Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2019 | Aug. 05, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Entity Registrant Name | VERU INC. | |
Entity Central Index Key | 0000863894 | |
Current Fiscal Year End Date | --09-30 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | veru | |
Entity Common Stock, Shares Outstanding | 65,038,247 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Current assets: | ||
Cash | $ 8,039,116 | $ 3,759,509 |
Accounts receivable, net | 4,766,962 | 3,972,632 |
Inventory, net | 3,130,720 | 2,302,030 |
Prepaid expenses and other current assets | 1,206,003 | 1,148,345 |
Total current assets | 17,142,801 | 11,182,516 |
Plant and equipment, net | 314,690 | 404,552 |
Deferred income taxes | 8,574,448 | 8,543,758 |
Intangible assets, net | 20,245,803 | 20,477,729 |
Goodwill | 6,878,932 | 6,878,932 |
Other assets | 684,091 | 965,152 |
Total assets | 53,840,765 | 48,452,639 |
Current liabilities: | ||
Accounts payable | 3,134,795 | 3,226,036 |
Accrued research and development costs | 1,464,298 | 981,357 |
Accrued expenses and other current liabilities | 2,403,620 | 2,465,657 |
Credit agreement, short-term portion (Note 8) | 4,660,572 | 6,692,718 |
Unearned revenue | 187,159 | |
Total current liabilities | 11,663,285 | 13,552,927 |
Credit agreement, long-term portion (Note 8) | 4,489,540 | 2,701,570 |
Residual royalty agreement (Note 8) | 1,824,745 | 1,753,805 |
Deferred income taxes | 895,861 | 844,758 |
Deferred rent | 201,167 | 88,161 |
Other liabilities | 30,000 | 30,000 |
Total liabilities | 19,104,598 | 18,971,221 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred stock; no shares issued and outstanding at June 30, 2019 and September 30,2018 | ||
Common stock, par value $0.01 per share; 154,000,000 and 77,000,000 shares authorized, 67,002,483 and 57,468,660 shares issued and 64,818,779 and 55,284,956 shares outstanding at June 30, 2019 and September 30, 2018, respectively | 670,025 | 574,687 |
Additional paid-in-capital | 109,612,826 | 95,496,506 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (67,158,560) | (58,201,651) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 34,736,167 | 29,481,418 |
Total liabilities and stockholders' equity | $ 53,840,765 | $ 48,452,639 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2019 | Sep. 30, 2018 |
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 | 77,000,000 |
Common Stock, shares issued | 67,002,483 | 57,468,660 |
Common Stock, shares outstanding | 64,818,779 | 55,284,956 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Condensed Consolidated Statements Of Operations [Abstract] | ||||
Net revenues | $ 9,727,060 | $ 5,501,730 | $ 23,074,984 | $ 10,661,215 |
Cost of sales | 3,155,902 | 2,427,542 | 7,250,895 | 5,075,470 |
Gross profit | 6,571,158 | 3,074,188 | 15,824,089 | 5,585,745 |
Operating expenses: | ||||
Research and development | 4,866,114 | 3,787,562 | 10,138,524 | 7,822,724 |
Selling, general and administrative | 3,547,046 | 4,024,146 | 10,663,884 | 10,869,535 |
Loss on settlement of accounts receivable | 227,208 | 3,991,346 | ||
Total operating expenses | 8,413,160 | 8,038,916 | 20,802,408 | 22,683,605 |
Operating loss | (1,842,002) | (4,964,728) | (4,978,319) | (17,097,860) |
Non-operating (expenses) income: | ||||
Interest expense | (1,091,276) | (1,380,122) | (3,627,971) | (1,730,717) |
Other income (expense), net | 18,345 | 64 | 70,376 | (15,516) |
Change in fair value of derivative liabilities | 157,000 | (378,000) | (246,000) | (399,000) |
Foreign currency transaction loss | (16,601) | (1,591) | (57,788) | (118,124) |
Total non-operating expenses | (932,532) | (1,759,649) | (3,861,383) | (2,263,357) |
Loss before income taxes | (2,774,534) | (6,724,377) | (8,839,702) | (19,361,217) |
Income tax (benefit) expense | (458) | 1,206,131 | 117,207 | (3,342,339) |
Net loss | $ (2,774,076) | $ (7,930,508) | $ (8,956,909) | $ (16,018,878) |
Net loss per basic and diluted common share outstanding | $ (0.04) | $ (0.15) | $ (0.14) | $ (0.30) |
Basic and diluted weighted average common shares outstanding | 62,917,362 | 53,789,409 | 62,745,355 | 53,432,404 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Stockholders’ Equity - USD ($) | Preferred Stock [Member] | 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, 2017 | $ 553,922 | $ 90,550,669 | $ (581,519) | $ (34,263,262) | $ (7,806,605) | $ 48,453,205 | |
Balance (in Shares) at Sep. 30, 2017 | 55,392,193 | ||||||
Share-based compensation | 207,454 | 207,454 | |||||
Shares issued in connection with common stock purchase agreement | $ 3,045 | 344,036 | 347,081 | ||||
Shares issued in connection with common stock purchase agreement (in Shares) | 304,457 | ||||||
Net loss | (4,257,152) | (4,257,152) | |||||
Balance at Dec. 31, 2017 | $ 556,967 | 91,102,159 | (581,519) | (38,520,414) | (7,806,605) | 44,750,588 | |
Balance (in Shares) at Dec. 31, 2017 | 55,696,650 | ||||||
Balance at Sep. 30, 2017 | $ 553,922 | 90,550,669 | (581,519) | (34,263,262) | (7,806,605) | 48,453,205 | |
Balance (in Shares) at Sep. 30, 2017 | 55,392,193 | ||||||
Net loss | (16,018,878) | ||||||
Balance at Jun. 30, 2018 | $ 569,281 | 93,971,011 | (581,519) | (50,282,140) | (7,806,605) | 35,870,028 | |
Balance (in Shares) at Jun. 30, 2018 | 56,928,120 | ||||||
Balance at Dec. 31, 2017 | $ 556,967 | 91,102,159 | (581,519) | (38,520,414) | (7,806,605) | 44,750,588 | |
Balance (in Shares) at Dec. 31, 2017 | 55,696,650 | ||||||
Share-based compensation | 411,848 | 411,848 | |||||
Net loss | (3,831,218) | (3,831,218) | |||||
Balance at Mar. 31, 2018 | $ 556,967 | 91,514,007 | (581,519) | (42,351,632) | (7,806,605) | 41,331,218 | |
Balance (in Shares) at Mar. 31, 2018 | 55,696,650 | ||||||
Share-based compensation | 459,974 | 459,974 | |||||
Shares issued in connection with common stock purchase agreement | $ 11,764 | 1,988,236 | 2,000,000 | ||||
Shares issued in connection with common stock purchase agreement (in Shares) | 1,176,470 | ||||||
Amortization of deferred costs | (56,656) | (56,656) | |||||
Issuance of shares pursuant to share-based awards | $ 550 | 65,450 | 66,000 | ||||
Issuance of shares pursuant to share-based awards ( in Shares) | 55,000 | ||||||
Net loss | (7,930,508) | (7,930,508) | |||||
Balance at Jun. 30, 2018 | $ 569,281 | 93,971,011 | (581,519) | (50,282,140) | (7,806,605) | 35,870,028 | |
Balance (in Shares) at Jun. 30, 2018 | 56,928,120 | ||||||
Balance at Sep. 30, 2018 | $ 574,687 | 95,496,506 | (581,519) | (58,201,651) | (7,806,605) | 29,481,418 | |
Balance (in Shares) at Sep. 30, 2018 | 57,468,660 | ||||||
Share-based compensation | 417,256 | 417,256 | |||||
Issuance of shares | $ 71,428 | 9,060,539 | 9,131,967 | ||||
Issuance of shares (in Shares) | 7,142,857 | ||||||
Issuance of shares pursuant to share-based awards | $ 1,900 | (1,900) | |||||
Issuance of shares pursuant to share-based awards ( in Shares) | 190,000 | ||||||
Net loss | (2,148,798) | (2,148,798) | |||||
Balance at Dec. 31, 2018 | $ 648,015 | 104,972,401 | (581,519) | (60,350,449) | (7,806,605) | 36,881,843 | |
Balance (in Shares) at Dec. 31, 2018 | 64,801,517 | ||||||
Balance at Sep. 30, 2018 | $ 574,687 | 95,496,506 | (581,519) | (58,201,651) | (7,806,605) | 29,481,418 | |
Balance (in Shares) at Sep. 30, 2018 | 57,468,660 | ||||||
Net loss | (8,956,909) | ||||||
Balance at Jun. 30, 2019 | $ 670,025 | 109,612,826 | (581,519) | (67,158,560) | (7,806,605) | 34,736,167 | |
Balance (in Shares) at Jun. 30, 2019 | 67,002,483 | ||||||
Balance at Dec. 31, 2018 | $ 648,015 | 104,972,401 | (581,519) | (60,350,449) | (7,806,605) | 36,881,843 | |
Balance (in Shares) at Dec. 31, 2018 | 64,801,517 | ||||||
Share-based compensation | 496,209 | 496,209 | |||||
Issuance of shares pursuant to share-based awards | $ 1,667 | 198,333 | 200,000 | ||||
Issuance of shares pursuant to share-based awards ( in Shares) | 166,667 | ||||||
Net loss | (4,034,035) | (4,034,035) | |||||
Balance at Mar. 31, 2019 | $ 649,682 | 105,666,943 | (581,519) | (64,384,484) | (7,806,605) | 33,544,017 | |
Balance (in Shares) at Mar. 31, 2019 | 64,968,184 | ||||||
Share-based compensation | 468,207 | 468,207 | |||||
Shares issued in connection with common stock purchase agreement | $ 20,000 | 3,580,000 | 3,600,000 | ||||
Shares issued in connection with common stock purchase agreement (in Shares) | 2,000,000 | ||||||
Amortization of deferred costs | (101,981) | (101,981) | |||||
Issuance of shares pursuant to share-based awards | $ 343 | (343) | |||||
Issuance of shares pursuant to share-based awards ( in Shares) | 34,299 | ||||||
Net loss | (2,774,076) | (2,774,076) | |||||
Balance at Jun. 30, 2019 | $ 670,025 | $ 109,612,826 | $ (581,519) | $ (67,158,560) | $ (7,806,605) | $ 34,736,167 | |
Balance (in Shares) at Jun. 30, 2019 | 67,002,483 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Cash Flows - USD ($) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
OPERATING ACTIVITIES | ||
Net loss | $ (8,956,909) | $ (16,018,878) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 126,084 | 131,920 |
Amortization of intangible assets | 231,926 | 206,447 |
Noncash interest expense | 3,627,971 | 1,730,717 |
Share-based compensation | 1,381,672 | 1,079,276 |
Deferred income taxes | 20,413 | (3,367,000) |
Loss on settlement of accounts receivable | 3,991,346 | |
Change in fair value of derivative liabilities | 246,000 | 399,000 |
Other | 261,172 | (39,155) |
Changes in current assets and liabilities: | ||
(Increase) decrease in accounts receivable | (791,272) | 2,339,947 |
(Increase) decrease in inventory | (941,188) | 114,037 |
Increase in prepaid expenses and other assets | (68,578) | (275,586) |
(Decrease) increase in accounts payable | (46,894) | 775,923 |
Decrease in unearned revenue | (187,159) | (253,536) |
Increase in accrued expenses and other current liabilities | 566,557 | 454,324 |
Net cash used in operating activities | (4,530,205) | (8,731,218) |
INVESTING ACTIVITIES | ||
Capital expenditures | (74,948) | (47,696) |
Net cash used in investing activities | (74,948) | (47,696) |
FINANCING ACTIVITIES | ||
Proceeds from sale of shares in public offering , net of fees and costs | 9,131,967 | |
Installment payments on SWK credit agreement | (4,047,207) | (642,485) |
Proceeds from stock option exercises | 200,000 | 66,000 |
Net proceeds from sale of shares under common stock purchase agreement | 3,600,000 | 1,922,160 |
Proceeds from SWK credit agreement | 10,000,000 | |
Payment of debt issuance costs | (266,923) | |
Net cash provided by financing activities | 8,884,760 | 11,078,752 |
Net increase in cash | 4,279,607 | 2,299,838 |
CASH AT BEGINNING OF PERIOD | 3,759,509 | 3,277,602 |
CASH AT END OF PERIOD | 8,039,116 | 5,577,440 |
Schedule of noncash investing and financing activities: | ||
Shares issued in connection with common stock purchase agreement | 347,081 | |
Amortization of deferred costs related to common stock purchase agreement | $ 101,981 | $ 56,656 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Jun. 30, 2019 | |
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, 2018 . The accompanying condensed consolidated balance sheet as of September 30, 2018 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations for the three and nine months ended June 30, 2019 and cash flows for the nine months ended June 30, 2019 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30, 201 9 .  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. Prior to the completion of the October 31, 2016 acquisition (the “APP Acquisition”) of APP through the merger of a wholly owned subsidiary of the Company into APP, the Company had been a single product company engaged in marketing, manufacturing and distributing a consumer healthcare product, the FC2 Female Condom/FC2 Internal Condom® (“FC2”) . The completion of the APP Acquisition transitioned the Company into a biopharmaceutical company focused on oncology and urology with multiple drug products under clinical development. Most of the Company’s net revenues during the three and nine months ended June 30, 2019 and 2018 were derived from sales of FC2.  Reclassifications : Certain prior period amounts in 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.  Cash concentration : The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England and Kuala Lumpur, Malaysia.  Restricted cash : Restricted cash relates to security provided to one of the Company’s U.K. banks for performance bonds issued in favor of customers. The Company has a facility of $250,000 for such performance bonds. Such security has been extended infrequently and only on occasions where it has been a contract term expressly stipulated as an absolute requirement by the customer or its provider of funds. The expiration of the bond is defined by the completion of the event such as, but not limited to, a period of time after the product has been distributed or expiration of the product shelf life. The Company had no restricted cash at June 30, 2019. Restricted cash was $135,000 at September 30, 2018 and is included in cash on the accompanying unaudited condensed consolidated balance sheets.  Patents and trademarks : The costs for patents and trademarks are expensed when incurred.  Deferred financing costs : Costs incurred in connection with the common stock purchase agreement discussed in Note 9 have been included in other assets on the accompanying unaudited condensed consolidated balance sheets at June 30, 2019 and September 30, 2018. When shares of the Company’s common stock are sold under the common stock purchase agreement, a pro-rata portion of the deferred costs is recorded to additional paid-in-capital.  As discussed in Note 9, in connection with the common stock offering that closed on October 1, 2018, we incurred c osts of approximately $190,000 through September 30, 2018. This amount was included in other assets on the accompanying unaudited condensed consolidated balance sheet at September 30, 2018. These costs were charged to additional paid-in capital in the nine months ended June 30, 2019 after the common stock offering was closed.  