Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share AYTU The NASDAQ Stock Market LLC 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 September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition peri ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-38247 AYTU BIOPHARMA, INC. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | --- | --- | |------------------------------------------------------- ...

Financial Data and Key Metrics Changes - Aytu BioPharma achieved record annual revenues of $107.4 million, an 11% increase compared to fiscal 2022 [33] - Gross margins increased to 62% for the year, up from 54% in the previous year [34] - Positive adjusted EBITDA of $3.2 million for the full fiscal year 2023, a significant improvement from a negative $21.5 million in fiscal 2022 [35] Business Line Data and Key Metrics Changes - The Rx segment generated $73.8 million in revenue for fiscal 2023, a 21% increase from $61.1 million in fiscal 2022 [33] - ADHD product revenue increased by 9% to $46.9 million in fiscal 2023, while the pediatric portfolio saw a 58% increase to $25.4 million [33] - Net revenue from the Consumer Health segment decreased by 5% to $33.6 million in fiscal 2023 [33] Market Data and Key Metrics Changes - Net revenue for ADHD products was up 30% for the fourth quarter and up 9% for the fiscal year [14][25] - Pediatric portfolio net revenue increased by 18% for the fourth quarter and 58% for the fiscal year [20][26] - The company experienced a 15% decrease in Consumer Health segment revenue for the fourth quarter compared to the same quarter last year [27] Company Strategy and Development Direction - The company is focusing exclusively on the Rx segment, winding down the Consumer Health segment to improve profitability [10][11] - Aytu BioPharma has suspended its pipeline programs to minimize R&D expenses until it can fund those efforts with internally generated cash flow [9] - The strategic focus on prescription products is expected to lead to company-wide adjusted EBITDA improvement in fiscal 2024 [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of the ADHD market due to stimulant shortages and increased diagnoses [14][43] - The company anticipates some residual write-downs associated with the exit from the Consumer Health segment but expects minimal impact on adjusted EBITDA [12] - Management highlighted the importance of maintaining supply to meet growing demand for ADHD products [14][56] Other Important Information - The company reported a net loss of $2.5 million for the fourth quarter, a significant improvement from a net loss of $16.1 million in the same quarter last year [32] - Cash and cash equivalents were $23 million as of June 30, 2023, compared to $19.2 million on March 31, 2023 [36] - The company is in the process of completing its audit and expects to file its 10-K by the week of October 1st [38] Q&A Session Summary Question: What initiatives will accelerate growth for ADHD and pediatric businesses in fiscal 2024? - Management highlighted ongoing initiatives in sales and marketing, capitalizing on stimulant shortages, and direct marketing to consumers [41][44][46] Question: Can you elaborate on the payer change regarding multivitamins? - Management noted that a specific PBM changed payment structures, but positive payer changes have also occurred, balancing the impact [47][49] Question: How have conversations with payers evolved due to increased prescriptions? - Management indicated that gross-to-net has stabilized and improved, with ongoing discussions with payers being opportunistic [51][52][54] Question: What is the confidence level in obtaining sufficient API for ADHD operations? - Management expressed high confidence in securing API, noting a strong relationship with the DEA and a history of meeting demand [56][59] Question: What impact will the transition away from Consumer Health and R&D have on margins and revenues? - Management stated that removing these segments will lead to a significantly EBITDA positive company focused on the Rx segment [63][64]

Aytu BioPharma, Inc. Nasdaq: AYTU Forward Looking Statements This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will, ...

Aytu BioPharma, Inc. (NASDAQ:AYTU) Q3 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Roger Weiss - Lytham Partners Josh Disbrow - Chief Executive Officer Mark Oki - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Fitzgerald Naz Rahman - Maxim Group, LLC Operator Greetings. Welcome to the Aytu BioPharma Fiscal 2023 Q3 Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note this conference is ...

