AYTU News & Events

Reports Q3 revenue $12.41M, consensus $12.05M. "Although we remain in the very early stages of the EXXUA launch, the initial traction we are seeing is highly encouraging," commented Josh Disbrow, Chief Executive Officer of Aytu. "Since the formal launch in mid-January, we have seen strong month-over-month growth, with more than 1,300 prescriptions written in the quarter by more than 450 unique prescribers. Importantly, the growth we are seeing in titration packs, together with early refill activity, reinforces our belief that EXXUA is beginning to have a meaningful impact for patients and that prescribers are increasingly recognizing its differentiated role in the treatment of MDD. We are also pleased with the execution across our channel partners, as sales of more than 3,200 units demonstrate their preparedness to support the compounding growth trajectory we anticipate as awareness, access and utilization continues to expand. While the first few months of any launch naturally include noise as coverage, gross-to-net dynamics and pharmacy ordering and prescribing patterns settle, the trends we are seeing are quite positive. Overall, we are very pleased with the launch fundamentals to date and remain focused on driving disciplined, efficient commercial execution as we work to build EXXUA into an important treatment option for the millions of Americans living with major depressive disorder."

Reports Q2 revenue $15.2M vs. $16.2M last year. Revenue was impacted by a deemphasis in marketing for the ADHD and pediatric portfolios as the company shifted focus to the launch of EXXUA. Reports ADHD portfolio net revenue $13.2M vs. $13.8M last year. "This is a truly momentous time for Aytu as we commercially launched EXXUA, the first and only 5HT1a agonist approved by the FDA for the treatment of MDD, representing a new way to treat MDD," said CEO Josh Disbrow.

Aytu BioPharma announced the nationwide commercial launch of EXXUA and completion of its launch meeting last week that finalized sales training and launch preparations for EXXUA, the first and only selective 5-HT1A agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder in adults, representing a new way to treat MDD. EXXUA is a once-daily monotherapy with a unique mechanism of action that selectively targets 5-HT1A receptors, important regulators of mood and emotion while minimizing activity at serotonin receptors linked to side effects such as sexual dysfunction and weight gain that are common with many first-line antidepressants. EXXUA is only approved for use in adults. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Aytu BioPharma announced the commercial availability of EXXUA in the United States. EXXUA is the first and only 5HT1a agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder, representing a new way to treat MDD. The immediate availability of EXXUA through participating Aytu RxConnect pharmacies enables patients and prescribers the ability to access EXXUA through Aytu's best-in-class patient access program, Aytu RxConnect. In parallel, distribution through all major United States wholesalers is progressing to enable nationwide availability across all pharmacy retailers in the coming weeks.