DENVER, CO / ACCESS Newswire / December 18, 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, will be hosting an Investor Day on Tuesday, January 20, 2026, at 11:00 a.m. Eastern time in New York City. ...

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Financial Performance - Aytu BioPharma reported a quarterly loss of $0.08 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.06, representing an earnings surprise of -33.33% [1] - The company posted revenues of $13.89 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 10.05%, but down from $16.57 million a year ago [2] - Over the last four quarters, Aytu BioPharma has not surpassed consensus EPS estimates and has topped revenue estimates only once [2] Stock Performance - Aytu BioPharma shares have increased by approximately 21.2% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] - The stock currently holds a Zacks Rank 5 (Strong Sell), indicating expectations of underperformance in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.24 on revenues of $13.01 million, and for the current fiscal year, it is -$0.45 on revenues of $52.65 million [7] - The trend of estimate revisions for Aytu BioPharma was unfavorable prior to the earnings release, which may impact future stock movements [6] Industry Context - Aytu BioPharma operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 35% of over 250 Zacks industries [8] - Research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]

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]