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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 has received FDA approval for a Prior Approval Supplement allowing the transfer of Adzenys XR-ODT manufacturing to a contract manufacturer. This shift is anticipated to enhance product margins by approximately 15%. Following the successful completion of a bioequivalence study for Cotempla XR-ODT, the company plans to submit a site transfer PAS to the FDA by mid-2023, expecting approval by late 2023 or early 2024. CEO Josh Disbrow emphasized the significance of these milestones for improving ADHD product profitability. The manufacturing transition is expected to conclude by early 2024, facilitating the anticipated margin improvements. Aytu's ADHD product portfolio includes Adzenys and Cotempla, alongside other prescription and consumer health products.
Aytu BioPharma (NASDAQ:AYTU) reported strong financial results for Q2 2023, with net revenue reaching $26.3 million, a 14% increase year-over-year. The prescription (Rx) segment alone generated $18.0 million, a growth of 23% compared to the previous year, driven significantly by a 95% surge in pediatric product revenues.
Adjusted EBITDA was positive at $0.7 million, a significant improvement from the $(7.6) million loss reported last year. Despite challenges in the Consumer Health segment, which saw a 3% revenue decline, the company's strategic shift to higher-margin e-commerce sales is expected to bolster profitability.
Aytu BioPharma (Nasdaq:AYTU) is set to report its financial results for the quarter ended December 31, 2022, on February 21, 2023, after market close. The company specializes in pediatric-focused prescription medications and consumer health solutions. A conference call will follow the results at 5:00 pm ET on the same day, accessible via phone or webcast, with a replay available until March 7, 2023. Aytu's portfolio includes ADHD treatments like Adzenys XR-ODT and Cotempla XR-ODT, alongside consumer health products promoting various health needs. For more details, visit aytubio.com.
Aytu BioPharma (NASDAQ:AYTU) announced a delay in filing its Form 10-Q for the second quarter of fiscal year 2023, ending December 31, 2022. The delay is due to an assessment and management review concerning an accounting matter related to warrants issued in previous financings. The Company assures that this issue will not impact assets, cash, revenue, or operational metrics. Aytu plans to file the report as soon as possible and will reschedule its quarterly conference call. The Company focuses on pediatric prescription drugs and consumer health solutions.
Aytu BioPharma (NASDAQ:AYTU) has announced it will report its financial results for the second quarter of fiscal year 2023, ending December 31, 2022, on February 14, 2023, after market close. A conference call will take place the same day at 4:30 pm ET to discuss the results. Interested participants can join by calling (888) 506-0062 or (973) 528-0011 with access code 371594. A live webcast will be available and archived for 90 days. Aytu specializes in pediatric-focused prescription drugs and consumer health solutions, including treatments for ADHD and various vitamin products for children.
Aytu BioPharma, Inc. (NASDAQ:AYTU) has announced that it has regained compliance with Nasdaq's minimum bid price requirement. The notification from Nasdaq confirms that Aytu's common stock closed at $1.00 per share or higher for ten consecutive business days, from January 6 to January 20, 2023. The issue is now resolved as per Listing Rule 5550(a)(2). Aytu specializes in pediatric-focused prescription drugs and consumer health products, and its portfolio includes medications for ADHD, allergy relief, and vitamin supplementation for children. This compliance is a positive development for Aytu's market position.
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