Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Jun. 30, 2021 | Aug. 09, 2021 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
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 | 48 NW 25th Street | |
Entity Address Address Line2 | Suite 102 | |
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, $0.01 par value per share | |
Trading Symbol | VERU | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --09-30 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Common Stock, Shares Outstanding | 79,853,748 | |
Amendment Flag | false | |
Entity Central Index Key | 0000863894 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 123,155,968 | $ 13,588,778 |
Accounts receivable, net | 8,313,543 | 5,227,237 |
Notes receivable | 5,000,000 | |
Inventory, net | 6,945,916 | 6,704,134 |
Prepaid research and development costs | 9,546,026 | 613,274 |
Prepaid expenses and other current assets | 1,444,081 | 881,267 |
Total current assets | 154,405,534 | 27,014,690 |
Plant and equipment, net | 392,012 | 312,691 |
Operating lease right-of-use assets | 1,069,472 | 1,352,315 |
Deferred income taxes | 12,379,578 | 9,466,800 |
Intangible assets, net | 4,066,667 | 5,752,127 |
Goodwill | 6,878,932 | 6,878,932 |
Other assets | 880,888 | 766,120 |
Total assets | 180,073,083 | 51,543,675 |
Current liabilities: | ||
Accounts payable | 4,927,680 | 2,812,673 |
Accrued research and development costs | 2,327,323 | 934,110 |
Accrued compensation | 2,760,029 | 2,274,396 |
Accrued expenses and other current liabilities | 2,095,688 | 1,177,126 |
Credit agreement liability | 884,917 | 5,841,874 |
Residual royalty agreement liability, short-term portion | 3,679,871 | 1,100,193 |
Operating lease liability, short-term portion | 536,449 | 586,769 |
Total current liabilities | 17,211,957 | 14,727,141 |
Residual royalty agreement liability, long-term portion | 7,100,145 | 5,617,494 |
Operating lease liability, long-term portion | 702,993 | 990,020 |
Deferred income taxes | 74,724 | 74,724 |
Other liabilities | 14,986 | 22,980 |
Total liabilities | 25,104,805 | 21,432,359 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock; no shares issued and outstanding at June 30, 2021 and September 30, 2020 | ||
Common stock, par value $0.01 per share; 154,000,000 shares authorized, 82,037,452 and 72,047,385 shares issued and 79,853,748 and 69,863,681 shares outstanding at June 30, 2021 and September 30, 2020, respectively | 820,375 | 720,474 |
Additional paid-in-capital | 240,039,725 | 126,971,518 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (77,503,698) | (89,192,552) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 154,968,278 | 30,111,316 |
Total liabilities and stockholders' equity | $ 180,073,083 | $ 51,543,675 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2021 | Sep. 30, 2020 |
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 | 82,037,452 | 72,047,385 |
Common Stock, shares outstanding | 79,853,748 | 69,863,681 |
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ||||
Net revenues | $ 17,655,592 | $ 10,321,754 | $ 45,613,068 | $ 30,842,874 |
Cost of sales | 3,782,480 | 3,802,636 | 9,995,023 | 9,618,163 |
Gross profit | 13,873,112 | 6,519,118 | 35,618,045 | 21,224,711 |
Operating expenses: | ||||
Research and development | 11,188,246 | 4,436,496 | 24,438,813 | 13,666,730 |
Selling, general and administrative | 5,556,730 | 3,475,474 | 14,745,507 | 11,034,904 |
Total operating expenses | 16,744,976 | 7,911,970 | 39,184,320 | 24,701,634 |
Gain on sale of PREBOOST business | 18,410,158 | |||
Operating (loss) income | (2,871,864) | (1,392,852) | 14,843,883 | (3,476,923) |
Non-operating expenses: | ||||
Interest expense | (1,287,525) | (1,169,692) | (3,728,259) | (3,476,079) |
Change in fair value of derivative liabilities | (1,372,000) | (169,000) | (2,029,000) | (94,000) |
Other expense, net | (34,540) | (53,334) | (170,841) | (63,369) |
Total non-operating expenses | (2,694,065) | (1,392,026) | (5,928,100) | (3,633,448) |
(Loss) income before income taxes | (5,565,929) | (2,784,878) | 8,915,783 | (7,110,371) |
Income tax (benefit) expense | (2,873,063) | 240,502 | (2,773,071) | 30,619 |
Net (loss) income | $ (2,692,866) | $ (3,025,380) | $ 11,688,854 | $ (7,140,990) |
Net (loss) income per basic common share outstanding | $ (0.03) | $ (0.05) | $ 0.16 | $ (0.11) |
Basic weighted average common shares outstanding | 79,729,370 | 66,728,782 | 75,054,871 | 65,709,139 |
Net (loss) income per diluted common share outstanding | $ (0.03) | $ (0.05) | $ 0.14 | $ (0.11) |
Diluted weighted average common shares outstanding | 79,729,370 | 66,728,782 | 82,807,156 | 65,709,139 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Treasury Stock, at Cost [Member] | Total |
Balance at Sep. 30, 2019 | $ 672,220 | $ 110,268,057 | $ (581,519) | $ (70,219,017) | $ (7,806,605) | $ 32,333,136 |
Balance (in Shares) at Sep. 30, 2019 | 67,221,951 | |||||
Share-based compensation | 614,498 | 614,498 | ||||
Issuance of shares pursuant to share-based awards | $ 8 | (8) | ||||
Issuance of shares pursuant to share-based awards (in Shares) | 867 | |||||
Net income (loss) | (3,305,101) | (3,305,101) | ||||
Balance at Dec. 31, 2019 | $ 672,228 | 110,882,547 | (581,519) | (73,524,118) | (7,806,605) | 29,642,533 |
Balance (in Shares) at Dec. 31, 2019 | 67,222,818 | |||||
Balance at Sep. 30, 2019 | $ 672,220 | 110,268,057 | (581,519) | (70,219,017) | (7,806,605) | 32,333,136 |
Balance (in Shares) at Sep. 30, 2019 | 67,221,951 | |||||
Amortization of deferred costs | (390,931) | |||||
Net income (loss) | (7,140,990) | |||||
Balance at Jun. 30, 2020 | $ 720,474 | 126,306,764 | (581,519) | (77,360,007) | (7,806,605) | 41,279,107 |
Balance (in Shares) at Jun. 30, 2020 | 72,047,385 | |||||
Balance at Dec. 31, 2019 | $ 672,228 | 110,882,547 | (581,519) | (73,524,118) | (7,806,605) | 29,642,533 |
Balance (in Shares) at Dec. 31, 2019 | 67,222,818 | |||||
Share-based compensation | 681,680 | 681,680 | ||||
Issuance of shares pursuant to share-based awards | $ 3,564 | 405,068 | 408,632 | |||
Issuance of shares pursuant to share-based awards (in Shares) | 356,424 | |||||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs | $ 3,000 | 1,224,000 | 1,227,000 | |||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs (in Shares) | 300,000 | |||||
Amortization of deferred costs | (34,759) | (34,759) | ||||
Net income (loss) | (810,509) | (810,509) | ||||
Balance at Mar. 31, 2020 | $ 678,792 | 113,158,536 | (581,519) | (74,334,627) | (7,806,605) | 31,114,577 |
Balance (in Shares) at Mar. 31, 2020 | 67,879,242 | |||||
Share-based compensation | 685,314 | 685,314 | ||||
Issuance of shares pursuant to share-based awards | $ 48 | 6,784 | 6,832 | |||
Issuance of shares pursuant to share-based awards (in Shares) | 4,800 | |||||
Shares issued in connection with common purchase agreement | $ 2,121 | 678,816 | 680,937 | |||
Shares issued in connection with common purchase agreement (in Shares) | 212,130 | |||||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs | $ 38,421 | 12,134,578 | 12,172,999 | |||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs (in Shares) | 3,842,070 | |||||
Issuance of shares pursuant to common stock purchase warrants | $ 1,092 | (1,092) | ||||
Issuance of shares pursuant to common stock purchase warrants (in Shares) | 109,143 | |||||
Amortization of deferred costs | (356,172) | (356,172) | ||||
Net income (loss) | (3,025,380) | (3,025,380) | ||||
Balance at Jun. 30, 2020 | $ 720,474 | 126,306,764 | (581,519) | (77,360,007) | (7,806,605) | 41,279,107 |
Balance (in Shares) at Jun. 30, 2020 | 72,047,385 | |||||
Balance at Sep. 30, 2020 | $ 720,474 | 126,971,518 | (581,519) | (89,192,552) | (7,806,605) | 30,111,316 |
Balance (in Shares) at Sep. 30, 2020 | 72,047,385 | |||||
Share-based compensation | 785,297 | 785,297 | ||||
Issuance of shares pursuant to share-based awards | $ 4,686 | 619,133 | 623,819 | |||
Issuance of shares pursuant to share-based awards (in Shares) | 468,611 | |||||
Issuance of shares pursuant to common stock purchase warrants | $ 15,746 | (15,746) | ||||
Issuance of shares pursuant to common stock purchase warrants (in Shares) | 1,574,611 | |||||
Net income (loss) | 17,227,701 | 17,227,701 | ||||
Balance at Dec. 31, 2020 | $ 740,906 | 128,360,202 | (581,519) | (71,964,851) | (7,806,605) | 48,748,133 |
Balance (in Shares) at Dec. 31, 2020 | 74,090,607 | |||||
Balance at Sep. 30, 2020 | $ 720,474 | 126,971,518 | (581,519) | (89,192,552) | (7,806,605) | 30,111,316 |
Balance (in Shares) at Sep. 30, 2020 | 72,047,385 | |||||
Net income (loss) | 11,688,854 | |||||
Balance at Jun. 30, 2021 | $ 820,375 | 240,039,725 | (581,519) | (77,503,698) | (7,806,605) | 154,968,278 |
Balance (in Shares) at Jun. 30, 2021 | 82,037,452 | |||||
Balance at Dec. 31, 2020 | $ 740,906 | 128,360,202 | (581,519) | (71,964,851) | (7,806,605) | 48,748,133 |
Balance (in Shares) at Dec. 31, 2020 | 74,090,607 | |||||
Share-based compensation | 1,002,281 | 1,002,281 | ||||
Issuance of shares pursuant to share-based awards | $ 3,573 | 645,702 | 649,275 | |||
Issuance of shares pursuant to share-based awards (in Shares) | 357,297 | |||||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs | $ 74,194 | 107,868,104 | 107,942,298 | |||
Shares issued in connection with public offering of common stock and common stock purchase agreement, net of fees and costs (in Shares) | 7,419,354 | |||||
Net income (loss) | (2,845,981) | (2,845,981) | ||||
Balance at Mar. 31, 2021 | $ 818,673 | 237,876,289 | (581,519) | (74,810,832) | (7,806,605) | 155,496,006 |
Balance (in Shares) at Mar. 31, 2021 | 81,867,258 | |||||
Share-based compensation | 1,900,085 | 1,900,085 | ||||
Issuance of shares pursuant to share-based awards | $ 1,702 | 263,351 | 265,053 | |||
Issuance of shares pursuant to share-based awards (in Shares) | 170,194 | |||||
Net income (loss) | (2,692,866) | (2,692,866) | ||||
Balance at Jun. 30, 2021 | $ 820,375 | $ 240,039,725 | $ (581,519) | $ (77,503,698) | $ (7,806,605) | $ 154,968,278 |
Balance (in Shares) at Jun. 30, 2021 | 82,037,452 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
OPERATING ACTIVITIES | ||
Net income (loss) | $ 11,688,854 | $ (7,140,990) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 170,713 | 347,159 |
Noncash change in right-of-use assets | 282,843 | 240,282 |
Noncash interest expense, net of interest paid | (2,923,628) | 3,476,079 |
Share-based compensation | 3,687,663 | 1,981,492 |
Gain on sale of PREBOOST business | (18,410,158) | |
Deferred income taxes | (2,912,778) | (198,202) |
Provision for obsolete inventory | 175,085 | 227,982 |
Change in fair value of derivative liabilities | 2,029,000 | 94,000 |
Other | (3,000) | 7,500 |
Changes in current assets and liabilities: | ||
(Increase) decrease in accounts receivable | (3,083,306) | 194,471 |
Increase in inventory | (416,867) | (1,775,018) |
Increase in prepaid expenses and other assets | (9,610,334) | (4,794) |
Increase in accounts payable | 2,115,007 | 648,239 |
Increase in accrued expenses and other current liabilities | 2,783,696 | 556,330 |
Decrease in operating lease liabilities | (337,346) | (243,514) |
Net cash used in operating activities | (14,764,556) | (1,588,984) |
INVESTING ACTIVITIES | ||
Cash proceeds from sale of PREBOOST business | 15,000,000 | |
Capital expenditures | (154,416) | (73,444) |
Net cash provided by (used in) investing activities | 14,845,584 | (73,444) |
FINANCING ACTIVITIES | ||
Proceeds from sale of shares in public offering, net of fees | 108,099,988 | |
Payment of costs related to public offering | (137,690) | |
Installment payments on SWK credit agreement | (3,325,180) | |
Proceeds from stock option exercises | 1,538,147 | 415,464 |
Proceeds from premium finance agreement | 1,061,442 | 836,780 |
Installment payments on premium finance agreement | (1,061,442) | (555,920) |
Proceeds from sale of shares under common stock purchase agreement | 13,399,999 | |
Cash paid for debt portion of finance lease | (14,283) | (9,444) |
Net cash provided by financing activities | 109,486,162 | 10,761,699 |
Net increase in cash | 109,567,190 | 9,099,271 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 13,588,778 | 6,295,152 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 123,155,968 | 15,394,423 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 6,651,887 | |
Schedule of non-cash investing and financing activities: | ||
Right-of-use assets recorded in exchange for lease liabilities | 1,253,233 | |
Notes receivable for sale of PREBOOST business | 5,000,000 | |
Amortization of deferred costs related to common stock purchase agreement | 390,931 | |
Shares issued in connection with common stock purchase agreement | 680,937 | |
Increase in other assets from accrued expenses | $ 50,284 | |
Costs related to public offering in accrued expenses and other current liabilities | $ 20,000 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Jun. 30, 2021 | |