PART I—FINANCIAL INFORMATION [Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements as of March 31, 2023, highlight a going concern warning Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2023 (in thousands) | June 30, 2022 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,179 | $19,360 | | Total current assets | $78,465 | $59,929 | | Total assets | $147,216 | $137,623 | | **Liabilities & Equity** | | | | Total current liabilities | $85,416 | $64,442 | | Total liabilities | $106,304 | $93,315 | | Total stockholders' equity | $40,912 | $44,308 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Income Statement Item | Three Months Ended Mar 31, 2023 (in thousands) | Nine Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Product revenue, net | $22,733 | $76,667 | | Gross profit | $12,743 | $48,068 | | Loss from operations | $(8,558) | $(17,234) | | Net loss | $(7,200) | $(14,594) | | Basic and diluted net loss per common share | $(1.93) | $(4.71) | - The company's ability to continue as a **going concern is in substantial doubt**, as it did not have sufficient working capital to fund planned operations for the next twelve months as of the filing date[30](index=30&type=chunk)[32](index=32&type=chunk) - The company corrected a prior-period error where certain warrants were incorrectly classified as equity instead of derivative warrant liabilities, with an **immaterial impact**[36](index=36&type=chunk)[37](index=37&type=chunk) [Note 1: Nature of Business, Financial Condition, Basis of Presentation](index=11&type=section&id=1.%20Nature%20of%20Business%2C%20Financial%20Condition%2C%20Basis%20of%20Presentation) The company operates in two segments, has suspended clinical programs, and faces a going concern issue with a **$301.7 million** accumulated deficit - The company operates through two business segments: the **Rx segment** (prescription products) and the **Consumer Health segment**[25](index=25&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - The company has indefinitely suspended active development of its clinical programs, including AR101 (enzastaurin), Healight, and NT0502, to focus on its revenue-generating commercial portfolio[28](index=28&type=chunk) - A **1-for-20 reverse stock split** was effected on January 6, 2023, with all share and per-share amounts adjusted accordingly[26](index=26&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$301.7 million** and used **$14.5 million** in cash from operations, raising substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) [Note 7: Goodwill and Other Intangible Assets](index=25&type=section&id=7.%20Goodwill%20and%20Other%20Intangible%20Assets) The company recorded a **$2.6 million** impairment charge after abandoning the NT0502 product candidate and terminating related license agreements - The company abandoned active development of its NT0502 product candidate, resulting in an **impairment charge of $2.6 million** during the nine months ended March 31, 2023[68](index=68&type=chunk) - The license agreement with Cedars-Sinai Medical Center for the Healight technology platform was also terminated as part of the company's strategic shift away from clinical development[68](index=68&type=chunk) Intangible Assets Summary (as of March 31, 2023) | Intangible Asset Type | Net Carrying Amount (in thousands) | | :--- | :--- | | Definite-lived intangibles | $63,464 | | Indefinite-lived intangibles (IPR&D) | $0 | | **Total** | **$63,464** | [Note 10: Line of Credit](index=31&type=section&id=10.%20Line%20of%20Credit) The company amended its revolving credit facility with Eclipse, increasing the maximum available amount to **$14.5 million** - On March 24, 2023, the company amended its loan agreement with Eclipse, increasing the maximum revolving credit facility to **$14.5 million**[99](index=99&type=chunk) - The revolving loans accrue interest at the one-month SOFR plus 4.50% and the facility matures on January 26, 2025[95](index=95&type=chunk)[96](index=96&type=chunk) - As of March 31, 2023, the company was in **compliance with all covenants** under the Eclipse Loan Agreement[101](index=101&type=chunk) [Note 11: Long-term Debt](index=33&type=section&id=11.