TG Therapeutics(TGTX) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The GAAP net loss for the year ended December 31, 2022, was $198 million or$ 1.46 per share, a decrease from a net loss of $348 million or$ 2.63 per share in 2021, reflecting a year-over-year decrease of approximately $150 million due to streamlined efforts [32] - The GAAP net loss for Q4 2022 was approximately$ 53 million or $0.39 per share, down from a net loss of approximately$ 93 million or $0.70 per share in Q4 2021, driven by a disciplined spending approach [53] Business Line Data and Key Metrics Changes - BRIUMVI received FDA approval to treat adult patients with relapsing forms of multiple sclerosis (RMS), marking a significant milestone for the company [4] - The launch of BRIUMVI is focused on building awareness, driving utilization, and minimizing access barriers, with early feedback indicating significant interest from healthcare providers [10][12] Market Data and Key Metrics Changes - Approximately 35% of covered lives in the U.S. now have payer coverage for BRIUMVI, ahead of internal goals [13] - The company estimates that nearly 1 million Americans are living with MS, with 75,000 to 80,000 seeking new treatment each year, indicating a substantial market opportunity [24] Company Strategy and Development Direction - The company aims to achieve coverage for the majority of covered lives in the U.S. by the first half of 2023, with a long-term goal of reaching 80% to 90% coverage by the end of the year [75] - The company is investing in a mix of promotional resources, including in-person and virtual marketing, to support the launch of BRIUMVI [48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early launch activities of BRIUMVI, noting that initial successes are ahead of schedule and position the company for an exciting year of commercial execution [99] - The company is focused on minimizing access barriers and achieving optimal patient access to BRIUMVI, with positive early feedback from infusion centers [50][51] Other Important Information - The company ended 2022 with approximately$ 220 million in cash, cash equivalents, and investment securities, including $45 million of available capacity under its Hercules facility [15] - Operating expenses for 2023 are expected to average approximately$ 40 million to $50 million per quarter, excluding BRIUMVI inventory build [16] Q&A Session Summary Question: What is the initial dosing protocol for patients switching from other anti-CD20 therapies? - Patients switching will go through the four-hour starting dose as per label, with a switch study planned to evaluate the necessity of this protocol [36][39] Question: What percentage of patients are utilizing patient assistance programs? - A higher percentage of patients are expected to engage with assistance programs in the first half of the year, which should decrease over time as coverage improves [42] Question: What is the company's strategy regarding the European market? - The company anticipates being six to nine months behind in the European market and is evaluating whether to partner or handle it independently [60] Question: How is the sales force currently structured? - The company feels that its sales force is appropriately sized for the current opportunity, with ongoing evaluations to ensure effectiveness [79][80] Question: What is the cash position and expected R&D and G&A mix for 2023? - The cash position at the end of Q4 2022 was$ 220 million, with operating expenses expected to be weighted towards SG&A rather than R&D [89]