Costs incurred in connection with the issuance of debt discussed in Note 8 are presented as a reduction of the debt on the accompanying unaudited condensed consolidated balance sheets at June 30, 2019 and September 30, 2018. These issuance costs are being amortized using the effective interest method over the expected repayment period of the debt, which is currently estimated to occur in the fourth quarter of fiscal 2021. The amortization is included in interest expense on the accompanying unaudited condensed consolidated statements of operations.  Fair value measurements : Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820 – Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying unaudited condensed consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements .  The carrying amounts reported in the accompanying unaudited condensed consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of long-term debt, taking into consideration debt discounts and related derivative instruments, is estimated to approximate fair value.  Derivative instruments : The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments. Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities incurred in connection with an embedded derivative are discussed in Note 8.  Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue.  Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, clinical trial costs and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did not have any capitalized nonrefundable advance payments as of June 30, 2019 and September 30, 2018.  The Company records estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract manufacturing activities. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations.  Share-based compensation : The Company recognizes share-based compensation expense in connection with its share-based awards, based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rates.  Advertising : The Company's policy is to expense advertising costs as incurred. Advertising costs were immaterial to the Company’s results of operations for the three and nine months ended June 30, 2019 and 2018. Income taxes : The Company files separate income tax returns for its foreign subsidiaries. FASB ASC Topic 740 requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are also provided for carryforwards for income tax purposes. In addition, the amount of any future tax benefits is reduced by a valuation allowance to the extent such benefits are not expected to be realized. Foreign currency translation and operations : Effective October 1, 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries’ functional currency. The evaluation indicated that the U.S. dollar is the currency with the most significant influence upon the subsidiaries. Because all of the U.K. subsidiary's future sales and cash flows would be denominated in U.S. dollars following the October 2009 cessation of production of the Company’s first-generation product, FC1, the U.K. subsidiary adopted the U.S. dollar as its functional currency effective October 1, 2009. As the Malaysia subsidiary is a direct and integral component of the U.K. parent’s operations, it, too, adopted the U.S. dollar as its functional currency as of October 1, 2009. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $0.6 million as of June 30, 2019 and September 30, 2018. Assets located outside of the U.S. totaled approximately $6.1 million and $5.2 million at June 30, 2019 and September 30, 2018, respectively. Other comprehensive loss : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss. Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss.  The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. For the three and nine months ended June 30, 2019 and 2018, comprehensive loss is equivalent to the reported net loss.  Recently Issued Accounting Pronouncements : In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014 ‑09, Revenue from Contracts with Customers (Topic 606) . This new accounting guidance on revenue recognition provides for a single five-step model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation. The new guidance also requires additional financial statement disclosures that will enable users to understand the nature, amount, timing and uncertainty of revenue and cash flows relating to customer contracts. The Company adopted the new guidance on October 1, 2018 using the modified retrospective method and elected to apply the guidance only to contracts that were not completed as of the date of adoption. The adoption of this guidance did not have a material effect on our consolidated financial statements and related disclosures. See Note 4 for disclosures relating to the Company's revenue recognition.  In February 2016, the FASB issued ASU 2016 ‑02, Leases (Topic 842) , which requires that lessees recognize a right-of-use asset and a lease liability for all leases with lease terms greater than twelve months in the balance sheet. ASU 2016-02 distinguishes leases as either a finance lease or an operating lease, which affects how the leases are measured and presented in the statement of operations and statement of cash flows, and requires disclosure of key information about leasing arrangements. ASU 2016 ‑02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required upon adoption. Early adoption is permitted. I n July 2018, the FASB issued ASU No. 2018 ‑10, Codification Improvements to Topic 842, Leases to clarify the implementation guidance and ASU No. 2018 ‑11, Leases (Topic 842) Targeted Improvements . This updated guidance provides an optional transition method, which allows for the initial application of the new accounting standard at the adoption date and the recognition of a cumulative-effect adjustment to the opening balance of retained earnings as of the beginning of the period of adoption. I n December 2018, the FASB issued ASU 2018-20, Leases (Topic 842): Narrow-Scope Improvements for Lessors to address certain implementation issues facing lessors when adopting ASU 2016 ‑02. I n March 2019, the FASB issued ASU 2019 ‑01, Leases (Topic 842): Codification Improvements to address, among other things, certain transition disclosure requirements subsequent to the adoption of ASU 2016 ‑02. The Company will adopt the new accounting standard on October 1, 2019 and intends to elect certain practical expedients, including the optional transition method that allows for the application of the new standard at its adoption date with no restatement of prior period amounts . We are evaluating the effect of the new guidance on our consolidated financial statements and related disclosures. The primary effect of adoption will be recording right-of-use assets and corresponding lease obligations for current operating leases. The adoption is expected to have a material impact on the Company’s consolidated balance sheets, but not on the consolidated statements of operations or cash flows. The Company is reviewing current accounting policies and related disclosures, and evaluating changes to business processes and controls to support adoption of the new standard.  In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash . The purpose of ASU 2016 ‑18 is to clarify guidance and presentation related to restricted cash in the statements of cash flows as well as increased disclosure requirements. It requires beginning-of-period and end-of-period total amounts shown on the statements of cash flows to include cash and cash equivalents as well as restricted cash and restricted cash equivalents. We adopted ASU 2016 ‑18 effective October 1, 2018. The adoption of ASU 2016 ‑18 did not have a material effect on the presentation of our consolidated statements of cash flows or 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 impaired 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. ASU 2017 ‑04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We do not expect the adoption of ASU 2017 ‑04 to have a material effect on our financial position or results of operations.  In May 2017, the FASB issued ASU 2017 ‑09, Compensation - Stock Compensation (Topic 718) : Scope of Modification Accounting . The purpose of ASU 2017 ‑09 is to provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The amendments in ASU 2017 ‑09 should be applied prospectively to an award modified on or after the adoption date. We adopted ASU 2017 ‑09 effective October 1, 2018. The adoption of ASU 2017 ‑09 did not have a material effect on our financial position or results of operations.  In June 2018, the FASB issued ASU 2018 ‑07, Compensation - Stock Compensation (Topic 718) : Improvements to Nonemployee Share-Based Payment Accounting . The purpose of ASU 2018-07 is to expand the scope of Topic 718, Compensation—Stock Compensation (which currently only includes share-based payments to employees) to include share-based payments issued to nonemployees for goods or services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. ASU 2018-07 will be effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than the Company’s adoption date of Topic 606, Revenue from Contracts with Customers . The Company has issued share-based payments to nonemployees in the past but is not able to predict the amount of future share-based payments to nonemployees, if any. The adoption of ASU 2018 ‑07 is not expected to have a material effect on our financial position or results of operations but should simplify the process by which the Company measures compensation expense for share-based payments to nonemployees. 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. ASU 2018 ‑13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted . The adoption of ASU 2018 ‑13 is not expected to have a material effect on our financial position or results of operations as it modifies disclosure requirements only. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2019 | |
Liquidity [Abstract] | |
Liquidity | Note 2 – Liquidity  The Company has incurred quarterly operating losses since the fourth quarter of fiscal 2016 and anticipates that it will continue to consume cash and incur substantial net losses as it develops its drug candidates. Because of the numerous risks and uncertainties associated with the development of pharmaceutical products, the Company is unable to estimate the exact amounts of capital outlays and operating expenditures necessary to fund development of its drug candidates and obtain regulatory approvals. The Company’s future capital requirements will depend on many factors.  The Company believes its current cash position and its ability to secure equity financing or other financing alternatives are adequate to fund planned operations of the Company for the next 12 months. Such financing alternatives may include debt financing, common stock offerings or financing involving convertible debt or other equity-linked securities and may include financings under the Company's effective shelf registration statement on Form S-3 (File No. 333-221120) (the “Shelf Registration Statement”). The Company intends to be opportunistic when pursuing equity financing which could include selling common stock under its common stock purchase agreement with Aspire Capital Fund, LLC (see Note 9) and/or a marketed deal with an investment bank.  |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | Note 3 – Fair Value Measurements  FASB ASC Topic 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The 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.  We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. There were no transfers between Level 1 , Level 2 and Level 3 during the nine months ended June 30, 2019 and 2018.  As of June 30, 2019 and September 30, 2018, 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 Company determines the fair value of hybrid instruments based on available market data using appropriate valuation models, considering all of the rights and obligations of each instrument. The Company estimates the fair value of hybrid instruments using various techniques (and combinations thereof) that are considered to be consistent with the objective of measuring fair value. In selecting the appropriate technique, the Company considers, among other factors, the nature of the instrument, the market risks that it embodies and the expected means of settlement. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. Increases in fair value during a given financial quarter result in the recognition of non-cash derivative expense. Conversely, decreases in fair value during a given financial quarter would result in the recognition of non-cash derivative income.  The following table provides a reconciliation of the beginning and ending liability balance associated with embedded derivatives measured at fair value using significant unobservable inputs (Level 3) as of June 30, 2019 and 2018:     Nine Months Ended June 30,  2019 2018   Beginning balance $ 2,426,000 $ —  Additions — 3,319,000  Change in fair value of derivative liabilities 246,000 399,000  Ending balance $ 2,672,000 $ 3,718,000  The expense associated with the change in fair value of the embedded derivatives is included as a separate line item on our 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 transaction details such as the contractual terms, expected cash outflows, expected repayment dates, probability of a change of control, expected volatility, and risk-free interest rates. A significant acceleration of the estimated repayment date or a significant decrease in the probability of a change of control event prior to repayment of the Credit Agreement, in isolation, would result in a significantly lower 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, 2019:     Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable)   Monte Carlo Simulation Estimated change of control dates March 2020 to December 2021  Discount rate 16.3% to 19.7%  Probability of change of control 0% to 90% |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 9 Months Ended |
Jun. 30, 2019 | |
