[Cautionary Information Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Information%20Regarding%20Forward-Looking%20Statements) This Annual Report contains forward-looking statements regarding anticipated regulatory events, future financial position, business strategy, and clinical trials, which are subject to various risks, uncertainties, and assumptions - This Annual Report contains forward-looking statements regarding anticipated regulatory events, future financial position, business strategy, and clinical trials, which are subject to various risks, uncertainties, and assumptions[10](index=10&type=chunk) [Summary of Risk Factors](index=4&type=section&id=Summary%20of%20Risk%20Factors) This section provides an overview of the company's key risk factors, including financial, commercialization, intellectual property, and operational challenges [Risks Related to Our Business and Financial Position](index=4&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Financial%20Position) The company has a history of operating losses and no assurance of profitability, requiring additional funding which may not be available on acceptable terms. It faces risks related to debt obligations, potential litigation, and limitations on using net operating loss carryforwards - The company has incurred losses since inception, with a net loss of **$13.6 million** for the year ended June 30, 2025, and an accumulated deficit of **$333.5 million**[17](index=17&type=chunk)[98](index=98&type=chunk)[102](index=102&type=chunk) - The company may need to raise additional funding through public or private equity or debt financings, which could dilute existing stockholders or impose restrictive covenants[17](index=17&type=chunk)[103](index=103&type=chunk)[106](index=106&type=chunk) - As of June 30, 2025, the company had federal net operating loss carryforwards of **$516.7 million**, but previous ownership changes have significantly limited their usability, with **$324.7 million** expected to expire unused by 2037[113](index=113&type=chunk)[114](index=114&type=chunk)[86](index=86&type=chunk) [Risks Related to Commercialization](index=4&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization risks include heavy dependence on product success, difficulty differentiating products from generics, potential delays in product launches, reliance on limited third-party manufacturers, intense competition, and government restrictions on pricing and reimbursement - The company is heavily dependent on the commercial success of its products but has not generated sufficient net revenue to achieve company-wide profitability[17](index=17&type=chunk)[116](index=116&type=chunk) - The company relies on third parties to manufacture its products, introducing risks of costs, delays, and inefficiencies that may prevent successful commercialization[17](index=17&type=chunk)[125](index=125&type=chunk) - Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact the company's ability to generate net revenue[17](index=17&type=chunk)[138](index=138&type=chunk) - Adzenys and Cotempla, classified as Schedule II controlled substances, are subject to extensive regulation by the DEA regarding their manufacture, use, sale, and distribution[17](index=17&type=chunk)[161](index=161&type=chunk) [Risks Related to Our Intellectual Property](index=5&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company faces risks from intellectual property disputes, dependence on license agreements, potential expiration or loss of patent protection, and challenges in enforcing intellectual property rights globally - A dispute concerning the infringement or misappropriation of proprietary rights could be time-consuming and costly, potentially leading to damages or injunctions[18](index=18&type=chunk)[172](index=172&type=chunk) - The company is dependent on license and commercialization agreements, and the expiration or loss of patent protection (e.g., Adzenys patents expire in **2026/2032**, Cotempla in **2032/2038**) may adversely affect future net revenue[18](index=18&type=chunk)[173](index=173&type=chunk)[176](index=176&type=chunk) [Risks Related to Our Organization, Structure and Operations](index=5&type=section&id=Risks%20Related%20to%20Our%20Organization%2C%20Structure%20and%20Operations) Risks include significant investments required for business expansion, difficulties integrating acquired businesses, high customer concentration, dependence on key personnel, and potential product liability lawsuits - Efforts to expand and transform businesses, including acquisitions and partnerships, may require significant investments and could lead to increased financial pressure if unsuccessful[19](index=19&type=chunk)[187](index=187&type=chunk)[189](index=189&type=chunk) - In fiscal 2025, four significant customers accounted for **85% of gross revenue** and **89% of gross accounts receivable**, posing a material adverse effect if any are lost or delay payments[20](index=20&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) [PART I](index=6&type=section&id=PART%20I) This section provides an overview of the company's business, risk factors, properties, and legal proceedings [Business Overview](index=6&type=section&id=Item%201.%20Business) Aytu BioPharma is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system (CNS) diseases, particularly Major Depressive Disorder (MDD) with the upcoming launch of EXXUA, and Attention Deficit Hyperactivity Disorder (ADHD). The company has strategically divested its Consumer Health business and suspended clinical development programs to concentrate on its revenue-generating prescription product portfolios and achieve profitability [Company Overview](index=6&type=section&id=Company%20Overview) Aytu BioPharma focuses on innovative CNS medicines, building a portfolio through in-licensing, acquisition, development, and commercialization, with EXXUA as a key growth driver - Aytu BioPharma, Inc. is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system (CNS) diseases to improve the quality of life for patients[22](index=22&type=chunk) - The company's strategy involves in-licensing, acquiring, developing, and commercializing novel prescription therapeutics to build a portfolio of revenue-generating products[23](index=23&type=chunk) - Aytu anticipates launching EXXUA (gepirone) extended-release tablets for Major Depressive Disorder (MDD) in the **fourth calendar quarter of 2025**, expecting it to be a major growth catalyst[24](index=24&type=chunk) - The company has indefinitely suspended active development of clinical programs and divested unprofitable operations, including the Consumer Health business, to focus on accelerating commercial business growth and achieving positive operating cash flows[25](index=25&type=chunk) - The continuing operations are focused on EXXUA and current prescription pharmaceutical products, primarily the ADHD Portfolio (Adzenys XR-ODT and Cotempla XR-ODT) and the Pediatric Portfolio (Karbinal ER, Poly-Vi-Flor, and Tri-Vi-Flor)[26](index=26&type=chunk) - The company incurred a net loss of **$13.6 million** for the year ended June 30, 2025, and had an accumulated deficit of **$333.5 million**, expecting to become profitable through commercial business growth[27](index=27&type=chunk) [Recent Business Development](index=7&type=section&id=Recent%20Business%20Development) Recent developments include the divestiture of the Consumer Health business, product portfolio revenue, manufacturing transfers, suspension of clinical programs, and ongoing patent litigation - Aytu completed the wind down and divestiture of its Consumer Health business in the **first quarter of fiscal 2025** to prioritize its prescription business[29](index=29&type=chunk) Net Revenue by Product Portfolio (Fiscal Year 2025) | Product Portfolio | Net Revenue (in millions) | | :---------------- | :------------------------ | | ADHD Portfolio | $57.6 | | Pediatric Portfolio | $8.8 | | Total Net Revenue | $66.4 | - The Pediatric Portfolio grew to **$8.8 million** in fiscal 2025, a **20% increase** from fiscal 2024, reflecting positive effects from a recently implemented return-to-growth plan[30](index=30&type=chunk) - Manufacturing of Adzenys and Cotempla was transferred to a United States-based third-party contract manufacturer in **Q4 fiscal 2024** to reduce costs and improve profitability[31](index=31&type=chunk) - The company terminated license agreements for Healight and NT0502 and indefinitely suspended clinical development programs, including AR101, transferring all rights to EnzCo, LLC[32](index=32&type=chunk) - Aytu received a Paragraph IV Certification Notice Letter from Granules Pharmaceuticals, Inc. regarding a generic version of Adzenys, leading to a patent infringement lawsuit filed on **December 11, 2024**, with a trial scheduled for **December 7, 2026**[34](index=34&type=chunk) [Debt and Equity Financings](index=8&type=section&id=Debt%20and%20Equity%20Financings) The company secured recent equity financings totaling $16.6 million gross proceeds and manages debt obligations including a $13.0 million term loan and a $14.5 million revolving loan - In June 2025, Aytu raised gross proceeds of **$16.6 million** (**$14.8 million net**) from the issuance of common stock and prefunded warrants, intended for working capital, general corporate purposes, and EXXUA commercialization[35](index=35&type=chunk) - In June 2024, the exercise of Tranche B Warrants generated **$3.5 million** in proceeds, partially used to repay a **$15.0 million** term loan[36](index=36&type=chunk) - The company has an Eclipse Term Loan with an outstanding principal of **$13.0 million** (SOFR + **7.0%**) and an Eclipse Revolving Loan with a potential maximum borrowing base of **$14.5 