Financial Data and Key Metrics Changes - The company reported net revenue of approximately $166 million for Q3 2023, which includes $140 million from an upfront licensing fee and $25.1 million from Briumvi net sales in the U.S. [7][20] - For the nine-month year-to-date period, total net revenue reached approximately $190 million, including about $49 million in Briumvi net product sales [20]. Business Line Data and Key Metrics Changes - Briumvi's net sales for Q3 were $25.1 million, reflecting a 57% growth quarter-over-quarter, driven by new patient infusions and increased demand [16]. - The total number of new patient prescriptions for Briumvi reached approximately 2,200, capturing about 80% to 90% of the total new scripts written [16]. Market Data and Key Metrics Changes - The company estimates that around 40,000 MS patients start CD20 therapy each year in the U.S., indicating a growing market for Briumvi [16]. - The company achieved 95% coverage for commercial and Medicare lives, exceeding its corporate goal for the year [18]. Company Strategy and Development Direction - The company aims to position Briumvi as the number one prescribed anti-CD20 therapy based on dynamic market share, focusing on both IV therapy centers and potential subcutaneous formulations [8][13]. - The company is evaluating additional indications for Briumvi and exploring new product opportunities in MS and autoimmune diseases [12]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in closing out the year strong and anticipates a solid revenue target of approximately $33 million to $37 million for Q4 2023 [15]. - The company believes it has a reasonable line of sight to profitability in the near term, supported by a cash position of approximately $229 million [15][28]. Other Important Information - The company received approval for Briumvi in the United Kingdom, with expectations for a launch in early 2024 [12]. - The company plans to discontinue sharing distributor-level data with third-party companies to reduce confusion and price volatility [14]. Q&A Session Summary Question: Thoughts on anti-CD20 market penetration and infusion vs. subcutaneous injections - Management noted that while the infusion market is growing, the overall market is likely expanding faster due to subcutaneous therapies reaching new neurologists [33]. Question: Real-world number of patients switching to Briumvi - Management indicated that the number of patients switching from other CD20 therapies has been higher than expected, primarily due to the shorter infusion time and tolerability issues [35]. Question: Breakdown of patient categories using Briumvi - Management reported a balanced distribution among new patients, switches from other therapies, and returning patients, with a slight majority coming from switches from non-CD20 therapies [42]. Question: Factors affecting conversion from prescriptions to revenue - Management highlighted the time lag from hub to infusion and patient compliance as key factors influencing revenue conversion [44]. Question: Guidance for 2024 revenue - Management has not yet provided guidance for 2024 but aims to offer insights as early as possible next year [45]. Question: Impact of J-Code on growth - Management expects continued steady growth and confidence in reimbursement following the establishment of the J-Code [81]. Question: Competitiveness of BTK therapies - Management believes that BTK therapies may be viewed as oral options for relapsing MS but do not see them as direct competitors to CD20 therapies [70][77].
TG Therapeutics(TGTX) - 2023 Q3 - Earnings Call Transcript