Revenue from Contract with Customer [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 direct product sales of FC2 in the global public sector, sales of FC2 in the U.S. prescription channel, and sales of PREBOOST® medicated wipes for prevention of premature ejaculation. The following table presents net revenues from these three categories:     Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  FC2  Public sector $ 4,905,874 $ 5,126,434 $ 13,039,878 $ 9,823,793  U.S. prescription channel 4,377,862 372,981 9,412,177 830,525  Total FC2 9,283,736 5,499,415 22,452,055 10,654,318  PREBOOST® 443,324 2,315 622,929 6,897  Net revenues $ 9,727,060 $ 5,501,730 $ 23,074,984 $ 10,661,215  The following table presents net revenue by geographic area:     Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   United States $ 5,548,987 $ 640,313 $ 11,234,870 $ 2,615,652  South Africa 260,644 1,791,100 494,136 2,823,970  Zimbabwe 610,004 372,000 2,558,308 1,049,500  Other 3,307,425 2,698,317 8,787,670 4,172,093  Net revenues $ 9,727,060 $ 5,501,730 $ 23,074,984 $ 10,661,215  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 balances sheets, was approximately $106,000 and $4,000 at June 30, 2019 and September 30, 2018, respectively.  The Company records an unearned revenue liability if a customer pays consideration for product that was shipped by the Company but revenue recognition criteria have not been met under the terms of a contract. Unearned revenue is recognized as revenue after control of the product is transferred to the customer and all revenue recognition criteria have been met. The Company had no unearned revenue at June 30, 2019. Unearned revenue at September 30, 2018 was approximately $187,000 and was comprised of sales made to a large distributor who had the right to return product under certain conditions. |
Accounts Receivable and Concent
Accounts Receivable and Concentration of Credit Risk | 9 Months Ended |
Jun. 30, 2019 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Accounts Receivable and Concentration of Credit Risk | Note 5 – Accounts Receivable and Concentration of Credit Risk  The Company's standard credit terms vary from 30 to 120 days, depending on the class of trade and customary terms within a territory, so accounts receivable is affected by the mix of 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. The Company has agreed to credit terms of up to 150 days with its distributor in the Republic of South Africa and up to 180 days with its distributor in Brazil.  The components of accounts receivable consist of th e following at June 30, 2019 and September 30, 2018 :      June 30, September 30,  2019 2018   Accounts receivable $ 4,838,665 $ 4,046,733  Less: allowance for doubtful accounts (33,143) (36,201)  Less: allowance for sales and payment term discounts (38,560) (37,900)  Accounts receivable, net $ 4,766,962 $ 3,972,632  On December 27, 2017, we entered into a settlement agreement with Semina, our distributor in Brazil, pursuant to which Semina made a payment of $2.2 million and was obligated to make a second payment of $1.5 million by February 28, 2018, to settle net amounts due to us totaling $7.5 million relating to the Brazil tender in 2014 . Semina did not make its second payment of $1.5 million by February 28, 2018. In July 2018, the Company agreed to accept $1.3 million as settlement of the $1.5 million that was owed. The settlement was not related to our belief in the ultimate collectability of the receivables or in the creditworthiness of Semina. We elected to settle these amounts due to the uncertainty regarding the timing of payment by the Brazilian Government and, ultimately to us, on the remaining amounts due. The result of the settlement was a net loss of $0.2 million and $4.0 million in the three and nine months ended June 30, 2018, respectively, which is presented as a separate line item in the accompanying unaudited condensed consolidated statements of operations.  At June 30, 2019, no customer had an accounts receivable balance that represented greater than 10% of current assets. At September 30, 2018, one customer had an accounts receivable balance that represented 15% of current assets.  At June 30, 2019, three customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 76% of net accounts receivable in the aggregate. At September 30, 2018, three customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 74% of net accounts receivable in the aggregate.  For the three months ended June 30, 2019, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 63% of the Company’s net revenues in the aggregate. For the three months ended June 30, 2018, there were two customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 78% of the Company’s net revenues in the aggregate.  For the nine months ended June 30, 2019, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 64% of the Company’s net revenues in the aggregate. For the nine months ended June 30, 2018, there were three customers whose individual net revenue to the Company exceeded 10% of the Company’s net revenues, representing 65% 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. The table below summarizes the change in the all owance for doubtful accounts for the nine months ended June 30, 2019 and 2018 .     Nine Months Ended June 30,  2019 2018   Beginning balance $ 36,201 $ 38,103  Charges to expense — 3,058  Charge-offs (3,058) (5,000)  Ending balance $ 33,143 $ 36,161  Recoveries of accounts receivable previously charged off are recorded when received. 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, 2019 | |
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, 2019 and September 30, 2018 :     June 30, September 30,  2019 2018  FC2  Raw material $ 701,344 $ 366,220  Work in process 126,550 77,669  Finished goods 2,752,787 2,232,864  Inventory, gross 3,580,681 2,676,753  Less: inventory reserves (450,367) (391,861)  FC2, net 3,130,314 2,284,892  PREBOOST®  Finished goods 406 17,138  Inventory, net $ 3,130,720 $ 2,302,030  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 which range as follows:     Manufacturing equipment 5 – 10 years  Office equipment 3 – 5 years  Furniture and fixtures 7 – 10 years  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, 2019 and September 30, 2018:         June 30, September 30,  2019 2018   Equipment, furniture and fixtures $ 3,535,560 $ 4,018,284  Leasehold improvements 287,686 287,686  3,823,246 4,305,970  Less: accumulated depreciation and amortization (3,508,556) (3,901,418)  Plant and equipment, net $ 314,690 $ 404,552  |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Jun. 30, 2019 | |
Intangible Assets and Goodwill [Abstract] | |
Intangible Assets and Goodwill | Note 7 – Intangible Assets and Goodwill  Intangible Assets  Intangible assets acquired in the APP Acquisition included in-process research and development (“IPR&D”), developed technology consisting of PREBOOST® medicated wipes for prevention of premature ejaculation, and covenants not-to-compete. IPR&D represents incomplete research and development projects at APP as of the date of the APP Acquisition. These intangible assets are carried at cost less accumulated amortization. Intangible assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. IPR&D is tested for impairment at least annually in the fourth quarter of each fiscal year until the underlying projects are completed or abandoned.  The gross carrying amounts and net book value of intangible assets are as follows at June 30, 2019:   Gross Carrying Accumulated Net Book  Amount Amortization Value  Intangible assets with finite lives:  Developed technology - PREBOOST ® $ 2,400,000 $ 463,721 $ 1,936,279  Covenants not-to-compete 500,000 190,476 309,524  Total intangible assets with finite lives 2,900,000 654,197 2,245,803  Acquired in-process research and development assets 18,000,000 — 18,000,000  Total intangible assets $ 20,900,000 $ 654,197 $ 20,245,803  The gross carrying amounts and net book value of intangible assets are as follows at September 30, 2018 :    Gross Carrying Accumulated Net Book  Amount Amortization Value  Intangible assets with finite lives:  Developed technology - PREBOOST ® $ 2,400,000 $ 285,366 $ 2,114,634  Covenants not-to-compete 500,000 136,905 363,095  Total intangible assets with finite lives 2,900,000 422,271 2,477,729  Acquired in-process research and development assets 18,000,000 — 18,000,000  Total intangible assets $ 20,900,000 $ 422,271 $ 20,477,729  Amortization is recorded over the projected related revenue stream for the PREBOOST® developed technology over 10 years and on a straight-line basis over seven years for the covenants not-to-compete. The amortization expense is recorded in selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations. The IPR&D assets will not be amortized until the underlying development projects are completed. If and when development is complete, which generally occurs when regulatory approval to market the product is obtained, the associated IPR&D assets would be accounted for as finite-lived intangible assets and amortized over the estimated period of economic benefit. If a development project is abandoned, the associated IPR&D assets would be charged to expense.  For the three months ended June 30, 2019 and 2018, amortization expense was approximately $77,000 and $69,000 , respectively. For the nine months ended June 30, 2019 and 2018, amortization expense was approximately $232,000 and $206,000 , respectively.  Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval, additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macroeconomic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. Considering the high-risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges are likely to occur in future periods.  Goodwill  The carrying amount of goodwill at June 30, 2019 and September 30, 2018 was $6.9 million. There was no change in the balance during the nine months ended June 30, 2019 and 2018. Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired in the APP Acquisition. Goodwill from the APP Acquisition principally relates to intangible assets that do not qualify for separate recognition, our expectation to develop and market new products, and the deferred tax liability generated as a result of the transaction. Goodwill is not tax deductible for income tax purposes and was assigned to the Company’s sole reporting unit in the Company’s Research and Development reporting segment, which consists of multiple drug products under clinical development for oncology and urology.  Goodwill is tested for impairment at least annually in the fourth quarter of each fiscal year or when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable, by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that its fair value exceeds the carrying value. Examples of qualitative factors include our share price, our financial performance compared to budgets, long-term financial plans, and macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets from the annual impairment test previously performed.  The estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Ultimately, future potential changes in these assumptions may impact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results are not consistent with our estimates and assumptions, we may be exposed to an impairment charge that could be material. |
Debt
Debt | 9 Months Ended |
Jun. 30, 2019 | |
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 will be 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 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 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 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, 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 will be adjusted to fair market value at each subsequent 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 in 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, 2019 and September 30, 2018, the Credit Agreement consisted of the following:     June 30, September 30,  2019 2018   Aggregate repayment obligation $ 17,650,000 $ 17,500,000  Less: Cumulative payments (4,689,692) (642,485)  Less: Unamortized discounts (5,440,322) (8,475,874)  Less: Unamortized deferred issuance costs (127,874) (204,353)  Credit agreement, net 7,392,112 8,177,288  Add: Embedded derivative liability at fair value (see Note 3) 1,758,000 1,217,000  9,150,112 9,394,288  Credit agreement, short-term portion (4,660,572) (6,692,718)  Credit agreement, long-term portion $ 4,489,540 $ 2,701,570   The short-term portion of the Credit Agreement represents the aggregate of the estimated quarterly revenue-based payments payable during the 12-month periods subsequent to June 30, 2019 and September 30, 2018, respectively.  At June 30, 2019 and September 30, 2018, the Residual Royalty Agreement liability consisted of the following:     June 30, September 30,  2019 2018   Residual Royalty Agreement liability, fair value at inception $ 346,000 $ 346,000  Less: Unamortized discounts — (2,420)  Add: Accretion of liability using effective interest rate 564,745 201,225  Residual Royalty Agreement liability, net 910,745 544,805  Add: Embedded derivative liability at fair value (see Note 3) 914,000 1,209,000  Residual Royalty Agreement liability $ 1,824,745 $ 1,753,805  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, 2019 and 2018, interest expense related to the Credit Agreement and Residual Royalty Agreement was as follows:     Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Amortization of Credit Agreement and Residual Royalty Agreement discounts $ 922,144 $ 1,255,062 $ 3,187,972 $ 1,572,809  Accretion of Residual Royalty Agreement liability 147,223 94,858 363,520 122,136  Amortization of deferred issuance costs 21,909 30,202 76,479 35,772  $ 1,091,276 $ 1,380,122 $ 3,627,971 $ 1,730,717 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 9 – Stockholders’ Equity  Preferred Stock  The Company has 5,000,000 shares designated as Class A Preferred Stock with a par value of $0.01 per share. There are 1,040,000 shares of Class A Preferred Stock – Series 1 authorized; 1,500,000 shares of Class A Preferred Stock – Series 2 authorized; 700,000 shares of Class A Preferred Stock – Series 3 authorized; and 548,000 shares of Class A Preferred Stock – Series 4 (the “Series 4 Preferred Stock”) authorized. There were no shares of Class A Preferred Stock of any series issued and outstanding at June 30, 2019 and September 30, 2018. The Company has 15,000 shares designated as Class B Preferred Stock with a par value of $0.50 per share. There were no shares of Class B Preferred Stock issued and outstanding at June 30, 2019 and September 30, 2018.  