Aytu BioPharma(AYTU)

Search documents
Aytu BioPharma(AYTU) - 2024 Q3 - Quarterly Results
2024-05-15 20:12
Exhibit 99.1 Aytu BioPharma Reports Fiscal 2024 Third Quarter Operational and Financial Results Q3 2024 ADHD Portfolio net revenue up 49% compared to Q3 2023 Q3 2024 adjusted EBITDA1 improved by $7.0 million compared to Q3 2023 TTM March 2024 operating income of $7.3 million for the Rx Business TTM March 2024 companywide adjusted EBITDA of positive $15.4 million TTM March 2024 adjusted EBITDA of positive $17.1 million for the Rx Business $19.8 million cash balance at March 31, 2024 Company to host conferenc ...
Aytu BioPharma(AYTU) - 2024 Q3 - Quarterly Report
2024-05-15 20:11
[Cautionary Information Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20INFORMATION%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines forward-looking statements regarding future events, financial position, business strategy, and operations, subject to risks and uncertainties detailed in SEC filings, with no obligation to update [Forward-Looking Statements Overview](index=3&type=section&id=Forward-Looking%20Statements%20Overview) This section outlines forward-looking statements regarding future events, financial position, business strategy, and operations, subject to risks and uncertainties detailed in SEC filings, with no obligation to update - Report includes forward-looking statements regarding future clinical/regulatory events, financial position, business strategy, and operations[4](index=4&type=chunk) - Forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described in "Risk Factors" in the 2023 Form 10-K[5](index=5&type=chunk) - The company operates in a very competitive and rapidly changing environment, with new risk factors emerging, and actual results could differ materially from those projected[5](index=5&type=chunk) - The company assumes no obligation to update or supplement forward-looking statements, except as may be required under applicable law[5](index=5&type=chunk) [PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part presents the company's unaudited consolidated financial statements and related disclosures for the reporting period [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited consolidated financial statements and notes, detailing financial condition, accounting policies, and key updates, addressing going concern doubts [Unaudited Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Consolidated%20Balance%20Sheets) This section presents the company's unaudited consolidated balance sheets as of March 31, 2024, and June 30, 2023 Unaudited Consolidated Balance Sheets (in thousands) | ASSETS | March 31, 2024 | June 30, 2023 | | :----------------------------------- | :------------- | :------------ | | **Current assets:** | | | | Cash and cash equivalents | $ 19,760 | $ 22,985 | | Accounts receivable, net | 29,925 | 28,937 | | Inventories | 13,193 | 11,995 | | Prepaid expenses | 7,249 | 8,047 | | Other current assets | 1,003 | 868 | | **Total current assets** | **71,130** | **72,832** | | **Non-current assets:** | | | | Property and equipment, net | 967 | 1,815 | | Operating lease right-of-use assets | 1,795 | 2,054 | | Intangible assets, net | 54,082 | 58,970 | | Other non-current assets | 889 | 792 | | **Total non-current assets** | **57,733** | **63,631** | | **Total assets** | **$ 128,863** | **$ 136,463** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | **Current liabilities:** | | | | Accounts payable | $ 10,475 | $ 13,478 | | Accrued liabilities | 44,091 | 46,799 | | Short-term line of credit | 1,581 | 1,563 | | Current portion of debt | 15,135 | 85 | | Current portion of derivative warrant liabilities | 3,261 | — | | Other current liabilities | 9,146 | 7,090 | | **Total current liabilities** | **83,689** | **69,015** | | **Non-current liabilities:** | | | | Debt, net of current portion | — | 14,713 | | Derivative warrant liabilities | 8,609 | 6,403 | | Other non-current liabilities | 5,788 | 6,975 | | **Total non-current liabilities** | **14,397** | **28,091** | | **Total liabilities and stockholders' equity** | **$ 128,863** | **$ 136,463** | [Unaudited Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) This section presents the company's unaudited consolidated statements of operations for the three and nine months ended March 31, 2024, and 2023 Unaudited Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | Net revenue | $ 17,993 | $ 22,733 | $ 63,026 | $ 76,667 | | Cost of sales | 6,300 | 9,990 | 20,346 | 28,599 | | Gross profit | 11,693 | 12,743 | 42,680 | 48,068 | | **Operating expenses:** | | | | | | Selling and marketing | 6,549 | 12,804 | 20,547 | 33,466 | | General and administrative | 5,442 | 7,177 | 17,837 | 22,517 | | Research and development | 619 | 856 | 1,747 | 3,630 | | Amortization of intangible assets | 1,303 | 1,198 | 3,909 | 3,593 | | Restructuring costs | 244 | — | 244 | — | | Impairment expense | — | — | — | 2,600 | | Gain from contingent consideration | — | (734) | — | (504) | | **Total operating expenses** | **14,157** | **21,301** | **44,284** | **65,302** | | Loss from operations | (2,464) | (8,558) | (1,604) | (17,234) | | Other expense, net | (1,195) | (1,215) | (3,083) | (3,527) | | Gain (loss) on derivative warrant liabilities | 1,017 | 2,573 | (5,467) | 6,167 | | Loss before income tax | (2,642) | (7,200) | (10,154) | (14,594) | | Income tax expense | (245) | — | (1,073) | — | | **Net loss** | **$ (2,887)** | **$ (7,200)** | **$ (11,227)** | **$ (14,594)** | | Basic and diluted net loss per common share | $ (0.52) | $ (1.93) | $ (2.04) | $ (4.71) | [Unaudited Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section presents the company's unaudited consolidated statements of stockholders' equity for the nine months ended March 31, 2024, and 2023 Unaudited Consolidated Statements of Stockholders' Equity (in thousands, except share data) | | Common Shares | Stock Amount | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Equity | | :--------------------------------------- | :------------ | :----------- | :------------------------- | :------------------ | :------------------------- | | **Balances, June 30, 2023** | **5,517,174** | **$ 1** | **$ 343,485** | **$ (304,129)** | **$ 39,357** | | Stock-based compensation expense | 13,061 | — | 930 | — | 930 | | Net loss | — | — | — | (8,120) | (8,120) | | **Balances, September 30, 2023** | **5,530,235** | **$ 1** | **$ 344,415** | **$ (312,249)** | **$ 32,167** | | Stock-based compensation expense | 108 | — | 820 | — | 820 | | Issuance of common stock with exercise of warrants | 37,004 | — | 86 | — | 86 | | Net loss | — | — | — | (220) | (220) | | **Balances, December 31, 2023** | **5,567,347** | **$ 1** | **$ 345,321** | **$ (312,469)** | **$ 32,853** | | Stock-based compensation expense | 562 | — | 811 | — | 811 | | Net loss | — | — | — | (2,887) | (2,887) | | **Balances, March 31, 2024** | **5,567,909** | **$ 1** | **$ 346,132** | **$ (315,356)** | **$ 30,777** | Unaudited Consolidated Statements of Stockholders' Equity (in thousands, except share data) - Prior Year | | Shares | Amount | Capital | Deficit | Equity | | :--------------------------------------- | :----------- | :----- | :-------- | :-------- | :------- | | **Balances, June 30, 2022** | **1,928,941** | **$ —** | **$ 331,386** | **$ (287,078)** | **$ 44,308** | | Stock-based compensation expense | (1,666) | — | 1,177 | — | 1,177 | | Issuance of common stock, net of issuance cost | 1,194,196 | — | 3,564 | — | 3,564 | | Net loss | — | — | — | (701) | (701) | | **Balances, September 30, 2022** | **3,121,471** | **$ —** | **$ 336,127** | **$ (287,779)** | **$ 48,348** | | Stock-based compensation expense | (19,228) | — | 3,067 | — | 3,067 | | Issuance of common stock, net of issuance cost | 280,902 | — | 1,095 | — | 1,095 | | Net loss | — | — | — | (6,693) | (6,693) | | **Balances, December 31, 2022** | **3,383,145** | **$ —** | **$ 340,289** | **$ (294,472)** | **$ 45,817** | | Stock-based compensation expense | 8,747 | — | 902 | — | 