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 (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, 2020. The accompanying condensed consolidated balance sheet as of September 30, 2020 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations for the three and nine months ended June 30, 2021 and cash flows for the nine months ended June 30, 2021 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30 , 2021. 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, Aspen Park Pharmaceuticals, Inc. (APP) and The Female Health Company Limited, and 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”), and The Female Health Company (UK) plc’s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the “Malaysia subsidiary”). All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancers. The Company has multiple drug products under clinical development. During fiscal 2020, the Sexual Health Business segment also included PREBOOST® 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. The PREBOOST® business was sold on December 8, 2020. See Note 2 for additional information. Most of the Company’s net revenues during the three and nine months ended June 30, 2021 and 2020 were derived from sales of the FC2 Female Condom/FC2 Internal Condom® (FC2), an FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. Reclassifications : Certain prior period amounts on the accompanying unaudited interim condensed consolidated financial statements have been reclassified to conform with the current period presentation. These reclassifications had no effect on the results of operations or financial position for any period presented. Other comprehensive income (loss) : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net income (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 income (loss), are components of other comprehensive loss. For the three and nine months ended June 30, 2021 and 2020, comprehensive income (loss) is equivalent to the reported net income (loss). Recently adopted accounting pronouncements : In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326). This ASU introduces a new accounting model, the Current Expected Credit Losses model (CECL), which could result in earlier recognition of credit losses and additional disclosures related to credit risk. The CECL model requires the Company to use a forward-looking expected credit loss impairment methodology for the recognition of credit losses for financial instruments at the time the financial asset is originated or acquired. The expected credit losses are adjusted each period for changes in expected lifetime credit losses. This model replaces the multiple existing impairment models in current U.S. GAAP, which generally require that a loss be incurred before it is recognized. The new standard also applies to receivables arising from revenue transactions such as accounts receivable. The Company adopted ASU 2016-13 on a modified-retrospective basis effective October 1, 2020. The adoption of ASU 2016-13 did not impact our consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other Topics (Topic 350): Simplifying the Test for Goodwill Impairment. The purpose of ASU 2017-04 is to reduce the cost and complexity of evaluating goodwill for impairment. It eliminates the need for entities to calculate the implied fair value of goodwill by assigning the fair value of a reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. Under this amendment, an entity will perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge is recognized for the amount by which the carrying value exceeds the reporting unit’s fair value. The Company adopted ASU 2017-04 on a prospective basis effective October 1, 2020. The adoption of ASU 2017-04 did not impact our consolidated financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Change to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 modifies the disclosure requirements by adding, removing, and modifying certain required disclosures for fair value measurements for assets and liabilities disclosed within the fair value hierarchy. The Company adopted ASU 2018-13 on a retrospective basis effective October 1, 2020. The adoption of ASU 2018-13 did not impact our financial position, results of operations, or cash flows as it modified disclosure requirements only. |
Sale of PREBOOST Business
Sale of PREBOOST Business | 9 Months Ended |
Jun. 30, 2021 | |
Sale of PREBOOST Business [Abstract] | |
Sale of PREBOOST Business | Note 2 – Sale of PREBOOST® Business On December 8, 2020, the Company entered into an Asset Purchase Agreement, pursuant to which the Company sold substantially all of the assets related to the Company's PREBOOST® business. PREBOOST® is a 4% benzocaine medicated individual wipe for the treatment of premature ejaculation and was a commercial product in the Company’s Sexual Health Division until the date of the sale. The transaction closed on December 8, 2020. The purchase price for the transaction was $ 20.0 million, consisting of $ 15.0 million paid at closing, a $ 2.5 million note receivable due 12 months after closing and a $ 2.5 million note receivable due 18 months after closing. Total assets sold, consisting of intangible assets, had a net book value of approximately $ 1.6 million, resulting in a pre-tax gain on sale of approximately $ 18.4 million. The Company had income before income taxes of $ 327,000 during the nine months ended June 30, 2021 related to the PREBOOST® business before the sale. The Company had income before income taxes of $ 450,000 and $ 729,000 during the three and nine months ended June 30, 2020, respectively, related to the PREBOOST® business. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2021 | |
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, 2021 and September 30, 2020, 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, 2021 and 2020: Nine Months Ended June 30, 2021 2020 Beginning balance $ 4,182,000 $ 3,625,000 Change in fair value of derivative liabilities 2,029,000 94,000 Ending balance $ 6,211,000 $ 3,719,000 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 provisions in the Credit Agreement and Residual Royalty Agreement. See Note 8 for additional information. There is no current observable market for these types of derivatives. The Company determined the fair value of the embedded derivatives using a Monte Carlo simulation model to value the financial liabilities at inception and on subsequent valuation dates. This valuation model incorporates the contractual terms of the instruments and assumptions including projected FC2 revenues, expected cash outflows, expected repayment dates, probability and estimated dates of a change of control, expected volatility, and 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 liabilities associated with the embedded derivatives. The following table presents quantitative information about the inputs and valuation methodologies used to determine the fair value of the embedded derivatives classified in Level 3 of the fair value hierarchy as of June 30, 2021 and September 30, 2020: Weighted Average (range, if applicable) Valuation Methodology Significant Unobservable Input June 30, 2021 September 30, 2020 Monte Carlo Simulation Estimated change of control dates September 2022 to September 2025 December 2021 to June 2022 Discount rate 4.6 % to 7.9 % 14.1 % to 16.0 % Probability of change of control 20 % to 90 % 20 % to 90 % |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 9 Months Ended |
Jun. 30, 2021 | |
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 PREBOOST® medicated wipes for prevention of premature ejaculation before the sale of the PREBOOST® business. The following table presents net revenues from these three categories: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 FC2 U.S. prescription channel $ 13,501,862 $ 5,391,523 $ 32,916,343 $ 18,395,280 Global public health sector 4,153,730 4,254,197 11,833,894 11,197,635 Total FC2 17,655,592 9,645,720 44,750,237 29,592,915 PREBOOST® - 676,034 862,831 1,249,959 Net revenues $ 17,655,592 $ 10,321,754 $ 45,613,068 $ 30,842,874 The following table presents net revenue by geographic area: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 United States $ 14,080,810 $ 6,396,762 $ 35,049,646 $ 20,575,515 South Africa * 1,182,225 * * Other 3,574,782 2,742,767 10,563,422 10,267,359 Net revenues $ 17,655,592 $ 10,321,754 $ 45,613,068 $ 30,842,874 * Less than 10 % of total net revenues and included in Other 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 $ 699,000 and $ 6,000 at June 30, 2021 and September 30, 2020, respectively . |
Accounts Receivable and Concent
Accounts Receivable and Concentration of Credit Risk | 9 Months Ended |
Jun. 30, 2021 | |
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 components of accounts receivable consist of the following at June 30, 2021 and September 30, 2020: June 30, September 30, 2021 2020 Trade receivables, gross $ 8,441,224 $ 5,332,786 Less: allowance for doubtful accounts ( 22,643 ) ( 25,643 ) Less: allowance for sales returns and payment term discounts ( 105,038 ) ( 79,906 ) Accounts receivable, net $ 8,313,543 $ 5,227,237 At June 30, 2021 and at September 30, 2020, no customers had a current accounts receivable balance that represented greater than 10% of current assets. At June 30, 2021, three customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 90 % of net accounts receivable in the aggregate. At September 30, 2020, three customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 89 % of net accounts receivable in the aggregate. For the three months ended June 30, 2021, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 75 % of the Company’s net revenues in the aggregate. For the three months ended June 30, 2020, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 72 % of the Company’s net revenues in the aggregate. For the nine months ended June 30, 2021, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 71 % of the Company’s net revenues in the aggregate. For the nine months ended June 30, 2020, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 74 % of the Company’s net revenues in the aggregate. The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments on accounts receivable. Management determines the allowance for doubtful accounts by identifying troubled accounts and by using historical experience applied to an aging of accounts. Management also periodically evaluates individual customer receivables and considers a customer’s financial condition, credit history, and the current economic conditions. Accounts receivable are charged-off when deemed uncollectible. There was no material change in the allowance for doubtful accounts for the nine months ended June 30, 2021 and 2020. 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, 2021 | |
Balance Sheet Information [Abstract] | |
Balance Sheet Information | Note 6 – Balance Sheet Information Inventory 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. Inventory consisted of the following at June 30, 2021 and September 30, 2020: June 30, September 30, 2021 2020 FC2: Raw material $ 1,317,901 $ 962,860 Work in process 90,583 106,272 Finished goods 5,679,518 5,634,612 FC2, gross 7,088,002 6,703,744 Less: inventory reserves ( 142,086 ) ( 29,331 ) FC2, net 6,945,916 6,674,413 PREBOOST® Finished goods — 29,721 Inventory, net $ 6,945,916 $ 6,704,134 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, 2021 and September 30, 2020: Estimated June 30, September 30, Useful Life 2021 2020 Plant and equipment: Manufacturing equipment 5 - 8 years $ 2,770,149 $ 2,752,854 Office equipment, furniture and fixtures 3 - 10 years 903,400 803,484 Leasehold improvements 3 - 8 years 298,886 298,886 Total plant and equipment 3,972,435 3,855,224 Less: accumulated depreciation and amortization ( 3,580,423 ) ( 3,542,533 ) Plant and equipment, net $ 392,012 $ 312,691 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Jun. 30, 2021 | |
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, 2021: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 333,333 $ 166,667 Indefinite-lived intangible assets: Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 4,400,000 $ 333,333 $ 4,066,667 The gross carrying amounts and net book value of intangible assets were as follows at September 30, 2020: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible assets with finite lives: Developed technology - PREBOOST ® $ 2,400,000 $ 768,111 $ 1,631,889 Covenants not-to-compete 500,000 279,762 220,238 Total intangible assets with finite lives 2,900,000 1,047,873 1,852,127 Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 6,800,000 $ 1,047,873 $ 5,752,127 As discussed in Note 2, the Company sold its intangible assets related to PREBOOST® as part of the sale of the PREBOOST® business on December 8, 2020. The remaining net book value of the PREBOOST® developed technology, acquired in the acquisition of APP, was $ 1.6 million on the date of the sale. Amortization expense was approximately $ 18,000 and $ 79,000 for the three months ended June 30, 2021 and 2020, respectively, and approximately $ 96,000 and $ 237,000 for the nine months ended June 30, 2021 and 2020, respectively. Goodwill The carrying amount of goodwill at June 30, 2021 and September 30, 2020 was $ 6.9 million. There was no change in the balance during the nine months ended June 30, 2021 and 2020. |
