Aurinia Pharmaceuticals Inc

Greetings and welcome to the Arinia Pharmaceuticals fourth quarter and full year 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communication and Investor Relations for Arinia. Thank you. You may begin.

Thank you, Operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Arania's President and Chief Executive Officer, Joe Miller, Arania's Chief Financial Officer, and Dr. Greg Keenan, Arania's Chief Medical Officer. Today, we will review and discuss Arania's fourth quarter and full year 2024 financial results and provide an update on recent corporate progress, as communicated in the company's press release and annual report, on Form 10K issued this morning. For more information, please refer to ARINIA's filings with the U.S. Securities and Exchange Commission and Canadian Securities Authorities, which are also available on ARINIA's website at ARINIApharma.com. During today's call, ARINIA 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. For a discussion of factors that could affect Arrhenius' future financial results and business, please refer to the disclosures in Arrhenius' press release, annual report on Form 10-K, and all other filings with the U.S. Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today, February 27, 2025, unless otherwise noted, and are based upon information currently available to us. Except as required by law, ARINIA assumes no obligation to update any such statements. Now, let me turn the call over to ARINIA's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. I want to thank you all for joining us on today's call. On this morning's call, I'll provide an update on our fourth quarter and full year 2024 results and provide an update on our recent progress. I'll then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results. With a continued focus on commercial execution and operational efficiency, we achieved significant growth in total revenue and record-setting net product sales in the fourth quarter of 2024. For the fourth quarter of 2024, total revenue was $59.9 million, up 33% from $45.1 million in the same period of 2023. For the full year 2024, total revenue was $235.1 million, up 34% from $175.5 million in 2023. For the fourth quarter of 2024, net product sales of Flukinus increased the first FDA-approved oral therapy for the treatment of adult patients with active LN, were $57.6 million, up 36%, compared to $42.3 million in the same period of 2023. For the full year of 2024, net product sales were $216.2 million, up 36%, from $158.5 million in 2023. The increase in both periods is primarily due to an increase in the number of loop kinase cartons sold to specialty pharmacies driven by further LN market penetration. For three months ended December 31st, 2024. Cash flow generated from operations was $30.1 million. compared to $14.3 million in the same period of 2023. For the year ended December 31, 2024, cash flow generated from operations was $44.4 million, compared to cash flow used in operations of $33.5 million in 2023. Following last year's strategic restructuring, we are pleased with how our cash flow improved throughout 2024. Exiting the year, we have cash, cash equivalents, restricted cash, and investments of $358.5 million as of December 31, 2024. As we are now into our fifth year on the market, we believe that our historical financial results provide sufficient insight into the health of our business to project forward-looking results. Therefore, we're not providing specific patient-level metrics. With our strong 36% sales growth for Lupkinis in 2024, we are poised for continued success and have a commercial strategy that is focused on four key growth drivers. First, we've sharpened our focus on expanding our base of business at academic medical centers and lupus centers. We've also targeted key rheumatology prescriber segments and identified key lupus nephritis patient types. This would include newly diagnosed patients, patients who are only on MMF and steroids, patients receiving treatment but not achieving treatment potential targets, and potential for loop kinase restarts. Second, we expect the new ACR lupus nephritis treatment guidelines to help drive positive momentum for loop kinase this year, and we're continuing to create a treat-to-target mindset among rheumatologists, that drives the overall treatment urgency to screen and treat lupus nephritis more aggressively. Third, we continue to reinforce the impressive three-year efficacy data and safety data from our Aurora clinical program to clinically differentiate lupkinus and position it earlier in the treatment paradigm. And lastly, we're focused on improving continuity of care for lupus nephritis patients by growing our hospital business and keeping patients on therapy for longer periods of time. We're very pleased to start 2025 in a solid position with a highly efficient organization focused on loop kinase growth and therefore expect total revenue for 2025 in the range of $250 to $260 million and net product sales in the range of $240 to $250 million for 2025. Finally, we are also continuing to advance the development of our pipeline product, AUR200, a potentially best-in-class dual-AF-APRIL inhibitor for the potential treatment of a range of autoimmune diseases. We initiated a Phase I study last September and expect to report out initial results from this study in the second quarter of 2025. I'd now like to turn the call over to Joe Miller, our CFO, for a more detailed review of the fourth quarter and full-year financial results. I'll then return to end the call for a quick wrap-up and open up the line to any questions you might have. Joe?