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DENVER, CO - Aytu BioPharma, Inc. (NASDAQ:AYTU), a pharmaceutical company with a market capitalization of $9.2 million, has announced an exclusive deal to commercialize EXXUA™, a novel antidepressant, in the U.S. market. According to InvestingPro analysis, the company currently trades at attractive valuation multiples, with a price-to-book ratio of 0.26x, suggesting potential undervaluation compared to peers. EXXUA, a first-in-class oral selective serotonin 5HT1a receptor agonist, is approved by the FDA for treating major depressive disorder (MDD) in adults. This new medication has been tested on over 5,000 patients, showing significant improvement in depression symptoms with a low incidence of sexual side effects, a common issue with existing treatments.
The company has expressed confidence that EXXUA will be a significant growth driver, planning its launch in the fourth quarter of 2025. While the stock has seen a -16% return over the past week, InvestingPro data shows strong momentum over the past three months. Aytu’s largest shareholder, Nantahala Capital Management, along with other healthcare-focused institutional investors, has financed the transaction, highlighting strong support from the investment community. For deeper insights into Aytu’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
EXXUA stands out as it does not carry label warnings about the risk of sexual dysfunction, unlike other antidepressants targeting serotonin receptors. Dr. Stephen Stahl, a neuropsychopharmacology expert, has emphasized EXXUA’s importance in treating mood disorders and suicide risk.
Aytu’s CEO, Josh Disbrow, stated that licensing EXXUA is a transformative milestone for the company and a significant advancement for patients with MDD. The company’s strategic pivot over the past two years has been towards acquiring differentiated, branded CNS products, and EXXUA fits this strategy well.
Fabre-Kramer Pharmaceuticals, which developed EXXUA, will partner with Aytu for its U.S. market launch. Dr. Stephen Kramer of Fabre-Kramer noted that EXXUA addresses unmet needs in MDD treatment, such as treatment-emergent sexual dysfunction and weight gain.
The financial terms of the agreement include an upfront payment to Fabre-Kramer, additional payments upon the one-year anniversary of the EXXUA launch, royalties on net revenue, a product transfer price, and performance-based milestone payments.
Aytu is actively preparing for EXXUA’s market introduction and expects it to be available in pharmacies later this year. With a gross profit margin of 66.4% and an InvestingPro Financial Health Score rated as "GOOD," the company appears well-positioned for this launch. The company’s portfolio also includes treatments for ADHD and a line of legacy products, contributing to its annual revenue of $77.7 million.
This information is based on a press release statement.
In other recent news, Aytu BioPharma reported a robust financial performance for Q3 FY2025, achieving a 32% year-over-year increase in net revenue. This growth was primarily driven by the company’s ADHD and pediatric portfolios, with the ADHD portfolio generating $15.4 million, up 25%, and the pediatric portfolio contributing $3.1 million, a 77% increase. The company also reported a net income of $4 million, marking a significant turnaround from a $2.9 million loss the previous year. Aytu BioPharma is actively exploring strategic acquisitions to complement its current product lines. Additionally, the company expressed confidence in its ongoing growth, particularly in the ADHD and pediatric sectors, and did not report any one-time effects influencing its Q3 performance. The company is also focused on leveraging its RxConnect platform to enhance patient access and manage prescription economics effectively. Aytu BioPharma’s strategic initiatives, including cost reduction and outsourcing manufacturing, have contributed to its improved financial results.
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