Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2019 | Dec. 10, 2019 | Mar. 31, 2019 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Period End Date | Sep. 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | veru | ||
Entity Public Float | $ 67.8 | ||
Entity Common Stock, Shares Outstanding | 65,039,114 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 6,295,152 | $ 3,759,509 |
Accounts receivable, net | 5,021,057 | 3,972,632 |
Inventory, net | 3,647,406 | 2,302,030 |
Prepaid expenses and other current assets | 1,843,297 | 1,148,345 |
Total current assets | 16,806,912 | 11,182,516 |
Plant and equipment, net | 351,895 | 404,552 |
Deferred income taxes | 8,433,669 | 8,543,758 |
Intangible assets, net | 20,168,495 | 20,477,729 |
Goodwill | 6,878,932 | 6,878,932 |
Other assets | 988,867 | 965,152 |
Total assets | 53,628,770 | 48,452,639 |
Current liabilities: | ||
Accounts payable | 3,124,751 | 3,226,036 |
Accrued research and development costs | 2,475,490 | 981,357 |
Accrued compensation | 1,597,197 | 687,248 |
Accrued expenses and other current liabilities | 1,436,888 | 1,778,409 |
Credit agreement, short-term portion (Note 9) | 5,385,649 | 6,692,718 |
Unearned revenue | 187,159 | |
Total current liabilities | 14,019,975 | 13,552,927 |
Credit agreement, long-term portion (Note 9) | 2,886,382 | 2,701,570 |
Residual royalty agreement (Note 9) | 3,845,518 | 1,753,805 |
Deferred income taxes | 296,605 | 844,758 |
Other liabilities | 247,154 | 118,161 |
Total liabilities | 21,295,634 | 18,971,221 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Preferred stock; no shares issued and outstanding at September 30, 2019 and 2018, respectively | ||
Common stock, par value $0.01 per share; 154,000,000 and 77,000,000 shares authorized, 67,221,951 and 57,468,660 shares issued and 65,038,247 and 55,284,956 shares outstanding at September 30, 2019 and 2018, respectively | 672,220 | 574,687 |
Additional paid-in-capital | 110,268,057 | 95,496,506 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (70,219,017) | (58,201,651) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 32,333,136 | 29,481,418 |
Total liabilities and stockholders' equity | $ 53,628,770 | $ 48,452,639 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2019 | Sep. 30, 2018 |
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 | 67,221,951 | 57,468,660 |
Common Stock, shares outstanding | 65,038,247 | 55,284,956 |
Treasury stock, shares | 2,183,704 | 2,183,704 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ||
Net revenues | $ 31,803,387 | $ 15,864,483 |
Cost of sales | 10,146,565 | 7,091,942 |
Gross profit | 21,656,822 | 8,772,541 |
Operating expenses: | ||
Research and development | 13,743,826 | 10,850,958 |
Selling, general and administrative | 14,348,890 | 14,807,472 |
Loss on settlement of accounts receivable | 3,986,518 | |
Total operating expenses | 28,092,716 | 29,644,948 |
Operating loss | (6,435,894) | (20,872,407) |
Non-operating (expenses) income: | ||
Interest expense | (4,706,056) | (2,950,501) |
Change in fair value of derivative liabilities | (1,199,000) | 893,000 |
Foreign currency transaction loss | (73,640) | (126,928) |
Other income (expense), net | 93,291 | (15,451) |
Total non-operating expenses | (5,885,405) | (2,199,880) |
Loss before income taxes | (12,321,299) | (23,072,287) |
Income tax (benefit) expense | (303,933) | 866,102 |
Net loss | $ (12,017,366) | $ (23,938,389) |
Net loss per basic and diluted common share outstanding | $ (0.19) | $ (0.44) |
Basic and diluted weighted average common shares outstanding | 63,323,127 | 53,861,981 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKOLDERS' 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 | 1,638,505 | 1,638,505 | |||||
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 | ||||||
Sale of shares under common stock purchase agreement | $ 17,170 | 2,982,830 | 3,000,000 | ||||
Sale of shares under common stock purchase agreement (in Shares) | 1,717,010 | ||||||
Amortization of deferred costs | (84,984) | (84,984) | |||||
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 | (23,938,389) | (23,938,389) | |||||
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 | 1,906,098 | 1,906,098 | |||||
Shares issued in connection with public offering of common stock, net of fees and costs | $ 71,429 | 9,060,538 | 9,131,967 | ||||
Shares issued in connection with public offering of common stock, net of fees and costs (in Shares) | 7,142,857 | ||||||
Sale of shares under common stock purchase agreement | $ 20,000 | 3,580,000 | 3,600,000 | ||||
Sale of shares under 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 | $ 6,104 | 326,896 | 333,000 | ||||
Issuance of shares pursuant to share-based awards ( in Shares) | 610,434 | ||||||
Net loss | (12,017,366) | (12,017,366) | |||||
Balance at Sep. 30, 2019 | $ 672,220 | $ 110,268,057 | $ (581,519) | $ (70,219,017) | $ (7,806,605) | $ 32,333,136 | |
Balance (in Shares) at Sep. 30, 2019 | 67,221,951 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
OPERATING ACTIVITIES | ||
Net loss | $ (12,017,366) | $ (23,938,389) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 162,187 | 176,786 |
Amortization of intangible assets | 309,234 | 275,262 |
Non-cash interest expense | 4,706,056 | 2,950,501 |
Share-based compensation | 1,906,098 | 1,638,505 |
Deferred income taxes | (438,064) | 630,150 |
Loss on settlement of accounts receivable | 3,986,518 | |
Provision for obsolete inventory | 109,107 | 90,856 |
Change in fair value of derivative liabilities | 1,199,000 | (893,000) |
Other | 142,590 | (2,756) |
Changes in current assets and liabilities: | ||
(Increase) decrease in accounts receivable | (1,351,709) | 1,874,555 |
(Increase) decrease in inventory | (1,454,483) | 375,038 |
Increase in prepaid expenses and other assets | (704,306) | (65,570) |
(Decrease) increase in accounts payable | (56,938) | 495,971 |
Decrease in unearned revenue | (187,159) | (487,068) |
Increase in accrued expenses and other current liabilities | 2,190,546 | 1,346,450 |
Net cash (used in) provided by operating activities | (5,485,207) | (11,546,191) |
INVESTING ACTIVITIES | ||
Capital expenditures | (108,517) | (50,654) |
