Welcome to our dedicated page for AYTU BioPharma news (Ticker: AYTU), a resource for investors and traders seeking the latest updates and insights on AYTU BioPharma stock.
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 reported a strong fiscal Q1 2022, with net revenues of $21.9 million, a 62% increase year-over-year. The company experienced a significant rise in prescription revenues, particularly in its ADHD product line, which grew 140%. Despite this growth, Aytu posted a net loss of $27.9 million, largely due to a $19.5 million impairment expense. Aytu ended the quarter with $40.6 million in cash and plans a pivotal study for AR101 in VEDS, expected to start in early 2022.
Aytu BioPharma (NASDAQ:AYTU) announced a conference call on November 15, 2021, at 4:30 p.m. ET for reviewing its first quarter fiscal 2022 results and discussing its business strategy. The company will also file its Form 10-K after market close on the same day. The call can be accessed via toll-free and international numbers, with a replay available for fourteen days. Aytu specializes in therapeutics for ADHD and has a growing product portfolio, including treatments for pediatric conditions.
Aytu BioPharma reported a 74% sequential increase in net revenue to $23.5M for the fourth quarter and 138% year-over-year growth to $65.6M for fiscal 2021. The company ended the quarter with approximately $50M in cash. A pivotal study for AR101, targeting Vascular Ehlers-Danlos Syndrome, is set to begin in early 2022. The merger with Neos Therapeutics is expected to generate $15M in annual synergies. However, the company reported a net loss of $19M in Q4 and $58.3M for the year due to acquisition-related expenses and impairment charges.
Aytu BioPharma (NASDAQ:AYTU) will host a conference call on September 27, 2021, at 4:30 p.m. ET to discuss its fourth quarter and fiscal year 2021 achievements.
The call will provide insights into the company's business strategy and growth plans. Aytu will file its Form 10-K prior to market opening on September 28, 2021, ensuring investors have timely access to financial results.
Key products include medications for ADHD and a developmental pipeline targeting rare diseases.
Aytu BioPharma (NASDAQ:AYTU) announced the formation of a Scientific Advisory Board (SAB) chaired by Dr. Hal Dietz, an expert in genetic disorders. The SAB aims to guide the development of AR101 (enzastaurin), an investigational treatment for Vascular Ehlers-Danlos Syndrome (VEDS), a rare genetic condition with no approved therapies. Initial members include renowned experts from leading institutions worldwide, who will provide insights to minimize clinical risks and advance AR101's pivotal studies. The company emphasizes that strong leadership from the SAB is vital as it seeks to enhance treatment options for VEDS patients.
Aytu BioPharma (NASDAQ:AYTU) announced that its CEO Josh Disbrow will present at two investor conferences in September 2021. The first presentation is at the H. C. Wainwright 23rd Annual Global Investment Conference, available on demand starting September 13, 2021, at 7 a.m. ET. The second is a live presentation at the 2021 Cantor Virtual Global Healthcare Conference on September 30, 2021, at 4:40 p.m. ET. Both presentations will be accessible on Aytu's website. Aytu specializes in therapeutics for pediatric conditions and is developing treatments for rare genetic diseases.
Aytu BioPharma announced the publication of laboratory data demonstrating that ultraviolet A (UVA) light used in its Healight technology significantly reduces cytokine release in cells infected with coronavirus. The study, published in Photodiagnosis and Photodynamics Therapy, shows that narrow band UVA therapy decreases pro-inflammatory cytokines such as IL-6 and TNF-α by over 50%. The company plans to initiate a larger Phase 2 clinical study in Europe later in 2021, aiming to further explore Healight's potential as a treatment for severe respiratory infections, including SARS-CoV-2.
Aytu BioPharma recently announced significant findings from a first-in-human clinical trial of its Healight technology, published in Advances In Therapy. The study involved five critically ill COVID-19 patients and demonstrated a substantial reduction in SARS-CoV-2 viral load, achieving log changes of -2.41 (>99%, p=0.0018) by day five and -3.2 (>99.9%, p=0.0005) by day six. WHO clinical severity scores improved by an average of 1.6 points on day 15 and 3.6 points on day 30. Importantly, no serious adverse effects were reported. Aytu plans a larger, randomized study in Europe in early 2022.
Aytu BioPharma (NASDAQ:AYTU) announced that CEO Josh Disbrow will present at two investor conferences in June 2021. The Jefferies Global Healthcare Conference will host a live virtual presentation on June 1 at 3:30 p.m. ET, which can be accessed via this link. The second presentation will be on June 23 at 12:40 p.m. ET at the Raymond James Human Health Innovations Conference. Both presentations will be available on the Aytu website and conference sites.
FAQ
What is the current stock price of AYTU BioPharma (AYTU)?
What is the market cap of AYTU BioPharma (AYTU)?
What is Aytu BioPharma's primary focus?
What are the main products offered by Aytu BioPharma?
What recent achievements has Aytu BioPharma reported?
How did Aytu BioPharma perform financially in fiscal 2023?
What strategic changes is Aytu BioPharma implementing?
What is the Aytu RxConnect platform?
What is the significance of the FDA approval for Cotempla XR-ODT®?
Where can I learn more about Aytu BioPharma's products?
How is Aytu BioPharma expanding its market reach?
What are Aytu BioPharma's future growth plans?
