Aytu BioPharma, Inc. develops and commercializes prescription medicines focused on complex central nervous system diseases. Its recurring company updates center on EXXUA (gepirone) extended-release tablets, an FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults, along with its ADHD products and legacy pediatric portfolio.
News from Aytu also covers operational and financial results, commercial launch activity, retail and Aytu RxConnect patient-access distribution, investor presentations, and product-level clinical and safety information for EXXUA. The company is a Nasdaq-listed specialty pharmaceutical issuer with prescription products sold through commercial distribution channels.
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.
Aytu BioPharma announced the addition of its fourth patent for AR101/Enzastaurin, enhancing its intellectual property portfolio for treating Vascular Ehlers-Danlos Syndrome (VEDS). Licensed from Johns Hopkins University, this patent expands the understanding of VEDS pathophysiology, with an expiry date of September 2041. The company plans to start the PREVEnt Trial for AR101 in early 2023, aiming to treat COL3A1-confirmed VEDS, a rare disorder with no approved therapies. Aytu holds Orphan Drug and Fast Track designations for AR101, which targets significant medical needs in VEDS.
Aytu BioPharma (NASDAQ:AYTU), a pharmaceutical company focused on rare pediatric-onset disorders, is set to participate in two upcoming investor conferences. The H.C. Wainwright 24th Annual Global Investment Conference will feature an on-demand presentation from September 12, 2022. Additionally, the Lytham Partners Fall 2022 Investor Conference offers a recorded fireside chat starting September 28, 2022. Both events will include opportunities for 1x1 virtual meetings. These presentations showcase Aytu's commitment to innovative therapeutics.
Aytu BioPharma (NASDAQ:AYTU) announced the issuance of U.S. Patent No. 11,273,148 for AR101 (enzastaurin), marking a significant milestone in its intellectual property portfolio. This patent covers methods for treating inherited aortic aneurysms and related conditions, including Vascular Ehlers-Danlos Syndrome (VEDS), with an expiry date in August 2038. The company aims to initiate the PREVEnt Trial for AR101 in VEDS, expecting to dose the first patient by early 2023. AR101 has received Orphan Drug and Fast Track designations from the FDA, highlighting its potential in addressing unmet medical needs.