million** (SOFR + **4.5%**), both maturing on **June 12, 2029**[38](index=38&type=chunk)[39](index=39&type=chunk) [Commercial Business Overview](index=9&type=section&id=Commercial%20Business%20Overview) Aytu's commercial operations focus on EXXUA for MDD, the ADHD Portfolio (Adzenys XR-ODT, Cotempla XR-ODT), and the Pediatric Portfolio, distributed in the US and internationally - Aytu operates through one business segment, focusing on EXXUA, the ADHD Portfolio, and the Pediatric Portfolio, primarily distributed in the United States through third-party channels[40](index=40&type=chunk)[41](index=41&type=chunk) - EXXUA is a novel first-in-class selective serotonin 5HT1a receptor agonist, FDA-approved for MDD, and is believed to be the only antidepressant acting on serotonin receptors without a sexual dysfunction warning[42](index=42&type=chunk)[24](index=24&type=chunk) - The ADHD Portfolio includes Adzenys XR-ODT and Cotempla XR-ODT, the first and only FDA-approved amphetamine and methylphenidate extended-release, orally disintegrating tablets for ADHD[43](index=43&type=chunk) - The Pediatric Portfolio comprises Karbinal ER (antihistamine) and Poly-Vi-Flor/Tri-Vi-Flor (fluoride-based multivitamin supplements) for infants and children[44](index=44&type=chunk) - The Aytu RxConnect patient support program offers affordable, predictable copays and hassle-free availability for commercially insured patients through a network of over **1,000 pharmacies**[46](index=46&type=chunk) - Aytu has international commercial agreements for Adzenys and Cotempla with Medomie Pharma Ltd (Israel/Palestinian Authority, **July 2023**) and Lupin Pharma Canada Ltd (Canada, **September 2024**)[47](index=47&type=chunk) [Strategy](index=10&type=section&id=Strategy) The company's strategy prioritizes increasing net revenue, enhancing financial performance through operational efficiencies, and portfolio optimization, with a focus on the EXXUA launch and existing product growth - The company's strategic priorities include increasing net revenue, enhancing financial performance through operational and manufacturing efficiencies, and portfolio prioritization[49](index=49&type=chunk) - Key strategic initiatives include successfully launching EXXUA in **Q4 2025**, growing existing commercial products (Adzenys, Cotempla, Karbinal, Poly-Vi-Flor, Tri-Vi-Flor), leveraging the Aytu RxConnect platform, and improving gross margins for the ADHD product franchise through manufacturing transfers[52](index=52&type=chunk) [Products and Markets](index=10&type=section&id=Products%20and%20Markets) Aytu's product portfolio targets the MDD market with EXXUA, the ADHD market with Adzenys and Cotempla, and the pediatric market with Karbinal ER and fluoride-based multivitamin supplements - The United States MDD market is significant, with over **340 million antidepressant prescriptions** written in 2024, but high patient dissatisfaction due to side effects like sexual dysfunction and weight gain[51](index=51&type=chunk)[54](index=54&type=chunk) - EXXUA is a novel first-in-class selective serotonin 5HT1a receptor agonist, FDA-approved for MDD, and is unique as the only antidepressant acting on serotonin receptors without a label warning about sexual dysfunction[53](index=53&type=chunk) - EXXUA demonstrated efficacy in two pivotal Phase 3 trials, with symptom improvement by **week 2-3** and a favorable tolerability profile, avoiding significant sexual dysfunction or weight gain[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - ADHD is a common neurobehavioral disorder, with approximately **104 million prescriptions** for ADHD medications written in the United States in 2024, generating **$28.6 billion** in sales[58](index=58&type=chunk)[59](index=59&type=chunk) - Adzenys and Cotempla are the first and only extended-release orally disintegrating tablets (XR-ODT) for ADHD, offering ease of administration, taste-masking, and prevention of 'cheeking'[61](index=61&type=chunk)[62](index=62&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - Adzenys composition-of-matter patents expire in **2026** and **2032**, with a generic version by Actavis (Teva) approved to launch on **September 1, 2025**[63](index=63&type=chunk)[120](index=120&type=chunk) - Cotempla composition-of-matter patents expire in **2032**, and a method-of-use patent extends protection to **2038**, with a generic version by Teva approved to launch on **July 1, 2026**[68](index=68&type=chunk)[120](index=120&type=chunk) - Karbinal ER is the only FDA-approved, **12-hour** carbinoxamine oral suspension, indicated for various allergic conditions in patients two years and older, positioned as a second-line treatment[70](index=70&type=chunk)[72](index=72&type=chunk) - Poly-Vi-Flor and Tri-Vi-Flor are prescription fluoride-based multivitamin supplements for infants and children with fluoride deficiency, containing proprietary L-methylfolate forms (Metafolin and Arcofolin) for enhanced bioavailability[74](index=74&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk) [Manufacturing](index=15&type=section&id=Manufacturing) Aytu relies on Contract Manufacturing Organizations (CMOs) for product manufacturing and testing, with key supply agreements in place for EXXUA, ADHD, and Pediatric portfolio products - Aytu contracts with CMOs for product manufacturing and testing, overseeing activities with internal technical, manufacturing, and quality experience personnel[80](index=80&type=chunk) - Key supply agreements include Fabre-Kramer for EXXUA (through **September 2028**), a US-based CMO for Adzenys and Cotempla (through **November 2028**), Tris for Karbinal (through **August 2032**), and US-based CMOs for Poly-Vi-Flor and Tri-Vi-Flor[84](index=84&type=chunk) [Research and Development](index=15&type=section&id=Research%20and%20Development) Research and development activities have been indefinitely suspended to reallocate resources towards commercialization efforts, resulting in a significant reduction in R&D spending - Research and development activities have been indefinitely suspended to focus resources on commercialization efforts, leading to a significant decline in R&D spending[81](index=81&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) Aytu actively seeks trademark protection for its brands in the United States and may license intellectual property from third parties to support its product portfolio - Aytu seeks trademark protection in the United States for its brands (e.g., Aytu, EXXUA, Adzenys, Cotempla, Karbinal, Poly-Vi-Flor, Tri-Vi-Flor) and may obtain licenses from third-party intellectual property holders[82](index=82&type=chunk) [Government Regulation](index=15&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA and other agencies, requiring rigorous testing, approval, and post-market compliance, especially for controlled substances like Adzenys and Cotempla - The company is subject to extensive regulation by the FDA and other federal, state, and local agencies, including requirements for testing, development, manufacturing, approval, labeling, and marketing of products[83](index=83&type=chunk) - FDA approval of a New Drug Application (NDA) is required before any new drug can be marketed in the United States, involving preclinical testing, clinical trials (Phase 1, 2, 3), and post-approval regulation[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk)[89](index=89&type=chunk) - Adzenys and Cotempla are regulated as Schedule II controlled substances by the DEA, subjecting their manufacture, use, sale, and distribution to strict requirements, including annual registration and production quotas[88](index=88&type=chunk)[90](index=90&type=chunk) [Human Capital](index=17&type=section&id=Human%20Capital) As of June 30, 2025, Aytu employed 83 individuals, primarily in commercialization, fostering a team-oriented, entrepreneurial culture focused on attracting and retaining diverse talent - As of **June 30, 2025**, Aytu employed **83 individuals** (**82 full-time**), with **52 in commercialization**, **5 in operations**, and **26 in general and administrative activities**, all located in the United States[92](index=92&type=chunk) - The company's values emphasize a team-oriented, hard-working, and entrepreneurial culture, focusing on attracting, retaining, and developing diverse talent through competitive pay, benefits, and engagement[93](index=93&type=chunk) [Available Information](index=17&type=section&id=Available%20Information) Aytu provides free access to its SEC filings, including annual, quarterly, and current reports, on its corporate website - Aytu maintains a website (https://aytubio.com) where its SEC filings, including annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K, are available free of charge[95](index=95&type=chunk) [Code of Ethics](index=17&type=section&id=Code%20of%20Ethics) The company has adopted a written code of ethics applicable to all officers, directors, and employees, publicly available on its corporate governance website - The company has adopted a written code of ethics applicable to officers, directors, and employees, publicly disclosed on its corporate governance website[96](index=96&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) This section details the significant risks facing Aytu BioPharma, including its history of operating losses and uncertainty of future profitability, the need for additional funding, restrictions imposed by debt agreements, and potential limitations on net operating loss carryforwards. It also covers commercialization challenges such as intense competition, reliance on third-party manufacturers, government pricing controls, and the difficulty of differentiating products. Intellectual property risks, organizational