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Aytu BioPharma Inc. (AYTU) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to a loss of $0.2 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -33.33%. A quarter ago, it was expected that this company would post a loss of $0.02 per share when it actually produced a loss of $0.26, delivering a surprise of -1200%.Over the last four quarters, the company has no ...

Financial Data and Key Metrics Changes - Net revenue for Q1 2026 was $13.9 million, down from $16.6 million in the prior year, but excluding a one-time rebate benefit from last year, net revenue increased by 5% [17][21] - ADHD portfolio net revenue was $13.2 million compared to $15.3 million in the prior year, but on an equivalent basis, it increased by about 10% [17][21] - Gross margin decreased to 66% from 72% year-over-year, but improved to 65% when excluding the rebate [18][21] - Operating expenses were $10.2 million, down from $11.2 million in the prior year, reflecting cost reduction efforts [19][21] Business Line Data and Key Metrics Changes - The ADHD portfolio showed resilience with a 10% increase in net revenue on an equivalent basis, despite a decrease in total prescriptions [17][21] - The pediatric portfolio revenue dropped to $0.7 million from $1.3 million due to manufacturing delays and a de-emphasis in marketing [18][21] Market Data and Key Metrics Changes - The company is preparing for the launch of Exxua, which is expected to significantly impact the market for major depressive disorder treatments [5][10] - The ADHD market remains highly genericized, but the company believes its unique distribution model will mitigate the impact of generic competition [12][13] Company Strategy and Development Direction - The company is focused on the successful launch of Exxua, with significant preparations underway including KOL engagement and Salesforce training [5][10] - Aytu is maintaining a Salesforce of approximately 40 people, with territory alignments adjusted for optimal market access [8][9] - The company is also working on lifecycle management approaches to extend exclusivity beyond 2030 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ADHD portfolio's resilience despite the threat of generic competition, citing the unique distribution model [12][13] - The company anticipates a strong launch for Exxua, with positive feedback from prescribers and a focus on targeting younger patients dissatisfied with current treatments [27][44] Other Important Information - The FDA's recent communication regarding fluoride-containing drugs is being monitored, but the impact on Aytu's financials is expected to be minimal [15][16] - Cash and cash equivalents were $32.6 million at the end of the quarter, up from $31 million [22] Q&A Session Summary Question: How significant were the territory realignments and what are the plans for incentive compensation post-Exxua launch? - Approximately one-third of the territories were affected, with a focus on enhancing coverage in key areas. A rich incentive compensation plan is being finalized to reward engagement with new prescribers [30][31] Question: What has been done regarding payer engagement pre-launch? - The company is taking a cautious approach to contracting with commercial payers to maintain best pricing on government contracts, with light engagement ongoing [33][35] Question: How much of the target prescriber market has been reached and what feedback has been received? - Feedback from engaged prescribers has been overwhelmingly positive, with a focus on targeting psychiatrists already familiar with Aytu's products [40][41] Question: What is the flexibility of the supply chain to ramp up production if demand exceeds expectations? - The company has sufficient supply to meet initial forecasts and can scale production as needed, with a low cost of goods sold projected [49][51]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ___________ Commission File Number: 001-38247 AYTU BIOPHARMA, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-0883144 | | - ...

Exhibit 99.1 Net income of $2.0 million, or $0.21 net income per share basic Adjusted EBITDA1 of $(0.6) million, which includes EXXUA launch investments $32.6 million cash balance at September 30, 2025 Company remains on track to launch EXXUA™ (gepirone) extended-release tablets ("EXXUA") in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts as it enters the over $22 billion United States prescription major depressive disorder ("MDD") market Company to host conference call and we ...

Total net revenue of $13.9 million Net income of $2.0 million, or $0.21 net income per share basic Adjusted EBITDA1 of $(0.6) million, which includes EXXUA launch investments $32.6 million cash balance at September 30, 2025 Company remains on track to launch EXXUA â"¢ (gepirone) extended-release tablets ("EXXUA " ) in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts as it enters the over $22 billion United States prescription major depressive disorder ("MDD") market Company to ...

Core Viewpoint - Aytu BioPharma, Inc. has successfully extended the method of use patent for its EXXUA product, which is significant for its market position and future revenue potential [1] Company Summary - Aytu BioPharma, Inc. focuses on developing innovative medicines aimed at treating complex central nervous system diseases, with the goal of improving patient quality of life [1] - The patent extension for EXXUA (gepirone) is now valid until September 2, 2030, providing a longer period of market exclusivity [1] Industry Summary - The pharmaceutical industry is characterized by the importance of patent protection, which plays a critical role in maintaining competitive advantages and ensuring revenue streams for companies [1]

