Core Insights - Aytu BioPharma reported net revenue of $15.2 million for Q2 2026, with ADHD portfolio revenue at $13.2 million, reflecting a slight decrease due to a strategic shift towards launching EXUA, the first FDA-approved 5HT1A agonist for treating major depressive disorder (MDD) [12][18] - The commercial launch of EXUA is supported by a targeted marketing strategy, including a strong sales team and the RX Connect platform to ensure patient access and minimize costs [13][19] - Management emphasized a cautious approach towards expanding the salesforce, contingent on achieving profitability and cash flow from EXUA sales [13][22] Financial Performance - Net revenue for the quarter was $15.2 million, down from $16.2 million in the prior year, with ADHD portfolio revenue at $13.2 million compared to $13.8 million [18] - Gross margin decreased to 63.5% due to transition-related expenses, but would have been 67.4% excluding a $600,000 inventory write-down [13][18] - The company reported a net loss of $10.6 million or $1.05 per share, compared to a net income of $0.8 million or $0.13 per share in the prior year [18] Product Launch and Strategy - EXUA was launched with early prescriptions written in 27 states, and over 100 doctors have prescribed it within the first month [12][19] - The RX Connect platform is designed to minimize administrative burdens for patients and prescribers, ensuring predictable coverage for commercially insured patients [13][19] - The marketing strategy includes a mix of personal and non-personal approaches, focusing on high-volume antidepressant prescribers and leveraging insights from the RX Connect platform [19][23] Market Context - Major depressive disorder affects an estimated 21 million US adults, with a significant portion of patients failing to achieve remission with traditional SSRIs and SNRIs [16][19] - The ADHD portfolio continues to perform above expectations despite a slight revenue decrease, attributed to a strategic shift towards EXUA [18][19] - The company has $30 million in cash and cash equivalents, with ongoing investments focused on EXUA's launch [14][18]

Financial Data and Key Metrics Changes - Net revenue for the quarter was $15.2 million, down from $16.2 million in the prior year [20] - ADHD portfolio net revenue was $13.2 million, compared to $13.8 million in the prior year, remaining flat with the previous quarter [20] - Pediatric portfolio revenue increased to $1.7 million from $715,000 in the previous quarter, but down from $2.7 million in the prior year [18][21] - Gross margin decreased to 63.5% from 66.5% year-over-year, primarily due to decreased net revenue and transition-related expenses [22] - The company reported a net loss of $10.6 million, compared to a net income of $0.8 million in the prior year [23] Business Line Data and Key Metrics Changes - The ADHD portfolio is experiencing a slight decrease in revenue due to a shift in marketing focus towards EXXUA and the introduction of generic competition [16][20] - The launch of an authorized generic for Adzenys has limited the impact of Teva's generic competition, with the authorized generic representing just under 20% of total prescriptions [17] - The pediatric portfolio saw a revenue increase due to reduced returns and stabilization of prescriptions, although it remains a non-core focus for the company [18] Market Data and Key Metrics Changes - The early feedback from patients on EXXUA has been positive, with reports of good tolerability and satisfaction [15] - Prescriptions for EXXUA have been written in 27 states, indicating broad market opportunity [14] - The majority of prescriptions are being filled through the RxConnect platform, with a favorable mix towards commercial insurance [48] Company Strategy and Development Direction - The company has launched EXXUA, the first FDA-approved 5-HT1A agonist for major depressive disorder, with a comprehensive commercial launch strategy focused on prescriber adoption and brand growth [4][31] - The marketing strategy includes a mix of personal and non-personal approaches, targeting high-volume antidepressant prescribers [11] - The company plans to maintain a focus on operational efficiency while scaling its promotional investments in line with performance [14][29] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the significant unmet need in the treatment of major depressive disorder, with 50%-60% of patients failing to achieve remission on current therapies [8][9] - The company expects to see a small initial ramp in EXXUA net revenue as it removes early access barriers and guarantees coverage for patients [26][27] - Management is optimistic about the early momentum of EXXUA and the potential for long-term growth, emphasizing the importance of cash flow for future expansion [39][40] Other Important Information - The company incurred a one-time FDA PDUFA fee of $400,000 during the quarter [23] - Adjusted EBITDA was -$0.8 million for the quarter, reflecting increased launch investments and a shift in marketing focus [25] - Cash and cash equivalents were $30 million at the end of the quarter, down from $32.6 million at the end of the previous quarter [25] Q&A Session Summary Question: Feedback from doctors on EXXUA prescriptions - Management noted mixed motivations for physicians to prescribe EXXUA, including interest in its mechanism of action and ease of prescribing through RxConnect [33][34][36] Question: Plans for sales force expansion - Management indicated that expansion would be unlikely in fiscal 2026 without sufficient cash flow and profitability to support it [38][39] Question: Direct-to-consumer campaign details - The campaign will focus on web-based strategies, including search engine optimization and social media, while maintaining compliance with FDA regulations [40][41] Question: Impact of weather on prescriptions - Management confirmed that recent weather events had a significant impact on prescriptions being filled and shipments to pharmacies, but supply issues have been resolved [46][53] Question: Supply ramp-up capabilities - Management assured that adequate supply is available to meet demand, with no issues anticipated in scaling production [53][54]