challenges, customer concentration, and legal proceedings are also highlighted - The company has incurred significant losses since inception, with a net loss of **$13.6 million** for the year ended June 30, 2025, and an accumulated deficit of **$333.5 million**, with no assurance of future profitability[98](index=98&type=chunk)[102](index=102&type=chunk) - The company may require additional funding through equity or debt financings, which could lead to significant dilution for existing stockholders or impose further restrictive covenants[103](index=103&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - As of June 30, 2025, the company has a **$13.0 million** term loan and up to **$16.0 million** in secured revolving loans, with failure to satisfy obligations potentially leading to acceleration of amounts due and enforcement of security interests[108](index=108&type=chunk)[110](index=110&type=chunk) - The company's ability to use its **$516.7 million** federal net operating loss carryforwards is limited by Section 382 of the IRC due to ownership changes, with **$324.7 million** expected to expire unused by 2037[113](index=113&type=chunk)[114](index=114&type=chunk) - Competition from generic versions of its products, such as Actavis' generic Adzenys (expected **September 1, 2025**) and Teva's generic Cotempla (expected **July 1, 2026**), could materially adversely impact net revenue and profitability[120](index=120&type=chunk) - Reliance on limited single-source suppliers and third-party manufacturers for products like Adzenys and Cotempla poses risks of supply chain disruptions, increased costs, and delays in commercialization[122](index=122&type=chunk)[125](index=125&type=chunk) - Government restrictions on pricing and reimbursement, including the PPACA and Health Care Reconciliation Act, may negatively impact the company's ability to generate net revenue and achieve profitability[138](index=138&type=chunk) - Four customers contributed over **10% of gross revenue** in fiscal 2025, accounting for **85% of gross revenue** and **89% of gross accounts receivable**, creating significant customer concentration risk[193](index=193&type=chunk)[194](index=194&type=chunk) - The company is currently involved in a patent infringement lawsuit against Granules Pharmaceuticals, Inc. regarding a generic version of Adzenys, with a trial scheduled for **December 7, 2026**[34](index=34&type=chunk)[238](index=238&type=chunk) - The company's stock price is highly volatile and may be influenced by numerous factors beyond its control, including product success, regulatory decisions, competition, and general economic conditions[211](index=211&type=chunk) [Unresolved Staff Comments](index=43&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments to report for the fiscal year - No unresolved staff comments were reported[227](index=227&type=chunk) [Cybersecurity](index=44&type=section&id=Item%201C.%20Cybersecurity) Aytu BioPharma relies on internal and third-party IT systems, facing risks from cyber-attacks and data breaches. The company has implemented security measures, including employee training, system monitoring, MFA, cloud-based operations, and adherence to NIST Cybersecurity Framework 2.0. The Board of Directors and Audit Committee oversee cybersecurity risk management, led by the CFO. No material cybersecurity incidents occurred in fiscal 2025 - The company relies on internal and third-party information technology systems and networks, making them vulnerable to damage, disruption, or unauthorized access from cyber-attacks[228](index=228&type=chunk)[229](index=229&type=chunk) - Aytu has implemented various cybersecurity measures, including regular employee training, system monitoring, multi-factor authentication (MFA), cloud-based environments, and external vulnerability assessments[230](index=230&type=chunk) - The Board of Directors, through its Audit Committee, actively oversees cybersecurity risk management, receiving quarterly updates on posture, threats, and incidents[231](index=231&type=chunk) - The Chief Financial Officer leads cybersecurity operations, overseeing strategy, policies, and a team with over **20 years of experience** in the field[232](index=232&type=chunk) - Aytu adheres to the National Institute of Standards and Technology (NIST) Cybersecurity Framework 2.0 and has developed internal policies and a systems disaster recovery plan[233](index=233&type=chunk) - No cybersecurity incidents materially affected the company's business strategy, results of operations, or financial condition during fiscal 2025[234](index=234&type=chunk) [Properties](index=45&type=section&id=Item%202.%20Properties) Aytu BioPharma leases its corporate headquarters in Denver, CO, and an additional office in Berwyn, PA, continuously reviewing and evaluating its property portfolio to optimize business operations Company Properties (as of June 30, 2025) | Location | Type | Purpose | | :---------- | :------ | :------------------ | | Denver, CO | Leased | Corporate headquarters | | Berwyn, PA | Leased | Office | [Legal Proceedings](index=45&type=section&id=Item%203.%20Legal%20Proceedings) Aytu BioPharma is involved in ongoing legal proceedings, including a patent infringement lawsuit against Granules Pharmaceuticals, Inc. regarding a generic version of Adzenys, with a trial scheduled for December 7, 2026. The company was also a nominal plaintiff in the 'Revive Investing' lawsuit, which resulted in a jury verdict of no liability on January 29, 2025, and is currently under appeal - The company filed a patent infringement lawsuit on **December 11, 2024**, against Granules Pharmaceuticals, Inc. concerning a generic version of Adzenys, triggering a **30-month stay** on FDA approval; a trial is scheduled for **December 7, 2026**[238](index=238&type=chunk)[479](index=479&type=chunk) - In the 'Revive Investing' lawsuit, a jury returned a verdict of no liability on **January 29, 2025**, and the plaintiffs filed an appeal on **March 6, 2025**; the outcome is not expected to materially affect the company's financial condition[239](index=239&type=chunk)[480](index=480&type=chunk) [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Aytu BioPharma - This item is not applicable to the company[240](index=240&type=chunk) [PART II](index=46&type=section&id=PART%20II) This section covers the company's common equity market, financial condition, results of operations, market risks, financial statements, and internal controls [Market for Common Equity and Stockholder Matters](index=46&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Aytu BioPharma's common stock trades on Nasdaq under 'AYTU.' As of September 15, 2025, there were 9,911,913 shares outstanding and 183 record holders. The company has an equity compensation plan (2023 Equity Incentive Plan) with 397,409 shares available for future issuance. No dividends have been declared or paid, with current intent to retain earnings for business development - As of **September 15, 2025**, the company had **9,911,913 shares** of common stock outstanding and **183 holders of record**[5](index=5&type=chunk)[242](index=242&type=chunk)[451](index=451&type=chunk) - The company's common stock has been listed on the Nasdaq under the symbol 'AYTU' since **October 20, 2017**[3](index=3&type=chunk)[242](index=242&type=chunk) Equity Compensation Plan Information (as of June 30, 2025) | Category | Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Securities Remaining Available for Issuance under Equity Compensation Plans (Excluding Securities Reflected in Column A) | | :------------------------------------------- | :---------------------------------------------------------------------------------------- | :-------------------------------------------------------------------------- | :--------------------------------------------------------------------------------------------------------------------------------- | | 2023 Equity Incentive Plan (Outstanding stock options) | 211,618 | $4.51 | 397,409 | | 2023 Equity Incentive Plan (Unvested restricted stock) | 32,912 | N/A | | | Equity compensation plans not approved by security holders | 4 | N/A | — | | **Total for all plans** | **244,534** | | **397,409** | - The company has never declared or paid any dividends on its capital stock and intends to retain all available funds and future earnings to fund business development[246](index=246&type=chunk) [Reserved](index=47&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[247](index=247&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Aytu BioPharma's financial performance and condition for the year ended June 30, 2025, compared to 2024. It highlights the company's strategic shift to focus on CNS prescription products, particularly the upcoming EXXUA launch and growth in ADHD and Pediatric portfolios, while divesting non-core assets. Key financial results show a net loss of $13.6 million in fiscal 2025, an increase in total net revenue, but a decrease in gross profit percentage due to higher cost of goods sold. Operating expenses decreased across selling, marketing, general, administrative, and R&D, but impairment expense increased significantly. The company's liquidity is supported by recent equity financings and loan agreements, but it continues to assess the impact of economic uncertainties and new legislation [Objective](index=47&type=section&id=Objective) The MD&A aims to provide relevant information for assessing and understanding the company's results of operations, cash flows, and financial condition for the year ended June 30, 2025 - The Management's Discussion and Analysis (MD&A) aims to provide relevant information for assessing and understanding the company's results of operations and