Financial Performance - Net product revenue for the three months ended March 31, 2023, was $4.4 million, an increase of $2.6 million from $1.8 million in the same period of 2022, driven by increased Trudhesa sales volume and improved net price realization [112]. - Cost of goods sold for the three months ended March 31, 2023, was $2.3 million, compared to $1.0 million for the same period in 2022, reflecting manufacturing and packing costs associated with Trudhesa [113]. - Gross profit for the three months ended March 31, 2023, was $2.1 million, up from $726,000 in the same period of 2022, representing an increase of $1.4 million [111]. - The net loss for the three months ended March 31, 2023, was $30.1 million, compared to a net loss of $27.0 million for the same period in 2022, reflecting an increase in loss of $3.1 million [111]. Expenses - Research and development expenses decreased to $3.0 million for the three months ended March 31, 2023, from $3.7 million in the same period of 2022, a reduction of $0.7 million due to a strategic reprioritization [115]. - Selling, general and administrative expenses increased to $22.0 million for the three months ended March 31, 2023, from $19.8 million in the same period of 2022, an increase of $2.2 million primarily due to higher commercial operations and marketing spend [118]. - The company incurred a restructuring charge of $1.5 million for the three months ended March 31, 2023, related to severance costs and impairment charges [119]. - The company recorded restructuring charges of $1.5 million in Q1 2023 due to a workforce reduction of approximately 16% [132]. Cash Flow and Capital - As of March 31, 2023, the company had an accumulated deficit of $351.2 million and a cash balance of $35.5 million [103]. - For the three months ended March 31, 2023, cash used in operating activities was $24.1 million, compared to $24.2 million for the same period in 2022 [126][128]. - The company plans to address its cash flow needs by raising additional capital in the second quarter of 2023 to avoid defaulting under the Senior Credit Agreement [133]. - The Senior Credit Agreement requires the company to maintain a minimum unrestricted cash balance of $12.5 million at all times [125]. - As of March 31, 2023, the company had cash and cash equivalents of $35.5 million and an accumulated deficit of $351.2 million [122]. - Cash used in investing activities for the three months ended March 31, 2023, was $1.0 million, primarily for purchases of property and equipment [129]. - The company has an effective shelf registration statement allowing for the sale of up to $200 million in various securities, with $45.0 million remaining eligible for sale under the 2022 ATM Program [123]. Product Development and Strategy - Approximately 81,400 prescriptions of Trudhesa have been generated since its launch, accounting for approximately 4.7% of total branded acute migraine prescriptions among over 2,700 unique prescribers [100]. - The company plans to reprioritize spending to capitalize on the positive momentum in payor and prescriber uptake of Trudhesa while halting research and development efforts on the prior product candidate INP105 [101]. - The company halted research and development efforts on INP105 to focus on the commercialization of Trudhesa [132]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future [133].
Impel Pharmaceuticals (IMPL) - 2023 Q1 - Quarterly Report