Neurocrine(NBIX)2024-08-01 19:24Financial Data and Key Metrics Changes - Q2 2024 gross sales reached $580 million, a 32% increase from $440 million in the prior year [6][4] - The company raised its 2024 gross and net sales guidance to a range of $2.25 billion to $2.3 billion, up from the previous range of $2.1 billion to $2.2 billion [6][7] - GAAP SG&A expense guidance was updated by approximately $35 million, with $20 million allocated for the growth of ININGREZZA and $15 million for a non-GAAP impairment charge [6][7] Business Line Data and Key Metrics Changes - ININGREZZA experienced over 30% year-over-year growth, with sales approaching $1.1 billion in the first half of 2024 [8][9] - The company is expanding its sales force to enhance the reach and education of healthcare providers regarding ININGREZZA [10][11] - A new sprinkle formulation of ININGREZZA was launched to cater to patients with swallowing difficulties [12][13] Market Data and Key Metrics Changes - The TD market has grown significantly, with more healthcare providers diagnosing and treating tardive dyskinesia (TD) [10][11] - The company plans to increase its psychiatry and long-term care sales teams to better serve the growing number of TD treaters [11][34] - The CAH market is expected to see significant changes with the potential approval of Crinecerfont, which has been granted priority review by the FDA [18][19] Company Strategy and Development Direction - The company aims to maintain its leadership in neuroscience by investing in its R&D pipeline and expanding its commercial footprint [6][8] - Neurocrine is focused on organic growth, moving towards internally discovered programs and exploring gene therapy [47][48] - The strategic plan includes launching Crinecerfont and advancing the clinical programs for NBI-'845 and NBI-'568 [46][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of ININGREZZA and the upcoming launch of Crinecerfont, highlighting the significant unmet needs in the CAH community [18][19] - The company is well-positioned financially, with $1.7 billion in cash, allowing for continued investment in R&D and potential new therapies [48] - Management emphasized the importance of evolving their approach to meet the needs of healthcare providers and patients [10][34] Other Important Information - The company has a robust clinical pipeline, with multiple new compounds entering the clinic and significant progress in ongoing studies [21][22] - The FDA has granted breakthrough therapy designation and orphan drug designation to Crinecerfont, enhancing its potential market position [18][19] Q&A Session Summary Question: Insights on NBI-'568 data and Phase I study - Management confirmed that data from the Phase I proof-of-concept study will be delivered soon, emphasizing confidence in the safety and tolerability of the doses chosen for the study [22][23] Question: Sales force expansion rationale - The company is expanding its sales force to meet the growing needs of the psychiatry segment and long-term care, expecting positive ROI from this investment [34][35] Question: Growth drivers for ININGREZZA - All three business segments (psychiatry, neurology, long-term care) are experiencing growth, with continued efforts to raise awareness and educate healthcare providers [37][38] Question: Future opportunities for M4 beyond schizophrenia - Management indicated that while there are many potential opportunities, the focus remains on the data from the Phase II study before considering expansions into other indications [71]