cash flows for the year ended **June 30, 2025**, and its financial condition[248](index=248&type=chunk) [Overview](index=47&type=section&id=Overview) Aytu BioPharma focuses on CNS medicines, building a revenue-generating portfolio, with EXXUA's upcoming launch as a key catalyst in the over $22 billion US MDD market - Aytu BioPharma is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases, aiming to build a portfolio of revenue-generating products through in-licensing, acquiring, developing, and commercializing novel prescription therapeutics[249](index=249&type=chunk) - The company anticipates launching EXXUA for Major Depressive Disorder (MDD) in the **fourth calendar quarter of 2025**, expecting it to be a major growth catalyst in the over **$22 billion** United States prescription MDD market[250](index=250&type=chunk) - The Consumer Health business was divested in the **first quarter of fiscal 2025**, and the company now operates as a single operating and reporting segment focused on prescription pharmaceutical products, including the ADHD and Pediatric Portfolios[251](index=251&type=chunk)[252](index=252&type=chunk) - The company incurred a net loss of **$13.6 million** for the year ended June 30, 2025, and had an accumulated deficit of **$333.5 million**, but expects to become profitable through continued commercial business growth[253](index=253&type=chunk) [Significant Developments](index=48&type=section&id=Significant%20Developments) Significant developments include ongoing inflationary pressures, a patent infringement lawsuit, strong net revenue from ADHD and Pediatric portfolios, manufacturing transfers, suspension of R&D programs, recent equity financing, new loan agreements, and assessment of new legislation - The company continues to experience inflationary pressures, economic uncertainty, and supply chain disruptions due to global geopolitical factors, but has maintained adequate supply for its ADHD and pediatric products[255](index=255&type=chunk) - A patent infringement lawsuit against Granules Pharmaceuticals, Inc. regarding a generic version of Adzenys is ongoing, with a trial scheduled for **December 7, 2026**[256](index=256&type=chunk) - Aytu recorded net revenue of **$66.4 million** for fiscal 2025, with the ADHD Portfolio generating **$57.6 million** and the Pediatric Portfolio growing **20%** to **$8.8 million**[258](index=258&type=chunk) - Manufacturing of Adzenys and Cotempla was transferred to a United States-based third-party manufacturer in **Q4 fiscal 2024** to reduce costs[259](index=259&type=chunk) - The company indefinitely suspended clinical development programs, including AR101, and terminated related license agreements to focus on revenue-generating products and profitability[260](index=260&type=chunk) - In June 2025, the company raised **$14.8 million** in net proceeds from a public offering of common stock and prefunded warrants, intended for working capital and EXXUA commercialization[261](index=261&type=chunk) - The company has a **$13.0 million** Eclipse Term Loan (SOFR + **7.0%**) and an Eclipse Revolving Loan with a potential maximum borrowing base of **$14.5 million** (SOFR + **4.5%**), both maturing on **June 12, 2029**[264](index=264&type=chunk) - The enactment of the One Big Beautiful Bill Act (OBBBA) on **July 4, 2025**, may adversely affect the company's business, financial condition, and future plans, with an ongoing assessment of its potential impact[265](index=265&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) Aytu's fiscal 2025 results show a net loss of $13.6 million, an increase in net revenue to $66.4 million, but a decrease in gross profit percentage due to higher cost of goods sold. Operating expenses decreased across most categories, except for a significant impairment expense Consolidated Statements of Operations (Year Ended June 30, 2025 vs. 2024) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :----------------------------------------- | :------------------ | :------------------ | :-------------------- | | Net revenue | $66,382 | $65,183 | $1,199 | | Cost of goods sold | $20,551 | $16,129 | $4,422 | | Gross profit | $45,831 | $49,054 | $(3,223) | | Selling and marketing | $20,906 | $22,083 | $(1,177) | | General and administrative | $17,379 | $19,954 | $(2,575) | | Research and development | $1,326 | $2,769 | $(1,443) | | Amortization of intangible assets | $3,683 | $3,683 | $0 | | Restructuring costs | $2,101 | $2,156 | $(55) | | Impairment expense | $8,263 | $0 | $8,263 | | Total operating expenses | $53,658 | $50,645 | $3,013 | | Loss from operations | $(7,827) | $(1,591) | $(6,236) | | Other (expense) income, net | $(512) | $870 | $(1,382) | | Interest expense | $(3,703) | $(5,059) | $1,356 | | Derivative warrant liabilities loss | $(1,703) | $(4,004) | $2,301 | | Loss on extinguishment of debt | $0 | $(594) | $594 | | Loss from continuing operations before income tax expense | $(13,745) | $(10,378) | $(3,367) | | Income tax expense | $(437) | $(2,142) | $1,705 | | Net loss from continuing operations | $(14,182) | $(12,520) | $(1,662) | | Net income (loss) from discontinued operations, net of tax | $620 | $(3,324) | $3,944 | | **Net loss** | **$(13,562)** | **$(15,844)** | **$2,282** | | Basic and diluted - net loss per share | $(2.16) | $(2.86) | $0.70 | Net Revenue by Product Portfolio (Year Ended June 30, 2025 vs. 2024) | Product Portfolio | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :---------------- | :------------------ | :------------------ | :-------------------- | | ADHD Portfolio | $57,576 | $57,784 | $(208) | | Pediatric Portfolio | $8,769 | $7,280 | $1,489 | | Other | $37 | $119 | $(82) | | **Total net revenue** | **$66,382** | **$65,183** | **$1,199** | - Gross profit decreased by **$3.2 million** (**7%**) in fiscal 2025, with the gross profit percentage falling to **69%** from **75%** in fiscal 2024, primarily due to increased cost of goods sold for ADHD Portfolio inventory[268](index=268&type=chunk) - Selling and marketing expense decreased by **$1.2 million** (**5%**) in fiscal 2025, but is expected to increase in fiscal 2026 due to the anticipated EXXUA launch[269](index=269&type=chunk) - General and administrative expense decreased by **$2.6 million** (**13%**) in fiscal 2025 due to cost reduction efforts, but is expected to increase in fiscal 2026 due to EXXUA launch support[270](index=270&type=chunk) - Research and development expense decreased by **$1.4 million** (**52%**) in fiscal 2025 due to the suspension of development programs, with further slight decreases expected[271](index=271&type=chunk) - Impairment expense of **$8.3 million** was recognized in fiscal 2025, primarily due to the increased focus on EXXUA and the ADHD Portfolio[274](index=274&type=chunk) - Interest expense decreased by **$1.4 million** (**27%**) in fiscal 2025, mainly due to the extinguishment of a **$15.0 million** term loan and more favorable terms on the new **$13.0 million** Eclipse Term Loan[277](index=277&type=chunk) - A derivative warrant liabilities loss of **$1.7 million** was recognized in fiscal 2025, driven by an increase in the fair value of June 2025 Prefunded Warrants, partially offset by a decrease in other warrants' fair value[278](index=278&type=chunk) - Income tax expense from continuing operations was **$0.4 million** in fiscal 2025, compared to **$2.1 million** in fiscal 2024, primarily driven by Section 382 limitations on net operating loss utilization[280](index=280&type=chunk) - Net income from discontinued operations was **$0.6 million** in fiscal 2025, compared to a net loss of **$3.3 million** in fiscal 2024, related to the wind down and divestiture of the Consumer Health business[281](index=281&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) Aytu's liquidity is supported by recent equity financings and loan agreements, with net cash provided by financing activities totaling $15.4 million in fiscal 2025, despite net cash used in operating and investing activities Consolidated Statements of Cash Flows (Year Ended June 30, 2025 vs. 2024) | Cash Flow Activity (in thousands) | 2025 | 2024 | | :------------------------------------------ | :-------- | :-------- | | Net cash used in operating activities | $(1,937) | $(1,388) | | Net cash used in investing activities | $(2,560) | $(329) | | Net cash provided by (used in) financing activities | $15,443 | $(1,262) | | **Net change in cash and cash equivalents** | **$10,946** | **$(2,979)** | | Cash and cash equivalents at beginning of period | $20,006 | $22,985 | | **Cash and cash equivalents at end of period** | **$30,952** | **$20,006** | - Net cash used in operating activities totaled **$1.9 million** in fiscal 2025, primarily due to increases in accounts receivable and prepaid expenses, partially offset by positive cash earnings[284](index=284&type=chunk) - Net cash used in investing activities was **$2.6 million** in fiscal 2025, primarily from a **$3.0 million** cash payment for acquired intangible assets related to the EXXUA Commercialization Agreement[287](index=287&type=chunk) - Net cash provided by financing activities was **$15.4 million** in fiscal 2025, primarily from **$14.8 million** in net proceeds from equity offerings and **$6.7 million** from the Eclipse Revolving Loan[288](index=288&type=chunk) - The company finances operations through common stock and warrant sales, borrowings under its revolving credit facility, and cash generated from operations[290](index=290&type=chunk) - A shelf registration statement on Form S-3, effective **October 15, 2024**, covers up to **$100.0 million** in securities, with the full amount remaining available[291](index=291&type=chunk) - In June 2025, the company raised **$14.8 million** in