Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2023 | Dec. 05, 2023 | Mar. 31, 2023 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Sep. 30, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 1-13602 | ||
Entity Registrant Name | Veru Inc. | ||
Entity Incorporation State Country Code | WI | ||
Entity Tax Identification Number | 39-1144397 | ||
Entity Address Address Line1 | 2916 N. Miami Avenue | ||
Entity Address Address Line2 | Suite 1000 | ||
Entity Address City Or Town | Miami | ||
Entity Address State Or Province | FL | ||
Entity Address Postal Zip Code | 33127 | ||
City Area Code | 305 | ||
Local Phone Number | 509-6897 | ||
Security 12b Title | Common stock, $0.01 par value | ||
Trading Symbol | VERU | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 77.7 | ||
Entity Common Stock, Shares Outstanding | 93,672,854 | ||
Documents Incorporated By Reference | DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the 2024 Annual Meeting of the Shareholders of the Registrant are incorporated by reference into Part III of this report. | ||
Current Fiscal Year End Date | --09-30 | ||
Auditor Firm ID | 49 | ||
Auditor Name | RSM US LLP | ||
Auditor Location | Chicago, Illinois | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0000863894 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 9,625,494 | $ 80,190,675 |
Accounts receivable, net | 4,506,508 | 3,550,895 |
Inventories, net | 6,697,117 | 8,618,944 |
Prepaid research and development costs | 1,579,086 | 10,444,587 |
Prepaid expenses and other current assets | 1,097,851 | 1,964,373 |
Total current assets | 23,506,056 | 104,769,474 |
Plant and equipment, net | 1,652,732 | 1,185,766 |
Operating lease right-of-use asset | 4,332,473 | 4,786,915 |
Deferred income taxes | 12,707,419 | 12,965,985 |
Intangible assets, net | 5,952 | 3,977,381 |
Goodwill | 6,878,932 | 6,878,932 |
Other assets | 1,512,361 | 1,561,564 |
Total assets | 50,595,925 | 136,126,017 |
Current liabilities: | ||
Accounts payable | 14,576,624 | 22,003,394 |
Accrued research and development costs | 853,987 | 9,071,503 |
Accrued compensation | 990,609 | 5,986,557 |
Accrued expenses and other current liabilities | 1,956,075 | 2,249,995 |
Residual royalty agreement, short-term portion (Note 9) | 864,623 | 1,169,095 |
Operating lease liability, short-term portion | 1,036,590 | 957,085 |
Total current liabilities | 20,278,508 | 41,437,629 |
Residual royalty agreement, long-term portion (Note 9) | 8,870,136 | 9,656,441 |
Operating lease liability, long-term portion | 3,634,114 | 4,093,667 |
Deferred income taxes | 81,067 | |
Other liabilities | 29,948 | 18,577 |
Total liabilities | 32,812,706 | 55,287,381 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Preferred stock, no shares issued and outstanding at September 30, 2023 and 2022, respectively | ||
Common stock, par value $0.01 per share; 308,000,000 and 154,000,000 shares authorized, 93,966,402 and 82,692,598 shares issued and 91,782,698 and 80,508,894 shares outstanding at September 30, 2023 and 2022, respectively | 939,664 | 826,926 |
Additional paid-in-capital | 283,894,830 | 253,974,032 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (258,663,151) | (165,574,198) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 17,783,219 | 80,838,636 |
Total liabilities and stockholders' equity | $ 50,595,925 | $ 136,126,017 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Sep. 30, 2022 |
CONSOLIDATED BALANCE SHEETS [Abstract] | ||
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common Stock, par value | $ 0.01 | $ 0.01 |
Common Stock, shares authorized | 308,000,000 | 154,000,000 |
Common Stock, shares issued | 93,966,402 | 82,692,598 |
Common Stock, shares outstanding | 91,782,698 | 80,508,894 |
Treasury stock, shares | 2,183,704 | 2,183,704 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ||
Net revenues | $ 16,296,958 | $ 39,354,352 |
Cost of sales | 8,731,030 | 8,762,964 |
Gross profit | 7,565,928 | 30,591,388 |
Operating expenses: | ||
Research and development | 51,138,480 | 70,646,103 |
Selling, general and administrative | 48,057,834 | 43,177,345 |
Provision for (recovery of) credit losses | 3,911,714 | (8,500) |
Impairment of intangible assets | 3,900,000 | |
Total operating expenses | 107,008,028 | 113,814,948 |
Gain on sale of ENTADFI® assets | 5,723,623 | |
Operating loss | (93,718,477) | (83,223,560) |
Non-operating income (expenses): | ||
Interest expense | (2,427,041) | (4,368,798) |
Change in fair value of derivative liabilities | 2,963,000 | 3,557,000 |
Other income, net | 573,771 | 495,735 |
Total non-operating income (expenses) | 1,109,730 | (316,063) |
Loss before income taxes | (92,608,747) | (83,539,623) |
Income tax expense | 480,206 | 236,397 |
Net loss | $ (93,088,953) | $ (83,776,020) |
Net loss per basic common share outstanding | $ (1.10) | $ (1.05) |
Basic weighted average common shares outstanding | 84,973,382 | 80,122,526 |
Net loss per diluted common share outstanding | $ (1.10) | $ (1.05) |
Diluted weighted average common shares outstanding | 84,973,382 | 80,122,526 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] Lincoln Park And Aspire Capital Purchase Agreements [Member] | Common Stock [Member] Jefferies Sales Agreement [Member] | Common Stock [Member] Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Lincoln Park And Aspire Capital Purchase Agreements [Member] | Additional Paid-in Capital [Member] Jefferies Sales Agreement [Member] | Additional Paid-in Capital [Member] Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Treasury Stock, at Cost [Member] | Lincoln Park And Aspire Capital Purchase Agreements [Member] | Jefferies Sales Agreement [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | Total |
Balance at Sep. 30, 2021 | $ 821,535 | $ 241,658,711 | $ (581,519) | $ (81,798,178) | $ (7,806,605) | $ 152,293,944 | |||||||||
Balance (in Shares) at Sep. 30, 2021 | 82,153,452 | ||||||||||||||
Share-based compensation | 11,242,423 | 11,242,423 | |||||||||||||
Issuance of shares pursuant to share-based awards | $ 5,391 | 1,072,898 | 1,078,289 | ||||||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 539,146 | ||||||||||||||
Net loss | (83,776,020) | (83,776,020) | |||||||||||||
Balance at Sep. 30, 2022 | $ 826,926 | 253,974,032 | (581,519) | (165,574,198) | (7,806,605) | 80,838,636 | |||||||||
Balance (in Shares) at Sep. 30, 2022 | 82,692,598 | ||||||||||||||
Share-based compensation | 17,918,603 | 17,918,603 | |||||||||||||
Issuance of shares pursuant to share-based awards | $ 1,918 | 387,140 | 389,058 | ||||||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 191,832 | ||||||||||||||
Shares issued in connection with common stock purchase agreement (in Shares) | 800,000 | ||||||||||||||
Shares issued in connection with common stock purchase agreement | $ 8,000 | 1,000,000 | $ 1,277,259 | 1,008,000 | |||||||||||
Sale/issuance of shares (in Shares) | 4,004,713 | 1,277,259 | 5,000,000 | ||||||||||||
Sale/issuance of shares | $ 40,047 | $ 12,773 | $ 50,000 | $ 4,806,644 | $ 1,027,548 | $ 4,919,045 | $ 4,846,691 | 1,040,321 | $ 4,969,045 | ||||||
Amortization of deferred costs | (138,182) | $ (3,000) | (138,182) | ||||||||||||
Net loss | (93,088,953) | (93,088,953) | |||||||||||||
Balance at Sep. 30, 2023 | $ 939,664 | $ 283,894,830 | $ (581,519) | $ (258,663,151) | $ (7,806,605) | $ 17,783,219 | |||||||||
Balance (in Shares) at Sep. 30, 2023 | 93,966,402 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
OPERATING ACTIVITIES | ||
Net loss | $ (93,088,953) | $ (83,776,020) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 269,874 | 209,595 |
Impairment of intangible assets | 3,900,000 | |
Provision for credit losses | 3,911,714 | (8,500) |
Gain on sale of ENTADFI® assets | (5,723,623) | |
Noncash change in right-of-use assets | 741,257 | 594,398 |
Noncash interest expense, net of interest paid | 1,872,223 | 1,748,189 |
Share-based compensation | 17,918,603 | 11,242,423 |
Deferred income taxes | 177,499 | 76,206 |
Provision for obsolete inventory | 185,499 | 82,019 |
Change in fair value of derivative liabilities | (2,963,000) | (3,557,000) |
Other | 290 | 1,723 |
Changes in operating assets and liabilities: | ||
(Increase) decrease in accounts receivable | (4,153,327) | 4,537,829 |
Decrease (increase) in inventories | 648,628 | (3,126,710) |
Decrease (increase) in prepaid expenses and other assets | 10,004,978 | (2,352,547) |
(Decrease) increase in accounts payable | (7,426,770) | 18,593,623 |
(Decrease) increase in accrued expenses and other current liabilities | (13,621,843) | 8,698,314 |
Decrease in operating lease liabilities | (666,863) | (468,546) |
Net cash used in operating activities | (88,013,814) | (47,505,004) |
INVESTING ACTIVITIES | ||
Cash proceeds from sale of ENTADFI® assets | 7,000,000 | |
Cash proceeds from sale of PREBOOST® business | 5,000,000 | |
Capital expenditures | (665,700) | (733,052) |
Net cash provided by investing activities | 6,334,300 | 4,266,948 |
FINANCING ACTIVITIES | ||
Proceeds from stock option exercises | 389,058 | 1,078,289 |
Payment of deferred equity financing issuance costs | (263,757) | |
Proceeds from premium finance agreement | 1,425,174 | |
Installment payments on premium finance agreement | (1,292,199) | |
Cash paid for debt portion of finance lease | (9,093) | |
Net cash provided by financing activities | 11,114,333 | 1,069,196 |
Net (decrease) increase in cash and cash equivalents | (70,565,181) | (42,168,860) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 80,190,675 | 122,359,535 |
CASH AND CASH EQUIVALENTS AT END OF YEAR | 9,625,494 | 80,190,675 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 247,361 | 422,135 |
Cash paid for interest | 554,818 | 2,620,609 |
Schedule of non-cash investing and financing activities: | ||
Shares issued in connection with common stock purchase agreement | 1,008,000 | |
Amortization of deferred costs related to common stock purchase agreement | 138,182 | |
Right-of-use assets recorded in exchange for lease liabilities | 286,815 | $ 4,411,474 |
Jefferies Sales Agreement [Member] | ||
FINANCING ACTIVITIES | ||
Proceeds from sale of shares | 1,040,321 | |
Lincoln Park And Aspire Capital Purchase Agreements [Member] | ||
FINANCING ACTIVITIES | ||
Proceeds from sale of shares | 4,846,691 | |
Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | ||
FINANCING ACTIVITIES | ||
Proceeds from sale of shares | $ 4,969,045 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2023 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Nature of Business and Significant Accounting Policies | Note 1 – Nature of Business and Significant Accounting Policies Principles of consolidation and nature of operations: Veru Inc. is referred to in these notes collectively with its subsidiaries as “we,” “our,” “us,” “Veru” or the “Company.” The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, Veru International Holdco Inc., Aspen Park Pharmaceuticals, Inc. (APP) and The Female Health Company Limited; The Female Health Company Limited’s wholly owned subsidiary, The Female Health Company (UK) plc (The Female Health Company Limited and The Female Health Company (UK) plc, collectively, the “U.K. subsidiary”); The Female Health Company (UK) plc’s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the “Malaysia subsidiary”); and Veru International Holdco Inc.’s wholly owned subsidiaries, Veru Biopharma UK Limited, Veru Biopharma Europe Limited, and Veru Biopharma Netherlands B.V. All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases (obesity), oncology, and acute respiratory distress syndrome (ARDS). Our drug development program includes enobosarm, a selective androgen receptor modulator, for preferential loss of fat while preventing the loss of muscle and bone, in combination with weight loss drugs, and for the management of advanced breast cancer and sabizabulin, a microtubule disruptor, for the treatment of hospitalized patients with viral induced ARDS. The Company also has the FC2 Female Condom/FC2 Internal Condom® (FC2), an FDA-approved commercial product for the dual protection against unplanned pregnancy and sexually transmitted infections. The Company had ENTADFI® (finasteride and tadalafil) capsules for oral use (ENTADFI), a new treatment for benign prostatic hyperplasia that was approved by the FDA in December 2021. We sold substantially all of the assets related to ENTADFI on April 19, 2023. See Note 15 for additional information. Most of the Company’s net revenues during fiscal 2023 and 2022 were derived from sales of FC2. FC2 has been distributed in either or both commercial (private sector) and public health sector markets in 150 countries. It is marketed to consumers in various countries through distributors, public health programs, and/or retailers and in the U.S. by prescription. Use of estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S. GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. Segments : We regularly review our operating segments and the approach used by management to evaluate performance and allocate resources. The Company operates as a single operating segment. Our determination that we operate as a single segment is consistent with the financial information regularly reviewed by the chief operating decision maker (CODM) for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. Our CODM allocates resources and assesses financial performance on a consolidated basis. Cash and cash equivalents and concentration : Cash and cash equivalents, which primarily consist of cash on deposit with financial institutions and highly liquid money market funds, are recorded in the consolidated balance sheets at cost, which approximates fair value. The Company treats short-term, highly liquid funds that are readily convertible to known amounts of cash and have original maturities of three months or less as cash equivalents. The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England; and Kuala Lumpur, Malaysia. Accounts receivable and concentration of credit risk : Accounts receivable are carried at original invoice amount less an estimate made for returns, discounts, and credit losses based on a review of all outstanding amounts on a periodic basis. Inventories : Inventories are valued at the lower of cost or net realizable value. The cost is determined using the first-in, first-out (FIFO) method. Inventories are also written down for management’s estimates of product which will not sell prior to its expiration date. Write-downs of inventories establish a new cost basis which is not increased for future increases in the net realizable value of inventories or changes in estimated obsolescence. The Company capitalizes inventory costs associated with its drug products following regulatory approval when future commercialization is considered probable and the future economic benefit is expected to be realized. Prior to an initial regulatory approval for our drug products under clinical development, we expense costs relating to the production of inventory as research and development expense in the Company’s consolidated statements of operations, in the period incurred. Fixed assets : We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method, over the estimated useful lives of the assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the assets. Leases : Leases are classified as either operating or finance leases at inception. A right-of-use (ROU) asset and corresponding lease liability are established at an amount equal to the present value of fixed lease payments over the lease term at the commencement date. The ROU asset includes any initial direct costs incurred and lease payments made at or before the commencement date and is reduced by lease incentive payments. The Company has elected not to separate the lease and nonlease components for all classes of underlying assets. The Company uses its incremental borrowing rate as the discount rate to determine the present value of the lease payments for leases that do not have a readily determinable implicit discount rate. The incremental borrowing rate is the rate of interest that the Company would be charged to borrow on a collateralized basis over a similar term and amount in a similar economic environment. The Company determines the incremental borrowing rates for its leases by adjusting the risk-free interest rate with a credit risk premium corresponding to the Company’s credit rating. Operating lease costs are recognized for fixed lease payments on a straight-line basis over the term of the lease. Finance lease costs are a combination of the amortization expense for the ROU asset and interest expense for the outstanding lease liability using the applicable discount rate. Variable lease payments are recognized when incurred based on occurrence or usage. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for short-term leases on a straight-line basis over the lease term. Patents and trademarks : The costs for patents and trademarks are expensed when incurred. Goodwill and intangible assets : The Company’s goodwill and intangible assets, primarily developed technology and in-process research and development (IPR&D), arose from the acquisition of APP (the “APP Acquisition”) on October 31, 2016. Goodwill and indefinite-lived intangible assets are not amortized. IPR&D is accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a finite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off. Goodwill and indefinite-lived assets are subject to an impairment review annually, in the fourth quarter of each fiscal year, and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Intangible assets with finite lives are tested for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. These intangible assets are carried at cost less accumulated amortization. Goodwill consists of the cost of an acquired business in excess of the fair value of the net assets acquired. The Company’s goodwill is assigned to the reporting unit that is expected to benefit from the synergies of a business combination. The Company has identified two reporting units within its single operating segment. The Company tests goodwill and indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the Company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the Company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and potentially result in different impacts to the Company's results of operations. Actual results may differ from the Company's estimates. The fair value of the reporting unit is compared with its carrying amount and an impairment charge would be recognized for the amount by which the carrying value exceeds the reporting unit’s fair value. Regarding goodwill, the estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Changes in these assumptions may impact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results are not consistent with our estimates and assumptions, we may be exposed to an impairment charge that could be material. Intangible assets are highly vulnerable to impairment charges, particularly IPR&D. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval, additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. During the second quarter of fiscal 2023, the Company recorded an impairment charge of $ 3.9 million related to IPR&D. The charge was primarily a result of the Company’s strategic decision to refocus its drug development efforts on those drug candidates that it believes to have the best opportunity to lead to long-term success and shareholder value creation, which led the Company to indefinitely cease development of sabizabulin for prostate cancer and zuclomiphene. See Note 8 for additional information. The Company’s intangible asset balance for IPR&D at September 30, 2023, after the impairment charge was recorded, is zero . Deferred financing costs : Costs incurred in connection with the common stock purchase agreements and the at-the-market sale agreement discussed in Note 10 have been included in other assets on the accompanying consolidated balance sheets at September 30, 2023 and 2022. When shares of the Company’s common stock are sold under the common stock purchase agreement or at-the market sale agreement, a pro-rata portion of the deferred costs is recorded to additional paid-in-capital. Fair value measurements : Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 820 – Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements . The carrying amounts reported in the accompanying consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of the residual royalty agreement liabilities, taking into consideration the related derivative instruments, is estimated to approximate fair value. Derivative instruments : The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments . Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities in curred in connection with an embedded derivative are discussed in Note 9. Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue. Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, costs to conduct clinical trials, and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did no t have any material capitalized nonrefundable advance payments as of September 30, 2023. The Company records estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract manufacturing activities. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. Share-based compensation : The Company recognizes share-based compensation expense in connection with its share-based awards, based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rate. Advertising : The Company's policy is to expense advertising costs as incurred. Advertising costs were $ 0.9 million and $ 0.6 million for the years ended September 30, 2023 and 2022, respectively. Income taxes : The Company files separate income tax returns for its foreign subsidiaries. FASB ASC Topic 740 requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are also provided for carryforwards for income tax purposes. In addition, the amount of any future tax benefits is reduced by a valuation allowance to the extent such benefits are not expected to be realized. Foreign currency translation and operations : Effective October 1, 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries’ functional currency, resulting in the adoption of the U.S. dollar as the functional currency for all foreign subsidiaries. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $ 0.6 million as of September 30, 2023 and September 30, 2022. Assets located outside of the U.S. totaled approximately $ 10.5 million and $ 10.8 million at September 30, 2023 and September 30, 2022, respectively. Other comprehensive loss : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss. Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. In fiscal 2023 and 2022, comprehensive income (loss) is equivalent to the reported net income (loss). Recent accounting pronouncements not yet adopted : In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the CODM and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures. We have reviewed all other recently issued accounting pronouncements and have determined that such standards that are not yet effective will not have a material impact on our financial statements or do not otherwise apply to our operations. |
Going Concern
Going Concern | 12 Months Ended |
Sep. 30, 2023 | |
Going Concern [Abstract] | |
Going Concern | Note 2 – Going Concern The Company is not profitable and has had negative cash flow from operations. We will need substantial capital to support our drug development and any related commercialization efforts for our drug candidates. Based upon the Company’s current operating plan, it estimates that its cash and cash equivalents as of the issuance date of these financial statements are insufficient for the Company to fund operating, investing and financing cash flow needs for the twelve months subsequent to the issuance date of these financial statements. To obtain the capital necessary to fund our operations, we expect to finance our cash needs through public or private equity offerings, debt financing transactions and/or other capital sources. Additional capital may not be available at such times and in such amounts as needed by us to fund our activities on a timely basis. These uncertainties raise substantial doubt regarding our ability to continue as a going concern for a period of twelve months subsequent to the issuance date of these financial statements. Certain elements of our operating plan to alleviate the conditions that raise substantial doubt, including but not limited to our ability to secure equity financing or other financing alternatives, are outside of our control and cannot be included in management’s evaluation under the requirement of ASC 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least twelve months subsequent to the issuance date of these financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | Note 3 – Fair Value Measurements FASB ASC Topic 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The three levels of the fair value hierarchy are as follows: Level 1 – Quoted prices for identical instruments in active markets. Level 2 – Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 – Instruments with primarily unobservable value drivers. There were no transfers between Level 1, Level 2 and Level 3 during fiscal 2023 and 2022. Amounts capitalized as IPR&D are subject to impairment testing until the completion or abandonment of the associated research and development efforts. We use probability-adjusted discounted cash flow calculations using Level 3 fair value measurements and inputs including estimated revenues, costs, probability of technical and regulatory success and discount rates to measure impairment, if any. During the second quarter of fiscal 2023, we recognized an impairment charge of $ 3.9 million associated with IPR&D intangible assets due to their meeting the criteria for abandonment under the accounting standards. See Note 8 for additional information. As of September 30, 2023 and 2022, the Company’s financial liabilities measured at fair value on a recurring basis, which consisted of embedded derivatives, are also classified within Level 3 of the fair value hierarchy . The Company determines the fair value of hybrid instruments based on available market data using appropriate valuation models, considering all of the rights and obligations of each instrument. The Company estimates the fair value of hybrid instruments using various techniques (and combinations thereof) that are considered to be consistent with the objective of measuring fair value. In selecting the appropriate technique, the Company considers, among other factors, the nature of the instrument, the market risks that it embodies and the expected means of settlement. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. Increases in fair value during a given financial quarter result in the recognition of non-cash derivative expense. Conversely, decreases in fair value during a given financial quarter would result in the recognition of non-cash derivative income. The following table provides a reconciliation of the beginning and ending liability balance associated with embedded derivatives measured at fair value using significant unobservable inputs (Level 3) for the years ended September 30, 2023 and 2022: 2023 2022 Beginning balance $ 4,294,000 $ 7,851,000 Change in fair value of derivative liabilities ( 2,963,000 ) ( 3,557,000 ) Ending balance $ 1,331,000 $ 4,294,000 The expense or income associated with the change in fair value of the embedded derivatives is presented as a separate line item in the accompanying consolidated statements of operations. The liabilities associated with embedded derivatives represent the fair value of the change of control provisions in the Residual Royalty Agreement. See Note 9 for additional information. There is no current observable market for these types of derivatives. The Company estimates the fair value of the embedded derivative within the Residual Royalty Agreement by using a scenario-based method, whereby different scenarios are valued and probability weighted. The scenario-based valuation model incorporates transaction details such as the contractual terms of the instrument and assumptions including projected FC2 revenues, expected cash outflows, probability and estimated dates of a change of control, risk-free interest rates and applicable credit risk. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. The decrease in the fair value of derivative liabilities in fiscal 2023 was driven by a decrease in the expected cash outflows under the Residual Royalty Agreement, due to decreases in projected FC2 net revenues in future periods, and increases in the discount rates used, due primarily to external market factors. The decrease in the fair value of derivative liabilities in fiscal 2022 was driven by a decrease in the expected cash outflows under the Residual Royalty Agreement, due to decreases in projected FC2 net revenues in future periods, and increases in the discount rates used, due primarily to external market factors. The following table presents quantitative information about the inputs and valuation methodologies used to determine the fair value of the embedded derivatives classified in Level 3 of the fair value hierarchy as of September 30, 2023 and 2022: Valuation Methodology Significant Unobservable Input 2023 2022 Scenario-Based Estimated change of control dates December 2024 to December 2026 September 2023 to September 2025 Discount rate 14.1 % to 15.1 % 13.6 % to 14.2 % Probability of change of control 20 % to 90 % 20 % to 90 % |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Sep. 30, 2023 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Contracts with Customers | Note 4 – Revenue from Contracts with Customers The Company generates nearly all its revenue from direct product sales. Revenue from direct product sales is generally recognized when the customer obtains control of the product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Sales taxes and other similar taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue. The amount of consideration the Company ultimately receives varies depending upon sales discounts, and other incentives that the Company may offer, which are accounted for as variable consideration when estimating the amount of revenue to recognize. The estimate of variable consideration requires significant judgment. The Company includes estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. The estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely upon an assessment of current contract sales terms and historical payment experience. Product returns are typically not significant because returns are generally not allowed unless the product is damaged at time of receipt. The Company’s revenue is primarily from sales of FC2 in the U.S. prescription channel and direct sales of FC2 in the global public health sector, and also included sales of ENTADFI through the date the ENTADFI assets were sold on April 19, 2023. The following table presents net revenues by product and sector for the years ended September 30, 2023 and 2022: 2023 2022 FC2 U.S. prescription channel $ 5,823,921 $ 30,223,079 Global public health sector 10,460,024 9,128,858 Total FC2 16,283,945 39,351,937 Other 13,013 2,415 Net revenues $ 16,296,958 $ 39,354,352 The following table presents net revenue by geographic area for the years ended September 30, 2023 and 2022: 2023 2022 United States $ 8,370,202 $ 31,430,235 South Africa 1,941,678 * Other 5,985,078 7,924,117 Net revenues $ 16,296,958 $ 39,354,352 *Less than 10 % of total net revenues The Company’s performance obligations consist mainly of transferring control of products identified in the contracts which occurs either when: i) the product is made available to the customer for shipment; ii) the product is shipped via common carrier; or iii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement. Some of the Company’s contracts require the customer to make advanced payments prior to transferring control of the products. These advanced payments create a contract liability for the Company. The balances of the Company’s contract liability, included in accrued expenses and other current liabilities on the accompanying consolidated balances sheets, was approximately $ 105,000 and $ 342,000 at September 30, 2023 and 2022, respectively. The amount of revenue recognized that was included in the contract liabilities and unearned revenues balance at the beginning of the period was $ 330,000 and $ 130,000 during the years ended September 30, 2023 and 2022, respectively, after satisfying its contract obligations and transferring control. |
Accounts Receivable and Concent
Accounts Receivable and Concentration of Credit Risk | 12 Months Ended |
Sep. 30, 2023 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Accounts Receivable and Concentration of Credit Risk | Note 5 – Accounts Receivable and Concentration of Credit Risk The Company’s standard credit terms vary from 30 to 120 days, depending on the class of trade and customary terms within a territory, so accounts receivable is affected by the mix of sales within the period. As is typical in the Company’s business, extended credit terms may occasionally be offered as a sales promotion or for certain sales. For sales to the Company’s distributor in Brazil, the Company has agreed to credit terms of up to 90 days subsequent to clearance of the product by the Ministry of Health in Brazil. The Company classified approximately $ 0.7 million of trade receivables with its distributor in Brazil as long-term as of September 30, 2022, because payment was expected in greater than one year. The long-term portion of trade receivables is included in other assets on the accompanying consolidated balance sheet. The Company has $ 1.4 million of trade receivables as of September 30, 2023 due from its distributor in Brazil for sales recognized in fiscal 2021, which the Company expects to be paid within one year. The components of accounts receivable consist of the following at September 30, 2023 and 2022: 2023 2022 Trade receivables, gross $ 8,445,370 $ 4,289,892 Less: allowance for credit losses ( 3,923,857 ) ( 12,143 ) Less: allowance for sales returns and payment term discounts ( 15,005 ) ( 12,854 ) Less: long-term trade receivables* — ( 714,000 ) Accounts receivable, net $ 4,506,508 $ 3,550,895 *Included in other assets on the accompanying consolidated balance sheets. No customer had a current accounts receivable balance that represented 10% of current assets at September 30, 2023 and 2022. At September 30, 2023, three customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 71 % of net accounts receivable in the aggregate. At September 30, 2022, two customers had an accounts receivable balance greater than 10% of net accounts receivable and long-term trade receivables, representing 83 % of the Company’s net accounts receivable and long-term trade receivables in the aggregate. For the year ended September 30, 2023, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 47 % of the Company’s net revenues in the aggregate, including The Pill Club that represented 24 % of the Company’s net revenues. For the year ended September 30, 2022, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 73 % of the Company’s net revenues in the aggregate, including The Pill Club that represented 44 % of the Company’s net revenues. The Company maintains an allowance for credit losses for estimated losses resulting from the inability of its customers to make required payments on accounts receivable. Management determines the allowance for credit losses by identifying troubled accounts and by using historical experience applied to an aging of accounts. Management also periodically evaluates individual customer receivables and considers a customer’s financial condition, credit history, and the current economic conditions. Accounts receivable are charged-off when deemed uncollectible. During the year ended September 30, 2023, the Company recorded a provision for credit losses of $ 3.9 million related to the total amount of receivables due from The Pill Club due to their Chapter 11 bankruptcy, filed on April 18, 2023. The table below summarizes the change in the allowance for credit losses on trade receivables for the years ended September 30, 2023 and 2022: 2023 2022 Beginning balance $ 12,143 $ 20,643 Charge-offs (recoveries), net 3,911,714 ( 8,500 ) Ending balance $ 3,923,857 $ 12,143 Recoveries of accounts receivable previously charged-off are recorded when received. In the global public health sector, the Company’s customers are primarily health care distributors, large global agencies, non-government organizations, ministries of health and other governmental agencies which purchase and distribute FC2 for use in HIV/AIDS prevention and family planning programs. In the U.S. prescription channel, the Company’s customers include primarily telemedicine providers. |
Inventories
Inventories | 12 Months Ended |
Sep. 30, 2023 | |
Inventories [Abstract] | |
Inventories | Note 6 – Inventories Inventories consisted of the following at September 30, 2023 and September 30, 2022 2023 2022 Raw material $ 1,854,810 $ 1,662,712 Work in process 112,799 872,596 Finished goods 4,913,295 6,099,343 Inventories, gross 6,880,904 8,634,651 Less: inventory reserves ( 183,787 ) ( 15,707 ) Inventories, net $ 6,697,117 $ 8,618,944 The Company had ENTADFI inventory of $ 1.1 million, which was included in the sale of ENTADFI assets, and was included in the inventories balance at September 30, 2022. See Note 15 for additional information. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2023 | |
