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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.
Englewood, CO / ACCESSWIRE / January 24, 2023 / Aytu BioPharma (NASDAQ:AYTU) announces CEO Josh Disbrow will present at the Lytham Partners Investor Select Conference on January 31, 2023. The event will be held virtually, with a company webcast available at 9:00 am ET on the same day. The presentation can be accessed via the Aytu website. Additionally, management will hold one-on-one meetings with investors throughout the event. Interested parties can arrange meetings through Lytham Partners. Aytu specializes in pediatric-focused prescription drugs and consumer health solutions, including treatments for ADHD and various health products.
Aytu BioPharma is addressing the ongoing supply disruption of generic Adderall by promoting its FDA-approved bioequivalent, Adzenys XR-ODT. This medication is available as an orally disintegrating tablet, providing an alternative for ADHD patients unable to fill their Adderall prescriptions. Aytu's RxConnect program helps patients navigate insurance challenges, offering reduced out-of-pocket costs, often capped at $35 for commercially insured patients. The company emphasizes the importance of maintaining treatment continuity for individuals with ADHD during this time.
Aytu BioPharma (NASDAQ:AYTU) announced a 1-for-20 reverse stock split effective January 6, 2023, to regain compliance with Nasdaq's $1.00 minimum bid price requirement. This decision follows approval from stockholders at a Special Meeting on October 5, 2022. Post-split, approximately 68.8 million shares will be reduced to about 3.4 million. A cash payment will be made for any fractional shares. The compliance deadline is May 22, 2023, requiring a consistent closing bid price of at least $1.00 for ten consecutive business days.
Aytu BioPharma announced a record 5,186 prescriptions for Adzenys XR-ODT for the week ending November 18, 2022, marking a 9.9% increase over the prior 13-week period. This increase is attributed to strong sales force execution and effective use of the Aytu RxConnect patient support program. Adzenys XR-ODT, an FDA-approved bioequivalent to Adderall XR, remains available without disruption, providing an alternative amid ongoing supply issues affecting Adderall. The company ensures consistent production at its Texas facility.
Aytu BioPharma has received a 180-day extension from Nasdaq to comply with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The deadline is set for May 22, 2023. Aytu must keep its stock price above $1.00 for at least 10 consecutive business days to regain compliance. The company is considering options, including a reverse stock split, to achieve this. If compliance is not met, Aytu’s stock could be delisted, although it can appeal any such decision. Aytu's stock continues to trade on Nasdaq under the symbol AYTU.
Aytu BioPharma has been ranked 94th on the Deloitte Technology Fast 500 and 21st among life sciences companies for the second consecutive year. This recognition highlights the company's growth, driven by a 47% increase in net revenue to $96.7 million in fiscal 2022, with an impressive 87% growth in prescription products sales. Aytu recently reported positive adjusted EBITDA in its first quarter of fiscal 2023. CEO Josh Disbrow emphasized the team's efforts in achieving commercial success and positive cash flows.
Aytu BioPharma (NASDAQ:AYTU) announced the passing of co-founder and board member Michael Macaluso on November 16, 2022. CEO Josh Disbrow expressed condolences, highlighting Macaluso's significant contributions since the company's inception in 2015. Macaluso served as Chair of the Compensation Committee and was integral to Aytu's growth, drawing on his four-decade entrepreneurial career in the life sciences sector. His diverse background included leadership roles at Ampio Pharmaceuticals and Isolagen, reflecting his deep industry expertise.
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.
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