net proceeds from a public offering of common stock and prefunded warrants, intended for working capital and EXXUA commercialization[292](index=292&type=chunk) - The company has a **$13.0 million** Eclipse Term Loan (SOFR + **7.0%**) and an Eclipse Revolving Loan with a potential maximum borrowing base of **$14.5 million** (SOFR + **4.5%**), both maturing on **June 12, 2029**[294](index=294&type=chunk) - Contractual obligations include loan agreements, milestone payments for licensed products, and manufacturing purchase commitments[295](index=295&type=chunk) - A **$3.1 million** settlement liability related to the termination of the Tuzistra License Agreement was paid in full during the **first quarter of fiscal 2026**[296](index=296&type=chunk) - The AR101 Rumpus Asset Purchase Agreement was terminated on **August 5, 2025**, transferring all rights to EnzCo, with no remaining obligations or penalties[298](index=298&type=chunk) [Critical Accounting Estimates](index=55&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates involve significant judgment in revenue recognition for 'Gross to Net' adjustments, annual impairment assessments of long-lived assets, and fair value measurement of liability classified warrants - Revenue recognition involves significant judgment in estimating 'Gross to Net' adjustments for product sales, considering legal interpretations, historical experience, payor channel mix, and inventory levels[303](index=303&type=chunk)[304](index=304&type=chunk) - The company assesses impairment of long-lived assets annually and when circumstances indicate carrying value may not be recoverable, leading to an **$8.3 million** impairment charge in fiscal 2025 due to shifted commercial focus[306](index=306&type=chunk)[307](index=307&type=chunk) - Liability classified warrants are carried at fair value using Black-Scholes or Monte Carlo models, with changes in fair value recorded as a gain or loss[309](index=309&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Aytu BioPharma is not required to provide information under this item - The company is not required to provide information under this item as it is a smaller reporting company[310](index=310&type=chunk) [Financial Statements and Supplementary Data](index=58&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements of Aytu BioPharma, Inc. and its subsidiaries for the fiscal years ended June 30, 2025, and 2024, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Stockholders' Equity, Cash Flows, and accompanying Notes. It also includes critical audit matters related to variable consideration and significant accounting policies - Grant Thornton LLP audited the consolidated financial statements for the periods ended **June 30, 2025**, and **2024**, and issued an unqualified opinion[315](index=315&type=chunk) - A critical audit matter identified was the variable consideration related to certain gross to net adjustments, particularly for the ADHD Portfolio savings offers, due to inherent limitations in management's visibility into source data and reliance on external data[321](index=321&type=chunk)[322](index=322&type=chunk) Consolidated Balance Sheets (as of June 30, 2025 and 2024) | ASSETS (in thousands) | 2025 | 2024 | | :------------------------------------ | :------ | :------ | | Cash and cash equivalents | $30,952 | $20,006 | | Accounts receivable, net | $31,155 | $23,526 | | Inventories | $11,434 | $12,141 | | Prepaid expenses and other current assets | $5,638 | $5,097 | | Current assets of discontinued operations | $0 | $1,121 | | **Total current assets** | **$79,179** | **$61,891** | | Property and equipment, net | $532 | $693 | | Operating lease right-of-use assets | $1,061 | $829 | | Intangible assets, net | $42,201 | $52,453 | | Other non-current assets | $1,204 | $2,185 | | Non-current assets of discontinued operations | $0 | $44 | | **Total non-current assets** | **$44,998** | **$56,204** | | **Total assets** | **$124,177** | **$118,095** | | LIABILITIES (in thousands) | 2025 | 2024 | | Accounts payable | $10,601 | $10,314 | | Accrued liabilities | $38,164 | $38,143 | | Revolving credit facility | $9,063 | $2,395 | | Current portion of debt | $1,857 | $1,857 | | Other current liabilities | $3,379 | $8,962 | | Current liabilities of discontinued operations | $0 | $557 | | **Total current liabilities** | **$63,064** | **$62,228** | | Debt, net of current portion | $10,895 | $10,877 | | Derivative warrant liabilities | $26,334 | $12,745 | | Other non-current liabilities | $4,918 | $4,529 | | **Total non-current liabilities** | **$42,147** | **$28,151** | | STOCKHOLDERS' EQUITY (in thousands) | 2025 | 2024 | | Common stock | $1 | $1 | | Additional paid-in capital | $352,500 | $347,688 | | Accumulated deficit | $(333,535) | $(319,973) | | **Total stockholders' equity** | **$18,966** | **$27,716** | | **Total liabilities and stockholders' equity** | **$124,177** | **$118,095** | Consolidated Statements of Operations (Year Ended June 30, 2025 vs. 2024) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :----------------------------------------- | :------------------ | :------------------ | | Net revenue | $66,382 | $65,183 | | Cost of goods sold | $20,551 | $16,129 | | Gross profit | $45,831 | $49,054 | | Operating expenses: | | | | Selling and marketing | $20,906 | $22,083 | | General and administrative | $17,379 | $19,954 | | Research and development | $1,326 | $2,769 | | Amortization of intangible assets | $3,683 | $3,683 | | Restructuring costs | $2,101 | $2,156 | | Impairment expense | $8,263 | $0 | | Total operating expenses | $53,658 | $50,645 | | Loss from operations | $(7,827) | $(1,591) | | Other (expense) income, net | $(512) | $870 |\ | Interest expense | $(3,703) | $(5,059) | | Derivative warrant liabilities loss | $(1,703) | $(4,004) | | Loss on extinguishment of debt | $0 | $(594) | | Loss from continuing operations before income tax expense | $(13,745) | $(10,378) | | Income tax expense | $(437) | $(2,142) | | Net loss from continuing operations | $(14,182) | $(12,520) | | Net income (loss) from discontinued operations, net of tax | $620 | $(3,324) | | **Net loss** | **$(13,562)** | **$(15,844)** | | Basic and diluted - net loss per share | $(2.16) | $(2.86) | Consolidated Statements of Cash Flows (Year Ended June 30, 2025 vs. 2024) | Cash Flow Activity (in thousands) | 2025 | 2024 | | :------------------------------------------ | :-------- | :-------- | | Net cash used in operating activities | $(1,937) | $(1,388) | | Net cash used in investing activities | $(2,560) | $(329) | | Net cash provided by (used in) financing activities | $15,443 | $(1,262) | | **Net change in cash and cash equivalents** | **$10,946** | **$(2,979)** | | Cash and cash equivalents at beginning of period | $20,006 | $22,985 | | **Cash and cash equivalents at end of period** | **$30,952** | **$20,006** | - The company's continuing operations now operate in a single operating and reportable segment following the divestiture of the Consumer Health business on **July 31, 2024**[338](index=338&type=chunk)[373](index=373&type=chunk) - The company is subject to credit risk from accounts receivable, with four large wholesale distributors accounting for **85% of gross revenue** and **89% of gross accounts receivable** in fiscal 2025[361](index=361&type=chunk)[363](index=363&type=chunk) Intangible Assets (as of June 30, 2025) | Asset Type | Gross Carrying Amount (in thousands) | Accumulated Amortization (in thousands) | Net Carrying Amount (in thousands) | Weighted Average Remaining Life (in years) | | :------------------------ | :----------------------------------- | :-------------------------------------- | :--------------------------------- | :----------------------------------------- | | Product technology rights | $22,200 | $(5,592) | $16,608 | 12.7 | | Technology rights | $30,200 | $(7,607) | $22,593 | 12.7 | | Commercialization rights | $3,000 | $0 | $3,000 | N/A (expected to be 12.7 upon launch) | | **Total** | **$55,400** | **$(13,199)** | **$42,201** | **12.7** | - The company recorded a full impairment of Karbinal (**$2.7 million**) and Poly-Vi-Flor/Tri-Vi-Flor (**$5.6 million**) intangible assets in **June 2025** due to a shifted focus on EXXUA and the ADHD Portfolio[401](index=401&type=chunk)[402](index=402&type=chunk) - As of **June 30, 2025**, the company had federal net operating losses of **$516.7 million**, with **$190.0 million** carried forward indefinitely and **$324.7 million** expected to expire by 2037 due to Section 382 limitations[439](index=439&type=chunk) - As of **June 30, 2025**, the company had **14,130,669 warrants** and prefunded warrants outstanding, with **10,293,983** being prefunded warrants with no expiration date[464](index=464&type=chunk)[469](index=469&type=chunk) - The company incurred **$2.1 million** in restructuring costs in fiscal 2025, primarily related to the closure of its Grand Prairie, Texas manufacturing site, and does not anticipate additional significant restructuring costs[472](index=472&type=chunk) - The EXXUA Commercialization Agreement includes an upfront cash payment of **$3.0 million**, a second **$3.0 million** payment (potentially **$5.0 million** if sales exceed **$35.0 million**) within **45 days** of the one-year anniversary of launch, and milestone payments ranging from **$5.0 million** to over **$100.0 million** based on sales[473](index=473&type=chunk) - The AR101 Rumpus Asset Purchase Agreement was terminated on **August 5, 2025**, transferring all rights to EnzCo, with no remaining obligations or penalties[487](index=487&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=98&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure for the fiscal year - No changes in or disagreements with accountants on accounting and financial disclosure were reported[489](index=489&type=chunk) [Controls and Procedures](index=98&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were effective at reasonable assurance levels. The company acknowledges inherent limitations in internal control systems but reports no material changes in internal control over financial reporting during Q4 fiscal 2025 - Management concluded that disclosure controls and procedures were effective as of **June 30, 2025**, at reasonable assurance levels[491](index=491&type=chunk) - No changes to internal control over financial reporting occurred during the **fourth quarter of fiscal 2025** that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[493](index=493&type=chunk) [Other Information](index=99&type=section&id=Item%209B.