Financial Performance - For the three months ended September 30, 2023, net product revenue was $5.0 million, an increase of $1.9 million from $3.1 million in the same period of 2022, primarily due to improved net price realization and a decrease in discounts[134]. - The company incurred a net loss of $13.8 million for the three months ended September 30, 2023, compared to a net loss of $31.1 million in the same period of 2022, representing an improvement of $17.3 million[133]. - Net product revenue increased to $16.0 million for the nine months ended September 30, 2023, compared to $7.6 million for the same period in 2022, an increase of $8.4 million[145]. - The company reported a net loss of $51.2 million for the nine months ended September 30, 2023, an improvement of $32.0 million compared to a net loss of $83.3 million in the same period of 2022[144]. - Other income (expense), net was income of $11.7 million for the nine months ended September 30, 2023, compared to an expense of $7.3 million for the same period in 2022, an increase of $19.0 million[154]. Expenses - The cost of goods sold for the same period was $2.2 million, compared to $1.5 million in 2022, reflecting manufacturing and packing costs associated with Trudhesa products sold[135]. - Research and development expenses decreased to $0.3 million for the three months ended September 30, 2023, down from $3.2 million in 2022, due to a strategic shift in focus towards commercial operations[137]. - Selling, general and administrative expenses were $56.6 million for the nine months ended September 30, 2023, down from $57.6 million in the same period of 2022, a decrease of $1.0 million[151]. - Research and development expenses decreased to $3.5 million for the nine months ended September 30, 2023, from $10.8 million in the same period of 2022, a reduction of $7.3 million[148]. - Total research and development expenses for the three months ended September 30, 2023, were $252,000, down from $3.2 million in the same period of 2022, a decrease of $2.9 million[150]. Cash Flow and Liquidity - As of September 30, 2023, the company had an accumulated deficit of $372.3 million and a cash balance of $0.2 million[125]. - The company estimates that its cash and cash equivalents as of September 30, 2023, are insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[159]. - Cash used in operating activities was $61.1 million for the nine months ended September 30, 2023, compared to $75.7 million for the same period in 2022, a decrease of $14.6 million[162]. - Cash provided by financing activities for the nine months ended September 30, 2023, was $7.1 million, related to proceeds from issuance of debt and common stock[166]. - Cash used in investing activities for the nine months ended September 30, 2023, was $1.9 million, compared to $0.4 million in 2022, related to purchases of property and equipment[165]. Strategic Actions - The company has secured managed care contracts providing access to Trudhesa for over 80% of commercial lives in the United States[121]. - Approximately 122,000 prescriptions of Trudhesa have been generated since its launch, accounting for approximately 4.9% of total branded acute migraine prescriptions[122]. - The company has entered into amended senior credit agreements with Oaktree, providing $20.0 million in term loans to address current and anticipated noncompliance with covenants[119]. - The company plans to reduce its workforce by approximately 16%, incurring a charge of approximately $1.5 million primarily for severance costs[123]. - The company is exploring strategic alternatives, including potential restructuring or refinancing of debt, to maximize stockholder value given its current liquidity position[118]. Risks and Assumptions - The company faces risks related to dilution of existing stockholders' ownership if substantial additional capital is raised through equity offerings[169]. - The management's estimates and assumptions for financial statements are based on historical experience and various factors, including commercialization costs for Trudhesa[170]. - There have been no material changes to critical accounting policies from those described in the Annual Report for the year ended December 31, 2022[172]. - The company will need substantial additional funding to support operations absent a strategic transaction, with potential bankruptcy protection under Chapter 11 being considered[168].
Impel Pharmaceuticals (IMPL) - 2023 Q3 - Quarterly Report