Aytu BioPharma, Inc. (AYTU): Business Model Canvas [Dec-2025 Updated]

You're digging into the mechanics of Aytu BioPharma, Inc., and what you'll see is a company making a calculated pivot, balancing a solid base against a major near-term catalyst. With fiscal 2025 total net revenue hitting $66.4 million, largely from their established ADHD and pediatric lines, they've built a foundation, but the real action is the EXXUA launch for MDD, which they are funding while managing $39.6 million in SG&A for the year. They are backing this with $31 million in cash as of June 30, 2025, all while keeping product gross margins strong at 69% in Q3 2025; this canvas shows you the exact resources, partnerships, and customer focus they are deploying to make that next-generation CNS product a success, so check out the details below to see the full operational blueprint.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Key Partnerships

You're looking at the structure Aytu BioPharma, Inc. uses to get its products to market and fund its growth initiatives. It's all about who they work with to move the needle, especially with the EXXUA launch slated for late 2025.

Fabre-Kramer Pharmaceuticals for exclusive US commercial rights to EXXUA

The agreement for EXXUA, which targets the over $22 billion United States prescription Major Depressive Disorder (MDD) market, has very specific financial triggers with Fabre-Kramer Pharmaceuticals. Aytu BioPharma anticipates launching EXXUA in the fourth calendar quarter of 2025.

The financial structure of this partnership includes several components:

• Initial upfront cash payment made by Aytu BioPharma: $3,000,000 as of June 5, 2025.
• Additional fixed payment due on the one-year anniversary of the EXXUA launch date.
• Potential Second Payment of $5,000,000 if first-year Product net sales reach $35 million.
• Variable milestone payments ranging from $5,000,000 to over $100,000,000 per year based on sales milestones after $100,000,000 in net sales are achieved.

Here's a breakdown of the royalty and supply price structure tied to net revenue:

Additionally, Aytu BioPharma is set to pay 10% of net sales that exceed $1 billion.

US-based Contract Manufacturing Organizations (CMOs) for product supply

Aytu BioPharma exited its in-house manufacturing facility at the end of calendar 2024, indicating a reliance on external Contract Manufacturing Organizations (CMOs) for product supply moving into 2025. No specific number of CMO partners or associated financial figures for these relationships were publicly detailed in the available data.

Network of approximately 1,000 independent pharmacies for Aytu RxConnect

The Aytu RxConnect patient access program is a key operational component, designed to ensure patients can get affordable and predictable access to Aytu's medications despite payer challenges. This program is currently available through approximately 1,000 pharmacies nationwide.

Major pharmaceutical wholesalers and distributors for product logistics

Aytu BioPharma, Inc. is listed as a registered entity involved in drug distribution, holding a license with the State of Oregon set to expire on 09/30/2026. This confirms their established position within the US pharmaceutical logistics network necessary for product movement, though specific contracts or volume data with major wholesalers weren't detailed.

Healthcare-focused institutional investors like Nantahala Capital Management

Healthcare-focused institutional investors, including Aytu BioPharma's largest shareholder, Nantahala Capital Management, provided financing for the EXXUA transaction. Nantahala Capital Management executed a purchase of 4,000,000 shares for $8M on June 6, 2025, at a price of $2.00 per share. Following this, their holding value in AYTU was reported at $10.5M, representing 4,815,217 shares. This investor group also led the financing for a public offering priced at $1.50 per share, which generated gross proceeds of approximately $14.4 million on June 6, 2025.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Key Activities

You're looking at the core engine of Aytu BioPharma, Inc. as they pivot hard into the CNS space with a major new product. Here's the breakdown of what the team is actively doing to drive the business forward as of late 2025.

Commercialization and promotion of CNS and Pediatric prescription products

The primary activity here is driving sales for the established portfolio, which includes CNS treatments for ADHD and the Pediatric line. For the full fiscal year 2025, the company reported total net revenue of $66.4 million. Looking specifically at the third quarter of fiscal 2025, the ADHD Portfolio, featuring Adzenys XR-ODT and Cotempla XR-ODT, brought in net revenue of $15.4 million, marking a 25% year-over-year increase. The Pediatric Portfolio, which includes Karbinal ER, Poly-Vi-Flor, and Tri-Vi-Flor, generated $3.1 million in net revenue for that same quarter, showing an exceptional 77% year-over-year growth. For the full fiscal year 2025, the ADHD Portfolio revenue was $57.8 million, while the Pediatric Portfolio revenue reached $8.8 million, up from $7.3 million in the prior year.

