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Aytu BioPharma, Inc. (NASDAQ: AYTU) is a specialty pharmaceutical company dedicated to developing and commercializing novel therapeutics in the healthcare sector. The company's diversified product portfolio includes commercial prescription medications and consumer health products, addressing a wide range of medical needs. Aytu's primary focus is on treatments for attention deficit hyperactivity disorder (ADHD) and other pediatric conditions, with its leading products being Adzenys XR-ODT® and Cotempla XR-ODT®, both extended-release orally disintegrating tablets for ADHD. These products are supported by the innovative Aytu RxConnect platform, enhancing patient support and medication adherence.
In addition to ADHD treatments, Aytu markets Karbinal® ER, an extended-release antihistamine for various allergic conditions, and the fluoride-based prescription vitamin product lines Poly-Vi-Flor® and Tri-Vi-Flor® aimed at infants and children with fluoride deficiency. The company's consumer health segment includes over-the-counter products for diabetes, allergies, hair regrowth, and gastrointestinal conditions.
Recent Achievements:
- Received FDA approval for the Cotempla XR-ODT® Prior Approval Supplement, enabling production transfer to a third-party manufacturer, expected to enhance product margins.
- Signed an exclusive collaboration agreement with Medomie Pharma Ltd to distribute Adzenys XR-ODT® and Cotempla XR-ODT® in Israel and the Palestinian Authority.
- Ranked 118th on the Deloitte Technology Fast 500™, highlighting significant revenue growth from 2019 to 2022.
Financial Condition: In fiscal 2023, Aytu reported net revenue of $107.4 million, a notable increase from the previous year. The company’s Rx segment, which includes prescription pharmaceutical products, generated positive adjusted EBITDA, demonstrating strong operational performance. The company is also in the process of winding down its Consumer Health segment to focus on its profitable Rx segment, ensuring future growth and shareholder value.
With a robust financial foundation and a clear strategic focus, Aytu BioPharma is well-positioned to continue its growth trajectory, bringing innovative healthcare solutions to patients and driving shareholder value.
Aytu BioPharma closed its merger with Neos Therapeutics, creating a $100 million revenue specialty pharmaceutical company. The recent quarter saw net revenue increase to $13.5 million, driven by strong performance in both the consumer health division, which reported $8.4 million, and the Rx division, which achieved $5.1 million. However, the company reported a net loss of $25.5 million, primarily due to merger-related expenses. The company has added AR101, a late-stage pediatric asset, to its pipeline, and appointed Rich Eisenstadt as CFO to support growth.
Aytu BioPharma (AYTU) announced the publication of a study demonstrating that ultraviolet (UV) A light can enhance the expression of mitochondrial antiviral-signaling (MAVS) protein in cells. The manuscript, published in BioRxiv, suggests that UVA light elicits an antiviral effect through cell-to-cell communication, potentially offering therapeutic benefits against SARS-CoV-2 without requiring direct exposure to the light. The study highlights increased MAVS levels in human tracheal epithelial cells exposed to narrow band UVA, with significant results indicating a promising avenue for antiviral therapies.
Aytu BioPharma, Inc. (NASDAQ:AYTU) will hold a conference call on May 17, 2021, at 4:30 p.m. ET to discuss its financial results for the fiscal third quarter ended March 31, 2021. This meeting aims to review recent accomplishments and provide insights into the company's performance. Interested parties can join the call or access the live webcast through the company’s website. Aytu specializes in novel therapeutics and consumer healthcare products, focusing on prescription treatments for pediatric conditions like ADHD.
Aytu BioPharma has secured a global license for AR101 (enzastaurin), targeting vascular Ehlers-Danlos Syndrome (vEDS), a severe genetic disorder lacking FDA-approved treatments. The company paid $1.5 million upfront, with potential milestone payments up to $67.5 million contingent on regulatory and commercial achievements. Two co-founders from Rumpus Therapeutics, Christopher Brooke and Nate Massari, are joining Aytu's executive team to lead the AR101 program. The acquisition aligns with Aytu's strategy to enhance its portfolio in pediatric specialty pharmaceuticals.
Aytu BioPharma (NASDAQ:AYTU) announced the appointment of Richard Eisenstadt as Chief Financial Officer, effective immediately. Eisenstadt brings over 20 years of pharmaceutical finance experience, including capital raising and clinical development. He succeeds David Green, who stepped down on March 31, 2021. Before joining Aytu, Eisenstadt was CFO at Neos Therapeutics, where he raised over $340 million. CEO Josh Disbrow expressed confidence in Eisenstadt’s ability to support the growth of Aytu’s therapeutic portfolio as the company enhances its development pipeline.
Aytu BioPharma (NASDAQ:AYTU) announced a strategic transaction with Acerus Pharmaceuticals, whereby Acerus will acquire all U.S. rights to Natesto. Aytu will receive $7.5M in total, paid in $250,000 monthly installments over 30 months. The deal enables Aytu to focus on pediatric and ADHD therapeutics following their recent merger with Neos Therapeutics. This transition supports Aytu's strategy to enhance shareholder value by concentrating resources on their expanded portfolio of pediatric products.
Aytu BioScience has successfully merged with Neos Therapeutics, becoming Aytu BioPharma. The newly combined company boasts an annual revenue of $100 million, with an anticipated $15 million in cost synergies for 2022. This merger enhances Aytu's position in pediatrics and specialty care markets. Former Neos board members Beth P. Hecht and Gerald McLaughlin join Aytu's board as part of the transition. The merger concluded following approval at shareholder meetings on March 18, 2021, positioning Aytu for future growth and shareholder value enhancement.
Aytu BioScience announced promising results from a pilot study using its Healight technology on mechanically ventilated COVID-19 patients. The study showed that endotracheal ultraviolet A (UVA) light therapy significantly reduced SARS-CoV-2 viral load by over 99% and improved clinical severity scores. Conducted on five patients, the treatment was well tolerated with no serious adverse effects reported. Aytu plans to further collaborate with the FDA and explore additional applications beyond COVID-19.
Aytu BioScience (NASDAQ:AYTU) has announced that CEO Josh Disbrow will present at three investor conferences in March 2021. The events include:
- Cowen 41st Annual Healthcare Conference: March 3, 2021, at 10:20 a.m. ET.
- H.C. Wainwright Global Life Sciences Conference: Pre-recorded chat available March 9, 2021, at 7:00 a.m. ET.
- Oppenheimer 31st Annual Healthcare Conference: March 16, 2021, at 4:30 p.m. ET.
These presentations can be accessed on the Aytu website.
Aytu BioScience announced a definitive merger with Neos Therapeutics, creating a combined specialty pharmaceutical entity with projected revenues of $100 million. For Q2 2021, Aytu reported net revenues of $15.1 million, a significant increase from $13.5 million in Q1 2021, with the Consumer Health division achieving an all-time revenue high of $7.9 million. The Rx division revenue rose 24% sequentially to $7.2 million. Despite a net loss of $9.5 million, Aytu maintains a strong cash position of $62.3 million, indicating financial stability as they approach the merger's closing in Q2 2021.
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