Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Jun. 30, 2023 | Aug. 08, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 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, $0.01 par value per share | |
Trading Symbol | VERU | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 90,280,439 | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Amendment Flag | false | |
Entity Central Index Key | 0000863894 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 16,213,136 | $ 80,190,675 |
Accounts receivable, net | 5,082,878 | 3,550,895 |
Notes receivable, short term portion | 8,536,535 | |
Inventories, net | 6,489,968 | 8,618,944 |
Prepaid research and development costs | 5,532,410 | 10,444,587 |
Prepaid expenses and other current assets | 1,366,237 | 1,964,373 |
Total current assets | 43,221,164 | 104,769,474 |
Plant and equipment, net | 1,492,183 | 1,185,766 |
Operating lease right-of-use assets | 4,495,336 | 4,786,915 |
Deferred income taxes | 13,098,090 | 12,965,985 |
Intangible assets, net | 23,810 | 3,977,381 |
Goodwill | 6,878,932 | 6,878,932 |
Notes receivable, long-term portion | 4,437,850 | |
Other assets | 1,548,049 | 1,561,564 |
Total assets | 75,195,414 | 136,126,017 |
Current liabilities: | ||
Accounts payable | 18,118,594 | 22,003,394 |
Accrued research and development costs | 1,112,788 | 9,071,503 |
Accrued compensation | 3,546,470 | 5,986,557 |
Accrued expenses and other current liabilities | 2,789,733 | 2,249,995 |
Residual royalty agreement liability, short-term portion | 1,061,893 | 1,169,095 |
Operating lease liability, short-term portion | 1,056,702 | 957,085 |
Total current liabilities | 27,686,180 | 41,437,629 |
Residual royalty agreement liability, long-term portion | 9,276,735 | 9,656,441 |
Operating lease liability, long-term portion | 3,805,137 | 4,093,667 |
Deferred income taxes | 81,067 | |
Other liabilities | 40,111 | 18,577 |
Total liabilities | 40,808,163 | 55,287,381 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock, no shares issued and outstanding at June 30, 2023 and September 30, 2022 | ||
Common stock, par value $0.01 per share; 154,000,000 shares authorized, 91,420,436 and 82,692,598 shares issued and 89,236,732 and 80,508,894 shares outstanding at June 30, 2023 and September 30, 2022, respectively | 914,204 | 826,926 |
Additional paid-in-capital | 276,756,250 | 253,974,032 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (234,895,079) | (165,574,198) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 34,387,251 | 80,838,636 |
Total liabilities and stockholders' equity | $ 75,195,414 | $ 136,126,017 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Sep. 30, 2022 |
CONDENSED 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 | 154,000,000 | 154,000,000 |
Common Stock, shares issued | 91,420,436 | 82,692,598 |
Common Stock, shares outstanding | 89,236,732 | 80,508,894 |
Treasury stock, shares | 2,183,704 | 2,183,704 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ||||
Net revenues | $ 3,341,185 | $ 9,602,195 | $ 12,434,946 | $ 36,765,721 |
Cost of sales | 2,110,567 | 2,533,572 | 6,410,198 | 6,679,738 |
Gross profit | 1,230,618 | 7,068,623 | 6,024,748 | 30,085,983 |
Operating expenses: | ||||
Research and development | 2,925,171 | 18,133,412 | 44,534,153 | 43,755,677 |
Selling, general and administrative | 10,902,916 | 10,761,486 | 41,283,275 | 24,887,830 |
Provision for (recovery of) credit losses | (2,500) | 3,911,714 | (6,500) | |
Impairment of intangible assets | 3,900,000 | |||
Total operating expenses | 13,828,087 | 28,892,398 | 93,629,142 | 68,637,007 |
Gain on sale of ENTADFI® assets | 17,456,814 | 17,456,814 | ||
Operating income (loss) | 4,859,345 | (21,823,775) | (70,147,580) | (38,551,024) |
Non-operating income (expenses): | ||||
Interest expense | (648,917) | (1,185,093) | (2,219,840) | (3,556,477) |
Change in fair value of derivative liabilities | 1,789,000 | 881,000 | 2,319,000 | (557,000) |
Other income, net | 372,327 | 69,895 | 650,253 | 135,897 |
Total non-operating income (expenses) | 1,512,410 | (234,198) | 749,413 | (3,977,580) |
Income (loss) before income taxes | 6,371,755 | (22,057,973) | (69,398,167) | (42,528,604) |
Income tax expense (benefit) | 57,551 | 137,603 | (77,286) | 224,808 |
Net income (loss) | $ 6,314,204 | $ (22,195,576) | $ (69,320,881) | $ (42,753,412) |
Net income (loss) per basic common shares outstanding | $ 0.07 | $ (0.28) | $ (0.83) | $ (0.53) |
Basic weighted average common shares outstanding | 88,266,152 | 80,088,431 | 83,218,748 | 80,054,594 |
Net income (loss) per diluted common shares outstanding | $ 0.07 | $ (0.28) | $ (0.83) | $ (0.53) |
Diluted weighted average common shares outstanding | 88,301,516 | 80,088,431 | 83,218,748 | 80,054,594 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] Aspire Capital Purchase Agreement, 2020 [Member] | Common Stock [Member] Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Aspire Capital Purchase Agreement, 2020 [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] | Aspire Capital Purchase Agreement, 2020 [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 | 1,880,428 | 1,880,428 | ||||||||||
Issuance of shares pursuant to share-based awards | $ 793 | 209,076 | 209,869 | |||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 79,334 | |||||||||||
Net loss | (6,380,006) | (6,380,006) | ||||||||||
Balance at Dec. 31, 2021 | $ 822,328 | 243,748,215 | (581,519) | (88,178,184) | (7,806,605) | 148,004,235 | ||||||
Balance (in Shares) at Dec. 31, 2021 | 82,232,786 | |||||||||||
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 | |||||||||||
Net loss | (42,753,412) | |||||||||||
Balance at Jun. 30, 2022 | $ 823,117 | 248,984,393 | (581,519) | (124,551,590) | (7,806,605) | 116,867,796 | ||||||
Balance (in Shares) at Jun. 30, 2022 | 82,311,689 | |||||||||||
Balance at Dec. 31, 2021 | $ 822,328 | 243,748,215 | (581,519) | (88,178,184) | (7,806,605) | 148,004,235 | ||||||
Balance (in Shares) at Dec. 31, 2021 | 82,232,786 | |||||||||||
Share-based compensation | 2,124,941 | 2,124,941 | ||||||||||
Issuance of shares pursuant to share-based awards | $ 173 | 46,924 | 47,097 | |||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 17,267 | |||||||||||
Net loss | (14,177,830) | (14,177,830) | ||||||||||
Balance at Mar. 31, 2022 | $ 822,501 | 245,920,080 | (581,519) | (102,356,014) | (7,806,605) | 135,998,443 | ||||||
Balance (in Shares) at Mar. 31, 2022 | 82,250,053 | |||||||||||
Share-based compensation | 2,910,976 | 2,910,976 | ||||||||||
Issuance of shares pursuant to share-based awards | $ 616 | 153,337 | 153,953 | |||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 61,636 | |||||||||||
Net loss | (22,195,576) | (22,195,576) | ||||||||||
Balance at Jun. 30, 2022 | $ 823,117 | 248,984,393 | (581,519) | (124,551,590) | (7,806,605) | 116,867,796 | ||||||
Balance (in Shares) at Jun. 30, 2022 | 82,311,689 | |||||||||||
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 | 4,845,269 | 4,845,269 | ||||||||||
Issuance of shares pursuant to share-based awards | $ 1,142 | 255,990 | 257,132 | |||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 114,234 | |||||||||||
Net loss | (36,842,179) | (36,842,179) | ||||||||||
Balance at Dec. 31, 2022 | $ 828,068 | 259,075,291 | (581,519) | (202,416,377) | (7,806,605) | 49,098,858 | ||||||
Balance (in Shares) at Dec. 31, 2022 | 82,806,832 | |||||||||||
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 | |||||||||||
Sale/issuance of shares (in Shares) | 2,779,713 | |||||||||||
Amortization of deferred costs | (105,000) | |||||||||||
Net loss | (69,320,881) | |||||||||||
Balance at Jun. 30, 2023 | $ 914,204 | 276,756,250 | (581,519) | (234,895,079) | (7,806,605) | 34,387,251 | ||||||
Balance (in Shares) at Jun. 30, 2023 | 91,420,436 | |||||||||||
Balance at Dec. 31, 2022 | $ 828,068 | 259,075,291 | (581,519) | (202,416,377) | (7,806,605) | 49,098,858 | ||||||
Balance (in Shares) at Dec. 31, 2022 | 82,806,832 | |||||||||||
Share-based compensation | 3,837,598 | 3,837,598 | ||||||||||
Issuance of shares pursuant to share-based awards | $ 339 | 79,139 | 79,478 | |||||||||
Issuance of shares pursuant to share-based awards (in Shares) | 33,891 | |||||||||||
Sale/issuance of shares (in Shares) | 1,920,013 | |||||||||||
Sale/issuance of shares | $ 19,200 | 2,552,351 | 2,571,551 | |||||||||
Amortization of deferred costs | (78,677) | (78,677) | ||||||||||
Net loss | (38,792,906) | (38,792,906) | ||||||||||
Balance at Mar. 31, 2023 | $ 847,607 | 265,465,702 | (581,519) | (241,209,283) | (7,806,605) | 16,715,902 | ||||||
Balance (in Shares) at Mar. 31, 2023 | 84,760,736 | |||||||||||
Share-based compensation | 4,550,832 | 4,550,832 | ||||||||||
Sale/issuance of shares (in Shares) | 859,700 | 5,000,000 | ||||||||||
Sale/issuance of shares | $ 8,597 | $ 50,000 | $ 846,843 | $ 4,919,045 | $ 855,440 | $ 4,969,045 | ||||||
Amortization of deferred costs | (26,172) | (26,172) | ||||||||||
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 | 1,008,000 | |||||||||
Net loss | 6,314,204 | 6,314,204 | ||||||||||
Balance at Jun. 30, 2023 | $ 914,204 | $ 276,756,250 | $ (581,519) | $ (234,895,079) | $ (7,806,605) | $ 34,387,251 | ||||||
Balance (in Shares) at Jun. 30, 2023 | 91,420,436 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
OPERATING ACTIVITIES | ||
Net loss | $ (69,320,881) | $ (42,753,412) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 199,690 | 147,156 |
Impairment of intangible assets | 3,900,000 | |
Provision for credit losses | 3,911,714 | (6,500) |
Gain on sale of ENTADFI® assets | (17,456,814) | |
Noncash change in right-of-use assets | 556,475 | 411,002 |
Noncash interest expense, net of interest paid | 1,832,092 | 1,415,978 |
Share-based compensation | 13,233,699 | 6,916,345 |
Deferred income taxes | (213,172) | 19,017 |
Change in fair value of derivative liabilities | (2,319,000) | 557,000 |
Other | (45,317) | 69,633 |
Changes in current assets and liabilities: | ||
Increase in accounts receivable | (4,729,697) | (930,021) |
Decrease (increase) in inventories | 845,688 | (2,216,377) |
Decrease (increase) in prepaid expenses and other assets | 5,780,913 | (1,737,701) |
(Decrease) increase in accounts payable | (3,884,800) | 3,526,541 |
(Decrease) increase in accrued expenses and other current liabilities | (10,358,135) | 8,258,099 |
Decrease in operating lease liabilities | (453,809) | (303,266) |
Net cash used in operating activities | (78,521,354) | (26,626,506) |
INVESTING ACTIVITIES | ||
Capital expenditures | (452,826) | (584,245) |