%20Long-term%20Debt) The company holds a **$15.0 million** long-term debt facility with Avenue Capital, featuring an extended interest-only payment period - The company has a **$15.0 million** loan with Avenue Capital, maturing in January 2025[104](index=104&type=chunk)[115](index=115&type=chunk) - In October 2022, the interest-only period for the loan was extended to January 2024 in exchange for resetting the exercise price of related warrants to **$8.60 per share**[112](index=112&type=chunk) Long-term Debt Composition (as of March 31, 2023) | Component | Amount (in thousands) | | :--- | :--- | | Long-term debt, due Jan 2025 | $15,000 | | Final payment fee | $638 | | Unamortized discount & costs | $(1,053) | | Financing leases | $106 | | **Total Debt** | **$14,691** | | Less: current portion | $(3,305) | | **Non-current portion of debt** | **$11,386** | [Note 13: Commitments and Contingencies](index=41&type=section&id=13.%20Commitments%20and%20Contingencies) The company faces significant commitments from sales agreements, potential earn-outs, and settled class-action lawsuits - The company has minimum annual unit sales commitments for Karbinal ER through 2025, with a potential make-whole payment capped at **$2.1 million** each year[130](index=130&type=chunk) - Potential earn-out payments related to the Rumpus (AR101) acquisition could total up to **$67.5 million**, contingent on regulatory and commercial milestones[133](index=133&type=chunk) - The Aponowicz and Paguia class-action lawsuits were settled and approved in March 2023, with the company accruing **$0.4 million** for plaintiff attorney fees[134](index=134&type=chunk) [Note 14: Capital Structure](index=43&type=section&id=14.%20Capital%20Structure) The company raised capital through its ATM facility and an underwritten public offering that generated **$10.0 million** in gross proceeds - The company raised approximately **$2.9 million** in net proceeds from its "at-the-market" (ATM) facility during the nine months ended March 31, 2023[136](index=136&type=chunk) - In August 2022, an underwritten public offering of common stock and warrants generated **$10.0 million** in gross proceeds[137](index=137&type=chunk) [Note 19: Segment Reporting](index=51&type=section&id=19.%20Segment%20Reporting) The Rx segment generated **$50.5 million** in revenue and the Consumer Health segment generated **$26.2 million** for the nine-month period Segment Financials for Nine Months Ended March 31, 2023 (in thousands) | Segment | Revenue | Net Loss | | :--- | :--- | :--- | | Rx Segment | $50,486 | $(10,931) | | Consumer Health Segment | $26,181 | $(3,663) | | **Consolidated** | **$76,667** | **$(14,594)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=53&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a strategic shift to commercial focus, cost savings from suspended R&D, and ongoing liquidity management - The company has shifted its strategy to focus on its commercial business and suspended clinical development programs, expected to save over **$20 million** in future study costs[171](index=171&type=chunk) Results of Operations Comparison (in thousands) | Metric | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | Nine Months Ended Mar 31, 2023 | Nine Months Ended Mar 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $22,733 | $24,199 | $76,667 | $69,221 | | Gross profit | $12,743 | $12,686 | $48,068 | $37,441 | | Loss from operations | $(8,558) | $(53,421) | $(17,234) | $(92,966) | | Net loss | $(7,200) | $(53,291) | $(14,594) | $(92,690) | - Net product revenue **decreased 6%** in Q3 2023 vs Q3 2022, but **increased 11%** for the nine-month period, driven by growth in the Pediatric and ADHD portfolios[190](index=190&type=chunk) - Research and development expenses **decreased by 74%** for the quarter and **61%** for the nine-month period year-over-year, reflecting the suspension of clinical programs[192](index=192&type=chunk) - Net cash used in operating activities was **$14.5 million** for the nine months ended March 31, 2023, compared to $21.7 million in the prior-year period[206](index=206&type=chunk)[210](index=210&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=67&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this section is not required and no information is provided - As a smaller reporting company, Aytu BioPharma is **not required to provide** quantitative and qualitative disclosures about market risk[220](index=220&type=chunk) [Controls and Procedures](index=67&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to a material weakness in accounting for complex financial instruments - The CEO and CFO concluded that disclosure controls and procedures were **not effective** as of March 31, 2023[221](index=221&type=chunk) - The ineffectiveness is due to a **material weakness** in internal controls related to the accounting for complex warrants, which were improperly classified as equity instead of liabilities[221](index=221&type=chunk)[222](index=222&type=chunk) - A remediation plan is underway, involving the implementation of enhanced controls for reviewing significant and complex contracts, but the **material weakness is not yet considered remediated**[223](index=223&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=70&type=section&id=Item%201.