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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 (NASDAQ:AYTU) has announced a settlement notification regarding a derivative action lawsuit (Witmer v. Armistice Capital ). The settlement involves D&O Defendants Joshua Disbrow, Gary Cantrell, John Donofrio, Jr., Carl Dockery, and Ketan B. Mehta.
A settlement hearing is scheduled for January 13, 2025, at 3:15 p.m. at the Court of Chancery of Delaware to determine if the settlement terms are fair and reasonable. Current AYTU shareholders as of October 9, 2024 (Record Date) may have rights regarding the proposed settlement and can obtain detailed information from the company's website or by contacting Morris Kandinov LLP.
Shareholders who don't object to the settlement need not take any action or appear at the hearing. Those who don't object or appear will be bound by the Court's final judgment.
Aytu BioPharma (Nasdaq:AYTU) has been ranked 380th on the 2024 Deloitte Technology Fast 500™, marking its fourth consecutive year on the list of North America's fastest-growing companies. The company reported significant financial improvements in fiscal 2024, with consolidated adjusted EBITDA reaching $9.2 million, a 162% increase from $3.5 million in fiscal 2023. Management expects continued growth in Rx Segment net revenue and adjusted EBITDA for fiscal 2025, focusing on driving prescription demand and improving portfolio coverage and patient access.
Aytu BioPharma reported positive financial results for Q1 fiscal 2025, marking its first-ever quarterly net income of $1.5 million. Net revenue was $16.6 million, with ADHD Portfolio revenue up 1% to $15.3 million and Pediatric Portfolio revenue showing a 54% sequential increase to $1.3 million. The company maintained a strong gross profit margin of 72% and reported Adjusted EBITDA of $1.9 million. Cash position remained stable at $20.1 million. The company implemented organizational changes expected to reduce operating expenses by at least $2.0 million annually, including executive changes and the promotion of Ryan Selhorn to CFO.
Aytu BioPharma (Nasdaq:AYTU) has scheduled its fiscal 2025 first quarter operational and financial results announcement for November 13, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern time on the same day, including a Q&A session. Interested parties can join via phone using the access code 428941 or watch the webcast live through the company's investor relations website. A replay will be available until November 27, 2024.
Aytu BioPharma (Nasdaq: AYTU) announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Josh Disbrow will engage in a fireside chat on Wednesday, October 16, 2024, at 2:00 p.m. Eastern time. The event is virtual, and interested parties can sign up to view the presentation through a provided link.
Following the event, one-on-one investor meetings will be available upon request. Investors can arrange these meetings by contacting their Maxim representative or Aytu's investor relations group at aytu@lythampartners.com.
Aytu BioPharma is a pharmaceutical company that focuses on commercializing novel therapeutics. This summit participation provides an opportunity for investors to gain insights into the company's operations and future plans.
Aytu BioPharma and Lupin Pharma Canada have signed an exclusive agreement to commercialize Adzenys XR-ODT and Cotempla XR-ODT in Canada for ADHD treatment. These products will be the only orally disintegrating, extended-release tablets for ADHD in Canada once approved by Health Canada. Adzenys XR-ODT is bioequivalent to Adderall XR, while Cotempla XR-ODT is the only extended-release orally disintegrating methylphenidate tablet.
Aytu's ADHD portfolio has seen a 16.5% increase in prescriptions over the past two years. The Canadian ADHD stimulant market recorded 4.5 million units and $1.1 Billion CAD in gross sales in 2023. Lupin will seek regulatory approvals for both products, expected within the next 18 to 24 months.
Aytu BioPharma reported fiscal 2024 full year and fourth quarter results. Key highlights include:
- Full year consolidated net revenue of $81.0 million, with Rx Segment revenue of $65.2 million
- ADHD Portfolio net revenue increased 23% to $57.8 million
- Adjusted EBITDA improved to $9.2 million, up $5.7 million from fiscal 2023
- Cash balance of $20.0 million as of June 30, 2024
The company expects Rx Segment net revenue and adjusted EBITDA growth in fiscal 2025. Aytu completed the wind down and divestiture of its Consumer Health Segment in July 2024, focusing on its higher-margin Rx Segment. The ADHD Portfolio saw strong growth, while the Pediatric Portfolio was impacted by payer changes but is showing signs of recovery.
Aytu BioPharma (Nasdaq: AYTU) has announced it will report its fiscal 2024 full year and fourth quarter operational and financial results on September 26, 2024, after market close. The company has scheduled a conference call and webcast for the same day at 4:30 p.m. Eastern time to review the results and conduct a Q&A session.
Interested parties can access the conference call by dialing (888) 506-0062 (US) or +1 (973) 528-0011 (international) using the participant access code 216512. The webcast will be available live and archived at a specific URL and on the Investors section of Aytu's website. A teleconference replay will be accessible until October 10, 2024.
Aytu BioPharma (Nasdaq: AYTU) has announced its participation in the upcoming Sidoti Micro-Cap Virtual Conference on August 14-15, 2024. The company's CEO, Josh Disbrow, will deliver a webcasted presentation on Thursday, August 15, at 12:15 p.m. Eastern time. This fireside chat will be accessible through Aytu's investor relations website and will remain available for replay after the event.
In addition to the presentation, Aytu's management team will engage in one-on-one meetings with investors throughout the conference. Interested parties can arrange meetings through their Sidoti representatives or by contacting Aytu's investor relations team directly. This event provides an opportunity for investors to gain insights into Aytu BioPharma, a pharmaceutical company focused on commercializing novel therapeutics.
Aytu BioPharma (Nasdaq: AYTU) has announced the sale of its Consumer Health business following a strategic wind down of operations. The divestiture includes the e-commerce platform, inventory, consumer brands, intellectual property, contracts, and liabilities. Aytu will receive revenue-based royalty payments on future sales of former Consumer Health products.
The move aligns with Aytu's strategy to focus on its prescription pharmaceutical business and achieve consistent profitability. The company expects this strategic shift, along with the closure of its Grand Prairie, Texas manufacturing site, to significantly enhance operating results and drive stockholder value. The Consumer Health business had been operating at near adjusted EBITDA breakeven during the wind down period.
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