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]

Financial Performance - For the three months ended September 30, 2025, net revenue decreased by $2.7 million, or 16%, to $13.9 million compared to $16.6 million for the same period in 2024[127]. - Gross profit for the same period decreased by $2.8 million, or 23%, to $9.2 million, with a gross profit percentage of 66% compared to 72% in 2024[129]. - The ADHD Portfolio generated $13.2 million in revenue, down from $15.3 million, a decrease of $2.1 million, while the Pediatric Portfolio revenue fell to $0.7 million from $1.3 million[128]. Expenses - Selling and marketing expenses decreased by $0.3 million, or 6%, to $5.3 million, primarily due to reduced commission expenses[130]. - General and administrative expenses decreased by $0.2 million, or 4%, to $4.9 million, attributed to cost reduction efforts[131]. - Research and development expenses were zero for the three months ended September 30, 2025, compared to $0.4 million in the same period in 2024, due to the suspension of development programs[133]. - Interest expense decreased by $0.5 million, or 48%, to $0.5 million, primarily due to the paydown of fixed payment arrangements[137]. Gains and Collaborations - The company recognized a gain of $3.8 million from derivative warrant liabilities for the three months ended September 30, 2025, compared to $2.9 million in 2024[138]. - The company anticipates launching EXXUA, a new antidepressant, in the second quarter of fiscal 2026, which is expected to be a major growth catalyst[120]. - The company has entered into exclusive collaboration agreements for ADHD products in Israel and Canada, with local partners responsible for regulatory approvals and marketing[123]. Financing Activities - The company filed a shelf registration statement covering the offering of up to $100.0 million of various securities, with $100.0 million remaining available as of the report date[142]. - In June 2025, the company raised gross proceeds of $16.6 million from the issuance of 2,806,688 shares of common stock at $1.50 per share and 8,233,332 prefunded warrants[143]. - Net cash provided by financing activities was $2.3 million for the three months ended September 30, 2025, primarily from $5.8 million of net proceeds from the Eclipse Revolving Loan[151]. Cash Flow and Debt - During the three months ended September 30, 2025, net cash used in operating activities was $0.6 million, an improvement of $572,000 compared to $1.2 million in the same period of 2024[146][148]. - The Eclipse Term Loan has an outstanding principal amount of $13.0 million with an interest rate of SOFR plus 7.0%, maturing on June 12, 2029[145]. - The Eclipse Revolving Loan has a maximum borrowing base of $14.5 million at an interest rate of SOFR plus 4.5%[145]. - The company had no remaining fixed payment arrangement accruals related to the acquisition of pediatric products from Cerecor, Inc. as of September 30, 2025[155]. - The company reported a decrease in accrued liabilities and an increase in accounts receivable, impacting cash flows during the three months ended September 30, 2025[148]. - There was no net cash provided by or used in investing activities during the three months ended September 30, 2025[150]. - The company has not entered into any off-balance sheet arrangements that could materially affect its financial condition[158].

Financial Performance - Total net revenue for Q1 Fiscal 2026 was $13.9 million, down from $16.6 million in Q1 Fiscal 2025, primarily due to a one-time rebate benefit of $3.3 million in the prior year [3]. - Net income increased to $2.0 million, or $0.21 per share, compared to $1.5 million, or $0.24 per share, in Q1 Fiscal 2025 [14]. - Adjusted EBITDA was $(0.6) million, a decrease from $1.9 million in the prior year, impacted by investments for the upcoming EXXUA launch [15]. - ADHD Portfolio net revenue was $13.2 million, down from $15.3 million in Q1 Fiscal 2025; excluding the rebate, it would have increased by 10% [10]. - Pediatric Portfolio net revenue decreased to $0.7 million from $1.3 million, attributed to manufacturing delays and reduced marketing focus [11]. - Gross profit was $9.2 million, representing 66% of net revenue, compared to 72% in the same quarter last year [12]. - Net revenue for the three months ended September 30, 2025, was $13,888 million, a decrease of 16.2% compared to $16,574 million in the same period of 2024 [29]. - Gross profit for the same period was $9,186 million, down from $11,985 million, reflecting a decline of 23.4% [29]. - Total operating expenses decreased to $10,690 million from $12,915 million, a reduction of 17.3% year-over-year [29]. - Net income for the three months ended September 30, 2025, was $1,965 million, compared to $1,474 million in 2024, representing an increase of 33.3% [29]. - Basic net income per share for continuing operations was $0.21, up from $0.18 in the prior year, an increase of 16.7% [29]. - Adjusted EBITDA for the three months ended September 30, 2025, was $(587) million, compared to $1,931 million in the same period of 2024 [33]. - The company reported a derivative warrant liabilities gain of $3,784 million, compared to $2,880 million in the prior year, an increase of 31.4% [29]. Assets and Liabilities - Cash and cash equivalents stood at $32.6 million as of September 30, 2025, an increase from $31.0 million at June 30, 2025 [15]. - Total current assets increased to $81,109 million from $79,179 million, a growth of 2.4% [31]. - Total liabilities decreased from $105,211 million to $101,817 million, a reduction of 3.2% [31]. - Stockholders' equity increased to $23,171 million from $18,966 million, reflecting a growth of 22.2% [31]. Product Launch and Strategy - The launch of EXXUA is on track for the fourth quarter of calendar 2025, targeting the $22 billion U.S. prescription MDD market [4]. - The method of use patent for EXXUA has been extended through September 2, 2030, enhancing the product's market exclusivity [5]. - The company is focused on KOL engagement, sales force training, and integration with the Aytu RxConnect® platform to ensure a successful launch of EXXUA [6].

Core Insights - The company reported total net revenue of $13.9 million and a net income of $2.0 million, equating to $0.21 net income per share basic [1] - Adjusted EBITDA was $(0.6) million, which includes investments related to the launch of EXXUA [1] - The company has a cash balance of $32.6 million as of September 30, 2025 [1] - The launch of EXXUA (gepirone) extended-release tablets is on track for the fourth calendar quarter of 2025, targeting the over $22 billion U.S. prescription major depressive disorder market [1] - A conference call and webcast is scheduled for November 13, 2025, at 4:30 p.m. Eastern time [1]

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.

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]