Aytu BioPharma(US:AYTU)2025-09-23 21:30Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [27] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, compared to $10.8 million in the prior year [33] - The net loss for the year was $13.6 million, an improvement from a net loss of $15.8 million in the previous year [32] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, slightly down from $57.8 million in the prior year, attributed to a decrease in the number of scripts written [27] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with more than 340 million prescriptions written annually [9] - SSRIs and SNRIs account for over 60% of all antidepressants prescribed, with approximately 220 million TRXs [9] Company Strategy and Development Direction - The company is focusing on the upcoming launch of Exua, a novel treatment for MDD, which is expected to transform its business [4] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect patient access platform for product acquisitions aligned with its focus [5] - The company aims to minimize coverage barriers and enhance patient access through selective payer contracting [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Exua launch, highlighting strong physician interest and potential market need for targeted therapies [11][41] - The company anticipates that the Exua opportunity will significantly enhance its growth trajectory, positioning it as a leading CNS-focused company [43] Other Important Information - The company has successfully launched an authorized generic of Adzenys, which is expected to help maintain market share despite potential competition from Teva [20] - Aytu BioPharma has restructured its operations, resulting in a new cost structure that projects a break-even level of approximately $52.6 million annually [31] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Yes, the company plans to load in by the end of 2025 and have a sales force meeting followed by a full launch in the first calendar quarter [46] Question: Will promotional materials be pre-cleared? - The company does not plan to pre-clear promotional materials but will follow the traditional submission process [47] Question: What is the approach to engaging with payers? - The company will engage with payers on a case-by-case basis, being selective to ensure favorable contracting without undermining margins [50][51] Question: What are the expectations for ADHD and pediatric franchises? - The ADHD portfolio is expected to maintain some level of stickiness, while the pediatric portfolio will cover general and administrative expenses going forward [58] Question: What is the medical affairs strategy for Exua? - The company plans to engage in extensive medical education and presence at medical conferences, focusing on key opinion leaders [60]