Debt
Debt | 9 Months Ended |
Jun. 30, 2021 | |
Debt [Abstract] | |
Debt | Note 8 – Debt SWK Credit Agreement 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. After payment by the Company of certain fees and expenses of the Agent and the Lenders as required in the Credit Agreement, the Company received net proceeds of approximately $ 9.9 million from the $ 10.0 million loan under the Credit Agreement. The Lenders are entitled to receive quarterly payments on the term loan based on the Company’s product revenue from net sales of FC2 as provided in the Credit Agreement until the Company has paid 176.5 % of the aggregate amount advanced to the Company under the Credit Agreement. I f product revenue from net sales of FC2 for the 12 -month period ended as of the last day of the respective quarterly payment period is less than $ 10.0 million, the quarterly payments will be 32.5 % of product revenue from net sales of FC2 during the quarterly period. If product revenue from net sales of FC2 for the 12 -month period ended as of the last day of the respective quarterly payment period is equal to or greater than $ 10.0 million, the quarterly payments are calculated as follows: (i) as it relates to each quarter during the 2019 calendar year, the sum of 12.5 % of product revenue from net sales of FC2 up to and including $ 12.5 million in the Elapsed Period (as defined in the Credit Agreement), plus 5 % of product revenue from net sales of FC2 greater than $ 12.5 million in the Elapsed Period, (ii) as it relates to each quarter during the 2020 calendar year, the sum of 25 % of product revenue from net sales of FC2 up to and including $ 12.5 million in the Elapsed Period, plus 10 % of product revenue from net sales of FC2 greater than $ 12.5 million in the Elapsed Period, and (iii) as it relates to each quarter during the 2021 calendar year and thereafter, the sum of 30 % of product revenue from net sales of FC2 up to and including $ 12.5 million in the Elapsed Period, plus 20 % of product revenue from net sales of FC2 greater than $ 12.5 million in the Elapsed Period. U pon the Credit Agreement’s termination date of March 5, 2025, the Company must pay 176.5 % of the aggregate amount advanced to the Company under the Credit Agreement less the amounts previously paid by the Company from product revenue. The payment requirements described above reflect an amendment to the Credit Agreement dated May 13, 2019 (the “Second Amendment”) which included a reduction to the percentages to be used to calculate the quarterly revenue-based payments due on product revenue from net sales of FC2 during calendar year 2019, a return to the original percentages to calculate the quarterly revenue-based payments due on product revenue from net sales of FC2 during calendar year 2020 and an increase to the percentages to be used to calculate the quarterly revenue-based payments due on product revenue from net sales of FC2 during calendar year 2021 and thereafter until the loan has been repaid. Upon a change of control of the Company or sale of the FC2 business, the Company must pay off the loan by making a payment to the Lenders equal to (i) 176.5 % of the aggregate amount advanced to the Company under the Credit Agreement less the amounts previously paid by the Company from product revenue from net sales of FC2, plus (ii) 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 . A “change of control” under the Credit Agreement includes (i) an acquisition by any person of direct or indirect ownership of more than 50 % of the Company’s issued and outstanding voting equity, (ii) a change of control or similar event in the Company’s articles of incorporation or bylaws, (iii) certain Key Persons as defined in the Credit Agreement cease to serve in their current executive capacities unless replaced within 90 days by a person reasonably acceptable to the Agent, which acceptance not to be unreasonably withheld, or (iv) the sale of all or substantially all of the Company’s assets. The Credit Agreement contains customary representations and warranties in favor of the Agent and the Lenders and certain covenants, including financial covenants addressing minimum quarterly marketing and distribution expenses for FC2 and a requirement to maintain minimum unencumbered liquid assets of $ 1.0 million. The Credit Agreement also restricts the payment of dividends and share repurchases. The recourse of the Lenders and the Agent for obligations under the Credit Agreement is limited to assets relating to FC2. 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 commencing after the Company would have paid 175 % of the aggregate amount advanced to the Company under the Credit Agreement based on a calculation of revenue-based payments under the Credit Agreement without taking into account the amendments to the payment requirements under the Credit Agreement effected by the Second Amendment. 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 Credit Agreement, or (ii) mutual agreement of the parties. If a change of control or sale of the FC2 business occurs prior to payment in full of the Credit Agreement, there will be no further payment due with respect to the Residual Royalty Agreement. If a change of control or sale of the FC2 business occurs after payment in full of the Credit Agreement, 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 . Pursuant to a Guarantee and Collateral Agreement dated as of March 5, 2018 (the “Collateral Agreement”) and an Intellectual Property Security Agreement dated as of March 5, 2018 (the “IP Security Agreement”), the Company’s obligations under the Credit Agreement are secured by a lien against substantially all of the assets of the Company that relate to or arise from FC2. In addition, pursuant to a Pledge Agreement dated as of March 5, 2018 (the “Pledge Agreement”), the Company’s obligations under the Credit Agreement are secured by a pledge of up to 65 % of the outstanding shares of The Female Health Company Limited, a wholly owned U.K. subsidiary. 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 Credit Agreement and a portion of the amount allocated to the Residual Royalty Agreement, in both cases equal to the fair value of the respective change of control provisions, was allocated to the embedded derivative liabilities. The derivative liabilities are adjusted to fair market value at each reporting period . For financial statement presentation, the embedded derivative liabilities have been included with their respective host instruments as noted in the following tables. The debt discounts are being amortized to interest expense over the expected term of the loan using the effective interest method. Additionally, the Company recorded deferred loan issuance costs of approximately $ 267,000 for legal fees incurred in connection with the Credit Agreement. The deferred loan issuance costs are presented as a reduction of the Credit Agreement obligation and are being amortized to interest expense over the expected term of the loan using the effective interest method. The Second Amendment was accounted for as a debt modification, which resulted in prospective adjustment to the effective interest rate. At June 30, 2021 and September 30, 2020, the Credit Agreement liability consisted of the following: June 30, September 30, 2021 2020 Aggregate repayment obligation $ 17,650,000 $ 17,650,000 Less: cumulative payments ( 16,704,398 ) ( 10,314,495 ) Remaining repayment obligation 945,602 7,335,505 Less: unamortized discounts ( 59,291 ) ( 1,459,330 ) Less: unamortized deferred issuance costs ( 1,394 ) ( 34,301 ) Credit agreement liability $ 884,917 $ 5,841,874 The Company made its final payment to repay the original principal of $ 10.0 million during the quarter ended September 30, 2020. Remaining quarterly payments under the Credit Agreement will be classified as interest payments, consistent with the terms of the Credit Agreement. The Company currently estimates the remaining repayment obligation under the Credit Agreement will be paid during the 12 - month period subsequent to June 30, 2021. At June 30, 2021 and September 30, 2020, the Residual Royalty Agreement liability consisted of the following: June 30, September 30, 2021 2020 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 4,485,000 2,189,687 Less: cumulative payments ( 261,984 ) — Residual royalty agreement liability, excluding embedded derivative liability 4,569,016 2,535,687 Add: embedded derivative liability at fair value (see Note 3) 6,211,000 4,182,000 Total residual royalty agreement liability 10,780,016 6,717,687 Residual royalty agreement liability, short-term portion ( 3,679,871 ) ( 1,100,193 ) Residual royalty agreement liability, long-term portion $ 7,100,145 $ 5,617,494 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 related to the Credit Agreement and the Residual Royalty Agreement consisted of amortization of the discounts, accretion of the liability for the Residual Royalty Agreement and amortization of the deferred issuance costs. For the three and nine months ended June 30, 2021 and 2020, interest expense related to the Credit Agreement and Residual Royalty Agreement was as follows: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Amortization of discounts $ 327,550 $ 782,169 $ 1,400,039 $ 2,488,747 Accretion of residual royalty agreement 952,276 369,138 2,295,313 928,835 Amortization of deferred issuance costs 7,699 18,385 32,907 58,497 Interest expense $ 1,287,525 $ 1,169,692 $ 3,728,259 $ 3,476,079 Premium Finance Agreement On November 1, 2020, the Company entered into a Premium Finance Agreement to finance $ 1.1 million of its directors and officers liability insurance premium at an annual percentage rate of 3.94 %. The financing was payable in three quarterly installments of principal and interest, beginning on January 1, 2021. The last payment was made in June 2021 and there was no balance outstanding as of June 30, 2021. On November 1, 2019, the Company entered into a Premium Finance Agreement to finance $ 837,000 of its directors and officers liability insurance premium at an annual percentage rate of 4.18 %. The financing was payable in three quarterly installments of principal and interest, which began on January 1, 2020. The last payment was made on July 1, 2020 and there was no balance outstanding as of September 30, 2020. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Jun. 30, 2021 | |
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, 2021 and September 30, 2020. 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, 2021 and September 30, 2020, and there was no activity during the nine-month periods then ended. Common Stock Offering On February 22, 2021, we completed an underwritten public offering of 7,419,354 shares of our common stock, which included the exercise in full of the underwriters’ option to purchase additional shares, at a public offering price of $ 15.50 per share. Net proceeds to the Company from this offering were $ 107.9 million after deducting underwriting discounts and commissions and costs incurred by the Company through June 30, 2021. All of the shares sold in the offering were by the Company. The offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-239493). Common Stock Purchase Warrants In connection with the closing of the acquisition of APP (the “APP Acquisition”) on October 31, 2016, the Company issued warrants to purchase up to 2,585,379 shares of the Company's common stock to Torreya Capital, the Company’s then financial advisor (the “Financial Advisor Warrants”). The Financial Advisor Warrants had a five -year term expiring October 31, 2021, a cashless exercise feature and a strike price equal to $ 1.93 per share. The Financial Advisor Warrants vested upon issuance. As of September 30, 2020, an aggregate of 2,326,841 shares of common stock remained available for purchase under the Financial Advisor Warrants. During the first quarter of fiscal 2021, the remaining Financial Advisor Warrants to purchase 2,326,841 shares of the Company’s common stock were exercised using the cashless exercise feature, resulting in the issuance of 1,574,611 shares of common stock. As of June 30, 2021, there were no outstanding common stock purchase warrants. 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 provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company has 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. Concurrently with entering into the 2020 Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the “Registration Rights Agreement”), in which the Company agreed to prepare and file under the Securities Act of 1933 one or more prospectus supplement for the sale or potential sale of the shares of the Company’s common stock that have been and may be issued to Aspire Capital under the 2020 Purchase Agreement. Under the 2020 Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a “Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 200,000 shares of the Company’s common stock per business day at a per share price (the “Purchase Price”) equal to the lesser of the lowest sale price of the Company’s common stock on the purchase date or the average of the three lowest closing sale prices for the Company’s common stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date. In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to 200,000 shares and the closing sale price of our common stock is equal to or greater than $ 0.50 per share, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of common stock equal to up to 30 % of the aggregate shares of the common stock traded on its principal market on the next trading day (the “VWAP Purchase Date”), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97 % of the volume-weighted average price for the Company’s common stock traded on its principal market on the VWAP Purchase Date. Since inception of the 2020 Purchase Agreement, we have sold 1,644,737 shares of common stock to Aspire Capital resulting in proceeds to the Company of $ 5.0 million. As of June 30, 2021, the amount remaining under the 2020 Purchase Agreement was $ 18.9 million, which is registered under the Company’s shelf registration statement on Form S-3 (File No. 333-239493). 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 of $ 578,000 at June 30, 2021 and September 30, 2020 is included in other assets on the accompanying unaudited condensed consolidated balance sheets. |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Jun. 30, 2021 | |
