DENVER - Aytu BioPharma, Inc. (NASDAQ:AYTU), a pharmaceutical company, and Lupin Pharma Canada Ltd, a subsidiary of Lupin Limited, announced an exclusive agreement for the distribution and supply of two Aytu ADHD medications in Canada. The products, Adzenys XR-ODT® and Cotempla XR-ODT®, are extended-release orally disintegrating tablets designed for the treatment of attention deficit hyperactivity disorder (ADHD).
Adzenys XR-ODT is approved by the FDA as bioequivalent to Adderall XR®, and is prescribed for patients aged six and older. Cotempla XR-ODT is also an FDA-approved methylphenidate medication for once-daily treatment of ADHD in patients aged 6 to 17 years. Both drugs are the only orally disintegrating, extended-release tablets for ADHD and are expected to offer new treatment options in Canada, where there has been a shortage of ADHD medications.
Dr. Sofia Muntaz, President of Lupin, expressed enthusiasm about the partnership, highlighting the potential benefits of the new formulation for patients and physicians in Canada. Josh Disbrow, CEO of Aytu, emphasized the importance of providing novel medications to underserved ADHD patients and improving outcomes and prescription compliance.
The agreement aims to extend Aytu's reach into the Canadian ADHD market, which is one of the largest outside the United States. According to IQVIA Canada, the Canadian ADHD stimulant market saw 4.5 million units and $1.1 billion CAD in gross sales in 2023.
Lupin will be responsible for seeking local regulatory approvals and marketing authorizations for the two products, a process that is anticipated to take 18 to 24 months.
Aytu's ADHD medication portfolio has seen a significant growth of 16.5% in prescriptions over the past two years. The partnership with Lupin is expected to further expand Aytu's presence in the global ADHD treatment market.
The transaction was advised by Shadow Lake Group Inc., a boutique life sciences advisory firm. This news is based on a press release statement from Aytu BioPharma, Inc.
In other recent news, Aytu BioPharma has announced a significant turnaround in its fiscal 2024 Q4 earnings call, with a strategic refocus on ADHD and pediatric therapeutics. The company reported an adjusted EBITDA increase of 162% to $9.2 million, an improvement in net losses from fiscal 2023, and a stable cash position of $20 million. Despite a cyberattack impacting prescription dispensing and a decline in pediatric revenue, Aytu BioPharma remains optimistic about future growth prospects in both ADHD and pediatric product lines. The company has exited its consumer health business and closed its Texas manufacturing facility, improving gross margins. ADHD prescriptions reached a record high, with a 23% revenue increase in the segment. However, the pediatric portfolio revenue declined due to payer changes. Aytu BioPharma refinanced a term loan, reducing potential interest expenses by $1.3 million. The company is optimistic about sales growth in both ADHD and pediatric products for fiscal 2025. These are some of the recent developments for Aytu BioPharma.
InvestingPro Insights
Aytu BioPharma's recent partnership with Lupin Pharma Canada Ltd. comes at a critical time for the company, as reflected in its financial metrics and market performance. According to InvestingPro data, Aytu's revenue for the last twelve months as of Q4 2024 stood at $81.0 million, with a concerning revenue decline of 24.58% over the same period. This context makes the Canadian expansion particularly significant for the company's growth strategy.
Despite the revenue challenges, there are some positive indicators for Aytu. An InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, which could provide financial flexibility as it pursues this new market opportunity. Additionally, analysts anticipate that Aytu will be profitable this year, a crucial turnaround given that it has not been profitable over the last twelve months.
The company's stock is currently trading near its 52-week low, with a price-to-book ratio of 0.52, suggesting it may be undervalued. This could present an opportunity for investors if the Canadian expansion proves successful and helps reverse the company's recent financial trends.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Aytu BioPharma, providing a deeper understanding of the company's financial health and market position.
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