Net cash provided by investing activities | 5,547,174 | 4,415,755 |
FINANCING ACTIVITIES | ||
Proceeds from stock option exercises | 336,610 | 410,919 |
Proceeds from sale of shares | 3,400,000 | |
Payment of deferred equity financing issuance costs | (263,757) | |
Proceeds from premium finance agreement | 1,425,174 | |
Installment payments on premium finance agreement | (897,422) | |
Cash paid for debt portion of finance lease | (9,093) | |
Net cash provided by financing activities | 8,996,641 | 401,826 |
Net decrease in cash | (63,977,539) | (21,808,925) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 80,190,675 | 122,359,535 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 16,213,136 | 100,550,610 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 387,748 | 2,140,499 |
Schedule of non-cash investing and financing activities: | ||
Notes receivable for sale of ENTADFI® assets | 12,733,191 | |
Shares issued in connection with common stock purchase agreement | 1,008,000 | |
Right-of-use asset recorded in exchange for lease liabilities | 264,896 | 4,411,474 |
Amortization of deferred costs related to common stock purchase agreement | 104,849 | |
Aspire Capital Purchase Agreement, 2020 [Member] | ||
FINANCING ACTIVITIES | ||
Proceeds from sale of shares | 3,426,991 | |
Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | ||
FINANCING ACTIVITIES | ||
Proceeds from sale of shares | 4,969,045 | |
ENTADFI [Member] | ||
INVESTING ACTIVITIES | ||
Cash proceeds from sale of PREBOOST business | $ 6,000,000 | |
PREBOOST [Member] | ||
INVESTING ACTIVITIES | ||
Cash proceeds from sale of PREBOOST business | $ 5,000,000 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Jun. 30, 2023 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | Note 1 – Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements for Veru Inc. (“we,” “our,” “us,” “Veru” or the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting of interim financial information. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. Accordingly, these statements do not include all the disclosures normally required by U.S. GAAP for annual financial statements and should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2022. The accompanying condensed consolidated balance sheet as of September 30, 2022 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations and cash flows for the three and nine months ended June 30, 2023 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30 , 2023. The preparation of our unaudited interim condensed consolidated financial statements in conformity with 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. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments (consisting of only normally recurring adjustments) necessary to present fairly the financial position and results of operations as of the dates and for the periods presented. 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 breast cancer and for the treatment of viral induced acute respiratory distress syndrome (ARDS). Our drug development program includes enobosarm, a selective androgen receptor agonist, for the management of advanced breast cancer, and sabizabulin, a microtubule disruptor, for the treatment of hospitalized patients on oxygen support that are at high risk for 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 the transmission of 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 the three and nine months ended June 30, 2023 and 2022 were derived from sales of FC2. 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 unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. For the three and nine months ended June 30, 2023 and 2022, comprehensive loss is equivalent to the reported net loss. Recent accounting pronouncements not yet adopted : We have reviewed all 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. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2023 | |
Liquidity [Abstract] | |
Liquidity | Note 2 – Liquidity The Company anticipates that we will continue to consume cash and incur losses as we develop and commercialize our drug candidates. Because of the numerous risks and uncertainties associated with the development of pharmaceutical products, the Company is unable to estimate the exact amounts of capital outlays and operating expenditures necessary to fund development of our drug candidates and obtain regulatory approvals. The Company’s future capital requirements will depend on many factors. The Company believes its current cash position, cash expected to be generated from sales of FC2, cash to be received from the sale of ENTADFI (see note 15), and its ability to secure equity financing or other financing alternatives will be adequate to fund planned operations of the Company for the next 12 months. To the extent the Company may need additional capital for its operations or the conditions for raising capital are favorable, the Company may access financing alternatives that may include debt financing, common stock offerings, or financing involving convertible debt or other equity-linked securities and may include financings under the Company’s current effective shelf registration statement on Form S-3 ( File No. 333-270606 ) or under a new registration statement. The Company intends to be opportunistic when pursuing equity or debt financing, which could include selling common stock under its common stock purchase agreement with Lincoln Park Capital Fund, LLC (see Note 9) or its open market sale agreement with Jefferies LLC, LLC (see Note 9). |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | Note 3 – Fair Value Measurements FASB Accounting Standards Codification (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 hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). 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. As of June 30, 2023 and September 30, 2022, the Company’s financial liabilities measured at fair value on a recurring basis, which consisted of embedded derivatives, were classified within Level 3 of the fair value hierarchy. 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) as of June 30, 2023 and 2022: Nine Months Ended June 30, 2023 2022 Beginning balance $ 4,294,000 $ 7,851,000 Change in fair value of derivative liabilities ( 2,319,000 ) 557,000 Ending balance $ 1,975,000 $ 8,408,000 The expense associated with the change in fair value of the embedded derivatives is included as a separate line item on the accompanying unaudited condensed consolidated statements of operations. The liabilities associated with embedded derivatives represent the fair value of the change of control provision in the Residual Royalty Agreement. See Note 8 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. A significant increase in projected FC2 revenues or a significant increase in the probability or acceleration of the timing of a change of control event, in isolation, would result in a significantly higher fair value measurement of the liability associated with the embedded derivative. The following tables present 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 June 30, 2023 and September 30, 2022: Valuation Methodology Significant Unobservable Input June 30, 2023 September 30, 2022 Scenario-Based Estimated change of control dates September 2023 to June 2025 September 2023 to September 2025 Discount rate 11.0 % to 11.3 % 13.6 % to 14.2 % Probability of change of control 50 % to 90 % 20 % to 90 % |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 9 Months Ended |
Jun. 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 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. The following table presents net revenues from these three categories: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 FC2 U.S. prescription channel $ 863,379 $ 6,736,158 $ 5,172,543 $ 29,900,890 Global public health sector 2,478,031 2,866,037 7,249,315 6,864,831 Total FC2 3,341,410 9,602,195 12,421,858 36,765,721 ENTADFI ( 225 ) — 13,088 — Net revenues $ 3,341,185 $ 9,602,195 $ 12,434,946 $ 36,765,721 The following table presents net revenues by geographic area: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 United States $ 1,449,883 $ 7,024,786 $ 7,046,518 $ 30,780,271 South Africa 612,000 * 1,941,678 * Other 1,279,302 2,577,409 3,446,750 5,985,450 Net revenues $ 3,341,185 $ 9,602,195 $ 12,434,946 $ 36,765,721 *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 unaudited condensed consolidated balance sheets, were approximately $ 6,000 and $ 342,000 at June 30, 2023 and September 30, 2022, respectively . |
Accounts Receivable and Concent
Accounts Receivable and Concentration of Credit Risk | 9 Months Ended |
Jun. 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 are affected by the mix of purchasers 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 unaudited condensed consolidated balance sheet. The components of accounts receivable consisted of the following at June 30, 2023 and September 30, 2022: June 30, September 30, 2023 2022 Trade receivables, gross $ 9,028,298 $ 4,289,892 Less: allowance for credit losses ( 3,923,857 ) ( 12,143 ) Less: allowance for sales returns and payment term discounts ( 21,563 ) ( 12,854 ) Less: long-term trade receivables* — ( 714,000 ) Accounts receivable, net $ 5,082,878 $ 3,550,895 *Included in other assets on the accompanying unaudited condensed consolidated balance sheets At June 30, 2023 and at September 30, 2022, no customers had a current accounts receivable balance that represented greater than 10% of current assets. At June 30, 2023, two customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 58 % 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 net accounts receivable and long-term trade receivables in the aggregate. For the three months ended June 30, 2023, there were five customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 79 % of the Company’s net revenues in the aggregate. For the three months ended June 30, 2022, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 92 % of the Company’s net revenues in the aggregate, including The Pill Club that represented 69 % of the Company’s net revenue in the aggregate. For the nine months ended June 30, 2023, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 56 % of the Company’s net revenues in the aggregate, including The Pill Club that represented 31 % of the Company’s net revenues in the aggregate. For the nine months ended June 30, 2022, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 78 % of the Company’s net revenues in the aggregate, including The Pill Club that represented 47 % of the Company’s net revenues in the aggregate. 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. In the case of a bankruptcy filing or other similar event indicating the collectability of specific customer accounts is no longer probable, a specific allowance for credit losses may be recorded to reduce the related receivable to the amount expected to be recovered. Accounts receivable are charged-off when deemed uncollectible. During the quarter ended March 31, 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 uncertainty related to their financial condition. On April 18, 2023, The Pill Club filed for Chapter 11 bankruptcy. The table below summarizes the change in the allowance for credit losses for the nine months ended June 30, 2023 and 2022: Nine Months Ended June 30, 2023 2022 Beginning balance $ 12,143 $ 20,643 Charges to expense, net of recoveries 3,911,714 ( 6,500 ) Ending balance $ 3,923,857 $ 14,143 Recoveries of accounts receivable previously charged off are recorded when received. In the global public health sector, the Company’s customers are primarily 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., the Company’s customers include telemedicine providers who sell into the prescription channel. |
