Financial Performance - Net product revenue for the three months ended June 30, 2023, was $6.6 million, an increase of $3.8 million from $2.8 million in the same period of 2022, driven by increased Trudhesa sales volume and improved net price realization [116]. - Net product revenue for the six months ended June 30, 2023, was $11.0 million, an increase of $6.4 million compared to $4.6 million for the same period in 2022, driven by increased Trudhesa sales volume and improved net price realization [128]. - The net loss for the three months ended June 30, 2023, was $7.4 million, a significant improvement from a net loss of $25.2 million in the same period of 2022 [115]. - Net loss for the six months ended June 30, 2023, was $37.4 million, an improvement of $14.8 million compared to a net loss of $52.2 million for the same period in 2022 [127]. - Other income for the six months ended June 30, 2023, was $9.1 million, compared to an expense of $0.6 million for the same period in 2022, an increase of $9.6 million primarily due to changes in the fair value of derivatives [137]. Expenses - Cost of goods sold for the three months ended June 30, 2023, was $3.2 million, compared to $1.7 million for the same period in 2022, reflecting manufacturing and packing costs related to Trudhesa [117]. - Cost of goods sold for the six months ended June 30, 2023, was $5.5 million, up from $2.8 million in the same period in 2022, including a $1.1 million charge related to excess and obsolescence reserves associated with Trudhesa [129]. - Research and development expenses decreased to $0.2 million for the three months ended June 30, 2023, from $4.0 million in the same period of 2022, primarily due to a strategic shift in focus towards commercial operations [119]. - Research and development expenses decreased to $3.2 million for the six months ended June 30, 2023, from $7.6 million in the same period in 2022, a reduction of $4.4 million due to decreased personnel and program costs [131]. - Selling, general and administrative expenses increased to $19.3 million for the three months ended June 30, 2023, compared to $18.1 million in the same period of 2022, mainly due to higher promotional and marketing spending [121]. - Selling, general and administrative expenses increased to $41.3 million for the six months ended June 30, 2023, compared to $37.9 million in the same period in 2022, an increase of $3.4 million primarily due to higher commercial operations and marketing spend [134]. Cash and Liquidity - As of June 30, 2023, the company had an accumulated deficit of $358.5 million and a cash balance of $15.2 million [107]. - Cash used in operating activities for the six months ended June 30, 2023, was $44.6 million, a decrease from $53.0 million in the same period in 2022 [143]. - The company is currently negotiating a potential $20.0 million bridge financing facility with Oaktree to address liquidity issues and noncompliance with covenants [102]. - The company is currently in default of its liquidity covenant requiring a minimum of $12.5 million in unrestricted cash, and is negotiating with Oaktree for a forbearance agreement [141]. - The company estimates that its cash and cash equivalents as of June 30, 2023, are insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern [140]. - Company requires substantial additional funding to support operations, with potential bankruptcy protection under Chapter 11 being considered [148]. Strategic Actions - The company plans to reduce its workforce by approximately 16%, incurring a charge of approximately $1.5 million primarily for severance costs [105]. - Company plans to reduce workforce by approximately 16% to reprioritize spending and capitalize on positive momentum in Trudhesa uptake [148]. - The company is exploring strategic alternatives, including potential restructuring or refinancing of debt, to maximize stockholder value given its current liquidity position [101]. - Company is exploring strategic alternatives, including potential transactions that may not deliver anticipated benefits [148]. - The timing and amount of operating expenditures will depend on the ability to raise additional capital, which may dilute existing stockholders' ownership [149]. Accounting and Reporting - Management's estimates for financial statements are based on historical experience and various factors, which may lead to actual results differing from estimates [151]. - No material changes to critical accounting policies have occurred since the last annual report [152]. - Company is classified as an "emerging growth company" under the JOBS Act, allowing for delayed adoption of new accounting standards [154]. - The extended transition period under the JOBS Act may result in financial statements that are not comparable to those of companies complying with new accounting pronouncements [155]. - Restructuring charges recorded in Q1 2023 amounted to $1.5 million, primarily for severance and related costs [148]. Product Performance - Approximately 102,000 prescriptions of Trudhesa have been generated since its launch, accounting for approximately 4.5% of total branded acute migraine prescriptions [104]. - Significant commercialization expenses are incurred for Trudhesa, impacting overall financial condition [148].
Impel Pharmaceuticals (IMPL) - 2023 Q2 - Quarterly Report