Net cash used in investing activities | (108,517) | (50,654) |
FINANCING ACTIVITIES | ||
Proceeds from sale of shares in public offering | 9,400,000 | |
Payment of costs related to public offering | (268,033) | |
Proceeds from SWK credit agreement | 10,000,000 | |
Payment of debt issuance costs | (266,923) | |
Installment payments on SWK credit agreement | (4,935,600) | (642,485) |
Proceeds from sale of shares under common stock purchase agreement | 3,600,000 | 3,000,000 |
Payment of costs related to common stock purchase agreement | (77,840) | |
Proceeds from stock option exercises | 333,000 | 66,000 |
Net cash provided by financing activities | 8,129,367 | 12,078,752 |
Net increase in cash and cash equivalents | 2,535,643 | 481,907 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 3,759,509 | 3,277,602 |
CASH AND CASH EQUIVALENTS AT END OF YEAR | 6,295,152 | 3,759,509 |
Supplemental disclosure of cash flow Information: | ||
Cash paid for income taxes | 303,582 | 222,223 |
Schedule of non-cash 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 | 84,984 |
Increase in other assets from accounts payable and accrued expenses | $ 190,000 | |
Acquisition of equipment, furniture, and fixtures through capital lease | $ 43,567 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2019 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Nature of Business and Significant Accounting Policies | Note 1 – Nature of Business and Significant Accounting Policies Principles of consolidation and nature of operations: Veru Inc. is referred to in these notes collectively with its subsidiaries as “we,” “our,” “us,” “Veru” or the “Company.” The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, 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 health care 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 fiscal 2019 and 2018 were derived from sales of FC2. FC2 has been distributed in either or both commercial (private sector) and public health sector markets in 150 countries. It is marketed to consumers in 25 countries through distributors, public health programs, and/or retailers and in the U.S. by prescription. Reclassifications: Certain prior period amounts in the accompanying 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. Use of estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. Cash and cash equivalents and concentration : Cash and cash equivalents, which primarily consist of cash on deposit with financial institutions and highly liquid money market funds, are recorded in the consolidated balance sheets at cost, which approximates fair value. The Company treats short-term, highly liquid funds that are readily convertible to known amounts of cash and have original maturities of three months or less as cash equivalents. The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England; and Kuala Lumpur, Malaysia. 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 September 30, 2019. Restricted cash was $135,000 at September 30, 2018 and is included in cash and cash equivalents on the accompanying consolidated balance sheets. Accounts receivable and concentration of credit risk : Accounts receivable are carried at original invoice amount less an estimate made for doubtful receivables based on a review of all outstanding amounts on a periodic basis. 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. Fixed assets : We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method, over the estimated useful lives of the assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the assets. Leases : Leases are classified as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for capital lease obligations are established at an amount equal to the present value of minimum lease payments during the lease term. The capital lease obligation is amortized over the life of the lease. Patents and trademarks : The costs for patents and trademarks are expensed when incurred. Goodwill and intangible assets : The Company’s goodwill and intangible assets, primarily developed technology and in-process research and development (“IPR&D”), arose from the APP A cquisition on October 31, 2016. Goodwill and indefinite-lived intangible assets are not amortized. IPR&D is accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a finite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off. Goodwill and indefinite-lived assets are subject to an impairment review annually, in the fourth quarter of each fiscal year, and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Intangible assets with finite lives are tested for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. These intangible assets are carried at cost less accumulated amortization. Goodwill consists of the cost of an acquired business in excess of the fair value of the net assets acquired. The Company’s goodwill is assigned to the Company’s sole reporting unit in the Company’s Research and Development reporting segment. The Company tests goodwill and indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the Company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the Company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and potentially result in different impacts to the Company's results of operations. Actual results may differ from the Company's estimates. Regarding goodwill, the estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Changes in these assumptions may impact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results are not consistent with our estimates and assumptions, we may be exposed to an impairment charge that could be material. Intangible assets are highly vulnerable to impairment charges, particularly IPR&D . These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval, additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. 