Balance Sheet Information
Balance Sheet Information | 9 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Information [Abstract] | |
Balance Sheet Information | Note 6 – Balance Sheet Information 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. Inventories consisted of the following at June 30, 2023 and September 30, 2022: June 30, September 30, 2023 2022 Raw material $ 1,245,019 $ 1,662,712 Work in process 75,848 872,596 Finished goods 5,376,970 6,099,343 Inventories, gross 6,697,837 8,634,651 Less: inventory reserves ( 207,869 ) ( 15,707 ) Inventories, net $ 6,489,968 $ 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. 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. Depreciation and amortization are computed over the estimated useful lives of the respective 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 improvements. Plant and equipment consisted of the following at June 30, 2023 and September 30, 2022: Estimated June 30, September 30, Useful Life 2023 2022 Plant and equipment: Manufacturing equipment 5 - 8 years $ 3,295,743 $ 2,902,715 Office equipment, furniture and fixtures 3 - 10 years 1,498,968 1,440,475 Leasehold improvements 3 - 8 years 484,460 484,460 Total plant and equipment 5,279,171 4,827,650 Less: accumulated depreciation and amortization ( 3,786,988 ) ( 3,641,884 ) Plant and equipment, net $ 1,492,183 $ 1,185,766 Depreciation expense was approximately $ 53,000 and $ 39,000 for the three months ended June 30, 2023 and 2022, respectively, and approximately $ 146,000 and $ 94,000 for the nine months ended June 30, 2023 and 2022, respectively. Plant and equipment included $ 501,000 and $ 276,000 at June 30, 2023 and September 30, 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 | 9 Months Ended |
Jun. 30, 2023 | |
Intangible Assets and Goodwill [Abstract] | |
Intangible Assets and Goodwill | Note 7 – Intangible Assets and Goodwill Intangible Assets The gross carrying amounts and net book value of intangible assets were as follows at June 30, 2023: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 476,190 $ 23,810 Indefinite-lived intangible assets: Acquired in-process research and development assets — — — Total intangible assets $ 500,000 $ 476,190 $ 23,810 The gross carrying amounts and net book value of intangible assets were 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 expense was approximately $ 18,000 for the three months ended June 30, 2023 and 2022 and approximately $ 54,000 for the nine months ended June 30, 2023 and 2022. During the second quarter of fiscal 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 during the quarter ended March 31, 2023. Goodwill The carrying amount of goodwill at June 30, 2023 and September 30, 2022 was $ 6.9 million. There was no change in the balance during the nine months ended June 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 June 30, 2023. |
Debt
Debt | 9 Months Ended |
Jun. 30, 2023 | |
Debt [Abstract] | |
Debt | Note 8 – Debt SWK Residual Royalty Agreements On March 5, 2018, the Company entered into a Credit Agreement (as amended, 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 respective change of control provisions, was allocated to an embedded derivative liability. The derivative liability is adjusted to fair market value at each reporting period . At June 30, 2023 and September 30, 2022, the Residual Royalty Agreement liability consisted of the following: June 30, September 30, 2023 2022 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,170,748 9,950,908 Less: cumulative payments ( 4,153,120 ) ( 3,765,372 ) Residual royalty agreement liability, excluding embedded derivative liability 8,363,628 6,531,536 Add: embedded derivative liability at fair value (see Note 3) 1,975,000 4,294,000 Total residual royalty agreement liability 10,338,628 10,825,536 Residual royalty agreement liability, short-term portion ( 1,061,893 ) ( 1,169,095 ) Residual royalty agreement liability, long-term portion $ 9,276,735 $ 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 unaudited condensed consolidated statements of cash flows. The short-term portion of the Residual Royalty Agreement liability represents the aggregate of the estimated quarterly payments on the Residual Royalty Agreement payable during the 12-month period subsequent to the balance sheet date. Interest expense on the accompanying unaudited condensed 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 a Premium Finance Agreement to finance $ 1.4 million of its directors and officers liability insurance premium at an annual percentage rate of 6.3 %. The financing is payable in eleven monthly installments of principal and interest, beginning on December 1, 2022. The balance of the insurance premium liability is $ 0.5 million as of June 30, 2023 and is included in accrued expenses and other current liabilities on the accompanying unaudited condensed consolidated balance sheet. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 9 – Stockholders’ Equity Preferred Stock The Company has 5,000,000 authorized 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 (the “Series 4 Preferred Stock”) authorized. There were no shares of Class A Preferred Stock of any series issued and outstanding at June 30, 2023 and September 30, 2022. The Company has 15,000 authorized 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 June 30, 2023 and September 30, 2022, and there was no activity during the nine months ended June 30, 2023 and 2022. 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 SEC on April 14, 2023. As of June 30, 2023, $ 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 “2020 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 2020 Purchase Agreement, to direct Aspire Capital to purchase up to $ 23.9 million of the Company’s common stock in the aggregate. During the nine months ended June 30, 2023, we sold 2,779,713 shares of common stock to Aspire Capital under the 2020 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 2020 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 2020 Purchase Agreement expired and no additional shares of common stock will be sold under the agreement. In consideration for entering into the 2020 Purchase Agreement and concurrently with the execution of the 2020 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 2020 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 unaudited condensed consolidated statements of operations for the three and nine month periods ended June 30, 2023. There were unamortized deferred costs related to the 2020 Purchase Agreement of $ 578,000 at September 30, 2022, which is included in other assets on the accompanying unaudited condensed 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 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 and are included in other assets on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2023. 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. Subsequent to June 30, 2023, we sold 1,000,000 shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement, resulting in proceeds to the Company of $ 1.2 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 deferred and are included in other assets on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2023. The Company has no t sold any shares of common stock under the Jefferies Sales Agreement. |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Jun. 30, 2023 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | Note 10 – 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. For the three and nine months ended June 30, 2023 and 2022, we recorded share-based compensation expenses as follows: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Cost of sales $ 112,515 $ 25,275 $ 263,879 $ 70,923 Selling, general and administrative 3,667,599 2,052,755 10,183,510 5,036,356 Research and development 770,718 832,946 2,786,310 1,809,066 Share-based compensation $ 4,550,832 $ 2,910,976 $ 13,233,699 $ 6,916,345 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 certain new hires who satisfied the requirements to be granted inducement grants under Nasdaq rules as an inducement material to the individual’s entry into employment with the Company. The Company reserved 4,000,000 shares of common stock under the Inducement Plan and as of June 30, 2023, 3,895,250 shares remain available for issuance under the Inducement Plan. In March 2018, the Company’s stockholders approved the Company's 2018 Equity Incentive Plan (as amended, 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 June 30, 2023, 2,431,616 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 June 30, 2023, 12,472 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 $ 317,000 and $ 1.8 million during the three and nine months ended June 30, 2023 for stock options forfeited during the period. The reduction in share-based compensation expense during the three and nine months ended June 30, 2022 for stock options forfeited was immaterial. The following table outlines the weighted average assumptions for options granted during the three and nine months ended June 30, 2023 and 2022 : Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Weighted Average Assumptions: Expected volatility 104.96 % 92.58 % 101.37 % 83.77 