Property and Equipment [Abstract] | |
Property and Equipment | Note 7 – Property and Equipment Property and equipment consisted of the following at September 30, 2023 and 2022: Estimated Useful Life 2023 2022 Property and equipment: Manufacturing equipment 5 - 8 years $ 3,008,122 $ 2,902,715 Office equipment, furniture and fixtures 3 - 10 years 1,471,870 1,440,475 Leasehold improvements 3 - 8 years 960,694 484,460 Total property and equipment 5,440,686 4,827,650 Less: accumulated depreciation and amortization ( 3,787,954 ) ( 3,641,884 ) Property and equipment, net $ 1,652,732 $ 1,185,766 Depreciation expense for the years ended September 30, 2023 and 2022 was approximately $ 198,000 and $ 138,000 , respectively. Property and equipment included $ 214,000 and $ 276,000 at September 30, 2023 and 2022, respectively, for deposits on equipment, furniture, and leasehold improvements, which have not been placed into service; therefore, the Company has not started to record depreciation expense. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Sep. 30, 2023 | |
Intangible Assets and Goodwill [Abstract] | |
Intangible Assets and Goodwill | Note 8 –Intangible Assets and Goodwill Intangible Assets Intangible assets includes IPR&D and covenants not-to-compete. The gross carrying amounts and net book value of intangible assets are as follows at September 30, 2023: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 494,048 $ 5,952 Indefinite-lived intangible assets: Acquired in-process research and development assets — — — Total intangible assets $ 500,000 $ 494,048 $ 5,952 The gross carrying amounts and net book value of intangible assets are as follows at September 30, 2022: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 422,619 $ 77,381 Indefinite-lived intangible assets: Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 4,400,000 $ 422,619 $ 3,977,381 Amortization is recorded on a straight-line basis over seven years for the covenants not-to-compete. The amortization expense is recorded in selling, general and administrative expenses in the accompanying consolidated statements of operations. Amortization expense was approximately $ 71,000 for the years ended September 30, 2023 and 2022. Based on finite-lived intangible assets recorded as of September 30, 2023, the estimated future amortization expense is approximately $ 6,000 in fiscal 2024. In March 2023, the Company announced its strategic decision to refocus its drug development efforts on those drug candidates that it believes have the best opportunity to lead to long-term success and shareholder value creation. As part of this strategic decision, the Company has indefinitely ceased development of sabizabulin for prostate cancer and zuclomiphene. The Company has no current plans that would invest funds in the development of these two assets or that would lead to the Company deriving value from these two assets, which has met the criteria for abandonment under the accounting standards. This resulted in writing off the carrying amount of these two acquired in-process research and development assets and recording an impairment charge of $ 3.9 million for the year ended September 30, 2023. Goodwill The carrying amount of goodwill at September 30, 2023 and 2022 was $ 6.9 million. There was no change in the balance during the years ended September 30, 2023 and 2022. The Company’s goodwill is assigned to the Research and Development reporting unit, which had a negative carrying amount as of September 30, 2023. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2023 | |
Debt [Abstract] | |
Debt | Note 9 – Debt SWK Residual Royalty Agreement On March 5, 2018, the Company entered into a Credit Agreement (the “Credit Agreement”) with the financial institutions party thereto from time to time (the “Lenders”) and SWK Funding LLC, as agent for the Lenders (the “Agent”), for a synthetic royalty financing transaction. On and subject to the terms of the Credit Agreement, the Lenders provided the Company with a term loan of $ 10.0 million, which was advanced to the Company on the date of the Credit Agreement. The Company repaid the loan and return premium specified in the Credit Agreement in August 2021, and as a result has no further obligations under the Credit Agreement. The Agent has released its security interest in Company collateral previously pledged to secure its obligations under the Credit Agreement. In connection with the Credit Agreement, the Company and the Agent also entered into a Residual Royalty Agreement, dated as of March 5, 2018 (as amended, the “Residual Royalty Agreement”), which provides for an ongoing royalty payment of 5 % of product revenue from net sales of FC2. The Residual Royalty Agreement will terminate upon (i) a change of control or sale of the FC2 business and the payment by the Company of the amount due in connection therewith pursuant to the Residual Royalty Agreement, or (ii) mutual agreement of the parties. If a change of control or sale of the FC2 business occurs, the Agent will receive a payment that is the greater of (A) $ 2.0 million or (B) the product of (x) 5 % of the product revenue from net sales of FC2 for the most recently completed 12 -month period multiplied by (y) five . For accounting purposes, the $ 10.0 million advance under the Credit Agreement was allocated between the Credit Agreement and the Residual Royalty Agreement on a relative fair value basis. A portion of the amount allocated to the Residual Royalty Agreement, equal to the fair value of the change of control provision, was allocated to an embedded derivative liability. The derivative liability is adjusted to fair market value at each reporting period . At September 30, 2023 and 2022, the Residual Royalty Agreement liability consisted of the following: 2023 2022 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,377,949 9,950,908 Less: cumulative payments ( 4,320,190 ) ( 3,765,372 ) Residual royalty agreement liability, excluding embedded derivative liability 8,403,759 6,531,536 Add: embedded derivative liability at fair value (see Note 3) 1,331,000 4,294,000 Total residual royalty agreement liability 9,734,759 10,825,536 Residual royalty agreement liability, short-term portion ( 864,623 ) ( 1,169,095 ) Residual royalty agreement liability, long-term portion $ 8,870,136 $ 9,656,441 As the Company has repaid the original principal of $ 10.0 million advanced in connection with the Credit Agreement and the Residual Royalty Agreement, payments under the Residual Royalty Agreement are classified as interest payments and included in operating activities on the accompanying consolidated statements of cash flows. The short-term portion of the Residual Royalty Agreement liability represents the aggregate of the estimated quarterly royalty payments payable during the 12-month period subsequent to the balance sheet dates. Interest expense on the accompanying consolidated statements of operations relates to the accretion of the liability for the Residual Royalty Agreement. The accretion of the liability is based on projected FC2 revenues. Premium Finance Agreement On November 1, 2022, the Company entered into an agreement to finance $ 1.4 million of its directors and officers liability insurance premium at an annual percentage rate of 6.3 %. The financing agreement was payable in eleven monthly installments of principal and interest, which began on December 1, 2022. The balance of the insurance premium liability is $ 0.1 million as of September 30, 2023 and is included in accrued expenses and other current liabilities on the accompanying consolidated balance sheet. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 10 – Stockholders’ Equity Preferred Stock The Company has 5,000,000 shares designated as Class A Preferred Stock with a par value of $ 0.01 per share. There are 1,040,000 shares of Class A Preferred Stock – Series 1 authorized; 1,500,000 shares of Class A Preferred Stock – Series 2 authorized; 700,000 shares of Class A Preferred Stock – Series 3 authorized; and 548,000 shares of Class A Preferred Stock – Series 4 authorized. There were no shares of Class A Preferred Stock of any series issued and outstanding at September 30, 2023 and September 30, 2022. The Company has 15,000 shares designated as Class B Preferred Stock with a par value of $ 0.50 per share. There were no shares of Class B Preferred Stock issued and outstanding at September 30, 2023 and September 30, 2022. Common Stock We are authorized to issue up to 308,000,000 shares of common stock, $ 0.01 par value per share. Following approval by stockholders at the Company’s annual meeting of stockholders held on July 24, 2023, the Company filed an amendment to its articles of incorporation to increase the number of authorized shares of common stock from 154,000,000 to 308,000,000 . Holders are entitled to one vote for each share of common stock. Shelf Registration Statement In March 2023, the Company filed a shelf registration statement on Form S-3 (File No. 333 - 270606) with a capacity of $ 200 million, which was declared effective by the Securities and Exchange Commission (“SEC”) on April 14, 2023. At September 30, 2022, $ 23.0 million remains available under that shelf registration statement. The Company’s prior shelf registration statement on Form S-3 (File No. 333-239493) expired on July 1, 2023. Aspire Capital Purchase Agreement On June 26, 2020, the Company entered into a common stock purchase agreement (the “Aspire Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company had the right, from time to time in its sole discretion during the 36 -month term of the Aspire Purchase Agreement, to direct Aspire Capital to purchase up to $ 23.9 million of the Company’s common stock in the aggregate. During the year ended September 30, 2023, we sold 2,779,713 shares of common stock to Aspire Capital under the Aspire Purchase Agreement resulting in proceeds to the Company of $ 3.4 million. As a result of these sales, we recorded approximately $ 105,000 of deferred costs to additional paid-in capital. During the 36-month term of the Aspire Purchase Agreement, we sold 4,424,450 shares of common stock to Aspire Capital resulting in proceeds to the Company of $ 8.4 million. On June 26, 2023, the term of the Aspire Purchase Agreement expired and no additional shares of common stock will be sold under the agreement. In consideration for entering into the Aspire Purchase Agreement, concurrently with the execution of the Aspire Purchase Agreement, the Company issued to Aspire Capital 212,130 shares of the Company’s common stock. The shares of common stock issued as consideration were valued at $ 681,000 , based on the closing price per share of the Company’s common stock on the date the shares were issued. This amount and related expenses of $ 50,000 , which total approximately $ 731,000 , were recorded as deferred costs. The unamortized amount of deferred costs related to the Aspire Purchase Agreement remaining when the agreement terminated was $ 473,000 and was expensed at the time of termination. It is included in selling, general and administrative expenses on the accompanying consolidated statement of operations for the year ended September 30, 2023. The unamortized amount of deferred costs related to the Aspire Purchase Agreement of $ 578,000 at September 30, 2022 is included in other assets on the accompanying consolidated balance sheet. Private Investment in Public Equity On April 12, 2023, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”) with Frost Gamma Investments Trust (“FGI”), pursuant to which, on the date thereof, the Company issued and sold 5,000,000 shares of the Company’s common stock to FGI at a price of $ 1.00 per share, for a total investment of $ 5.0 million, through a private investment in public equity financing. Proceeds were recorded net of issuance costs of $ 31,000 . The shares of common stock issued to FGI pursuant to the Stock Purchase Agreement were not registered under the Securities Act. The Company filed a registration statement under the Securities Act to register the resale of the shares of common stock issued to FGI, which was declared effective by the SEC on May 24, 2023. Lincoln Park Capital Fund LLC Purchase Agreement On May 2, 2023, the Company entered into a purchase agreement (the “Lincoln Park Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $ 100.0 million of shares (the “Purchase Shares”) of the Company’s common stock over the 36 month term of the Lincoln Park Purchase Agreement. The Lincoln Park Purchase Agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park. Lincoln Park has covenanted not to in any manner whatsoever enter into or effect, directly or indirectly, any short selling or hedging of the Company’s common stock. The issuance of shares of common stock pursuant to the Lincoln Park Purchase Agreement have been registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-270606), and a related prospectus supplement that was filed with the SEC on May 3, 2023. Under the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, on any business day selected by the Company (the “Purchase Date”), provided that on such day the closing sale price per share of the Company’s common stock is above the Floor Price, as defined in the Lincoln Park Purchase Agreement, to require Lincoln Park to purchase up to 225,000 shares of the Company’s common stock (the “Regular Purchase Amount”) at the Purchase Price (as defined below) per purchase notice (each such purchase, a “Regular Purchase”) provided, however, that (1) the limit on the Regular Purchase Amount will be increased to 250,000 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date is not below $ 6.00 and to 275,000 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date is not below $ 8.00 . Lincoln Park’s committed obligation under each Regular Purchase shall not exceed $ 2,500,000 or 2,000,000 Purchase Shares per each Regular Purchase. The purchase price for Regular Purchases (the “Purchase Price”) shall be equal to the lesser of: (i) the lowest sale price of the Company’s common stock during the Purchase Date, or (ii) the average of the three lowest closing sale prices of the Company’s common stock on the 10 consecutive business days ending on the business day immediately preceding such Purchase Date. The Company shall have the right to submit a Regular Purchase notice to Lincoln Park as often as every business day. A Regular Purchase notice is delivered to Lincoln Park after the market has closed (i.e., after 4:00 P.M. Eastern Time) so that the Purchase Price is always fixed and known at the time the Company elects to sell shares to Lincoln Park. In addition to Regular Purchases and provided that the Company has directed a Regular Purchase in full, the Company in its sole discretion may require Lincoln Park on each Purchase Date to purchase on the following business day (“Accelerated Purchase Date”) up to the lesser of (i) three (3) times the number of shares purchased pursuant to such Regular Purchase or (ii) 30 % of the trading volume on the Accelerated Purchase Date (the “Accelerated Purchase”) at a purchase price equal to the lesser of 97 % of (i) the closing sale price on the Accelerated Purchase Date, or (ii) the Accelerated Purchase Date’s volume weighted average price (the “Accelerated Purchase Price”). The Company may also direct Lincoln Park, on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Lincoln Park Purchase Agreement, to make additional purchases upon the same terms as an Accelerated Purchase (an “Additional Accelerated Purchase”). The purchase price of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases and the minimum closing sale price for a Regular Purchase will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction occurring during the business days used to compute the purchase price. The aggregate number of shares that the Company can sell to Lincoln Park under the Lincoln Park Purchase Agreement may in no case exceed 17,678,502 shares (subject to adjustment as described above) of the Company’s common stock (which is equal to approximately 19.99 % of the shares of the Company’s common stock outstanding immediately prior to the execution of the Lincoln Park Purchase Agreement) (the “Exchange Cap”), unless (i) shareholder approval is obtained to issue Purchase Shares above the Exchange Cap, in which case the Exchange Cap will no longer apply, or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the Lincoln Park Purchase Agreement equals or exceeds $ 1.26 per share (subject to adjustment as described above) (which represents the Minimum Price, as defined under Nasdaq Listing Rule 5635(d), on the Nasdaq Capital Market immediately preceding the signing of the Lincoln Park Purchase Agreement, such that the transactions contemplated by the Lincoln Park Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules). In consideration for entering into the Lincoln Park Purchase Agreement, concurrently with the execution of the Lincoln Park Purchase Agreement, the Company issued 800,000 shares of the Company’s common stock to Lincoln Park. The shares of common stock issued as consideration were valued at $ 1.0 million, based on the closing price per share of the Company’s common stock on the date the shares were issued. This amount and related expenses of $ 57,000 , which total approximately $ 1.1 million, were recorded as deferred costs. We are obligated to issue $ 1.0 million of shares of the Company’s common stock at the time Lincoln Park’s purchases cumulatively reach an aggregate amount of $ 50.0 million of Purchase Shares. During the year ended September 30, 2023, we sold 1,225,000 shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement resulting in proceeds to the Company of $ 1.4 million. As a result of these sales, we recorded approximately $ 30,000 of deferred costs to additional paid-in capital. The unamortized amount of deferred costs related to the Lincoln Park Purchase Agreement is $ 1.0 million at September 30, 2023 and is included in other assets on the accompanying consolidated balance sheet. Subsequent to September 30, 2023, we sold 1,800,000 shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement, resulting in proceeds to the Company of $ 1.7 million. At-the-Market Sale Agreement On May 12, 2023, the Company entered into an Open Market Sale Agreement ℠ (the “Jefferies Sales Agreement”) with Jefferies LLC (“Jefferies”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Jefferies, shares of the Company’s common stock, with an aggregate value of up to $ 75 million (not to exceed the lesser of 39,609,072 shares of common stock or the number of authorized, unissued and available shares of common stock at any time). Shares of common stock offered and sold pursuant to the Jefferies Sale Agreement have been registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-270606), and