902 | | Issuance of common stock, net of issuance cost | 387,621 | — | 1,393 | — | 1,393 | | Net loss | — | — | — | (7,200) | (7,200) | | **Balances, March 31, 2023** | **3,779,513** | **$ —** | **$ 342,584** | **$ (301,672)** | **$ 40,912** | [Unaudited Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's unaudited consolidated statements of cash flows for the nine months ended March 31, 2024, and 2023 Unaudited Consolidated Statements of Cash Flows (in thousands) | Cash flows from operating activities: | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :---------------------------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $ (11,227) | $ (14,594) | | Adjustments to reconcile net loss to cash used in operating activities: | | | | Depreciation, amortization and accretion | 6,328 | 6,699 | | Stock-based compensation expense | 2,561 | 5,146 | | Loss (gain) on derivative warrant liabilities | 5,467 | (6,167) | | Amortization of senior debt discount | 463 | 413 | | Inventory write-down | 476 | 199 | | Impairment expense | — | 2,600 | | Gain from contingent consideration | — | (504) | | Other noncash adjustments | (50) | (29) | | Changes in operating assets and liabilities: | | | | Accounts receivable, net | (988) | (12,335) | | Inventories | (1,674) | (2,987) | | Prepaid expenses and other current assets | 863 | (3,603) | | Accounts payable | (2,937) | 3,720 | | Accrued liabilities | (3,774) | 7,031 | | Other operating assets and liabilities, net | 3,892 | (83) | | **Net cash used in operating activities** | **(600)** | **(14,494)** | | **Cash flows from investing activities:** | | | | Other investing activities | (295) | 38 | | **Net cash (used in) provided by investing activities** | **(295)** | **38** | | **Cash flows from financing activities:** | | | | Proceeds from issuance of stock and warrants | 86 | 13,012 | | Net proceeds received from, short-term line of credit | 18 | 6,590 | | Payment made to fixed payment arrangement | (2,204) | (4,117) | | Payment of stock issuance costs | (160) | (1,045) | | Payments made to borrowings | (70) | (73) | | Payment for debt issuance costs | — | (92) | | **Net cash (used in) provided by financing activities** | **(2,330)** | **14,275** | | **Net change in cash and cash equivalents** | **(3,225)** | **(181)** | | Cash and cash equivalents at beginning of period | 22,985 | 19,360 | | **Cash and cash equivalents at end of period** | **$ 19,760** | **$ 19,179** | | **Supplemental disclosure of cash flow information:** | | | | Cash paid for interest | $ 3,164 | $ 2,861 | | Cash paid for income taxes | $ 562 | $ — | | Non-cash investing and financing activities: | | | | Other noncash investing and financing activities | $ 718 | $ — | [Notes to the Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Consolidated%20Financial%20Statements) The notes provide detailed information supporting the unaudited consolidated financial statements, covering the company's business nature, financial condition, significant accounting policies, revenue recognition, asset valuations, liabilities, debt, equity, and commitments. Key updates include the winding down of the Consumer Health Segment, indefinite suspension of clinical development programs, and the reclassification of certain prior year amounts for contingent consideration. The company faces substantial doubt about its ability to continue as a going concern due to the upcoming maturity of the Avenue Note and historical cash consumption, with management focusing on improving cash flows, refinancing debt, and potentially raising additional capital [Note 1 - Nature of Business, Financial Condition, Basis of Presentation](index=8&type=section&id=Note%201%20-%20Nature%20of%20Business%2C%20Financial%20Condition%2C%20Basis%20of%20Presentation) This note describes the company's business, financial condition, and the basis of presentation for the financial statements, including going concern considerations - Aytu BioPharma, Inc. is a pharmaceutical company focused on commercializing novel therapeutics, operating through two segments: Rx Segment (prescription products) and Consumer Health Segment (consumer healthcare products)[21](index=21&type=chunk) - The company's strategy is to build its portfolio of revenue-generating prescription pharmaceutical products and has indefinitely suspended active development of clinical programs (AR101, Healight, NT0502) and is winding down the Consumer Health Segment in fiscal 2024 due to negative cash flows[24](index=24&type=chunk) - As of March 31, 2024, the company had **$19.8 million** in cash and cash equivalents and **$29.9 million** in accounts receivable[25](index=25&type=chunk) Net Loss and Accumulated Deficit (in thousands) | Metric | Three Months Ended March 31, 2024 | Nine Months Ended March 31, 2024 | As of March 31, 2024 | As of June 30, 2023 | | :------------------- | :-------------------------------- | :------------------------------- | :------------------- | :------------------ | | Net Loss | $ (2,900) | $ (11,200) | N/A | N/A | | Accumulated Deficit | N/A | N/A | $ (315,400) | $ (304,100) | | Cash used in operations | N/A | $ (600) | N/A | N/A | - The company's **$15 million** Avenue Capital term note became current in Q3 FY2024, raising substantial doubt about its ability to continue as a going concern[26](index=26&type=chunk) - Management plans to mitigate going concern risk by improving operating cash flows, winding down the Consumer Health Segment, refinancing the Avenue Note, and potentially raising additional capital or monetizing assets[27](index=27&type=chunk) - Certain prior year amounts in the consolidated statements of operations were reclassified to conform to current year presentation, specifically the fair value adjustment from contingent consideration, which did not impact net loss or cash flows[29](index=29&type=chunk) [Note 2 - Significant Accounting Policies](index=9&type=section&id=Note%202%20-%20Significant%20Accounting%20Policies) This note outlines the significant accounting policies used in preparing the consolidated financial statements, including estimates, warrant classification, income taxes, and recent accounting pronouncements - Management uses estimates for various financial statement items, including stock-based compensation, revenue recognition, inventory valuation, financial instruments, and income tax provision, with actual results potentially differing from these estimates[30](index=30&type=chunk) - Warrants are classified as either equity or liability based on specific terms and FASB guidance, valued using Black-Scholes or Monte Carlo Simulation models[31](index=31&type=chunk) - The quarterly income tax provision is based on estimated annual effective tax rates, with the effective tax rate for the three and nine months ended March 31, 2024, being **(9.3)%** and **(10.6)%** respectively, primarily due to Section 382 limitations on losses[32](index=32&type=chunk) - The company adopted ASU 2016-13 and ASU 2019-05 on July 1, 2023, regarding financial instruments and credit losses, with no material impact on consolidated financial statements[36](index=36&type=chunk) - The company will adopt ASU No. 2020-06 (Debt with Conversion and Other Options) on July 1, 2024, and does not expect a material impact[37](index=37&type=chunk) - The company is evaluating ASU No. 2023-07 (Segment Reporting) for fiscal years beginning after December 15, 2023, and assessing its potential impact[38](index=38&type=chunk) - The company recorded a **$3.8 million** Employee Retention Credit (ERC) accrual in other non-current liabilities in Q1 FY2024, accounted for by analogy to IAS 20[35](index=35&type=chunk) [Note 3 - Revenue](index=11&type=section&id=Note%203%20-%20Revenue) This note details the company's revenue recognition policies and provides a breakdown of net revenue by segment and product portfolio - Rx Segment net revenue is from prescription pharmaceutical products sold primarily through wholesalers, recognized upon product transfer (delivery)[40](index=40&type=chunk) - Consumer