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 - No directors or executive officers adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the quarter ended **June 30, 2025**[499](index=499&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=99&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to Aytu BioPharma - This item is not applicable[500](index=500&type=chunk) [PART III](index=100&type=section&id=PART%20III) This section incorporates by reference information regarding directors, executive compensation, security ownership, related transactions, and principal accountant fees from the company's proxy statement [Directors, Executive Officers and Corporate Governance](index=100&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required for this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A for the 2026 annual meeting of stockholders - Information required by this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A relating to its **2026 annual meeting of stockholders**[503](index=503&type=chunk) [Executive Compensation](index=100&type=section&id=Item%2011.%20Executive%20Compensation) Information required for this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A for the 2026 annual meeting of stockholders - Information required by this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A relating to its **2026 annual meeting of stockholders**[504](index=504&type=chunk) [Security Ownership and Related Stockholder Matters](index=100&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required for this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A for the 2026 annual meeting of stockholders - Information required by this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A relating to its **2026 annual meeting of stockholders**[505](index=505&type=chunk) [Certain Relationships, Related Transactions, and Director Independence](index=100&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information required for this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A for the 2026 annual meeting of stockholders - Information required by this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A relating to its **2026 annual meeting of stockholders**[506](index=506&type=chunk) [Principal Accountant Fees and Services](index=100&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information required for this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A for the 2026 annual meeting of stockholders - Information required by this item is incorporated by reference from the company's Definitive Proxy Statement on Schedule 14A relating to its **2026 annual meeting of stockholders**[507](index=507&type=chunk) [PART IV](index=101&type=section&id=PART%20IV) This section details the financial statements, supplementary data, and a comprehensive list of exhibits filed as part of the Annual Report [Exhibits and Financial Statement Schedules](index=101&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements filed as part of the Annual Report, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Stockholders' Equity, Cash Flows, and accompanying Notes. It also provides a comprehensive list of exhibits, including merger agreements, certificates of incorporation, loan and security agreements, and equity incentive plans - The section includes the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Stockholders' Equity, Cash Flows, and Notes to the Consolidated Financial Statements[510](index=510&type=chunk) - A comprehensive list of exhibits is provided, detailing various agreements and corporate documents, including merger agreements, certificates of incorporation, loan and security agreements, and equity incentive plans[511](index=511&type=chunk)[512](index=512&type=chunk)[513](index=513&type=chunk)[514](index=514&type=chunk)[515](index=515&type=chunk) [Form 10–K Summary](index=105&type=section&id=Item%2016.%20Form%2010%E2%80%93K%20Summary) This item is not applicable to Aytu BioPharma - This item is not applicable[517](index=517&type=chunk) [Signatures](index=106&type=section&id=SIGNATURES) The report is formally signed by the Chief Executive Officer, Chief Financial Officer, and other directors on September 23, 2025 - The report is signed by Joshua R. Disbrow, Chief Executive Officer, and Ryan J. Selhorn, Chief Financial Officer, along with other directors, on **September 23, 2025**[521](index=521&type=chunk)[523](index=523&type=chunk)

[Executive Summary & Business Outlook](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Outlook) Aytu BioPharma reported fiscal 2025 results, detailed EXXUA launch plans, and discussed strategic direction [Full Year Fiscal 2025 Highlights](index=1&type=section&id=Full%20Year%20Fiscal%202025%20Highlights) FY2025 net revenue increased 2% to $66.4 million, with a net loss of $13.6 million and $9.2 million adjusted EBITDA Full Year Fiscal 2025 Key Financial Highlights | Metric | FY2025 | FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Revenue | $66.4 million | $65.2 million | +2% | | ADHD Portfolio Net Revenue | $57.6 million | $57.8 million | -0.3% | | Pediatric Portfolio Net Revenue | $8.8 million | $7.3 million | +20.5% | | Net Loss | $(13.6) million | $(15.8) million | Improved | | Adjusted EBITDA | $9.2 million | $10.8 million | -14.8% | | Cash & Cash Equivalents (June 30, 2025) | $31.0 million | N/A | N/A | [Q4 Fiscal 2025 Highlights](index=1&type=section&id=Q4%20Fiscal%202025%20Highlights) Q4 FY2025 net revenue grew 4% to $15.1 million, with a net loss of $19.8 million and $2.0 million adjusted EBITDA Q4 Fiscal 2025 Key Financial Highlights | Metric | Q4 FY2025 | Q4 FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Revenue | $15.1 million | $14.6 million | +4% | | ADHD Portfolio Net Revenue | $13.1 million | $13.8 million | -5.1% | | Pediatric Portfolio Net Revenue | $2.0 million | $0.8 million | +150% | | Net Loss | $(19.8) million | $(4.6) million | Worsened | | Adjusted EBITDA | $2.0 million | $2.0 million | 0% | [EXXUA Commercial Launch Update](index=2&type=section&id=EXXUA%20Calendar%20Fourth%20Quarter%202025%20Commercial%20Launch%20Remains%20on%20Track) EXXUA launch is on track for Q4 calendar 2025, targeting the significant U.S. MDD market - EXXUA launch is on track for Q4 calendar 2025, expected to be a major growth catalyst in the over **$22 billion** U.S. MDD market[1](index=1&type=chunk)[5](index=5&type=chunk) - Key launch activities include finalizing product manufacturing, labeling, serialization, engaging key opinion leaders, refining sales territories and physician targeting, preparing promotional materials, and assessing commercial and government payors[6](index=6&type=chunk)[9](index=9&type=chunk) [Management Discussion](index=2&type=section&id=Management%20Discussion) CEO highlighted EXXUA's strategic fit, portfolio stability, and 9th consecutive quarter of positive adjusted EBITDA - EXXUA is a "perfect strategic fit" and will be a "centerpiece of Aytu's commercial efforts" due to its significant potential, uniqueness, sales force's CNS focus, and alignment with the Aytu RxConnect platform[7](index=7&type=chunk) - The company achieved its **9th consecutive quarter of positive adjusted EBITDA**, demonstrating stability in existing ADHD and Pediatric portfolios and focus on operational efficiencies[7](index=7&type=chunk) [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) Detailed analysis of net revenue by product portfolio and comprehensive financial results for FY2025 and Q4 [Net Revenue by Product Portfolio](index=2&type=section&id=Net%20Revenue%20by%20Product%20Portfolio) Detailed breakdown of net revenue contributions from ADHD and Pediatric portfolios for Q4 and full fiscal year 2025 Net Revenue by Product Portfolio (in thousands) | Portfolio | Q4 FY2025 (in thousands) | Q4 FY2024 (in thousands) | FY2025 (in thousands) | FY2024 (in thousands) | | :---------------- | :----------------------- | :----------------------- | :-------------------- | :-------------------- | | ADHD Portfolio | $13,107 | $13,758 | $57,576 | $57,784 | | Pediatric Portfolio | $2,017 | $841 | $8,769 | $7,280 | | Other | $11 | $(6) | $37 | $119 | | **Total Net Revenue** | **$15,135** | **$14,593** | **$66,382** | **$65,183** | [Full Year Fiscal 2025 Financial Results](index=3&type=section&id=Full%20Year%20Fiscal%202025%20Financial%20Results) FY2025 net revenue increased 2% to $66.4 million, with gross profit decline and improved net loss despite impairments - Net revenue increased **2% to $66.4 million**, driven by Pediatric Portfolio growth (**49% increase in units sold**) offsetting a slight decrease in ADHD prescriptions[10](index=10&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - Gross profit percentage decreased from **75% to 69%** due to increased cost of sales in ADHD inventory, attributed to overhead allocation from a closed manufacturing facility to reduced production, which is expected