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, 2021 and 2020, we recorded share-based compensation expenses as follows: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Cost of sales $ 15,921 $ 7,743 $ 50,548 $ 38,713 Selling, general and administrative 1,444,145 490,647 2,719,232 1,442,970 Research and development 440,019 186,924 917,883 499,809 Share-based compensation $ 1,900,085 $ 685,314 $ 3,687,663 $ 1,981,492 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 March 2018, the Company’s stockholders approved the Company's 2018 Equity Incentive Plan (as amended, the “2018 Plan”). A total of 11.0 million shares are authorized for issuance under the 2018 Plan. As of June 30, 2021, 2,848,780 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, 2021, 18,433 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 following table outlines the weighted average assumptions for options granted during the three and nine months ended June 30, 2021 and 2020 : Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Weighted Average Assumptions: Expected volatility 78.53 % — 68.88 % 63.13 % Expected dividend yield 0.00 % — 0.00 % 0.00 % Risk-free interest rate 1.10 % — 0.64 % 1.63 % Expected term (in years) 6.0 — 5.9 5.9 Fair value of options granted $ 5.98 $ — $ 3.46 $ 1.14 During the three and nine months ended June 30, 2021 and 2020, 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, 2021: Weighted Average Remaining Aggregate Number of Exercise Price Contractual Term Intrinsic Shares Per Share (years) Value Outstanding at September 30, 2020 8,599,000 $ 1.67 Granted 3,228,625 $ 5.47 Exercised ( 996,102 ) $ 1.54 Forfeited and expired ( 91,269 ) $ 1.74 Outstanding at June 30, 2021 10,740,254 $ 2.83 7.91 $ 60,768,816 Exercisable at June 30, 2021 5,933,601 $ 1.66 7.01 $ 38,057,411 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, 2021 of $ 8.07 , 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, 2021 and 2020 was approximately $ 8.3 million and $ 1.1 million, respectively. Cash received from options exercised during the nine months ended June 30, 2021 and 2020 was approximately $ 1.5 million and $ 415,000 , respectively. D uring the nine months ended June 30, 2020, 223,415 options were exercised using the cashless exercise feature available under the 2017 Plan and 2018 Plan, which resulted in the issuance of 143,958 shares of common stock. There were no options exercised using the cashless exercise feature during the nine months ended June 30, 2021. As of June 30, 2021, the Company had unrecognized compensation expense of approximately $ 10.6 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 1.8 years. During the quarter ended June 30, 2021, the Company modified stock options held by an optionee upon resignation from the board of directors. As permitted under the 2018 Plan and with the approval of the Compensation Committee of the Board of Directors, the stock options were modified to accelerate vesting to the date of resignation. The aggregate amount of expense recognized in connection with the modification of stock options for the three and nine months ended June 30, 2021 was approximately $ 536,000 and is included in selling, general and administrative expenses on the accompanying unaudited condensed consolidated statements of operations . Stock Appreciation Rights In connection with the closing of 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, 2021, vested stock appreciation rights based on 50,000 shares of common stock remain outstanding. |
Leases
Leases | 9 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | Note 11 – Leases The Company has operating leases for its office, manufacturing and warehouse space, and office equipment. The Company has a finance lease for office equipment, furniture, and fixtures. The Company’s leases have remaining lease terms of less than one year to five 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. In June 2021, the Company executed a lease for its new corporate headquarters in Miami, Florida. The Company will be leasing approximately 12,000 square feet of office space for an eight year term commencing on the later of March 1, 2022 or the date the landlord substantially completes tenant improvements. The space will replace the Company’s current corporate headquarters in Miami, Florida when the existing lease terminates at the end of February 2022. Annual base rent payments will be $ 58.00 per square foot and are subject to a 3 % annual escalation. Based on the terms of the lease agreement, the Company paid a security deposit of approximately $ 117,000 , which is included in other assets on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2021 . The Company does not have any other leases that have not yet commenced as of June 30, 2021. The components of the Company’s lease cost were as follows for the three and nine months ended June 30, 2021 and 2020: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets $ 2,178 $ 2,178 $ 6,535 $ 6,535 Interest on lease liabilities 611 1,238 2,327 4,097 Operating lease cost 136,140 124,326 408,079 378,006 Short-term lease cost 1,863 1,863 5,589 5,589 Variable lease cost 48,061 24,213 124,283 91,349 Sublease income ( 44,844 ) ( 45,382 ) ( 134,533 ) ( 135,071 ) Total lease cost $ 144,009 $ 108,436 $ 412,280 $ 350,505 The Company paid cash of $ 497,000 and $ 350,000 for amounts included in the measurement of operating lease liabilities during the nine months ended June 30, 2021 and 2020, 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, 2021 and September 30, 2020. Other information related to the Company’s leases as of June 30, 2021 and September 30, 2020 was as follows: June 30, September 30, 2021 2020 Operating Leases Weighted-average remaining lease term 3.1 3.6 Weighted-average discount rate 11.5 % 11.5 % Finance Leases Weighted-average remaining lease term 0.7 1.4 Weighted-average discount rate 13.9 % 13.9 % 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, 2021 | |
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 $ 20.0 million. Litigation From time to time we may be involved in litigation or other contingencies arising in the ordinary course of business. Based on the information presently available, management believes there are no contingencies, claims or actions, pending or threatened, the ultimate resolution of which will have a material adverse effect on our financial position, liquidity or results of operations. In accordance with FASB ASC 450, Contingencies, we accrue loss contingencies including costs of settlement, damages and defense related to litigation to the extent they are probable and reasonably estimable. Otherwise, we expense these costs as incurred. If the estimate of a probable loss is a range and no amount within the range is more likely, we accrue the minimum amount of the range. 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. |
Income Taxes
Income Taxes | 9 Months Ended |
Jun. 30, 2021 | |
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, 2020, the Company had U.S. federal and state NOL carryforwards of $ 42.0 million and $ 25.6 million, respectively, for income tax purposes with $ 13.8 million and $ 19.8 million, respectively, expiring in years 2022 to 2040 and $ 28.2 million and $ 5.8 million, respectively, which can be carried forward indefinitely. As of September 30, 2020, the Company also had U.S. federal research and development tax credit carryforwards of $ 0.9 million, expiring in 2040 . The Company’s U.K. subsidiary has U.K. NOL carryforwards of $ 61.3 million as of September 30, 2020, which can be carried forward indefinitely to be used to offset future U.K. taxable income. On June 10, 2021 the U.K. Finance Act 2021 was enacted increasing the U.K. tax rate from 19 % to 25 % effective April 1, 2023. The increase in the tax rate increased the value of the deferred tax assets in the U.K. by $ 3.7 million with a corresponding valuation allowance of $ 0.8 million , which resulted in a net income tax benefit of $ 3.0 million for the three and nine months ended June 30, 2021. A reconciliation of income tax (benefit) expense and the amount computed by applying the U.S. statutory rate of 21 % to (loss) income before income taxes is as follows: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Income tax (benefit) expense at U.S. federal statutory rates $ ( 1,168,845 ) $ ( 584,825 ) $ 1,872,314 $ ( 1,493,179 ) State income tax (benefit) expense, net of federal (benefit) expense ( 90,502 ) ( 45,268 ) 144,971 ( 115,615 ) Non-deductible expenses ( 2,807 ) 332,230 ( 2,807 ) 335,869 Effect of stock options exercised 53,011 — — — Effect of common stock purchase warrants exercised — — ( 2,038,919 ) — Effect of Paycheck Protection Program funds 8,784 — ( 113,442 ) — U.S. research and development tax credit ( 919,415 ) — ( 919,415 ) — Effect of foreign income tax rates ( 3,716,935 ) ( 16,478 ) ( 3,744,512 ) 49,908 Effect of global intangible low taxed income 78,626 85,522 148,383 101,642 Change in valuation allowance 2,834,482 415,449 1,828,730 1,097,900 Other, net 50,538 53,872 51,626 54,094 Income tax (benefit) expense $ ( 2,873,063 ) $ 240,502 $ ( 2,773,071 ) $ 30,619 Significant components of the Company’s deferred tax assets and liabilities are as follows: June 30, September 30, 2021 2020 Deferred tax assets: Federal net operating loss carryforwards $ 8,269,223 $ 8,759,589 State net operating loss carryforwards 1,647,082 1,682,104 Foreign net operating loss carryforwards – U.K. 15,259,909 11,655,853 Foreign capital allowance – U.K. 149,371 113,522 U.S. research and development tax credit carryforwards 919,415 — Share-based compensation 770,598 1,255,983 Interest expense 1,165,193 850,248 Change in fair value of derivative liabilities 654,354 195,265 Other, net – U.K. 123,341 93,739 Other, net – U.S. 187,644 179,677 Gross deferred tax assets 29,146,130 24,785,980 Valuation allowance for deferred tax assets ( 15,903,470 ) ( 14,074,740 ) Net deferred tax assets 13,242,660 10,711,240 Deferred tax liabilities: In-process research and development ( 882,427 ) ( 882,427 ) Developed technology — ( 369,237 ) Covenant not-to-compete ( 37,711 ) ( 49,832 ) Other, net – Malaysia ( 11,297 ) ( 11,297 ) Other, net – U.S. ( 6,371 ) ( 6,371 ) Net deferred tax liabilities ( 937,806 ) ( 1,319,164 ) Net deferred tax asset $ 12,304,854 $ 9,392,076 The deferred tax amounts have been classified on the accompanying unaudited condensed consolidated balance sheets as follows: June 30, September 30, 2021 2020 Deferred tax asset – U.K. $ 12,379,578 $ 9,466,800 Total deferred tax asset $ 12,379,578 $ 9,466,800 Deferred tax liability – U.S. $ ( 63,427 ) $ ( 63,427 ) Deferred tax liability – Malaysia ( 11,297 ) ( 11,297 ) Total deferred tax liability $ ( 74,724 ) $ ( 74,724 ) |
Paycheck Protection Program
Paycheck Protection Program | 9 Months Ended |
Jun. 30, 2021 | |
Paycheck Protection Program [Abstract] | |