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 3.51 % 3.01 % 3.92 % 2.10 % Expected term (in years) 6.0 6.0 6.0 6.0 Fair value of options granted $ 1.12 $ 8.97 $ 5.55 $ 6.92 During the three and nine months ended June 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 June 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 4,927,775 $ 6.93 Exercised ( 148,125 ) $ 2.27 Forfeited and expired ( 1,078,262 ) $ 11.00 Outstanding at June 30, 2023 17,964,858 $ 5.19 7.19 $ 35,604 Exercisable at June 30, 2023 10,213,653 $ 3.43 5.77 $ 34,604 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 quarter ended June 30, 2023 of $ 1.19 , less the respective weighted average exercise price per share at period end . The total intrinsic value of options exercised during the nine months ended June 30, 2023 and 2022 was approximately $ 486,000 and $ 1.3 million, respectively. Cash received from options exercised during the nine months ended June 30, 2023 and 2022 was approximately $ 337,000 and $ 411,000 , respectively. As of June 30, 2023, the Company had unrecognized compensation expense of approximately $ 34.8 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 2.1 years. Stock Appreciation Rights In connection with the closing of our acquisition of Aspen Park Pharmaceuticals, Inc. on October 31, 2016 (the “APP Acquisition”), the Company issued stock appreciation rights based on 50,000 and 140,000 shares of the Company’s common stock to an employee and an outside director, respectively, that vested on October 31, 2018 . The stock appreciation rights have a ten-year term and an exercise price per share of $ 0.95 , which was the closing price per share of the Company’s common stock as quoted on Nasdaq on the trading day immediately preceding the date of the completion of the APP Acquisition. Upon exercise, the stock appreciation rights will be settled in common stock issued under the 2017 Plan. As of June 30, 2023, vested stock appreciation rights based on 50,000 shares of common stock remain outstanding. |
Leases
Leases | 9 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 11 – Leases The Company has operating leases for its office, manufacturing and warehouse space, and office equipment. The Company’s leases have remaining lease terms of less than one year to seven years , which include the option to extend a lease when the Company is reasonably certain to exercise that option. Certain of our lease agreements include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for certain equipment leases. For one of our office space leases, the Company entered into a sublease, for which it receives sublease income. Sublease income is recognized as a reduction to operating lease costs as the sublease is 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 Company does not have any leases that have not yet commenced as of June 30, 2023. 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 commenced, it was reasonably certain that the Company would exercise that option. The option to exercise required 6 months of 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 components of the Company’s lease cost were as follows for the three and nine months ended June 30, 2023 and 2022: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Finance lease cost: Amortization of right-of-use assets $ — $ — $ — $ 3,631 Interest on lease liabilities — — — 403 Operating lease cost 277,211 285,010 838,112 598,965 Short-term lease cost 10,903 11,112 32,003 36,817 Variable lease cost 33,926 69,531 136,569 162,287 Sublease income ( 44,844 ) ( 44,844 ) ( 134,533 ) ( 134,533 ) Total lease cost $ 277,196 $ 320,809 $ 872,151 $ 667,570 The Company paid cash of $ 777,000 and $ 449,000 for amounts included in the measurement of operating lease liabilities during the nine months ended June 30, 2023 and 2022, respectively. The Company’s operating lease right-of-use assets and the related lease liabilities are presented as separate line items on the accompanying unaudited condensed consolidated balance sheets as of June 30, 2023 and September 30, 2022. Other information related to the Company’s leases as of June 30, 2023 and September 30, 2022 was as follows: June 30, September 30, 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. |
Contingent Liabilities
Contingent Liabilities | 9 Months Ended |
Jun. 30, 2023 | |
Contingent Liabilities [Abstract] | |
Contingent Liabilities | Note 12 – Contingent Liabilities The testing, manufacturing and marketing of consumer products by the Company and the clinical testing of our product candidates 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. Legal Proceedings 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 certain of its current officers and directors (the "Ewing Complaint"). The Ewing Complaint alleges that certain public statements about sabizabulin as a treatment for COVID-19 between May 11, 2022 and November 9, 2022 violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The Company believes that the allegations asserted in the Ewing Complaint are without merit, and the Company intends to vigorously defend the lawsuit. There can be no assurance that the Company 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, 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”). This 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 Complaint. 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 Company believes that the allegations asserted in the Maglia Lawsuit are without merit, and the Company intends to vigorously defend the lawsuit. There can be no assurance that the Company will be successful. At this time, the Company is unable to estimate potential losses, if any, related to the Maglia 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 on the accompanying unaudited condensed 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 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 | 9 Months Ended |
Jun. 30, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | Note 13 – 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. As of September 30, 2022, the Company had U.S. federal and state NOL carryforwards of $ 112.7 million and $ 51.3 million, respectively, for income tax purposes with $ 29.7 million and $ 31.6 million, respectively, expiring in years 2023 to 2042 and $ 82.9 million and $ 19.6 million, respectively, which can be carried forward indefinitely. As of September 30, 2022, the Company also had U.S. federal research and development tax credit carryforwards of $ 5.9 million, expiring in years 2038 to 2042 . The Company’s U.K. subsidiary has U.K. NOL carryforwards of $ 63.1 million as of September 30, 2022, 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 June 30, 2023, we recorded a decrease to income tax benefit and an increase to deferred tax assets, before applying a valuation allowance, of approximately $ 8.7 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 . A reconciliation of income tax expense (benefit) and the amount computed by applying the U.S. statutory rate of 21 % to loss before income taxes is as follows: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Income tax expense (benefit) at U.S. federal statutory rates $ 1,338,068 $ ( 4,632,174 ) $ ( 14,573,616 ) $ ( 8,931,007 ) State income tax expense (benefit), net of federal benefit 103,605 ( 358,662 ) ( 1,128,414 ) ( 691,515 ) Non-deductible expenses ( 262,005 ) ( 355,069 ) 185,564 4,860 Effect of stock options exercised — ( 147,570 ) 63,849 ( 170,920 ) U.S. research and development tax credit 2,835,378 ( 1,283,944 ) 415,378 ( 4,160,374 ) Effect of foreign income tax rates 406,324 366,493 307,188 327,055 Effect of global intangible low taxed income ( 24,691 ) ( 12,989 ) ( 24,691 ) — Change in valuation allowance ( 4,317,909 ) 6,504,878 14,705,293 13,637,539 Other, net ( 21,219 ) 56,640 ( 27,837 ) 209,170 Income tax expense (benefit) $ 57,551 $ 137,603 $ ( 77,286 ) $ 224,808 Significant components of the Company’s deferred tax assets and liabilities are as follows: June 30, September 30, 2023 2022 Deferred tax assets: Federal net operating loss carryforwards $ 26,685,200 $ 23,627,461 State net operating loss carryforwards 3,100,416 2,850,956 Foreign net operating loss carryforwards – U.K. 16,083,790 15,773,497 Foreign capital allowance – U.K. 128,490 128,490 U.S. research and development tax credit carryforwards 8,066,411 8,481,789 U.S. research and development expense 8,722,825 — Accrued compensation 764,724 1,227,290 Share-based compensation 6,926,088 4,325,354 Interest expense 2,520,769 2,206,484 Credit loss provision 885,562 — Change in fair value of derivative liabilities — 220,607 Other, net – U.K. 265,631 265,631 Other, net – Malaysia 4,712 — Other, net – U.S. 81,387 81,507 Gross deferred tax assets 74,236,005 59,189,066 Valuation allowance for deferred tax assets ( 60,077,745 ) ( 45,372,452 ) Net deferred tax assets 14,158,260 13,816,614 Deferred tax liabilities: In-process research and development — ( 882,427 ) Change in fair value of derivative liabilities ( 304,098 ) — Gain on sale of ENTADFI ® assets ( 750,686 ) — Other, net - Malaysia — ( 17,641 ) Other, net – U.S. ( 5,386 ) ( 31,628 ) Net deferred tax liabilities ( 1,060,170 ) ( 931,696 ) Net deferred tax asset $ 13,098,090 $ 12,884,918 The deferred tax amounts have been classified on the accompanying unaudited condensed consolidated balance sheets as follows: June 30, September 30, 2023 2022 Deferred tax asset – U.K. $ 13,093,378 $ 12,965,985 Deferred tax asset – Malaysia 4,712 — Total deferred tax asset $ 13,098,090 $ 12,965,985 Deferred tax liability – U.S. $ — $ ( 63,426 ) Deferred tax liability – Malaysia — ( 17,641 ) Total deferred tax liability $ — $ ( 81,067 ) |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Jun. 30, 2023 | |
Net Income (Loss) Per Share [Abstract] | |