a related prospectus supplement that was filed with the SEC on May 12, 2023. The Company is not obligated to sell any shares of common stock under the Jefferies Sales Agreement. Subject to the terms and conditions of the Jefferies Sales Agreement, Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices, to sell shares of common stock from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Upon delivery of a placement notice, and subject to our instructions in that notice, and the terms and conditions of the Jefferies Sales Agreement generally, Jefferies may sell the Company’s common stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act. Under the terms of the Sales Agreement, the Company cannot cause or request Jefferies to sell shares of common stock exceeding the number of shares of common stock authorized, unissued and available for issuance at any time. The Company will pay Jefferies a commission of 3 % of the aggregate gross proceeds from each sale of common stock and has agreed to provide Jefferies with customary indemnification and contribution rights, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. The Company has also agreed to reimburse Jefferies for certain specified expenses. The Company incurred issuance costs of $ 207,000 , which were recorded as deferred costs. During the year ended September 30, 2023, we sold 1,277,259 shares of common stock under the Jefferies Sales Agreement resulting in net proceeds to the Company of $ 1.0 million. As a result of these sales, we recorded approximately $ 3,000 of deferred costs to additional paid-in capital. The unamortized amount of deferred costs related to the Jefferies Sales Agreement is $ 0.2 million at September 30, 2023 and is included in other assets on the accompanying consolidated balance sheet. Subsequent to September 30, 2023, we sold 90,156 shares of common stock under the Jefferies Sales Agreement, resulting in proceeds to the Company of $ 67,000 . |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Sep. 30, 2023 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | Note 11 – Share-based Compensation We allocate share-based compensation expense to cost of sales, selling, general and administrative expense and research and development expense based on the award holder’s employment function. We recorded income tax benefits for share-based compensation expense of approximately $ 4.0 million and $ 2.5 million in fiscal 2023 and 2022, respectively. For fiscal 2023 and 2022, we recorded share-based compensation expenses as follows: 2023 2022 Cost of sales $ 361,843 $ 328,225 Selling, general and administrative 13,785,067 8,151,505 Research and development 3,771,693 2,762,693 $ 17,918,603 $ 11,242,423 We have issued share-based awards to employees and non-executive directors under the Company’s approved equity plans. Upon the exercise of share-based awards, new shares are issued from authorized common stock. Equity Plans In June 2022, the Company’s board of directors adopted the Company’s 2022 Employment Inducement Equity Incentive Plan (the “Inducement Plan”). The Inducement Plan is a non-shareholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The Inducement Plan is used exclusively for the issuance of equity awards to new hires who satisfy the requirements to be granted inducement grants under Nasdaq listing rules as an inducement material to the individual’s entry into employment with the Company. The terms of the Inducement Plan are substantially similar to the terms of our 2018 Plan. The Company has reserved 4,000,000 shares of common stock under the Inducement Plan and as of September 30, 2023, 3,901,250 shares remain available for issuance. In March 2018, the Company’s stockholders approved the Company's 2018 Equity Incentive Plan (the “2018 Plan”). On March 29, 2022, the Company’s stockholders approved an increase in the number of shares that may be issued under the 2018 Plan to 18.5 million. As of September 30, 2023, 2,593,491 shares remain available for issuance under the 2018 Plan. In July 2017, the Company’s stockholders approved the Company's 2017 Equity Incentive Plan (the “2017 Plan”). A total of 4.7 million shares are authorized for issuance under the 2017 Plan. As of September 30, 2023, 398,105 shares remain available for issuance under the 2017 Plan. The 2017 Plan replaced the Company's 2008 Stock Incentive Plan (the “2008 Plan”), and no further awards will be made under the 2008 Plan. Stock Options Each option grants the holder the right to purchase from us one share of our common stock at a specified price, which is generally the closing price per share of our common stock on the date the option is issued. Options generally vest on a pro-rata basis on each anniversary of the issuance date within three years of the date the option is issued. Options may be exercised after they have vested and prior to the specified expiry date provided applicable exercise conditions are met, if any. The expiry date can be for periods of up to ten years from the date the option is issued. The fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model based on the assumptions established at that time. The Company accounts for forfeitures as they occur and does not estimate forfeitures as of the option grant date. The Company recognized a reduction in share-based compensation expense of $ 1.9 million during the year ended September 30, 2023. The reduction in share-based compensation expense during the year ended September 30, 2022 was immaterial. The following table outlines the weighted average assumptions for options granted during fiscal 2023 and 2022: 2023 2022 Weighted Average Assumptions: Expected Volatility 101.37 % 84.53 % Expected Dividend Yield 0.00 % 0.00 % Risk-free Interest Rate 3.92 % 2.17 % Expected Term (in years) 6.0 6.0 Fair Value of Options Granted $ 5.55 $ 7.10 During the years ended September 30, 2023 and 2022, the Company used historical volatility of our common stock over a period equal to the expected life of the options to estimate their fair value. The dividend yield assumption is based on the Company’s recent history and expectation of future dividend payouts on the common stock. The risk-free interest rate is based on the implied yield available on U.S. treasury zero-coupon issues with an equivalent remaining term. The following table summarizes the stock options outstanding and exercisable at September 30, 2023: Weighted Average Remaining Aggregate Number of Exercise Price Contractual Term Intrinsic Shares Per Share (years) Value Outstanding at September 30, 2022 14,263,470 $ 5.00 Granted 4,934,955 6.92 Exercised ( 191,832 ) 2.03 Forfeited ( 1,638,950 ) 8.19 Outstanding at September 30, 2023 17,367,643 $ 5.28 7.10 $ — Exercisable at September 30, 2023 9,759,441 $ 3.54 5.76 $ — The aggregate intrinsic values in the table above are before income taxes and represent the number of in-the-money options outstanding or exercisable multiplied by the closing price per share of the Company’s common stock on the last trading day of the year ended September 30, 2023 of $ 0.72 , less the respective weighted average exercise price per share at period end . The total intrinsic value of options exercised was approximately $ 0.5 million and $ 8.1 million during the years ended September 30, 2023 and 2022, respectively. Cash received from options exercised was $ 0.4 million and $ 1.1 million in the years ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the Company had unrecognized compensation expense of approximately $ 29.5 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 1.8 years. During fiscal 2023 and 2022, the Company modified stock options held by certain optionees upon termination of their employment by the Company. As permitted under the 2018 Plan, the stock options were primarily modified to accelerate vesting or to allow for continued vesting. The aggregate amount of expense recognized in connection with these modifications was approximately $ 25,000 and $ 1.0 million during the years ended September 30, 2023 and 2022, respectively. Stock Appreciation Rights In fiscal 2017, the Company issued stock appreciation rights based on 50,000 shares of the Company’s common stock to an employee that vested on October 31, 2018 . The stock appreciation rights have a ten-year term and an exercise price per share of $ 0.95 . Upon exercise, the stock appreciation rights will be settled in common stock issued under the 2017 Plan. As of September 30, 2023 and 2022, vested stock appreciation rights based on 50,000 shares of common stock remain outstanding. |
Leases
Leases | 12 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 12 – Leases The Company has operating leases for its office, manufacturing and warehouse space, and office equipment. The Company has a finance lease for office equipment, furniture, and fixtures. Corporate Headquarters In June 2021, the Company executed a lease for its new corporate headquarters in Miami, Florida. The Company is leasing approximately 12,000 square feet of office space for an eight year term, which commenced on March 1, 2022. The space replaced the Company’s previous corporate headquarters in Miami, Florida when the lease terminated at the end of February 2022. Annual base rent payments are $ 58.00 per square foot and are subject to a 3 % annual escalation. Based on the terms of the lease agreement, the Company paid a security deposit of approximately $ 117,000 , which is included in other assets on the accompanying consolidated balance sheet as of September 30, 2023 and 2022. Chicago Lease The Company leases approximately 6,600 square feet of office space located in Chicago, Illinois. The Company executed the lease for this office in May 2016, for a seven -year period commencing on November 1, 2016 and ending on October 31, 2023 . The lease granted the Company a seven -month lease holiday beginning November 1, 2016, a five-month lease abatement beginning June 1, 2017, and provided a tenant improvement allowance. Annual base rent payments were $ 14.00 per square foot in year one and increase on an annual basis to $ 17 per square foot in the final year of the lease. The lease also requires payment of related expenses, including real estate taxes, common area maintenance, utilities and insurance expenses from June 1, 2017 to October 31, 2023. Based on the terms of the lease agreement, the Company paid a security deposit of $ 55,000 . Effective September 1, 2017, the Company entered into a sublease for this office space through October 31, 2023 . Monthly sublease payments of approximately $ 15,200 commenced in January 2018 and ended August 2023. The monthly sublease payment was subject to annual increases in September of each year and increased to approximately $ 17,300 per month in the final year of the sublease. Sublease income was recognized as a reduction to operating lease costs as the sublease was outside of the Company’s normal business operations. This is consistent with the Company’s recognition of sublease income prior to the adoption of FASB ASC Topic 842. The tenant under the sublease provided a security deposit of $ 30,000 to the Company. The Company continued to be responsible for performance under the lease until it expired on October 31, 2023. International Leases The Company leases approximately 6,400 square feet of office space located in London, England. The lease was effective in August 2020 with a five year term and a tenant’s option to cancel after three years with no penalty to the Company. At the time the lease was commenced, it was reasonably certain that the Company will exercise that option. The option to exercise required 6 months notice on February 28, 2023. At that time, the Company determined that it would not exercise the option to cancel and recorded an adjustment of $ 265,000 to its lease liabilities and right-of-use asset to reflect the additional lease term. The Company maintains a security deposit of approximately $ 58,000 . The lease requires quarterly payments of approximately $ 41,100 . The Company leases 45,800 square feet of manufacturing and warehouse space in Selangor D.E., Malaysia. The Company executed the lease for this space in August 2019, for a three -year term commencing September 1, 2019 and ending August 31, 2022 . The Company had an option to extend the term of the lease for a period of three years , which was executed so that the lease is effective through August 31, 2025. The lease requires monthly payments of approximately $ 15,400 . Based on the terms of the lease agreement, the Company maintains a security deposit of approximately $ 46,000 . Certain of our lease agreements include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for the office equipment leases. The components of the Company’s lease cost were as follows for the years ended September 30, 2023 and 2022: 2023 2022 Finance lease cost: Amortization of right-of-use assets $ — $ 3,631 Interest on lease liabilities — 403 Operating lease cost 1,117,463 883,928 Short-term lease cost 42,809 46,117 Variable lease cost 186,904 211,840 Sublease income ( 179,378 ) ( 179,378 ) Total lease cost $ 1,167,798 $ 966,541 The Company paid cash of $ 860,000 and $ 680,000 for amounts included in the measurement of operating lease liabilities during the year ended September 30, 2023 and 2022, respectively. The Company’s operating lease ROU assets and related lease liabilities are presented as separate line items on the accompanying consolidated balance sheet as of September 30, 2023 and 2022. Other information related to the Company’s leases as of September 30, 2023 and 2022 was as follows: 2023 2022 Operating Leases Weighted-average remaining lease term 6.1 6.8 Weighted-average discount rate 7.7 % 7.6 % The Company’s lease agreements do not provide a readily determinable implicit rate. Therefore, the Company estimates its incremental borrowing rate based on information available at lease commencement in order to discount lease payments to present value. As of September 30, 2023, maturities of lease liabilities were as follows: Operating Leases Fiscal year ended September 30, 2024 $ 1,085,368 2025 1,034,855 2026 800,693 2027 814,311 2028 832,997 Thereafter 1,217,797 Total lease payments 5,786,021 Less imputed interest ( 1,115,317 ) Total lease liabilities $ 4,670,704 The Company does no t have any leases that have not yet commenced as of September 30, 2023. The lease liabilities presented above do not include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for the office equipment leases. These amounts are not fixed and can fluctuate from year to year. |
Contingent Liabilities
Contingent Liabilities | 12 Months Ended |
Sep. 30, 2023 | |
Contingent Liabilities [Abstract] | |
Contingent Liabilities | N ote 13 – Contingent Liabilities The testing, manufacturing and marketing of consumer products by the Company entail an inherent risk that product liability claims will be asserted against the Company. The Company maintains product liability insurance coverage for claims arising from the use of its products. The coverage amount is currently $ 10.0 million. Litigation On December 5, 2022, a putative class action complaint was filed in federal district court for the Southern District of Florida (Ewing v. Veru Inc., et al., Case No. 1:22-cv-23960) against the Company and Mitchell Steiner, its Chairman, CEO and President, and Michele Greco, its CFO (the “Ewing Lawsuit”). The First Amended Class Action Complaint, filed on September 15, 2023 by purported stockholders Dr. Myo Thant and Karen Brounstein, alleges that certain public statements about sabizabulin as a treatment for COVID-19 between March 1, 2021 and March 2, 2023 violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, and seeks monetary damages. The Defendants intend to vigorously defend the lawsuit. There can be no assurance that the defense will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the lawsuit. On July 7, 2023, Anthony Maglia, a purported stockholder, filed a derivative action in the Circuit Court for the Eleventh Judicial Circuit, Miami-Dade County, Florida (Maglia v. Steiner et al., Case No. 2023-019406-CA-01), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Michele Greco, Harry Fisch, Mario Eisenberger, Grace S. Hyun, Lucy Lu and Michael L. Rankowitz (the “Maglia Lawsuit”). The Maglia lawsuit asserts claims for breach of fiduciary duty, waste of corporate assets, and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Maglia Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, injunctive relief, restitution, and an award of reasonable fees and expenses. The Defendants intend to vigorously defend the lawsuit. There can be no assurance that the defense will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the Maglia Lawsuit. On September 1, 2023, Anthony Franchi, a purported stockholder, filed a derivative action in the United States District Court for the Eastern District of Wisconsin (Franchi v. Steiner et al., Case No. 2:23-CV-01164), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Mario Eisenberger, Harry Fisch, Michael L. Rankowitz, Grace Hyun, Lucy Lu, and Michele Greco (the “Franchi Lawsuit”). The Franchi lawsuit asserts claims for breach of fiduciary duty and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Franchi Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, restitution, and an award of reasonable fees and expenses. On November 8, 2023, this action was consolidated with the Renbarger action, discussed below. The Defendants intend to vigorously defend the lawsuit. There can be no assurance that the defense will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the Franchi Lawsuit. On September 28, 2023, Philip Renbarger, a purported stockholder, filed a derivative action in the United States District Court for the Eastern District of Wisconsin (Renbarger v. Steiner et al., Case No. 2:23-CV-01291), against the Company as a nominal defendant, and Company officers and directors Mitchell Steiner, Mario Eisenberger, Harry Fisch, Michael L. Rankowitz, Grace S. Hyun, Lucy Lu, and Michele Greco (the “Renbarger Lawsuit”). The Renbarger lawsuit asserts claims for breach of fiduciary duty, aiding and abetting, gross mismanagement, waste of corporate assets, and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Renbarger Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages and an award of reasonable fees and expenses. On November 8, 2023, the Renbarger Lawsuit was consolidated with the Franchi Lawsuit, discussed above. The Defendants intend to vigorously defend the lawsuit. There can be no assurance that the defense will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the Renbarger Lawsuit. On October 9, 2023, Mohamed Alshourbagy, a purported stockholder, filed a derivative action in the United States District Court for the Southern District of Florida (Alshourbagy