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. Deferred financing costs : Costs incurred in connection with the common stock purchase agreement discussed in Note 10 have been included in other assets on the accompanying consolidated balance sheets at September 30, 2019 and 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 10, 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 is included in other assets on the accompanying consolidated balance sheet at September 30, 2018. These costs were charged to additional paid-in capital in the first quarter of fiscal 2019 when the common stock offering closed. Costs incurred in connection with the issuance of debt discussed in Note 9 are presented as a reduction of the debt on the accompanying consolidated balance sheet at September 30, 2019 and 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 third quarter of fiscal 2021. The amortization is included in interest expense on the accompanying 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 consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements . The carrying amounts reported in the accompanying consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of 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 in curred in connection with an embedded derivative are discussed in Note 9. Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue. Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, costs to conduct clinical trials, and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did not have any capitalized nonrefundable advance payments as of September 30, 2019 and 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 rate. 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 years ended September 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 , resulting in the adoption of the U.S. dollar as the functional currency for all foreign subsidiaries . The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $0.6 million as of September 30, 2019 and 2018 . Assets located outside of the U.S. totaled approximately $8.2 million and $5.2 million at September 30, 2019 and 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 consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. In fiscal 2019 and 201 8 , 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. In July 2018, the FASB issued ASU 2018‑10, Codification Improvements to Topic 842, Leases to clarify the implementation guidance and ASU 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. In 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. In 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, using the optional transition method provided by ASU 2018-11, under which we will apply the new requirements to only those leases that exist as of October 1, 2019. Prior periods will be presented under existing lease guidance. Upon adoption, we will elect the package of practical expedients permitted under the transition guidance, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification, and the initial direct costs. We do not expect to elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to us. We will make an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company currently estimates the adoption of this guidance will result in the recognition of right of use assets and lease liabilities for operating leases, which will increase our total assets and total liabilities by approximately $1.2 million, as of October 1, 2019. The Company does not expect the adoption will have a material impact on its consolidated statement of operations or cash flows. The adoption will have no impact on our debt covenant compliance under our current agreements. 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 implied fair value of goodwill by assigning the fair value of a reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. Under this amendment, an entity will perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge is recognized for the amount by which the carrying value exceeds the reporting unit's fair value. 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 | 12 Months Ended |
Sep. 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 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 , cash expected to be generated from sales of the Company’s commercial products, 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 , including existing purchase agreements, 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 10). |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 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 three levels of the fair value hierarchy are as follows: Level 1 – Quoted prices for identical instruments in active markets. Level 2 – Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 – Instruments with primarily unobservable value drivers. There were no transfers between Level 1 , Level 2 and Level 3 during fiscal 201 9 and 201 8 . As of September 30, 201 9 and 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, considerin g all of the rights and obligations of each instrument. The Company estimates the fair value of hybrid instruments using various techniques (and combinations thereof) that are considered to be consistent with the objective of measuring fair value. In selecting the appropriate technique, the Company considers, among other factors, the nature of the instrument, the market risks that it embodies and the expected means of settlement. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. Increases in fair value during a given financial quarter result in the recognition of non-cash derivative expense. Conversely, decreases in fair value during a given financial quarter would result in the recognition of non-cash derivative income. The following table provides a reconciliation of the beginning and ending liability balance associated with embedded derivatives measured at fair value using significant unobservable inputs (Level 3) for the year s ended September 30, 201 9 and 2018 : 2019 2018 Beginning balance $ 2,426,000 $ — Additions — 3,319,000 Change in fair value of derivative liabilities 1,199,000 (893,000) Ending balance $ 3,625,000 $ 2,426,000 The expense or income associated with the change in fair value of the embedded derivatives is presented as a separate line item in the accompanying consolidated statements of operations. The liabilities associated with embedded derivatives represent the fair value of the change of control provisions in the Credit Agreement and Residual Royalty Agreement. See Note 9 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. The assumptions used in calculating the fair value of financial instruments represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, the use of different estimates or assumptions would result in a higher or lower fair value and different amounts being recorded in the Company’s financial statements. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. The increase in fair value of derivative liabilities in fiscal 2019 is driven by an increase in the expected cash outflows under the Residual Royalty Agreement . The decrease in fair value in fiscal 2018 was primarily driven by shifts in the estimated change of control dates into future periods and a reduction in estimated near-term cash outflows under the Credit Agreement. The following table presents quantitative information about the inputs and valuation methodologies used to determine the fair value of the embedded derivatives classified in Level 3 of the fair value hierarchy as of September 30, 201 9 and 2018 : Weighted Average (range, if applicable) Valuation Methodology Significant Unobservable Input 2019 2018 Monte Carlo Simulation Estimated change of control dates September 2020 to December 2021 September 2019 to December 2021 Discount rate 14.4% to 16.8% 11.1 % to 12.0 % Probability of change of control 10% to 90% 10 % to 90 % |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Sep. 30, 2019 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Contracts with Customers | Note 4 – Revenue from Contracts with Customers The Company generates nearly all its revenue from direct product sales. Revenue from direct product sales is generally recognized when the customer obtains control of the product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Sales taxes and other similar taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue. The amount of consideration the Company ultimately receives varies depending upon sales discounts, and other incentives that the Company may offer, which are accounted for as variable consideration when estimating the amount of revenue to recognize. The estimate of variable consideration requires significant judgment. The Company includes estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. The estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely upon an assessment of current contract sales terms and historical payment experience. Product returns are typically not significant because returns are generally not allowed unless the product is damaged at time of receipt. The Company’s revenue is from 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 the treatment of premature ejaculation. The following table presents net revenues from these three categories for the years ended September 30, 2019 and 2018: 2019 2018 FC2 Global public sector $ 16,835,998 $ 13,458,365 U.S. prescription channel 14,083,368 2,394,219 Total FC2 30,919,366 15,852,584 PREBOOST ® 884,021 11,899 Net revenues $ 31,803,387 $ 15,864,483 The following table presents net revenue by geographic area for the years ended September 30, 2019 and 2018: 2019 2018 United States $ 17,260,174 $ 5,221,052 Zimbabwe * 2,159,263 South Africa * 2,960,677 Other 14,543,213 5,523,491 Net revenues $ 31,803,387 $ 15,864,483 * Less than 10% of total net revenues The Company’s performance obligations consist mainly of transferring control of products identified in the contracts which occurs either when: i) the product is made available to the customer for shipment; ii) the product is shipped via common carrier; or iii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement. Some of the Company’s contracts require the customer to make advanced payments prior to transferring control of the products. These advanced payments create a contract liability for the Company. The balances of the Company’s contract liability, included in accrued expenses and other current liabilities on the accompanying consolidated balances sheets, was approximately $249,000 and $4,000 at September 30, 2019 and 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 un der the terms of a contract; for example, if a distributor has a right to return product sold under certain conditions. 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 September 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 | 12 Months Ended |
Sep. 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 sales within the period. As is typical in the Company’s business, extended credit terms may occasionally be offered as a sales promotion or for certain sales. For sales to the Company’s distributor in Brazil, the Company has agreed to credit terms of up to 180 days subsequent to clearance of the product by the Ministry of Health in Brazil. As of September 30, 2019, the Company classified approximately $300,000 of trade receivables with its distributor in Brazil as long-term because payment is expected in greater than one year. As of September 30, 2018 the Company did not have any trade receivables classified as long-term. The long-term portion of trade receivables is included in other assets on the accompanying consolidated balance sheets. The components of accounts receivable consist of th e following at September 30, 201 9 and 201 8 : 2019 2018 Trade receivables $ 5,103,823 $ 4,046,733 Less: allowance for doubtful accounts (33,143) (36,201) Less: allowance for sales returns and payment term discounts (49,623) (37,900) Trade receivables, net $ 5,021,057 $ 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. 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 second payment of $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 approximately $ 4.0 million for the year ended September 30, 2018, which is presented as a separate line item in the accompanying consolidated statements of operations. At September 30, 201 9 , no customer had an accounts receivable balance that represented greater than 10% of current assets. At September 30, 201 8 , one customer had an accounts receivable balance that represented 15% of current assets. At September 30, 201 9 , two customers had an accounts receivable balance greater than 10% of net accounts receivable, representing 64% of net accounts receivable in the aggregate. At September 30, 201 8 , three customers had an accounts receivable balance greater than 10% of net accounts receivable, represent ing 74% of the Company’s net accounts receivable in the aggregate . For the year ended September 30, 201 9 , 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 year ended September 30, 2018, 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 . 