Aytu Biopharma FY Conference Summary Company Overview - **Company**: Aytu Biopharma (NasdaqCM:AYTU) - **Focus**: Launch of Exua, a new antidepressant targeting major depressive disorder (MDD) Key Points Exua Launch and Market Positioning - Exua was discovered at the JPMorgan Healthcare Conference and is positioned as a unique antidepressant that does not fall under the SSRI or SNRI categories, which dominate the market with over 345 million prescriptions annually in the U.S. [3][6] - The drug specifically targets the 5-HT1A serotonin receptors, aiming to reduce common side effects associated with traditional antidepressants, such as sexual dysfunction and weight gain [7][8] - Aytu Biopharma has a sales force of approximately 44 representatives already aligned with psychiatry, facilitating a smooth transition to marketing Exua [9][10] Commercial Strategy - The company has established a focused commercial infrastructure that includes a patient access program called RxConnect, designed to simplify the prescription process for physicians and patients [25][26] - The sales team is fully aligned with high-prescribing psychiatrists, ensuring targeted marketing efforts [11][12] - Aytu aims to position Exua as a second or third-line therapy initially, with potential to move up the treatment hierarchy as familiarity with the drug increases [20][21][22] Financial Performance and Legacy Business - Aytu's legacy business, primarily in ADHD medications, generated approximately $55.5 million over the last 12 months, with stable performance despite a highly genericized market [34][35] - The company also has a smaller pediatric product line generating around $8 million, which is not a focus for resource allocation [36] - Aytu has raised $17 million gross for the Exua launch and ended the last quarter with $32.6 million in cash, indicating no immediate need for additional funding [47][48] Competitive Landscape and Risks - The ADHD market faces generic competition, particularly from Teva, which has launched an authorized generic for Adzenis. However, Aytu's RxConnect program is expected to mitigate the impact of this competition [38][39][40] - The company anticipates that Exua's unique mechanism of action and patient access program will help it capture market share in the antidepressant space, which is significantly larger than the ADHD market [44][46] Future Outlook - Aytu Biopharma is optimistic about Exua's potential to transform the company, with expectations of achieving multiples of its current business revenue [44][46] - The company is focused on maintaining a strong market presence and ensuring that Exua is accessible to patients through its innovative RxConnect program [31][32] Additional Insights - The company emphasizes a strategic focus on psychiatry, avoiding a broad approach to maximize efficiency and effectiveness in marketing [14][15] - Aytu's approach to patient access and cost predictability is designed to alleviate common barriers faced by physicians when prescribing new medications [27][30] This summary encapsulates the key discussions and insights from the Aytu Biopharma FY Conference, highlighting the company's strategic direction, market positioning, and financial outlook.

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.

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on June 5, 2023 Registration No. 333-271556 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-effective Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of incorporation or organization) Delaware 2834 47-0883144 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 373 Inverness Parkway, Suite 206 Engl ...

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on May 1, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aytu Biopharma, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-0883144 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 3 ...