to normalize[13](index=13&type=chunk) - Operating expenses (excluding amortization, restructuring, impairment) decreased by **$5.2 million to $39.6 million**, reflecting continued cost reduction and operational efficiencies[14](index=14&type=chunk) Full Year Fiscal 2025 Key Financial Results | Metric | FY2025 | FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Loss | $(13.6) million | $(15.8) million | Improved | | Net Loss per Share (Basic & Diluted) | $(2.16) | $(2.86) | Improved | | Adjusted EBITDA | $9.2 million | $10.8 million | -14.8% | | Cash and Cash Equivalents (June 30) | $31.0 million | $20.0 million | +55% | - Net loss was impacted by **$8.3 million impairment expense** on the Pediatric Portfolio due to shifted focus to psychiatric products and EXXUA launch, **$1.7 million derivative warrant liabilities loss**, and **$2.1 million restructuring costs** related to the Grand Prairie facility closure[16](index=16&type=chunk) [Q4 Fiscal 2025 Financial Results](index=4&type=section&id=Q4%20Fiscal%202025%20Financial%20Results) Q4 net revenue grew 4% to $15.1 million, with gross profit decline and widened net loss due to impairment and liabilities - Q4 net revenue increased **4% to $15.1 million**, driven by the Pediatric Portfolio's return-to-growth plan, while ADHD portfolio revenue decreased due to fewer prescriptions[18](index=18&type=chunk)[19](index=19&type=chunk) - Gross profit percentage decreased from **76% to 68%** in Q4[19](index=19&type=chunk) - Operating expenses (excluding amortization, restructuring, impairment) decreased by **$1.8 million to $8.7 million**, reflecting ongoing cost reduction and operational efficiencies[20](index=20&type=chunk) Q4 Fiscal 2025 Key Financial Results | Metric | Q4 FY2025 | Q4 FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Loss | $(19.8) million | $(4.6) million | Worsened | | Net Loss per Share (Basic & Diluted) | $(2.92) | $(0.82) | Worsened | | Adjusted EBITDA | $2.0 million | $2.0 million | 0% | - Q4 net loss was significantly impacted by **$8.3 million impairment expense** on the Pediatric Portfolio and **$9.9 million derivative warrant liabilities loss**, primarily due to an increase in the fair value of prefunded warrants and the company's stock price[22](index=22&type=chunk) [Corporate Information & Product Details](index=4&type=section&id=Corporate%20Information%20%26%20Product%20Details) Overview of Aytu BioPharma, EXXUA product details, and investor communication information [Conference Call Details](index=4&type=section&id=Conference%20Call%20Details) Details for the fiscal 2025 results conference call and webcast, including replay information - Conference call and webcast held on September 23, 2025, at 4:30 p.m. Eastern time, with replay available until October 7, 2025[24](index=24&type=chunk)[25](index=25&type=chunk) [About Aytu BioPharma](index=5&type=section&id=About%20Aytu%20BioPharma) Aytu BioPharma focuses on innovative CNS medicines, including EXXUA, ADHD, and pediatric products - Aytu BioPharma focuses on advancing innovative medicines for complex central nervous system diseases[1](index=1&type=chunk)[26](index=26&type=chunk) - Key prescription products include EXXUA (MDD), Adzenys XR-ODT and Cotempla XR-ODT (ADHD), and legacy pediatric products[26](index=26&type=chunk) [About EXXUA](index=5&type=section&id=About%20EXXUA) EXXUA is a novel oral selective serotonin 5HT1a receptor agonist for major depressive disorder (MDD) in adults - EXXUA is a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults[27](index=27&type=chunk)[28](index=28&type=chunk) [Indications and Important Safety Information for EXXUA](index=5&type=section&id=INDICATIONS%20and%20IMPORTANT%20SAFETY%20INFORMATION%20for%20EXXUA) EXXUA is indicated for MDD in adults, with warnings for suicidal thoughts and contraindications - EXXUA is indicated for MDD in adults, but not approved for pediatric patients[28](index=28&type=chunk)[29](index=29&type=chunk) - Boxed WARNING: Antidepressants, including EXXUA, increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies, requiring close monitoring[29](index=29&type=chunk) - Contraindications include prolonged QTc interval, use with strong CYP3A4 inhibitors, severe liver problems, and concurrent use with MAOIs[29](index=29&type=chunk)[31](index=31&type=chunk) - Serious side effects may include QT prolongation (irregular heartbeats) and serotonin syndrome when taken with certain other medicines[29](index=29&type=chunk)[30](index=30&type=chunk) [Supplementary Information](index=6&type=section&id=Supplementary%20Information) Details on non-GAAP reconciliation, forward-looking statements, and investor contact information [Adjusted EBITDA Non-GAAP Reconciliation](index=6&type=section&id=Footnote%201) Adjusted EBITDA is a non-GAAP measure used for performance analysis, reconciled to GAAP net loss - Adjusted EBITDA is a non-GAAP financial indicator used to analyze and compare companies based on operating performance, with net loss being the most directly comparable GAAP measure[32](index=32&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) Press release contains forward-looking statements subject to risks and uncertainties detailed in SEC filings - The press release contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially[33](index=33&type=chunk) - Risks include overall financial and operational performance, changes in financial position, market acceptance of products, financing ability, regulatory challenges, and future collaborations[33](index=33&type=chunk) [Contacts for Investors](index=6&type=section&id=Contacts%20for%20Investors) Investor contacts provided for Aytu BioPharma's CFO and Lytham Partners for inquiries - Investor contacts are Ryan Selhorn (CFO, Aytu BioPharma) and Robert Blum (Lytham Partners)[34](index=34&type=chunk) [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) Presentation of Aytu BioPharma's consolidated statements of operations, balance sheets, and EBITDA reconciliation [Consolidated Statements of Operations](index=7&type=section&id=Aytu%20BioPharma,%20Inc.%20Consolidated%20Statements%20of%20Operations) Presents revenues, costs, expenses, and net loss for Q4 and full fiscal year 2025 and 2024 Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Q4 FY2025 | Q4 FY2024 | FY2025 | FY2024 | | :------------------------------------ | :-------- | :-------- | :------- | :------- | | Net revenue | $15,135 | $14,593 | $66,382 | $65,183 | | Cost of goods sold | $4,881 | $3,541 | $20,551 | $16,129 | | Gross profit | $10,254 | $11,052 | $45,831 | $49,054 | | Total operating expenses | $17,877 | $13,325 | $53,658 | $50,645 | | Net loss | $(19,818) | $(4,617) | $(13,562) | $(15,844) | | Basic and diluted - net loss per share | $(2.92) | $(0.82) | $(2.16) | $(2.86) | [Consolidated Balance Sheets](index=8&type=section&id=Aytu%20BioPharma,%20Inc.%20Consolidated%20Balance%20Sheets) Snapshot of assets, liabilities, and equity as of June 30, 2025 and 2024, showing increases in assets and liabilities Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | | :------------------------------------ | :------------ | :------------ | | **ASSETS** | | | | Cash and cash equivalents | $30,952 | $20,006 | | Accounts receivable, net | $31,155 | $23,526 | | Inventories | $11,434 | $12,141 | | Total current assets | $79,179 | $61,891 | | Intangible assets, net | $42,201 | $52,453 | | Total assets | $124,177 | $118,095 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $63,064 | $62,228 | | Derivative warrant liabilities | $26,334 | $12,745 | | Total liabilities | $105,211 | $90,379 | | Total stockholders' equity | $18,966 | $27,716 | | Total liabilities and stockholders' equity | $124,177 | $118,095 | [Reconciliation of Net Loss to Adjusted EBITDA](index=9&type=section&id=Aytu%20BioPharma,%20Inc.%20Reconciliation%20of%20Net%20Loss%20to%20Adjusted%20EBITDA) Reconciliation of GAAP net loss to non-GAAP Adjusted EBITDA for Q4 and full fiscal year 2025 and 2024 Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Metric (in thousands) | Q4 FY2025 | Q4 FY2024 | FY2025 | FY2024 | | :------------------------------------ | :-------- | :-------- | :------- | :------- | | Net loss - GAAP | $(19,818) | $(4,617) | $(13,562) | $(15,844) | | Interest expense | $730 | $1,253 | $3,703 | $5,059 | | Income tax expense | $437 | $841 | $437 | $2,142 | | Depreciation and amortization | $1,278 | $1,398 | $5,191 | $5,910 | | Stock-based compensation expense | $113 | $243 | $576 | $2,374 | | Derivative warrant liabilities loss (gain) | $9,860 | $(1,463) | $1,703 | $4,004 | | Impairment expense | $8,263 | $0 | $8,263 | $0 | | Net (income) loss from discontinued operations, net of tax | $(62) | $1,239 | $(620) | $3,324 | | **Adjusted EBITDA - non-GAAP** | **$2,039** | **$2,029** | **$9,186** | **$10,833** |

Full year fiscal 2025 net revenue of $66.4 million Full year fiscal 2025 net loss of $13.6 million Full year fiscal 2025 adjusted EBITDA1 of $9.2 million $31.0 million cash balance at June 30, 2025 Exclusive agreement in June 2025 to commercialize EXXUAâ"¢ (gepirone) extended-release tablets ("EXXUA") is expected to serve as a major growth catalyst; the Company anticipates launching EXXUA in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts as it enters the over $22 billion Unit ...

Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

DENVER, CO / ACCESS Newswire / September 16, 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 report its operational and financial results for its fiscal 2025 full year and fourth quarter, after the market close on Tuesday, September 23, 2025. The Company has scheduled a conference call and webcast that same day, Tuesday, Septemb ...

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.