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 allowance for doubtful accounts for the years ended September 30, 201 9 and 2018: 2019 2018 Beginning balance $ 36,201 $ 38,103 Charges to expense — 16,058 Charge-offs (3,058) (17,960) Ending balance $ 33,143 $ 36,201 Recoveries of accounts receivable previously charged-off are recorded when received. The Company’s customers are primarily health care distributors, large global agencies, non-government organizations, ministries of health and other governmental agencies which purchase and distribute FC2 for use in HIV/AIDS prevention and family planning programs and, in the U.S. prescription channel, telemedicine providers . |
Inventory
Inventory | 12 Months Ended |
Sep. 30, 2019 | |
Inventory [Abstract] | |
Inventory | Note 6 – Inventory Inventory consisted of the following at September 30, 201 9 and 201 8: 2019 2018 FC2 Raw material $ 426,590 $ 366,220 Work in process 187,970 77,669 Finished goods 3,157,952 2,232,864 FC2, gross 3,772,512 2,676,753 Less: inventory reserves (125,106) (391,861) FC2, net 3,647,406 2,284,892 PREBOOST ® Finished goods — 17,138 Inventory, net $ 3,647,406 $ 2,302,030 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2019 | |
Property and Equipment [Abstract] | |
Property and Equipment | Note 7 – Property and Equipment Property and equipment consisted of the following at September 30, 2019 and 2018: Estimated Useful Life 2019 2018 Property and equipment: Manufacturing equipment 5 - 8 years $ 2,716,647 $ 3,256,884 Office equipment, furniture and fixtures 3 - 10 years 795,228 761,400 Leasehold improvements 3 - 8 years 298,886 287,686 Total property and equipment 3,810,761 4,305,970 Less: accumulated depreciation and amortization (3,458,866) (3,901,418) Property and equipment, net $ 351,895 $ 404,552 Depreciation and amortization expense for the years ended September 30, 2019 and 2018 was $162,000 and $177,000, respectively. In September 2019, the Company entered into a lease agreement for office space, which included a capital lease for office equipment, furniture, and fixtures. At September 30, 2019, the value of the assets under capital lease was $44,000 , included in office equipment, furniture and fixtures above. The Company did not have any assets under capital lease at September 30, 2018. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Sep. 30, 2019 | |
Intangible Assets and Goodwill [Abstract] | |
Intangible Assets and Goodwill | Note 8 –Intangible Assets and Goodwill Intangible Assets Intangible assets acquired in the APP Acquisition included IPR&D, developed technology consisting of PREBOOST ® medicated wipes for the treatment of premature ejaculation, and covenants not-to-compete. The gross carrying amounts and net book value of intangible assets are as follows at September 30, 201 9 : Gross Carrying Accumulated Net Book Amount Amortization Value Intangible assets with finite lives: Developed technology - PREBOOST ® $ 2,400,000 $ 523,172 $ 1,876,828 Covenants not-to-compete 500,000 208,333 291,667 Total intangible assets with finite lives 2,900,000 731,505 2,168,495 Acquired in-process research and development assets 18,000,000 — 18,000,000 Total intangible assets $ 20,900,000 $ 731,505 $ 20,168,495 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 consolidated statements of operations. Amortization expense was approximately $ 309,000 and $ 275 ,000 , for the years ended September 30, 201 9 and 201 8 , respectively. Based on finite-lived intangible assets recorded as of September 30, 201 9 , the estimated future amortization expense is as follows: Estimated Year Ending September 30, Amortization Expense 2020 $ 316,368 2021 323,706 2022 331,316 2023 339,062 2024 281,603 Thereafter 576,440 Total $ 2,168,495 Goodwill The carrying amount of goodwill at September 30, 201 9 and 201 8 was $6.9 million . There was no change in the balance during the years ended September 30, 2019 and 2018. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2019 | |
Debt [Abstract] | |
Debt | Note 9 – 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 provide d the Company with a term loan of $10.0 million , which was advan ced 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 year 2019, a return to the original percentages to calculate the quarterly revenue-based payments due on product revenue from net sales of FC2 during calendar year 2020 and an increase to the percentages to be used to calculate the quarterly revenue-based payments due on product revenue from net sales of FC2 during calendar year 2021 and thereafter until the loan has been repaid. Upon a change of control of the Company or sale of the FC2 business, the Company must pay off the loan by making a payment to the Lenders equal to (i) 176.5% of the aggregate amount advanced to the Company under the Credit Agreement less the amounts previously paid by the Company from product revenue from net sales of FC2 , plus (ii) the greater of (A) $2.0 million or (B) the product of (x) 5% of the product revenue from net sales of FC2 for the most recently completed 12 -month period multiplied by (y) five . A “change of control” under the Credit Agreement includes (i) an acquisition by any person of direct or indirect ownership of more than 50% of the Company’s issued and outstanding voting equity, (ii) a change of control or similar event in the Company’s articles of incorporation or bylaws, (iii) certain Key Persons as defined in the Credit Agreement cease to serve in their current executive capacities unless replaced within 90 days by a person reasonably acceptable to the Agent, which acceptance not to be unreasonably withheld, or (iv) the sale of all or substantially all of the Company’s assets. The Credit Agreement contains customary representations and warranties in favor of the Agent and the Lenders and certain covenants, including financial covenants addressing minimum quarterly marketing