Xeris Biopharma(XERS) - 2024 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of $49.7 million, compared to a net loss of $48.9 million for the same period in 2023, with an accumulated deficit of $666.7 million as of September 30, 2024[83]. - Product revenue increased by 26.8% to $52.9 million for the three months ended September 30, 2024, compared to $41.7 million for the same period in 2023[96]. - The net loss for the three months ended September 30, 2024, was $15.7 million, compared to a net loss of $12.2 million for the same period in 2023, reflecting a 29.1% increase[96]. - Total revenue for the nine months ended September 30, 2024, increased by 19.6% to $143.0 million compared to $119.5 million for the same period in 2023[96]. - The company has an accumulated deficit of $666.7 million as of September 30, 2024[107]. - Net cash used in operating activities was $39.0 million for the nine months ended September 30, 2024, a decrease from $54.5 million for the same period in 2023[112]. - Net cash used in investing activities was $5.1 million for the nine months ended September 30, 2024, compared to $20.9 million for the same period in 2023[113]. - Net cash provided by financing activities was $35.8 million for the nine months ended September 30, 2024, compared to a cash outflow of $0.4 million for the same period in 2023[114]. Product Development - Gvoke, Recorlev, and Keveyis are the three commercial products with total addressable markets of approximately $5.0 billion, $3.0 billion, and greater than $0.5 billion in the United States, respectively[77]. - The company is focused on developing XP-8121, a once-weekly subcutaneous injection of levothyroxine, which has shown positive Phase 1 data indicating a four-time target dose conversion factor when switching from oral levothyroxine[81]. - The Phase 1 study of XP-8121 involved 30 healthy participants, comparing its pharmacokinetics to oral levothyroxine, with results indicating slower absorption and higher extended exposure[80]. - The proprietary formulation technologies, XeriSol and XeriJect, enable the development of room-temperature stable, highly concentrated injectable formulations, enhancing drug delivery and patient experience[78]. - The company is pursuing formulation and development partnerships to enhance the clinical profile of other companies' proprietary drugs using its formulation science[75]. Expenses and Costs - Research and development expenses are expected to remain significant as the company advances its pipeline candidates and conducts clinical trials[91]. - Research and development expenses rose by $0.9 million or 17.0% for the three months ended September 30, 2024, driven by higher spending on the pipeline[101]. - Selling, general and administrative expenses increased by $7.7 million or 20.6% for the three months ended September 30, 2024, mainly due to CEO succession and restructuring costs[103]. - Cost of goods sold increased by 65.7% to $13.6 million for the three months ended September 30, 2024, primarily due to manufacturing process changes[100]. - Interest expense increased by $0.9 million or 13.7% for the three months ended September 30, 2024, due to a higher principal amount and increased interest rates[105]. Future Outlook and Financing - The company anticipates continued significant expenses and operating losses in the near term due to ongoing commercialization and research efforts[83]. - The company expects to incur substantial additional expenditures to support the marketing and selling of Gvoke, Recorlev, and Keveyis, as well as ongoing research and development activities[107]. - The Amended and Restated Credit Agreement provided for the New Lenders to extend $200.0 million in term loans to the company on the closing date[106]. - The company may need to obtain additional financing in the future, which may include public or private debt and/or equity financings[110]. - A hypothetical one-percentage point increase or decrease in interest rates would increase or decrease interest income by approximately $0.7 million on an annual basis[119]. - Interest on the 2025 Convertible Notes is assessed at a fixed rate of 5.0% annually, while interest on the 2028 Convertible Notes is assessed at a fixed rate of 8.0% annually[119]. - The company has granted a first priority security interest on substantially all of its assets, including intellectual property, under the Amended and Restated Credit Agreement[106].