2/26/2026

speaker
Operator
Conference Operator

Good morning. Welcome to the Irinia Pharmaceuticals' fourth quarter and full year 2025 conference call. Please be advised that a Q&A session will follow Irinia's prepared remarks, and we ask you please ask one question and one follow-up to return to the queue. I will now turn the call over to Peter Greenleaf, President and Chief Executive Officer of Irinia. Peter, please go ahead.

speaker
Peter Greenleaf
President and Chief Executive Officer

Good morning. We want to thank you all for joining us today to discuss Arinia's fourth quarter and full year 2025 update. Joining me on the call today are Joe Miller, our Chief Financial Officer, and Dr. Greg Keenan, our Chief Medical Officer. On today's call, we will report fourth quarter and full year 2025 financial results and provide an update on recent business progress. During today's call, we may make forward-looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially. We are pleased to have delivered strong Lucana sales in 2025, growing at a rate of 25% year-over-year. And for 2026, we expect net product sales of $305 million to $315 million, up 12 to 16% compared to 2025. And with that introduction, I'd like to now turn the call over to Joe to review our financial results. Joe?

speaker
Joe Miller
Chief Financial Officer

Thank you, Peter. Total revenue for the fourth quarter of 2025 was $77.1 million, up 29% compared to $59.9 million for the same period of 2024. Net product sales of Loop Kindness for the fourth quarter of 2025 were $74.2 million, up 29% compared to $57.6 million in 2024. Net income for the fourth quarter of 2025 was $210.8 million, up 14,957% from $1.4 million in 2024. In the fourth quarter of 2025, the company recorded an income tax benefit of $175.1 million, primarily due to the release of its valuation allowance on deferred tax assets that the company now expects to realize. Net income before income taxes for the fourth quarter of 2025 was $35.7 million, up 2,875% from $1.2 million in 2024. Diluted earnings per share for the fourth quarter of 2025 was $1.53, up 15,200% from 1 cent in 2024. Lastly, cash flows from operating activities for the fourth quarter of 2025 were $45.7 million, up 52% from $30.1 million in 2024. Total revenue for the year ended December 31, 2025 was $283.1 million, up 20% compared to the $235.1 million for the same period of 2024. As a reminder, the 2024 period included a milestone payment of $10 million associated with Loop Kindness regulatory approval in Japan. Excluding the one-time milestone, total revenue increased by 26% over the same period in 2024. Net product sales of Loop Kindness for the year ended December 31, 2025, were $271.3 million, up 25% from $216.2 million in 2024. Net income for the year ended December 31, 2025 was $287.2 million, up 4,852% from $5.8 million in 2024. For the year ended December 31, 2025, the company recorded an income tax benefit of $173 million primarily due to the release of its valuation allowance on deferred tax assets that the company now expects to realize. Net income before income taxes for the year ended December 31, 2025 was $114.2 million, up 1,443% from $7.4 million in 2024. Diluted earnings per share for the year ended December 31, 2025 was $2.07, up 5,075% from $0.04 in 2024. Lastly, cash flows from operating activities for the year ended December 31, 2025 were $135.7 million, up 206% from $44.4 million in 2024. As of December 31, 2025, the company had cash, cash equivalents, restricted cash, and investments of $398 million, compared to $358.5 million at December 31, 2024. For the year ended December 31, 2025, the company repurchased 12.2 million common shares for $98.2 million and fully diluted shares outstanding were reduced from 149.8 million to 139.7 million. As a result of Loopkindness continued momentum, we are pleased to announce our 2026 guidance. We expect total revenue of 315 million to 325 million, up 11% to 15% compared to 2025. We expect next product sales of $305 million to $315 million, up 12% to 16% compared to 2025. Now, I would like to turn the call back over to Peter for some business updates.

Disclaimer

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