Health Segment revenue is from consumer health products sold via e-commerce and direct-to-consumer channels, recognized upon shipping[41](index=41&type=chunk) Net Revenue by Segment (in thousands) | Segment | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | Rx Segment | $ 14,025 | $ 13,805 | $ 50,590 | $ 50,486 | | Consumer Health Segment | 3,968 | 8,928 | 12,436 | 26,181 | | **Total consolidated net revenue** | **$ 17,993** | **$ 22,733** | **$ 63,026** | **$ 76,667** | Rx Segment Net Revenue by Product Portfolio (in thousands) | Rx Segment Product Portfolio | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :--------------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | ADHD Portfolio | $ 12,326 | $ 8,272 | $ 44,026 | $ 30,977 | | Pediatric Portfolio | 1,729 | 5,266 | 6,439 | 18,152 | | Other | (30) | 267 | 125 | 1,357 | | **Total Rx Segment net revenue** | **$ 14,025** | **$ 13,805** | **$ 50,590** | **$ 50,486** | - The Company's net revenue is predominately within the United States, with insignificant sales internationally[46](index=46&type=chunk) [Note 4 - Inventories](index=12&type=section&id=Note%204%20-%20Inventories) This note describes the company's inventory valuation policies and provides a breakdown of inventory composition and write-downs - Inventories consist of raw materials, work in process and finished goods, and are recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis[47](index=47&type=chunk) Inventory Write-downs (in thousands) | Period | Inventory Write-downs | | :-------------------------------- | :-------------------- | | Three Months Ended March 31, 2024 | $ 300 | | Three Months Ended March 31, 2023 | $ 100 | | Nine Months Ended March 31, 2024 | $ 500 | | Nine Months Ended March 31, 2023 | $ 200 | Inventories Composition (in thousands) | Inventory Component | March 31, 2024 | June 30, 2023 | | :------------------ | :------------- | :------------ | | Raw materials | $ 1,850 | $ 1,301 | | Work in process | 5,020 | 2,956 | | Finished goods | 6,323 | 7,738 | | **Total Inventories** | **$ 13,193** | **$ 11,995** | [Note 5 - Property and Equipment](index=13&type=section&id=Note%205%20-%20Property%20and%20Equipment) This note outlines the company's accounting policies for property and equipment and provides a detailed breakdown of these assets and associated depreciation - Properties and equipment are recorded at cost and depreciated on a straight-line basis over the assets' estimated economic life[49](index=49&type=chunk) Property and Equipment, Net (in thousands) | Asset Category | March 31, 2024 | June 30, 2023 | | :-------------------------------------- | :------------- | :------------ | | Manufacturing equipment | $ 1,191 | $ 2,433 | | Office equipment, furniture and other | 1,018 | 1,125 | | Leasehold improvements | 887 | 999 | | Lab equipment | 742 | 832 | | Assets under construction | — | 107 | | **Property and equipment, gross** | **3,838** | **5,496** | | Less: accumulated depreciation and amortization | (2,871) | (3,681) | | **Property and equipment, net** | **$ 967** | **$ 1,815** | Depreciation and Amortization Expense (Property and Equipment, in thousands) | Period | Depreciation and Amortization Expense | | :-------------------------------- | :------------------------------------ | | Three Months Ended March 31, 2024 | $ 200 | | Three Months Ended March 31, 2023 | $ 300 | | Nine Months Ended March 31, 2024 | $ 800 | | Nine Months Ended March 31, 2023 | $ 1,000 | [Note 6 - Leases](index=13&type=section&id=Note%206%20-%20Leases) This note details the company's lease agreements, including operating and finance leases, and provides information on lease costs, balance sheet impact, and future payments - The Company has entered into various operating lease agreements for certain of its offices, manufacturing facilities and equipment, and finance lease agreements for certain equipment, with original lease periods expiring between fiscal 2024 and fiscal 2029[51](index=51&type=chunk) - In May 2023, the Company entered into a lease agreement to relocate its principal office, commencing September 2023, and recorded an operating lease right-of-use (ROU) asset of **$0.7 million** and a lease liability of **$0.7 million**[52](index=52&type=chunk) Components of Lease Cost (in thousands) | Lease Cost Component | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | Operating lease cost | $ 388 | $ 360 | $ 1,129 | $ 1,076 | | Short-term lease cost | 25 | 27 | 69 | 71 | | Amortization of leased assets (Finance) | 14 | 14 | 43 | 51 | | Interest on lease liabilities (Finance) | 1 | 2 | 3 | 7 | | **Total lease cost** | **$ 428** | **$ 403** | **$ 1,244** | **$ 1,205** | Supplemental Balance Sheet Information Related to Leases (in thousands) | Asset/Liability | March 31, 2024 | June 30, 2023 | | :-------------------------- | :------------- | :------------ | | Operating lease assets | $ 1,795 | $ 2,054 | | Finance lease assets | — | 159 | | **Total lease assets** | **$ 1,795** | **$ 2,213** | | Current Operating leases | $ 1,133 | $ 1,258 | | Current Finance leases | 16 | 85 | | Non-current Operating leases | 783 | 832 | | **Total lease liabilities** | **$ 1,932** | **$ 2,175** | Weighted-Average Lease Term and Discount Rate | Metric | March 31, 2024 | June 30, 2023 | | :-------------------------------------- | :------------- | :------------ | | Weighted-average remaining lease term (years): | | | | Operating lease assets | 2.65 | 1.72 | | Finance lease assets | 0.12 | 0.87 | | Weighted-average discount rate: | | | | Operating lease assets | 9.18% | 7.78% | | Finance lease assets | 6.54% | 6.54% | Future Minimum Lease Payments as of March 31, 2024 (in thousands) | Year | Operating Lease Payments | Finance Lease Payments | | :---------------------- | :----------------------- | :--------------------- | | 2024 (remaining 3 months) | $ 391 | $ 16 | | 2025 | 938 | — | | 2026 | 282 | — | | 2027 | 241 | — | | 2028 | 199 | — | | 2029 | 151 | — | | **Total lease payments** | **2,202** | **16** | | Less: imputed interest | (286) | — | | **Lease liabilities** | **$ 1,916** | **$ 16** | [Note 7 - Intangible Assets](index=15&type=section&id=Note%207%20-%20Intangible%20Assets) This note provides a detailed breakdown of the company's intangible assets, including their carrying amounts, amortization, and estimated remaining useful lives Intangible Assets, Net (in thousands) | Intangible Asset Category | Carrying Amount (March 31, 2024) | Accumulated Amortization (March 31, 2024) | Net (March 31, 2024) | Weighted-Average Remaining Life (years) (March 31, 2024) | | :----------------------------------- | :------------------------------- | :---------------------------------------- | :------------------- | :------------------------------------------------------- | | Acquired product technology rights | $ 41,467 | $ (12,580) | $ 28,887 | 10.89 | | Acquired technology right | 30,200 | (5,387) | 24,813 | 14.00 | | Acquired product distribution rights | 6,207 | (5,825) | 382 | 0.25 | | **Total intangible assets** | **$ 77,874** | **$ (23,792)** | **$ 54,082** | **12.24** | | | | | | | | Intangible Asset Category | Carrying Amount (June 30, 2023) | Accumulated Amortization (June 30, 2023) | Net (June 30, 2023) | Weighted-Average Remaining Life (years) (June 30, 2023) | | :----------------------------------- | :------------------------------- | :---------------------------------------- | :------------------ | :------------------------------------------------------- | | Acquired product technology rights | $ 42,176 | $ (10,881) | $ 31,295 | 11.49 | | Acquired technology right | 30,200 | (4,054) | 26,146 | 14.75 | | Acquired product distribution rights | 6,207 | (4,678) | 1,529 | 1.00 | | **Total intangible assets** | **$ 78,583** | **$ (19,613)** | **$ 58,970** | **12.67** | Amortization Expense of Intangible Assets (in thousands) | Period | Amortization Expense | | :-------------------------------- | :------------------- | | Three Months Ended March 31, 2024 | $ 1,600 | | Three Months Ended March 