v. Steiner et al., Case No. 1:23-cv-23846), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Mario A. Eisenberger, Harry D. Fisch, Michael L. Rankowitz, Grace S. Hyun, Lucy Lu, and Michele J. Greco (the “Alshourbagy Lawsuit”). The Alshourbagy lawsuit asserts claims for breach of fiduciary duty and contribution primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Alshourbagy Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, injunctive relief, restitution, and an award of reasonable fees and expenses. The Defendants intend to vigorously defend the lawsuit. There can be no assurance that the defense will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the Alshourbagy Lawsuit. License and Purchase Agreements From time to time, we license or purchase rights to technology or intellectual property from third parties. These licenses and purchase agreements require us to pay upfront payments as well as development or other payments upon successful completion of preclinical, clinical, regulatory or revenue milestones. In addition, these agreements may require us to pay royalties on sales of products arising from the licensed or acquired technology or intellectual property. Because the achievement of future milestones is not reasonably estimable, we have not recorded a liability in the accompanying consolidated financial statements for any of these contingencies. Collaborative Arrangements On January 31, 2022, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the “Lilly Agreement”) with Eli Lilly and Company (“Lilly”). Under the Lilly Agreement, the Company is sponsoring a clinical trial in which both the Company’s enobosarm compound and Lilly’s compound are being dosed in combination. The ENABLAR-2 clinical trial is active but not currently recruiting. The Company is conducting the research at its own cost and Lilly is contributing its compound towards the study at no cost to the Company. The parties will continue to hold exclusive rights to all intellectual property relating solely to their own respective compounds. The Company will provide to Lilly copies of clinical data relating to the clinical trial and certain rights to use the clinical data. Veru maintains full exclusive, global commercialization rights to the enobosarm compound. The terms of the Lilly Agreement meet the criteria under ASC Topic 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants in the activity and are exposed to the risks and rewards dependent on the commercial success of the activity. ASC 808 does not provide guidance on how to account for the activities under the collaboration, and the Company determined that Lilly did not meet the definition of a customer under ASC 606, Revenue from Contracts with Customers. The Company has concluded that ASC 730, Research and Development, should be applied by analogy. There is no financial statement impact for the Lilly Agreement as the value of the drug supply received from Lilly is offset against the drug supply cost within research and development expense. |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | Note 14 – Income Taxes The Company accounts for income taxes using the liability method, which requires the recognition of deferred tax assets or liabilities for the tax-effected temporary differences between the financial reporting and tax bases of its assets and liabilities, and for net operating loss (NOL) and tax credit carryforwards. Within the calculation of the Company’s annual effective tax rate the Company has used assumptions and estimates that may change as a result of future guidance, interpretations, and rule-making from the Internal Revenue Service, the SEC, the FASB and/or various other taxing jurisdictions. For example, the Company anticipates that state jurisdictions will continue to determine and announce their conformity to the Tax Act which would have an impact on the annual effective tax rate. The Company’s calculations are based on the information available, prepared or analyzed (including computations) in reasonable detail. The Company completes a detailed analysis of its deferred income tax valuation allowances on an annual basis or more frequently if information comes to its attention that would indicate that a revision to its estimates is necessary. In evaluating the Company’s ability to realize its deferred tax assets, management considers all available positive and negative evidence on a country-by-country basis, including past operating results, forecasts of future taxable income, and the potential Section 382 limitation on the NOL carryforwards due to a change in control. In determining future taxable income, management makes assumptions to forecast U.S. federal and state, U.K. and Malaysia operating income, the reversal of temporary differences, and the implementation of any feasible and prudent tax planning strategies. These assumptions require significant judgment regarding the forecasts of the future taxable income in each tax jurisdiction and are consistent with the forecasts used to manage the Company’s business. The Company had a cumulative pretax loss in the U.S. for fiscal 2023 and the two preceding fiscal years. Forming a conclusion that a valuation allowance is not needed is difficult when there is significant negative evidence such as cumulative losses in recent years. Management has projected future pretax losses in the U.S. driven by the investment in research and development and based on our analysis, concluded that a full valuation allowance should be recorded related to federal and state NOL carryforwards as of September 30, 2023. The valuation allowance against U.S. deferred tax assets was increased by $ 19.9 million during the year ended September 30, 2023. As of September 30, 2023 and 2022 respectively, the Company has recorded a valuation allowance of $ 62.1 million and $ 42.2 million against U.S. deferred tax assets. In addition, the Company’s U.K. holding company for the non-U.S. operating companies, The Female Health Company Limited, continues to have a full valuation allowance of $ 3.2 million as of September 30, 2023 and 2022. The operating U.K. subsidiary, The Female Health Company (UK) plc does no t have a valuation allowance due to projections of future taxable income. The Company projects that the deferred tax assets of The Female Health Company (UK) plc will be realized over a significant period of time, which may exceed 20 years. Veru Biopharma UK Limited has a full valuation allowance of $ 0.3 million. As of September 30, 2023, the Company had U.S. federal and state NOL carryforwards of approximately $ 140.5 million and $ 62.4 million, respectively, for income tax purposes with $ 29.7 million and $ 35.2 million, respectively, expiring in fiscal years 2024 to 2043 and $ 110.8 million and $ 27.2 million, respectively, which can be carried forward indefinitely. The Company also has U.S. federal research and development tax credit carryforwards of $ 8.3 million, expiring in fiscal years 2038 to 2043 . The Company’s U.K. subsidiary and Veru Biopharma UK Limited have U.K. NOL carryforwards of approximately $ 63.0 million as of September 30, 2023, which can be carried forward indefinitely to be used to offset future U.K. taxable income. The Tax Cuts and Jobs Act of 2017, which was signed into U.S. law in December 2017, eliminated the option to immediately deduct research and development expenditures in the year incurred under Section 174 of the Internal Revenue Code (“Section 174”) effective for the Company October 1, 2022. The amended provision under Section 174 requires us to capitalize and amortize these expenditures over five years, for U.S.-based research, and over 15 years, for foreign-based research. As of September 30, 2023, we recorded a decrease to income tax benefit and an increase to deferred tax assets, before applying a valuation allowance, of approximately $ 9.8 million as a result of the amended provision under Section 174. Because the Company has a full valuation allowance recorded against U.S. deferred tax assets, the net impact to income tax benefit and deferred tax assets from the amended provision under Section 174 is zero . Loss before income taxes was taxed by the following jurisdictions for the years ended September 30, 2023 and 2022: 2023 2022 Domestic $ ( 90,458,648 ) $ ( 82,186,464 ) Foreign ( 2,150,099 ) ( 1,353,159 ) Total $ ( 92,608,747 ) $ ( 83,539,623 ) A reconciliation between the effective tax rate and the U.S. statutory rate and the related income tax expense is as follows: 2023 2022 Amount Tax Rate Amount Tax Rate Income tax benefit at U.S. federal statutory rates $ ( 19,447,837 ) 21.0 % $ ( 17,543,321 ) 21.0 % State income tax benefit, net of federal benefits ( 1,505,818 ) 1.6 ( 1,358,354 ) 1.6 Non-deductible expenses 330,281 ( 0.3 ) 76,913 ( 0.1 ) U.S. research and development tax credit 178,378 ( 0.2 ) ( 5,720,374 ) 6.9 Effect of foreign income tax rates 454,808 ( 0.5 ) 409,048 ( 0.5 ) Effect of common stock options exercised 180,847 ( 0.2 ) ( 1,580,756 ) 1.9 Effect of global intangible low-taxed income ( 24,691 ) ( 0.0 ) 24,691 ( 0.0 ) Change in valuation allowance 20,191,386 ( 21.8 ) 25,792,441 ( 30.9 ) Other, net 122,852 ( 0.1 ) 136,109 ( 0.2 ) Income tax expense $ 480,206 ( 0.5 ) % $ 236,397 ( 0.3 ) % The federal and state income tax expense (benefit) for the years ended September 30, 2023 and 2022 is summarized below: 2023 2022 Deferred – U.S. $ ( 63,426 ) $ — Deferred – U.K. 262,612 ( 42,089 ) Deferred – Malaysia ( 21,687 ) 118,295 Subtotal 177,499 76,206 Current – U.S. ( 8,624 ) 126,079 Current – Malaysia 311,331 34,112 Subtotal 302,707 160,191 Income tax expense $ 480,206 $ 236,397 Significant components of the Company’s deferred tax assets and liabilities are as follows: 2023 2022 Deferred tax assets: Federal net operating loss carryforwards $ 29,510,855 $ 23,627,461 State net operating loss carryforwards 3,354,274 2,850,956 Foreign net operating loss carryforwards – U.K. 15,749,809 15,773,497 Foreign capital allowance – U.K. 174,748 128,490 Share-based compensation – U.K. 217,821 265,631 U.S. research and development tax credit carryforward 8,303,411 8,481,789 U.S. research and development expense 9,758,373 — Accrued compensation 190,397 1,227,290 Share-based compensation 7,896,221 4,325,354 Interest expense 2,602,890 2,206,484 U.S. credit loss provision 885,562 — Change in fair value of derivative liability — 220,607 Other, net – Malaysia 4,046 — Other, net – U.K. 2,500 — Other, net – U.S. 71,509 81,507 Gross deferred tax assets 78,722,416 59,189,066 Valuation allowance for deferred tax assets ( 65,563,838 ) ( 45,372,452 ) Net deferred tax assets 13,158,578 13,816,614 Deferred tax liabilities: Change in fair value of derivative liability ( 449,812 ) — In process research and development — ( 882,427 ) Covenant not-to-compete ( 1,347 ) ( 17,508 ) Other, net – Malaysia — ( 17,641 ) Other — ( 14,120 ) Net deferred tax liabilities ( 451,159 ) ( 931,696 ) Net deferred tax asset $ 12,707,419 $ 12,884,918 The deferred tax amounts have been classified in the accompanying consolidated balance sheets as follows: 2023 2022 Long-term deferred tax asset – U.K. $ 12,703,373 $ 12,965,985 Long-term deferred tax asset – Malaysia 4,046 — Total long-term deferred tax asset $ 12,707,419 $ 12,965,985 Long-term deferred tax liability – U.S. $ — $ ( 63,426 ) Long-term deferred tax liability – Malaysia — ( 17,641 ) Total long-term deferred tax liability $ — $ ( 81,067 ) ASC Topic 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740 developed a two-step process to evaluate a tax position and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company has not recorded a reserve for any tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility. The Company files tax returns in all appropriate jurisdictions, including foreign, U.S. federal and state tax returns. The following summarizes open tax years in the relevant jurisdictions: For the U.S., a tax return may be audited any time within 3 years from filing date or 3 years after an NOL is utilized. The U.S. open tax years are for fiscal 2004 through 2007, fiscal 2015 through fiscal 2019, and fiscal 2022, for which the Company is carrying forward NOLs, which expire in years 2024 through 2038 or are being carried forward indefinitely with no expiration. For Malaysia, a tax return may be audited any time within 5 years from filing date (7 months after the fiscal year end). The Malaysia open tax years are for 2018 through 2022, which expire on December 31, 2023 through 2027. For the U.K., a tax return may be audited within 1 year from the later of: the filing date or the filing deadline (1 year after the end of the accounting period). The U.K. open tax year is for 2022, which expires in 2024. The fiscal 2023 tax returns for all jurisdictions have not been filed as of the date of this filing. As of September 30, 2023 and 2022, the Company has no recorded liability for unrecognized tax benefits. The Company recognizes interest and penalties related to uncertain tax positions as income tax expense as incurred. No material expense for interest and penalties was recognized for the years ended September 30, 2023 and 2022. |
Sale of ENTADFI
Sale of ENTADFI | 12 Months Ended |
Sep. 30, 2023 | |
Sale of ENTADFI [Abstract] | |
Sale of ENTADFI | Note 15 – Sale of ENTADFI On April 19, 2023, the Company entered into an asset purchase agreement (the “BWV Asset Purchase Agreement”) to sell substantially all of the assets related to ENTADFI® (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia that was approved by the FDA in December 2021, with Blue Water Biotech Inc. formerly known as Blue Water Vaccines Inc. (“BWV”). The transaction closed on April 19, 2023. The purchase price for the transaction was $ 20.0 million, consisting of $ 6.0 million paid at closing, $ 4.0 million payable by September 30, 2023, $ 5.0 million payable 12 months after closing, and $ 5.0 million payable by September 30, 2024, plus up to $ 80.0 million based on BWV’s net revenues from ENTADFI after closing (the “Milestone Payments”). The Company cannot determine the likelihood of receiving any Milestone Payments at this time. On September 29, 2023, the Company entered into an Amendment to the BWV Asset Purchase Agreement providing that the promissory note for the $ 4.0 million installment of the purchase price due September 30, 2023 would be deemed paid and fully satisfied upon (1) the payment to the Company of the sum of $ 1.0 million in immediately available funds on September 29, 2023 and (2) the issuance to the Company by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock of BWV. The Company received payment of $ 1.0 million on September 29, 2023 and the 3,000 Series A Convertible Preferred Stock on October 3, 2023. There is no market for the Series A Convertible Preferred Stock and therefore, little likelihood of any liquidity in the Series A Preferred Stock. The Company determined that it was not probable, at the time of the transaction and at September 30, 2023, that substantially all of the consideration promised under the BWV Asset Purchase Agreement would be collected. Therefore, the Company recognizes the difference between the nonrefundable consideration received and the carrying amount of the assets as a gain. The gain is recorded considering only the nonrefundable consideration of $ 7.0 million received by the Company as of September 30, 2023. Total assets sold, consisting primarily of inventory, had a net book value of approximately $ 1.3 million. The Company recorded a gain of approximately $ 5.7 million on the transaction during fiscal 2023. The gain calculation will be updated if additional consideration is received in future periods or when it is deemed probable that substantially all of the consideration promised will be collected. The Company will continue to evaluate the collectability of the notes receivable. |
Loss Per Share
Loss Per Share | 12 Months Ended |
Sep. 30, 2023 | |
Loss Per Share [Abstract] | |
Loss Per Share | Note 16 – Loss per Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing net income by the weighted average number of common shares outstanding during the period after giving effect to all dilutive potential common shares that were outstanding during the period. Dilutive potential common shares consist of the incremental common shares issuable upon the exercise of stock options and stock appreciation rights as determined under the treasury stock method. Due to our net loss for the periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Note 11 for a discussion of our potentially dilutive common shares. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Sep. 30, 2023 | |
Employee Benefit Plans [Abstract] | |
Employee Benefit Plans | Note 17 – Employee Benefit Plans Effective January 1, 2018, the Company established a 401(k) plan in which substantially all U.S. employees are eligible to participate. Contributions made by employees are limited to the maximum allowable for U.S. federal income tax purposes. The Company matches employee contributions at a rate of 100 % of applicable contributions up to 6 % of included compensation. Company contributions to the 401(k) plan were approximately $ 616,000 and $ 461,000 for the years ended September 30, 2023 and 2022, respectively. In March 2014, the Company elected to contribute 3 % of eligible employee compensation into the personal pension schemes of certain senior U.K. employees. Effective January 1, 2019, this contribution amount was increased to 4 %. Company contributions were approximately $ 29,000 and $ 41,000 for the years ended September 30, 2023 and 2022, respectively. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (Policy) | 12 Months Ended |
Sep. 30, 2023 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Principles of consolidation and nature of operations | Principles of consolidation and nature of operations: Veru Inc. is referred to in these notes collectively with its subsidiaries as “we,” “our,” “us,” “Veru” or the “Company.” The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, Veru International Holdco Inc., Aspen Park Pharmaceuticals, Inc. (APP) and The Female Health Company Limited; The Female Health Company Limited’s wholly owned subsidiary, The Female Health Company (UK) plc (The Female Health Company Limited and The Female Health Company (UK) plc, collectively, the “U.K. subsidiary”); The Female Health Company (UK) plc’s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the “Malaysia subsidiary”); and Veru International Holdco Inc.’s wholly owned subsidiaries, Veru Biopharma UK Limited, Veru Biopharma Europe Limited, and Veru Biopharma Netherlands B.V. All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases (obesity), oncology, and acute respiratory distress syndrome (ARDS). Our drug development program includes enobosarm, a selective androgen receptor modulator, for preferential loss of fat while preventing the loss of muscle and bone, in combination with weight loss drugs, and for the management of advanced breast cancer and sabizabulin, a microtubule disruptor, for the treatment of hospitalized patients with viral induced ARDS. The Company also has the FC2 Female Condom/FC2 Internal Condom® (FC2), an FDA-approved commercial product for the dual protection against unplanned pregnancy and sexually transmitted infections. The Company had ENTADFI® (finasteride and tadalafil) capsules for oral use (ENTADFI), a new treatment for benign prostatic hyperplasia that was approved by the FDA in December 2021. We sold substantially all of the assets related to ENTADFI on April 19, 2023. See Note 15 for additional information. Most of the Company’s net revenues during fiscal 2023 and 2022 were derived from sales of FC2. FC2 has been distributed in either or both commercial (private sector) and public health sector markets in 150 countries. It is marketed to consumers in various countries through distributors, public health programs, and/or retailers and in the U.S. by prescription. |