Paycheck Protection Program | Note 14 – Paycheck Protection Program The CARES Act established the Paycheck Protection Program (PPP) administered by the U.S. Small Business Administration (SBA), which authorized forgivable loans to small businesses. Pursuant to the CARES Act, PPP loans will be fully forgiven if the funds are used for payroll costs, rent and utilities, subject to certain conditions, including maintaining employees and maintaining salary levels. In April 2020, the Company applied for a PPP loan and received funding of approximately $ 540,000 . The Company expended the funds received under the PPP in full on qualifying expenses, and maintained the conditions set forth by the PPP. The Company submitted its application for forgiveness in September 2020 and the SBA approved the forgiveness of the full amount of the loan and the related interest on November 10, 2020. For accounting purposes, the Company treated the PPP loan as a government grant. As a result, the Company recorded a reduction to selling, general and administrative expenses of approximately $ 420,000 and a reduction to payroll-related research and development expenses of approximately $ 120,000 related to these funds within the unaudited condensed consolidated statements of operations for the three and nine months ended June 30, 2020. |
Net (Loss) Income) Per Share
Net (Loss) Income) Per Share | 9 Months Ended |
Jun. 30, 2021 | |
Net (Loss) Income Per Share [Abstract] | |
Net Income (Loss) Per Share | Note 15 – Net (Loss) Income Per Share Basic net (loss) income per common share is computed by dividing net (loss) income by the weighted average number of common shares outstanding for the period. Diluted net (loss) income per share is computed by dividing net (loss) 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, stock appreciation rights and common stock purchase warrants as determined under the treasury stock method. The following table provides a reconciliation of the net (loss) income per basic and diluted common share outstanding: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Net (loss) income $ ( 2,692,866 ) $ ( 3,025,380 ) $ 11,688,854 $ ( 7,140,990 ) Basic weighted average common shares outstanding 79,729,370 66,728,782 75,054,871 65,709,139 Net effect of dilutive instruments: Stock options — — 7,208,123 — Stock appreciation rights — — 44,379 — Common stock purchase warrants — — 499,783 — Total net effect of dilutive instruments — — 7,752,285 — Diluted weighted average common shares outstanding 79,729,370 66,728,782 82,807,156 65,709,139 Net (loss) income per basic common share outstanding $ ( 0.03 ) $ ( 0.05 ) $ 0.16 $ ( 0.11 ) Net (loss) income per diluted common share outstanding $ ( 0.03 ) $ ( 0.05 ) $ 0.14 $ ( 0.11 ) For the nine months ended June 30, 2021, approximately 819,000 potentially dilutive instruments were excluded from the computation of net income per diluted weighted average common share outstanding because their effect would have been antidilutive. Due to our net loss for the three months ended June 30, 2021 and three and nine months ended June 30, 2020, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Notes 9 and 10 for a discussion of our potentially dilutive instruments. |
Industry Segments
Industry Segments | 9 Months Ended |
Jun. 30, 2021 | |
Industry Segments [Abstract] | |
Industry Segments | Note 16 – Industry Segments The Company currently operates in two reporting segments: Sexual Health Business and Research and Development . The Sexual Health Business segment consists of the Company’s commercial product, FC2. The Sexual Health Business also included PREBOOST® before the sale of the business in December 2020. The Research and Development segment consists of multiple drug products under clinical development. The Company’s Sexual Health Business segment will include any future revenues, cost of sales and selling expenses for TADFIN™, if approved. Costs associated with the development of TADFIN™ are currently included in the Research and Development segment. There are no significant inter-segment sales. We evaluate the performance of each segment based on operating profit or loss. There is no inter-segment allocation of non-operating expenses and income taxes. Our chief operating decision-maker (CODM) is Mitchell S. Steiner, M.D., our Chairman, President and Chief Executive Officer. The Company's operating (loss) income by segment was as follows: Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Sexual health business $ 12,960,770 $ 5,749,513 $ 32,804,711 $ 18,052,461 Research and development ( 11,362,155 ) ( 4,432,497 ) ( 24,962,340 ) ( 13,606,628 ) Corporate ( 4,470,479 ) ( 2,709,868 ) 7,001,512 ( 7,922,756 ) Operating (loss) income $ ( 2,871,864 ) $ ( 1,392,852 ) $ 14,843,883 $ ( 3,476,923 ) All of our net revenues, which are primarily derived from the sale of FC2, are attributed to the Sexual Health Business reporting segment. See Note 4 for additional information regarding our net revenues. Costs related to the office located in London, England are fully dedicated to FC2 and are presented as a component of the Sexual Health Business segment. Drug commercialization costs are included in the Research and Development segment. Certain expenses in the three and nine months ended June 30, 2020 have been reclassified to conform to the current period presentation. The gain on sale of the PREBOOST® business and depreciation and amortization related to long-lived assets that are not utilized in the production of FC2 are not reported as part of the reporting segments or reviewed by the CODM. These amounts are included in Corporate in the reconciliations above. Total assets are not presented by reporting segment as they are not reviewed by the CODM when evaluating the reporting segments’ performance. |
Basis of Presentation (Policy)
Basis of Presentation (Policy) | 9 Months Ended |
Jun. 30, 2021 | |
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 (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, 2020. The accompanying condensed consolidated balance sheet as of September 30, 2020 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations for the three and nine months ended June 30, 2021 and cash flows for the nine months ended June 30, 2021 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30 , 2021. 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, Aspen Park Pharmaceuticals, Inc. (APP) and The Female Health Company Limited, and 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”), and The Female Health Company (UK) plc’s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the “Malaysia subsidiary”). All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancers. The Company has multiple drug products under clinical development. During fiscal 2020, the Sexual Health Business segment also included PREBOOST® 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. The PREBOOST® business was sold on December 8, 2020. See Note 2 for additional information. Most of the Company’s net revenues during the three and nine months ended June 30, 2021 and 2020 were derived from sales of the FC2 Female Condom/FC2 Internal Condom® (FC2), an FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. |
Reclassifications | Reclassifications : Certain prior period amounts on the accompanying unaudited interim condensed consolidated financial statements have been reclassified to conform with the current period presentation. These reclassifications had no effect on the results of operations or financial position for any period presented. |
Other comprehensive income (loss) | Other comprehensive income (loss) : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net income (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 income (loss), are components of other comprehensive loss. For the three and nine months ended June 30, 2021 and 2020, comprehensive income (loss) is equivalent to the reported net income (loss). |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements : In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326). This ASU introduces a new accounting model, the Current Expected Credit Losses model (CECL), which could result in earlier recognition of credit losses and additional disclosures related to credit risk. The CECL model requires the Company to use a forward-looking expected credit loss impairment methodology for the recognition of credit losses for financial instruments at the time the financial asset is originated or acquired. The expected credit losses are adjusted each period for changes in expected lifetime credit losses. This model replaces the multiple existing impairment models in current U.S. GAAP, which generally require that a loss be incurred before it is recognized. The new standard also applies to receivables arising from revenue transactions such as accounts receivable. The Company adopted ASU 2016-13 on a modified-retrospective basis effective October 1, 2020. The adoption of ASU 2016-13 did not impact our consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other Topics (Topic 350): Simplifying the Test for Goodwill Impairment. The purpose of ASU 2017-04 is to reduce the cost and complexity of evaluating goodwill for impairment. It eliminates the need for entities to calculate the implied fair value of goodwill by assigning the fair value of a reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. Under this amendment, an entity will perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge is recognized for the amount by which the carrying value exceeds the reporting unit’s fair value. The Company adopted ASU 2017-04 on a prospective basis effective October 1, 2020. The adoption of ASU 2017-04 did not impact our consolidated financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Change to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 modifies the disclosure requirements by adding, removing, and modifying certain required disclosures for fair value measurements for assets and liabilities disclosed within the fair value hierarchy. The Company adopted ASU 2018-13 on a retrospective basis effective October 1, 2020. The adoption of ASU 2018-13 did not impact our financial position, results of operations, or cash flows as it modified disclosure requirements only. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Reconciliation of the Beginning and Ending Liability Balance | Nine Months Ended June 30, 2021 2020 Beginning balance $ 4,182,000 $ 3,625,000 Change in fair value of derivative liabilities 2,029,000 94,000 Ending balance $ 6,211,000 $ 3,719,000 |
Schedule of Qualitative Information | Weighted Average (range, if applicable) Valuation Methodology Significant Unobservable Input June 30, 2021 September 30, 2020 Monte Carlo Simulation Estimated change of control dates September 2022 to September 2025 December 2021 to June 2022 Discount rate 4.6 % to 7.9 % 14.1 % to 16.0 % Probability of change of control 20 % to 90 % 20 % to 90 % |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Customers by Products | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 FC2 U.S. prescription channel $ 13,501,862 $ 5,391,523 $ 32,916,343 $ 18,395,280 Global public health sector 4,153,730 4,254,197 11,833,894 11,197,635 Total FC2 17,655,592 9,645,720 44,750,237 29,592,915 PREBOOST® - 676,034 862,831 1,249,959 Net revenues $ 17,655,592 $ 10,321,754 $ 45,613,068 $ 30,842,874 |
Revenue by Geographic Area | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 United States $ 14,080,810 $ 6,396,762 $ 35,049,646 $ 20,575,515 South Africa * 1,182,225 * * Other 3,574,782 2,742,767 10,563,422 10,267,359 Net revenues $ 17,655,592 $ 10,321,754 $ 45,613,068 $ 30,842,874 * 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, 2021 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Components of Accounts Receivable | June 30, September 30, 2021 2020 Trade receivables, gross $ 8,441,224 $ 5,332,786 Less: allowance for doubtful accounts ( 22,643 ) ( 25,643 ) Less: allowance for sales returns and payment term discounts ( 105,038 ) ( 79,906 ) Accounts receivable, net $ 8,313,543 $ 5,227,237 |
Balance Sheet Information (Tabl
Balance Sheet Information (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Information [Abstract] | |
Components of Inventory | June 30, September 30, 2021 2020 FC2: Raw material $ 1,317,901 $ 962,860 Work in process 90,583 106,272 Finished goods 5,679,518 5,634,612 FC2, gross 7,088,002 6,703,744 Less: inventory reserves ( 142,086 ) ( 29,331 ) FC2, net 6,945,916 6,674,413 PREBOOST® Finished goods — 29,721 Inventory, net $ 6,945,916 $ 6,704,134 |
Summary of Plant and Equipment | Estimated June 30, September 30, Useful Life 2021 2020 Plant and equipment: Manufacturing equipment 5 - 8 years $ 2,770,149 $ 2,752,854 Office equipment, furniture and fixtures 3 - 10 years 903,400 803,484 Leasehold improvements 3 - 8 years 298,886 298,886 Total plant and equipment 3,972,435 3,855,224 Less: accumulated depreciation and amortization ( 3,580,423 ) ( 3,542,533 ) Plant and equipment, net $ 392,012 $ 312,691 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