Net Loss Per Share | Note 14 – Net Income (Loss) Per Share Basic net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (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. The following table provides a reconciliation of the net income (loss) per basic and diluted common share outstanding: Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Net income (loss) $ 6,314,204 $ ( 22,195,576 ) $ ( 69,320,881 ) $ ( 42,753,412 ) Basic weighted average common shares outstanding 88,266,152 80,088,431 83,218,748 80,054,594 Net effect of dilutive instruments: Stock options 25,962 — — — Stock appreciation rights 9,402 — — — Common stock purchase warrants — — — — Total net effect of dilutive instruments 35,364 — — — Diluted weighted average common shares outstanding 88,301,516 80,088,431 83,218,748 80,054,594 Net income (loss) per basic common share outstanding $ 0.07 $ ( 0.28 ) $ ( 0.83 ) $ ( 0.53 ) Net income (loss) per diluted common share outstanding $ 0.07 $ ( 0.28 ) $ ( 0.83 ) $ ( 0.53 ) For the three months ended June 30, 2023, approximately 16.9 million potentially dilutive instruments were excluded from the computation of net income per diluted weighted average common share outstanding because their effect would have been anti-dilutive. Due to our net loss for the three months ended June 30, 2022 and the nine months ended June 30, 2023 and 2022, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Note 10 for a discussion of our potentially dilutive common shares. |
Sale of ENTADFI Assets
Sale of ENTADFI Assets | 9 Months Ended |
Jun. 30, 2023 | |
Sale of ENTADFI Assets [Abstract] | |
Sale of ENTADFI Assets | Note 15 – Sale of ENTADFI Assets On April 19, 2023, the Company entered into an 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 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. The Company determined the gain on sale of ENTADFI based on the purchase price of $ 20.0 million, net of imputed interest on the interest-free notes receivable, using an interest rate of 10 %, of $ 1.3 million. Total assets sold, consisting primarily of inventory, had a net book value of approximately $ 1.3 million. The Company recorded a gain of approximately $ 17.5 million on the transaction and recognized imputed interest income of $ 241,000 during the three months ended June 30, 2023. As of June 30, 2023, the net short-term and long-term notes receivable balances are $ 8.5 million and $ 4.4 million, respectively, and are presented as separate line items on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2023. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 16 – Subsequent Events On July 24, 2023, the Company held a special meeting at which the Company’s shareholders approved an increase in the number of authorized shares of common stock from 154,000,000 to 308,000,000 . |
Basis of Presentation (Policy)
Basis of Presentation (Policy) | 9 Months Ended |
Jun. 30, 2023 | |
Basis of Presentation [Abstract] | |
Basis of presentation | The accompanying unaudited interim condensed consolidated financial statements for Veru Inc. (“we,” “our,” “us,” “Veru” or the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting of interim financial information. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. Accordingly, these statements do not include all the disclosures normally required by U.S. GAAP for annual financial statements and should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2022. The accompanying condensed consolidated balance sheet as of September 30, 2022 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations and cash flows for the three and nine months ended June 30, 2023 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30 , 2023. The preparation of our unaudited interim condensed consolidated financial statements in conformity with 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. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments (consisting of only normally recurring adjustments) necessary to present fairly the financial position and results of operations as of the dates and for the periods presented. |
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 breast cancer and for the treatment of viral induced acute respiratory distress syndrome (ARDS). Our drug development program includes enobosarm, a selective androgen receptor agonist, for the management of advanced breast cancer, and sabizabulin, a microtubule disruptor, for the treatment of hospitalized patients on oxygen support that are at high risk for 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 the transmission of 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 the three and nine months ended June 30, 2023 and 2022 were derived from sales of FC2. |
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 unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. For the three and nine months ended June 30, 2023 and 2022, comprehensive loss is equivalent to the reported net loss. |
Recent accounting pronouncements not yet adopted | Recent accounting pronouncements not yet adopted : We have reviewed all 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) | 9 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements [Abstract] | |
Reconciliation of the Beginning and Ending Liability Balance | Nine Months Ended June 30, 2023 2022 Beginning balance $ 4,294,000 $ 7,851,000 Change in fair value of derivative liabilities ( 2,319,000 ) 557,000 Ending balance $ 1,975,000 $ 8,408,000 |
Schedule of Qualitative Information | Valuation Methodology Significant Unobservable Input June 30, 2023 September 30, 2022 Scenario-Based Estimated change of control dates September 2023 to June 2025 September 2023 to September 2025 Discount rate 11.0 % to 11.3 % 13.6 % to 14.2 % Probability of change of control 50 % to 90 % 20 % to 90 % |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Customers by Products | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 FC2 U.S. prescription channel $ 863,379 $ 6,736,158 $ 5,172,543 $ 29,900,890 Global public health sector 2,478,031 2,866,037 7,249,315 6,864,831 Total FC2 3,341,410 9,602,195 12,421,858 36,765,721 ENTADFI ( 225 ) — 13,088 — Net revenues $ 3,341,185 $ 9,602,195 $ 12,434,946 $ 36,765,721 |
Revenue by Geographic Area | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 United States $ 1,449,883 $ 7,024,786 $ 7,046,518 $ 30,780,271 South Africa 612,000 * 1,941,678 * Other 1,279,302 2,577,409 3,446,750 5,985,450 Net revenues $ 3,341,185 $ 9,602,195 $ 12,434,946 $ 36,765,721 *Less than 10% of total net revenues |
Accounts Receivable and Conce_2
Accounts Receivable and Concentration of Credit Risk (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Components of Accounts Receivable | June 30, September 30, 2023 2022 Trade receivables, gross $ 9,028,298 $ 4,289,892 Less: allowance for credit losses ( 3,923,857 ) ( 12,143 ) Less: allowance for sales returns and payment term discounts ( 21,563 ) ( 12,854 ) Less: long-term trade receivables* — ( 714,000 ) Accounts receivable, net $ 5,082,878 $ 3,550,895 *Included in other assets on the accompanying unaudited condensed consolidated balance sheets |
Summary of Components of Allowance for Doubtful Accounts | Nine Months Ended June 30, 2023 2022 Beginning balance $ 12,143 $ 20,643 Charges to expense, net of recoveries 3,911,714 ( 6,500 ) Ending balance $ 3,923,857 $ 14,143 |
Balance Sheet Information (Tabl
Balance Sheet Information (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Information [Abstract] | |
Components of Inventories | June 30, September 30, 2023 2022 Raw material $ 1,245,019 $ 1,662,712 Work in process 75,848 872,596 Finished goods 5,376,970 6,099,343 Inventories, gross 6,697,837 8,634,651 Less: inventory reserves ( 207,869 ) ( 15,707 ) Inventories, net $ 6,489,968 $ 8,618,944 |
Summary of Plant and Equipment | Estimated June 30, September 30, Useful Life 2023 2022 Plant and equipment: Manufacturing equipment 5 - 8 years $ 3,295,743 $ 2,902,715 Office equipment, furniture and fixtures 3 - 10 years 1,498,968 1,440,475 Leasehold improvements 3 - 8 years 484,460 484,460 Total plant and equipment 5,279,171 4,827,650 Less: accumulated depreciation and amortization ( 3,786,988 ) ( 3,641,884 ) Plant and equipment, net $ 1,492,183 $ 1,185,766 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Intangible Assets and Goodwill [Abstract] | |
Gross Carrying Amounts and Net Book Value of Intangible Assets | The gross carrying amounts and net book value of intangible assets were as follows at June 30, 2023: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 476,190 $ 23,810 Indefinite-lived intangible assets: Acquired in-process research and development assets — — — Total intangible assets $ 500,000 $ 476,190 $ 23,810 The gross carrying amounts and net book value of intangible assets were 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) | 9 Months Ended |
Jun. 30, 2023 | |
Debt [Abstract] | |
Residual Royalty Agreement Liability | June 30, September 30, 2023 2022 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,170,748 9,950,908 Less: cumulative payments ( 4,153,120 ) ( 3,765,372 ) Residual royalty agreement liability, excluding embedded derivative liability 8,363,628 6,531,536 Add: embedded derivative liability at fair value (see Note 3) 1,975,000 4,294,000 Total residual royalty agreement liability 10,338,628 10,825,536 Residual royalty agreement liability, short-term portion ( 1,061,893 ) ( 1,169,095 ) Residual royalty agreement liability, long-term portion $ 9,276,735 $ 9,656,441 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Share-based Compensation [Abstract] | |
Recorded Share-Based Compensation Expenses | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Cost of sales $ 112,515 $ 25,275 $ 263,879 $ 70,923 Selling, general and administrative 3,667,599 2,052,755 10,183,510 5,036,356 Research and development 770,718 832,946 2,786,310 1,809,066 Share-based compensation $ 4,550,832 $ 2,910,976 $ 13,233,699 $ 6,916,345 |
Weighted Average Assumptions for Options Granted | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Weighted Average Assumptions: Expected volatility 104.96 % 92.58 % 101.37 % 83.77 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 3.51 % 3.01 % 3.92 % 2.10 % Expected term (in years) 6.0 6.0 6.0 6.0 Fair value of options granted $ 1.12 $ 8.97 $ 5.55 $ 6.92 |
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 4,927,775 $ 6.93 Exercised ( 148,125 ) $ 2.27 Forfeited and expired ( 1,078,262 ) $ 11.00 Outstanding at June 30, 2023 17,964,858 $ 5.19 7.19 $ 35,604 Exercisable at June 30, 2023 10,213,653 $ 3.43 5.77 $ 34,604 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Components of Lease Cost | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Finance lease cost: Amortization of right-of-use assets $ — $ — $ — $ 3,631 Interest on lease liabilities — — — 403 Operating lease cost 277,211 285,010 838,112 598,965 Short-term lease cost 10,903 11,112 32,003 36,817 Variable lease cost 33,926 69,531 136,569 162,287 Sublease income ( 44,844 ) ( 44,844 ) ( 134,533 ) ( 134,533 ) Total lease cost $ 277,196 $ 320,809 $ 872,151 $ 667,570 |
