Financial Performance - For the three months ended June 30, 2022, net product revenue was $2.8 million, with a gross profit of $1.1 million [170][171]. - The company incurred a net loss of $25.2 million for the three months ended June 30, 2022, compared to a net loss of $15.5 million for the same period in 2021 [170]. - Net product revenue recognized for the six months ended June 30, 2022, was $4.6 million related to sales of Trudhesa, following its FDA approval in September 2021 [181]. - The net loss for the six months ended June 30, 2022, was $52.2 million, compared to a net loss of $26.8 million for the same period in 2021, representing an increase of 94.8% [187]. - Cash used in operating activities for the six months ended June 30, 2022, was $53.0 million, compared to $25.9 million for the same period in 2021, an increase of 104.3% [192]. - Other income (expense), net was an expense of $8.5 million for the six months ended June 30, 2022, compared to an expense of $2.0 million for the same period in 2021, an increase of 325% [187]. - Total operating expenses for the six months ended June 30, 2022, were $45.5 million, up from $24.8 million in the same period of 2021, an increase of 83.4% [179]. Expenses - Research and development expenses for the three months ended June 30, 2022, were $3.9 million, a decrease of $2.1 million from $6.1 million in the prior year [170]. - Selling, general and administrative expenses increased by $9.2 million to $18.1 million for the three months ended June 30, 2022, compared to $8.9 million in 2021 [170]. - Research and development expenses decreased to $4.0 million for the three months ended June 30, 2022, from $6.1 million in the same period of 2021, a reduction of 34.4% [174]. - Selling, general and administrative expenses increased to $18.1 million for the three months ended June 30, 2022, compared to $8.9 million in the same period of 2021, an increase of 103.4% [176]. Cash Position - As of June 30, 2022, the company had an accumulated deficit of $267.0 million and a cash balance of $97.8 million [153]. - As of June 30, 2022, the company had available cash and cash equivalents of $97.8 million and an accumulated deficit of $267.0 million [188]. - The company recorded a cash increase of $9.6 million for the six months ended June 30, 2022, compared to a cash increase of $53.9 million for the same period in 2021 [191]. Strategic Plans - The company plans to expand its sales force for Trudhesa to approximately 120 representatives in early 2023 [150]. - The company plans to continue incurring significant commercialization expenses for Trudhesa and expects to finance cash needs primarily through equity or debt financings [198]. - The company is assessing costs and timing for commercialization activities related to Trudhesa and other product candidates pending marketing approval [202]. - The company is focused on establishing strategic collaborations and managing costs associated with patent applications and intellectual property rights [202]. Research and Development - The CALM-201 study for INP105, a nasal olanzapine product, was initiated in July 2022, with results expected in the first half of 2023 [152]. Financing and Capital - The company entered into a senior secured loan agreement for $50.0 million and a Revenue Interest Financing Agreement to receive payments based on future net revenues of Trudhesa [154][155]. - The company may face dilution of existing stockholders' ownership if additional capital is raised through public or private equity or convertible debt offerings [199]. Accounting and Compliance - The management's financial analysis is based on condensed consolidated financial statements prepared in accordance with GAAP, requiring estimates and assumptions that may differ from actual results [200]. - There have been no material changes to the company's critical accounting policies from the previous year [201]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards [204]. - The company has elected to use the extended transition period under the JOBS Act, which may affect the comparability of its financial statements with other public companies [205]. - As a smaller reporting company, the company is not required to provide detailed market risk disclosures [206]. Product Performance - Trudhesa generated approximately 26,150 prescriptions since its launch, accounting for about 4.3% of total branded acute migraine prescriptions among prescribers [150]. - Approximately 68% of new Trudhesa patients eligible for a refill have received a second prescription, indicating strong patient retention [150].
Impel Pharmaceuticals (IMPL) - 2022 Q2 - Quarterly Report