Financial Performance - The company reported a net loss of $25.0 million for the three months ended September 30, 2021, compared to a net loss of $9.1 million for the same period in 2020, representing an increase in loss of $15.9 million[152]. - The net loss for the nine months ended September 30, 2021, was $51.8 million, compared to a net loss of $31.8 million for the same period in 2020, an increase of $20 million[160]. - Cash used in operating activities was $43.2 million for the nine months ended September 30, 2021, compared to $28.9 million in 2020, indicating a higher cash burn[177]. - Cash used in operating activities for the nine months ended September 30, 2020 was $28.9 million, consisting of a net loss of $31.8 million[179]. Revenue and Product Launch - Product revenue for the third quarter of 2021 was $0.1 million, following the launch of Trudhesa in September 2021[153]. - Net product revenue of $0.1 million was recognized in Q3 2021 following the FDA approval of Trudhesa in September 2021, with shipments commencing in the same month[161]. - Revenue from product sales is recognized when the customer obtains control of the product, which occurs upon transfer of title[192]. Expenses - Research and development expenses decreased to $5.9 million in Q3 2021 from $6.1 million in Q3 2020, primarily due to reduced program-specific costs for clinical development[155]. - Selling, general and administrative expenses increased significantly to $16.3 million in Q3 2021 from $2.9 million in Q3 2020, reflecting costs associated with the commercialization of Trudhesa[152]. - Selling, general and administrative expenses increased to $16.3 million for Q3 2021, up from $2.9 million in Q3 2020, a rise of $13.4 million due to increased commercial and marketing activities for Trudhesa[157]. - Selling, general and administrative expenses for the nine months ended September 30, 2021, totaled $31.0 million, up from $12.2 million in 2020, an increase of $18.8 million[165]. - Total operating expenses for the nine months ended September 30, 2021, were $47.1 million, compared to $31.8 million in 2020, reflecting an increase of $15.3 million[160]. Cash Position and Financing - The company had an accumulated deficit of $190.1 million and a cash balance of $111.3 million as of September 30, 2021[134]. - The company completed an IPO in April 2021, raising approximately $72.0 million in net proceeds, and a follow-on public offering in September 2021, raising approximately $48.3 million[136][137]. - The company completed a follow-on public offering in September 2021, issuing 3,450,000 shares at $15.00 per share, resulting in net proceeds of approximately $48.3 million[170]. - For the nine months ended September 30, 2021, cash provided by financing activities was $147.6 million, primarily from the IPO and follow-on offering[181]. - The company entered into a loan agreement in July 2021, borrowing $20 million initially, with the potential to borrow an additional $30 million based on future milestones[171]. - The company expects to finance its cash needs primarily through a combination of equity or debt financings until substantial product revenue is generated[183]. Operational Considerations - The company is actively monitoring the impact of COVID-19 on its operations and has implemented strategies to minimize disruptions to the commercialization of Trudhesa[139]. - The company has retained all development and commercial rights to Trudhesa and other product candidates, aiming for independent commercialization[132]. - The company plans to incur significant commercialization expenses for Trudhesa, including sales, marketing, and outsourced manufacturing[183]. - The company has not engaged in any off-balance sheet arrangements since its inception[185]. Inventory and Cost of Goods Sold - The cost of goods sold for Q3 2021 was $0.3 million, related to conversion and packing costs for Trudhesa products sold[154]. - Cost of goods sold for the three months ended September 30, 2021 included a charge of $0.1 million related to the write down of inventory to net realizable value[204]. - As of September 30, 2021, the company determined that an allowance for doubtful accounts was not required based on its review of contractual payment terms[201]. Research and Development - The company expects to continue incurring significant research and development expenses as clinical programs progress and new studies are initiated[147]. - Research and development expenses decreased to $16.1 million for the nine months ended September 30, 2021, down from $19.5 million in the same period of 2020, a reduction of $3.4 million[163].
Impel Pharmaceuticals (IMPL) - 2021 Q3 - Quarterly Report