Common Stock  On March 27, 2019, following approval by stockholders at the Company’s annual meeting of stockholders held on March 26, 2019, the Company filed an amendment to its articles of incorporation to increase the number of authorized shares of common stock from 77,000,000 to 154,000,000 shares.  Common Stock Offering  On October 1, 2018, we completed an underwritten public offering of 7,142,857 shares of our common stock, at a public offering price of $1.40 per share. Net proceeds to the Company from this offering were $9.1 million after deducting underwriting discounts and commissions and costs paid by the Company. All of the shares sold in the offering were by the Company. The offering was made pursuant to the Shelf Registration Statement.  Common Stock Purchase Warrants  In connection with the closing of the APP Acquisition, the Company issued a warrant to purchase up to 2,585,379 shares of the Company's common stock to Torreya Capital, the Company's financial advisor (the “Financial Advisor Warrant”). The Financial Advisor Warrant has 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 Warrant vested upon issuance and remains outstanding at June 30, 2019.  In May 2018, the Company issued two warrants to purchase a total of up to 750,000 shares of the Company's common stock at $2.31 per share in connection with a services agreement. The services agreement was terminated in March 2019 and the warrants were cancelled at the same time. Prior to termination of the services agreement, for measurement and recognition purposes, the Company utilized the lowest aggregate amount within the range of potential values, which was zero . Therefore, in prior periods, the Company had determined the fair value of these warrants to be zero and had not recognized any compensation expense related to these warrants.  Aspire Capital Purchase Agreement  On December 29, 2017, the Company entered into a common stock purchase agreement (the “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 Purchase Agreement, to direct Aspire Capital to purchase up to $15.0 million of the Company’s common stock in the aggregate. Concurrently with entering into the 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 and under the Shelf Registration Statement, a 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 Purchase Agreement.  Under the 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, up to $15.0 million of the Company’s common stock in the aggregate 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.  In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 304,457 shares of the Company’s common stock. The shares of common stock issued as consideration were valued at approximately $347,000 . This amount and related expenses of approximately $78,000 , which total approximately $425,000 , were recorded as deferred costs.  During the third quarter of fiscal 2019, we sold 2,000,000 shares of common stock to Aspire Capital under the Purchase Agreement resulting in proceeds to the Company of $3.6 million. As a result of this sale, we recorded approximately $102,000 of the deferred costs noted above to additional paid-in capital. During the third quarter of fiscal 2018, we sold 1,176,470 shares of common stock to Aspire Capital under the Purchase Agreement resulting in proceeds to the Company of $2.0 million. As a result of this sale, we recorded approximately $57,000 of the deferred costs noted above to additional paid-in capital. The unamortized amount of deferred costs of approximately $238,000 and $340,000 at June 30, 2019 and September 30, 2018, respectively, is included in other assets on the accompanying unaudited condensed consolidated balance sheets. As of June 30, 2019, the amount remaining under the Purchase Agreement was $8.4 million.  |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Jun. 30, 2019 | |
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, 2019 and 2018 , we recorded share-based compensation expenses as follows:    Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Cost of sales $ 9,998 $ 6,174 $ 25,728 $ 11,235  Selling, general and administrative 347,165 376,507 1,081,600 913,851  Research and development 111,044 77,293 274,344 154,190  $ 468,207 $ 459,974 $ 1,381,672 $ 1,079,276  Equity Plans  In March 2018, the Company’s stockholders approved the Company's 2018 Equity Incentive Plan (the “2018 Plan”). On March 26, 2019, the Company’s stockholders approved an increase in the number of shares that may be issued under the 2018 Plan to 6.0 million. As of June 30, 2019, 3,006,239 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, 2019, 46,514 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 option s granted during the three and nine months ended June 30, 2019 and 2018 :    Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  Weighted Average Assumptions:  Expected volatility 65.29% 60.56% 65.91% 61.00%  Expected dividend yield 0.00% 0.00% 0.00% 0.00%  Risk-free interest rate 2.23% 2.86% 2.37% 2.63%  Expected term (in years) 6.0 6.0 5.9 5.9  Fair value of options granted $ 0.97 $ 1.10 $ 0.92 $ 1.00  During the three and nine months ended June 30, 2019 and 2018, 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, 2019:   Weighted Average  Remaining Aggregate  Number of Exercise Price Contractual Term Intrinsic  Shares Per Share (years) Value   Outstanding at September 30, 2018 5,645,312 $ 1.59  Granted 2,255,282 $ 1.53  Exercised (283,333) $ 1.19  Forfeited (480,847) $ 1.89  Outstanding at June 30, 2019 7,136,414 $ 1.56 8.17 $ 4,082,982  Exercisable at June 30, 2019 2,240,384 $ 1.48 7.10 $ 1,460,499  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, 2019 of $2.13 , 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, 2019 and 2018 was approximately $105,000 and $44,000 , respectively. Cash received from options exercised during the nine months ended June 30, 2019 and 2018 was approximately $200,000 and $66,000 , respectively.  As of June 30, 2019, the Company had unrecognized compensation expense of approximately $3.5 million related to unvested stock options. This expense is expected to be recognized over approximately three years.  Restricted Stock  The Company has issued restricted stock to employees, directors and consultants. Such issuances had vesting periods that ranged from one to three years. All such shares of restricted stock vest provided the grantee has not voluntarily terminated service or been terminated for cause prior to the vesting date. There were no shares of restricted stock outstanding at June 30, 2019 and September 30, 2018.  Restricted Stock Units  In connection with the closing of the APP Acquisition, the Company issued 50,000 and 140,000 restricted stock units to an employee and an outside director, respectively, that vested on October 31, 2018 . The restricted stock units were settled in common stock issued under the 2017 Plan. As of June 30, 2019, there are no outstanding restricted stock units.  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, 2019, these vested stock appreciation rights remain outstanding. |
Contingent Liabilities
Contingent Liabilities | 9 Months Ended |
Jun. 30, 2019 | |
Contingent Liabilities [Abstract] | |
Contingent Liabilities | Note 11 – Contingent Liabilities  The testing, manufacturing and marketing of consumer products by the Company entail an inherent risk that product liability claims will be asserted against the Company. The Company maintains product liability insurance coverage for claims arising from the use of its products. The coverage amount is currently $10.0 million.  Litigation  In response to the APP Acquisition, two purported derivative and class action lawsuits were filed against the Company and certain of its officers and directors in the Circuit Court of Cook County, Illinois, captioned Glotzer v. The Female Health Company, et al., Case No. 2016-CH-13815, and Schartz v. Parrish, et al., Case No. 2016-CH-14488. These lawsuits were originally filed on or about October 21, 2016 and November 7, 2016, respectively. On January 9, 2017, these two lawsuits were consolidated. On March 31, 2017, the plaintiffs filed a consolidated complaint. The consolidated complaint named as defendants Veru, the members of our board of directors prior to the closing of the APP Acquisition and the members of our board of directors after the closing of the APP Acquisition. The consolidated complaint alleged, among other things, that the directors breached their fiduciary duties, or aided and abetted such breaches, by consummating the APP Acquisition in violation of the Wisconsin Business Corporation Law and NASDAQ voting requirements and by causing us to issue the shares of our common stock and Series 4 Preferred Stock to the former stockholders of APP pursuant to the APP Acquisition in order to evade the voting requirements of the Wisconsin Business Corporation Law. The consolidated complaint also alleged that Dr. Steiner, a director and the Chairman, President and Chief Executive Officer of Veru and a co-founder of APP, and Dr. Fisch, a director and Vice Chairman of Veru and a co-founder of APP, were unjustly enriched in receiving shares of our common stock and Series 4 Preferred Stock in the APP Acquisition.  On May 5, 2017, the defendants filed a motion to dismiss the consolidated complaint. On August 15, 2017, the court entered an order dismissing without prejudice the claims that the post-acquisition directors aided and abetted the alleged breaches of fiduciary duties by the pre-acquisition directors and that Dr. Steiner and Dr. Fisch were unjustly enriched. The court did not dismiss the claims that our directors prior to the closing of the APP Acquisition breached their fiduciary duties and the claims that Veru consummated the APP Acquisition in violation of the Wisconsin Business Corporation Law and NASDAQ voting requirements. On November 30, 2018, plaintiffs filed an Amended Consolidated Complaint. The Amended Consolidated Complaint makes allegations similar to those in the original consolidated complaint as to the claims that were not dismissed and names as defendants Veru and the members of our board of directors prior to the closing of the APP Acquisition. The Amended Consolidated Complaint also makes claims against Dr. Steiner for allegedly aiding and abetting the pre-acquisition directors’ breach of fiduciary duty and for unjust enrichment. Like the original consolidated complaint, which was previously dismissed in part, the Amended Consolidated Complaint seeks equitable relief, including rescission of the APP Acquisition, money damages, disgorgement of the shares of our common stock and Series 4 Preferred Stock issued to Dr. Steiner, and costs and expenses of the litigation, including attorneys' fees . On December 14, 2018, the defendants filed their answer to the Amended Consolidated Complaint wherein they denied any and all liability and asserted additional defenses. On January 14, 2019, the plaintiffs filed a motion for class certification. On May 6, 2019, the Court granted plaintiffs’ motion and certified a class consisting of “All holders of common stock of the Female Health Company as of October 31, 2016 and their successors in interest, excluding the named defendants to the Action and any person, firm, trust, corporation or other entity related to or affiliated with any of the Defendants.” The parties filed cross-motions for summary judgment on April 15, 2019. On July 10, 2019, the Court denied plaintiffs’ motion for summary judgment, granted defendants’ motion for summary judgment on all counts, dismissed the Amended Consolidated Complaint, and entered final judgment in favor of all defendants. Plaintiffs have a right to appeal the final judgment. Veru will continue vigorously defending itself on appeal if necessary. No amount has been accrued for possible losses relating to this litigation as any such losses are not both probable and reasonably estimable.  License and Purchase Agreements  From time to time, we license or purchase rights to technology or intellectual property from third parties. These licenses and purchase agreements require us to pay upfront payments as well as development or other payments upon successful completion of preclinical, clinical, regulatory or revenue milestones. In addition, these agreements may require us to pay royalties on sales of products arising from the licensed or acquired technology or intellectual property. Because the achievement of future milestones is not reasonably estimable, we have not recorded a liability in the accompanying unaudited condensed consolidated financial statements for any of these contingencies.  |
Income Taxes
Income Taxes | 9 Months Ended |