Financial Data and Key Metrics Changes - Net revenue for the quarter was $15.2 million, down from $16.2 million in the prior year [20] - Gross margin decreased to 63.5% from 66.5% year-over-year, primarily due to decreased net revenue and transition-related expenses [21][22] - The company reported a net loss of $10.6 million, compared to a net income of $0.8 million in the prior year [23] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $13.2 million, a slight decrease from $13.8 million in the prior year and flat compared to the previous quarter [20][16] - Pediatric portfolio revenue increased to $1.7 million from $715,000 in the previous quarter, but down from $2.7 million year-over-year [18][21] Market Data and Key Metrics Changes - Exxua prescriptions have been written in 27 states, with over 100 doctors prescribing it within the first month of launch [14][15] - The majority of prescriptions are being filled through the RxConnect platform, with a favorable mix towards commercial insurance [47] Company Strategy and Development Direction - The company has launched Exxua, the first FDA-approved 5-HT1A agonist for major depressive disorder, focusing on prescriber adoption and brand growth [4][31] - A comprehensive commercial launch strategy includes a motivated sales organization and targeted promotional efforts [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Exxua's market potential and early positive feedback from patients and prescribers [31][15] - The company is focused on maintaining operational efficiency while ramping up Exxua's market presence [29] Other Important Information - The company has a cash balance of $30 million as of December 31, 2025, down from $32.6 million at the end of the previous quarter [25] - The launch investment budget for Exxua has been reduced from $10 million to under $8 million due to execution efficiencies [29] Q&A Session Summary Question: Feedback from doctors prescribing Exxua - Early feedback indicates that physicians are motivated by the unique mechanism of action and the ease of prescribing through RxConnect [33][34] Question: Plans for sales force expansion - Management indicated that expansion would depend on achieving internal forecasts and cash flow, with no immediate plans for expansion in fiscal 2026 [38][39] Question: Direct-to-consumer campaign details - The campaign will focus on web-based strategies, including search engine optimization and social media, while maintaining compliance with regulations [40][41] Question: Impact of weather on prescription fulfillment - Weather has caused delays in prescriptions being filled, but the company has adequate supply to meet demand [46][53]

