DENVER, CO / ACCESS Newswire / October 10, 2025 /Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced management will participate at the following investor conferences: 2025 Maxim Growth Summit Date: October 22, 2025 Location: New York City Investors should reach out to their Maxim sales representatives, or Robert Blum of Lytham ...

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.

Summary of Aytu Biopharma Conference Call Company Overview - Aytu Biopharma is a specialty pharmaceutical company founded in 2015, focusing on ADHD and pediatric products, with a revenue of approximately $66 million, of which $58 million is from ADHD products [4][5] - The company has a program called Aytu Rx Connect, partnering with 1,000 pharmacies to ensure patients have access to prescriptions at a maximum cost of $50 [6] New Product Launch - Aytu Biopharma is preparing to launch a new product, ExuA, for major depressive disorder (MDD), which is a $22 billion market [8] - ExuA is a novel treatment that targets the 5-HT1A receptor, differentiating it from existing SSRIs and SNRIs that often cause side effects like sexual dysfunction and weight gain [9][10] - The product is expected to launch by December 2025, with initial sales to wholesalers and a more significant revenue impact anticipated by June 2026 [32] Market Dynamics - The MDD market sees 340 million prescriptions annually in the U.S., with SSRIs and SNRIs accounting for about 60% of these [12] - Competitors like Trintellix, Avelity, and Spravato have seen growth but share similar side effects that ExuA aims to avoid [13][14] - Government payers are required to cover depression treatments, which could account for 30-40% of the market for ExuA [19] Financial Performance - For the fiscal year 2025, Aytu reported $66.4 million in revenue and an adjusted EBITDA of $9.2 million, marking three consecutive years of positive adjusted EBITDA [36] - The company raised $15 million in June 2025 to support the launch of ExuA, with a cash balance of $31 million as of June 30, 2025 [39][40] Strategic Initiatives - Aytu is focusing on refining sales territories and engaging with psychiatrists, as 60% of their current psychiatrist contacts overlap with the target market for ExuA [18] - The company is also working on branding and promotional strategies to effectively communicate the benefits of ExuA to clinicians [20] Investor Outlook - The management believes ExuA could quickly become a $50 million business within a year of launch, based on the number of prescriptions and the product's unique selling points [42] - The company is exploring ways to extend the patent life of ExuA, which currently has a five-year runway [52][53] Key Takeaways - Aytu Biopharma is positioned for growth with the upcoming launch of ExuA, targeting a significant market opportunity in MDD while leveraging its existing ADHD business [5][8] - The company has a solid financial foundation and strategic plans in place to maximize the potential of its new product [36][39]

Core Viewpoint - Aytu BioPharma, Inc. is actively participating in upcoming investor conferences to enhance visibility and engagement with investors [1] Group 1: Upcoming Conferences - Aytu will participate in the MicroCap Rodeo Fall Conference on September 25, 2025, in New York City, with a presentation scheduled for 2:00 p.m. Eastern time [1] - The company will also attend the Lytham Partners Fall 2025 Investor Conference on September 30, 2025, which will be held virtually, with a presentation time of 2:45 p.m. [1] - A webcast link for the MicroCap Rodeo Fall Conference is provided for interested investors [1]

Market Overview - U.S. stock futures are showing modest gains as investors react to mixed corporate earnings and economic signals, with a focus on Federal Reserve commentary [1] - S&P 500 futures are up approximately 0.1% to 0.3%, while Nasdaq 100 futures have climbed between 0.2% and 0.4%, indicating a potential recovery after a previous session's profit-taking [2] Federal Reserve Commentary - Fed Chair Jerome Powell's remarks about stock prices being "fairly highly valued" contributed to a cautious market sentiment, leading to a dip in major indexes [3] Upcoming Economic Data - Key economic data releases include the final reading on second-quarter GDP growth and the Personal Consumption Expenditures (PCE) price index, which are critical for future interest rate policy [4] Earnings Reports - Companies reporting earnings include Cintas Corporation, Thor Industries Inc., and KB Home, with Baker Hughes scheduled to release third-quarter results on October 23 [5] Corporate Developments - Micron Technology's shares rose after better-than-expected fourth-quarter results and a strong revenue forecast, driven by demand from AI developers [6] - Alibaba's U.S.-listed shares surged nearly 10% following plans to increase investment in AI infrastructure and a partnership with Nvidia [7] - Lithium Americas shares skyrocketed 60% due to news of potential investment from the Trump administration, with General Motors shares also advancing approximately 3% [8] Notable Movers - SHF Holdings shares increased by 150% after securing a stock purchase deal, while Cyclerion Therapeutics rose 39% following a licensing agreement with MIT [9] - Aytu BioPharma fell 14% postmarket after reporting disappointing revenue and losses, while Cohu declined 10% after-hours due to plans to offer convertible senior notes [9] Commodities Market - Gold prices are near recent record highs, while oil prices have edged higher due to falling U.S. crude inventories and geopolitical concerns [10]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SHF