31, 2023 | $ 1,500 | | Nine Months Ended March 31, 2024 | $ 4,900 | | Nine Months Ended March 31, 2023 | $ 4,600 | Estimated Future Amortization Expense (in thousands) | Fiscal Year | Estimated Amortization Expense | | :---------- | :----------------------------- | | 2024 (remaining 3 months) | $ 1,630 | | 2025 | 4,989 | | 2026 | 4,989 | | 2027 | 4,989 | | 2028 | 4,989 | | 2029 | 4,989 | | Thereafter | 27,507 | | **Total future amortization expense** | **$ 54,082** | - Acquired product technology rights are related to the Pediatric Portfolio (Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor) and ADHD Portfolio (Adzenys XR-ODT, Cotempla XR-ODT)[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) - The acquired technology right includes the Time Release Resin Particle (TRRP) proprietary drug delivery technology, underlying the ADHD portfolio and potentially future products[66](index=66&type=chunk) - Acquired product distribution rights (and customer list) from the Innovus Acquisition are fully amortized; a **$3.0 million** impairment charge was recorded in Q4 FY2023 due to discontinuation of Consumer Health Segment products[67](index=67&type=chunk) - In-process R&D for NT0502 was fully impaired in Q2 FY2023, resulting in a **$2.6 million** impairment expense, following the termination of its development program[68](index=68&type=chunk) [Note 8 - Accrued Liabilities](index=17&type=section&id=Note%208%20-%20Accrued%20Liabilities) This note provides a detailed breakdown of the company's accrued liabilities as of March 31, 2024, and June 30, 2023 Accrued Liabilities (in thousands) | Accrued Liability Category | March 31, 2024 | June 30, 2023 | | :------------------------------------ | :------------- | :------------ | | Accrued savings offers | $ 16,617 | $ 15,739 | | Accrued program liabilities | 10,900 | 11,012 | | Accrued customer and product related fees | 6,148 | 6,579 | | Return reserve | 4,660 | 5,777 | | Accrued employee compensation | 3,892 | 5,675 | | Other accrued liabilities | 1,874 | 2,017 | | **Total accrued liabilities** | **$ 44,091** | **$ 46,799** | - Accrued savings offers represent programs for the Company's patients covered under commercial payor plans in which the cost of a prescription to such patients is discounted. Accrued program liabilities include government and commercial rebates[70](index=70&type=chunk) - Accrued customer and product related fees include accrued expenses and deductions for rebates, wholesaler chargebacks and fees, and other product-related fees and deductions such as royalties for Pediatric Portfolio products, accrued distributor fees, and Medicaid liabilities. The return reserve represents the Company's accrual for estimated product returns[70](index=70&type=chunk) [Note 9 - Other Liabilities](index=17&type=section&id=Note%209%20-%20Other%20Liabilities) This note provides a detailed breakdown of the company's other liabilities, including fixed payment arrangements and the Employee Retention Credit accrual Other Liabilities (in thousands) | Other Liability Category | March 31, 2024 | June 30, 2023 | | :------------------------------------ | :------------- | :------------ | | Fixed payment arrangements | $ 8,695 | $ 10,420 | | Operating lease liabilities | 1,916 | 2,090 | | Employee retention credit | 3,759 | — | | Other | 564 | 1,555 | | **Total other liabilities** | **14,934** | **14,065** | | Less: current portion | (9,146) | (7,090) | | **Total other liabilities, non-current** | **$ 5,788** | **$ 6,975** | - Fixed payment arrangements represent obligations to an investor assumed as part of the acquisition of products from Cerecor, Inc. in 2019, including fixed and variable payments. The Tris Karbinal Agreement also contains minimum unit sales commitments, which is based on a commercial year that spans from August 1 through July 31, of **70,000 units annually through 2025**. The Company is required to pay Tris a royalty make-whole payment of **$30** for each unit under the **70,000-unit** annual minimum sales commitment through 2025. The Tris Karbinal Agreement make-whole payment is capped at **$2.1 million** each year[72](index=72&type=chunk)[73](index=73&type=chunk) - The Company agreed to pay Tris a total of approximately **$9.0 million** to terminate the Tuzistra XR License Agreement, which reduced its total liability for minimum payments by approximately **$8.0 million** from the original License Agreement. As of March 31, 2024, the balance was **$6.1 million** in other current liabilities[74](index=74&type=chunk) - The **$3.8 million** Employee Retention Credit (ERC) accrual in other non-current liabilities as of March 31, 2024, represents the proceeds the Company received from the ERC program during the first quarter of fiscal 2024[76](index=76&type=chunk) [Note 10 - Line of Credit](index=18&type=section&id=Note%2010%20-%20Line%20of%20Credit) This note describes the company's secured revolving credit agreement, including its terms, interest rate, and compliance with covenants - The Company has a secured credit agreement with Eclipse Business Capital LLC for up to **$14.0 million** (less a **$3.5 million** availability block) in secured revolving loans, accruing interest at the one-month Secure Overnight Financing Rate (SOFR) plus **4.50%**[78](index=78&type=chunk) - The maturity date under the Eclipse Loan Agreement is **January 26, 2025**, and the Company was in compliance with the covenants as of March 31, 2024[78](index=78&type=chunk)[80](index=80&type=chunk) Interest Expense on Revolving Loans (in thousands) | Period | Interest Expense | | :-------------------------------- | :--------------- | | Three Months Ended March 31, 2024 | $ 21.7 | | Three Months Ended March 31, 2023 | $ 194.3 | | Nine Months Ended March 31, 2024 | $ 71.7 | | Nine Months Ended March 31, 2023 | $ 468.9 | - As of March 31, 2024, and June 30, 2023, the outstanding Revolving Loans under the Eclipse Loan Agreement were **$1.6 million**[81](index=81&type=chunk) [Note 11 - Long-term Debt](index=19&type=section&id=Note%2011%20-%20Long-term%20Debt) This note details the company's long-term debt, including the Avenue Capital loan, associated warrants, interest expense, and future principal payments - The Company has a secured **$15.0 million** loan with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P., with an interest rate of the greater of the prime rate or **3.25%**, plus **7.4%**, maturing **January 26, 2025**[82](index=82&type=chunk) - The Interest-Only Period for the Avenue Capital loan was extended through the maturity date (**January 26, 2025**) after the Company achieved certain defined milestones[83](index=83&type=chunk) - Upon full payment of obligations, the Company is required to pay Avenue Capital a **$0.6 million** "Final Payment" fee, accounted for as an additional obligation on the debt and recorded as a debt discount[83](index=83&type=chunk) - As of March 31, 2024, the Company was in compliance with the covenants under the Avenue Capital Agreement[85](index=85&type=chunk) - Warrants issued to Avenue Capital Lenders in conjunction with the loan were initially valued at approximately **$0.6 million** and classified as a liability, with the exercise price reset to **$8.60** in October 2022[86](index=86&type=chunk)[88](index=88&type=chunk) Total Interest Expense (Avenue Capital Loan, in thousands) | Period | Total Interest Expense | | :-------------------------------- | :--------------------- | | Three Months Ended March 31, 2024 | $ 700 | | Three Months Ended March 31, 2023 | $ 700 | | Nine Months Ended March 31, 2024 | $ 2,200 | | Nine Months Ended March 31, 2023 | $ 2,000 | Long-term Debt (in thousands) | Debt Component | March 31, 2024 | June 30, 2023 | | :-------------------------------------- | :------------- | :------------ | | Long-term debt, due on January 26, 2025 | $ 15,000 | $ 15,000 | | Long-term, final payment fee | 638 | 638 | | Unamortized discount and issuance costs | (519) | (925) | | Financing leases, maturing through May 2024 | 16 | 85 | | **Total