TG Therapeutics(US:TGTX)2021-08-02 19:36Financial Data and Key Metrics Changes - The company reported a net loss of approximately $62 million for Q2 2021, a decrease of $12 million from Q1 2021, primarily due to one-time licensing milestone payments in Q1 [37] - GAAP net loss for Q2 2021 was $78.5 million or $0.59 per share, compared to a net loss of $52.9 million or $0.47 per share in Q2 2020 [38] - The company ended Q2 2021 with approximately $456 million in cash, cash equivalents, and investment securities, expected to last into 2023 [36] Business Line Data and Key Metrics Changes - UKONIQ achieved $1.5 million in net sales in Q2 2021, capturing 3% to 4% of new patient starts in its labeled indication [25][26] - The company provided over 35% of UKONIQ bottles free of charge through its patient assistance program in Q2 2021 [27] - The company is targeting net sales of $7.5 million to $12.5 million for the full year 2021, with expectations of growth to $50 million to $75 million in 2022 [29] Market Data and Key Metrics Changes - The company estimates approximately 8,000 patients annually will seek treatment in the approved marginal zone lymphoma (MZL) and follicular lymphoma indications [9] - For chronic lymphocytic leukemia (CLL), the estimated patient population is between 30,000 to 40,000 annually, significantly larger than MZL and follicular lymphoma [11] - The company expects to participate in a projected $10 billion to $15 billion market for anti-CD20 monoclonal antibodies in the treatment of multiple sclerosis (MS) [14] Company Strategy and Development Direction - The company aims to enhance its Hematology Oncology franchise by broadening the potential U2 label to new indications and combination uses in CLL [15] - The core focus will be on regulatory and commercial execution of opportunities in CLL and MS, with a multi-phase strategy in place [14] - The company is also exploring additional programs in auto-inflammatory diseases and other forms of MS [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for penetration in the MZL and follicular markets, aiming for 20% to 30% penetration as a strong target [53] - The management noted that COVID-19 has impacted patient visits and treatment starts, but they expect recovery as the pandemic subsides [32] - The company is optimistic about achieving a $1 billion sales target by 2025, with a balanced contribution from MS and hematology indications [50] Other Important Information - The company is on track to submit a BLA for MS this quarter, with a target PDUFA date in Q3 2022 [13] - The company has received positive feedback on the clinical profile of UKONIQ, particularly regarding its safety profile compared to other PI3K inhibitors [47] - The company is finalizing the design for a randomized trial to convert accelerated approval of UKONIQ into full approval [62] Q&A Session Summary Question: How has penetration occurred in the heme/onc accounts during COVID? - Management indicated good penetration in top centers but noted that frequency of engagement has been affected by the Delta variant, leading to some restrictions [44] Question: What is the feedback on the safety differentiation of UKONIQ? - Feedback has been positive, with UKONIQ seen as differentiated due to the lack of a black box warning compared to other PI3K inhibitors [47] Question: What are the anticipated sales for 2022 and the breakdown between MS and hematology? - Management expects modest penetration for CLL in 2022, with a balanced contribution from both MS and hematology by 2025 [50][68] Question: What is the pathway for full approval of UKONIQ? - Full approval will require a randomized trial, with the design being finalized with the FDA [62] Question: What are the obstacles to UKONIQ adoption? - The main obstacles include COVID-related access issues, decreased patient visits, and competition from other therapies [60]