%20Legal%20Proceedings) The company provides updates on settled class-action suits and other ongoing litigation matters - The Aponowicz and Paguia class-action securities litigations were settled, with court approval in March 2023 and an accrual of **$0.4 million** for plaintiff attorney fees[227](index=227&type=chunk) - The company is a defendant in the Witmer derivative suit, which alleges breaches of fiduciary duties by directors and Armistice Capital in connection with past acquisitions[228](index=228&type=chunk) - The Sabby Litigation involves a dispute with warrantholders over the calculation of the warrant exercise price and the number of shares issuable upon exercise[229](index=229&type=chunk) - The Stein Litigation is an employment-related lawsuit filed by a former territory manager alleging retaliation[230](index=230&type=chunk) [Risk Factors](index=72&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the last Annual Report on Form 10-K - **No material changes** to risk factors have occurred since the fiscal year 2022 Annual Report on Form 10-K was filed on September 27, 2022[232](index=232&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None[232](index=232&type=chunk) [Defaults Upon Senior Securities](index=72&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - None[232](index=232&type=chunk) [Mine Safety Disclosures](index=72&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not Applicable[232](index=232&type=chunk) [Other Information](index=72&type=section&id=Item%205.%20Other%20Information) No other information was required to be reported for the period - None[232](index=232&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed, including loan amendments and Sarbanes-Oxley certifications - Filed exhibits include Amendment No. 4 to the Loan and Security Agreement with Eclipse Business Capital and the Second Amendment to Loan Documents with Avenue Capital[234](index=234&type=chunk) - A Settlement and Termination of License Agreement with TRIS Pharma, Inc. is included as an exhibit[234](index=234&type=chunk) - Certifications by the Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed[234](index=234&type=chunk)

Aytu BioPharma, Inc. (NASDAQ:AYTU) Q2 2023 Earnings Conference Call February 21, 2023 4:30 PM ET Company Participants Roger Weiss - Lytham Partners Josh Disbrow - Chief Executive Officer Mark Oki - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Fitzgerald Vernon Bernardino - H.C. Wainwright Operator Greetings. Welcome to the Aytu BioPharma Fiscal 2023 Q2 Results Conference Call. At this time, all participants are on a listen-only mode. [Operator Instructions]. Please note this co ...

Revenue and Profit - For the three months ended December 31, 2022, net product revenue increased by $3.2 million, or 14%, compared to the same period in 2021, driven primarily by growth in the Pediatric Portfolio [175]. - Gross profit for the three months ended December 31, 2022, was $17.3 million, an increase of $5.0 million, or 41%, compared to the same period in 2021, with gross margin percentage rising to 66% [179]. Expenses and Losses - Research and development expenses decreased by $2.8 million, or 62%, for the three months ended December 31, 2022, due to the suspension of development programs AR101 and Healight [181]. - Operating expenses totaled $24.1 million for the three months ended December 31, 2022, a slight increase of $0.5 million compared to the same period in 2021 [176]. - The company reported a net loss of $6.7 million for the three months ended December 31, 2022, compared to a net loss of $11.5 million in the same period in 2021, reflecting a reduction of $4.9 million [176]. - The company incurred an impairment charge of $2.6 million related to the cessation of active development of the NT0502 product candidate [184]. Future Projections and Savings - The