debt** | **15,135** | **14,798** | | Less: current portion | (15,135) | (85) | | **Non-current portion of debt** | **$ —** | **$ 14,713** | Future Principal Payments of Long-term Debt (in thousands) | Year | Future Principal Payments | | :------------------------------ | :------------------------ | | 2024 (remaining 3 months) | $ 16 | | 2025 | 15,638 | | **Future principal payments** | **15,654** | | Less: unamortized discount and issuance costs | (519) | | Less: current portion | (15,135) | | **Non-current portion of debt** | **$ —** | [Note 12 - Fair Value Considerations](index=20&type=section&id=Note%2012%20-%20Fair%20Value%20Considerations) This note explains the company's approach to fair value measurements for financial instruments, including the fair value hierarchy and valuation models used for derivative warrant liabilities - The Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs (Level 1, 2, 3)[92](index=92&type=chunk) - The carrying amounts of certain short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to their short maturities[93](index=93&type=chunk) Recurring Fair Value Measurements of Liabilities (in thousands) | Liability Category | Fair Value at March 31, 2024 | Level 1 | Level 2 | Level 3 | | :------------------------------------------ | :--------------------------- | :------ | :------ | :------ | | Current portion of derivative warrant liabilities | $ 3,261 | $ — | $ — | $ 3,261 | | Derivative warrant liabilities | 8,609 | — | — | 8,609 | | **Total** | **$ 11,870** | **$ —** | **$ —** | **$ 11,870** | | | | | | | | Liability Category | Fair Value at June 30, 2023 | Level 1 | Level 2 | Level 3 | | :------------------------------------------ | :-------------------------- | :------ | :------ | :------ | | Current portion of derivative warrant liabilities | $ — | $ — | $ — | $ — | | Derivative warrant liabilities | 6,403 | — | — | 6,403 | | **Total** | **$ 6,403** | **$ —** | **$ —** | **$ 6,403** | Summary of Level 3 Input Changes for Derivative Warrant Liabilities (in thousands) | Metric | Derivative Warrant Liabilities | | :----------------------------- | :----------------------------- | | Balance as of June 30, 2023 | $ 6,403 | | Included in earnings | 5,467 | | **Balance as of March 31, 2024** | **$ 11,870** | - The Black-Scholes option pricing model and Monte Carlo Simulation model are used to value warrants with significant Level 3 inputs, relying on financial projections not observable in the market[99](index=99&type=chunk) [Note 13 - Commitments and Contingencies](index=22&type=section&id=Note%2013%20-%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, commitments, and contingencies, including licensing agreements and legal proceedings - The Tris Karbinal Agreement grants the Company exclusive rights to commercialize Karbinal ER, requiring a **23.5%** royalty on net revenue and minimum unit sales commitments of **70,000 units annually through 2025**, with a make-whole payment capped at **$2.1 million** each year[100](index=100&type=chunk)[101](index=101&type=chunk) - For AR101, up to **$67.5 million** in earn-out payments are contingent on regulatory and commercial milestones, plus potential payments of up to **$101.7 million** to Denovo and **$1.6 million** to Johns Hopkins University, with development currently suspended[102](index=102&type=chunk)[166](index=166&type=chunk) - The Witmer Class-Action Securities Litigation, alleging fiduciary duty breaches and unjust enrichment, has been agreed to be settled for various corporate governance modifications and the payment of plaintiff's attorneys' fees, subject to court approval[103](index=103&type=chunk) - The Sabby Litigation, concerning improper warrant exercise price adjustments, was settled in October 2023[104](index=104&type=chunk) - The Stein Litigation, a retaliation complaint, is in early stages, and the company intends to vigorously defend it, unable to predict a material financial impact at this time[105](index=105&type=chunk) - The Company has a remaining liability of **$6.0 million** for minimum payments related to the termination of the Tuzistra License Agreement with Tris Pharma Inc[164](index=164&type=chunk) - Up to **$3.0 million** of fixed and product milestone payments remain from the acquisition of pediatric products from Cerecor, Inc[165](index=165&type=chunk) [Note 14 - Capital Structure](index=23&type=section&id=Note%2014%20-%20Capital%20Structure) This note describes the company's capital structure, including authorized shares, outstanding restricted stock, and details of recent equity offerings and shelf registration statements - The Company has **200 million** shares of common stock authorized with a par value of **$0.0001** per share and **50 million** shares of preferred stock authorized with a par value of **$0.0001** per share[106](index=106&type=chunk) - As of March 31, 2024, **31,897** shares of unvested restricted stock were outstanding[106](index=106&type=chunk) - The 2020 Shelf registration statement expired in June 2023, and the ATM Sales Agreement was terminated in July 2023[107](index=107&type=chunk) - As of March 31, 2024, approximately **$82.4 million** remained available under the 2021 Shelf registration statement, subject to SEC 1.B.6 limitations[108](index=108&type=chunk) - The August 2022 Offering raised **$10.0 million** in gross proceeds, issuing common stock, pre-funded warrants, and common warrants (classified as derivative warrant liabilities with a combined fair value of approximately **$6.0 million** at issuance)[109](index=109&type=chunk) - The June 2023 offering raised **$4.0 million** in gross proceeds, issuing common stock, pre-funded warrants, Tranche A Warrants, and Tranche B Warrants (classified as derivative warrant liabilities with a combined fair value of approximately **$5.0 million** at issuance)[110](index=110&type=chunk) [Note 15 - Equity Incentive Plans](index=24&type=section&id=Note%2015%20-%20Equity%20Incentive%20Plans) This note details the company's equity incentive plans, including stock option, restricted stock, and RSU activity, along with associated compensation expenses - The 2023 Equity Incentive Plan was approved on May 18, 2023, consolidating shares from previous plans, with **182,118** shares available for grant as of March 31, 2024[111](index=111&type=chunk) Stock Option Activity | Metric | Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | | :---------------------------- | :---------------- | :------------------------------ | :-------------------------------------------------- | | Outstanding June 30, 2023 | 52,762 | $ 18.37 | 9.06 | | Granted | 113,500 | $ 1.74 | 9.38 | | Forfeited/cancelled | (18,859) | $ 3.30 | — | | Expired | (702) | $ 186.18 | — | | **Outstanding at March 31, 2024** | **146,701** | **$ 6.32** | **9.06** | | Exercisable at March 31, 2024 | 21,817 | $ 29.80 | 8.15 | - As of March 31, 2024, there was **$0.2 million** total unrecognized compensation costs related to non-vested stock options, expected to be recognized over a weighted average period of **2.2 years**[114](index=114&type=chunk) Restricted Stock Activity | Metric | Number of Shares | Weighted Average Grant Date Fair Value | | :-------------------------- | :--------------- | :------------------------------------- | | Unvested at June 30, 2023 | 38,075 | $ 142.20 | | Granted | 12,500 | $ 1.77 | | Vested | (19,892) | $ 114.09 | | Forfeited/cancelled | (457) | $ 136.80 | | **Unvested at March 31, 2024** | **30,226** | **$ 102.70** | - As of March 31, 2024, there was **$1.3 million** total unrecognized compensation costs related to non-vested restricted stock, expected to be recognized over a weighted average period of **2.1 years**[115](index=115&type=chunk) Restricted Stock Units (RSUs) Activity | Metric | Number of Shares | Weighted Average Grant Date Fair Value | | :-------------------------- | :--------------- | :------------------------------------- | | Unvested at June 30, 2023 | 4,963 | $ 25.62 | | Vested | (1,688) | $ 24.28 | | Forfeited | (939) | $ 31.60 | | **Unvested at March 31, 2024** | **2,336** | **$ 24.17** | - As of March 31, 2024, there was **$49.2 thousand** total unrecognized compensation costs related to non-vested RSUs, expected to be recognized over a weighted average period of **0.9 years**[120](index=120&type=chunk) Stock-based Compensation Expense by Operating Expense Category (in thousands) | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | Cost of sales | $ — | $ 4 | $ 1 | $ 12 | | Research and development | 2 | 2 | 5 | 25 | | Selling and marketing | — | 3 | — | 9 | | General and administrative | 809 | 893 | 2,555 | 5,100 | | **Total stock-based compensation expense** | **$ 811** | **$ 902** | **$ 2,561** | **$ 5,146** | [Note 16 - Warrants](index=26&type=section&id=Note%2016%20-%20Warrants) This note provides a summary of the company's warrant activity, including their classification, exercise prices, and remaining contractual lives - Warrants from the June 8, 2023, securities purchase agreement (Tranche A and B Warrants) are immediately exercisable at a price of **$1.59** per share and are classified as derivative warrant liabilities[122](index=122&type=chunk) - Warrants from the August 11, 2022, offering are classified as derivative warrant liabilities, with the exercise price adjusted to **$2.32** due to subsequent equity offerings and a reverse stock split[123](index=123&type=chunk)[124](index=124&type=chunk) Summary of Warrants Activity | Metric | Number of Warrants | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | | :---------------------------- | :----------------- | :------------------------------ | :-------------------------------------------------- | | Outstanding June 30, 2023 | 6,538,052 | $ 4.42 | 4.71 | | Warrants exercised | (37,004) | $ 2.32 | — | | Warrants expired | (20,958) | $ 300.00 | — | | **Outstanding at March 31, 2024** | **6,480,090** | **$ 3.48** | **3.97** | [Note 17 - Earnings Per Share](index=27&type=section&id=Note%2017%20-%20Earnings%20Per%20Share) This note explains the calculation of basic loss per common share and lists anti-dilutive securities excluded from diluted EPS calculations - Basic loss per common share is calculated by dividing the net loss available to the common stockholders by the weighted average number of common shares outstanding during that period[127](index=127&type=chunk) Anti-Dilutive Securities Excluded from Diluted EPS Calculation | Security Type | March 31, 2024 | March 31, 2023 | | :------------------------------------------ | :------------- | :------------- | | Warrants to purchase common stock - liability classified | 6,461,976 | 1,642,235 | | Warrant to purchase common stock - equity classified | 18,114 | 39,072 | | Employee stock options | 146,701 | 52,784 | | Employee unvested restricted stock | 31,897 | 48,818 | | Employee unvested restricted stock units | 2,336 | 5,920 | | **Total** | **6,661,024** | **1,788,829** | [Note 18 - License Agreements](index=27&type=section&id=Note%2018%20-%20License%20Agreements) This note outlines key license agreements, including those granting rights to generic versions of the company's ADHD products - Teva Pharmaceuticals USA, Inc. has a non-exclusive license to certain patents owned by Neos, granting the right to manufacture and market its generic version of Cotempla XR-ODT beginning on **July 1, 2026**[129](index=129&type=chunk) - Actavis (now Teva) has a non-exclusive license to certain patents owned by Neos, granting the right to manufacture and market its generic version of Adzenys XR-ODT beginning on **September 1, 2025**[130](index=130&type=chunk) [Note 19 - Segment Reporting](index=28&type=section&id=Note%2019%20-%20Segment%20Reporting) This note provides financial information by the company's two reportable segments: Rx (prescription products) and Consumer Health (consumer healthcare products) - The Company manages and aggregates its operational and financial information in accordance with two reportable segments: Rx (prescription products) and Consumer Health (consumer healthcare products)[132](index=132&type=chunk) - Common expenses such as corporate administration, executive and board compensation, and insurance are allocated to the Rx Segment, which also includes pipeline research and development. Asset information is not regularly reviewed by segment[132](index=132&type=chunk) Select Financial Information by Segment (Three Months Ended March 31, 2024 and 2023, in thousands) | Metric | Rx Segment (3M 2024) | Consumer Health Segment (3M 2024) | Consolidated (3M 2024) | Rx Segment (3M 2023) | Consumer Health Segment (3M 2023) | Consolidated (3M 2023) | | :--------------------------------------- | :------------------- | :-------------------------------- | :--------------------- | :------------------- | :-------------------------------- | :--------------------- | | Net revenue | $ 14,025 | $ 3,968 | $ 17,993 | $ 13,805 | $ 8,928 | $ 22,733 | | Loss from operations | $ (1,598) | $ (866) | $ (2,464) | $ (7,122) | $ (1,436) | $ (8,558) | | Depreciation and amortization | $ 1,449 | $ 385 | $ 1,834 | $ 1,563 | $ 280 | $ 1,843 | | Stock-based compensation expense | $ 699 | $ 112 | $ 811 | $ 788 | $ 114 | $ 902 | Select Financial Information by Segment (Nine Months Ended March 31, 2024 and 2023, in thousands) | Metric | Rx Segment (9M 2024) | Consumer Health Segment (9M 2024) | Consolidated (9M 2024) | Rx Segment (9M 2023) | Consumer Health Segment (9M 2023) | Consolidated (9M 2023) | | :--------------------------------------- | :------------------- | :-------------------------------- | :--------------------- | :------------------- | :-------------------------------- | :--------------------- | | Net revenue | $ 50,590 | $ 12,436 | $ 63,026 | $ 50,486 | $ 26,181 | $ 76,667 | | Income (loss) from operations | $ 682 | $ (2,286) | $ (1,604) | $ (13,579) | $ (3,655) | $ (17,234) | | Depreciation and amortization | $ 4,513 | $ 1,161 | $ 5,674 | $ 4,709 | $ 842 | $ 5,551 | | Impairment expense | $ 2,600 | $ — | $ 2,600 | $ 2,600 | $ — | $ 2,600 | | Stock-based compensation expense | $ 2,131 | $ 430 | $ 2,561 | $ 4,937 | $ 209 | $ 5,146 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This MD&A reviews financial performance, condition, and strategy, addressing significant losses, going concern doubts, and a focus on Rx business growth and operating cash flows [Objective](index=29&type=section&id=Objective) This section outlines the objective of the Management's Discussion and Analysis (MD&A) - The Management's Discussion and Analysis (MD&A) aims to present information relevant to assessing and understanding the company's results of operations and cash flows for the three and nine months ended March 31, 2024, and its financial condition as of March 31, 2024[136](index=136&type=chunk) [Overview](index=29&type=section&id=Overview) This section provides an overview of the company's business, financial performance, and going concern status - The company is a pharmaceutical company focused on commercializing novel therapeutics, operating through two business segments: Rx Segment and Consumer Health Segment[137](index=137&type=chunk) - The company is moving production of its ADHD products to a third-party manufacturer to improve profitability[137](index=137&type=chunk) Net Loss and Accumulated Deficits (in thousands) | Metric | Three Months Ended March 31, 2024 | Nine Months Ended March 31, 2024 | As of March 31, 2024 | As of June 30, 2023 | | :------------------- | :-------------------------------- | :------------------------------- | :------------------- | :------------------ | | Net Loss | $ 2,900 | $ 11,200 | N/A | N/A | | Accumulated Deficit | N/A | N/A | $ 315,400 | $ 304,100 | - As of March 31, 2024, there is significant uncertainty about the company's ability to fund planned operations for the twelve months following the filing date, raising substantial doubt about its ability to continue as a going concern, largely due to the **January 2025** maturity of the Avenue Note[138](index=138&type=chunk) [Company