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, 2021: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible asset with finite life: Covenants not-to-compete $ 500,000 $ 333,333 $ 166,667 Indefinite-lived intangible assets: Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 4,400,000 $ 333,333 $ 4,066,667 The gross carrying amounts and net book value of intangible assets were as follows at September 30, 2020: Gross Carrying Accumulated Net Book Amount Amortization Value Intangible assets with finite lives: Developed technology - PREBOOST ® $ 2,400,000 $ 768,111 $ 1,631,889 Covenants not-to-compete 500,000 279,762 220,238 Total intangible assets with finite lives 2,900,000 1,047,873 1,852,127 Acquired in-process research and development assets 3,900,000 — 3,900,000 Total intangible assets $ 6,800,000 $ 1,047,873 $ 5,752,127 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Debt [Abstract] | |
Credit Agreement | June 30, September 30, 2021 2020 Aggregate repayment obligation $ 17,650,000 $ 17,650,000 Less: cumulative payments ( 16,704,398 ) ( 10,314,495 ) Remaining repayment obligation 945,602 7,335,505 Less: unamortized discounts ( 59,291 ) ( 1,459,330 ) Less: unamortized deferred issuance costs ( 1,394 ) ( 34,301 ) Credit agreement liability $ 884,917 $ 5,841,874 |
Residual Royalty Agreement Liability | June 30, September 30, 2021 2020 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 4,485,000 2,189,687 Less: cumulative payments ( 261,984 ) — Residual royalty agreement liability, excluding embedded derivative liability 4,569,016 2,535,687 Add: embedded derivative liability at fair value (see Note 3) 6,211,000 4,182,000 Total residual royalty agreement liability 10,780,016 6,717,687 Residual royalty agreement liability, short-term portion ( 3,679,871 ) ( 1,100,193 ) Residual royalty agreement liability, long-term portion $ 7,100,145 $ 5,617,494 |
Credit Agreement Interest Expense | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Amortization of discounts $ 327,550 $ 782,169 $ 1,400,039 $ 2,488,747 Accretion of residual royalty agreement 952,276 369,138 2,295,313 928,835 Amortization of deferred issuance costs 7,699 18,385 32,907 58,497 Interest expense $ 1,287,525 $ 1,169,692 $ 3,728,259 $ 3,476,079 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Share-based Compensation [Abstract] | |
Recorded Share-Based Compensation Expenses | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Cost of sales $ 15,921 $ 7,743 $ 50,548 $ 38,713 Selling, general and administrative 1,444,145 490,647 2,719,232 1,442,970 Research and development 440,019 186,924 917,883 499,809 Share-based compensation $ 1,900,085 $ 685,314 $ 3,687,663 $ 1,981,492 |
Weighted Average Assumptions for Options Granted | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Weighted Average Assumptions: Expected volatility 78.53 % — 68.88 % 63.13 % Expected dividend yield 0.00 % — 0.00 % 0.00 % Risk-free interest rate 1.10 % — 0.64 % 1.63 % Expected term (in years) 6.0 — 5.9 5.9 Fair value of options granted $ 5.98 $ — $ 3.46 $ 1.14 |
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, 2020 8,599,000 $ 1.67 Granted 3,228,625 $ 5.47 Exercised ( 996,102 ) $ 1.54 Forfeited and expired ( 91,269 ) $ 1.74 Outstanding at June 30, 2021 10,740,254 $ 2.83 7.91 $ 60,768,816 Exercisable at June 30, 2021 5,933,601 $ 1.66 7.01 $ 38,057,411 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Components of Lease Cost | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets $ 2,178 $ 2,178 $ 6,535 $ 6,535 Interest on lease liabilities 611 1,238 2,327 4,097 Operating lease cost 136,140 124,326 408,079 378,006 Short-term lease cost 1,863 1,863 5,589 5,589 Variable lease cost 48,061 24,213 124,283 91,349 Sublease income ( 44,844 ) ( 45,382 ) ( 134,533 ) ( 135,071 ) Total lease cost $ 144,009 $ 108,436 $ 412,280 $ 350,505 |
Summary of Lease Information | June 30, September 30, 2021 2020 Operating Leases Weighted-average remaining lease term 3.1 3.6 Weighted-average discount rate 11.5 % 11.5 % Finance Leases Weighted-average remaining lease term 0.7 1.4 Weighted-average discount rate 13.9 % 13.9 % |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Income Taxes [Abstract] | |
Reconciliation of Income Tax Expense (Benefit) | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Income tax (benefit) expense at U.S. federal statutory rates $ ( 1,168,845 ) $ ( 584,825 ) $ 1,872,314 $ ( 1,493,179 ) State income tax (benefit) expense, net of federal (benefit) expense ( 90,502 ) ( 45,268 ) 144,971 ( 115,615 ) Non-deductible expenses ( 2,807 ) 332,230 ( 2,807 ) 335,869 Effect of stock options exercised 53,011 — — — Effect of common stock purchase warrants exercised — — ( 2,038,919 ) — Effect of Paycheck Protection Program funds 8,784 — ( 113,442 ) — U.S. research and development tax credit ( 919,415 ) — ( 919,415 ) — Effect of foreign income tax rates ( 3,716,935 ) ( 16,478 ) ( 3,744,512 ) 49,908 Effect of global intangible low taxed income 78,626 85,522 148,383 101,642 Change in valuation allowance 2,834,482 415,449 1,828,730 1,097,900 Other, net 50,538 53,872 51,626 54,094 Income tax (benefit) expense $ ( 2,873,063 ) $ 240,502 $ ( 2,773,071 ) $ 30,619 |
Significant Components of Deferred Tax Assets and Liabilities | June 30, September 30, 2021 2020 Deferred tax assets: Federal net operating loss carryforwards $ 8,269,223 $ 8,759,589 State net operating loss carryforwards 1,647,082 1,682,104 Foreign net operating loss carryforwards – U.K. 15,259,909 11,655,853 Foreign capital allowance – U.K. 149,371 113,522 U.S. research and development tax credit carryforwards 919,415 — Share-based compensation 770,598 1,255,983 Interest expense 1,165,193 850,248 Change in fair value of derivative liabilities 654,354 195,265 Other, net – U.K. 123,341 93,739 Other, net – U.S. 187,644 179,677 Gross deferred tax assets 29,146,130 24,785,980 Valuation allowance for deferred tax assets ( 15,903,470 ) ( 14,074,740 ) Net deferred tax assets 13,242,660 10,711,240 Deferred tax liabilities: In-process research and development ( 882,427 ) ( 882,427 ) Developed technology — ( 369,237 ) Covenant not-to-compete ( 37,711 ) ( 49,832 ) Other, net – Malaysia ( 11,297 ) ( 11,297 ) Other, net – U.S. ( 6,371 ) ( 6,371 ) Net deferred tax liabilities ( 937,806 ) ( 1,319,164 ) Net deferred tax asset $ 12,304,854 $ 9,392,076 |
Schedule of Deferred Tax Amounts Classified in Balance Sheets | June 30, September 30, 2021 2020 Deferred tax asset – U.K. $ 12,379,578 $ 9,466,800 Total deferred tax asset $ 12,379,578 $ 9,466,800 Deferred tax liability – U.S. $ ( 63,427 ) $ ( 63,427 ) Deferred tax liability – Malaysia ( 11,297 ) ( 11,297 ) Total deferred tax liability $ ( 74,724 ) $ ( 74,724 ) |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Net (Loss) Income Per Share [Abstract] | |
Schedule Of Earnings Per Share, Basic And Diluted | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Net (loss) income $ ( 2,692,866 ) $ ( 3,025,380 ) $ 11,688,854 $ ( 7,140,990 ) Basic weighted average common shares outstanding 79,729,370 66,728,782 75,054,871 65,709,139 Net effect of dilutive instruments: Stock options — — 7,208,123 — Stock appreciation rights — — 44,379 — Common stock purchase warrants — — 499,783 — Total net effect of dilutive instruments — — 7,752,285 — Diluted weighted average common shares outstanding 79,729,370 66,728,782 82,807,156 65,709,139 Net (loss) income per basic common share outstanding $ ( 0.03 ) $ ( 0.05 ) $ 0.16 $ ( 0.11 ) Net (loss) income per diluted common share outstanding $ ( 0.03 ) $ ( 0.05 ) $ 0.14 $ ( 0.11 ) |
Industry Segments (Tables)
Industry Segments (Tables) | 9 Months Ended |
Jun. 30, 2021 | |
Industry Segments [Abstract] | |
Schedule of Segment Reporting Information | Three Months Ended Nine Months Ended June 30, June 30, 2021 2020 2021 2020 Sexual health business $ 12,960,770 $ 5,749,513 $ 32,804,711 $ 18,052,461 Research and development ( 11,362,155 ) ( 4,432,497 ) ( 24,962,340 ) ( 13,606,628 ) Corporate ( 4,470,479 ) ( 2,709,868 ) 7,001,512 ( 7,922,756 ) Operating (loss) income $ ( 2,871,864 ) $ ( 1,392,852 ) $ 14,843,883 $ ( 3,476,923 ) |
Sale of PREBOOST Business (Narr
Sale of PREBOOST Business (Narrative) (Details) - USD ($) | Dec. 08, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Cash proceeds | $ 15,000,000 | ||||
Pre-tax gain | 18,410,158 | ||||
Income before income taxes | $ (5,565,929) | $ (2,784,878) | $ 8,915,783 | $ (7,110,371) | |
PREBOOST [Member] | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Purchase price | $ 20,000,000 | ||||
Cash proceeds | 15,000,000 | ||||
Purchase price receivable, payment one | 2,500,000 | ||||
Purchase price receivable, period payable, payment one | 12 months | ||||
Purchase price receivable, payment two | 2,500,000 | ||||
Purchase price receivable, period payable, payment two | 18 months | ||||
Net book value | 1,600,000 | ||||
Pre-tax gain | $ 18,400,000 | ||||
Income before income taxes | $ 450,000 | $ 327,000 | $ 729,000 |
Fair Value Measurements (Reconc
Fair Value Measurements (Reconciliation of the Beginning and Ending Liability Balance) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Fair Value Measurements [Abstract] | ||
Beginning balance | $ 4,182,000 | $ 3,625,000 |
Change in fair value of derivative liabilities | 2,029,000 | 94,000 |
Ending balance | $ 6,211,000 | $ 3,719,000 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Qualitative Information) (Details) - item | 9 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Sep. 30, 2020 | |
Minimum [Member] | Estimated Change Of Control Dates [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | Sep. 1, 2022 | Dec. 1, 2021 |
Minimum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 4.6 | 14.1 |
Minimum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 20 | 20 |
Maximum [Member] | Estimated Change Of Control Dates [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | Sep. 1, 2025 | Jun. 1, 2022 |
Maximum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 7.9 | 16 |
Maximum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Significant unobservable input | 90 | 90 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Narrative) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Revenue from Contracts with Customers [Abstract] | ||
Contract liability | $ 699,000 | $ 6,000 |
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue, Major Customer [Line Items] | ||||
Revenues | $ 17,655,592 | $ 10,321,754 | $ 45,613,068 | $ 30,842,874 |
FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 17,655,592 | 9,645,720 | 44,750,237 | 29,592,915 |
PREBOOST Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 676,034 | 862,831 | 1,249,959 | |
U.S. Prescription Channel Segment [Member] | FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 13,501,862 | 5,391,523 | 32,916,343 | 18,395,280 |
Global Public Health Sector [Member] | FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | $ 4,153,730 | $ 4,254,197 | $ 11,833,894 | $ 11,197,635 |
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||
Revenues | $ 17,655,592 | $ 10,321,754 | $ 45,613,068 | $ 30,842,874 | |||
United States [Member] | |||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||
Revenues | 14,080,810 | 6,396,762 | 35,049,646 | 20,575,515 | |||
South Africa [Member] | |||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||
Revenues | [1] | 1,182,225 | [1] | [1] | |||
Other Countries [Member] | |||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||
Revenues | $ 3,574,782 | $ 2,742,767 | $ 10,563,422 | $ 10,267,359 | |||
Maximum [Member] | |||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||
Percent of revenue benchmark | 10.00% | 10.00% | 10.00% | ||||
[1] | Less than 10 % of total net revenues and included in Other |
Accounts Receivable and Conce_3
Accounts Receivable and Concentration of Credit Risk (Narrative) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2021customer | Jun. 30, 2020customer | Jun. 30, 2021USD ($)customer | Jun. 30, 2020USD ($)item | Sep. 30, 2020customer | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Change in allowance for doubtful accounts | $ | $ 0 | $ 0 | |||
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 | ||||
Assets, Current [Member] | Customer Concentration Risk [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Number of customers | 0 | 0 | |||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Number of customers | 3 | 3 | |||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Concentration risk, percentage | 90.00% | 89.00% | |||
Total Revenue [Member] | Customer Concentration Risk [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Number of customers | 2 | 3 | 2 | 3 | |
Total Revenue [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Concentration risk, percentage | 72.00% | ||||
Total Revenue [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Concentration risk, percentage | 75.00% | 71.00% | 74.00% | ||
Brazil [Member] | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Credit terms | 90 days |
Accounts Receivable and Conce_4
Accounts Receivable and Concentration of Credit Risk (Components of Accounts Receivable) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||