The core commercial focus is supported by the sales force and platform, as seen in the Q3 FY2025 results:

• ADHD Portfolio net revenue in Q3 FY2025: $15.4 million.
• Pediatric Portfolio net revenue in Q3 FY2025: $3.1 million.
• Full Year Fiscal 2025 Net Revenue: $66.4 million.

Managing the proprietary Aytu RxConnect patient access platform

Aytu BioPharma views its proprietary platform as a significant differentiator, crucial for ensuring patient access and adherence to its brands. This platform is heavily utilized; over 85% of Aytu's core brands are dispensed through Aytu RxConnect partner pharmacies. The value proposition is concrete, offering a 32% Reduction in Patients' Out-of-Pocket Costs and a 100%+ Increase in Rx Refills for patients using the service. The network itself is comprised of approximately 1,000 pharmacies nationwide, including independent locations and regional grocery chains committed to stocking Aytu products. The platform's efficiency helps the commercial team by reducing pharmacy call backs related to payor access barriers like prior authorizations or step edits.

Executing the late 2025/early 2026 launch of EXXUA for MDD

This is the near-term centerpiece activity. Aytu BioPharma is actively executing the commercial launch plan for EXXUA (gepirone) extended-release tablets, which is targeted for the fourth quarter of calendar 2025. This launch is a direct entry into the U.S. prescription Major Depressive Disorder (MDD) market, valued at over $22 billion annually. The company secured necessary capital to support this, closing an offering that raised gross proceeds of $16.6 million. EXXUA is positioned as a first-in-class oral selective serotonin 5HT1a receptor agonist, studied in over 5,000 patients.

Key launch preparation metrics include:

Regulatory compliance and quality assurance for FDA-approved drugs

Maintaining compliance is a constant, non-negotiable activity for all marketed products, including the ADHD and Pediatric lines, and the newly approved EXXUA. The FDA approval for EXXUA itself is a key milestone achieved, confirming its status as the first oral selective serotonin 5HT1a receptor agonist for MDD. Quality assurance extends to manufacturing, as the company previously outsourced its ADHD manufacturing to a U.S.-based CMO. The company reported a gross profit percentage of 69% for the full fiscal year 2025, down from 75% the previous year, partly related to inventory cost of sales, which speaks to ongoing quality and cost management in production.

Strategic business development for in-licensing new CNS assets

Aytu BioPharma is actively looking to expand its CNS-focused sales footprint by acquiring or in-licensing new assets. Management signaled this focus following the Q3 2025 results, emphasizing the pursuit of additional products that can utilize the existing CNS-focused sales team and the Aytu RxConnect platform. The company's overall strategy is to advance innovative medicines for complex CNS diseases. The EXXUA agreement itself, signed in June 2025 with Fabre-Kramer Pharmaceuticals, is a prime example of this business development activity.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Key Resources

You're looking at the core assets Aytu BioPharma, Inc. (AYTU) relies on to execute its strategy as of late 2025. These aren't just line items; they are the tangible and intangible things that make the business run, especially with the EXXUA launch imminent.

The product portfolio forms the bedrock. Aytu BioPharma, Inc. holds the FDA-approved prescription product portfolio, which includes the ADHD treatments Adzenys XR-ODT and Cotempla XR-ODT, alongside the newly launched EXXUA (gepirone) extended-release tablets for Major Depressive Disorder (MDD). The ADHD portfolio generated net revenue of $57.6 million for the full year fiscal 2025, while the Pediatric Portfolio contributed $8.8 million, totaling a full-year net revenue of $66.4 million.

Intellectual Property (IP) provides a crucial moat, particularly for the newest asset. The method of use patent (U.S. Patent No. 7,538,116) for EXXUA has been extended through September 2, 2030, expanding upon the New Chemical Entity (NCE) exclusivity period. This protection is vital as EXXUA targets the estimated 21 million Americans affected by MDD.

The company's operational backbone includes proprietary technology and human capital. The proprietary patient access platform, Aytu RxConnect, is already in use, helping enable improvements in the 'growth to nets' for the existing ADHD portfolio. Furthermore, the company maintains a dedicated sales force, specified as a 40-person team focused on US psychiatrists, to drive the commercialization of EXXUA.

Financial resources are key to funding the commercial push. Aytu BioPharma, Inc. reported $31 million in cash and cash equivalents as of June 30, 2025. This position strengthened slightly to $32.6 million by September 30, 2025, following a successful capital raise in June 2025.

