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TG Therapeutics(TGTX) - 2023 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the fourth quarter of 2023, U.S. BRIUMVI net product revenue was $39.9 million, representing a 60% growth quarter-over-quarter, contributing to a full year revenue of approximately $234 million [41][59][62] - The company reported a net income of $12.7 million for the full year 2023, with a net loss of $14.4 million for the fourth quarter [61][62] - Operating expenses for the fourth quarter and full year were $56 million and $213 million respectively, with cash operating expenditures of approximately $47 million and $175 million [60][62] Business Line Data and Key Metrics Changes - BRIUMVI's sales momentum resulted in approximately $90 million in U.S. net revenue for its first partial year of sales [15][23] - The company reported approximately 3,200 new patient prescriptions through its hub in 2023, translating to about 3,500 total new patient scripts [43] - The fourth quarter saw a significant increase in prescriptions from major academic centers, with more scripts coming from academic centers than private practices for the first time [42] Market Data and Key Metrics Changes - The CD20 market continues to grow, capturing approximately 50% to 55% share of new patients annually, with an estimated 40,000 patients starting CD20 therapy each year [48][50] - The company estimates a 10% market share based on approximately 1,000 prescriptions received in the fourth quarter [50] Company Strategy and Development Direction - The company aims to become the number one prescribed CD20 therapy by market share, focusing on differentiating BRIUMVI through its unique attributes and patient convenience [24][25][36] - Plans include developing a subcutaneous (subcu) formulation of BRIUMVI and expanding its use beyond multiple sclerosis (MS) into other autoimmune diseases [33][34][36] - The company has recently acquired a worldwide license for an allogeneic CD19 CAR T cell therapy program, which is expected to enhance its pipeline [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early demand for BRIUMVI, targeting $220 million to $260 million in U.S. sales revenue for 2024 [23][54] - The company is focused on lifecycle management activities for BRIUMVI and believes recent patent issuances extending protection through 2042 will provide a long runway for growth [28][116] Other Important Information - The company has received three additional patents for BRIUMVI, enhancing its competitive position and extending patent protection through 2042 [28][102] - The company ended 2023 with approximately $217.5 million in cash and equivalents, providing sufficient capital to fund operations towards cash flow positivity [62] Q&A Session Summary Question: What can we expect on growth-to-net cadence for the balance of the year? - Management indicated that while there will be variability quarter-to-quarter, they have not provided precise guidance for 2024 [71] Question: Do you have any numbers on the switches from prior therapies and how that's impacting your sales growth? - Management noted that the largest group of patients switching to BRIUMVI are those previously treated but naive to CD20 therapy, with a balanced distribution across patient types [75][76] Question: Can you give us your thoughts on the launch in Germany and in other countries? - Management highlighted the importance of launching in Germany as the largest market in Europe and mentioned that other countries will follow later this year into next year [78] Question: How should we be thinking about the growth or the ramp of SG&A expenses? - Management confirmed that most of the expansion in the sales force is already incorporated into the current operating expense estimates for 2024 [80] Question: What timeframe do you think it's possible to achieve the number one prescribed IV CD20 for BRIUMVI by dynamic share? - Management has not set a specific timeframe but is working towards this goal, indicating that 2024 may not be the year to achieve it [85] Question: How important is it to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence for subcu BRIUMVI? - Management believes that a bioequivalence study will be sufficient, similar to competitors, without needing a full efficacy study [106]