Vanda Pharmaceuticals(US:VNDA)2022-11-03 02:35Financial Data and Key Metrics Changes - Total revenues for the first nine months of 2022 were $189.9 million, a 5% decrease compared to $200.7 million for the same period in 2021 [19] - Net loss for the first nine months of 2022 was $600,000 compared to net income of $26.1 million for the same period in 2021 [20] - Operating expenses for the first nine months of 2022 were $190.2 million, an increase from $167.1 million for the same period in 2021 [21] - Total revenues for the third quarter of 2022 were $65.3 million, a 7% decrease compared to $70.1 million for the third quarter of 2021 [22] - Net income for the third quarter of 2022 was $3.3 million, down from $7.8 million for the third quarter of 2021 [23] - Cash balance as of September 30, 2022, was $454.8 million, representing a 3% increase compared to June 30, 2022 [25] Business Line Data and Key Metrics Changes - HETLIOZ net product sales for the first nine months of 2022 were $119.6 million, an 8% decrease compared to the same period in 2021 [19] - Fanapt net product sales for the first nine months of 2022 were $70.3 million, reflecting a 1% decrease compared to the same period in 2021 [20] - HETLIOZ net product sales for the third quarter of 2022 were $41.3 million, a 9% decrease compared to $45.6 million for the third quarter of 2021 [22] - Fanapt net product sales for the third quarter of 2022 were $24 million, a 2% decrease compared to $24.5 million for the third quarter of 2021 [23] Market Data and Key Metrics Changes - Continued reimbursement challenges for prescriptions for patients with non-24 have impacted net sales for both HETLIOZ and Fanapt [22][23] Company Strategy and Development Direction - The company is focused on enhancing the performance of its current commercial products and advancing clinical programs to position for long-term growth [6] - Ongoing clinical programs include studies for Fanapt in bipolar mania and performance anxiety, with results expected by the end of the quarter [7] - The company is preparing for a new drug application for gastroparesis, with FDA submission expected in the first half of 2023 [8] - A supplemental NDA for HETLIOZ in the treatment of insomnia is planned for submission this quarter [11] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of ongoing litigation to hold regulators accountable and protect the company's interests [14][15] - The company expects to achieve net product sales from both HETLIOZ and Fanapt between $240 million and $270 million for 2022, slightly adjusted from prior guidance [25][26] Other Important Information - The company announced a research and development agreement with OliPass to develop antisense oligonucleotides [12] - The FDA granted orphan drug designation for VPO-227 for the treatment of cholera, with an investigational new drug application expected in 2023 [11] Q&A Session Summary Question: What led to the decision to file an sNDA for HETLIOZ and for insomnia now? - Management clarified that the sNDA has not been filed yet but is planned for this quarter, and the application will include the 2008 study along with additional studies [30] Question: Will you be using the 2008 study or is there new data being submitted? - Management confirmed that the chronic insomnia four-week study is the 2008 study, and two additional studies will support the application [30]