planned an advisory committee meeting for March or April 2022; the company said a decision by the March 25, 2022 target date was unlikely.
- In January 2022, the FDA placed selected U2 and component trials in CLL and NHL on partial clinical hold, barring new enrollment in affected studies while allowing certain patients already benefiting to continue treatment. In February 2022, FDA announced it was investigating a possible increased risk of death with UKONIQ and reassessing its benefit-risk profile in approved indications.
- The FDA accepted the ublituximab BLA for relapsing forms of multiple sclerosis, with a September 28, 2022 target action date and no advisory committee planned at the time of filing. The two Phase 3 trials met their primary annualized-relapse-rate endpoints.
- No specific revenue or earnings guidance is provided in the supplied filing text. Management’s liquidity outlook assumes continued access to funding; the company reported persistent losses and expected losses to continue. It also disclosed a January 2022 workforce and external-expense streamlining effort.
- Other principal risks include commercialization and reimbursement uncertainty, competition, reliance on single-source contract manufacturers, clinical and regulatory uncertainty, COVID-19 effects, potential dilution from future financing, and debt covenants. The company reported no material pending legal proceedings. KPMG gave an unqualified opinion on the 2021 financial statements and internal controls.
Investor facts to verify
- FDA and advisory committee decisions on U2, UKONIQ’s existing indications, and the partial clinical hold; assess the updated UNITY-CLL overall-survival and safety data.
- UKONIQ sales trajectory, net-to-gross adjustments, access and reimbursement, and whether the accelerated-approval indications remain available.
- Cash burn, actual runway, further Hercules borrowing availability and covenant compliance, and any need for additional financing or equity issuance.
- Ublituximab’s RMS review outcome, commercial readiness, manufacturing supply, and the status and funding of other pipeline programs.