Use of estimates | Use of estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S. GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. |
Segments | Segments : We regularly review our operating segments and the approach used by management to evaluate performance and allocate resources. The Company operates as a single operating segment. Our determination that we operate as a single segment is consistent with the financial information regularly reviewed by the chief operating decision maker (CODM) for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. Our CODM allocates resources and assesses financial performance on a consolidated basis. |
Cash and cash equivalents and concentration | Cash and cash equivalents and concentration : Cash and cash equivalents, which primarily consist of cash on deposit with financial institutions and highly liquid money market funds, are recorded in the consolidated balance sheets at cost, which approximates fair value. The Company treats short-term, highly liquid funds that are readily convertible to known amounts of cash and have original maturities of three months or less as cash equivalents. The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England; and Kuala Lumpur, Malaysia. |
Accounts receivable and concentration of credit risk | Accounts receivable and concentration of credit risk : Accounts receivable are carried at original invoice amount less an estimate made for returns, discounts, and credit losses based on a review of all outstanding amounts on a periodic basis. |
Inventories | Inventories : Inventories are valued at the lower of cost or net realizable value. The cost is determined using the first-in, first-out (FIFO) method. Inventories are also written down for management’s estimates of product which will not sell prior to its expiration date. Write-downs of inventories establish a new cost basis which is not increased for future increases in the net realizable value of inventories or changes in estimated obsolescence. The Company capitalizes inventory costs associated with its drug products following regulatory approval when future commercialization is considered probable and the future economic benefit is expected to be realized. Prior to an initial regulatory approval for our drug products under clinical development, we expense costs relating to the production of inventory as research and development expense in the Company’s consolidated statements of operations, in the period incurred. |
Fixed assets | Fixed assets : We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method, over the estimated useful lives of the assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the assets. |
Leases | Leases : Leases are classified as either operating or finance leases at inception. A right-of-use (ROU) asset and corresponding lease liability are established at an amount equal to the present value of fixed lease payments over the lease term at the commencement date. The ROU asset includes any initial direct costs incurred and lease payments made at or before the commencement date and is reduced by lease incentive payments. The Company has elected not to separate the lease and nonlease components for all classes of underlying assets. The Company uses its incremental borrowing rate as the discount rate to determine the present value of the lease payments for leases that do not have a readily determinable implicit discount rate. The incremental borrowing rate is the rate of interest that the Company would be charged to borrow on a collateralized basis over a similar term and amount in a similar economic environment. The Company determines the incremental borrowing rates for its leases by adjusting the risk-free interest rate with a credit risk premium corresponding to the Company’s credit rating. Operating lease costs are recognized for fixed lease payments on a straight-line basis over the term of the lease. Finance lease costs are a combination of the amortization expense for the ROU asset and interest expense for the outstanding lease liability using the applicable discount rate. Variable lease payments are recognized when incurred based on occurrence or usage. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for short-term leases on a straight-line basis over the lease term. |
Patents and trademarks | Patents and trademarks : The costs for patents and trademarks are expensed when incurred. |
Goodwill and intangible assets | Goodwill and intangible assets : The Company’s goodwill and intangible assets, primarily developed technology and in-process research and development (IPR&D), arose from the acquisition of APP (the “APP Acquisition”) on October 31, 2016. Goodwill and indefinite-lived intangible assets are not amortized. IPR&D is accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a finite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off. Goodwill and indefinite-lived assets are subject to an impairment review annually, in the fourth quarter of each fiscal year, and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Intangible assets with finite lives are tested for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. These intangible assets are carried at cost less accumulated amortization. Goodwill consists of the cost of an acquired business in excess of the fair value of the net assets acquired. The Company’s goodwill is assigned to the reporting unit that is expected to benefit from the synergies of a business combination. The Company has identified two reporting units within its single operating segment. The Company tests goodwill and indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the Company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the Company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and potentially result in different impacts to the Company's results of operations. Actual results may differ from the Company's estimates. The fair value of the reporting unit is compared with its carrying amount and an impairment charge would be recognized for the amount by which the carrying value exceeds the reporting unit’s fair value. Regarding goodwill, the estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Changes in these assumptions may impact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results are not consistent with our estimates and assumptions, we may be exposed to an impairment charge that could be material. Intangible assets are highly vulnerable to impairment charges, particularly IPR&D. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval, additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. During the second quarter of fiscal 2023, the Company recorded an impairment charge of $ 3.9 million related to IPR&D. The charge was primarily a result of the Company’s strategic decision to refocus its drug development efforts on those drug candidates that it believes to have the best opportunity to lead to long-term success and shareholder value creation, which led the Company to indefinitely cease development of sabizabulin for prostate cancer and zuclomiphene. See Note 8 for additional information. The Company’s intangible asset balance for IPR&D at September 30, 2023, after the impairment charge was recorded, is zero . |
Deferred financing costs | Deferred financing costs : Costs incurred in connection with the common stock purchase agreements and the at-the-market sale agreement discussed in Note 10 have been included in other assets on the accompanying consolidated balance sheets at September 30, 2023 and 2022. When shares of the Company’s common stock are sold under the common stock purchase agreement or at-the market sale agreement, a pro-rata portion of the deferred costs is recorded to additional paid-in-capital. |
Fair value measurements | Fair value measurements : Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 820 – Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements . The carrying amounts reported in the accompanying consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of the residual royalty agreement liabilities, taking into consideration the related derivative instruments, is estimated to approximate fair value. |
Derivative instruments | Derivative instruments : The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments . Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities in curred in connection with an embedded derivative are discussed in Note 9. |
Revenue recognition | Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue. |
Research and development costs | Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, costs to conduct clinical trials, and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did no t have any material capitalized nonrefundable advance payments as of September 30, 2023. The Company records estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract manufacturing activities. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. |
Share-based compensation | Share-based compensation : The Company recognizes share-based compensation expense in connection with its share-based awards, based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rate. |
Advertising | Advertising : The Company's policy is to expense advertising costs as incurred. Advertising costs were $ 0.9 million and $ 0.6 million for the years ended September 30, 2023 and 2022, respectively. |
Income taxes | Income taxes : The Company files separate income tax returns for its foreign subsidiaries. FASB ASC Topic 740 requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are also provided for carryforwards for income tax purposes. In addition, the amount of any future tax benefits is reduced by a valuation allowance to the extent such benefits are not expected to be realized. |
Foreign currency translation and operations | Foreign currency translation and operations : Effective October 1, 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries’ functional currency, resulting in the adoption of the U.S. dollar as the functional currency for all foreign subsidiaries. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $ 0.6 million as of September 30, 2023 and September 30, 2022. Assets located outside of the U.S. totaled approximately $ 10.5 million and $ 10.8 million at September 30, 2023 and September 30, 2022, respectively. |
Other comprehensive loss | Other comprehensive loss : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss. Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. In fiscal 2023 and 2022, comprehensive income (loss) is equivalent to the reported net income (loss). |
Recent accounting pronouncements not yet adopted | Recent accounting pronouncements not yet adopted : In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the CODM and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures. We have reviewed all other recently issued accounting pronouncements and have determined that such standards that are not yet effective will not have a material impact on our financial statements or do not otherwise apply to our operations. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements [Abstract] | |
Reconciliation of the Beginning and Ending Liability Balance | 2023 2022 Beginning balance $ 4,294,000 $ 7,851,000 Change in fair value of derivative liabilities ( 2,963,000 ) ( 3,557,000 ) Ending balance $ 1,331,000 $ 4,294,000 |
Schedule of Qualitative Information | Valuation Methodology Significant Unobservable Input 2023 2022 Scenario-Based Estimated change of control dates December 2024 to December 2026 September 2023 to September 2025 Discount rate 14.1 % to 15.1 % 13.6 % to 14.2 % Probability of change of control 20 % to 90 % 20 % to 90 % |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Customers by Products | 2023 2022 FC2 U.S. prescription channel $ 5,823,921 $ 30,223,079 Global public health sector 10,460,024 9,128,858 Total FC2 16,283,945 39,351,937 Other 13,013 2,415 Net revenues $ 16,296,958 $ 39,354,352 |
Revenue by Geographic Area | 2023 2022 United States $ 8,370,202 $ 31,430,235 South Africa 1,941,678 * Other 5,985,078 7,924,117 Net revenues $ 16,296,958 $ 39,354,352 *Less than 10 % of total net revenues |
Accounts Receivable and Conce_2
Accounts Receivable and Concentration of Credit Risk (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Components of Accounts Receivable | 2023 2022 Trade receivables, gross $ 8,445,370 $ 4,289,892 Less: allowance for credit losses ( 3,923,857 ) ( 12,143 ) Less: allowance for sales returns and payment term discounts ( 15,005 ) ( 12,854 ) Less: long-term trade receivables* — ( 714,000 ) Accounts receivable, net $ 4,506,508 $ 3,550,895 *Included in other assets on the accompanying consolidated balance sheets. |
Summary of Change in Allowance for Credit Losses on Trade Receivables | 2023 2022 Beginning balance $ 12,143 $ 20,643 Charge-offs (recoveries), net 3,911,714 ( 8,500 ) Ending balance $ 3,923,857 $ 12,143 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Inventories [Abstract] | |
Components of Inventories | 2023 2022 Raw material $ 1,854,810 $ 1,662,712 Work in process 112,799 872,596 Finished goods 4,913,295 6,099,343 Inventories, gross 6,880,904 8,634,651 Less: inventory reserves ( 183,787 ) ( 15,707 ) Inventories, net $ 6,697,117 $ 8,618,944 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Property and Equipment [Abstract] | |
Summary of Plant and Equipment | Estimated Useful Life 2023 2022 Property and equipment: Manufacturing equipment 5 - 8 years $ 3,008,122 $ 2,902,715 Office equipment, furniture and fixtures 3 - 10 years 1,471,870 1,440,475 Leasehold improvements 3 - 8 years 960,694 484,460 Total property and equipment 5,440,686 4,827,650 Less: accumulated depreciation and amortization ( 3,787,954 ) ( 3,641,884 ) Property and equipment, net $ 1,652,732 $ 1,185,766 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Intangible Assets and Goodwill [Abstract] | |
Gross Carrying Amounts and Net Book Value of Intangible Assets | Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 494,048 $ 5,952 Indefinite-lived intangible assets: Acquired in-process research and development assets — — — Total intangible assets $ 500,000 $ 494,048 $ 5,952 The gross carrying amounts and net book value of intangible assets are as follows at September 30, 2022: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 422,619 $ 77,381 Indefinite-lived intangible assets: Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 4,400,000 $ 422,619 $ 3,977,381 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Debt [Abstract] | |
Residual Royalty Agreement Liability | 2023 2022 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,377,949 9,950,908 Less: cumulative payments ( 4,320,190 ) ( 3,765,372 ) Residual royalty agreement liability, excluding embedded derivative liability 8,403,759 6,531,536 Add: embedded derivative liability at fair value (see Note 3) 1,331,000 4,294,000 Total residual royalty agreement liability 9,734,759 10,825,536 Residual royalty agreement liability, short-term portion ( 864,623 ) ( 1,169,095 ) Residual royalty agreement liability, long-term portion $ 8,870,136 $ 9,656,441 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Share-based Compensation [Abstract] | |
Recorded Share-Based Compensation Expenses | 2023 2022 Cost of sales $ 361,843 $ 328,225 Selling, general and administrative 13,785,067 8,151,505 Research and development 3,771,693 2,762,693 $ 17,918,603 $ 11,242,423 |
Weighted Average Assumptions for Options Granted | 2023 2022 Weighted Average Assumptions: Expected Volatility 101.37 % 84.53 % Expected Dividend Yield 0.00 % 0.00 % Risk-free Interest Rate 3.92 % 2.17 % Expected Term (in years) 6.0 6.0 Fair Value of Options Granted $ 5.55 $ 7.10 |
Summary of Stock Options Outstanding and Exercisable | Weighted Average Remaining Aggregate Number of Exercise Price Contractual Term Intrinsic Shares Per Share (years) Value Outstanding at September 30, 2022 14,263,470 $ 5.00 Granted 4,934,955 6.92 Exercised ( 191,832 ) 2.03 Forfeited ( 1,638,950 ) 8.19 Outstanding at September 30, 2023 17,367,643 $ 5.28 7.10 $ — Exercisable at September 30, 2023 9,759,441 $ 3.54 5.76 $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Components of Lease Cost | 2023 2022 Finance lease cost: Amortization of right-of-use assets $ — $ 3,631 Interest on lease liabilities — 403 Operating lease cost 1,117,463 883,928 Short-term lease cost 42,809 46,117 Variable lease cost 186,904 211,840 Sublease income ( 179,378 ) ( 179,378 ) Total lease cost $ 1,167,798 $ 966,541 |
Summary of Lease Information | 2023 2022 Operating Leases Weighted-average remaining lease term 6.1 6.8 Weighted-average discount rate 7.7 % 7.6 % |
Schedule of Maturities of Lease Liabilities | Operating Leases Fiscal year ended September 30, 2024 $ 1,085,368 2025 1,034,855 2026 800,693 2027 814,311 2028 832,997 Thereafter 1,217,797 Total lease payments 5,786,021 Less imputed interest ( 1,115,317 ) Total lease liabilities $ 4,670,704 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Income Taxes [Abstract] | |
Schedule of (Loss) Income Before Income Taxes by Jurisdiction | 2023 2022 Domestic $ ( 90,458,648 ) $ ( 82,186,464 ) Foreign ( 2,150,099 ) ( 1,353,159 ) Total $ ( 92,608,747 ) $ ( 83,539,623 ) |
Reconciliation of Income Tax Expense (Benefit) | 2023 2022 Amount Tax Rate Amount Tax Rate Income tax benefit at U.S. federal statutory rates $ ( 19,447,837 ) 21.0 % $ ( 17,543,321 ) 21.0 % State income tax benefit, net of federal benefits ( 1,505,818 ) 1.6 ( 1,358,354 ) 1.6 Non-deductible expenses 330,281 ( 0.3 ) 76,913 ( 0.1 ) U.S. research and development tax credit 178,378 ( 0.2 ) ( 5,720,374 ) 6.9 Effect of foreign income tax rates 454,808 ( 0.5 ) 409,048 ( 0.5 ) Effect of common stock options exercised 180,847 ( 0.2 ) ( 1,580,756 ) 1.9 Effect of global intangible low-taxed income ( 24,691 ) ( 0.0 ) 24,691 ( 0.0 ) Change in valuation allowance 20,191,386 ( 21.8 ) 25,792,441 ( 30.9 ) Other, net 122,852 ( 0.1 ) 136,109 ( 0.2 ) Income tax expense $ 480,206 ( 0.5 ) % $ 236,397 ( 0.3 ) % |