Summary of Lease Information | June 30, September 30, 2023 2022 Operating Leases Weighted-average remaining lease term 6.1 6.8 Weighted-average discount rate 7.7 % 7.6 % |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Income Taxes [Abstract] | |
Reconciliation of Income Tax Expense (Benefit) | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Income tax expense (benefit) at U.S. federal statutory rates $ 1,338,068 $ ( 4,632,174 ) $ ( 14,573,616 ) $ ( 8,931,007 ) State income tax expense (benefit), net of federal benefit 103,605 ( 358,662 ) ( 1,128,414 ) ( 691,515 ) Non-deductible expenses ( 262,005 ) ( 355,069 ) 185,564 4,860 Effect of stock options exercised — ( 147,570 ) 63,849 ( 170,920 ) U.S. research and development tax credit 2,835,378 ( 1,283,944 ) 415,378 ( 4,160,374 ) Effect of foreign income tax rates 406,324 366,493 307,188 327,055 Effect of global intangible low taxed income ( 24,691 ) ( 12,989 ) ( 24,691 ) — Change in valuation allowance ( 4,317,909 ) 6,504,878 14,705,293 13,637,539 Other, net ( 21,219 ) 56,640 ( 27,837 ) 209,170 Income tax expense (benefit) $ 57,551 $ 137,603 $ ( 77,286 ) $ 224,808 |
Significant Components of Deferred Tax Assets and Liabilities | June 30, September 30, 2023 2022 Deferred tax assets: Federal net operating loss carryforwards $ 26,685,200 $ 23,627,461 State net operating loss carryforwards 3,100,416 2,850,956 Foreign net operating loss carryforwards – U.K. 16,083,790 15,773,497 Foreign capital allowance – U.K. 128,490 128,490 U.S. research and development tax credit carryforwards 8,066,411 8,481,789 U.S. research and development expense 8,722,825 — Accrued compensation 764,724 1,227,290 Share-based compensation 6,926,088 4,325,354 Interest expense 2,520,769 2,206,484 Credit loss provision 885,562 — Change in fair value of derivative liabilities — 220,607 Other, net – U.K. 265,631 265,631 Other, net – Malaysia 4,712 — Other, net – U.S. 81,387 81,507 Gross deferred tax assets 74,236,005 59,189,066 Valuation allowance for deferred tax assets ( 60,077,745 ) ( 45,372,452 ) Net deferred tax assets 14,158,260 13,816,614 Deferred tax liabilities: In-process research and development — ( 882,427 ) Change in fair value of derivative liabilities ( 304,098 ) — Gain on sale of ENTADFI ® assets ( 750,686 ) — Other, net - Malaysia — ( 17,641 ) Other, net – U.S. ( 5,386 ) ( 31,628 ) Net deferred tax liabilities ( 1,060,170 ) ( 931,696 ) Net deferred tax asset $ 13,098,090 $ 12,884,918 |
Schedule of Deferred Tax Amounts Classified in Balance Sheets | June 30, September 30, 2023 2022 Deferred tax asset – U.K. $ 13,093,378 $ 12,965,985 Deferred tax asset – Malaysia 4,712 — Total deferred tax asset $ 13,098,090 $ 12,965,985 Deferred tax liability – U.S. $ — $ ( 63,426 ) Deferred tax liability – Malaysia — ( 17,641 ) Total deferred tax liability $ — $ ( 81,067 ) |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Jun. 30, 2023 | |
Net Income (Loss) Per Share [Abstract] | |
Schedule of Reconciliation of Net (Loss) Income Per Basic and Diluted Common Share Outstanding | Three Months Ended Nine Months Ended June 30, June 30, 2023 2022 2023 2022 Net income (loss) $ 6,314,204 $ ( 22,195,576 ) $ ( 69,320,881 ) $ ( 42,753,412 ) Basic weighted average common shares outstanding 88,266,152 80,088,431 83,218,748 80,054,594 Net effect of dilutive instruments: Stock options 25,962 — — — Stock appreciation rights 9,402 — — — Common stock purchase warrants — — — — Total net effect of dilutive instruments 35,364 — — — Diluted weighted average common shares outstanding 88,301,516 80,088,431 83,218,748 80,054,594 Net income (loss) per basic common share outstanding $ 0.07 $ ( 0.28 ) $ ( 0.83 ) $ ( 0.53 ) Net income (loss) per diluted common share outstanding $ 0.07 $ ( 0.28 ) $ ( 0.83 ) $ ( 0.53 ) |
Fair Value Measurements (Reconc
Fair Value Measurements (Reconciliation of the Beginning and Ending Liability Balance) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Fair Value Measurements [Abstract] | ||
Beginning balance | $ 4,294,000 | $ 7,851,000 |
Change in fair value of derivative liabilities | (2,319,000) | 557,000 |
Ending balance | $ 1,975,000 | $ 8,408,000 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Qualitative Information) (Details) - item | 9 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Sep. 30, 2022 | |
Minimum [Member] | Estimated Change Of Control Dates [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | 2023-09 | 2023-09 |
Minimum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.110 | 0.136 |
Minimum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.50 | 0.20 |
Maximum [Member] | Estimated Change Of Control Dates [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | 2025-06 | 2025-09 |
Maximum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 0.113 | 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 ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Revenue from Contracts with Customers [Abstract] | ||
Contract liability | $ 6,000 | $ 342,000 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Revenue from Customers by Products) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 3,341,185 | $ 9,602,195 | $ 12,434,946 | $ 36,765,721 |
FC2 [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 3,341,410 | 9,602,195 | 12,421,858 | 36,765,721 |
FC2, U.S. Prescription Channel [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 863,379 | 6,736,158 | 5,172,543 | 29,900,890 |
FC2, Global Public Health Sector [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 2,478,031 | $ 2,866,037 | 7,249,315 | $ 6,864,831 |
Other [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ (225) | $ 13,088 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers (Revenue by Geographic Area) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 3,341,185 | $ 9,602,195 | $ 12,434,946 | $ 36,765,721 |
United States [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 1,449,883 | 7,024,786 | 7,046,518 | 30,780,271 |
South Africa [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 612,000 | 1,941,678 | ||
Other Countries [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 1,279,302 | $ 2,577,409 | $ 3,446,750 | $ 5,985,450 |
Accounts Receivable and Conce_3
Accounts Receivable and Concentration of Credit Risk (Narrative) (Details) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2023 customer | Mar. 31, 2023 USD ($) | Jun. 30, 2022 customer | Jun. 30, 2023 customer | Jun. 30, 2022 customer | Sep. 30, 2022 USD ($) customer | |
Pill Club [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Change in allowance for doubtful accounts | $ | $ 3.9 | |||||
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 | |||||
Current Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Number of customers | 0 | 0 | ||||
Net Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Number of customers | 2 | |||||
Net Accounts Receivable [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 58% | |||||
Net Accounts Receivable And Long-Term Trade Receivables [Member] | Customer Concentration Risk [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Number of customers | 2 | |||||
Net Accounts Receivable And Long-Term Trade Receivables [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 83% | |||||
Net Revenues [Member] | Customer Concentration Risk [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Number of customers | 5 | 3 | 2 | 2 | ||
Net Revenues [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 92% | |||||
Net Revenues [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 56% | 78% | ||||
Net Revenues [Member] | Customer Concentration Risk [Member] | Five Customers [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 79% | |||||
Net Revenues [Member] | Customer Concentration Risk [Member] | Pill Club [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Concentration risk, percentage | 69% | 31% | 47% | |||
Brazil [Member] | ||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||
Credit terms | 90 days | |||||
Long term trade receivable | $ | $ 0.7 |
Accounts Receivable and Conce_4
Accounts Receivable and Concentration of Credit Risk (Components of Accounts Receivable) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||||
Trade receivables, gross | $ 9,028,298 | $ 4,289,892 | ||
Less: allowance for credit losses | (3,923,857) | (12,143) | $ (14,143) | $ (20,643) |
Less: allowance for sales returns and payment term discounts | (21,563) | (12,854) | ||
Less: long-term trade receivables | (714,000) | |||
Accounts receivable, net | $ 5,082,878 | $ 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 ($) | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |||
Beginning balance | $ 12,143 | $ 20,643 | |
Charges to expense, net of recoveries | $ (2,500) | 3,911,714 | (6,500) |
Ending balance | $ 14,143 | $ 3,923,857 | $ 14,143 |
Balance Sheet Information (Narr
Balance Sheet Information (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2022 | |
Property, Plant and Equipment [Line Items] | |||||
Inventory, net | $ 6,489,968 | $ 6,489,968 | $ 8,618,944 | ||
Depreciation expense | 53,000 | $ 39,000 | 146,000 | $ 94,000 | |
ENTADFI [Member] | |||||
Property, Plant and Equipment [Line Items] | |||||
Inventory, net | 1,100,000 | ||||
Equipment, Furniture And Leasehold Improvements [Member] | |||||
Property, Plant and Equipment [Line Items] | |||||
Deposits | $ 501,000 | $ 501,000 | $ 276,000 |
Balance Sheet Information (Comp
Balance Sheet Information (Components of Inventories) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Balance Sheet Information [Abstract] | ||
Raw material | $ 1,245,019 | $ 1,662,712 |
Work in process | 75,848 | 872,596 |
Finished goods | 5,376,970 | 6,099,343 |
Inventories, gross | 6,697,837 | 8,634,651 |
Less: inventory reserves | (207,869) | (15,707) |
Inventories, net | $ 6,489,968 | $ 8,618,944 |
Balance Sheet Information (Summ
Balance Sheet Information (Summary of Plant and Equipment) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 5,279,171 | $ 4,827,650 |
Less: accumulated depreciation and amortization | (3,786,988) | (3,641,884) |
Plant and equipment, net | 1,492,183 | 1,185,766 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 3,295,743 | 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 | $ 1,498,968 | 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 | $ 484,460 | $ 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 | 9 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2022 | |
Intangible Assets and Goodwill [Abstract] | ||||||
Goodwill | $ 6,878,932 | $ 6,878,932 | $ 6,878,932 | |||
Change in goodwill | 0 | $ 0 | ||||
Amortization of intangible assets | $ 18,000 | $ 18,000 | 54,000 | $ 54,000 | ||