Here's a quick look at the financial context supporting these resources as of the end of fiscal year 2025:

The existing portfolio's efficiency is also a key resource, showing the path to profitability even before EXXUA scales. The company's new cost structure projects a pro-forma annual expense of $36.3 million, setting the break-even level for the current ADHD and pediatric base at about $52.6 million annually, or $13.2 million quarterly.

The FDA-approved products include:

• EXXUA (gepirone) for MDD
• Adzenys XR-ODT for ADHD
• Cotempla XR-ODT for ADHD
• Karbinal ER for allergic conditions

Finance: draft 13-week cash view by Friday.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Value Propositions

You're looking at the core reasons Aytu BioPharma, Inc. (AYTU) is positioning itself in the CNS market as of late 2025. The value propositions center on differentiated products and a strong patient access infrastructure.

First-in-class MDD treatment (EXXUA) with no sexual dysfunction or weight gain warnings

The value here is the novel mechanism of action for Major Depressive Disorder (MDD). EXXUA (gepirone) extended-release tablets are the first FDA-approved selective serotonin 5HT1a receptor agonist for adults with MDD. This product is set to enter the over $22 billion United States prescription MDD market, with a planned commercial launch in the fourth calendar quarter of 2025.

The clinical profile offers a key differentiator:

• Studied in over 5,000 patients.
• Incidence of sexual side effects was comparable to placebo.
• Shows no significant adverse effects on weight, blood pressure, heart rate, or liver function.
• The method of use patent is extended through September 2, 2030.

Orally Disintegrating Tablet (ODT) formulations for ADHD (Adzenys, Cotempla)

Aytu BioPharma maintains a stable ADHD Portfolio, anchored by ODT formulations that offer convenience. Adzenys XR-ODT is indicated for Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Cotempla XR-ODT is indicated for ADHD in patients 6 to 17 years of age. The ADHD Portfolio generated net revenue of $57.6 million for the full fiscal year 2025.

Best-in-class patient access and affordability via Aytu RxConnect

The Aytu RxConnect platform is a critical enabler, driving improvements in gross-to-net performance. In the third quarter of fiscal 2025, more than 85% of the company's scripts were driven through this network. This infrastructure is being finalized for the EXXUA launch.

For the ADHD ODTs, specific affordability measures exist:

Established, consistent revenue-generating pediatric product line

This portfolio provides a consistent revenue base, which saw significant year-over-year growth recently. The Pediatric Portfolio net revenue for the full fiscal year 2025 was $8.8 million. The products include Karbinal ER, Poly-Vi-Flor, and Tri-Vi-Flor, prescribed for conditions like allergic rhinitis or to prevent fluoride deficiency in infants and children.

Here's a look at the revenue performance for this segment:

• Fiscal 2025 Full Year Net Revenue: $8.8 million
• Fourth Quarter Fiscal 2025 Net Revenue: $2.0 million
• Third Quarter Fiscal 2025 Net Revenue: $3.1 million (a 77% increase year-over-year)

The company reported total net revenue for fiscal year 2025 was $66.4 million.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Customer Relationships

You're looking at how Aytu BioPharma, Inc. connects with the prescribers and patients who use their CNS-focused prescription products. The relationship strategy centers on a highly focused commercial infrastructure designed to reduce friction in access and boost patient persistence.

Dedicated, high-touch sales force engagement with key prescribers (psychiatrists)

Aytu BioPharma, Inc. deploys an in-house, Focused Specialty Sales Force. This team is developed internally to drive patient adherence and increase script pull-through for Aytu's prescription brands. The company anticipates further aligning this force to psychiatry and psychiatric extenders, especially with the launch of EXXUA™ (gepirone) extended-release tablets. While the overall ADHD market is substantial, the lean, direct sales force previously covered approximately 59% of the $12 billion ADHD market. The promotional footprint has been substantially increased to support growth initiatives.

Proprietary Aytu RxConnect program offering capped patient cash outlays

The Aytu RxConnect program is positioned as a best-in-class patient access platform, supporting affordable, predictable, and hassle-free access for all commercially insured patients. This platform is critical to managing the economics of the portfolio. As of the fiscal year-end June 30, 2025, the program has delivered tangible financial benefits to patients:

This platform enables Aytu BioPharma, Inc. to manage gross-to-net (GTN) parameters, which offset decreases in the number of scripts written for the ADHD portfolio in fiscal 2025, where net revenue was $57.6 million.

