AYTU BIOPHARMA, INC

Aytu BioPharma, Inc. is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases, with a strategy of in-licensing, acquiring, developing, and commercializing novel prescription therapeutics. The company operates in the United States prescription pharmaceutical market, with its primary commercial focus on EXXUA for major depressive disorder (MDD), a market estimated at over $22 billion ¹, and on attention deficit hyperactivity disorder (ADHD) treatments. The company's products are sold primarily through third-party wholesalers and pharmacies, and it operates as a single operating and reporting segment following the divestiture of its Consumer Health business. The industry is intensely competitive, with competition based on brand recognition, product quality, price, and innovation, and the company faces competition from companies with considerably more resources and experience.

The company's competitive positioning is centered on its belief that EXXUA is a novel first-in-class selective serotonin 5HT1a receptor agonist and the only antidepressant acting on serotonin receptors that does not carry a label warning about the risk of sexual dysfunction ². In the ADHD market, Adzenys and Cotempla are the first and only FDA-approved amphetamine and methylphenidate extended-release, orally disintegrating tablets, respectively ³. The company also leverages its proprietary Aytu RxConnect patient support platform, which operates through a network of over 1,000 pharmacies ⁴, and its internal commercial organization with approximately 40 sales territories for EXXUA ⁵. Management believes its history of acquiring companies and in-licensing products is a distinct competitive advantage.

The company generates revenue by selling its prescription pharmaceutical products through third-party intermediaries in its distribution channels as well as directly to pharmacy customers. Its business consists of three primary product portfolios: EXXUA, the ADHD Portfolio (Adzenys and Cotempla), and the Pediatric Portfolio (primarily Karbinal). The company's revenue is transactional in nature, derived from product sales, and it relies on third-party manufacturers for all its products. The Aytu RxConnect patient support program is a key platform designed to reduce access barriers and establish affordable, predictable copays for all commercially insured patients, regardless of their individual insurance plan.

EXXUA, the centerpiece of the company's commercial efforts, is an extended-release medication FDA-approved for the treatment of MDD in adults. It has been extensively studied in over 5,000 patients ⁶ and is believed to be the only antidepressant acting on serotonin receptors without a label warning about sexual dysfunction risk. For fiscal 2026, the company recorded net revenue of $6.6 million from EXXUA ⁷. The ADHD Portfolio includes Adzenys XR-ODT and Cotempla XR-ODT, which are extended-release stimulant medications formulated as orally disintegrating tablets using the company's internally developed patented microparticle modified-release drug delivery technology platform. Revenue for the ADHD Portfolio decreased by 20.4% to $45.8 million in fiscal 2026 ⁸.

The Pediatric Portfolio primarily includes Karbinal ER, an extended-release carbinoxamine (a first-generation antihistamine) suspension indicated for various allergic conditions in patients two years of age and above. Karbinal is the only FDA-approved, 12-hour carbinoxamine oral suspension ⁹. The Pediatric Portfolio declined to $5.1 million in fiscal 2026, a 41.4% decrease from fiscal 2025 ¹⁰, primarily due to the shift in efforts toward the commercial launch of EXXUA. The company owns exclusive rights to commercialize Karbinal in the United States through August 2033 ¹¹.

In June 2025, the company entered into an Exclusive Commercialization Agreement with Fabre-Kramer Holdings, Inc. to commercialize EXXUA in the United States ¹². The company made EXXUA commercially available in mid-December 2025, completed sales force training in mid-January 2026, and deployed the full sales force in late February 2026 ¹³. In June 2025, the company raised gross proceeds of $16.6 million from a public offering ¹⁴. The company also entered into Amendment No. 6 to its loan and security agreement with Eclipse Business Capital LLC, which included a $1.5 million incremental advance ¹⁵. On August 5, 2025, the company reached terms with Rumpus and EnzCo to transfer all rights, title, and interest in AR101, extinguishing all obligations under the Rumpus Asset Purchase Agreement ¹⁶.

For fiscal 2026, the company recorded total net revenue of $57.6 million ¹⁷. The company's net loss was $14.3 million for the year ended June 30, 2026 ¹⁸, compared to a net loss of $13.6 million for the year ended June 30, 2025 ¹⁹. As of June 30, 2026, the company had an accumulated deficit of $347.8 million ²⁰ and cash and cash equivalents totaling $26.3 million ²¹. The company has incurred significant losses in each year since inception and expects to continue to incur significant expenses in connection with its ongoing activities.

The company's management has not provided specific quantitative revenue, margin, or EPS guidance for the upcoming period in the filing.

The primary growth vector is the acceleration of EXXUA adoption following its fiscal 2026 commercial launch, which the company considers the centerpiece of its commercialization efforts. The company believes EXXUA can become a very important treatment option for the estimated 21.0 million Americans affected by MDD ²², and it competes in the over $22 billion United States prescription MDD market ²³. The company expects EXXUA to serve as a major growth catalyst and has shifted its commercial prioritization toward this opportunity. The company also plans to continue growing its commercial branded products, including Adzenys, Cotempla, and Karbinal, by increasing product sales and improving patient access.