Impairment charge | $ 3,900,000 | $ 3,900,000 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Gross Carrying Amounts and Net Book Value of Intangible Assets) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite life, Accumulated Amortization | $ 476,190 | $ 422,619 |
Total intangible assets, Gross Carrying Amount | 500,000 | 4,400,000 |
Total intangible assets, Net Book Value | 23,810 | 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 | 476,190 | 422,619 |
Intangible assets with finite life,, Net Book Value | $ 23,810 | $ 77,381 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | 9 Months Ended | 42 Months Ended | ||
Nov. 01, 2022 USD ($) item | Jun. 30, 2023 USD ($) item | Aug. 31, 2021 USD ($) | Mar. 05, 2018 USD ($) | |
Line of Credit Facility [Line Items] | ||||
Payments on notes payable | $ 897,422 | |||
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] | ||||
Payment terms, period of revenue calculation | 12 months | |||
Payment terms, payment percentage | 5% | |||
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 | $ 500,000 |
Debt (Residual Royalty Agreemen
Debt (Residual Royalty Agreement Liability) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Residual Royalty Agreement Disclosures [Line Items] | ||
Residual royalty agreement liability, short-term portion | $ (1,061,893) | $ (1,169,095) |
Residual royalty agreement, long-term portion | 9,276,735 | 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 | 12,170,748 | 9,950,908 |
Less: cumulative payments | (4,153,120) | (3,765,372) |
Residual royalty agreement liability, excluding embedded derivative liability | 8,363,628 | 6,531,536 |
Add: embedded derivative liability at fair value (see Note 3) | 1,975,000 | 4,294,000 |
Total residual royalty agreement liability | 10,338,628 | 10,825,536 |
Residual royalty agreement liability, short-term portion | (1,061,893) | (1,169,095) |
Residual royalty agreement, long-term portion | $ 9,276,735 | $ 9,656,441 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | 34 Months Ended | ||||||
May 12, 2023 | May 02, 2023 | Apr. 12, 2023 | Jun. 26, 2020 | Aug. 10, 2023 | Jun. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | |
Class of Stock [Line Items] | |||||||||||
Shelf registration statement maximum capacity | $ 200,000,000 | $ 200,000,000 | $ 200,000,000 | ||||||||
Shelf registration statement remaining capacity | $ 23,000,000 | $ 23,000,000 | $ 23,000,000 | ||||||||
Preferred stock, issued | 0 | 0 | 0 | 0 | |||||||
Preferred stock, outstanding | 0 | 0 | 0 | 0 | |||||||
Proceeds from sale of shares | $ 3,400,000 | ||||||||||
Common Stock, shares outstanding | 89,236,732 | 89,236,732 | 89,236,732 | 80,508,894 | |||||||
Value of shares issued for services | $ 1,008,000 | ||||||||||
Deferred costs recorded in additional paid in capital | 26,172 | $ 78,677 | $ 105,000 | ||||||||
Sale of shares under common stock purchase agreement | $ 2,571,551 | ||||||||||
Maximum Share Purchase, Stock Price Range One [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock purchase agreement, maximum purchase of shares per business day | 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 | 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 | 2,000,000 | ||||||||||
Aspire Capital Purchase Agreement, 2020 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued | 2,779,713 | 4,424,450 | |||||||||
Proceeds from sale of shares | $ 3,426,991 | $ 8,400,000 | |||||||||
Stock purchase agreement, term | 36 months | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ 23,900,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | 212,130 | ||||||||||
Value of shares issued for services | $ 681,000 | ||||||||||
Related expenses | 50,000 | ||||||||||
Stock issuance expenses | $ 473,000 | ||||||||||
Unamortized deferred assets | $ 578,000 | ||||||||||
Stock issued during period, shares, new issues | 2,779,713 | 4,424,450 | |||||||||
Sale of shares under common stock purchase agreement | 855,440 | ||||||||||
Deferred costs, related expenses | $ 50,000 | ||||||||||
Shares issued in connection with common stock purchase agreement (in Shares) | 212,130 | ||||||||||
Deferred costs | $ 731,000 | ||||||||||
Stock Purchase Agreement With Frost Gamma Investment Trust (FGI) [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued | 5,000,000 | ||||||||||
Stock issuance price | $ 1 | ||||||||||
Proceeds from sale of shares | $ 4,969,045 | ||||||||||
Stock issued during period, shares, new issues | 5,000,000 | ||||||||||
Stock issuance price | $ 1 | ||||||||||
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 | ||||||||||
Stock purchase agreement, maximum purchase of shares per business day | 250,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | 800,000 | ||||||||||
Related expenses | $ 57,000 | ||||||||||
Stock purchase agreement, maximum purchase of shares per regular purchase, amount | $ 225,000 | ||||||||||
Share price | $ 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 | 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 | $ 1.26 | ||||||||||
Stock purchase agreement, shares issuable upon threshold for aggregate purchases, value | $ 1,000,000 | ||||||||||
Deferred costs, related expenses | 57,000 | ||||||||||
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 | ||||||||||
Shares issued in connection with common stock purchase agreement (in Shares) | 800,000 | ||||||||||
Deferred costs | $ 1,100,000 | ||||||||||
Lincoln Park Purchase Agreement [Member] | Subsequent Event [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from sale of shares | $ 1,200,000 | ||||||||||
Stock purchase agreement, number of shares issued for initial fee | 1,000,000 | ||||||||||
Shares issued in connection with common stock purchase agreement (in Shares) | 1,000,000 | ||||||||||
Jefferies Sales Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued | 0 | ||||||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ 75,000,000 | ||||||||||
Remaining amount authorized | 39,609,072 | ||||||||||
Stock issued during period, shares, new issues | 0 | ||||||||||
Deferred costs | $ 207,000 | ||||||||||
Percentage commission of aggregate gross from sales of common stock | 3% | ||||||||||
Preferred Class A [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | |||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Preferred stock, issued | 0 | 0 | 0 | 0 | |||||||
Preferred stock, outstanding | 0 | 0 | 0 | 0 | |||||||
Preferred Class A Series 1 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 1,040,000 | 1,040,000 | 1,040,000 | 1,040,000 | |||||||
Preferred Class A Series 2 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 1,500,000 | 1,500,000 | 1,500,000 | 1,500,000 | |||||||
Preferred Class A Series 3 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 700,000 | 700,000 | 700,000 | 700,000 | |||||||
Preferred Class A Series 4 [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 548,000 | 548,000 | 548,000 | ||||||||
Preferred Class B [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 15,000 | 15,000 | 15,000 | 15,000 | |||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ 0.50 | $ 0.50 | $ 0.50 | $ 0.50 | |||||||
Preferred stock, issued | 0 | 0 | 0 | 0 | |||||||
Preferred stock, outstanding | 0 | 0 | 0 | 0 | |||||||
Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Share price | $ 8 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Oct. 31, 2018 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jul. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock option conversion ratio | 100% | |||||
Proceeds from stock option exercises | $ 336,610 | $ 410,919 | ||||
Share-based compensation | $ 4,550,832 | $ 2,910,976 | $ 13,233,699 | 6,916,345 | ||
Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Award vesting period | 3 years | |||||
Share price | $ 1.19 | $ 1.19 | ||||
Options, exercises in period, intrinsic value | $ 486,000 | $ 1,300,000 | ||||
Unrecognized compensation expense, stock options | $ 34,800,000 | $ 34,800,000 | ||||
Unrecognized compensation expense, period for recognition | 2 years 1 month 6 days | |||||
Share-based compensation | $ 317,000 | $ 1,800,000 | ||||
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 | |||||
Stock Appreciation Rights (SARs) [Member] | Directors [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issued | 140,000 | |||||
2008 Stock Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 0 | 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 | 12,472 | 12,472 | ||||
2018 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 18,500,000 | 18,500,000 | ||||
Number of shares available | 2,431,616 | 2,431,616 | ||||
2022 Inducement Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized | 4,000,000 | 4,000,000 | ||||
Number of shares available | 3,895,250 | 3,895,250 |
Share-based Compensation (Recor
Share-based Compensation (Recorded Share-Based Compensation Expenses) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 4,550,832 | $ 2,910,976 | $ 13,233,699 | $ 6,916,345 |
Cost of Sales [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 112,515 | 25,275 | 263,879 | 70,923 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 3,667,599 | 2,052,755 | 10,183,510 | 5,036,356 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 770,718 | $ 832,946 | $ 2,786,310 | $ 1,809,066 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted Average Assumptions for Options Granted) (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 104.96% | 92.58% | ||
Expected Dividend Yield | 0% | 0% | ||
Risk-free Interest Rate | 3.51% | 3.01% | ||
Expected Term (in years) | 6 years | 6 years | ||
Fair Value of Options Granted | $ 1.12 | $ 8.97 | ||
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 101.37% | 83.77% | ||
Expected Dividend Yield | 0% | 0% | ||
Risk-free Interest Rate | 3.92% | 2.10% | ||
Expected Term (in years) | 6 years | 6 years | ||
Fair Value of Options Granted | $ 5.55 | $ 6.92 |
Share-based Compensation (Summa
Share-based Compensation (Summary of Stock Options Outstanding and Exercisable) (Details) - Stock Option [Member] | 9 Months Ended |
Jun. 30, 2023 USD ($) $ / 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 | 4,927,775 |
Number of Shares Exercised | shares | (148,125) |
Number of Shares Forfeited and expired | shares | (1,078,262) |
Number of Shares Outstanding at End of Period | shares | 17,964,858 |
Number of Shares Exercisable at End of Period | shares | 10,213,653 |
Weighted Average Exercise Price Per Share Outstanding at Beginning of Period | $ / shares | $ 5 |
