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Sep 30, 2021
Aytu BioScience Q1 2022 Earnings Report
Reported a 62% increase in quarterly net revenue to $21.9 million.
Key Takeaways
Aytu BioPharma reported strong Q1 2022 financial results, with net revenues increasing by 62% to $21.9 million compared to the same quarter last year. The company's prescription and consumer health product revenues grew organically, and its late-stage development pipeline advanced toward key milestones. The company ended the quarter with $40.6 million in cash, cash equivalents and restricted cash.
Net revenue increased 62% year-over-year to $21.9 million.
Consumer health division revenue grew over 3% year-over-year to $8.0 million.
Prescription division revenue grew over 140% year-over-year to $13.9 million.
Gross profit increased to $12.5 million, the highest quarterly gross profit.
Aytu BioScience
Aytu BioScience
Forward Guidance
Aytu BioPharma is pursuing Orphan Drug Designation from the FDA and the European Medicines Agency (EMA) for AR101, with the goal of receiving ODD in the first half of calendar year 2022. The company plans to launch a single pivotal trial, the PREVEnt Trial, of AR101 in patients with VEDS in the first half of calendar 2022. The company is on track to initiate a study evaluating Healight for the treatment of patients with SARS-CoV-2 in 2021.
Positive Outlook
- Pursuing Orphan Drug Designation from the FDA and EMA for AR101, with the goal of receiving ODD in the first half of calendar year 2022.
- Planning to launch a single pivotal trial, the PREVEnt Trial, of AR101 in patients with VEDS in the first half of calendar 2022.
- Patient enrollment for this randomized, placebo-controlled study is 260, randomized 1:1.
- The primary endpoint of this trial is reduction in fatal or non-fatal arterial events, such as ruptures, dissections, and pseudo-aneurisms.
- Expecting to fully enroll the study by early calendar year 2023.
Challenges Ahead
- Study evaluating Healight for the treatment of patients with SARS-CoV-2 in 2021 may face delays.
- The primary endpoint of this study is change in viral load in endotracheal tube aspirates between day zero and the last day of treatment between treated and untreated subjects.
- Top-line data is expected to be reported in the first half of 2022.
- AR101 clinical development and commercialization plans are subject to risks and uncertainties.
- Potential adverse changes to the company’s financial position or business.