Trade receivables, gross | $ 8,441,224 | $ 5,332,786 |
Less: allowance for doubtful accounts | (22,643) | (25,643) |
Less: allowance for sales returns and payment term discounts | (105,038) | (79,906) |
Accounts receivable, net | $ 8,313,543 | $ 5,227,237 |
Balance Sheet Information (Comp
Balance Sheet Information (Components Of Inventory) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Inventory [Line Items] | ||
Inventory, net | $ 6,945,916 | $ 6,704,134 |
FC2 [Member] | ||
Inventory [Line Items] | ||
Raw material | 1,317,901 | 962,860 |
Work in process | 90,583 | 106,272 |
Finished goods | 5,679,518 | 5,634,612 |
Inventory, gross | 7,088,002 | 6,703,744 |
Less: inventory reserves | (142,086) | (29,331) |
Inventory, net | 6,945,916 | 6,674,413 |
PREBOOST [Member] | ||
Inventory [Line Items] | ||
Finished goods | 29,721 | |
Inventory, net | $ 6,945,916 | $ 6,704,134 |
Balance Sheet Information (Summ
Balance Sheet Information (Summary of Plant and Equipment) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2021 | Sep. 30, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 3,972,435 | $ 3,855,224 |
Less: accumulated depreciation and amortization | (3,580,423) | (3,542,533) |
Plant and equipment, net | 392,012 | 312,691 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total plant and equipment | $ 2,770,149 | 2,752,854 |
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 | $ 903,400 | 803,484 |
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 | $ 298,886 | $ 298,886 |
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 08, 2020 | Sep. 30, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Amortization expense | $ 18,000 | $ 79,000 | $ 96,000 | $ 237,000 | ||
Goodwill | $ 6,878,932 | 6,878,932 | $ 6,878,932 | |||
Change in goodwill | $ 0 | $ 0 | ||||
Intangible assets, net book value | 1,852,127 | |||||
Developed Technology - PREBOOST [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Intangible assets, net book value | $ 1,600,000 | $ 1,631,889 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Gross Carrying Amounts and Net Book Value of Intangible Assets) (Details) - USD ($) | Jun. 30, 2021 | Dec. 08, 2020 | Sep. 30, 2020 |
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets with finite life, Gross Carrying Amount | $ 2,900,000 | ||
Intangible assets with finite life, Accumulated Amortization | $ 333,333 | 1,047,873 | |
Indefinite-lived intangible assets, Net Book Value | 1,852,127 | ||
Total intangible assets, Gross Carrying Amount | 4,400,000 | 6,800,000 | |
Total intangible assets, Net Book Value | 4,066,667 | 5,752,127 | |
Acquired In-Process Research And Development Assets [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Indefinite-lived intangible assets, Net Book Value | 3,900,000 | 3,900,000 | |
Developed Technology - PREBOOST [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets with finite life, Gross Carrying Amount | 2,400,000 | ||
Intangible assets with finite life, Accumulated Amortization | 768,111 | ||
Indefinite-lived intangible assets, Net Book Value | $ 1,600,000 | 1,631,889 | |
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 | 333,333 | 279,762 | |
Indefinite-lived intangible assets, Net Book Value | $ 166,667 | $ 220,238 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Nov. 01, 2020USD ($)item | Nov. 01, 2019USD ($)item | Mar. 05, 2018USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2021USD ($)item | Jun. 30, 2020USD ($) |
Line of Credit Facility [Line Items] | ||||||
Payments on notes payable | $ 1,061,442 | $ 555,920 | ||||
SWK Credit Agreement [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Loan amount | $ 10,000,000 | $ 17,650,000 | $ 17,650,000 | |||
Repayment percentage | 176.50% | |||||
Payment terms, product revenue threshold | $ 10,000,000 | |||||
Percentage of outstanding shares acquired which constitutes a change of control | 50.00% | |||||
Period to replace key persons | 90 days | |||||
Required minimum liquid assets | $ 1,000,000 | |||||
Pledge percentage | 65.00% | |||||
Net proceeds after fees and expenses | $ 9,900,000 | |||||
Deferred loan issuance costs | $ 267,000 | |||||
Payments on notes payable | 10,000,000 | |||||
SWK Credit Agreement [Member] | Product Revenue Under $10 Million [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, period of revenue calculation | 12 months | |||||
Payment terms, payment percentage | 32.50% | |||||
SWK Credit Agreement [Member] | Product Revenue Over $10 Million [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, period of revenue calculation | 12 months | |||||
SWK Credit Agreement [Member] | Product Revenue Over $10 Million, 2019 [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, payment percentage | 12.50% | |||||
Payment terms, percentage of product revenue after initial threshold | 5.00% | |||||
SWK Credit Agreement [Member] | Product Revenue Over $10 Million, 2020 [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, payment percentage | 25.00% | |||||
Payment terms, elapsed period payment threshold | $ 12,500,000 | |||||
Payment terms, percentage of product revenue after initial threshold | 10.00% | |||||
SWK Credit Agreement [Member] | Product Revenue Over $10 Million, 2021 [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, payment percentage | 30.00% | |||||
Payment terms, elapsed period payment threshold | $ 12,500,000 | |||||
Payment terms, percentage of product revenue after initial threshold | 20.00% | |||||
SWK Credit Agreement [Member] | Change In Control Or Sale Of Business [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Repayment percentage | 176.50% | |||||
Payment terms, period of revenue calculation | 12 months | |||||
Payment terms, payment percentage | 5.00% | |||||
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 multiple | item | 5 | |||||
Residual Royalty Agreement [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, period of revenue calculation | 12 months | |||||
Payment terms, payment percentage | 5.00% | |||||
Payment terms, percentage of advanced amount to be repaid before regular royalty payment | 175.00% | |||||
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 | 5.00% | |||||
Payment terms, change in control or sale of business fee, percentage multiple | item | 5 | |||||
Premium Finance Agreement [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Loan amount | $ 1,100,000 | $ 837,000 | ||||
Interest rate | 3.94% | 4.18% | ||||
Number of installments | item | 3 | 3 | ||||
Loan payable | $ 0 | $ 0 | ||||
Maximum [Member] | SWK Credit Agreement [Member] | Product Revenue Over $10 Million, 2019 [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Payment terms, elapsed period payment threshold | $ 12,500,000 |
Debt (Credit Agreement) (Detail
Debt (Credit Agreement) (Details) - SWK Credit Agreement [Member] - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 | Mar. 05, 2018 |
Line of Credit Facility [Line Items] | |||
Aggregate repayment obligation | $ 17,650,000 | $ 17,650,000 | $ 10,000,000 |
Less: cumulative payments | (16,704,398) | (10,314,495) | |
Remaining repayment obligation | 945,602 | 7,335,505 | |
Less: unamortized discounts | (59,291) | (1,459,330) | |
Less: unamortized deferred issuance costs | (1,394) | (34,301) | |
Credit agreement liability | $ 884,917 | $ 5,841,874 |
Debt (Residual Royalty Agreemen
Debt (Residual Royalty Agreement Liability) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Residual Royalty Agreement Disclosures [Line Items] | ||
Residual royalty agreement liability, short-term portion | $ (3,679,871) | $ (1,100,193) |
Residual royalty agreement liability, long-term portion | 7,100,145 | 5,617,494 |
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 | 4,485,000 | 2,189,687 |
Less: cumulative payments | (261,984) | |
Residual royalty agreement liability, excluding embedded derivative liability | 4,569,016 | 2,535,687 |
Add: embedded derivative liability at fair value (see Note 3) | 6,211,000 | 4,182,000 |
Total residual royalty agreement liability | 10,780,016 | 6,717,687 |
Residual royalty agreement liability, short-term portion | (3,679,871) | (1,100,193) |
Residual royalty agreement liability, long-term portion | $ 7,100,145 | $ 5,617,494 |
Debt (Credit Agreement Interest
Debt (Credit Agreement Interest Expense) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Debt [Abstract] | ||||
Amortization of discounts | $ 327,550 | $ 782,169 | $ 1,400,039 | $ 2,488,747 |
Accretion of residual royalty agreement | 952,276 | 369,138 | 2,295,313 | 928,835 |
Amortization of deferred issuance costs | 7,699 | 18,385 | 32,907 | 58,497 |
Interest expense | $ 1,287,525 | $ 1,169,692 | $ 3,728,259 | $ 3,476,079 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) | Feb. 22, 2021USD ($)$ / sharesshares | Jun. 26, 2020USD ($)shares | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)shares / d$ / sharesshares | Jun. 30, 2021USD ($)shares / d$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Oct. 31, 2016shares |
Class of Stock [Line Items] | |||||||
Preferred stock, issued | 0 | 0 | 0 | ||||
Preferred stock, outstanding | 0 | 0 | 0 | ||||
Shares issued | 7,419,354 | ||||||
Stock issuance price | $ / shares | $ 15.50 | ||||||
Proceeds from sale of shares in public offering, net of fees | $ | $ 107,900,000 | $ 108,099,988 | |||||
Common Stock, shares outstanding | 79,853,748 | 79,853,748 | 69,863,681 | ||||
Value of shares issued for services | $ | $ 680,937 | ||||||
Aspire Capital Purchase Agreement, 2020 [Member] | |||||||
Class of Stock [Line Items] | |||||||
Stock issuance price | $ / shares | $ 0.50 | $ 0.50 | |||||
Proceeds from sale of shares in public offering, net of fees | $ | $ 5,000,000 | ||||||
Stock purchase agreement, term | 36 months | ||||||
Stock purchase agreement, aggregate amount of stock purchase authorized | $ | $ 23,900,000 | ||||||
Maximum purchase of shares per business day | shares / d | 200,000 | 200,000 | |||||
Maximum VWAP percentage | 30.00% | ||||||
General percentage of VWAP pursuant to notice | 97.00% | ||||||
Common Stock, shares outstanding | 1,644,737 | 1,644,737 | |||||
Remaining amount authorized | $ | $ 18,900,000 | $ 18,900,000 | |||||
Shares issued in connection with common purchase agreement (in Shares) | 212,130 | ||||||
Value of shares issued for services | $ | $ 681,000 | ||||||
Related expenses | $ | 50,000 | ||||||
Deferred costs | $ | $ 731,000 | ||||||
Unamortized deferred assets | $ | $ 578,000 | $ 578,000 | $ 578,000 | ||||
Financial Advisor Warrant [Member] | |||||||
Class of Stock [Line Items] | |||||||
Warrant to purchase common stock shares | 2,326,841 | 2,326,841 | 2,585,379 | ||||
Warrant term | 5 years | ||||||
Warrant exercise price | $ / shares | $ 1.93 | $ 1.93 | |||||
Warrants outstanding | 0 | 0 | 2,326,841 | ||||
Issuance of shares pursuant to common stock purchase warrants | 1,574,611 | ||||||
Preferred Class A [Member] | |||||||
Class of Stock [Line Items] | |||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | ||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Preferred stock, issued | 0 | 0 | 0 | ||||
Preferred stock, outstanding | 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 | ||||
Preferred Class A Series 2 [Member] | |||||||
Class of Stock [Line Items] | |||||||
Preferred stock, shares authorized | 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 | ||||
Preferred Class A Series 4 [Member] | |||||||
Class of Stock [Line Items] | |||||||
Preferred stock, shares authorized | 548,000 | 548,000 | |||||
Preferred Class B [Member] | |||||||
Class of Stock [Line Items] | |||||||
Preferred stock, shares authorized | 15,000 | 15,000 | 15,000 | ||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.50 | $ 0.50 | $ 0.50 | ||||
Preferred stock, issued | 0 | 0 | 0 | ||||
Preferred stock, outstanding | 0 | 0 | 0 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jul. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option conversion ratio | 100.00% | ||||
Proceeds from stock option exercises | $ 1,538,147 | $ 415,464 | |||
Cashless options, exercises in period | 0 | ||||
Expense recognized | $ 1,900,085 | $ 685,314 | $ 3,687,663 | 1,981,492 | |
Outside Directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expense recognized | $ 536,000 | $ 536,000 | |||
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 3 years | ||||
Share price | $ 8.07 | $ 8.07 | |||
Options, exercises in period, intrinsic value | $ 8,300,000 | $ 1,100,000 | |||
Issuance of common stock upon cashless exercise of options | 143,958 | ||||
Cashless options, exercises in period | 223,415 | ||||
Unrecognized compensation expense, stock options | $ 10,600,000 | $ 10,600,000 | |||
Unrecognized compensation expense, period for recognition | 1 year 9 months 18 days | ||||
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] | |||||
Award term | 10 years | ||||
Exercise price per share | $ 0.95 | $ 0.95 | |||
Vested shares | 50,000 | 50,000 | |||