Summary of Aytu Biopharma Conference Call Company Overview - Aytu Biopharma is a NASDAQ-listed specialty pharmaceutical company based in Denver, Colorado, focused on central nervous system (CNS) conditions [1][2] - The company has transformed into a pure-play CNS company, concentrating on ADHD and a new product for major depressive disorder (MDD) [1][2] Business Transformation - In October 2022, Aytu suspended its clinical development program for a rare disease asset and divested its consumer health care business [2] - The company outsourced its manufacturing to a U.S.-based third-party contract manufacturer and closed its own facility in December 2024 [2] - Aytu's adjusted EBITDA improved by approximately $35 million due to these transformations [3] Financial Performance - Aytu reported total revenue of approximately $66 million, with $58 million coming from ADHD products Adzenys and Cotempla [3][5] - The company experienced significant growth in 2024 due to an ADHD medication shortage, leading to increased prescriptions [5] - Gross margins are around 69%, expected to remain stable with the introduction of Exua [19][20] New Product Launch: Exua - Exua, a product for MDD, was approved in September 2023 and is set to launch in December 2025 [4][10] - The MDD market is valued at approximately $22 billion, significantly larger than the ADHD market, which is around $7 billion [9][10] - Exua's key differentiator is its lack of common side effects associated with other MDD medications, such as sexual dysfunction and weight gain [10][11] Clinical Studies and Market Potential - Exua underwent two well-controlled studies, showing efficacy comparable to existing treatments but with fewer side effects [10][13] - The product targets a market where 40% of patients switch medications due to side effects, indicating a strong opportunity for Exua [12][15] - Aytu plans to position Exua as a third or fourth-line therapy, with potential for substantial revenue growth [15][16] Marketing and Sales Strategy - Aytu's marketing strategy focuses on direct engagement with psychiatrists, leveraging a sales force already familiar with the MDD space [18][21] - The company has received positive feedback from psychiatrists, with a high willingness to prescribe Exua [16][17] Financial Position and Future Outlook - Aytu has a market cap of approximately $50 million, trading below its annual revenue [22] - The company has cleaned up its balance sheet, with $31 million in cash and reduced debt levels [20] - Aytu aims to generate cash flow to explore further licensing opportunities in the CNS space [26][29] Management and Shareholder Structure - The management team has extensive experience in launching pharmaceutical products, with a history of success in the industry [21] - Major shareholders include Nantahala Capital and Stone Pine, holding significant stakes in the company [22] Conclusion - Aytu Biopharma is positioned for growth with the upcoming launch of Exua and a streamlined focus on CNS conditions, backed by a solid management team and positive market feedback [21][30]

Core Viewpoint - Aytu BioPharma, Inc. is actively participating in investor conferences to enhance engagement with potential investors and stakeholders [1] Group 1: Investor Conferences - Aytu will participate in the 2025 Maxim Growth Summit on October 22, 2025, in New York City [1] - The company will also be present at the Planet MicroCap Showcase in Toronto from October 22 to October 23, 2025, with a presentation scheduled for 2:30 p.m. [1] - Investors are encouraged to schedule one-on-one meetings with Aytu's management through Maxim sales representatives or Robert Blum of Lytham Partners [1]

Aytu BioPharma Conference Summary Company Overview - **Company**: Aytu BioPharma (Ticker: AYTU) - **Industry**: Pharmaceuticals, specifically focusing on Central Nervous System (CNS) conditions, including ADHD and Major Depressive Disorder (MDD) [2][3] Key Points and Arguments Financial Performance - Aytu recently completed a successful fiscal year, reporting over **$66 million** in trailing 12-month net revenues [18][19] - The company has demonstrated consistent positive adjusted EBITDA in the **$9 to $10 million** range over the last three years [5][6] Strategic Realignment - Aytu has undergone a significant strategic realignment to focus on profitability by exiting unprofitable businesses and R&D programs [6][7] - The company divested its consumer health business and in-house manufacturing, which were costly and not aligned with its profitability goals [6][7] Product Portfolio - Aytu's primary focus is on its ADHD medications, including **Adzenys XR-ODT** and **Cotempla XR-ODT**, which are established brands in the market [9][10] - The company is preparing to launch a new antidepressant, **Exua**, targeting MDD, which is expected to be commercially available by the end of **2025** [11][12] Market Opportunity - The MDD market is substantial, with over **20 million** Americans affected and more than **340 million** prescriptions written annually [11][12] - Exua is positioned to address significant side effects associated with current antidepressants, such as sexual dysfunction and weight gain, making it a unique offering in the market [13][14][29] Unique Mechanism of Action - Exua targets the **5-HT1A receptor**, differentiating it from traditional SSRIs and SNRIs, which are known to cause side effects [14][29] - The product has been studied extensively, with over **5,000 patients** involved in clinical trials, demonstrating efficacy and safety [15][16] Commercial Strategy - Aytu has a dedicated **40-person sales force** focused on psychiatrists, which will facilitate the launch of Exua [27][28] - The company has established a patient access program, **Aytu ARCs Connect**, to ensure affordability and accessibility of its medications [20][21] Competitive Landscape - Exua is expected to be priced at a premium compared to other antidepressants, with a favorable reimbursement landscape, particularly for government programs like Medicaid and Medicare [32][33] - The product is patent protected through late **2030**, providing a significant competitive advantage [31] Future Outlook - Aytu is optimistic about the potential for Exua to capture market share, especially among patients dissatisfied with current treatment options due to side effects [41][42] - The company is well-funded with over **$30 million** in cash and a manageable debt load, positioning it for future growth [44] Additional Important Information - The company has made significant improvements in margins and cash flow due to its strategic changes [44] - Aytu's ADHD portfolio will continue to support the launch of Exua, leveraging existing relationships with prescribers [17][19] This summary encapsulates the key insights from Aytu BioPharma's conference, highlighting the company's strategic direction, product offerings, and market opportunities.