and distribution expenses for FC2 and a requirement to maintain minimum unencumbered liquid assets of $1.0 million. The Credit Agreement also restricts the payment of dividends and share repurchases. The recourse of the Lenders and the Agent for obligations under the Credit Agreement is limited to assets relating to FC2. In connection with the Credit Agreement, the Company and the Agent also entered into a Residual Royalty Agreement, dated as of March 5, 2018 (as amended, the “Residual Royalty Agreement”), which provides for an ongoing royalty payment of 5% of product revenue from net sales of FC2 commencing after the Company would have paid 175% of the aggregate amount advance to the Company under the Credit Agreement based on a calculation of revenue-based payments under the Credit Agreement without taking into account the amendments to the payment requirements under the Credit Agreement effected by the Second Amendment. The Residual Royalty Agreement will terminate upon (i) a change of control or sale of the FC2 business and the payment by the Company of the amount due in connection therewith pursuant to the Credit Agreement, or (ii) mutual agreement of the parties. If a change of control or sale of the FC2 business occurs prior to payment in full of the Credit Agreement, there will be no further payment due with respect to the Residual Royalty Agreement. If a change of control or sale of the FC2 business occurs after payment in full of the Credit Agreement, the Agent will receive a payment that is the greater of (A) $2.0 million or (B) the product of (x) 5% of the product revenue from net sales of FC2 for the most recently completed 12 -month period multiplied by (y) five . Pursuant to a Guarantee and Collateral Agreement dated as of March 5, 2018 (the “Collateral Agreement”) and an Intellectual Property Security Agreement dated as of March 5 , 2018 (the “IP Security Agreement”), the Company’s obligations under the Credit Agreement are secured by a lien against substantially all of the assets of the Company that relate to or arise from FC2. In addition, pursuant to a Pledge Agreement dated as of March 5, 2018 (the “Pledge Agreement”), the Company’s obligations under the Credit Agreement are secured by a pledge of up to 65% of the outstanding shares of The Female Health Company Limited, a wholly - owned U.K. subsidiary. For accounting purposes, the $10.0 million advance under the Credit Agreement was allocated between the Credit Agreement and the Residual Royalty Agreement on a relative fair value basis. A portion of the amount allocated to the Credit Agreement and a portion of the amount allocated to the Residual Royalty Agreement, in both cases equal to the fair value of the respective change of control provisions, was allocated to the embedded derivative liabilities. The derivative liabilities are adju sted to fair market value at each reporting period . For financial statement presentation, the embedded derivative liabilities have been included with their respective host instruments as noted in the following tables. The debt discounts, which totaled $11.3 million, are being amortized to interest expense over the expected term of the loan using the effective interest method. Additionally, the Company recorded deferred loan issuance costs of approximately $267,000 for legal fees incurred in connection with the Credit Agreement. The deferred loan issuance costs are presented as a reduction of the Credit Agreement obligation and are being amortized to interest expense over the expected term of the loan using the effective interest method. The Second Amendment was accounted for as a debt modification, which resulted in prospective adjustment to the effective interest rate. At September 30, 2019 and 2018, the Credit Agreement liability consisted of the following: 2019 2018 Aggregate repayment obligation $ 17,650,000 $ 17,500,000 Less: payments (5,578,085) (642,485) Less: unamortized discounts (4,590,974) (8,475,874) Less: unamortized deferred issuance costs (107,910) (204,353) Credit agreement, excluding embedded derivative liability, net 7,373,031 8,177,288 Add: embedded derivative liability at fair value (see Note 3) 899,000 1,217,000 Credit agreement, net 8,272,031 9,394,288 Credit agreement, short-term portion (5,385,649) (6,692,718) Credit agreement, long-term portion $ 2,886,382 $ 2,701,570 The short-term portion of the Credit Agreement represents the aggregate of the estimated quarterly revenue-based payment s payable during the 12-month periods subsequent to September 30, 2019 and September 30, 20 18, respectively . At September 30, 2019 and 2018, the Residual Royalty Agreement liability consisted of the following: 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 773,518 201,225 Residual royalty agreement, excluding embedded derivative liability, net 1,119,518 544,805 Add: embedded derivative liability at fair value (see Note 3) 2,726,000 1,209,000 Residual royalty agreement $ 3,845,518 $ 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 years ended September 30, 2019 and 2018, i nterest expense related to the Credit Agreement and Residual Royalty Agreement was as follows: 2019 2018 Amortization of discounts $ 4,037,320 $ 2,686,706 Accretion of residual royalty agreement 572,293 201,225 Amortization of deferred issuance costs 96,443 62,570 Interest expense $ 4,706,056 $ 2,950,501 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 10 – Stockholders’ Equity Preferred Stock The Company has 5,000,000 shares designated as Class A Preferred Stock with a par value of $0.01 per share. There are 1,040,000 shares of Class A Preferred Stock – Series 1 authorized; 1,500,000 shares of Class A Preferred Stock – Series 2 authorized; 700,000 shares of Class A Preferred Stock – Series 3 authorized; and 548,000 shares of Class A Preferred Stock – Series 4 authorized. There were no shares of Class A Preferred Stock of any series issued and outstanding at September 30, 201 9 or September 30, 201 8 . The Company has 15,000 shares designated as Class B Preferred Stock with a par value of $0.50 per share. There were no shares of Class B Preferred Stock issued and outstanding at September 30, 201 9 or September 30, 201 8 . Common Stock We are authorized to issue up to 154,000,000 shares of common stock, $0.01 par value per share. On March 27 , 201 9 , following approval by stockholders at the Company ’s annual mee ting 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. Holders are entitled to one vote for each share of common stock. 