Xenon Pharmaceuticals Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 26 February 2026: press release. Guidance figures: 6 new, 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss rose on higher spending: Net loss was $105.3 million in Q4 2025 and $345.9 million for the year, against $65.7 million and $234.3 million a year earlier. Management attributed the increase mainly to higher R&D on the azetukalner program. Source
• Next milestone is X-TOLE2 readout: Management named the X-TOLE2 topline readout in focal onset seizures as the next milestone for azetukalner, ahead of an anticipated NDA submission. Source
• Long-term open-label extension data shown: Management presented 48-month data from the X-TOLE open-label extension at the American Epilepsy Society meeting, with more than 775 patient-years of exposure in the extension. Source
• Pain Phase 1 completion expected 2026: Phase 1 SAD/MAD studies of XEN1701 (NaV1.7) and XEN1120 (KV7) are underway in healthy adults. Completion in 2026 would support Phase 2 proof-of-concept studies in acute pain. Source
• R&D rose on azetukalner Phase 3 work: The full-year R&D increase was attributed mainly to the ongoing azetukalner Phase 3 studies in epilepsy, MDD and BPD, plus personnel costs, stock-based compensation and pre-clinical programs. Source
• ATM sales raised $242.2 million: Net ATM proceeds totaled $242.2 million, including $112.2 million in the fourth quarter of 2025, with further sales after year-end. Source
• Year-end cash balance declined: Cash, cash equivalents and marketable securities were $586.0 million at year-end, down from $754.4 million a year earlier. Management said this funds operations into the second half of 2027. Source

“2025 marked a period of significant momentum and strong execution across multiple Phase 3 clinical trials of azetukalner in epilepsy and neuropsychiatry, as well as our early-stage pipeline that includes two novel ion channel modulators for pain,”

Ian Mortimer, President and Chief Executive Officer of Xenon

Guidance

What changed from last quarter

• New guidance: An NDA submission for azetukalner is now given a timing, the second half of 2026, after the X-TOLE2 readout. The prior release did not give one. Source
• New guidance: A timing for X-NOVA2 topline data in major depressive disorder is given, H1 2027. The prior release did not give one. Source
• New guidance: A 2026 timing is given for Phase 1 data on XEN1701 and XEN1120 to support pain Phase 2 studies. The prior release gave no timing. Source
• New guidance: A 2026 completion timing is given for X-TOLE3 enrollment outside Japan. The prior release gave no timing. Source
• New: Net proceeds of $130.0 million were raised in Q1 2026 from ATM sales, after year-end. Source
• New: Japan enrollment within X-TOLE3 was agreed with PMDA. This is not in the prior release. Source
• New: 48-month data from the X-TOLE open-label extension were presented at the American Epilepsy Society annual meeting. Source
• New: An ethnobridging study was completed and results were shared with Japan's PMDA. The prior release did not report this. Source

Results and net loss

• Net loss rose on higher spending: Net loss was $105.3 million in Q4 2025 and $345.9 million for the year, against $65.7 million and $234.3 million a year earlier. Management attributed the increase mainly to higher R&D on the azetukalner program. Source
• Net loss per share rose: Basic and diluted net loss per share was $(1.31) in Q4 2025 and $(4.36) for the year, against $(0.84) and $(3.01) in the prior-year periods. Weighted average shares were 80,126,081 in the quarter. Source
• Other income declined on lower interest: Other income was $5.0 million in Q4 2025 and $28.2 million for the year, down from $7.9 million and $40.9 million. The full-year decrease was primarily attributed to lower interest income. Source

Azetukalner clinical programs

• Next milestone is X-TOLE2 readout: Management named the X-TOLE2 topline readout in focal onset seizures as the next milestone for azetukalner, ahead of an anticipated NDA submission. Source
• Long-term open-label extension data shown: Management presented 48-month data from the X-TOLE open-label extension at the American Epilepsy Society meeting, with more than 775 patient-years of exposure in the extension. Source
• Depression Phase 3 studies enrolling: Enrollment continues in the Phase 3 X-NOVA2 and X-NOVA3 studies in major depressive disorder, and the Phase 3 X-CEED study in bipolar depression is underway. Source
• X-ACKT epilepsy study continues enrolling: The Phase 3 X-ACKT study in primary generalized tonic-clonic seizures continues to enroll and is intended to support submissions for an additional epilepsy indication. Source
• Japan path for X-TOLE3: The company aligned with PMDA on a Japan enrollment plan for X-TOLE3, after completing an ethnobridging study that it shared with the agency. Source