Strategy](index=29&type=section&id=Company%20Strategy) This section outlines the company's strategic focus on accelerating Rx business growth and achieving operating cash flows - The company's strategy is to focus efforts on accelerating the growth of its Rx business and achieving operating cash flows[139](index=139&type=chunk) - Clinical development programs were indefinitely suspended, and the Consumer Health Segment is being wound down in fiscal 2024 due to negative cash flows[139](index=139&type=chunk) [Business Environment](index=29&type=section&id=Business%20Environment) This section discusses the business environment, including inflationary pressures, supply chain disruptions, and product supply status - The company has continued to experience significant inflationary pressure and supply chain disruptions related to raw materials, energy, logistics, and labor during fiscal 2023 and 2024, most notably affecting the Consumer Health Segment[140](index=140&type=chunk) - Inflationary pressures and supply chain disruptions are expected to continue to be significant across the business throughout fiscal 2024[140](index=140&type=chunk) - The Company has not experienced stock outages for its ADHD products since launch, and pediatric product supply has remained adequate[140](index=140&type=chunk) [Net revenue](index=30&type=section&id=Net%20revenue) This section analyzes the company's net revenue performance for the three and nine months ended March 31, 2024, compared to prior periods Net Revenue Performance (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (3M) | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | Change (9M) | | :------------------- | :-------------------------------- | :-------------------------------- | :---------- | :------------------------------- | :------------------------------- | :---------- | | Net revenue | $ 17,993 | $ 22,733 | $ (4,740) | $ 63,026 | $ 76,667 | $ (13,641) | - Net revenue decreased by **$4.7 million (21%)** for the three months and **$13.6 million (18%)** for the nine months ended March 31, 2024, primarily due to the winding down of the Consumer Health Segment and a decline in the Pediatric Portfolio[142](index=142&type=chunk) - These declines were partially offset by an increase in net revenue from the ADHD Portfolio of **$4.1 million (49%)** for the three months and **$13.0 million (42%)** for the nine months ended March 31, 2024[142](index=142&type=chunk) [Gross margin](index=30&type=section&id=Gross%20margin) This section analyzes the company's gross profit and gross margin percentage for the three and nine months ended March 31, 2024, compared to prior periods Gross Profit and Gross Margin Percentage | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Nine Months Ended March 31, 2024 | Nine Months Ended March 31, 2023 | | :---------------------- | :-------------------------------- | :-------------------------------- | :------------------------------- | :------------------------------- | | Gross profit | $ 11,693 | $ 12,743 | $ 42,680 | $ 48,068 | | Gross margin percentage | 65% | 56% | 68% | 63% | - Gross profit decreased by **8%** and **11%** for the three and nine months, respectively, compared to the same periods in 2023. Gross margin percentage improved to **65%** and **68%** for the three and nine months, respectively, primarily due to a decline in lower-margin Consumer Health Segment net revenue and efficiencies in ADHD Portfolio production[143](index=143&type=chunk) [Advertising and direct marketing](index=30&type=section&id=Advertising%20and%20direct%20marketing) This section analyzes changes in advertising and direct marketing expenses for the three and nine months ended March 31, 2024 Advertising and Direct Marketing Expense (in thousands) | Period | Advertising and Direct Marketing Expense | Change | | :-------------------------------- | :--------------------------------------- | :------- | | Three Months Ended March 31, 2024 | $ 1,197 | $ (3,828) (76%) | | Three Months Ended March 31, 2023 | $ 5,025 | | | Nine Months Ended March 31, 2024 | $ 3,886 | $ (10,186) (72%) | | Nine Months Ended March 31, 2023 | $ 14,072 | | - The significant decrease in advertising and direct marketing expense is attributed to the ongoing wind-down of the Consumer Health Segment[144](index=144&type=chunk) [Other selling and marketing](index=31&type=section&id=Other%20selling%20and%20marketing) This section analyzes changes in other selling and marketing expenses for the three and nine months ended March 31, 2024 Other Selling and Marketing Expense (in thousands) | Period | Other Selling and Marketing Expense | Change | | :-------------------------------- | :---------------------------------- | :------- | | Three Months Ended March 31, 2024 | $ 5,352 | $ (2,427) (31%) | | Three Months Ended March 31, 2023 | $ 7,779 | | | Nine Months Ended March 31, 2024 | $ 16,661 | $ (2,733) (14%) | | Nine Months Ended March 31, 2023 | $ 19,394 | | - Decreases were primarily driven by lower commission expense (based on prescriptions generated by the sales force) and commercial marketing program fees, correlating with decreased product sales[145](index=145&type=chunk) [General and administrative](index=31&type=section&id=General%20and%20administrative) This section analyzes changes in general and administrative expenses for the three and nine months ended March 31, 2024 General and Administrative Expense (in thousands) | Period | General and Administrative Expense | Change | | :-------------------------------- | :--------------------------------- | :------- | | Three Months Ended March 31, 2024 | $ 5,442 | $ (1,735) (24%) | | Three Months Ended March 31, 2023 | $ 7,177 | | | Nine Months Ended March 31, 2024 | $ 17,837 | $ (4,680) (21%) | | Nine Months Ended March 31, 2023 | $ 22,517 | | - The decrease is primarily a result of ongoing cost-cutting initiatives and operational improvements[146](index=146&type=chunk) [Research and development](index=31&type=section&id=Research%20and%20development) This section analyzes changes in research and development expenses for the three and nine months ended March 31, 2024 Research and Development Expense (in thousands) | Period | Research and Development Expense | Change | | :-------------------------------- | :------------------------------- | :------- | | Three Months Ended March 31, 2024 | $ 619 | $ (237) (28%) | | Three Months Ended March 31, 2023 | $ 856 | | | Nine Months Ended March 31, 2024 | $ 1,747 | $ (1,883) (52%) | | Nine Months Ended March 31, 2023 | $ 3,630 | | - R&D costs significantly declined due to the suspension of AR101 and Healight development in October 2022, as the company focuses on commercial operations[147](index=147&type=chunk) [Amortization of intangible assets](index=31&type=section&id=Amortization%20of%20intangible%20assets) This section analyzes the amortization expense of intangible assets for the three and nine months ended March 31, 2024 - Amortization expense of intangible assets, excluding amounts included in cost of sales, was relatively consistent for the three and nine months ended March 31, 2024, compared to the same periods ended March 31, 2023[148](index=148&type=chunk) Amortization of Intangible Assets (in thousands) | Period | Amortization of Intangible Assets | Change | | :-------------------------------- | :-------------------------------- | :------- | | Three Months Ended March 31, 2024 | $ 1,303 | $ 105 | | Three Months Ended March 31, 2023 | $ 1,198 | | | Nine Months Ended March 31, 2024 | $ 3,909 | $ 316 | | Nine Months Ended March 31, 2023 | $ 3,593 | | [Restructuring costs](index=31&type=section&id=Restructuring%20costs) This section analyzes the restructuring costs incurred by the company for the three and nine months ended March 31, 2024 Restructuring Costs (in thousands) | Period | Restructuring Costs | Change | | :-------------------------------- | :------------------ | :------- | | Three Months Ended March 31, 2024 | $ 244 | $ 244 | | Three Months Ended March 31, 2023 | $ — | | | Nine Months Ended March 31, 2024 | $ 