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 cost s pa id 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 an exercise price equal to $1.93 per share. The Financial Advisor Warrant vested upon issuance and remains outstanding as of September 30, 201 9 . 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 service s agreement was terminated in March 2019 and the warrants were cancelled at the same time. None of the specified performance goals contained in the warrants had been achieved prior to cancellation of the warrants. 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 ha d determined the fair value of these warrants to be zero and ha d not recognized any 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 R egistration S tatement, 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 fiscal 201 9 , 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 th is sale in fiscal 2019 , we recorded approximately $102,000 of the deferred costs noted above to additional paid-in capital. During fiscal 2018, we sold an aggregate of 1,717,010 shares of common stock to Aspire Capital under the Purchase Agreement resulting in proceeds to the Company of $3.0 million. As a result of these sales in fiscal 2018 , we recorded approximately $85,000 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 September 30, 2019 and 2018, respectively, is included in other assets on the accompanying consolidated balance sheet s . As of September 30, 201 9 , the amount remaining under the Purchase Agreement was $8.4 million. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Sep. 30, 2019 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | Note 11 – Share-based Compensation We allocate share-based compensation expense to cost of sales, selling, general and administrative expense and research and development expense based on the award holder’s employment function. We recorded income tax benefits for share-based compensation expense of approximately $431,000 and $426,000 in fiscal 201 9 and 201 8 , respectively. For fiscal 2019 and 2018 , we recorded share-based compensation expenses as follows: 2019 2018 Cost of sales $ 38,026 $ 19,187 Selling, general and administrative 1,471,391 1,284,287 Research and development 396,681 335,031 $ 1,906,098 $ 1,638,505 We have issued share-based awards to employees and non-executive directors under the Company’s approved equity plans. Upon the exercise of share-based awards, new shares are issued from authorized common stock. Equity Plans In March 2018, the Company’s stockholders approved the Company's 2018 Equity Incentive Plan (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 September 30, 20 19, 2,967,614 shares remain available for issuance under the 2018 Plan. In July 2017, the Company’s stockholders approved the Company's 2017 Equity Incentive Plan (the “2017 Plan”). A total of 4.7 million shares are authorized for issuance under the 2017 Plan. As of September 30, 2019, 4 9,514 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 years ended September 30, 201 9 and 201 8 : 2019 2018 Weighted Average Assumptions: Expected Volatility 65.85% 60.95% Expected Dividend Yield 0.00% 0.00% Risk-free Interest Rate 2.36% 2.65% Expected Term (in years) 5.9 5.9 Fair Value of Options Granted $ 0.93 $ 1.00 During the years ended September 30, 201 9 and 201 8 , the Company used historical volatility of our common stock over a period equal to the expected life of the options to estimate their fair value. The dividend yield assumption is based on the Company’s recent history and expectation of future dividend payouts on the common stock. The risk-free interest rate is based on the implied yield available on U.S. treasury zero-coupon issues with an equivalent remaining term. The following table summarizes the stock options outstanding and exercisable at September 30, 201 9 : 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 2,295,407 1.54 Exercised (427,383) 1.11 Forfeited (485,347) 1.89 Outstanding at September 30, 2019 7,027,989 $ 1.58 7.95 $ 4,098,686 Exercisable at September 30, 2019 2,700,166 $ 1.47 7.11 $ 1,855,420 The aggregate intrinsic values in the table above are before income taxes and represent the number of in-the-money options outstanding or exercisable multiplied by the closing price per share of the Company’s common stock on the last trading day of the year ended September 30, 201 9 of $2.16 , less the respective weighted average exercise price per share at period end . As of September 30, 201 9 , the Company had unrecognized compensation expense of approximately $3.0 million related to unvested stock options. This expense is expected to be recognized over approximately 3 years. The total intrinsic value of options exercised was approximately $274,000 and $44,000 during the years ended September 30, 2019 and 2018, respectively. Cash received from options exercised was $333,000 and $66,000 in the year s ended September 30, 2019 and 2018, respectively . During fiscal 2019 and 2018, the Company modified stock options held by certain optionees upon termination of their employment by the Company, retirement from the board of directors or resignation from the board of directors. The stock options were primarily modified to accelerate vesting to the date of termination or retirement. The aggregate amount of expense recognized in connection with these modifications for the year s ended September 30, 2019 and 2018 was approximately $53,000 and $362,000 , respectively . Restricted Stock The Company has issued restricted stock to employees, directors and consultants. Such issuances had vesting periods that range d from one to three years. All such shares of restricted stock vest ed provided the grantee ha d not voluntarily terminated service or been terminated for cause prior to the vesting date. There were no shares of restricted stock outstanding at September 30, 2019 and 2018. No shares of restricted stock vested during the year ended September 30, 2019. The fair value of shares of restricted stock that vested during the year ended September 30, 2018 was approximately $272,000 . 