Weighted Average Exercise Price Per Share Granted | $ / shares | 6.93 |
Weighted Average Exercise Price Per Share Exercised | $ / shares | 2.27 |
Weighted Average Exercise Price Per Share, Forfeited and expired | $ / shares | 11 |
Weighted Average Exercise Price Per Share Outstanding at End of Period | $ / shares | 5.19 |
Weighted Average Exercise Price Per Share Exercisable at End of Period | $ / shares | $ 3.43 |
Weighted Average Remaining Contractual Term (years) Outstanding at End of Period | 7 years 2 months 8 days |
Weighted Average Remaining Contractual Term (years) Exercisable at End of Period | 5 years 9 months 7 days |
Aggregate Intrinsic Value Outstanding at End of Period | $ | $ 35,604 |
Aggregate Intrinsic Value Exercisable at End of Period | $ | $ 34,604 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) | 9 Months Ended | |
Jun. 30, 2023 USD ($) ft² item | Jun. 30, 2022 USD ($) | |
Operating Leased Assets [Line Items] | ||
Number of subleases | item | 1 | |
Operating lease payments | $ 777,000 | $ 449,000 |
Right-of-use assets recorded in exchange for lease liabilities | $ 264,896 | $ 4,411,474 |
Minimum [Member] | ||
Operating Leased Assets [Line Items] | ||
Remaining term of leases | 1 year | |
Maximum [Member] | ||
Operating Leased Assets [Line Items] | ||
Remaining term of leases | 7 years | |
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 option to exercise cancellation with no penalty term | 6 months | |
Operating lease abatement term | 3 years | |
Right-of-use assets recorded in exchange for lease liabilities | $ 265,000 |
Leases (Components of Lease Cos
Leases (Components of Lease Cost) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 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 | $ 277,211 | $ 285,010 | $ 838,112 | 598,965 |
Short-term lease cost | 10,903 | 11,112 | 32,003 | 36,817 |
Variable lease cost | 33,926 | 69,531 | 136,569 | 162,287 |
Sublease income | (44,844) | (44,844) | (134,533) | (134,533) |
Total lease cost | $ 277,196 | $ 320,809 | $ 872,151 | $ 667,570 |
Leases (Summary of Lease Inform
Leases (Summary of Lease Information) (Details) | Jun. 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% |
Contingent Liabilities (Narrati
Contingent Liabilities (Narrative) (Details) $ in Millions | Jun. 30, 2023 USD ($) |
Contingent Liabilities [Abstract] | |
Product liability insurance, coverage amount | $ 10 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Dec. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2022 | |
Income Tax Expense (Benefit) [Line Items] | ||||||
Decrease in income tax benefit related to change in recognition of research and development expense | $ 8,700,000 | |||||
Increase in deferred tax assets related to change in recognition of research and development expense | 8,700,000 | |||||
Net impact to income tax benefit related change in recognition of research and development expense | 0 | |||||
Net impact to deferred tax assets related change in recognition of research and development expense | $ 0 | |||||
Income tax expense (benefit) | $ 57,551 | $ 137,603 | $ (77,286) | $ 224,808 | ||
Deferred Tax Assets, Research And Development Expense | $ 8,722,825 | $ 8,722,825 | ||||
Corporate income tax rate | 21% | |||||
Minimum [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Tax credit carryforward, expiration date | Dec. 31, 2038 | |||||
Operating loss carryforwards, expiration date | Dec. 31, 2023 | |||||
Maximum [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Tax credit carryforward, expiration date | Dec. 31, 2042 | |||||
Operating loss carryforwards, expiration date | Dec. 31, 2042 | |||||
Domestic [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | $ 112,700,000 | |||||
Domestic [Member] | Tax Period 2023 To 2042 [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 | 82,900,000 | |||||
Domestic [Member] | Tax Period 2038 To 2042 [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Tax credit carryforward | 5,900,000 | |||||
State [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 51,300,000 | |||||
State [Member] | Tax Period 2023 To 2042 [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 31,600,000 | |||||
State [Member] | Indefinite [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 19,600,000 | |||||
Foreign [Member] | Indefinite [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | $ 63,100,000 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Income Tax Expense (Benefit)) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Taxes [Abstract] | ||||
Income tax benefit at U.S. federal statutory rates | $ 1,338,068 | $ (4,632,174) | $ (14,573,616) | $ (8,931,007) |
State income tax benefit, net of federal benefit | 103,605 | (358,662) | (1,128,414) | (691,515) |
Non-deductible expenses | (262,005) | (355,069) | 185,564 | 4,860 |
Effect of stock options exercised | (147,570) | 63,849 | (170,920) | |
U.S. research and development tax credit | 2,835,378 | (1,283,944) | 415,378 | (4,160,374) |
Effect of foreign income tax rates | 406,324 | 366,493 | 307,188 | 327,055 |
Effect of global intangible low taxed income | (24,691) | (12,989) | (24,691) | |
Change in valuation allowance | (4,317,909) | 6,504,878 | 14,705,293 | 13,637,539 |
Other, net | (21,219) | 56,640 | (27,837) | 209,170 |
Income tax (benefit) expense | $ 57,551 | $ 137,603 | $ (77,286) | $ 224,808 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Federal net operating loss carryforwards | $ 26,685,200 | $ 23,627,461 |
State net operating loss carryforwards | 3,100,416 | 2,850,956 |
Foreign net operating loss carryforwards - U.K. | 16,083,790 | 15,773,497 |
Foreign capital allowance - U.K. | 128,490 | 128,490 |
U.S. research and development tax credit carryforwards | 8,066,411 | 8,481,789 |
U.S. research and development expense | 8,722,825 | |
Accrued compensation | 764,724 | 1,227,290 |
Share-based compensation | 6,926,088 | 4,325,354 |
Interest expense | 2,520,769 | 2,206,484 |
Credit loss provision | 885,562 | |
Change in fair value of derivative liabilities | (220,607) | |
Gross deferred tax assets | 74,236,005 | 59,189,066 |
Valuation allowance for deferred tax assets | (60,077,745) | (45,372,452) |
Net deferred tax assets | 14,158,260 | 13,816,614 |
Deferred tax liabilities: | ||
In-process research and development | (882,427) | |
Change in fair value of derivative liabilities | (304,098) | |
Gain on sale of ENTADFI assets | (750,686) | |
Net deferred tax liabilities | (1,060,170) | (931,696) |
Net deferred tax asset | 13,098,090 | 12,884,918 |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 265,631 | 265,631 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 4,712 | |
Deferred tax liabilities: | ||
Other, net | (17,641) | |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 81,387 | 81,507 |
Deferred tax liabilities: | ||
Other, net | $ (5,386) | $ (31,628) |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Amounts Classified in Balance Sheets) (Details) - USD ($) | Jun. 30, 2023 | Sep. 30, 2022 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 13,098,090 | $ 12,965,985 |
Deferred tax liability | (81,067) | |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | 13,093,378 | 12,965,985 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 4,712 | |
Deferred tax liability | (17,641) | |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax liability | $ (63,426) |
Net Income (Loss) Per Share (Na
Net Income (Loss) Per Share (Narrative) (Details) shares in Millions | 3 Months Ended |
Jun. 30, 2023 shares | |
Net Income (Loss) Per Share [Abstract] | |
Anti-dilutive shares | 16.9 |
Net (Loss) Income Per Share (Sc
Net (Loss) Income Per Share (Schedule of Reconciliation of Net (Loss) Income Per Basic and Diluted Common Share Outstanding) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | |
Net income (loss) | $ 6,314,204 | $ (38,792,906) | $ (36,842,179) | $ (22,195,576) | $ (14,177,830) | $ (6,380,006) | $ (69,320,881) | $ (42,753,412) |
Basic weighted average common shares outstanding | 88,266,152 | 80,088,431 | 83,218,748 | 80,054,594 | ||||
Total net effect of dilutive instruments | 35,364 | |||||||
Diluted weighted average common shares outstanding | 88,301,516 | 80,088,431 | 83,218,748 | 80,054,594 | ||||
Net income (loss) per basic common share outstanding | $ 0.07 | $ (0.28) | $ (0.83) | $ (0.53) | ||||
Net income (loss) per diluted common share outstanding | $ 0.07 | $ (0.28) | $ (0.83) | $ (0.53) | ||||
Stock Options [Member] | ||||||||
Stock appreciation rights | 25,962 | |||||||
Stock Appreciation Rights (SARs) [Member] | ||||||||
Stock appreciation rights | 9,402 |
Sale of ENTADFI Assets (Narrati
Sale of ENTADFI Assets (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Apr. 30, 2023 | Apr. 19, 2023 | Sep. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Apr. 30, 2024 | Sep. 30, 2023 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Notes receivable, short term portion | $ 8,536,535 | $ 8,536,535 | |||||||
Notes receivable, long-term portion | 4,437,850 | 4,437,850 | |||||||
Gain on asset disposal | 17,456,814 | 17,456,814 | |||||||
Income before income taxes | 6,371,755 | $ (22,057,973) | (69,398,167) | $ (42,528,604) | |||||
PREBOOST [Member] | |||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Cash proceeds | $ 5,000,000 | ||||||||
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 | $ 6,000,000 | ||||||||
Cash proceeds | 6,000,000 | ||||||||
Consideration receivable | $ 4,000,000 | ||||||||
Net of imputed interest on the interest-free notes receivable using an interest rate | 10% | ||||||||
Imputed interest on the interest-free notes receivable | $ 1,300,000 | ||||||||
Net book value of total assets sold | 1,300,000 | ||||||||
Recognized imputed interest income | $ 241,000 | ||||||||
Notes receivable, short term portion | 8,500,000 | 8,500,000 | |||||||
Notes receivable, long-term portion | $ 4,400,000 | $ 4,400,000 | |||||||
Scenario, Forecast [Member] | ENTADFI [Member] | |||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Purchase price | $ 20,000,000 | ||||||||
Consideration receivable | 5,000,000 | $ 5,000,000 | |||||||
Contingent consideration | 80,000,000 | ||||||||
Gain on asset disposal | $ 17,500,000 |
Subsequent Events (Narrative) (
Subsequent Events (Narrative) (Details) - shares | Jul. 24, 2023 | Jun. 30, 2023 | Sep. 30, 2022 |
Subsequent Event [Line Items] | |||
Common Stock, shares authorized | 154,000,000 | 154,000,000 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Common Stock, shares authorized | 308,000,000 |