Financial Data and Key Metrics Changes - The company reported net product revenue of $7.8 million in the first quarter, exceeding internal expectations [31] - The net loss for Q1 2023 was approximately $32.6 million, down more than 50% from $67 million in Q1 2022, reflecting a disciplined spending approach [35] - GAAP net loss for Q1 2023 was $39.4 million or $0.28 per share, compared to a loss of $69 million or $0.51 per share in Q1 2022 [35] Business Line Data and Key Metrics Changes - BRIUMVI's launch has seen early adoption from both major academic centers and community practices, with over 165 physicians from more than 125 centers prescribing the drug [31][32] - The company has achieved coverage policies for over 50% of covered lives across the US, ahead of the mid-year goal [33] Market Data and Key Metrics Changes - The company anticipates an acceleration in prescriptions in the second half of the year as operational hurdles are addressed and the J-Code becomes effective on July 1, 2023 [33] - There is significant growth potential for the CD20 class in the EU, with positive discussions with key opinion leaders in Germany [9] Company Strategy and Development Direction - The company is evaluating its commercial pathway in Europe, considering either a solo launch or a partnership, with a decision expected in the coming months [29] - The company aims to achieve broad access to BRIUMVI with greater than 80% coverage by the end of 2023 [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's best-in-class potential and the positive reception from healthcare providers [26][28] - The company believes that operational hurdles will continue to improve throughout the year, facilitating further growth [33] Other Important Information - The company ended the quarter with approximately $160 million in cash, which is expected to last into mid-2024 based on current revenue assumptions [30][36] - The company has capitalized $25 million in inventory on the balance sheet, which will likely be the sole campaign in 2023 [15] Q&A Session Summary Question: Can you elaborate on the mix between new to CD20 versus switches? - The company is seeing a mix of both naive and switch patients, with a broad distribution from various therapies [40][41] Question: What percentage of patients are utilizing the patient access programs? - Approximately 10% to 15% of free goods were provided, primarily through the quick-start program [49] Question: What are the expectations for R&D and SG&A expenses throughout the year? - R&D is expected to remain consistent with Q1 levels, while SG&A is also anticipated to stay stable [50][51] Question: How many patients were infused in the first quarter? - The company does not have exact numbers on infusions, as they only track prescriptions that go through the hub [55][56] Question: What was the gross to net discount for this quarter? - The gross to net discount in Q1 was 77%, with expectations for fluctuations in future quarters [60]
TG Therapeutics(TGTX) - 2023 Q1 - Earnings Call Transcript