244 | $ 244 | | Nine Months Ended March 31, 2023 | $ — | | - The Company incurred **$0.2 million** of restructuring costs related to its previously announced operational realignment and related costs during the three and nine months ended March 31, 2024[149](index=149&type=chunk) [Impairment expense](index=31&type=section&id=Impairment%20expense) This section discusses impairment expenses recorded during the three and nine months ended March 31, 2024, and prior periods - No impairment expense was recorded during the three and nine months ended March 31, 2024[150](index=150&type=chunk) - A **$2.6 million** impairment charge was incurred during the second quarter of fiscal 2023 related to the cessation of active development of the NT0502 product candidate and termination of its license agreement[150](index=150&type=chunk) [Other expense, net](index=31&type=section&id=Other%20expense%2C%20net) This section analyzes changes in other expense, net, for the three and nine months ended March 31, 2024 Other Expense, Net (in thousands) | Period | Other Expense, Net | Change | | :-------------------------------- | :----------------- | :------- | | Three Months Ended March 31, 2024 | $ (1,195) | $ 20 | | Three Months Ended March 31, 2023 | $ (1,215) | | | Nine Months Ended March 31, 2024 | $ (3,083) | $ 444 | | Nine Months Ended March 31, 2023 | $ (3,527) | | - Other expense, net, decreased primarily due to **$0.5 million** in other income from insurance proceeds for damage of inventory in the first quarter of fiscal 2024[151](index=151&type=chunk) [Gain (loss) on derivative warrant liabilities](index=31&type=section&id=Gain%20(loss)%20on%20derivative%20warrant%20liabilities) This section analyzes the gain or loss recognized on derivative warrant liabilities for the three and nine months ended March 31, 2024 Gain (Loss) on Derivative Warrant Liabilities (in thousands) | Period | Gain (Loss) on Derivative Warrant Liabilities | Change | | :-------------------------------- | :------------------------------------------ | :--------- | | Three Months Ended March 31, 2024 | $ 1,017 | $ (1,556) | | Three Months Ended March 31, 2023 | $ 2,573 | | | Nine Months Ended March 31, 2024 | $ (5,467) | $ (11,634) | | Nine Months Ended March 31, 2023 | $ 6,167 | | - For the three and nine months ended March 31, 2024, the company recognized an unrealized gain of **$1.0 million** and an unrealized loss of **$5.5 million**, respectively, from the fair value adjustments of derivative warrant liabilities[152](index=152&type=chunk) [Income tax expense](index=32&type=section&id=Income%20tax%20expense) This section analyzes the company's income tax expense and effective tax rate for the three and nine months ended March 31, 2024 Income Tax Expense and Effective Tax Rate | Period | Income Tax Expense (in thousands) | Effective Tax Rate | | :-------------------------------- | :-------------------------------- | :----------------- | | Three Months Ended March 31, 2024 | $ (245) | (9.3)% | | Three Months Ended March 31, 2023 | $ — | 0% | | Nine Months Ended March 31, 2024 | $ (1,073) | (10.6)% | | Nine Months Ended March 31, 2023 | $ — | 0% | - Income tax expense for the three and nine months ended March 31, 2024, was primarily driven by limitations on losses as a result of Section 382 of the Internal Revenue Code changes in ownership coupled with existing valuation allowances[153](index=153&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's liquidity and capital resources, including financing methods and available funds - The company finances its operations through a combination of sales of common stock and warrants, borrowings under its line of credit facility, and cash generated from operations[154](index=154&type=chunk) - As of March 31, 2024, approximately **$82.4 million** remained available under the 2021 Shelf registration statement, subject to SEC 1.B.6 limitations[155](index=155&type=chunk) - The Eclipse Loan Agreement provides up to **$14.5 million** (less a **$3.5 million** availability block) in secured revolving loans, with a maturity date of **January 26, 2025**[156](index=156&type=chunk) [Net Cash Used in Operating Activities](index=32&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) This section analyzes the net cash used in operating activities for the nine months ended March 31, 2024, and 2023 Net Cash Used in Operating Activities (in thousands) | Period | Net Cash Used in Operating Activities | Change | | :------------------------------- | :------------------------------------ | :------- | | Nine Months Ended March 31, 2024 | $ (600) | $ 13,894 | | Nine Months Ended March 31, 2023 | $ (14,494) | | - During the nine months ended March 31, 2024, net cash used in operating activities totaled **$0.6 million**, primarily due to positive cash earnings, Employee Retention Credit funds, and decreases in accounts receivable and inventories, partially offset by decreases in accounts payable and accrued liabilities[157](index=157&type=chunk) - During the nine months ended March 31, 2023, net cash used in operating activities totaled **$14.5 million**, primarily due to net losses and increases in accounts receivable, inventory, and prepaid expenses[160](index=160&type=chunk) [Net Cash (Used in) Provided by Investing Activities](index=33&type=section&id=Net%20Cash%20(Used%20in)%20Provided%20by%20Investing%20Activities) This section analyzes the net cash flows from investing activities for the nine months ended March 31, 2024, and 2023 Net Cash (Used in) Provided by Investing Activities (in thousands) | Period | Net Cash (Used in) Provided by Investing Activities | Change | | :------------------------------- | :------------------------------------------ | :------- | | Nine Months Ended March 31, 2024 | $ (295) | $ (333) | | Nine Months Ended March 31, 2023 | $ 38 | | - Net cash flows from investing activities were nominal during both the nine months ended March 31, 2024, and 2023[161](index=161&type=chunk)
Aytu BioPharma(AYTU) - 2024 Q2 - Earnings Call Transcript
2024-02-15 03:52
Aytu BioPharma, Inc. (NASDAQ:AYTU) Q2 2024 Earnings Conference Call February 14, 2024 4:30 PM ET Company Participants Roger Weiss - Investor Relations Joshua Disbrow - Chief Executive Officer Mark Oki - Chief Financial Officer Conference Call Participants Naz Rahman - Maxim Group Operator Greetings. Welcome to the Aytu BioPharma Fiscal 2024 Q2 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Roger Weiss. You may begin. R ...
Aytu BioPharma(AYTU) - 2024 Q2 - Quarterly Report
2024-02-13 16:00
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 December 31, 2023 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 No. 001-38247 AYTU BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 47-0883144 (State or othe ...
Aytu BioPharma(AYTU) - 2024 Q1 - Earnings Call Transcript
2023-11-15 00:30
Aytu BioPharma, Inc. (NASDAQ:AYTU) Q1 2024 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Robert Blum - IR Josh Disbrow - CEO Mark Oki - CFO Conference Call Participants Naz Rahman - Maxim Group Robert Blum Good afternoon, everyone, and thank you for joining us for Aytu BioPharma's Fiscal 2024 First Quarter Financial Results Conference Call for the period ended September 30, 2023. Joining us on today's call is Aytu’s CEO, Josh Disbrow, and the company's Chief Financial Officer, M ...
Aytu BioPharma(AYTU) - 2024 Q1 - Quarterly Report
2023-11-13 16:00
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 ...
Aytu BioPharma(AYTU) - 2023 Q4 - Annual Report
2023-10-11 16:00
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) | --- | --- | --- | --- | |------------------------------------------------------- ...
Aytu BioPharma(AYTU) - 2023 Q4 - Earnings Call Transcript
2023-09-27 23:01
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(AYTU) - 2023 Q1 - Earnings Call Presentation
2023-05-19 13:50
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(AYTU) - 2023 Q3 - Earnings Call Transcript
2023-05-12 01:57
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 ...