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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 announces the appointment of Vivian Liu to its board of directors, effective July 1, 2022. Liu, with extensive experience in biotechnology, is expected to bolster the company's focus on growth, particularly in developing therapeutics for rare diseases. CEO Josh Disbrow expressed confidence in Liu's ability to drive the company's strategic plans. Currently, Liu is Head of Corporate Affairs for PREMIA Holdings and has held leadership roles in several pharmaceutical companies. Aytu is focused on enhancing its therapeutic pipeline and expanding commercial operations.
Aytu BioPharma (NASDAQ:AYTU) will participate in the Lytham Partners Summer 2022 Investor Conference on June 21-22, 2022. Aytu's webcast presentation is scheduled for 9:00 am ET on June 21 and will be available for replay on the company’s website. Management will also engage in virtual one-on-one meetings during the conference. Aytu focuses on developing novel therapeutics, including treatments for rare pediatric disorders and conditions like ADHD. Their pipeline includes AR101, aimed at Vascular Ehlers-Danlos Syndrome, which has received FDA Orphan Drug designation.
Aytu BioPharma reported a 79% increase in quarterly net revenue, reaching $24.2 million, the highest in its history. Prescription revenue surged 170% year-over-year to $13.9 million. The company is focusing on enhancing financial performance, with plans to improve gross margins through manufacturing efficiencies. However, it recorded a net loss of $53.1 million primarily due to a $45.2 million impairment related to goodwill from the Neos acquisition. Cash reserves stand at $27.6 million as of March 31, 2022.
Aytu BioPharma, Inc. (NASDAQ:AYTU) announced positive results from a preclinical study demonstrating the effectiveness of its Healight™ ultraviolet light endotracheal catheter in delaying ventilator-associated pneumonia (VAP) development in a porcine model. The study observed a 46% reduction in multidrug-resistant Pseudomonas aeruginosa after two treatments. Given that VAP carries a high mortality rate, this development addresses a significant clinical need. Aytu plans to pursue further studies to advance Healight’s potential treatment applications and report more data later in 2022.
Aytu BioPharma, Inc. (NASDAQ:AYTU) announced that the FDA has granted Fast Track designation to AR101 (enzastaurin) for treating Vascular Ehlers-Danlos Syndrome (VEDS). This designation allows for expedited development and review, highlighting the need for treatments in this serious condition. The planned PREVEnt Trial will enroll approximately 260 patients to assess AR101's efficacy compared to standard care. With Orphan Drug designations in the US and Europe, Aytu aims to initiate patient dosing by late 2022 or early 2023.
Aytu BioPharma announced the listing of its newly issued US patent No. 11,166,947 for Cotempla XR-ODT in the FDA's Orange Book, effective March 23, 2022. This patent covers pediatric dosing methods for treating ADHD with methylphenidate and extends the product's exclusivity through at least 2038. Cotempla XR-ODT, approved by the FDA in June 2017, serves children ages 6-17, offering a unique orally disintegrating tablet form. The CEO emphasized the importance of this patent in protecting the product as the ADHD medication market grows.
Aytu BioPharma (NASDAQ:AYTU) announced its participation in the Cantor Fitzgerald Virtual Rare Orphan Disease Summit on March 29, 2022, at 11:00 a.m. ET. The panel will focus on managing clinical trials for rare diseases during and after COVID-19. Aytu is a pharmaceutical company dedicated to developing treatments for rare, pediatric-onset disorders. Their product line includes medications for ADHD and allergy treatment, and they are advancing their therapeutic pipeline, including AR101 for Vascular Ehlers-Danlos Syndrome, a condition with no existing treatments.
Aytu BioPharma (NASDAQ:AYTU) announced that CFO Mark Oki and CCO Greg Pyszczymuka will participate in a fireside chat at the 34th Annual Roth Conference on March 15, 2022, at 2:00 p.m. PT in Dana Point, California. The conference runs from March 13-15. A live webcast will be accessible on the company’s website and archived for 90 days.
Aytu BioPharma specializes in developing therapeutics for rare pediatric disorders and offers prescription products for ADHD and allergy treatment, along with a pipeline drug, AR101, for vascular Ehlers-Danlos Syndrome.
Aytu BioPharma announced the closing of an underwritten offering, raising $7.6 million through the sale of 3,030,000 shares of common stock and associated warrants. Each share and pre-funded warrant was priced at $1.25, with warrants exercisable for 1.1 shares at $1.30. The proceeds will support growth initiatives, including the PREVEnt Trial for AR101, aimed at treating vascular Ehlers-Danlos Syndrome. There is no public market for the pre-funded and common warrants. Canaccord Genuity and Roth Capital Partners facilitated the offering.
Aytu BioPharma (NASDAQ:AYTU) announced an underwritten offering of 3,030,000 shares of common stock and related warrants to a healthcare-dedicated institutional investor, aiming for approximately $7.6 million in gross proceeds. Each share and pre-funded warrant are priced at $1.25, with associated common warrants exercisable for 1.1 shares at $1.30. The proceeds will support the company’s commercial business growth, advance development of pipeline assets like AR101 for treating vascular Ehlers-Danlos Syndrome, and cover working capital needs. Closing is expected by March 7, 2022.
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