Jun. 30, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | Note 12 – 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 and tax credit carryforwards.  On December 22, 2017, significant changes were enacted to the U.S. tax law pursuant to the federal tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017 (the “Tax Act”). The Tax Act includes a permanent reduction in the U.S. federal corporate income tax rate from 35% to 21% , a one-time repatriation tax on deferred foreign income, and changes to deductions, credits and business-related exclusions.  The Tax Act also repealed the alternative minimum tax (“AMT”) for corporations. The new law provides that AMT carryovers can be utilized to reduce or eliminate the tax liability in subsequent years or to obtain a tax refund. For tax years beginning in 2018, 2019 and 2020, to the extent the AMT credit carryovers exceed regular tax liability, 50% of the excess AMT credit carryovers will be refundable. Any remaining credits will be fully refundable in 2021. At September 30, 2018, the Company reclassified $0.5 million of its AMT credit carryovers from its deferred tax assets to other assets due to the expectation that the AMT credits will be refundable over the next several years.  Within the calculation of the Company’s annual effective tax rate the Company has used assumptions and estimates that may change as a result of future guidance, interpretations, and rule-making from the Internal Revenue Service, the SEC, the FASB and/or various other taxing jurisdictions. For example, the Company anticipates that state jurisdictions will continue to determine and announce their conformity to the Tax Act which would have an impact on the annual effective tax rate. The Company’s calculations are based on the information available, prepared or analyzed (including computations) in reasonable detail.  The Company completes a detailed analysis of its deferred income tax valuation allowances on an annual basis or more frequently if information comes to its attention that would indicate that a revision to its estimates is necessary. In evaluating the Company’s ability to realize its deferred tax assets, management considers all available positive and negative evidence on a country-by-country basis, including past operating results, forecasts of future taxable income, and the potential Section 382 limitation on the net operating loss carryforwards due to a change in control. In determining future taxable income, management makes assumptions to forecast U.S. federal and state, U.K. and Malaysia operating income, the reversal of temporary differences, and the implementation of any feasible and prudent tax planning strategies. These assumptions require significant judgment regarding the forecasts of the future taxable income in each tax jurisdiction and are consistent with the forecasts used to manage the Company’s business. It should be noted that the Company realized significant losses through 2005 on a consolidated basis. From fiscal year 2006 through fiscal year 2015, the Company generated taxable income on a consolidated basis. However, the Company had a cumulative pretax loss in the U.S. for fiscal 2018 and the two preceding fiscal years. Forming a conclusion that a valuation allowance is not needed is difficult when there is significant negative evidence such as cumulative losses in recent years. Management has projected future taxable losses in the U.S. driven by the investment in research and development, and based on their analysis concluded that a valuation allowance should continue to be recorded against the U.S. deferred tax assets related to federal and state net operating loss carryforwards as of June 30, 2019. An additional valuation allowance has been recorded against the U.S. deferred tax assets and net operating loss carryforwards as of June 30, 2019 of $2.4 million. In addition, the Company’s holding company for the non-U.S. operating companies, The Female Health Company Limited, continues to have a full valuation allowance. The operating U.K. subsidiary, The Female Health Company (UK) plc does not have a valuation allowance due to projections of future taxable income for the next 10 years.  As of September 30, 2018, the Company had U.S. federal and state net operating loss carryforwards of $33.2 million and $36.2 million, respectively, for income tax purposes with $14.4 million and $19.6 million, respectively, expiring in years 2022 to 2037 and $18.8 million and $16.6 million, respectively, which can be carried forward indefinitely. The Company’s U.K. subsidiary has U.K. net operating loss carryforwards of $62.3 million as of September 30, 2018, which can be carried forward indefinitely to be used to offset future U.K. taxable income.  ASC Topic 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740 developed a two-step process to evaluate a tax position and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company has not recorded a reserve for any tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility.  A reconciliation of income tax expense and the amount computed by applying the statutory federal income tax rate to income before income taxes is as follows:     Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Income tax benefit at statutory rates $ (582,652) $ (1,412,119) $ (1,856,337) $ (5,040,855)  State income tax benefit, net of federal benefits (138,089) (15,213) (439,952) (963,608)  Effect of change in U.S. tax rate — 190,319 — 3,319  Non-deductible expenses – other 2,269 862 7,052 13,564  Effect of lower foreign income tax rates 43 (67,765) (3,484) 12,621  Recharacterization of foreign tax credits to net operating loss — 1,311,429 — 1,311,429  Effect of deemed dividend 2,554 — 66,182 —  Increase in valuation allowance 716,442 933,000 2,367,633 933,000  Other (1,025) 265,618 (23,887) 388,191  Income tax (benefit) expense $ (458) $ 1,206,131 $ 117,207 $ (3,342,339)  Significant components of the Company’s deferred tax assets and liabilities are as follows:      June 30, September 30,  2019 2018  Deferred tax assets:  Federal net operating loss carryforwards $ 8,527,304 $ 6,973,047  State net operating loss carryforwards 2,579,909 2,195,865  Foreign net operating loss carryforwards – U.K. 10,626,155 10,595,518  Foreign capital allowance – U.K. 102,098 102,098  U.K. bad debts 1,700 1,700  Restricted stock – U.K. 17,586 17,586  U.S. deferred rent 52,257 22,902  Share-based compensation 843,466 622,442  Other, net – U.S. 159,497 91,419  Other, net – Malaysia 33,896 33,843  Gross deferred tax assets 22,943,868 20,656,420  Valuation allowance for deferred tax assets (9,998,711) (7,631,078)  Net deferred tax assets 12,945,157 13,025,342  Deferred tax liabilities:  In process research and development (4,675,860) (4,675,860)  Developed technology (502,987) (549,318)  Covenant not-to-compete (80,405) (94,321)  Other (7,318) (6,843)  Net deferred tax liabilities (5,266,570) (5,326,342)  Net deferred tax asset $ 7,678,587 $ 7,699,000  The deferred tax amounts have been classified in the accompanying unaudited condensed consolidated balance sheets as follows:     June 30, September 30,  2019 2018   Deferred tax asset – U.K. $ 8,540,552 $ 8,509,915  Deferred tax asset – Malaysia 33,896 33,843  Total deferred tax asset $ 8,574,448 $ 8,543,758   Deferred tax liability – U.S. (895,861) (844,758)  Total deferred tax liability $ (895,861) $ (844,758)  |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Jun. 30, 2019 | |
Net Loss Per Share [Abstract] | |
Net Loss Per Share | Note 13 – Net Loss Per Share  Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing net income by the weighted average number of common shares outstanding during the period after giving effect to all dilutive potential common shares that were outstanding during the period. Dilutive potential common shares consist of the incremental common shares issuable upon the exercise of stock options, stock appreciation rights and warrants, and the vesting of unvested restricted stock and restricted stock units. Due to our net loss for the periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Notes 9 and 10 for a discussion of our dilutive potential common shares.  |
Industry Segments
Industry Segments | 9 Months Ended |
Jun. 30, 2019 | |
Industry Segments [Abstract] | |
Industry Segments | Note 14 – Industry Segments  The Company currently operates in two reporting segments: Commercial and Research and Development . The Commercial segment consists of FC2, PREBOOST® and drug commercialization costs. The Research and Development segment consists of multiple drug products under clinical development for oncology and urology. 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 income (loss) by segment is as follows:      Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  (In thousands) (In thousands)  Commercial $ 5,621 $ 1,328 $ 12,493 $ 1,309  Research and development (4,853) (3,787) (10,104) (7,780)  Corporate (2,610) (2,506) (7,367) (10,627)  Operating loss $ (1,842) $ (4,965) $ (4,978) $ (17,098)  All of our net revenues, which are primarily derived from the sale of FC2, are attributed to our Commercial reporting segment. See Note 4 for additional information regarding our net revenues. The loss on settlement of accounts receivable 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, 2019 | |
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, 2018 . The accompanying condensed consolidated balance sheet as of September 30, 2018 has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations for the three and nine months ended June 30, 2019 and cash flows for the nine months ended June 30, 2019 are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending September 30, 201 9 .  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. Prior to the completion of the October 31, 2016 acquisition (the “APP Acquisition”) of APP through the merger of a wholly owned subsidiary of the Company into APP, the Company had been a single product company engaged in marketing, manufacturing and distributing a consumer healthcare product, the FC2 Female Condom/FC2 Internal Condom® (“FC2”) . The completion of the APP Acquisition transitioned the Company into a biopharmaceutical company focused on oncology and urology with multiple drug products under clinical development. Most of the Company’s net revenues during the three and nine months ended June 30, 2019 and 2018 were derived from sales of FC2. |
Reclassifications | Reclassifications : Certain prior period amounts in 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. |
Cash concentration | Cash concentration : The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England and Kuala Lumpur, Malaysia. |
Restricted cash | Restricted cash : Restricted cash relates to security provided to one of the Company’s U.K. banks for performance bonds issued in favor of customers. The Company has a facility of $250,000 for such performance bonds. Such security has been extended infrequently and only on occasions where it has been a contract term expressly stipulated as an absolute requirement by the customer or its provider of funds. The expiration of the bond is defined by the completion of the event such as, but not limited to, a period of time after the product has been distributed or expiration of the product shelf life. The Company had no restricted cash at June 30, 2019. Restricted cash was $135,000 at September 30, 2018 and is included in cash on the accompanying unaudited condensed consolidated balance sheets. |
Patents and trademarks | Patents and trademarks : The costs for patents and trademarks are expensed when incurred. |
Deferred financing costs | Deferred financing costs : Costs incurred in connection with the common stock purchase agreement discussed in Note 9 have been included in other assets on the accompanying unaudited condensed consolidated balance sheets at June 30, 2019 and September 30, 2018. When shares of the Company’s common stock are sold under the common stock purchase agreement, a pro-rata portion of the deferred costs is recorded to additional paid-in-capital.  As discussed in Note 9, in connection with the common stock offering that closed on October 1, 2018, we incurred c osts of approximately $190,000 through September 30, 2018. This amount was included in other assets on the accompanying unaudited condensed consolidated balance sheet at September 30, 2018. These costs were charged to additional paid-in capital in the nine months ended June 30, 2019 after the common stock offering was closed.  Costs incurred in connection with the issuance of debt discussed in Note 8 are presented as a reduction of the debt on the accompanying unaudited condensed consolidated balance sheets at June 30, 2019 and September 30, 2018. These issuance costs are being amortized using the effective interest method over the expected repayment period of the debt, which is currently estimated to occur in the fourth quarter of fiscal 2021. The amortization is included in interest expense on the accompanying unaudited condensed consolidated statements of operations. |
Fair value measurements | Fair value measurements : Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820 – Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying unaudited condensed consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements .  The carrying amounts reported in the accompanying unaudited condensed consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of long-term debt, taking into consideration debt discounts and related derivative instruments, is estimated to approximate fair value. |
Derivative instruments | Derivative instruments : The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments. Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities incurred in connection with an embedded derivative are discussed in Note 8. |
Revenue recognition | Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue. |
Research and development costs | Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, clinical trial costs and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did not have any capitalized nonrefundable advance payments as of June 30, 2019 and September 30, 2018.  The Company records estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract manufacturing activities. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. |
Share-based compensation | Share-based compensation : The Company recognizes share-based compensation expense in connection with its share-based awards, based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rates. |