Direct-to-patient support to increase refill rates and adherence

The primary mechanism for direct-to-patient support is the RxConnect program itself, which is explicitly designed to increase Rx stickiness through greater patient adherence, quantified by the 100%+ increase in Rx refills. This focus on adherence is a key driver for the commercial infrastructure. The platform also reduces pharmacy call backs related to payor access barriers like prior authorizations and step edits, which directly helps the patient journey.

• Drives patient adherence and increased script pull-through.
• Quantified refill rate increase: 100%+.
• Designed to reduce out-of-pocket costs by 32%.

Account management with major payers to secure formulary access

Aytu BioPharma, Inc. integrates EXXUA™ into the Aytu RxConnect access platform upon launch to gain strong insights on reimbursement and coverage rates. These insights are intended to guide selective and smart payer contracts. The company notes success in navigating the payer landscape, even in the ADHD category where brand reimbursement is described as spotty. For government pay scenarios, there is a mandate for Medicare and Medicaid plans to cover products for both depression and schizophrenia, suggesting near universal coverage in that segment.

The overall commercial strategy, underpinned by this access infrastructure, contributed to the company achieving an Adjusted EBITDA of $9.2 million for the full year fiscal 2025, while maintaining a cash balance of $31.0 million as of June 30, 2025.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Channels

You're looking at how Aytu BioPharma, Inc. gets its prescription therapeutics into the hands of patients and prescribers as of late 2025. The structure relies on a focused internal team augmented by a proprietary patient access platform and established distribution lines.

Dedicated 40-person specialty sales force for direct physician detailing.

Aytu BioPharma, Inc. maintains a lean, direct sales force to call on physicians across the country. This team is specifically focused on driving patient adherence and script pull-through for their core prescription brands, particularly in the ADHD and the newly launching MDD space.

• Commercial sales team size is reported as over 40 representatives.
• This direct sales force covers approximately 59% of the United States ADHD market, which is valued at over $12 billion.
• The sales force is augmented by the Aytu RxConnect pharmacy partners.

Aytu RxConnect pharmacy network for controlled patient access and dispensing.

The Aytu RxConnect program is a key differentiator, designed to ensure affordable and predictable patient access, which helps with compliance. This proprietary platform works directly with pharmacies to streamline the process for prescribers and reduce patient out-of-pocket costs.

• The program is available through approximately 1,000 pharmacies nationwide.
• Aytu RxConnect is designed to guarantee a maximum patient copay of $50 for eligible branded prescriptions.
• The network provides 100% sales territory coverage, supporting the direct sales force efforts.

Here's a quick look at the scale of the commercial infrastructure supporting prescription fulfillment:

Major pharmaceutical wholesalers (e.g., McKesson, Cardinal Health) for bulk distribution.

Aytu BioPharma, Inc. utilizes established channel network partners for the bulk movement of its products through the supply chain. While specific wholesaler agreements aren't detailed, this represents the traditional mechanism for getting inventory to the dispensing points.

Traditional retail and mail-order pharmacies for prescription fulfillment.

Fulfillment occurs through the network of pharmacies integrated with Aytu RxConnect, which includes both retail and mail-order options. This integration is critical for increasing Rx stickiness, meaning a higher refill rate for patients utilizing the program.

Finance: draft 13-week cash view by Friday.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Customer Segments

You're looking at the specific groups Aytu BioPharma, Inc. targets with its current commercial portfolio as of late 2025. This is about who buys or is prescribed their products.

US Psychiatrists and other CNS specialists (primary prescribers)

• The existing psychiatry-centric sales force is comprised of 40-plus people.
• More than 85% of the company's total prescriptions are driven through the Aytu RxConnect network.
• This sales force is being aligned to make the upcoming EXXUA launch their primary promotional responsibility.

Adults diagnosed with Major Depressive Disorder (MDD)

This segment is targeted for the planned launch of EXXUA, a novel treatment for MDD in adults, expected in the fourth calendar quarter of 2025.

• The United States prescription MDD market is valued at over $22 billion.
• The company anticipates investing approximately $10 million in the initial launch of EXXUA in fiscal 2026.

Pediatric patients (ages 6+) with Attention Deficit Hyperactivity Disorder (ADHD)

This segment is served by the ADHD Portfolio, which includes Adzenys XR-ODT® and Cotempla XR-ODT®. Prescriptions for this portfolio were approximately 99,000 written in the first quarter of fiscal 2025.

