TG Therapeutics(US:TGTX)2025-08-04 13:30Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - U.S. net sales for BREONVY in Q2 totaled approximately $139 million, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption of BREONVY continues to grow, with nearly one in every three new IV anti-CD20 patients being prescribed BREONVY [6][15] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales and continues to grow, with BREONVY steadily increasing its market share [15] - The company estimates that approximately 35% to 40% of the anti-CD20 dynamic market segment currently prefers a self-administered option [7] Company Strategy and Development Direction - The company is focused on expanding choice and flexibility for patients through the development of subcutaneous BREONVY, which is expected to significantly expand the addressable market [7][8] - The strategic plan includes initiating patient enrollment into a pivotal Phase III trial for subcutaneous BREONVY in the coming weeks, with a BLA filing anticipated in 2027 and a potential launch in 2028 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BREONVY revenues, raising full-year U.S. net revenue guidance to $560 million to $575 million for 2025 [19] - The management highlighted strong execution across commercial and clinical fronts, with a growing confidence in BREONVY from both physicians and patients [11] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by ongoing investments in R&D [22][23] - The company closed the quarter with approximately $279 million in cash and cash equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - The management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Share and Competitors - The company captures about one-third of the IV segment, with the remaining market share divided among competitors [31] Question: Subcutaneous Product Development - The subcutaneous product will start with injections from a vial, followed by a bridging study to an auto-injector, with a target filing in 2027 and approval in 2028 [36][37] Question: Revenue Guidance and Market Trends - The management noted that they are not seeing significant impact from competitors and that the overall market for IV therapies is stable [42][43] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for patients on BREONVY [53][56] Question: Subcutaneous Dosing and Volume - Preliminary bioavailability information suggests that both every other month and quarterly dosing are achievable for the subcutaneous product [60]