Holdings, Inc. (SHFS) increased by 150% to $8.17 - Lithium Americas Corp. (LAC) rose by 69% to $5.18 - Aqua Metals, Inc. (AQMS) gained 50% reaching $6.11 - CleanCore Solutions, Inc. (ZONE) up by 44% at $2.87 - Cyclerion Therapeutics, Inc. (CYCN) increased by 33% to $4.03 - Twin Vee Powercats Co. (VEEE) rose by 17% to $2.92 - Solidion Technology, Inc. (STI) up by 11% at $5.09 - China Pharma Holdings, Inc. (CPHI) increased by 11% to $2.18 - Stardust Power Inc. (SDST) rose by 10% to $3.04 - Aligos Therapeutics, Inc. (ALGS) increased by 7% to $11.03 [3] Premarket Losers - Aytu BioPharma, Inc. (AYTU) decreased by 15% to $2.11 - Professional Diversity Network, Inc. (IPDN) down by 13% to $4.10 - STRATA Skin Sciences, Inc. (SSKN) fell by 10% to $2.31 - Cohu, Inc. (COHU) decreased by 9% to $20.68 - Super League Enterprise, Inc. (SLE) down by 9% to $7.74 - CTW Cayman (CTW) fell by 9% to $2.29 - Fitell Corporation (FTEL) decreased by 8% to $7.70 - Soluna Holdings, Inc. (SLNH) down by 8% to $2.16 - StableX Technologies, Inc. (SBLX) decreased by 5% to $5.22 - Indaptus Therapeutics, Inc. (INDP) down by 5% to $2.95 [4]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [28] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, down from $10.8 million in the prior year [34][33] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [29][30] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, slightly down from $57.8 million, attributed to a decrease in the number of prescriptions written [28] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with Exua targeting a significant portion of this market [7][9] - SSRIs and SNRIs represent over 60% of all antidepressants prescribed, indicating a competitive landscape for Exua [9][10] Company Strategy and Development Direction - The company is focusing on the launch of Exua, a novel treatment for MDD, which is expected to transform its business model [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary patient access platform to drive product acquisitions aligned with its focus [6][19] - The company aims to minimize coverage barriers and enhance patient access through strategic payer contracting [17][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming launch of Exua, highlighting positive feedback from psychiatrists regarding the product [41][43] - The company anticipates that the Exua launch will position it as one of the fastest-growing CNS-focused companies in the industry [44] Other Important Information - The company has launched an authorized generic of Adzenys to maintain market share amid potential competition from Teva [21] - Aytu BioPharma has successfully raised $16.6 million through a public offering to support the Exua launch [35] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is planned before the full launch in the first calendar quarter of 2026 [47] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials but will follow the traditional submission process [48] Question: What is the strategy for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on ensuring favorable contracting without undermining margins [50][52] Question: What are the expectations for ADHD and pediatric portfolio contributions? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a break-even target of approximately $13 million quarterly [60][62] Question: What is the medical affairs strategy for Exua? - Management outlined plans for extensive medical affairs efforts, including presentations at medical conferences and educational programs [63]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [27] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, compared to $10.8 million in the prior year [32] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [28][29] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, down from $57.8 million, attributed to a decrease in the number of prescriptions written [27] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [28] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with Exua targeting a significant portion of this market [7][9] - SSRIs and SNRIs represent over 60% of all antidepressants prescribed, indicating a competitive landscape for Exua [9][10] Company Strategy and Development Direction - The company is focusing on the launch of Exua, a novel treatment for MDD, which is expected to transform its business model [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect platform for the launch of Exua [6][14] - The company aims to maintain market share in the ADHD segment despite the entry of generics by launching an authorized generic of Adzenys [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming launch of Exua and its potential to address unmet needs in the MDD market [4][11] - The company anticipates a positive trajectory for Exua as it ramps up commercial efforts, expecting to exit fiscal 2026 as one of the fastest-growing CNS-focused companies [42] Other Important Information - The company has successfully raised $16.6 million through a public offering to support the Exua launch [34] - Aytu BioPharma has restructured its operations, resulting in a new cost structure that projects a break-even level of approximately $52.6 million annually [30] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is planned before the full launch in the first calendar quarter of 2026 [45] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials but will follow the traditional submission process [46] Question: What is the strategy for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on government payers due to favorable coverage for MDD [50][52] Question: What are the expectations for the ADHD and pediatric franchises? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a focus on maintaining margin positivity [58][60] Question: What is the plan for medical affairs and education for Exua? - Management outlined extensive efforts in medical affairs, including engagement with key opinion leaders and participation in medical conferences [61]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [28] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA [34] - The net loss for the year was $13.6 million, an improvement from a net loss of $15.8 million in the prior year [32] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, down from $57.8 million, attributed to a decrease in the number of prescriptions written [28] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] - Gross margin decreased to 69% from 75%, primarily due to increased cost of sales in ADHD inventory [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with more than 340 million prescriptions written annually [9] - SSRIs and SNRIs account for approximately 220 million TRXs, representing over 60% of all antidepressants prescribed [9] Company Strategy and Development Direction - The company is focusing on the upcoming launch of Exua, a novel treatment for MDD, which is expected to transform its business [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect patient access platform for product acquisitions aligned with its focus [6] - The company aims to minimize coverage barriers and enhance patient access through selective payer contracting [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Exua launch, highlighting positive feedback from psychiatrists regarding the product's potential [41][43] - The company anticipates that the Exua opportunity will significantly enhance its growth trajectory, positioning it as a leading CNS-focused company [44] Other Important Information - The company has successfully completed a public offering totaling $16.6 million gross, which is seen as validation of the Exua opportunity [35] - Aytu BioPharma has launched an authorized generic of Adzenys to maintain market share amid potential competition from Teva [21] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is expected before the full launch in the first calendar quarter of 2026 [47] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials, citing confidence in their compliant promotional platform [48] Question: What is the plan for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on ensuring favorable contracting without undermining margins [52][54] Question: What are the expectations for the ADHD and pediatric franchises? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a focus on maintaining margin positivity [60][62] Question: What is the medical affairs strategy for Exua? - Management outlined an extensive medical affairs effort, including engagement with key opinion leaders and participation in medical conferences [63]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [27] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, compared to $10.8 million in the prior year [33] - The net loss for the year was $13.6 million, an improvement from a net loss of $15.8 million in the previous year [32] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, slightly down from $57.8 million in the prior year, attributed to a decrease in the number of scripts written [27] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with more than 340 million prescriptions written annually [9] - SSRIs and SNRIs account for over 60% of all antidepressants prescribed, with approximately 220 million TRXs [9] Company Strategy and Development Direction - The company is focusing on the upcoming launch of Exua, a novel treatment for MDD, which is expected to transform its business [4] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect patient access platform for product acquisitions aligned with its focus [5] - The company aims to minimize coverage barriers and enhance patient access through selective payer contracting [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Exua launch, highlighting strong physician interest and potential market need for targeted therapies [11][41] - The company anticipates that the Exua opportunity will significantly enhance its growth trajectory, positioning it as a leading CNS-focused company [43] Other Important Information - The company has successfully launched an authorized generic of Adzenys, which is expected to help maintain market share despite potential competition from Teva [20] - Aytu BioPharma has restructured its operations, resulting in a new cost structure that projects a break-even level of approximately $52.6 million annually [31] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Yes, the company plans to load in by the end of 2025 and have a sales force meeting followed by a full launch in the first calendar quarter [46] Question: Will promotional materials be pre-cleared? - The company does not plan to pre-clear promotional materials but will follow the traditional submission process [47] Question: What is the approach to engaging with payers? - The company will engage with payers on a case-by-case basis, being selective to ensure favorable contracting without undermining margins [50][51] Question: What are the expectations for ADHD and pediatric franchises? - The ADHD portfolio is expected to maintain some level of stickiness, while the pediatric portfolio will cover general and administrative expenses going forward [58] Question: What is the medical affairs strategy for Exua? - The company plans to engage in extensive medical education and presence at medical conferences, focusing on key opinion leaders [60]