XBiotech(US:XBIT)2023-11-09 19:41Financial Performance - As of September 30, 2023, the accumulated deficit was $47.7 million, with net losses before income tax of $7.1 million and $19.6 million for the three months and nine months ended September 30, 2023, respectively[80]. - The company does not expect any revenues in the next year and anticipates significant and increasing operating losses as it advances its drug candidates[80]. - The company expects to continue incurring operating losses in the future and does not anticipate receiving additional revenue under the clinical manufacturing agreement with Janssen[113]. Research and Development Expenses - Total research and development expenses for the three months and nine months ended September 30, 2023 were $7.5 million and $25.0 million, respectively, compared to $7.0 million and $24.2 million for the same periods in 2022, reflecting an increase of 8% and 3%[101][102]. - Research and development expenses accounted for 89% and 87% of total operating expenses for the three months and nine months ended September 30, 2023, compared to 89% and 82% for the same periods in 2022[85]. - Clinical trials and sponsored research expenses increased by 357% to $1.6 million for the three months ended September 30, 2023, compared to $0.3 million for the same period in 2022[100]. - Research and development expenses included share-based compensation of $0.8 million and $2.2 million for the three months and nine months ended September 30, 2023, respectively[84]. - Total research and development expenses from inception through September 30, 2023 amounted to $304.1 million[84]. General and Administrative Expenses - General and administrative expenses for the three months and nine months ended September 30, 2023 were $1.0 million and $3.9 million, respectively, compared to $0.8 million and $5.2 million for the same periods in 2022[87]. - General and administrative expenses increased by $0.1 million to $1.0 million for the three months ended September 30, 2023, compared to $0.8 million for the same period in 2022, while decreasing by $1.3 million to $3.9 million for the nine months ended September 30, 2023, compared to $5.2 million in 2022[103][105]. Employee and Compensation Information - The company had 85 employees as of September 30, 2023[80]. - Salaries and related expenses decreased by 50% to $1.1 million for the nine months ended September 30, 2023, compared to $2.3 million in 2022, with the CEO's bonus increasing to $4.5 million in 2023 from $3.8 million in 2022[105]. - Share-based compensation decreased by 72% to $339,000 for the nine months ended September 30, 2023, compared to $1.2 million in 2022[105]. Cash Flow and Investments - The company reported a total net cash used in operating activities of $15.3 million for the nine months ended September 30, 2023, compared to $11.7 million in 2022, primarily due to net losses[110]. - Cash and cash equivalents increased to $202.2 million as of September 30, 2023, compared to $160.6 million at the same date in 2022[108]. - The company generated net cash from investing activities of $61.6 million for the nine months ended September 30, 2023, compared to a cash outflow of $60.0 million in 2022[111]. Other Expenses - Professional fees increased by 233% to $410,000 for the three months ended September 30, 2023, compared to $123,000 in 2022[103]. - Interest income for the three months ended September 30, 2023, was $2.5 million, up from $1.0 million in 2022, and for the nine months, it was $7.8 million compared to $1.4 million in 2022[106]. - The company has not engaged in any off-balance sheet activities since inception[114]. Manufacturing Revenue - Manufacturing revenue was $1.7 million for the three months ended September 30, 2022, and $3.7 million for the nine months ended September 30, 2022, with no revenue recorded for the same periods in 2023 due to the completion of the Janssen Transaction Addendum[95][96].