Advertising | Advertising : The Company's policy is to expense advertising costs as incurred. Advertising costs were immaterial to the Company’s results of operations for the three and nine months ended June 30, 2019 and 2018. |
Income taxes | Income taxes : The Company files separate income tax returns for its foreign subsidiaries. FASB ASC Topic 740 requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are also provided for carryforwards for income tax purposes. In addition, the amount of any future tax benefits is reduced by a valuation allowance to the extent such benefits are not expected to be realized. |
Foreign currency translation and operations | Foreign currency translation and operations : Effective October 1, 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries’ functional currency. The evaluation indicated that the U.S. dollar is the currency with the most significant influence upon the subsidiaries. Because all of the U.K. subsidiary's future sales and cash flows would be denominated in U.S. dollars following the October 2009 cessation of production of the Company’s first-generation product, FC1, the U.K. subsidiary adopted the U.S. dollar as its functional currency effective October 1, 2009. As the Malaysia subsidiary is a direct and integral component of the U.K. parent’s operations, it, too, adopted the U.S. dollar as its functional currency as of October 1, 2009. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $0.6 million as of June 30, 2019 and September 30, 2018. Assets located outside of the U.S. totaled approximately $6.1 million and $5.2 million at June 30, 2019 and September 30, 2018, respectively. |
Other comprehensive loss | Other comprehensive loss : Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss. Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss.  The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. For the three and nine months ended June 30, 2019 and 2018, comprehensive loss is equivalent to the reported net loss. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements : In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014 ‑09, Revenue from Contracts with Customers (Topic 606) . This new accounting guidance on revenue recognition provides for a single five-step model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation. The new guidance also requires additional financial statement disclosures that will enable users to understand the nature, amount, timing and uncertainty of revenue and cash flows relating to customer contracts. The Company adopted the new guidance on October 1, 2018 using the modified retrospective method and elected to apply the guidance only to contracts that were not completed as of the date of adoption. The adoption of this guidance did not have a material effect on our consolidated financial statements and related disclosures. See Note 4 for disclosures relating to the Company's revenue recognition.  In February 2016, the FASB issued ASU 2016 ‑02, Leases (Topic 842) , which requires that lessees recognize a right-of-use asset and a lease liability for all leases with lease terms greater than twelve months in the balance sheet. ASU 2016-02 distinguishes leases as either a finance lease or an operating lease, which affects how the leases are measured and presented in the statement of operations and statement of cash flows, and requires disclosure of key information about leasing arrangements. ASU 2016 ‑02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required upon adoption. Early adoption is permitted. I n July 2018, the FASB issued ASU No. 2018 ‑10, Codification Improvements to Topic 842, Leases to clarify the implementation guidance and ASU No. 2018 ‑11, Leases (Topic 842) Targeted Improvements . This updated guidance provides an optional transition method, which allows for the initial application of the new accounting standard at the adoption date and the recognition of a cumulative-effect adjustment to the opening balance of retained earnings as of the beginning of the period of adoption. I n December 2018, the FASB issued ASU 2018-20, Leases (Topic 842): Narrow-Scope Improvements for Lessors to address certain implementation issues facing lessors when adopting ASU 2016 ‑02. I n March 2019, the FASB issued ASU 2019 ‑01, Leases (Topic 842): Codification Improvements to address, among other things, certain transition disclosure requirements subsequent to the adoption of ASU 2016 ‑02. The Company will adopt the new accounting standard on October 1, 2019 and intends to elect certain practical expedients, including the optional transition method that allows for the application of the new standard at its adoption date with no restatement of prior period amounts . We are evaluating the effect of the new guidance on our consolidated financial statements and related disclosures. The primary effect of adoption will be recording right-of-use assets and corresponding lease obligations for current operating leases. The adoption is expected to have a material impact on the Company’s consolidated balance sheets, but not on the consolidated statements of operations or cash flows. The Company is reviewing current accounting policies and related disclosures, and evaluating changes to business processes and controls to support adoption of the new standard.  In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash . The purpose of ASU 2016 ‑18 is to clarify guidance and presentation related to restricted cash in the statements of cash flows as well as increased disclosure requirements. It requires beginning-of-period and end-of-period total amounts shown on the statements of cash flows to include cash and cash equivalents as well as restricted cash and restricted cash equivalents. We adopted ASU 2016 ‑18 effective October 1, 2018. The adoption of ASU 2016 ‑18 did not have a material effect on the presentation of our consolidated statements of cash flows or 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 impaired 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. ASU 2017 ‑04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We do not expect the adoption of ASU 2017 ‑04 to have a material effect on our financial position or results of operations.  In May 2017, the FASB issued ASU 2017 ‑09, Compensation - Stock Compensation (Topic 718) : Scope of Modification Accounting . The purpose of ASU 2017 ‑09 is to provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The amendments in ASU 2017 ‑09 should be applied prospectively to an award modified on or after the adoption date. We adopted ASU 2017 ‑09 effective October 1, 2018. The adoption of ASU 2017 ‑09 did not have a material effect on our financial position or results of operations.  In June 2018, the FASB issued ASU 2018 ‑07, Compensation - Stock Compensation (Topic 718) : Improvements to Nonemployee Share-Based Payment Accounting . The purpose of ASU 2018-07 is to expand the scope of Topic 718, Compensation—Stock Compensation (which currently only includes share-based payments to employees) to include share-based payments issued to nonemployees for goods or services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. ASU 2018-07 will be effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than the Company’s adoption date of Topic 606, Revenue from Contracts with Customers . The Company has issued share-based payments to nonemployees in the past but is not able to predict the amount of future share-based payments to nonemployees, if any. The adoption of ASU 2018 ‑07 is not expected to have a material effect on our financial position or results of operations but should simplify the process by which the Company measures compensation expense for share-based payments to nonemployees. 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. ASU 2018 ‑13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted . The adoption of ASU 2018 ‑13 is not expected to have a material effect on our financial position or results of operations as it modifies disclosure requirements only. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements [Abstract] | |
Reconciliation of the Beginning and Ending Liability Balance |   Nine Months Ended June 30,  2019 2018   Beginning balance $ 2,426,000 $ —  Additions — 3,319,000  Change in fair value of derivative liabilities 246,000 399,000  Ending balance $ 2,672,000 $ 3,718,000  |
Schedule of Qualitative Information |    Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable)   Monte Carlo Simulation Estimated change of control dates March 2020 to December 2021  Discount rate 16.3% to 19.7%  Probability of change of control 0% to 90%  |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Customers by Products |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  FC2  Public sector $ 4,905,874 $ 5,126,434 $ 13,039,878 $ 9,823,793  U.S. prescription channel 4,377,862 372,981 9,412,177 830,525  Total FC2 9,283,736 5,499,415 22,452,055 10,654,318  PREBOOST® 443,324 2,315 622,929 6,897  Net revenues $ 9,727,060 $ 5,501,730 $ 23,074,984 $ 10,661,215  |
Revenue by Geographic Area |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   United States $ 5,548,987 $ 640,313 $ 11,234,870 $ 2,615,652  South Africa 260,644 1,791,100 494,136 2,823,970  Zimbabwe 610,004 372,000 2,558,308 1,049,500  Other 3,307,425 2,698,317 8,787,670 4,172,093  Net revenues $ 9,727,060 $ 5,501,730 $ 23,074,984 $ 10,661,215  |
Accounts Receivable and Conce_2
Accounts Receivable and Concentration of Credit Risk (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Components Of Accounts Receivable |   June 30, September 30,  2019 2018   Accounts receivable $ 4,838,665 $ 4,046,733  Less: allowance for doubtful accounts (33,143) (36,201)  Less: allowance for sales and payment term discounts (38,560) (37,900)  Accounts receivable, net $ 4,766,962 $ 3,972,632  |
Summary Of Components Of Allowance For Doubtful Accounts |   Nine Months Ended June 30,  2019 2018   Beginning balance $ 36,201 $ 38,103  Charges to expense — 3,058  Charge-offs (3,058) (5,000)  Ending balance $ 33,143 $ 36,161  |
Balance Sheet Information (Tabl
Balance Sheet Information (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Information [Abstract] | |
Components Of Inventory |   June 30, September 30,  2019 2018  FC2  Raw material $ 701,344 $ 366,220  Work in process 126,550 77,669  Finished goods 2,752,787 2,232,864  Inventory, gross 3,580,681 2,676,753  Less: inventory reserves (450,367) (391,861)  FC2, net 3,130,314 2,284,892  PREBOOST®  Finished goods 406 17,138  Inventory, net $ 3,130,720 $ 2,302,030  |
Schedule of Estimated Useful Lives of Assets |    Manufacturing equipment 5 – 10 years  Office equipment 3 – 5 years  Furniture and fixtures 7 – 10 years  |
Plant and Equipment |   June 30, September 30,  2019 2018   Equipment, furniture and fixtures $ 3,535,560 $ 4,018,284  Leasehold improvements 287,686 287,686  3,823,246 4,305,970  Less: accumulated depreciation and amortization (3,508,556) (3,901,418)  Plant and equipment, net $ 314,690 $ 404,552  |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Intangible Assets and Goodwill [Abstract] | |
Gross Carrying Amounts of Finite Intangible Assets |   Gross Carrying Accumulated Net Book  Amount Amortization Value  Intangible assets with finite lives:  Developed technology - PREBOOST ® $ 2,400,000 $ 463,721 $ 1,936,279  Covenants not-to-compete 500,000 190,476 309,524  Total intangible assets with finite lives 2,900,000 654,197 2,245,803  Acquired in-process research and development assets 18,000,000 — 18,000,000  Total intangible assets $ 20,900,000 $ 654,197 $ 20,245,803  The gross carrying amounts and net book value of intangible assets are as follows at September 30, 2018 :    Gross Carrying Accumulated Net Book  Amount Amortization Value  Intangible assets with finite lives:  Developed technology - PREBOOST ® $ 2,400,000 $ 285,366 $ 2,114,634  Covenants not-to-compete 500,000 136,905 363,095  Total intangible assets with finite lives 2,900,000 422,271 2,477,729  Acquired in-process research and development assets 18,000,000 — 18,000,000  Total intangible assets $ 20,900,000 $ 422,271 $ 20,477,729  |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Debt [Abstract] | |
Credit Agreement |   June 30, September 30,  2019 2018   Aggregate repayment obligation $ 17,650,000 $ 17,500,000  Less: Cumulative payments (4,689,692) (642,485)  Less: Unamortized discounts (5,440,322) (8,475,874)  Less: Unamortized deferred issuance costs (127,874) (204,353)  Credit agreement, net 7,392,112 8,177,288  Add: Embedded derivative liability at fair value (see Note 3) 1,758,000 1,217,000  9,150,112 9,394,288  Credit agreement, short-term portion (4,660,572) (6,692,718)  Credit agreement, long-term portion $ 4,489,540 $ 2,701,570   |
Residual Royalty Agreement Liability |   June 30, September 30,  2019 2018   Residual Royalty Agreement liability, fair value at inception $ 346,000 $ 346,000  Less: Unamortized discounts — (2,420)  Add: Accretion of liability using effective interest rate 564,745 201,225  Residual Royalty Agreement liability, net 910,745 544,805  Add: Embedded derivative liability at fair value (see Note 3) 914,000 1,209,000  Residual Royalty Agreement liability $ 1,824,745 $ 1,753,805  |
Credit Agreement Interest Expense |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Amortization of Credit Agreement and Residual Royalty Agreement discounts $ 922,144 $ 1,255,062 $ 3,187,972 $ 1,572,809  Accretion of Residual Royalty Agreement liability 147,223 94,858 363,520 122,136  Amortization of deferred issuance costs 21,909 30,202 76,479 35,772  $ 1,091,276 $ 1,380,122 $ 3,627,971 $ 1,730,717  |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Share-based Compensation [Abstract] | |
Recorded Share-Based Compensation Expenses |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Cost of sales $ 9,998 $ 6,174 $ 25,728 $ 11,235  Selling, general and administrative 347,165 376,507 1,081,600 913,851  Research and development 111,044 77,293 274,344 154,190  $ 468,207 $ 459,974 $ 1,381,672 $ 1,079,276  |