Another growth vector is the expansion into foreign markets, specifically through an exclusive collaboration, distribution, and supply agreement with Lupin Pharma Canada Ltd to commercialize Adzenys and Cotempla in Canada. Under this agreement, Lupin is responsible for seeking local regulatory approvals and marketing authorizations, which is expected to occur over the next 12 months ²⁴. The company will supply the products based on forecasts and provide various commercialization, regulatory, and quality assurance resources. This partnership represents a strategic move to penetrate the less developed ADHD market outside the United States.

The company's margin and cost outlook is focused on achieving positive operating cash flows through operational and manufacturing efficiencies and portfolio prioritization. The company has indefinitely suspended active development of its clinical development programs and has wound down and divested unprofitable operations, including the Consumer Health business, to reduce costs. The company expects to continue to incur significant expenses in connection with its ongoing activities, but believes continued growth of its commercial business will support future profitability. The company has also transitioned manufacturing of Adzenys and Cotempla to a United States-based third-party contract manufacturer to improve manufacturing efficiency and profitability.

The company's operational outlook involves relying on third-party manufacturers for all its products. EXXUA is purchased through Fabre-Kramer, with the manufacturing agreement having an initial term ending in September 2028 ²⁵. The ADHD products are manufactured by a United States-based CMO under an agreement with an initial term beginning in November 2023 and ending in November 2028 ²⁶. Karbinal is purchased through a supply agreement with Tris that terminates in August 2033 ²⁷. The company believes these third-party manufacturers have adequate capacity to meet anticipated commercial demands. As of June 30, 2026, the company employed 76 employees, of which 75 were full-time ²⁸.

The company's capital allocation strategy is focused on servicing its debt obligations and funding the commercialization of EXXUA. As of June 30, 2026, the company had a $13.0 million term loan and up to $16.0 million of secured revolving loans under the Eclipse Agreement ²⁹. The company used the net proceeds from its June 2025 public offering for working capital, general corporate purposes, and its exclusive commercialization of EXXUA. The company does not pay a dividend and has not authorized a share repurchase program. Research and development spending has significantly declined as the company has indefinitely suspended active development of its clinical programs.

A significant headwind is the entry of generic competition. Actavis (now owned by Teva) has the right to market a generic version of Adzenys beginning on September 1, 2025, and launched it in December 2025 ³⁰. Teva has the right to market a generic version of Cotempla beginning on July 1, 2026 ³¹. Additionally, the company is engaged in ongoing patent litigation with Granules Pharmaceuticals, which has filed a Paragraph IV certification for a generic version of Adzenys, with trial rescheduled to January 12, 2027 ³². The company also faces customer concentration risk, as five customers accounted for 83% of gross revenue during fiscal 2026 ³³.

The company faces constraints related to its significant debt obligations and the risk of not having sufficient cash to make interest or principal payments. As of June 30, 2026, $11.1 million was outstanding under the term loan and $6.1 million was outstanding under the secured revolving loan ³⁴. The company's ability to use its net operating loss carryforwards is limited, with $288.8 million of net operating losses expected to expire unused by 2037 ³⁵. The company also faces regulatory and pricing pressures, including government restrictions on pricing and reimbursement, which could negatively impact its ability to generate net revenue.

The company is heavily dependent on the commercial success of EXXUA, which only began generating revenue in fiscal 2026, and has not yet achieved sustained profitability. The entry of generic competition poses a material threat, as Actavis launched a generic version of Adzenys in December 2025 ³⁶, and Teva has the right to market a generic version of Cotempla beginning July 1, 2026 ³⁷. The company also faces ongoing patent litigation with Granules Pharmaceuticals, which could result in earlier generic competition for Adzenys. Customer concentration is a significant risk, as five customers accounted for 83% of gross revenue and 90% of gross accounts receivable during fiscal 2026 ³⁸. The company's substantial debt obligations, including $11.1 million outstanding under its term loan and $6.1 million under its revolving loan as of June 30, 2026 ³⁹, create financial risk, and the terms of its loan agreement restrict operating flexibility. Additionally, the company's ability to use its net operating loss carryforwards is limited, with $288.8 million expected to expire unused by 2037 ⁴⁰.

Management's message to shareholders emphasizes a strategic transformation focused on the commercial launch and growth of EXXUA as the centerpiece of its efforts, while continuing to grow its ADHD and Pediatric portfolios. The company has made a deliberate shift to prioritize EXXUA, which it believes has the potential to be a major growth catalyst. Management's strategic priorities are to accelerate adoption of EXXUA, continue to grow its commercial branded products, and leverage the Aytu RxConnect patient support platform to reduce access barriers. The company is focused on achieving positive operating cash flows and has taken actions to wind down and divest unprofitable operations, including the Consumer Health business and clinical development programs. Management believes that focusing resources on its most profitable, growing products provides the most effective pathway to achieve company-wide profitability and continued growth.