Stock Appreciation Rights (SARs) [Member] | The APP Merger [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vest date | Oct. 31, 2018 | ||||
Stock Appreciation Rights (SARs) [Member] | Employee [Member] | The APP Merger [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares issued | 50,000 | ||||
Stock Appreciation Rights (SARs) [Member] | Outside Directors [Member] | The APP Merger [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 | 18,433 | 18,433 | |||
2018 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized | 11,000,000 | 11,000,000 | |||
Number of shares available | 2,848,780 | 2,848,780 |
Share-based Compensation (Recor
Share-based Compensation (Recorded Share-Based Compensation Expenses) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 1,900,085 | $ 685,314 | $ 3,687,663 | $ 1,981,492 |
Cost of Sales [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 15,921 | 7,743 | 50,548 | 38,713 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 1,444,145 | 490,647 | 2,719,232 | 1,442,970 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 440,019 | $ 186,924 | $ 917,883 | $ 499,809 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted Average Assumptions for Options Granted) (Details) - Stock Option [Member] - $ / shares | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 78.53% | 68.88% | 63.13% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate | 1.10% | 0.64% | 1.63% |
Expected term (in years) | 6 years | 5 years 10 months 24 days | 5 years 10 months 24 days |
Fair value of options granted | $ 5.98 | $ 3.46 | $ 1.14 |
Share-based Compensation (Summa
Share-based Compensation (Summary of Stock Options Outstanding and Exercisable) (Details) - Stock Option [Member] - USD ($) | 9 Months Ended |
Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Outstanding at Beginning of Period | 8,599,000 |
Number of Shares Granted | 3,228,625 |
Number of Shares Exercised | (996,102) |
Number of Shares Forfeited and expired | (91,269) |
Number of Shares Outstanding at End of Period | 10,740,254 |
Number of Shares Exercisable at End of Period | 5,933,601 |
Weighted Average Exercise Price Per Share, Outstanding at Beginning of Period | $ 1.67 |
Weighted Average Exercise Price Per Share, Granted | 5.47 |
Weighted Average Exercise Price Per Share, Exercised | 1.54 |
Weighted Average Exercise Price Per Share, Forfeited and expired | 1.74 |
Weighted Average Exercise Price Per Share, Outstanding at End of Period | 2.83 |
Weighted Average Exercise Price Per Share, Exercisable at End of Period | $ 1.66 |
Weighted Average Remaining Contractual Term, Outstanding at End of Period | 7 years 10 months 28 days |
Weighted Average Remaining Contractual Term, Exercisable at End of Period | 7 years 3 days |
Aggregate Intrinsic Value Outstanding at End of Period | $ 60,768,816 |
Aggregate Intrinsic Value Exercisable at End of Period | $ 38,057,411 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) | Mar. 01, 2022ft²$ / ft² | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) |
Operating Leased Assets [Line Items] | |||
Security deposit | $ 117,000 | ||
Operating lease payments | $ 497,000 | $ 350,000 | |
Scenario, Forecast [Member] | |||
Operating Leased Assets [Line Items] | |||
Area of real estate property | ft² | 12,000 | ||
Operating lease term | 8 years | ||
Annual base rent escalation | 3.00% | ||
Base rent amount per square foot | $ / ft² | 58 | ||
Minimum [Member] | |||
Operating Leased Assets [Line Items] | |||
Remaining term of leases | 1 year | ||
Maximum [Member] | |||
Operating Leased Assets [Line Items] | |||
Remaining term of leases | 5 years |
Leases (Components of Lease Cos
Leases (Components of Lease Cost) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Finance lease cost: Amortization of right-of-use assets | $ 2,178 | $ 2,178 | $ 6,535 | $ 6,535 |
Finance lease cost: Interest on lease liabilities | 611 | 1,238 | 2,327 | 4,097 |
Operating lease cost | 136,140 | 124,326 | 408,079 | 378,006 |
Short-term lease cost | 1,863 | 1,863 | 5,589 | 5,589 |
Variable lease cost | 48,061 | 24,213 | 124,283 | 91,349 |
Sublease income | (44,844) | (45,382) | (134,533) | (135,071) |
Total lease cost | $ 144,009 | $ 108,436 | $ 412,280 | $ 350,505 |
Leases (Summary of Lease Inform
Leases (Summary of Lease Information) (Details) | Jun. 30, 2021 | Sep. 30, 2020 |
Leases [Abstract] | ||
Operating Leases, Weighted-average remaining lease term | 3 years 1 month 6 days | 3 years 7 months 6 days |
Operating Leases, Weighted-average discount rate | 11.50% | 11.50% |
Finance Leases, Weighted-average remaining lease term | 8 months 12 days | 1 year 4 months 24 days |
Finance Leases, Weighted-average discount rate | 13.90% | 13.90% |
Contingent Liabilities (Narrati
Contingent Liabilities (Narrative) (Details) $ in Millions | Jun. 30, 2021USD ($) |
Contingent Liabilities [Abstract] | |
Product liability insurance, coverage amount | $ 20 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | Apr. 01, 2023 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Sep. 30, 2020 |
Income Tax Expense (Benefit) [Line Items] | ||||||
Corporate income tax rate | 21.00% | |||||
Income tax benefit | $ 2,873,063 | $ (240,502) | $ 2,773,071 | $ (30,619) | ||
Tax Rate, Income tax benefit at U.S. federal statutory rates | 21.00% | |||||
United Kingdom [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Corporate income tax rate | 19.00% | |||||
Tax Rate, Income tax benefit at U.S. federal statutory rates | 19.00% | |||||
Scenario, Forecast [Member] | United Kingdom [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Corporate income tax rate | 25.00% | |||||
Tax Rate, Income tax benefit at U.S. federal statutory rates | 25.00% | |||||
Minimum [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards, expiration date | Dec. 31, 2022 | |||||
Maximum [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards, expiration date | Dec. 31, 2040 | |||||
Domestic [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | $ 42,000,000 | |||||
Domestic [Member] | 2022 to 2040 [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 13,800,000 | |||||
Domestic [Member] | Indefinite [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 28,200,000 | |||||
Domestic [Member] | Expiring 2040 [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Tax credit carryforward | 900,000 | |||||
State [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 25,600,000 | |||||
State [Member] | 2022 to 2040 [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 19,800,000 | |||||
State [Member] | Indefinite [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | 5,800,000 | |||||
Foreign [Member] | Indefinite [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Operating loss carryforwards | $ 61,300,000 | |||||
U.K. [Member] | Enacted U.K. Tax Rate Increase [Member] | ||||||
Income Tax Expense (Benefit) [Line Items] | ||||||
Change in valuation allowance | 800,000 | $ 800,000 | ||||
Increase in deferred tax assets | 3,700,000 | 3,700,000 | ||||
Income tax benefit | $ 3,000,000 | $ 3,000,000 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Income Tax Expense (Benefit)) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Tax Expense (Benefit) [Line Items] | ||||
Income tax (benefit) expense at U.S. federal statutory rates | $ (1,168,845) | $ (584,825) | $ 1,872,314 | $ (1,493,179) |
State income tax (benefit) expense, net of federal (benefit) expense | (90,502) | (45,268) | 144,971 | (115,615) |
Non-deductible expenses | (2,807) | 332,230 | (2,807) | 335,869 |
Effect of stock options exercised | 53,011 | |||
Effect of common stock purchase warrants exercised | (2,038,919) | |||
Effect of Paycheck Protection Program funds | 8,784 | (113,442) | ||
U.S. research and development tax credit | (919,415) | (919,415) | ||
Effect of foreign income tax rates | (3,716,935) | (16,478) | (3,744,512) | 49,908 |
Effect of global intangible low taxed income | 78,626 | 85,522 | 148,383 | 101,642 |
Change in valuation allowance | 2,834,482 | 415,449 | 1,828,730 | 1,097,900 |
Other, net | 50,538 | 53,872 | 51,626 | 54,094 |
Income tax (benefit) expense | $ (2,873,063) | $ 240,502 | $ (2,773,071) | $ 30,619 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Federal net operating loss carryforwards | $ 8,269,223 | $ 8,759,589 |
State net operating loss carryforwards | 1,647,082 | 1,682,104 |
Foreign net operating loss carryforwards - U.K. | 15,259,909 | 11,655,853 |
Foreign capital allowance - U.K. | 149,371 | 113,522 |
U.S. research and development tax credit carryforwards | 919,415 | |
Share-based compensation | 770,598 | 1,255,983 |
Interest expense | 1,165,193 | 850,248 |
Change in fair value of derivative liabilities | 654,354 | 195,265 |
Gross deferred tax assets | 29,146,130 | 24,785,980 |
Valuation allowance for deferred tax assets | (15,903,470) | (14,074,740) |
Net deferred tax assets | 13,242,660 | 10,711,240 |
Deferred tax liabilities: | ||
In-process research and development | (882,427) | (882,427) |
Developed technology | (369,237) | |
Covenant not-to-compete | (37,711) | (49,832) |
Net deferred tax liabilities | (937,806) | (1,319,164) |
Net deferred tax asset | 12,304,854 | 9,392,076 |
Malaysia [Member] | ||
Deferred tax liabilities: | ||
Other, net | (11,297) | (11,297) |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 187,644 | 179,677 |
Deferred tax liabilities: | ||
Other, net | (6,371) | (6,371) |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | $ 123,341 | $ 93,739 |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Amounts Classified in Balance Sheets) (Details) - USD ($) | Jun. 30, 2021 | Sep. 30, 2020 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 12,379,578 | $ 9,466,800 |
Deferred tax liability | (74,724) | (74,724) |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | 12,379,578 | 9,466,800 |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax liability | (63,427) | (63,427) |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax liability | $ (11,297) | $ (11,297) |
Paycheck Protection Program (Na
Paycheck Protection Program (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Apr. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2020 | |
Paycheck Protection Program [Abstract] | |||
Proceeds from PPP loan | $ 540,000 | ||
Reduction of selling general and administrative expense | $ 420,000 | $ 420,000 | |
Reduction of research and development expense | $ 120,000 | $ 120,000 |
Net (Loss) Income Per Share (Na
Net (Loss) Income Per Share (Narrative) (Details) | 9 Months Ended |
Jun. 30, 2021shares | |
Net (Loss) Income Per Share [Abstract] | |
Anti-dilutive shares | 819,000 |
Net (Loss) Income Per Share (Sc
Net (Loss) Income Per Share (Schedule Of Earnings Per Share, Basic And Diluted) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | |
Schedule of Earnings Per Share, Basic and Diluted [Line Items] | ||||||||
Net (loss) income | $ (2,692,866) | $ (2,845,981) | $ 17,227,701 | $ (3,025,380) | $ (810,509) | $ (3,305,101) | $ 11,688,854 | $ (7,140,990) |
Basic weighted average common shares outstanding | 79,729,370 | 66,728,782 | 75,054,871 | 65,709,139 | ||||
Common stock purchase warrants | 499,783 | |||||||
Total net effect of dilutive instruments | 7,752,285 | |||||||
Diluted weighted average common shares outstanding | 79,729,370 | 66,728,782 | 82,807,156 | 65,709,139 | ||||
Net (loss) income per basic common share outstanding | $ (0.03) | $ (0.05) | $ 0.16 | $ (0.11) | ||||
Net (loss) income per diluted common share outstanding | $ (0.03) | $ (0.05) | $ 0.14 | $ (0.11) | ||||
Stock Options [Member] | ||||||||
Schedule of Earnings Per Share, Basic and Diluted [Line Items] | ||||||||
Net effect of dilutive instruments | 7,208,123 | |||||||
Stock Appreciation Rights (SARs) [Member] | ||||||||
Schedule of Earnings Per Share, Basic and Diluted [Line Items] | ||||||||
Net effect of dilutive instruments | 44,379 |
Industry Segments (Narrative) (
Industry Segments (Narrative) (Details) | 9 Months Ended |
Jun. 30, 2021segment | |
Industry Segments [Abstract] | |
Number of reportable segments | 2 |
Industry Segments (Schedule of
Industry Segments (Schedule of Segment Reporting Information) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Segment Reporting Information [Line Items] | ||||
Operating (loss) income | $ (2,871,864) | $ (1,392,852) | $ 14,843,883 | $ (3,476,923) |
Operating Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating (loss) income | (2,871,864) | (1,392,852) | 14,843,883 | (3,476,923) |
Sexual Health Business [Member] | Operating Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating (loss) income | 12,960,770 | 5,749,513 | 32,804,711 | 18,052,461 |
Research and Development [Member] | Operating Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating (loss) income | (11,362,155) | (4,432,497) | (24,962,340) | (13,606,628) |
Corporate [Member] | Operating Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating (loss) income | $ (4,470,479) | $ (2,709,868) | $ 7,001,512 | $ (7,922,756) |