Weighted Average Assumptions For Options Granted |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  Weighted Average Assumptions:  Expected volatility 65.29% 60.56% 65.91% 61.00%  Expected dividend yield 0.00% 0.00% 0.00% 0.00%  Risk-free interest rate 2.23% 2.86% 2.37% 2.63%  Expected term (in years) 6.0 6.0 5.9 5.9  Fair value of options granted $ 0.97 $ 1.10 $ 0.92 $ 1.00  |
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, 2018 5,645,312 $ 1.59  Granted 2,255,282 $ 1.53  Exercised (283,333) $ 1.19  Forfeited (480,847) $ 1.89  Outstanding at June 30, 2019 7,136,414 $ 1.56 8.17 $ 4,082,982  Exercisable at June 30, 2019 2,240,384 $ 1.48 7.10 $ 1,460,499  |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Income Taxes [Abstract] | |
Reconciliation Of Income Tax Expense (Benefit) |    Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018   Income tax benefit at statutory rates $ (582,652) $ (1,412,119) $ (1,856,337) $ (5,040,855)  State income tax benefit, net of federal benefits (138,089) (15,213) (439,952) (963,608)  Effect of change in U.S. tax rate — 190,319 — 3,319  Non-deductible expenses – other 2,269 862 7,052 13,564  Effect of lower foreign income tax rates 43 (67,765) (3,484) 12,621  Recharacterization of foreign tax credits to net operating loss — 1,311,429 — 1,311,429  Effect of deemed dividend 2,554 — 66,182 —  Increase in valuation allowance 716,442 933,000 2,367,633 933,000  Other (1,025) 265,618 (23,887) 388,191  Income tax (benefit) expense $ (458) $ 1,206,131 $ 117,207 $ (3,342,339)  |
Significant Components Of Deferred Tax Assets And Liabilities |    June 30, September 30,  2019 2018  Deferred tax assets:  Federal net operating loss carryforwards $ 8,527,304 $ 6,973,047  State net operating loss carryforwards 2,579,909 2,195,865  Foreign net operating loss carryforwards – U.K. 10,626,155 10,595,518  Foreign capital allowance – U.K. 102,098 102,098  U.K. bad debts 1,700 1,700  Restricted stock – U.K. 17,586 17,586  U.S. deferred rent 52,257 22,902  Share-based compensation 843,466 622,442  Other, net – U.S. 159,497 91,419  Other, net – Malaysia 33,896 33,843  Gross deferred tax assets 22,943,868 20,656,420  Valuation allowance for deferred tax assets (9,998,711) (7,631,078)  Net deferred tax assets 12,945,157 13,025,342  Deferred tax liabilities:  In process research and development (4,675,860) (4,675,860)  Developed technology (502,987) (549,318)  Covenant not-to-compete (80,405) (94,321)  Other (7,318) (6,843)  Net deferred tax liabilities (5,266,570) (5,326,342)  Net deferred tax asset $ 7,678,587 $ 7,699,000  |
Schedule Of Deferred Tax Amounts Classified In Balance Sheets |    June 30, September 30,  2019 2018   Deferred tax asset – U.K. $ 8,540,552 $ 8,509,915  Deferred tax asset – Malaysia 33,896 33,843  Total deferred tax asset $ 8,574,448 $ 8,543,758   Deferred tax liability – U.S. (895,861) (844,758)  Total deferred tax liability $ (895,861) $ (844,758)  |
Industry Segments (Tables)
Industry Segments (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Industry Segments [Abstract] | |
Schedule of Segment Reporting Information |   Three Months Ended Nine Months Ended  June 30, June 30,  2019 2018 2019 2018  (In thousands) (In thousands)  Commercial $ 5,621 $ 1,328 $ 12,493 $ 1,309  Research and development (4,853) (3,787) (10,104) (7,780)  Corporate (2,610) (2,506) (7,367) (10,627)  Operating loss $ (1,842) $ (4,965) $ (4,978) $ (17,098)  |
Basis of Presentation (Narrativ
Basis of Presentation (Narrative) (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | ||
Restricted cash | $ 0 | $ 135,000 |
Stock issuance costs incurred | 190,000 | |
Total assets | 53,840,765 | 48,452,639 |
Cumulative foreign currency translation gain (loss) | (600,000) | (600,000) |
Performance Bond [Member] | ||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | ||
Restricted cash | 250,000 | |
Outside United States [Member] | ||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | ||
Total assets | $ 6,100,000 | $ 5,200,000 |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Fair Value Measurements [Abstract] | ||
Transfers to level 1 | $ 0 | $ 0 |
Transfers to level 2 | 0 | 0 |
Transfers to Level 3 | $ 0 | $ 0 |
Fair Value Measurements (Reconc
Fair Value Measurements (Reconciliation of the Beginning and Ending Liability Balance) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Fair Value Measurements [Abstract] | ||
Beginning balance | $ 2,426,000 | |
Additions | 3,319,000 | |
Change in fair value of derivative liabilities | 246,000 | 399,000 |
Ending balance | $ 2,672,000 | $ 3,718,000 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Qualitative Information) (Details) | 9 Months Ended |
Jun. 30, 2019USD ($) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Valuation Methodology | Monte Carlo Simulation |
Maximum [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Estimated change of control dates | Dec. 31, 2021 |
Maximum [Member] | Discount Rate [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Discount rate | 19.70 |
Maximum [Member] | Probability Of Change Of Control [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Probability of change of control | 90.00% |
Minimum [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Estimated change of control dates | Mar. 1, 2020 |
Minimum [Member] | Discount Rate [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Discount rate | 16.30 |
Minimum [Member] | Probability Of Change Of Control [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Probability of change of control | 0.00% |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Narrative) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Revenue from Contract with Customer [Abstract] | ||
Contract liability | $ 106,000 | $ 4,000 |
Unearned revenue | $ 0 | $ 187,000 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue, Major Customer [Line Items] | ||||
Revenues | $ 9,727,060 | $ 5,501,730 | $ 23,074,984 | $ 10,661,215 |
FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 9,283,736 | 5,499,415 | 22,452,055 | 10,654,318 |
PREBOOST Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 443,324 | 2,315 | 622,929 | 6,897 |
Public Sector Segment [Member] | FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | 4,905,874 | 5,126,434 | 13,039,878 | 9,823,793 |
U.S. Prescription Channel Segment [Member] | FC2 Segment [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Revenues | $ 4,377,862 | $ 372,981 | $ 9,412,177 | $ 830,525 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 9,727,060 | $ 5,501,730 | $ 23,074,984 | $ 10,661,215 |
United States [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 5,548,987 | 640,313 | 11,234,870 | 2,615,652 |
South Africa [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 260,644 | 1,791,100 | 494,136 | 2,823,970 |
Zimbabwe [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 610,004 | 372,000 | 2,558,308 | 1,049,500 |
Other Countries [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 3,307,425 | $ 2,698,317 | $ 8,787,670 | $ 4,172,093 |
Accounts Receivable and Conce_3
Accounts Receivable and Concentration of Credit Risk (Narrative) (Details) | Dec. 27, 2017USD ($) | Jul. 31, 2018USD ($) | Jun. 30, 2019USD ($)customer | Jun. 30, 2018USD ($)customer | Jun. 30, 2019USD ($)customer | Jun. 30, 2018USD ($)customer | Sep. 30, 2018USD ($)customer | Feb. 28, 2018USD ($) |
Current accounts receivable, net | $ 4,766,962 | $ 4,766,962 | $ 3,972,632 | |||||
Net revenues | $ 9,727,060 | $ 5,501,730 | $ 23,074,984 | $ 10,661,215 | ||||
Minimum [Member] | ||||||||
Credit terms | 30 days | |||||||
Maximum [Member] | ||||||||
Credit terms | 120 days | |||||||
Assets, Current [Member] | ||||||||
Concentration risk, percentage | 15.00% | |||||||
Number of Customers | customer | 0 | 1 | ||||||
Accounts Receivable [Member] | ||||||||
Concentration risk, percentage | 76.00% | 74.00% | ||||||
Number of Customers | customer | 3 | 3 | ||||||
Total Revenue [Member] | ||||||||
Concentration risk, percentage | 63.00% | 78.00% | 64.00% | 65.00% | ||||
Number of Customers | customer | 3 | 2 | 3 | 3 | ||||
Semina [Member] | ||||||||
Current accounts receivable, net | $ 1,500,000 | |||||||
Payments to settle agreement | $ 2,200,000 | $ 1,300,000 | ||||||
Long term trade receivable | $ 7,500,000 | |||||||
Settlement loss on receivables | $ 200,000 | $ 4,000,000 | ||||||
South Africa [Member] | ||||||||
Credit terms | 150 days | |||||||
Net revenues | $ 260,644 | $ 1,791,100 | $ 494,136 | $ 2,823,970 |
Accounts Receivable and Conce_4
Accounts Receivable and Concentration of Credit Risk (Components Of Accounts Receivable) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||||
Accounts receivable | $ 4,838,665 | $ 4,046,733 | ||
Less: allowance for doubtful accounts | (33,143) | (36,201) | $ (36,161) | $ (38,103) |
Less: allowance for sales and payment term discounts | (38,560) | (37,900) | ||
Accounts receivable, net | $ 4,766,962 | $ 3,972,632 |
Accounts Receivable and Conce_5
Accounts Receivable and Concentration of Credit Risk (Summary Of Components Of Allowance For Doubtful Accounts) (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||
Beginning balance | $ 36,201 | $ 38,103 |
Charges to expense | 3,058 | |
Charge-offs | (3,058) | (5,000) |
Ending balance | $ 33,143 | $ 36,161 |
Balance Sheet Information (Comp
Balance Sheet Information (Components Of Inventory) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Inventory [Line Items] | ||
Inventory, net | $ 3,130,720 | $ 2,302,030 |
FC2 [Member] | ||
Inventory [Line Items] | ||
Raw material | 701,344 | 366,220 |
Work in process | 126,550 | 77,669 |
Finished goods | 2,752,787 | 2,232,864 |
Inventory, gross | 3,580,681 | 2,676,753 |
Less: inventory reserves | (450,367) | (391,861) |
Inventory, net | 3,130,314 | 2,284,892 |
PREBOOST [Member] | ||
Inventory [Line Items] | ||
Finished goods | $ 406 | $ 17,138 |
Balance Sheet Information (Sche
Balance Sheet Information (Schedule of Estimated Useful Lives of Assets) (Details) | 9 Months Ended |
Jun. 30, 2019 | |
Manufacturing Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 10 years |
Manufacturing Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 5 years |
Office Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 5 years |
Office Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 3 years |
Furniture And Fixtures [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 10 years |
Furniture And Fixtures [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful lives | 7 years |
Balance Sheet Information (Plan
Balance Sheet Information (Plant and Equipment) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 3,823,246 | $ 4,305,970 |
Less: accumulated depreciation and amortization | (3,508,556) | (3,901,418) |
Plant and equipment, net | 314,690 | 404,552 |
Equipment, Furniture And Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,535,560 | 4,018,284 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 287,686 | $ 287,686 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Sep. 30, 2018 | |
Amortization expense | $ 77,000 | $ 69,000 | $ 231,926 | $ 206,447 | |
Goodwill | $ 6,878,932 | $ 6,878,932 | $ 6,878,932 | ||
Developed Technology - PREBOOST [Member] | |||||
Amortization period | 10 years | ||||
Covenants Not-To-Compete [Member] | |||||
Amortization period | 7 years |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Gross Carrying Amounts of Finite Intangible Assets) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite lives, Gross Carrying Amount | $ 2,900,000 | $ 2,900,000 |
Accumulated Amortization | 654,197 | 422,271 |
Intangible assets with finite lives, Net Book Value | 2,245,803 | 2,477,729 |
Total intangible assets, Gross Carrying Amount | 20,900,000 | 20,900,000 |
Total intangible assets, Net Book Value | 20,245,803 | 20,477,729 |
Acquired In-Process Research And Development Assets [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with Indefinite lives,Net Book Value | 18,000,000 | 18,000,000 |
Developed Technology - PREBOOST [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite lives, Gross Carrying Amount | 2,400,000 | 2,400,000 |
Accumulated Amortization | 463,721 | 285,366 |
Intangible assets with finite lives, Net Book Value | 1,936,279 | 2,114,634 |
Covenants Not-To-Compete [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets with finite lives, Gross Carrying Amount | 500,000 | 500,000 |
Accumulated Amortization | 190,476 | 136,905 |
Intangible assets with finite lives, Net Book Value | $ 309,524 | $ 363,095 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Mar. 05, 2018USD ($) | Jun. 30, 2019USD ($)item |
Line of Credit Facility [Line Items] | ||
Net proceeds after fees and expenses | $ 9,900,000 | |
Change In Control Or Sale Of Business [Member] | ||
Line of Credit Facility [Line Items] | ||
Payment terms, change in control or sale of business fee, percentage multiple | item | 5 | |
SWK Credit Agreement [Member] | ||
Line of Credit Facility [Line Items] | ||
Loan amount | $ 10,000,000 | |
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% | |
Deferred loan issuance costs | $ 267,000 | |
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 | |
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, 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 | |
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) - USD ($) | 9 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Sep. 30, 2018 | |
Credit agreement, short-term portion | $ (4,660,572) | $ (6,692,718) |
Credit agreement, long-term portion | 4,489,540 | 2,701,570 |
SWK Credit Agreement [Member] | ||
Aggregate repayment obligation | 17,650,000 | 17,500,000 |
Less: Cumulative payments | (4,689,692) | (642,485) |
Less: Unamortized discounts | (5,440,322) | (8,475,874) |
Less: Unamortized deferred issuance costs | (127,874) | (204,353) |
Credit agreement, net | 7,392,112 | 8,177,288 |
Add: Embedded derivative liability at fair value (see Note 3) | 1,758,000 | 1,217,000 |
Credit agreement | 9,150,112 | 9,394,288 |
Credit agreement, short-term portion | (4,660,572) | (6,692,718) |
Credit agreement, long-term portion | $ 4,489,540 | $ 2,701,570 |
