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Aytu BioPharma Inc (AYTU) delivers innovative therapeutics addressing critical needs in urology and neurobehavioral health. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's prescription drug developments, regulatory milestones, and strategic initiatives.
Access timely announcements including FDA approvals, clinical trial results, financial disclosures, and partnership agreements. Our curated collection ensures you stay informed about AYTU's advancements in prostate cancer diagnostics, ADHD treatments, and operational efficiency programs.
Key updates cover prescription drug pipeline progress, market expansion efforts, and expert analyses of corporate developments. Bookmark this page for direct access to primary source materials and objective reporting on Aytu BioPharma's position in the specialty pharmaceuticals sector.
Aytu BioPharma has received a 180-day extension from Nasdaq to comply with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The deadline is set for May 22, 2023. Aytu must keep its stock price above $1.00 for at least 10 consecutive business days to regain compliance. The company is considering options, including a reverse stock split, to achieve this. If compliance is not met, Aytu’s stock could be delisted, although it can appeal any such decision. Aytu's stock continues to trade on Nasdaq under the symbol AYTU.
Aytu BioPharma has been ranked 94th on the Deloitte Technology Fast 500 and 21st among life sciences companies for the second consecutive year. This recognition highlights the company's growth, driven by a 47% increase in net revenue to $96.7 million in fiscal 2022, with an impressive 87% growth in prescription products sales. Aytu recently reported positive adjusted EBITDA in its first quarter of fiscal 2023. CEO Josh Disbrow emphasized the team's efforts in achieving commercial success and positive cash flows.
Aytu BioPharma (NASDAQ:AYTU) announced the passing of co-founder and board member Michael Macaluso on November 16, 2022. CEO Josh Disbrow expressed condolences, highlighting Macaluso's significant contributions since the company's inception in 2015. Macaluso served as Chair of the Compensation Committee and was integral to Aytu's growth, drawing on his four-decade entrepreneurial career in the life sciences sector. His diverse background included leadership roles at Ampio Pharmaceuticals and Isolagen, reflecting his deep industry expertise.
Aytu BioPharma reported a record quarterly net revenue of $27.7 million for Q1 2023, a 26% increase from $21.9 million year-over-year. Revenue from the Rx segment rose 34% to $18.7 million, with ADHD products increasing by 24% and pediatric products by 73%. The company achieved a positive Adjusted EBITDA of $1.4 million compared to a loss of $4.2 million last year. Strategic leadership changes were made to enhance commercial operations. The indefinite suspension of R&D programs is projected to save over $20 million in future costs.
Aytu BioPharma (Nasdaq: AYTU) will announce its first quarter fiscal year 2023 financial results after the market closes on November 14, 2022. A conference call to discuss these results is scheduled for the same day at 4:30 pm ET. Investors can join the call by dialing (877) 545-0523 or (973) 528-0016, using access code 883834. The call will also be available via webcast, with an archive lasting 90 days. Aytu's product portfolio includes prescription drugs for ADHD and a variety of consumer health products.
Aytu BioPharma announced an amendment to its secured loan agreement with Avenue Venture Debt Fund, extending the interest-only period to January 2024. This amendment defers over $3 million in principal payments into 2024 and 2025, aiding cash conservation. The loan matures in January 2025, with additional interest-only extensions possible upon achieving certain milestones. The reset of the warrant exercise price to $0.43 is part of this agreement, reflecting the company's latest equity financing. CEO Josh Disbrow emphasized this move supports their operational goals.
Aytu BioPharma has announced a strategic shift focusing on commercial operations, leading to the indefinite suspension of clinical development programs including AR101/enzastaurin for Vascular Ehlers-Danlos Syndrome (VEDS). This decision aims to save over $20 million in future study costs and is expected to enable the company to achieve positive quarterly Adjusted EBITDA in the first half of 2023. In the last fiscal year, Aytu's commercial operations generated $96.7 million in revenue, with a slight negative Adjusted EBITDA of $(961,000) for the quarter ending June 30, 2022.
Aytu BioPharma announces the uninterrupted supply of Adzenys XR-ODT, FDA-approved as a bioequivalent to Adderall XR, amidst reported disruptions affecting generic ADHD medications. Adzenys XR-ODT is an extended-release, orally disintegrating tablet for treating ADHD in patients aged six and older, with a twelve-hour duration of action. The company has ensured consistent production at its Texas facility, offering various strengths. Patients are encouraged to consult their physicians regarding medication options due to ongoing supply issues with other ADHD treatments.
Aytu BioPharma reported record fourth quarter net revenue of $27.4 million, a 17% increase from last year, driven by a 28% growth in the Prescription segment. Full year revenue rose 47% to $96.7 million, with Prescription products achieving 87% growth at $61.1 million. Adjusted EBITDA for Prescription was $1.1 million, contrasting with $(5.5) million last year. Despite a 2% decline in Consumer Health revenue due to supply chain issues, the overall Gross Profit margin improved to 54%. Net loss for the quarter was $(17.7) million, improving from $(19.0) million year-over-year.
Aytu BioPharma (NASDAQ:AYTU) will report its financial results for Q4 and fiscal year ending June 30, 2022, after market close on September 27, 2022. A conference call is scheduled for the same day at 4:30 pm ET to discuss the results. Aytu's product portfolio focuses on novel therapeutics for rare pediatric disorders, including Adzenys XR-ODT and Cotempla XR-ODT for ADHD treatment. The company is also advancing therapies like AR101 for Vascular Ehlers-Danlos Syndrome, which has received multiple designations from the FDA and the European Commission.