Summary of Federal and State Income Tax Provision (Benefit) | 2023 2022 Deferred – U.S. $ ( 63,426 ) $ — Deferred – U.K. 262,612 ( 42,089 ) Deferred – Malaysia ( 21,687 ) 118,295 Subtotal 177,499 76,206 Current – U.S. ( 8,624 ) 126,079 Current – Malaysia 311,331 34,112 Subtotal 302,707 160,191 Income tax expense $ 480,206 $ 236,397 |
Significant Components of Deferred Tax Assets and Liabilities | 2023 2022 Deferred tax assets: Federal net operating loss carryforwards $ 29,510,855 $ 23,627,461 State net operating loss carryforwards 3,354,274 2,850,956 Foreign net operating loss carryforwards – U.K. 15,749,809 15,773,497 Foreign capital allowance – U.K. 174,748 128,490 Share-based compensation – U.K. 217,821 265,631 U.S. research and development tax credit carryforward 8,303,411 8,481,789 U.S. research and development expense 9,758,373 — Accrued compensation 190,397 1,227,290 Share-based compensation 7,896,221 4,325,354 Interest expense 2,602,890 2,206,484 U.S. credit loss provision 885,562 — Change in fair value of derivative liability — 220,607 Other, net – Malaysia 4,046 — Other, net – U.K. 2,500 — Other, net – U.S. 71,509 81,507 Gross deferred tax assets 78,722,416 59,189,066 Valuation allowance for deferred tax assets ( 65,563,838 ) ( 45,372,452 ) Net deferred tax assets 13,158,578 13,816,614 Deferred tax liabilities: Change in fair value of derivative liability ( 449,812 ) — In process research and development — ( 882,427 ) Covenant not-to-compete ( 1,347 ) ( 17,508 ) Other, net – Malaysia — ( 17,641 ) Other — ( 14,120 ) Net deferred tax liabilities ( 451,159 ) ( 931,696 ) Net deferred tax asset $ 12,707,419 $ 12,884,918 |
Schedule of Deferred Tax Amounts Classified in Balance Sheets | 2023 2022 Long-term deferred tax asset – U.K. $ 12,703,373 $ 12,965,985 Long-term deferred tax asset – Malaysia 4,046 — Total long-term deferred tax asset $ 12,707,419 $ 12,965,985 Long-term deferred tax liability – U.S. $ — $ ( 63,426 ) Long-term deferred tax liability – Malaysia — ( 17,641 ) Total long-term deferred tax liability $ — $ ( 81,067 ) |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (Narrative) (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) item country segment | Sep. 30, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Number of countries in which entity operates | country | 150 | ||
Number of primary financial institutions where cash is maintained | item | 3 | ||
Number of reporting units | item | 2 | ||
Number of operating segments | segment | 1 | ||
Impairment charge | $ 3,900,000 | ||
Capitalized nonrefundable advance payments | 0 | ||
Research and development | 51,138,480 | $ 70,646,103 | |
Advertising costs | 900,000 | 600,000 | |
Assets | 50,595,925 | 136,126,017 | |
Foreign currency gains (losses) | 0 | 0 | |
Accumulated Foreign Currency Translation Loss [Member] | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Accumulated other comprehensive income (loss) | (600,000) | (600,000) | |
Outside United States [Member] | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Assets | 10,500,000 | $ 10,800,000 | |
Acquired In-Process Research and Development [Member] | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Impairment charge | $ 3,900,000 | ||
Intangible assets, net | $ 0 |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Sep. 30, 2023 | |
Impairment of intangible assets | $ 3,900,000 | |
Acquired In-Process Research and Development [Member] | ||
Impairment of intangible assets | $ 3,900,000 |
Fair Value Measurements (Reconc
Fair Value Measurements (Reconciliation of the Beginning and Ending Liability Balance) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Measurements [Abstract] | ||
Beginning balance | $ 4,294,000 | $ 7,851,000 |
Change in fair value of derivative liabilities | (2,963,000) | (3,557,000) |
Ending balance | $ 1,331,000 | $ 4,294,000 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Qualitative Information) (Details) - item | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | 2024-12 | 2023-09 |
Minimum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.141 | 0.136 |
Minimum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.20 | 0.20 |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | 2026-12 | 2025-09 |
Maximum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.151 | 0.142 |
Maximum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.90 | 0.90 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Narrative) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from Contracts with Customers [Abstract] | ||
Contract liability | $ 105,000 | $ 342,000 |
Revenue recognized from previously recorded contract liabilities and unearned revenue | $ 330,000 | $ 130,000 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Revenue from Customers by Products) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 16,296,958 | $ 39,354,352 |
FC2 [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 16,283,945 | 39,351,937 |
FC2, U.S. Prescription Channel [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 5,823,921 | 30,223,079 |
FC2, Global Public Health Sector [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 10,460,024 | 9,128,858 |
Other [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 13,013 | $ 2,415 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers (Revenue by Geographic Area) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 16,296,958 | $ 39,354,352 |
United States [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 8,370,202 | 31,430,235 |
South Africa [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,941,678 | |
Other Countries [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 5,985,078 | $ 7,924,117 |
Maximum [Member] | South Africa [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue percentage | 10% |
Accounts Receivable and Conce_3
Accounts Receivable and Concentration of Credit Risk (Narrative) (Details) | 12 Months Ended | |
Sep. 30, 2023 USD ($) customer | Sep. 30, 2022 USD ($) customer | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Provision for credit losses | $ | $ 3,911,714 | $ (8,500) |
Minimum [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Credit terms | 30 days | |
Maximum [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Credit terms | 120 days | |
Net Accounts Receivable And Long-Term Trade Receivables [Member] | Customer Concentration Risk [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Number of customers | 3 | |
Assets, Current [Member] | Customer Concentration Risk [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Number of customers | 0 | 0 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Number of customers | 2 | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Concentration risk, percentage | 83% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Concentration risk, percentage | 71% | |
Net Revenues [Member] | Customer Concentration Risk [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Number of customers | 2 | 2 |
Net Revenues [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Concentration risk, percentage | 73% | |
Net Revenues [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Concentration risk, percentage | 47% | |
Net Revenues [Member] | Customer Concentration Risk [Member] | Pill Club [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Concentration risk, percentage | 24% | 44% |
Brazil [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Credit terms | 90 days | |
Long term trade receivable | $ | $ 700,000 | |
Current trade receivables | $ | $ 1,400,000 |
Accounts Receivable and Conce_4
Accounts Receivable and Concentration of Credit Risk (Components of Accounts Receivable) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |||
Trade receivables, gross | $ 8,445,370 | $ 4,289,892 | |
Less: allowance for credit losses | (3,923,857) | (12,143) | $ (20,643) |
Less: allowance for sales returns and payment term discounts | (15,005) | (12,854) | |
Less: long-term trade receivables | (714,000) | ||
Accounts receivable, net | $ 4,506,508 | $ 3,550,895 |
Accounts Receivable and Conce_5
Accounts Receivable and Concentration of Credit Risk (Summary of Components of Allowance for Doubtful Accounts) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||
Beginning balance | $ 12,143 | $ 20,643 |
Charges-offs (recoveries), net | 3,911,714 | (8,500) |
Ending balance | $ 3,923,857 | $ 12,143 |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Inventory [Line Items] | ||
Inventory, net | $ 6,697,117 | $ 8,618,944 |
Held-for-Sale [Member] | ENTADFI [Member] | ||
Inventory [Line Items] | ||
Inventory, net | $ 1,100,000 |
Inventories (Components of Inve
Inventories (Components of Inventories) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Inventories [Abstract] | ||
Raw material | $ 1,854,810 | $ 1,662,712 |
Work in process | 112,799 | 872,596 |
Finished goods | 4,913,295 | 6,099,343 |
Inventories, gross | 6,880,904 | 8,634,651 |
Less: inventory reserves | (183,787) | (15,707) |
Inventories, net | $ 6,697,117 | $ 8,618,944 |
Property and Equipment (Narrati
Property and Equipment (Narrative) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation expense | $ 198,000 | $ 138,000 |
Equipment, Furniture And Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Deposits | $ 214,000 | $ 276,000 |
Property and Equipment (Summary
Property and Equipment (Summary of Plant and Equipment) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 5,440,686 | $ 4,827,650 |
Less: accumulated depreciation and amortization | (3,787,954) | (3,641,884) |
Plant and equipment, net | 1,652,732 | 1,185,766 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 3,008,122 | 2,902,715 |
Manufacturing Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 5 years | |
Manufacturing Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 8 years | |
Office Equipment, Furniture And Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 1,471,870 | 1,440,475 |
Office Equipment, Furniture And Fixtures [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 3 years | |
Office Equipment, Furniture And Fixtures [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 10 years | |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 960,694 | $ 484,460 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 3 years | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 8 years |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Finite-Lived Intangible Assets [Line Items] | |||
Goodwill | $ 6,878,932 | $ 6,878,932 | |
Change in goodwill | 0 | 0 | |
Amortization of intangible assets | 71,000 | $ 71,000 | |
Estimated future amortization, 2024 | 6,000 | ||
Impairment charge | $ 3,900,000 | ||
Covenants Not-To-Compete [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization period | 7 years | ||
Acquired In-Process Research and Development [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Impairment charge | $ 3,900,000 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Gross Carrying Amounts and Net Book Value of Intangible Assets) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite life, Accumulated Amortization | $ 494,048 | $ 422,619 |
Intangible Assets, Gross (Excluding Goodwill), Total | 500,000 | 4,400,000 |
Total intangible assets, Net Book Value | 5,952 | 3,977,381 |
Acquired In-Process Research And Development Assets [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets | 3,900,000 | |
Covenants Not-To-Compete [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite life, Gross Carrying Amount | 500,000 | 500,000 |
Intangible assets with finite life, Accumulated Amortization | 494,048 | 422,619 |
Intangible assets with finite life, Net Book Value | $ 5,952 | $ 77,381 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | 12 Months Ended | 42 Months Ended | ||
Nov. 01, 2022 USD ($) item | Sep. 30, 2023 USD ($) item | Aug. 31, 2021 USD ($) | Mar. 05, 2018 USD ($) | |
Line of Credit Facility [Line Items] | ||||
Payments on notes payable | $ 1,292,199 | |||
SWK Credit Agreement [Member] | ||||
Line of Credit Facility [Line Items] | ||||
Loan amount | $ 10,000,000 | |||
Residual Royalty Agreement [Member] | ||||
Line of Credit Facility [Line Items] | ||||
Repayment percentage | 5% | |||
Payment terms, period of revenue calculation | 12 months | |||
Payment terms, change in control or sale of business fee, amount | $ 2,000,000 | |||
Payment terms, change in control or sale of business fee, percentage of product revenue | 5% | |||
Payment terms, change in control or sale of business fee, percentage multiple | item | 5 | |||
Payments on notes payable | $ 10,000,000 | |||
Premium Finance Agreement [Member] | ||||
Line of Credit Facility [Line Items] | ||||
Loan amount | $ 1,400,000 | |||
Interest rate | 6.30% | |||
Number of installments | item | 11 | |||
Loan payable | $ 100,000 |
Debt (Residual Royalty Agreemen
Debt (Residual Royalty Agreement Liability) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Residual Royalty Agreement Disclosures [Line Items] | ||
Residual royalty agreement liability, short-term portion | $ (864,623) | $ (1,169,095) |
Residual royalty agreement, long-term portion | 8,870,136 | 9,656,441 |
Residual Royalty Agreement [Member] | ||
Residual Royalty Agreement Disclosures [Line Items] | ||
Residual royalty agreement liability, fair value at inception | 346,000 | 346,000 |
Add: accretion of liability using effective interest rate | 12,377,949 | 9,950,908 |
Less: cumulative payments | (4,320,190) | (3,765,372) |
Residual royalty agreement liability, excluding embedded derivative liability | 8,403,759 | 6,531,536 |
Add: embedded derivative liability at fair value (see Note 3) | 1,331,000 | 4,294,000 |
Total residual royalty agreement liability | 9,734,759 | 10,825,536 |
Residual royalty agreement liability, short-term portion | (864,623) | (1,169,095) |
Residual royalty agreement, long-term portion | $ 8,870,136 | $ 9,656,441 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) | 1 Months Ended | 12 Months Ended | 36 Months Ended | ||||||||
Dec. 05, 2023 USD ($) shares | Nov. 30, 2023 USD ($) shares | Jun. 26, 2023 USD ($) | May 02, 2023 USD ($) shares $ / shares | Apr. 12, 2023 USD ($) $ / shares shares | Jun. 26, 2020 USD ($) shares | Mar. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) item / shares $ / shares shares | Jun. 25, 2023 USD ($) shares | May 12, 2023 USD ($) shares | Sep. 30, 2022 USD ($) $ / shares shares | |
Class of Stock [Line Items] | |||||||||||
Preferred stock, issued | shares | 0 | 0 | |||||||||
Preferred stock, outstanding | shares | 0 | 0 | |||||||||
Common Stock, shares authorized | shares | 308,000,000 | 154,000,000 | |||||||||
Common Stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||||||
Common stock voting rights per share | item / shares | 1 | ||||||||||
Shelf registration statement capacity | $ 200,000,000 | $ 23,000,000 | |||||||||
Deferred costs recorded in additional paid in capital | $ 138,182 | ||||||||||
Common Stock, shares outstanding | shares | 91,782,698 | 80,508,894 | |||||||||
Value of shares issued for services | $ 1,008,000 | ||||||||||
Maximum Share Purchase, Stock Price Range One [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, maximum purchase of shares per business day | shares | 275,000 | ||||||||||
Maximum Share Purchase, Stock Price Range Three [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, maximum purchase of shares per business day | shares | 2,500,000 | ||||||||||
Maximum Share Purchase, Stock Price Range Two [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, maximum purchase of shares per business day | shares | 2,000,000 | ||||||||||
Aspire Capital Purchase Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, term | 36 months | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ 23,900,000 | ||||||||||
Shares issued | shares | 2,779,713 | 4,424,450 | |||||||||
Proceeds from sale of shares | $ 3,400,000 | $ 8,400,000 | |||||||||
Deferred costs recorded in additional paid in capital | 105,000 | ||||||||||
Remaining amount authorized | $ 0 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | shares | 212,130 | ||||||||||
Value of shares issued for services | $ 681,000 | ||||||||||
Related expenses | 50,000 | ||||||||||
Deferred costs | $ 731,000 | ||||||||||
Stock issuance expenses | $ 473,000 | ||||||||||
Unamortized deferred assets | $ 578,000 | ||||||||||
Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued | shares | 5,000,000 | ||||||||||
Stock issuance price | $ / shares | $ 1 | ||||||||||
Proceeds from sale of shares | 4,969,045 | ||||||||||
Sale of shares under common stock purchase agreement | $ 5,000,000 | 4,969,045 | |||||||||
Net issuance costs | $ 31,000 | ||||||||||
Lincoln Park Purchase Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, term | 36 months | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ 100,000,000 | ||||||||||
Proceeds from sale of shares | 1,400,000 | ||||||||||
Deferred costs recorded in additional paid in capital | $ 30,000 | ||||||||||
Stock purchase agreement, maximum purchase of shares per business day | shares | 250,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | shares | 800,000 | 1,225,000 | |||||||||
Related expenses | $ 57,000 | ||||||||||
Deferred costs | 1,100,000 | ||||||||||
Unamortized deferred assets | $ 1,000,000 | ||||||||||
Stock purchase agreement, maximum purchase of shares per regular purchase, amount | $ 225,000 | ||||||||||
Share price | $ / shares | $ 6 | ||||||||||
Stock purchase agreement, alternate stock price calculation, number of consecutive trading days used for stock price measurement | 10 days | ||||||||||
Stock purchase agreement, percentage of trading volume used to calculate maximum share purchase on day following initial purchase | 30% | ||||||||||
Stock purchase agreement, share purchase price as percentage of stock closing price or volume weighted average stock price on day following initial purchase | 97% | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized, shares | shares | 17,678,502 | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized, percentage of outstanding common stock | 19.99% | ||||||||||
Stock purchase agreement, average minimum share price threshold for determination of additional purchases | $ / shares | $ 1.26 | ||||||||||
Stock purchase agreement, shares issuable upon threshold for aggregate purchases, value | $ 1,000,000 | ||||||||||
Issue of shares of the company's common stock at the time Lincoln Park's purchases | 1,000,000 | ||||||||||
Aggregate amount of cumulative purchases | $ 50,000,000 | ||||||||||
