11/4/2025

speaker
Operator
Conference Operator

Good morning. Welcome to the Orinia Pharmaceuticals third quarter 2025 conference call. Please be advised that a Q&A session will follow Orinia's prepared remarks. I will now turn the call over to Peter Greenlee, President and Chief Executive Officer of Orinia.

speaker
Peter Greenlee
President and Chief Executive Officer

Thank you all for joining us to discuss Orinia's third quarter 2025 update. Joining me on the call today are Joe Miller, our Chief Financial Officer, and Dr. Greg Keenan, our Chief Medical Officer. Before we begin our discussion, I'd like to direct your attention to slide two, which contains important information regarding forward-looking statements. Additionally, we note that on November 2nd, ARINIA filed a complaint against Dr. George Tidmarsh arising from his statements about Bacillus borum, The complaint is pending in the United States District Court for the District of Maryland and is available online. If you have questions regarding the complaint, we refer you to the complaint itself as we will not be commenting further on this matter. On today's call, we will report third quarter 2025 financial results and provide an update on recent business progress. We're pleased to report that third quarter 2025 loop kind of sales experienced continued momentum following last year's inclusion in the American College of Rheumatology lupus nephritis treatment guidelines, growing at a rate of 27% for the quarter year over year. As a result, we're raising loop kind of sales guidance for 2025 for the second time this year, to 265 million to 270 million. Further, we have conducted new loop kinase data analyses, which we will share shortly, that reinforce loop kinase robust clinical profile in the treatment of patients with lupus nephritis. And lastly, following a positive phase one results that were announced in June, We're excited to be advancing our intercept toward clinical studies into autoimmune diseases. I'd like to turn the call over now to Joe to review our financial results. Joe? Thank you, Peter.

speaker
Joe Miller
Chief Financial Officer

For the third quarter of 2025, total revenue was $73.5 million, up 8% from $67.8 million in 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 27% over the same period in 2024. Net product sales of Loop Kindness were 70.6 million, up 27% from 55.5 million in 2024. Net income was 31.6 million, up 119% from 14.4 million in 2024. Diluted earnings per share was $0.23, up 130% from $0.10 in 2024. Lastly, cash flows from operating activities were $44.5 million, up 162% from $17 million in 2024. For the nine months ended September 30, 2025, total revenue was $205.9 million, up 17% from $175.3 million in the same period of 2024. Again, the 2024 period included a $10 million milestone payment associated with Loop Kindness approval in Japan. Excluding the one-time milestone, total revenue increased by 25% over the same period in 2024. Net product sales of Loop Kindness were $197.2 million, up 24% from $158.6 million in 2024. Net income was $76.4 million, up 1,677% from $4.3 million in 2024. Diluted earnings per share was $0.55, up 1,733% from $0.03 in 2024. Lastly, cash flows from operating activities were $90 million, up 529% from $14.3 million in 2024. As of September 30, 2025, we have cash, cash equivalents, restricted cash, and investments of $351.8 million compared to $315.1 million at June 30, 2025, and $358.5 million at December 31, 2024. As previously mentioned, for the three and nine months ended September 30, 2025, cash flows from operating activities were $44.5 million and $90 million respectively. For the nine months ended September 30, 2025, The company repurchased 12.2 million shares for $98.2 million, and diluted shares outstanding were reduced from 149.8 million to 138.2 million. As a result of LoopKindness continued momentum, we are pleased to increase our 2025 guidance for the second time this year. For total revenue, we are increasing guidance from a range of 260 million to 270 million to a range of 275 million to 280 million. For net product sales, we are increasing guidance from a range of $250 million to $260 million to a range of $265 million to $270 million. Now, I would like to turn the call over to Greg from Scientific Updates.

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