Financial Data and Key Metrics Changes - Total revenue grew 32% to $18,500,000 compared to $14,000,000 in the same quarter last year [22] - Net income was $4,000,000, a significant improvement from a net loss of $2,900,000 in the prior year [27] - Adjusted EBITDA increased to $3,900,000 from $900,000 in the previous year [27] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue rose 25% to $15,400,000, driven by improvements in gross to net [22][9] - Pediatric portfolio net revenue increased 77% to $3,100,000, reflecting the success of a return to growth plan [14][22] Market Data and Key Metrics Changes - ADHD prescriptions were approximately 94,000 during the third quarter, indicating a recovery in the stimulant market [10] - The pediatric portfolio saw a sequential revenue increase of 27%, showcasing effective promotional strategies [14][22] Company Strategy and Development Direction - The company has focused on its prescription pharmaceutical business, halting clinical development and selling its consumer health business [7][19] - Future growth is expected to come from leveraging the A2 RxConnect platform and pursuing additional in-licensed or acquired products [9][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining growth in both ADHD and pediatric portfolios, citing effective optimization efforts [35][36] - The company is monitoring macro factors, including potential impacts from political changes regarding fluoride supplementation [50] Other Important Information - The company has achieved three consecutive quarters of positive net income and eight straight quarters of positive adjusted EBITDA [31] - Cash and cash equivalents were $18,200,000, with a focus on managing debt and operational efficiency [28][29] Q&A Session Summary Question: Were there any one-time effects in the ADHD or pediatric business this quarter? - Management confirmed that the growth was organic and driven by optimization efforts, with no one-time effects [34] Question: What are the expectations for the ADHD franchise moving forward? - Management expects continued growth, emphasizing the balance and prioritization across the product portfolio [35][36] Question: What is the potential for the pediatric business? - Management indicated realistic growth expectations but does not foresee reaching a $25,000,000 annual run rate [38][39] Question: What are the main factors affecting business development and valuations? - The main gating factor is finding the right asset that complements the company's capabilities, with valuations currently being higher due to market conditions [40][43] Question: What impact do tariffs have on the company? - Management stated that tariffs have a minimal impact as all ADHD products are manufactured in the US, with only small components sourced internationally [45][46] Question: Can you elaborate on the return to growth plan for the pediatric business? - The plan involved deploying more sales force resources to pediatric targets and improving payer coverage [53][54]

Financial Data and Key Metrics Changes - Total revenue grew 32% to $18,500,000 compared to $14,000,000 in the same quarter last year [22] - Net income was $4,000,000, a significant improvement from a net loss of $2,900,000 in the prior year [6][27] - Basic earnings per share increased to $0.65 from a loss of $0.52 in the same quarter last year [6][27] - Adjusted EBITDA rose to $3,900,000 from $900,000 in the prior year [6][27] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue increased by 25% to $15,400,000 compared to $12,300,000 in Q3 of the previous year [22] - Pediatric portfolio net revenue surged 77% to $3,100,000 from $1,700,000 in the same quarter last year [22][14] Market Data and Key Metrics Changes - ADHD prescriptions were approximately 94,000 during the third quarter, reflecting a return to normalized market conditions following previous shortages [10] - The pediatric business saw a rebound due to a return to growth plan and improved payer coverage [14][15] Company Strategy and Development Direction - The company has focused on its prescription pharmaceutical business, halting clinical development and selling its consumer health business [7] - Future growth is expected to be driven by leveraging the A2 RxConnect platform and pursuing additional in-licensed or acquired products [8][19] - The company aims to maintain a balanced focus on both ADHD and pediatric portfolios for growth [18] Management's Comments on Operating Environment and Future Outlook - Management expressed satisfaction with the operational and financial performance, highlighting the achievement of positive income from operations for the second consecutive quarter [5][6] - The company is optimistic about future growth, particularly in the ADHD and pediatric segments, and is focused on operational efficiencies [18][19] Other Important Information - Gross margin for the third quarter was 69%, down from 74% in the same quarter last year, with expectations for improvement as inventory issues are resolved [22][25] - The company paid down $2,500,000 in long-term debt during the quarter, maintaining compliance with all debt covenants [29] Q&A Session Summary Question: Were there any one-time effects in the ADHD or pediatric business this quarter? - Management confirmed that the growth was organic and driven by optimization efforts, with no one-time effects impacting the numbers [35] Question: What are the expectations for the ADHD franchise moving forward? - Management expects continued growth in the ADHD franchise, supported by optimization efforts and a balanced focus on both ADHD and pediatric products [36][37] Question: What is the potential for the pediatric business? - Management indicated realistic growth expectations but does not foresee returning to a $25,000,000 annual business, aiming for something north of current levels [39][40] Question: What are the main factors affecting business development and asset acquisition? - The main gating factor is finding the right asset that complements the company's capabilities and therapeutic focus, with a preference for commercial-ready products [41][42] Question: What impact do tariffs have on the company? - Management stated that tariffs have a minimal impact as all ADHD products are manufactured in the U.S., with only small components sourced internationally [46][47] Question: Can you elaborate on the return to growth plan for the pediatric business? - The plan involved deploying the sales force against more pediatric targets and expanding coverage through creative contracting with payers [54][56] Question: What is the breakeven revenue number based on current operating expenses? - The breakeven revenue is approximately $15,000,000 on a quarterly basis, with a cash-based breakeven closer to $13,100,000 [61][62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ___________ Commission File Number: 001-38247 AYTU BIOPHARMA, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-0883144 | | --- | ...

[Q3 2025 Highlights & Management Discussion](index=1&type=section&id=Q3%202025%20Highlights) The company reported significant revenue growth and a return to profitability, driven by its strategic focus on the prescription pharmaceutical business Q3 FY2025 Key Financial Metrics | Metric | Q3 FY2025 | Q3 FY2024 | Change | | :--- | :--- | :--- | :--- | | Total Net Revenue | $18.5 million | $14.0 million | +32% | | ADHD Portfolio Revenue | $15.4 million | $12.3 million | +25% | | Pediatric Portfolio Revenue | $3.1 million | $1.7 million | +77% | | Net Income (Loss) | $4.0 million | ($2.9 million) | N/A | | Net Income (Loss) per Share (basic) | $0.65 | ($0.52) | N/A | | Adjusted EBITDA | $3.9 million | $0.9 million | +333% | | Cash and Cash Equivalents | $18.2 million | - | - | - The CEO stated that the **strategic realignment** to focus on the profitable prescription pharmaceutical business is beginning to fully manifest in the company's financial performance[3](index=3&type=chunk) - Aytu is actively pursuing in-licensed or acquired products to leverage its CNS-focused sales team and the **Aytu RxConnect platform**[3](index=3&type=chunk) - The company **reduced company-wide operating expenses by 13%** year-over-year while growing revenue, demonstrating improved operational efficiency[3](index=3&type=chunk) [Q3 2025 Detailed Financial Results](index=2&type=section&id=Q3%202025%20Financial%20Results) Net revenue grew 32% to $18.5 million, and despite a temporary gross margin dip, reduced operating expenses led to a significant operating income turnaround [Revenue by Portfolio](index=2&type=section&id=Revenue%20by%20Portfolio) Total net revenue grew 32% YoY, fueled by strong performance in both the ADHD and Pediatric portfolios Net Revenue by Portfolio (in thousands) | Portfolio | Q3 2025 | Q3 2024 | % Change | | :--- | :--- | :--- | :--- | | ADHD Portfolio | $15,389 | $12,326 | +25% | | Pediatric Portfolio | $3,059 | $1,729 | +77% | | **Total Net Revenue** | **$18,452** | **$14,025** | **+32%** | - ADHD Portfolio growth was primarily driven by **improvements in gross-to-nets** through the Aytu RxConnect platform[7](index=7&type=chunk) - Pediatric Portfolio growth reflects the positive effects from the Company's recently implemented **return-to-growth plan**[8](index=8&type=chunk) [Profitability and Operations](index=2&type=section&id=Profitability%20and%20Operations) Reduced operating expenses and operational efficiencies drove a significant turnaround to operating income despite a temporary gross margin decline - Gross profit margin decreased to **69% from 74% YoY** due to higher cost of sales for ADHD inventory from a now-closed facility, which is expected to normalize[9](index=9&type=chunk) - Operating expenses, excluding amortization and restructuring, were **reduced by 13% YoY to $9.5 million** due to cost reduction efforts and operational efficiencies[10](index=10&type=chunk) Profitability Comparison (in millions) | Metric | Q3 FY2025 | Q3 FY2024 | | :--- | :--- | :--- | | Income from Operations | $2.4 | ($1.6) | | Net Income (Loss) | $4.0 | ($2.9) | [Balance Sheet and Cash Position](index=2&type=section&id=Balance%20Sheet%20and%20Cash%20Position) The company maintained a solid cash position of $18.2 million while actively paying down $2.5 million in debt during the quarter - Cash and cash equivalents were **$18.2 million** at March 31, 2025[13](index=13&type=chunk) - The Company **paid down a combined $2.5 million** in long-term debt and other fixed payment arrangements during the third quarter[13](index=13&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the unaudited consolidated statements of operations and balance sheets, alongside a non-GAAP to GAAP reconciliation [Unaudited Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) The company shifted from a prior-year net loss to a net income of $4.0 million, or $0.21 per diluted share, in Q3 FY2025 Q3 2025 vs Q3 2024 Statement of Operations Highlights (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net revenue | $18,452 | $14,025 | | Gross profit | $12,806 | $10,361 | | Income (loss) from operations | $2,421 | ($1,597) | | Net income (loss) | $3,994 | ($2,887) | | Diluted net income (loss) per share | $0.21 | ($0.52) | [Unaudited Consolidated Balance Sheets](index=6&type=section&id=Unaudited%20Consolidated%20Balance%20Sheets) The balance sheet shows total assets of $124.2 million and an increase in total stockholders' equity to $34.9 million as of March 31, 2025 Balance Sheet Highlights (in thousands) | Line Item | March 31, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $18,173 | $20,006 | | Total current assets | $72,512 | $61,891 | | Total assets | $124,201 | $118,095 | | Total current liabilities | $70,706 | $62,228 | | Total liabilities | $89,303 | $90,379 | | Total stockholders' equity | $34,898 | $27,716 | [Unaudited Reconciliation of Net Income (Loss) to Adjusted EBITDA](index=7&type=section&id=Unaudited%20Reconciliation%20of%20Net%20Income%20(Loss)%20to%20Adjusted%20EBITDA) A reconciliation from GAAP net income of $4.0 million to a non-GAAP Adjusted EBITDA of $3.9 million highlights strong operational performance Reconciliation to Adjusted EBITDA (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net income (loss) - GAAP | $3,994 | ($2,887) | | Adjustments (Net) | ($51) | $3,818 | | **Adjusted EBITDA - non-GAAP** | **$3,943** | **$931** | [Other Information](index=3&type=section&id=Other%20Information) This section provides details on the investor conference call, a corporate overview, and the forward-looking statements disclaimer - The company hosted a conference call and webcast on **May 14, 2025**, to discuss the quarterly results[14](index=14&type=chunk) - Aytu's prescription products include **Adzenys XR-ODT®** and **Cotempla XR-ODT®** for ADHD, **Karbinal® ER** for allergies, and fluoride-based vitamins[16](index=16&type=chunk) - The press release contains **forward-looking statements** that are subject to risks and uncertainties, and readers are referred to the company's SEC filings[17](index=17&type=chunk)