Debt (Residual Royalty Agreemen
Debt (Residual Royalty Agreement Liability) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Sep. 30, 2018 | |
Add: Accretion of liability using effective interest rate | $ 147,223 | $ 94,858 | $ 363,520 | $ 122,136 | |
Residual Royalty Agreement liability | 1,824,745 | 1,824,745 | $ 1,753,805 | ||
Residual Royalty Agreement [Member] | |||||
Residual Royalty Agreement liability, fair value at inception | 346,000 | 346,000 | 346,000 | ||
Less: Unamortized discounts | (2,420) | ||||
Add: Accretion of liability using effective interest rate | 564,745 | 201,225 | |||
Residual Royalty Agreement liability, net | 910,745 | 910,745 | 544,805 | ||
Add: Embedded derivative liability at fair value (see Note 3) | 914,000 | 914,000 | 1,209,000 | ||
Residual Royalty Agreement liability | $ 1,824,745 | $ 1,824,745 | $ 1,753,805 |
Debt (Credit Agreement Interest
Debt (Credit Agreement Interest Expense) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Debt [Abstract] | ||||
Amortization of Credit Agreement and Residual Royalty Agreement discounts | $ 922,144 | $ 1,255,062 | $ 3,187,972 | $ 1,572,809 |
Accretion of Residual Royalty Agreement liability | 147,223 | 94,858 | 363,520 | 122,136 |
Amortization of deferred issuance costs | 21,909 | 30,202 | 76,479 | 35,772 |
Interest expense | $ 1,091,276 | $ 1,380,122 | $ 3,627,971 | $ 1,730,717 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | Oct. 01, 2018 | May 31, 2018 | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2019 | Jun. 30, 2018 | Mar. 27, 2019 | Mar. 26, 2019 | Sep. 30, 2018 | Dec. 29, 2017 |
Preferred stock, shares authorized | 154,000,000 | 77,000,000 | ||||||||||
Preferred stock, issued | 0 | 0 | 0 | |||||||||
Preferred stock, outstanding | 0 | 0 | 0 | |||||||||
Aggregate purchase price of shares | $ 670,025 | $ 670,025 | $ 574,687 | |||||||||
Maximum purchase of shares per business day | 154,000,000 | 154,000,000 | 77,000,000 | |||||||||
Net proceeds from sale of shares | $ 9,131,967 | |||||||||||
Additional paid-in capital | $ 101,981 | $ 56,656 | ||||||||||
Value of shares issued for services | 3,600,000 | $ 2,000,000 | $ 347,081 | |||||||||
Net proceeds from sale of shares under common stock purchase agreement | $ 3,600,000 | $ 1,922,160 | ||||||||||
Aspire Capital [Member] | ||||||||||||
Aggregate purchase price of shares | $ 8,400,000 | $ 8,400,000 | $ 15,000,000 | |||||||||
Term of purchase agreement | 36 months | |||||||||||
Price per share of common stock agreed to sell under purchase agreement | $ 0.50 | $ 0.50 | ||||||||||
Maximum purchase of shares per business day | 200,000 | 200,000 | ||||||||||
Maximum VWAP percentage | 30.00% | |||||||||||
General percentage of VWAP pursuant to notice | 97.00% | |||||||||||
Issuance of common stock | 304,457 | |||||||||||
Common stock | $ 347,000 | |||||||||||
Issuance of shares (in Shares) | 2,000,000 | 1,176,470 | ||||||||||
Net proceeds from sale of shares | $ 3,600,000 | $ 2,000,000 | ||||||||||
Additional paid-in capital | 102,000 | $ 57,000 | ||||||||||
Related expenses | 78,000 | |||||||||||
Deferred assets | 425,000 | 425,000 | ||||||||||
Unamortized deferred assets | $ 238,000 | $ 238,000 | $ 340,000 | |||||||||
Financial Advisor Warrant [Member] | ||||||||||||
Warrant to purchase common stock shares | 2,585,379 | 2,585,379 | ||||||||||
Award expiration period | 5 years | |||||||||||
Strike price per share | $ 1.93 | |||||||||||
Consulting Services Warrants [Member] | ||||||||||||
Number or Warrants Issued | 2 | |||||||||||
Warrant to purchase common stock shares | 750,000 | |||||||||||
Closing price per share | $ 2.31 | |||||||||||
Fair value of warrant | $ 0 | $ 0 | ||||||||||
Preferred Class A [Member] | ||||||||||||
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) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Preferred stock, issued | 0 | 0 | 0 | |||||||||
Preferred stock, outstanding | 0 | 0 | 0 | |||||||||
Preferred Class A Series 1 [Member] | ||||||||||||
Preferred stock, shares authorized | 1,040,000 | 1,040,000 | 1,040,000 | |||||||||
Preferred Class A Series 2 [Member] | ||||||||||||
Preferred stock, shares authorized | 1,500,000 | 1,500,000 | 1,500,000 | |||||||||
Preferred Class A Series 3 [Member] | ||||||||||||
Preferred stock, shares authorized | 700,000 | 700,000 | 700,000 | |||||||||
Preferred Class A Series 4 [Member] | ||||||||||||
Preferred stock, shares authorized | 548,000 | 548,000 | 548,000 | |||||||||
Preferred Class B [Member] | ||||||||||||
Preferred stock, shares authorized | 15,000 | 15,000 | 15,000 | |||||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ 0.50 | $ 0.50 | $ 0.50 | |||||||||
Preferred stock, issued | 0 | 0 | 0 | |||||||||
Preferred stock, outstanding | 0 | 0 | 0 | |||||||||
Common Stock [Member] | ||||||||||||
Price per share of common stock agreed to sell under purchase agreement | $ 1.40 | |||||||||||
Issuance of shares (in Shares) | 7,142,857 | 7,142,857 | ||||||||||
Net proceeds from sale of shares | $ 71,428 | |||||||||||
Shares issued in connection with common stock purchase agreement (in Shares) | 2,000,000 | 1,176,470 | 304,457 | |||||||||
Value of shares issued for services | $ 20,000 | $ 11,764 | $ 3,045 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 9 Months Ended | ||||
Jun. 30, 2019 | Jun. 30, 2018 | Sep. 30, 2018 | Mar. 31, 2018 | Jul. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from stock option exercises | $ 200,000 | $ 66,000 | |||
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 3 years | ||||
Proceeds from stock option exercises | $ 200,000 | 66,000 | |||
Options, exercises in period, intrinsic value | $ 105,000 | $ 44,000 | |||
Share price | $ 2.13 | ||||
Unrecognized compensation expense, stock options | $ 3,500,000 | ||||
Unrecognized compensation expense, period for recognition | 3 years | ||||
Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock outstanding | 0 | 0 | |||
Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock outstanding | 0 | ||||
Restricted Stock Units (RSUs) [Member] | The APP Merger [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vest date | Oct. 31, 2018 | ||||
Restricted Stock Units (RSUs) [Member] | Employee [Member] | The APP Merger [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares issued | 50,000 | ||||
Restricted Stock Units (RSUs) [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 | ||||
Stock Appreciation Rights (SARs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award expiration period | 10 years | ||||
Exercise price per share | $ 0.95 | ||||
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 | ||||
Minimum [Member] | Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 1 year | ||||
Maximum [Member] | Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award expiration period | 10 years | ||||
Maximum [Member] | Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 3 years | ||||
2008 Stock Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized | 0 | ||||
2017 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized | 4,700,000 | ||||
Number of shares available | 46,514 | ||||
2018 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized | 6,000,000 | ||||
Number of shares available | 3,006,239 |
Share-based Compensation (Recor
Share-based Compensation (Recorded Share-Based Compensation Expenses) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 468,207 | $ 459,974 | $ 1,381,672 | $ 1,079,276 |
Cost of Sales [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 9,998 | 6,174 | 25,728 | 11,235 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 347,165 | 376,507 | 1,081,600 | 913,851 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 111,044 | $ 77,293 | $ 274,344 | $ 154,190 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 65.29% | 60.56% | 65.91% | 61.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-free interest rate | 2.23% | 2.86% | 2.37% | 2.63% |
Expected term (in years) | 6 years | 6 years | 5 years 10 months 24 days | 5 years 10 months 24 days |
Fair Value of Options Granted | $ 0.97 | $ 1.10 | $ 0.92 | $ 1 |
Share-based Compensation (Summa
Share-based Compensation (Summary Of Stock Options Outstanding And Exercisable) (Details) - Stock Option [Member] - USD ($) | 9 Months Ended |
Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Outstanding at Beginning of Period | 5,645,312 |
Number of Shares Granted | 2,255,282 |
Number of Shares Exercised | (283,333) |
Number of Shares Forfeited | (480,847) |
Number of Shares Outstanding at End of Period | 7,136,414 |
Number of Shares Exercisable at End of Period | 2,240,384 |
Weighted Average Exercise Price Per Share, Outstanding at Beginning of Period | $ 1.59 |
Weighted Average Exercise Price Per Share, Granted | 1.53 |
Weighted Average Exercise Price Per Share, Exercised | 1.19 |
Weighted Average Exercise Price Per Share, Forfeited | 1.89 |
Weighted Average Exercise Price Per Share, Outstanding at End of Period | 1.56 |
Weighted Average Exercise Price Per Share, Exercisable at End of Period | $ 1.48 |
Weighted Average Remaining Contractual Term, Outstanding at End of Period | 8 years 2 months 1 day |
Weighted Average Remaining Contractual Term, Exercisable at End of Period | 7 years 1 month 6 days |
Aggregate Intrinsic Value, Outstanding at End of Period | $ 4,082,982 |
Aggregate Intrinsic Value, Exercisable at End of Period | $ 1,460,499 |
Contingent Liabilities (Narrati
Contingent Liabilities (Narrative) (Details) | 9 Months Ended |
Jun. 30, 2019USD ($)lawsuit | |
Contingent Liabilities [Abstract] | |
Loss contingency, range of possible loss, maximum | $ 10,000,000 |
Number of class action lawsuits filed | lawsuit | 2 |
Possible losses accrued | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Sep. 30, 2017 | Sep. 30, 2018 | |
Income Tax Expense (Benefit) [Line Items] | |||
Corporate income tax rate | 21.00% | 35.00% | |
Valuation allowance | $ 2.4 | ||
Alternative Minimum Tax [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | $ 0.5 | ||
Foreign Tax Authority [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 62.3 | ||
Federal [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 33.2 | ||
Federal [Member] | 2022 to 2037 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 14.4 | ||
Federal [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 18.8 | ||
State [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 36.2 | ||
State [Member] | 2022 to 2037 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 19.6 | ||
State [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | $ 16.6 |
Income Taxes (Reconciliation Of
Income Taxes (Reconciliation Of Income Tax Expense (Benefit)) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income tax benefit at statutory rates | $ (582,652) | $ (1,412,119) | $ (1,856,337) | $ (5,040,855) |
State income tax benefit, net of federal benefits | (138,089) | (15,213) | (439,952) | (963,608) |
Recharacterization of foreign income tax credits to net operating loss | 1,311,429 | 1,311,429 | ||
Non-deductible expenses- other | 2,269 | 862 | 7,052 | 13,564 |
Effect of deemed dividend | 2,554 | 66,182 | ||
Increase in valuation allowance | 716,442 | 933,000 | 2,367,633 | 933,000 |
Other | (1,025) | 265,618 | (23,887) | 388,191 |
Income tax (benefit) expense | (458) | 1,206,131 | 117,207 | (3,342,339) |
Federal [Member] | ||||
Effect of change in tax rates | 190,319 | 3,319 | ||
Foreign Tax Authority [Member] | ||||
Effect of change in tax rates | $ 43 | $ (67,765) | $ (3,484) | $ 12,621 |
Income Taxes (Significant Compo
Income Taxes (Significant Components Of Deferred Tax Assets And Liabilities) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Federal net operating loss carryforwards | $ 8,527,304 | $ 6,973,047 |
State net operating loss carryforwards | 2,579,909 | 2,195,865 |
Foreign net operating loss carryforwards - U.K. | 10,626,155 | 10,595,518 |
Foreign capital allowance - U.K. | 102,098 | 102,098 |
U.K. bad debts | 1,700 | 1,700 |
Restricted stock - U.K. | 17,586 | 17,586 |
U.S. deferred rent | 52,257 | 22,902 |
Share-based compensation | 843,466 | 622,442 |
Gross deferred tax assets | 22,943,868 | 20,656,420 |
Valuation allowance for deferred tax assets | (9,998,711) | (7,631,078) |
Net deferred tax assets | 12,945,157 | 13,025,342 |
Deferred Tax Liabilities: | ||
In process research and development | (4,675,860) | (4,675,860) |
Developed Technology | (502,987) | (549,318) |
Covenant not-to-compete | (80,405) | (94,321) |
Other | (7,318) | (6,843) |
Net deferred tax liabilities | (5,266,570) | (5,326,342) |
Net deferred tax assets | 7,678,587 | 7,699,000 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 33,896 | 33,843 |
U.S. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | $ 159,497 | $ 91,419 |
Income Taxes (Schedule Of Defer
Income Taxes (Schedule Of Deferred Tax Amounts Classified In Balance Sheets) (Details) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | $ 8,574,448 | $ 8,543,758 |
Deferred tax liability | (895,861) | (844,758) |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | 8,540,552 | 8,509,915 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax asset | 33,896 | 33,843 |
U.S. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Deferred tax liability | $ (895,861) | $ (844,758) |
Industry Segments (Narrative) (
Industry Segments (Narrative) (Details) | 9 Months Ended |
Jun. 30, 2019segment | |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating (loss) income | $ (1,842,002) | $ (4,964,728) | $ (4,978,319) | $ (17,097,860) |
Operating Segments [Member] | ||||
Operating (loss) income | (1,842,000) | (4,965,000) | (4,978,000) | (17,098,000) |
Commercial [Member] | Operating Segments [Member] | ||||
Operating (loss) income | 5,621,000 | 1,328,000 | 12,493,000 | 1,309,000 |
Research and development [Member] | Operating Segments [Member] | ||||
Operating (loss) income | (4,853,000) | (3,787,000) | (10,104,000) | (7,780,000) |
Corporate [Member] | Operating Segments [Member] | ||||
Operating (loss) income | $ (2,610,000) | $ (2,506,000) | $ (7,367,000) | $ (10,627,000) |