Financial Data and Key Metrics Changes - Net revenue for Q2 2026 was $15.2 million, down from $16.2 million in the prior year, with ADHD portfolio revenue at $13.2 million compared to $13.8 million last year [19][20] - Gross margin decreased to 63.5% from 66.5% year-over-year, primarily due to decreased net revenue and transition-related expenses [21][22] - The company reported a net loss of $10.6 million or $5 per share, compared to a net income of $0.8 million or $0.13 per share in the prior year [23][24] Business Line Data and Key Metrics Changes - ADHD net revenue was $13.2 million, flat compared to Q1 2026, despite a slight decrease from the previous year, attributed to a shift in marketing focus towards EXXUA [16][19] - Pediatric portfolio revenue increased to $1.7 million from $715,000 in Q1 2026, but decreased from $2.7 million in the prior year [18][20] Market Data and Key Metrics Changes - The launch of EXXUA has seen prescriptions written from 27 states, with over 100 doctors prescribing it within the first month [13][14] - Most prescriptions are being filled through the RxConnect platform, with a significant portion also coming from retail pharmacies [46] Company Strategy and Development Direction - The company is focused on the commercial launch of EXXUA, the first FDA-approved 5-HT1A agonist for major depressive disorder, with a comprehensive strategy aimed at prescriber adoption and brand growth [4][31] - The marketing strategy includes a mix of personal and non-personal approaches, targeting high-volume antidepressant prescribers and leveraging the RxConnect platform for patient access [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early feedback from patients on EXXUA, noting good tolerability and satisfaction [15] - The company anticipates a gradual ramp-up in EXXUA net revenue as initial barriers to access are removed, with expectations for increased prescriptions ahead of revenue recognition [27][30] Other Important Information - The company incurred a one-time FDA PDUFA fee of $400,000 for Cotempla during the quarter [22] - Adjusted EBITDA was -$0.8 million for Q2 2026, down from $1.3 million in the prior year [25] Q&A Session Summary Question: Feedback from doctors prescribing EXXUA - Management noted mixed motivations for early prescriptions, including interest in the mechanism of action and ease of prescribing through RxConnect [33][34] Question: Expectations for sales force expansion - Management indicated that expansion would be unlikely in fiscal 2026, with triggers for expansion tied to achieving internal forecasts and cash flow [37][38] Question: Direct-to-consumer campaign details - The campaign will be web-based, focusing on search engine optimization and social media, while maintaining compliance with FDA regulations [39][40] Question: Impact of weather on prescription filling - Management confirmed significant weather impacts on script filling and shipments, but noted that supply issues have been corrected [44][51]

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]

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]

Aytu BioPharma (AYTU) Conference Call Summary Company Overview - **Company**: Aytu BioPharma - **Product**: ExuA, a novel treatment for Major Depressive Disorder (MDD) - **Market Size**: Over $22 billion in the U.S. depression market with more than 345 million prescriptions annually Key Points and Arguments Commercialization Agreement - Aytu BioPharma has entered an exclusive commercialization agreement with Faber Kramer Pharmaceuticals for ExuA in the U.S. [2][13] - The agreement includes an upfront cash payment of $3 million and additional payments based on sales milestones, potentially exceeding $100 million [42][43] Market Opportunity - The U.S. depression market is significantly larger than the ADHD market, with SSRIs and SNRIs being the most prescribed classes [10][25] - ExuA targets a specific receptor (5-HT1A) and is expected to have fewer side effects compared to traditional antidepressants [18][19] - The market is characterized by high patient switching due to dissatisfaction with current treatments, indicating a strong need for new therapies [12][26] Product Profile - ExuA is a 5-HT1A receptor agonist, distinct from SSRIs and SNRIs, and does not cause sexual dysfunction or weight gain [17][19] - Clinical trials have shown robust efficacy in over 5,000 patients, with significant improvements in both depression and anxiety symptoms [21][22] Launch Strategy - Aytu plans to leverage its existing sales force, which already covers a significant portion of the branded MDD market, to launch ExuA efficiently [32][33] - The launch is targeted for late 2025, with a focus on establishing clinical value and engaging key opinion leaders [35][38] Financial Projections - Aytu anticipates that capturing just 10% of the market share from existing products could yield approximately $25 million in net revenue [48] - The company expects to generate significant revenue in fiscal 2026, with a more pronounced impact in fiscal 2027 [73] Reimbursement Landscape - The MDD market has favorable reimbursement conditions, with government payers required to cover antidepressants [66][67] - Aytu plans to integrate ExuA into its existing patient access program to minimize coverage barriers [37][40] Future Considerations - Aytu is focused on ExuA as its primary product for the near term but is also evaluating opportunities for lifecycle management and potential new psychiatric assets [81][82] - The company has not pursued international markets for ExuA, focusing solely on the U.S. [78] Additional Important Insights - The MDD market is characterized by a high rate of treatment failure, with 40% of patients relapsing after the first line of treatment and up to 71% after multiple lines [62][63] - There is a significant interest from psychiatrists in novel medications that target serotonin pathways, indicating a favorable reception for ExuA [30][31] This summary encapsulates the critical aspects of Aytu BioPharma's conference call regarding the ExuA opportunity, highlighting the company's strategic plans, market potential, and product differentiation in the competitive landscape of depression treatments.