company expects to save over $20 million in projected future study costs over the next three fiscal years due to the suspension of clinical development programs [165]. - The company entered into an agreement to extend the interest-only period of its senior secured loan facility, which is expected to conserve approximately $3.0 million in cash related to principal payments in 2023 [170]. Financial Position and Cash Flow - As of December 31, 2022, the accumulated deficit was $294.5 million, up from $287.1 million as of June 30, 2022 [164]. - Net cash used in operating activities totaled $11.6 million for the six months ended December 31, 2022, a decrease of $1.0 million compared to $12.6 million in the same period of 2021 [193]. - Net cash provided by financing activities was $11.7 million during the six months ended December 31, 2022, primarily from $9.1 million in proceeds from the August 2022 equity raise [196]. - As of December 31, 2022, approximately $82.4 million remains available under the 2021 Shelf registration statement [186]. Obligations and Liabilities - The company has obligations for fixed and contingent milestone payments totaling up to $16.0 million related to the acquisition of Innovus Pharmaceuticals, Inc. [202]. - The company may be required to pay up to $67.5 million in regulatory and commercial-based earn-out payments to Rumpus, contingent on milestone achievements [203]. - The company had $0.4 million accrued for plaintiff's attorney fees related to ongoing class-action securities litigations as of December 31, 2022 [211]. Strategic Initiatives - The company plans to evaluate strategic options for the Healight asset, including potential partnerships and modifications to existing licensing agreements [166]. - The company experienced significant inflationary pressure and supply chain disruptions during fiscal 2022 and 2023, which are expected to continue impacting operations [169]. Amortization and Gains - Amortization expense of intangible assets decreased by $0.3 million (20%) and $0.6 million (21%) for the three and six months ended December 31, 2022, respectively, compared to the same periods in 2021 [185]. - The company recognized an unrealized gain of $1.4 million and $3.6 million from derivative warrant liabilities for the three and six months ended December 31, 2022, respectively [185]. Loan Agreements - The Eclipse Loan Agreement provides up to $12.5 million in Revolving Loans, with a maturity date of January 26, 2025 [190].

Aytu BioPharma, Inc. (NASDAQ:AYTU) Q1 2023 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Roger Weiss - Lytham Partners Josh Disbrow - CEO Mark Oki - CFO Conference Call Participants Jennifer Kim - Cantor Fitzgerald Operator Good afternoon, ladies and gentlemen, and welcome to the Aytu BioPharma Fiscal 2023 Q1 Results Call. At this time, all participants are placed on a listen-only mode and the floor for questions and comments after the presentation. It is now my pleasure to turn ...

Financial Performance - FY 2022 total net revenue increased 47% to $96.7 million from $65.6 million in FY 2021[4] - Rx Segment net revenue was $61.1 million, compared to $32.7 million last year, a growth of 87%[4] - Consumer Health net product revenue was $35.5 million, an increase of 8% compared to $33.0 million in FY 2021[4] - Q4 2022 Rx segment Adjusted EBITDA was a positive $1.1 million, while Consumer Health was a negative $2.1 million[4] - Commercial Operations (excluding Pipeline R&D) Adjusted EBITDA was $(961,000) during Q4 FY 2022[10] Strategic Shift and Cost Reduction - Aytu expects to generate positive quarterly Adjusted EBITDA by the end of FY 2023[4, 10] - A strategic shift to focus on Commercial Operations and indefinitely suspended all clinical development programs is expected to save >$20 million over three years[10] - Manufacturing outsourcing is expected to improve the gross profit margin of ADHD products by 15% or more[30, 50] Market Dynamics and Growth Drivers - Widespread shortages of Adderall XR generics were reported in September & October of 2022, presenting an opportunity for Adzenys XR-ODT[4, 19] - In 2021, approximately 84.8 million prescriptions for medications with ADHD labeling were written in the United States and generated approximately $22.6 billion in sales[19] - Aytu RxConnect drives value with a 49% reduction in patient out-of-pocket expenses, 2X improvement in Aytu margin, and 41% increase in Rx refills[26]