Infants and children requiring prescription fluoride and vitamin supplements

This group is served by the Pediatric Portfolio, specifically the Poly-Vi-Flor® and Tri-Vi-Flor® lines, which are prescription vitamin product lines with fluoride.

The revenue contribution from the core product segments for the full fiscal year 2025 was as follows:

For context on the business scale as of late 2025, the trailing twelve-month revenue as of September 30, 2025, was $63.7M, and the cash balance at that date was $32.6 million.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Cost Structure

You're looking at the expenses Aytu BioPharma, Inc. incurs to keep the lights on and drive growth, especially with the EXXUA launch on the horizon. This structure is heavily weighted toward commercialization and supporting the existing prescription portfolio.

The Selling, General, and Administrative (SG&A) expenses for the prior fiscal year, FY 2025, totaled $39.6 million. This covers the overhead for running the business, including executive functions, finance, and the core administrative side of the house.

For the core prescription products, like the ADHD portfolio, the Cost of Goods Sold (COGS) directly impacts profitability. For the third quarter of fiscal 2025 (Q3 2025), the gross margin on these products landed at 69%. That margin was temporarily compressed by working through higher-cost inventory from the now-closed Grand Prairie, Texas facility, but management expected a return to the low-to-mid 70% range as that inventory cleared.

The big anticipated cost driver is the commercialization of EXXUA. Management outlined a significant investment of approximately $10 million earmarked specifically for the initial launch activities within fiscal year 2026. This investment is incremental to the baseline operating expenses. For context, in the first quarter of fiscal 2026, operating expenses excluding amortization and restructuring were $10.2 million, which already included some initial EXXUA launch investments.

The deal structure for EXXUA with Fabre-Kramer Pharmaceuticals introduces several variable and fixed cost components tied to the product's success. These payments are a key part of the cost structure moving forward:

A continuous operational cost is managing the Aytu RxConnect pharmacy network. This proprietary platform is a key resource, designed to drive patient adherence and reduce friction points like prior authorizations for Aytu's entire portfolio. While it creates value by improving gross-to-net economics, the internal infrastructure, support team, and analytics required to run this best-in-class access program represent an ongoing operational expense, though a specific dollar amount for its management isn't broken out separately from general SG&A.

You should keep an eye on the operating expense run-rate, especially as the $10 million EXXUA launch spend hits the books in fiscal 2026, layered on top of the existing base costs.

Aytu BioPharma, Inc. (AYTU) - Canvas Business Model: Revenue Streams

You're looking at Aytu BioPharma, Inc.'s revenue generation as of late 2025. The model is clearly centered on product sales from two main prescription pharmaceutical portfolios, with a major new revenue catalyst on the immediate horizon.

The foundation of the revenue base for the full fiscal year 2025 was built on established product lines. Honestly, the numbers show a clear concentration in one area.

Here's the quick math on the product sales for the full fiscal year 2025:

• Net product sales from the ADHD portfolio (Adzenys, Cotempla) totaled $57.6 million for FY 2025.
• Net product sales from the Pediatric portfolio (Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor) accounted for $8.8 million for FY 2025.
• Total net revenue for the full fiscal year 2025 was $66.4 million.

The company's ability to drive revenue through its existing assets is evident, but the near-term focus is definitely shifting. The sales team's optimization, partly through the Aytu RxConnect network, which drives more than 85% of the company's scripts, is key to maximizing these current streams.

The next major piece of the revenue puzzle is the commercial launch of EXXUA, which Aytu BioPharma, Inc. anticipated rolling out in the fourth calendar quarter of 2025. This is a transformational event, moving the company into the over $22 billion United States prescription major depressive disorder (MDD) market with a novel first-in-class treatment.

While initial revenue from EXXUA is expected to be minimal in the immediate quarters following the late 2025 launch, the structure of the commercialization agreement sets up significant future potential through royalties and milestone payments. What this estimate hides is the ramp-up time; management expects meaningful results as the product ramps into fiscal 2027.

The financial structure tied to the EXXUA commercialization agreement provides a clear roadmap for potential future revenue beyond the initial sales period. You should watch these triggers closely:

Regarding potential milestone payments and royalties from other out-licensed assets, the public filings focus heavily on the EXXUA deal structure as the primary source of future contingent revenue. Generally, out-licensing noncore assets involves an upfront cash payment, milestone payments upon development or commercial success, and a royalty on net sales, but specific details on other such agreements for Aytu BioPharma, Inc. weren't the focus of the latest disclosures.

Finance: draft 13-week cash view by Friday.