Xenon(US:XENE)2025-11-03 21:31Financial Performance - For the nine months ended September 30, 2025, the company recognized revenue of $7.5 million, compared to nil for the same period in 2024[57]. - The company incurred a net loss of $240.6 million for the nine months ended September 30, 2025, compared to a net loss of $168.6 million for the same period in 2024[58]. - As of September 30, 2025, the company had an accumulated deficit of $1,140.1 million[58]. - Collaboration revenue for the nine months ended September 30, 2025, was $7.5 million, a significant increase from $0 in the same period in 2024[77]. - Net cash used in operating activities was $197.6 million for the nine months ended September 30, 2025, compared to $127.0 million for the same period in 2024, reflecting increased expenses[88]. - For the nine months ended September 30, 2025, net cash provided by financing activities was $3.6 million, compared to nil for the same period in 2024[91]. Research and Development - The Phase 3 X-TOLE2 study of azetukalner in focal onset seizures has completed patient enrollment with 380 patients randomized, with topline data anticipated in early 2026[56]. - The company is advancing azetukalner for multiple indications, including major depressive disorder and bipolar depression, with ongoing Phase 3 studies[56]. - A Phase 1 study for NBI-921355, a selective inhibitor of voltage-gated sodium channels, is underway as part of a collaboration with Neurocrine Biosciences[57]. - The company expects research and development expenses to increase substantially as it continues to invest in product candidates and clinical studies[66]. - Direct external costs related to azetukalner increased by $13.1 million (44.3%) for the three months and $41.5 million (54.5%) for the nine months ended September 30, 2025, compared to the same periods in 2024[78]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future as it prepares for the potential commercial launch of azetukalner[84]. Expenses - Research and development expenses increased by $20.1 million (35.2%) for the three months and $62.3 million (41.3%) for the nine months ended September 30, 2025, compared to the same periods in 2024[78]. - General and administrative expenses rose by $2.6 million (15.4%) for the three months and $6.7 million (13.1%) for the nine months ended September 30, 2025, compared to the same periods in 2024[79]. - The company anticipates an increase in general and administrative expenses as it expands its operating activities and prepares for commercialization[69]. Cash and Securities - As of September 30, 2025, the company had cash and cash equivalents and marketable securities of $555.3 million[81]. - As of September 30, 2025, the company had U.S. dollar denominated cash and cash equivalents and marketable securities of $497.3 million and Canadian dollar denominated cash and cash equivalents and marketable securities of CAD$79.6 million[95]. - A 100 basis point increase in interest rates would have resulted in approximately a $2.7 million decrease in the fair value of the company's marketable securities as of September 30, 2025[98]. Foreign Currency Risk - The company is exposed to foreign currency exchange rate risk, particularly with transactions denominated in Canadian dollars[96]. - The company does not currently hedge its exposure to foreign currency exchange rates, assuming the risk of future gains or losses[97]. Strategic Focus - The company is focused on maintaining existing collaborations and establishing new ones, which may generate milestone payments and royalties[90]. - The company is expanding its research and development and initiating pre-commercial and commercial activities, which will impact headcount growth and associated costs[90]. - The company plans to prepare for the potential commercial launch of azetukalner and invest significantly in its development[63]. Other Information - There have been no material changes in the company's significant contractual obligations as of September 30, 2025, compared to those disclosed in the Annual Report on Form 10-K[92]. - As of October 30, 2025, the company had 77,275,005 common shares issued and outstanding, along with various outstanding warrants and stock options[93].