“We’re looking forward to several upcoming milestones, starting with reporting topline data for our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures in the first half of March,”

Ian Mortimer, President and Chief Executive Officer of Xenon

Early-stage pain and channel programs

• Pain Phase 1 completion expected 2026: Phase 1 SAD/MAD studies of XEN1701 (NaV1.7) and XEN1120 (KV7) are underway in healthy adults. Completion in 2026 would support Phase 2 proof-of-concept studies in acute pain. Source
• NaV1.1 program in IND-enabling work: IND-enabling studies continue for the NaV1.1 program. Pre-clinical data suggest that targeting NaV1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome. Source
• Partnered NBI-921355 Phase 1 ongoing: With Neurocrine Biosciences, a Phase 1 study is ongoing for NBI-921355, a selective inhibitor of NaV1.2 and NaV1.6 channels in development for certain types of epilepsy. Source
• Expanding potassium and sodium channel portfolio: The company said it continues to expand its portfolio of potassium and sodium channel modulators, using its human genetics heritage and ion channel expertise. Source

Operating costs

• R&D rose on azetukalner Phase 3 work: The full-year R&D increase was attributed mainly to the ongoing azetukalner Phase 3 studies in epilepsy, MDD and BPD, plus personnel costs, stock-based compensation and pre-clinical programs. Source
• G&A rose on headcount and fees: General and administrative expense rose for the year, driven by personnel costs from higher headcount and by higher professional and consulting fees. Source
• Total operating expenses increased: Total operating expenses were $109.8 million in Q4 2025 and $380.6 million for the year, against $77.5 million and $279.3 million a year earlier. Source

Cash, financing and runway

• ATM sales raised $242.2 million: Net ATM proceeds totaled $242.2 million, including $112.2 million in the fourth quarter of 2025, with further sales after year-end. Source
• Year-end cash balance declined: Cash, cash equivalents and marketable securities were $586.0 million at year-end, down from $754.4 million a year earlier. Management said this funds operations into the second half of 2027. Source
• Year-end share and warrant count: At December 31, 2025, the company had 80,010,790 common shares and 2,173,081 pre-funded warrants outstanding. Source

Strategy and milestones

• Investor call set for X-TOLE2 readout: Management said the next investor call will be held for the X-TOLE2 topline data readout. Source
• Azetukalner described as only KV7 opener: The company described azetukalner as the only KV7 potassium channel opener in development for multiple indications, backed by long-term epilepsy data and MDD proof-of-concept data. Source
• Azetukalner as lead molecule: The company describes azetukalner as its lead molecule, in Phase 3 trials for epilepsy, major depressive disorder and bipolar depression, alongside early-stage Phase 1 pain programs. Source

Coming up, as management said on 26 February 2026

• X-TOLE2 topline data: Topline data from the Phase 3 X-TOLE2 study is due in the first half of March 2026, and the next investor call will be held for that readout. Source
• Investor call on X-TOLE2 readout: The next investor call will be held for the X-TOLE2 topline data readout. Source
• NDA submission after X-TOLE2: An NDA submission is anticipated in the second half of 2026, following the X-TOLE2 topline data. Source
• X-NOVA2 MDD topline data: Topline data from Phase 3 X-NOVA2 in MDD is expected in H1 2027. Source
• Pain Phase 1 data in 2026: Data from the XEN1701 and XEN1120 Phase 1 studies are expected in 2026, to support Phase 2 proof-of-concept studies in pain. Source
• X-TOLE3 enrollment outside Japan completes: Enrollment in X-TOLE3 outside Japan is expected to complete in 2026. Source

Figures management reported

Earlier plans management reported on

• On track: Management said the X-TOLE2 topline data readout is on track for the first half of March 2026. Source
• Not stated: The prior release planned to show OLE data at the American Epilepsy Society meeting. This release says the 48-month data were presented there, without a status word. Source

Other quarters

• Q3 FY2026 earnings call
• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.