Lincoln Park Purchase Agreement [Member] | Subsequent Event [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from sale of shares | $ 1,700,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | shares | 1,800,000 | ||||||||||
Jefferies Sales Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ 75,000,000 | ||||||||||
Proceeds from sale of shares | 1,040,321 | ||||||||||
Deferred costs recorded in additional paid in capital | 3,000 | ||||||||||
Value of shares issued for services | 1,277,259 | ||||||||||
Deferred costs | $ 207,000 | ||||||||||
Unamortized deferred assets | 200,000 | ||||||||||
Sale of shares under common stock purchase agreement | $ 1,040,321 | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized, shares | shares | 39,609,072 | ||||||||||
Commission percentage | 3% | ||||||||||
Jefferies Sales Agreement [Member] | Subsequent Event [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from sale of shares | $ 67,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | shares | 90,156 | ||||||||||
Preferred Class A [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 5,000,000 | ||||||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.01 | ||||||||||
Preferred stock, issued | shares | 0 | 0 | |||||||||
Preferred stock, outstanding | shares | 0 | 0 | |||||||||
Preferred Class A Series 1 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 1,040,000 | ||||||||||
Preferred Class A Series 2 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 1,500,000 | ||||||||||
Preferred Class A Series 3 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 700,000 | ||||||||||
Preferred Class A Series 4 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 548,000 | ||||||||||
Preferred Class B [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | shares | 15,000 | ||||||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.50 | ||||||||||
Preferred stock, issued | shares | 0 | 0 | |||||||||
Preferred stock, outstanding | shares | 0 | 0 | |||||||||
Minimum [Member] | Lincoln Park Purchase Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Share price | $ / shares | $ 8 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 12 Months Ended | |||||
Oct. 18, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2017 | Mar. 29, 2022 | Jul. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Tax benefit of stock-based compensation expense | $ 4,000,000 | $ 2,500,000 | ||||
Stock option conversion ratio | 100% | |||||
Options, exercises in period, intrinsic value | $ 500,000 | 8,100,000 | ||||
Proceeds from stock option exercises | 389,058 | 1,078,289 | ||||
Share-based compensation | $ 17,918,603 | 11,242,423 | ||||
Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Award vesting period | 3 years | |||||
Share price | $ 0.72 | |||||
Unrecognized compensation expense, stock options | $ 29,500,000 | |||||
Unrecognized compensation expense, period for recognition | 1 year 9 months 18 days | |||||
Share-based compensation | $ 1,900,000 | |||||
Aggregate expense related to modifications | $ 25,000 | $ 1,000,000 | ||||
Stock Option [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Award term | 10 years | |||||
Stock Appreciation Rights (SARs) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting date | Oct. 31, 2018 | |||||
Award term | 10 years | |||||
Exercise price per share | $ 0.95 | |||||
Vested shares | 50,000 | 50,000 | ||||
Stock Appreciation Rights (SARs) [Member] | Employee [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issued | 50,000 | |||||
2008 Stock Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 0 | |||||
2017 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 4,700,000 | |||||
Number of shares available | 398,105 | |||||
2018 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 18,500,000 | |||||
Number of shares available | 2,593,491 | |||||
2022 Inducement Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 4,000,000 | |||||
Number of shares available | 3,901,250 |
Share-based Compensation (Recor
Share-based Compensation (Recorded Share-Based Compensation Expenses) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 17,918,603 | $ 11,242,423 |
Cost of Sales [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | 361,843 | 328,225 |
Selling, General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | 13,785,067 | 8,151,505 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 3,771,693 | $ 2,762,693 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted Average Assumptions for Options Granted) (Details) - Stock Option [Member] - $ / shares | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected Volatility | 101.37% | 84.53% |
Expected Dividend Yield | 0% | 0% |
Risk-free Interest Rate | 3.92% | 2.17% |
Expected Term (in years) | 6 years | 6 years |
Fair Value of Options Granted | $ 5.55 | $ 7.10 |
Share-based Compensation (Summa
Share-based Compensation (Summary of Stock Options Outstanding and Exercisable) (Details) - Stock Option [Member] | 12 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Outstanding at Beginning of Period | shares | 14,263,470 |
Number of Shares Granted | shares | 4,934,955 |
Number of Shares Exercised | shares | (191,832) |
Number of Shares Forfeited | shares | (1,638,950) |
Number of Shares Outstanding at End of Period | shares | 17,367,643 |
Number of Shares Exercisable at End of Period | shares | 9,759,441 |
Weighted Average Exercise Price Per Share Outstanding at Beginning of Period | $ / shares | $ 5 |
Weighted Average Exercise Price Per Share Granted | $ / shares | 6.92 |
Weighted Average Exercise Price Per Share Exercised | $ / shares | 2.03 |
Weighted Average Exercise Price Per Share Forfeited | $ / shares | 8.19 |
Weighted Average Exercise Price Per Share Outstanding at End of Period | $ / shares | 5.28 |
Weighted Average Exercise Price Per Share Exercisable at End of Period | $ / shares | $ 3.54 |
Weighted Average Remaining Contractual Term (years) Outstanding at End of Period | 7 years 1 month 6 days |
Weighted Average Remaining Contractual Term (years) Exercisable at End of Period | 5 years 9 months 3 days |
Leases (Narrative) (Details)
Leases (Narrative) (Details) | 12 Months Ended | ||
Mar. 01, 2022 ft² $ / sqft | Sep. 30, 2023 USD ($) ft² $ / sqft | Sep. 30, 2022 USD ($) | |
Operating Leased Assets [Line Items] | |||
Operating lease payments | $ 860,000 | $ 680,000 | |
Right-of-use assets recorded in exchange for lease liabilities | 286,815 | 4,411,474 | |
Operating lease liabilities not yet commenced | $ 0 | ||
Miami, Florida [Member] | Corporate Headquarters [Member] | |||
Operating Leased Assets [Line Items] | |||
Area of real estate property | ft² | 12,000 | ||
Operating lease term | 8 years | ||
Annual base rent escalation | 3% | ||
Security deposit | $ 117,000 | $ 117,000 | |
Base rent amount per square foot | $ / sqft | 58 | ||
Chicago, Illinois [Member] | Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Area of real estate property | ft² | 6,600 | ||
Operating lease term | 7 years | ||
Operating lease holiday term | 7 months | ||
Operating lease abatement term | 5 months | ||
Lease expiration date | Oct. 31, 2023 | ||
Security deposit | $ 55,000 | ||
Chicago, Illinois [Member] | Subleased Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Lease expiration date | Oct. 31, 2023 | ||
Security deposit | $ 30,000 | ||
Chicago, Illinois [Member] | Minimum [Member] | Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Base rent amount per square foot | $ / sqft | 14 | ||
Chicago, Illinois [Member] | Minimum [Member] | Subleased Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Operating lease monthly payments | $ 15,200 | ||
Chicago, Illinois [Member] | Maximum [Member] | Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Base rent amount per square foot | $ / sqft | 17 | ||
Chicago, Illinois [Member] | Maximum [Member] | Subleased Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Operating lease monthly payments | $ 17,300 | ||
London, England [Member] | Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Area of real estate property | ft² | 6,400 | ||
Operating lease term | 5 years | ||
Operating lease abatement term | 3 years | ||
Operating lease quarterly rental payments | $ 41,100 | ||
Security deposit | 58,000 | ||
Operating lease cancellation penalty | 0 | ||
Right-of-use assets recorded in exchange for lease liabilities | $ 265,000 | ||
Selangor D.E., Malaysia [Member] | Manufacturing and Warehouse Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Area of real estate property | ft² | 45,800 | ||
Operating lease term | 3 years | ||
Lease expiration date | Aug. 31, 2022 | ||
Operating lease renewal term | 3 years | ||
Operating lease monthly payments | $ 15,400 | ||
Security deposit | $ 46,000 |
Leases (Components of Lease Cos
Leases (Components of Lease Cost) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Finance lease cost: Amortization of right-of-use assets | $ 3,631 | |
Finance lease cost: Interest on lease liabilities | 403 | |
Operating lease cost | $ 1,117,463 | 883,928 |
Short-term lease cost | 42,809 | 46,117 |
Variable lease cost | 186,904 | 211,840 |
Sublease income | (179,378) | (179,378) |
Total lease cost | $ 1,167,798 | $ 966,541 |
Leases (Summary of Lease Inform
Leases (Summary of Lease Information) (Details) | Sep. 30, 2023 | Sep. 30, 2022 |
Leases [Abstract] | ||
Operating Leases, Weighted-average remaining lease term | 6 years 1 month 6 days | 6 years 9 months 18 days |
Operating Leases, Weighted-average discount rate | 7.70% | 7.60% |
Leases (Schedule of Maturities
Leases (Schedule of Maturities of Lease Liabilities) (Details) | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
Operating Leases, 2024 | $ 1,085,368 |
Operating Leases, 2025 | 1,034,855 |
Operating Leases, 2026 | 800,693 |
Operating Leases, 2027 | 814,311 |
Operating Leases, 2028 | 832,997 |
Operating Leases, Thereafter | 1,217,797 |
Operating Leases, Total lease payments | 5,786,021 |
Operating Leases, Less imputed interest | (1,115,317) |
Operating Leases, Total lease liabilities | $ 4,670,704 |
Contingent Liabilities (Narrati
Contingent Liabilities (Narrative) (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Contingent Liabilities [Abstract] | |
Product liability insurance, coverage amount | $ 10 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Expense (Benefit) [Line Items] | |||
Increase in deferred tax assets related to change in recognition of research and development expense | $ 9,800,000 | ||
Net impact to income tax benefit related change in recognition of research and development expense | $ 0 | ||
Unrecognized tax benefits | $ 0 | $ 0 | |
Minimum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2024 | ||
Maximum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2043 | ||
Tax Period 2038 To 2043 [Member] | U.S. federal research and development tax credit carryforwards [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Tax credit carryforward | $ 8,300,000 | ||
Tax Period 2038 To 2043 [Member] | Minimum [Member] | U.S. federal research and development tax credit carryforwards [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Tax credit carryforward, expiration date | Dec. 31, 2038 | ||
Tax Period 2038 To 2043 [Member] | Maximum [Member] | U.S. federal research and development tax credit carryforwards [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Tax credit carryforward, expiration date | Dec. 31, 2043 | ||
Domestic [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | $ 140,500,000 | ||
Domestic [Member] | Minimum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2024 | ||
Domestic [Member] | Maximum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2038 | ||
Domestic [Member] | Tax Period 2024 To 2043 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | $ 29,700,000 | ||
Domestic [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 110,800,000 | ||
State [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 62,400,000 | ||
State [Member] | Tax Period 2024 To 2043 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 35,200,000 | ||
State [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 27,200,000 | ||
Foreign [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 63,000,000 | ||
United States [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | 62,100,000 | 42,200,000 | |
Valuation allowance, deferred tax asset, change in amount | 19,900,000 | ||
U.K. [Member] | The Female Health Company Limited [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | 3,200,000 | 3,200,000 | |
U.K. [Member] | The Female Health Company UK [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | 0 | 0 | |
U.K. [Member] | Veru Biopharma UK Limited [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | $ 300,000 | $ 300,000 |
Income Taxes (Schedule of (Loss
Income Taxes (Schedule of (Loss) Income Before Income Taxes by Jurisdiction) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Loss before income taxes | $ (92,608,747) | $ (83,539,623) |
Domestic [Member] | ||
Loss before income taxes | (90,458,648) | (82,186,464) |
Foreign [Member] | ||
Loss before income taxes | $ (2,150,099) | $ (1,353,159) |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Effective Tax Expense) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Income Taxes [Abstract] | ||
Income tax benefit at U.S. federal statutory rates | $ (19,447,837) | $ (17,543,321) |
State income tax benefit, net of federal benefits | (1,505,818) | (1,358,354) |
Amount, Non-deductible expenses | 330,281 | 76,913 |
U.S. research and development tax credit | 178,378 | (5,720,374) |
Effect of foreign income tax rates | 454,808 | 409,048 |
Amount, Effect of common stock options exercised | 180,847 | (1,580,756) |
Amount, Effect of global intangible low taxed income | 24,691 | 24,691 |
Change in valuation allowance | 20,191,386 | 25,792,441 |
Other, net | 122,852 | 136,109 |
Income tax expense | $ 480,206 | $ 236,397 |
Tax Rate, Income tax benefit at U.S. federal statutory rates | 21% | 21% |
Tax Rate, State income tax expense (benefit), net of federal benefits | 1.60% | 1.60% |
Tax Rate, Non-deductible expenses - other | (0.30%) | (0.10%) |
Tax Rate, U.S. research and development tax credit | (0.20%) | 6.90% |
Tax Rate, Effect of foreign income tax rates | (0.50%) | (0.50%) |
Tax Rate, Effect of common stock options exercised | (0.20%) | 1.90% |
Tax Rate, Effect of global intangible low-taxed income | 0% | 0% |
Tax Rate, Change in valuation allowance | (21.80%) | (30.90%) |
Tax Rate, Other net | (0.10%) | (0.20%) |
Tax Rate, Income tax expense (benefit) | (0.50%) | (0.30%) |
Income Taxes (Summary of Federa
Income Taxes (Summary of Federal and State Income Tax Provision (Benefit)) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Components of Income Tax Expense (Benefit) [Line Items] | ||
Subtotal - Deferred | $ 177,499 | $ 76,206 |
Subtotal - Current | 302,707 | 160,191 |
Income tax expense | 480,206 | 236,397 |
United States [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Foreign | (63,426) | |
Current - Federal | (8,624) | 126,079 |
U.K. [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Foreign | 262,612 | (42,089) |
Malaysia [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Foreign | (21,687) | 118,295 |
Current - Foreign | $ 311,331 | $ 34,112 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Federal net operating loss carryforwards | $ 29,510,855 | $ 23,627,461 |
State net operating loss carryforwards | 3,354,274 | 2,850,956 |
Foreign net operating loss carryforwards - U.K. | 15,749,809 | 15,773,497 |
Foreign capital allowance - U.K. | 174,748 | 128,490 |
U.S. research and development tax credit carryforwards | 8,303,411 | 8,481,789 |
U.S. research and development expense | 9,758,373 | |
Accrued compensation | 190,397 | 1,227,290 |
Share-based compensation | 7,896,221 | 4,325,354 |
Interest expense | 2,602,890 | 2,206,484 |
U.S. credit loss provision | 885,562 | |
Change in fair value of derivative liabilities | 220,607 | |
Gross deferred tax assets | 78,722,416 | 59,189,066 |
Valuation allowance for deferred tax assets | (65,563,838) | (45,372,452) |
Net deferred tax assets | 13,158,578 | 13,816,614 |
Deferred tax liabilities: | ||
Change in fair value of derivative liabilities | (449,812) | |
In-process research and development | (882,427) | |
Covenant not-to-compete | (1,347) | (17,508) |
Other, net - Malaysia | (17,641) | |
Other, net | (14,120) | |
Net deferred tax liabilities | (451,159) | (931,696) |
Net deferred tax asset | 12,707,419 | 12,884,918 |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Share-based compensation | 217,821 | 265,631 |
Other, net | 2,500 | |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 4,046 | |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | $ 71,509 | $ 81,507 |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Amounts Classified in Balance Sheets) (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 12,707,419 | $ 12,965,985 |
Deferred tax liability | (81,067) | |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | 12,703,373 | 12,965,985 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 4,046 | |
Deferred tax liability | (17,641) | |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax liability | $ (63,426) |
Sale of ENTADFI (Narrative) (De
Sale of ENTADFI (Narrative) (Details) - USD ($) | 12 Months Ended | ||||||
Oct. 03, 2023 | Sep. 29, 2023 | Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2024 | Apr. 30, 2024 | Apr. 19, 2023 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Proceeds from sale of assets | $ 7,000,000 | ||||||
Gain on asset disposal | 5,723,623 | ||||||
ENTADFI [Member] | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Purchase price | $ 20,000,000 | ||||||
Proceeds from sale of assets | $ 1,000,000 | $ 6,000,000 | |||||
Consideration receivable | 4,000,000 | ||||||
Contingent consideration | $ 80,000,000 | ||||||
Nonrefundable consideration | 7,000,000 | ||||||
Net book value | 1,300,000 | ||||||
Gain on asset disposal | $ 5,700,000 | ||||||
ENTADFI [Member] | BWV Series A Preferred Stock [Member] | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Number of shares issued in transaction | 3,000 | 3,000 | |||||
Scenario, Forecast [Member] | ENTADFI [Member] | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Consideration receivable | $ 5,000,000 | $ 5,000,000 |
Employee Benefit Plans (Narrati
Employee Benefit Plans (Narrative) (Details) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Mar. 31, 2014 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
401(k) [Member] | ||||
Defined Contribution Plan [Line Items] | ||||
Company matching contribution rate | 100% | |||
Company matching contribution, percent of compensation | 6% | |||
Company contributions | $ 616,000 | $ 461,000 | ||
Foreign Postretirement Benefit Plan [Member] | ||||
Defined Contribution Plan [Line Items] | ||||
Company matching contribution, percent of compensation | 3% | 4% | ||
Company contributions | $ 29,000 | $ 41,000 |