Revenue and Sales Performance - Trudhesa generated net product revenue of $3.1 million for the three months ended September 30, 2022, compared to $0.1 million for the same period in 2021, reflecting a significant increase in sales following its launch [165]. - Net product revenue for the nine months ended September 30, 2022, was $7.6 million, a significant increase from $0.1 million in the same period in 2021, reflecting the commercial launch of Trudhesa [175]. - Approximately 42,775 prescriptions of Trudhesa have been generated since its launch, capturing about 5.2% of total branded acute migraine prescriptions among over 2,000 unique prescribers [146]. Costs and Expenses - The cost of goods sold for Trudhesa was $1.5 million for the three months ended September 30, 2022, up from $0.3 million in the same period in 2021, due to manufacturing and packing costs post-FDA approval [166]. - Cost of goods sold rose to $4.3 million for the nine months ended September 30, 2022, compared to $0.3 million for the same period in 2021, primarily due to manufacturing costs associated with Trudhesa [177]. - Selling, general and administrative expenses increased to $19.7 million for the three months ended September 30, 2022, from $16.3 million in the same period in 2021, reflecting higher costs associated with commercialization efforts [164]. - Selling, general and administrative expenses for the nine months ended September 30, 2022, were $57.6 million, up from $31.0 million in the same period in 2021, an increase of $26.6 million [181]. - Research and development expenses for the three months ended September 30, 2022, were $3.2 million, down from $5.9 million in the same period in 2021, showing a reduction in R&D spending [164]. - Total research and development expenses for the nine months ended September 30, 2022, were $10.8 million, down from $16.1 million in the same period in 2021, a decrease of $5.3 million [179]. Financial Losses and Deficits - The net loss for the three months ended September 30, 2022, was $31.1 million, compared to a net loss of $25.0 million for the same period in 2021, indicating an increase in losses year-over-year [164]. - The company has an accumulated deficit of $298.1 million as of September 30, 2022, indicating significant operating losses since inception [149]. - Other income (expense), net was an expense of $18.3 million for the nine months ended September 30, 2022, compared to an expense of $4.6 million for the same period in 2021, an increase of $13.7 million [182]. Cash Flow and Financing - Cash used in operating activities was $75.7 million for the nine months ended September 30, 2022, compared to $43.2 million for the same period in 2021 [187]. - As of September 30, 2022, the company had available cash and cash equivalents of $79.7 million and an accumulated deficit of $298.1 million [184]. - The company plans to address liquidity concerns through additional equity or debt financings, with substantial doubt about its ability to continue as a going concern [186]. - Cash provided by financing activities for the nine months ended September 30, 2022, was $67.5 million, a decrease of 54.3% compared to $147.6 million for the same period in 2021 [192][193]. - The cash inflow for 2022 primarily came from net proceeds of $95.9 million from Oaktree Financing and Revenue Interest Financing, offset by a loan repayment of $32.9 million [192]. Future Plans and Development - The company plans to expand its sales force for Trudhesa to approximately 120 representatives in early 2023 to support its targeted launch strategy [146]. - The company initiated the CALM-201 study in July 2022 for INP105, with results expected in the first half of 2023, indicating ongoing development of new product candidates [148]. - The company expects to continue incurring significant research and development expenses as clinical programs progress and new studies are initiated [159]. - The company plans to continue incurring significant research and development expenses for Trudhesa and other product candidates, indicating ongoing investment in commercialization efforts [194]. - Future operating expenditures will depend on the success of raising additional capital, which may dilute existing stockholders' ownership [195]. Accounting and Compliance - The company has not reported any material changes to its critical accounting policies since the last annual report [198]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards [200]. - The financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates due to the extended transition period [201]. - The company expects to finance its cash needs primarily through equity or debt financings until substantial product revenue is generated [194]. Commercialization Efforts - The costs and timing of commercialization activities for Trudhesa will significantly impact financial performance [196]. - The company has incurred significant commercialization expenses related to product sales, marketing, and outsourced manufacturing for Trudhesa [194].
Impel Pharmaceuticals (IMPL) - 2022 Q3 - Quarterly Report