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 vest ed on October 31, 2018 with an intrinsic value of approximately $230,000 . The restricted stock units were settled in common stock issued under the 2017 Plan. As of September 30, 2019, there were 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 vest ed 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 of a 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, t he stock appreciation rights will be settled in common stock issued under the 2017 Plan. During the year ended September 30, 2019, stock appreciation rights based on 140,000 shares of the Company’s common stock were exercised resulting in the issuance of 77,559 shares of common stock. As of September 30, 2019, vested stock appreciation rights based on 50,000 shares of common stock remain outstanding. |
Operating Leases
Operating Leases | 12 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Operating Leases | Note 1 2 – Operating Leases Corporate Headquarters On June 20, 2019, the Company executed a lease for its new corporate headquarters in Miami, Florida. Under the terms of the lease, which was amended on August 13, 2019, the Company is leasing approximately 4,640 square feet of office space for a 30 -month term commencing on September 1, 2019 and ending on February 27, 2022. Annual b ase rent payments are $33.00 per square foot and a r e subject to a 2.9% annual escalation on September 1 of each subsequent year. Based on the terms of the lease agreement, the Company paid a security deposit of approximately $12,000 . The lease included a capital lease for office equipment, furniture, and fixtures. At September 30, 2019, the Company’s capital lease obligation was $42,000 , included in accrued expenses and other current liabilities and other liabilities on the accompanying consolidated balance sheet. The Company did not have any capital lease obligations at September 30, 2018. Under the lease for the Company’s former headquarters in Miami, Florida, the Company leased approximately 3,900 square feet of office space for a three -year term commencing on November 1, 2016 and ending on October 31, 2019. The Company executed the lease for this office space effective October 31, 2016 and amended the lease in June 2017. Effective with the June 2017 amendment, annual base rent payments we re $36.00 per square foot and were subject to a 4% annual escalation on November 1 of each subsequent year. The lease also required payment of related expenses, including real estate taxes, common area maintenance and insurance. The Company had two renewal options to extend the term for a period of three years each. The Company did not renew the lease agreement and it terminated on October 31, 2019 . Chicago Lease The Company leases approximately 6,600 square feet of office space located in Chicago, Illinois. The Company executed the lease for this office in May 2016, for a seven -year period commencing on November 1, 2016 and ending on October 31, 2023 . The lease granted the Company a seven -month lease holiday beginning November 1, 2016, a five -month lease abatement beginning June 1, 2017, and provided a tenant improvement allowance. Annual b ase rent payments were $14.00 per square foot in year one and increase on an annual basis to $17 per square foot in the final year of the lease. The lease also requires payment of related expenses, including real estate taxes, common area maintenance, utilities and insurance expenses from June 1, 2017 to October 31, 2023. Based on the terms of the lease agreement, the Company paid a security deposit of $55,000 . Effective September 1, 2017, the Company entered into a sublease for this office space through October 31, 2023 . Monthly sublease payments of approximately $15,200 commenced in January 2018 and will end in August 2023. The monthly sublease payment is subject to annual increase s in September of each year and will increase to approximately $17,300 per month in the final year of the sublease. The tenant under the sublease provided a security deposit of $30,000 to the Company. The Company continues to be responsible for performance under the lease until it expires on October 31, 2023. International Leases The Company leases approximately 6,400 square feet of office space located in London, England . The Company executed this lease in June 2010, for a ten-year term ending in June 2020. The lease requires quarterly payments of approximately $23,000 . Based on the terms of the lease agreement, the Company paid a security deposit of approximately $57,000 . The Company leases 45,800 square feet of manufacturing and warehouse space in Selangor D.E., Malaysia . The Company executed the lease for this space in August 2019, for a three -year term commencing September 1, 2019 and ending August 31, 2022. The Company has an option to extend the term of the lease for a period of three years. The lease requires monthly payments of approximately $15,300 . Based on the terms of the lease agreement, the Company maintains a security deposit of approximately $46,000 . Operating lease expense, including real estate taxes, common area maintenance charges and insurance charges, net of sublease income, was approx imately $683,000 and $717,000 for the years ended September 30, 2019 and 2018, respectively. Future minimum payments under operating leases consist of the following as of September 30, 201 9 : Operating Sublease Leases Income Net Total 2020 $ 469,002 $ 193,753 $ 275,249 2021 433,751 198,668 235,083 2022 337,456 203,584 133,872 2023 114,493 190,749 (76,256) 2024 11,238 — 11,238 Total minimum lease payments $ 1,365,940 $ 786,754 $ 579,186 The minimum lease payments presented above do not include real estate taxes, common area maintenance charges or insurance charges payable under the Company’s operating leases for office and manufacturing facility space. These amounts are generally not fixed and can fluctuate from year to year. |
Contingent Liabilities
Contingent Liabilities | 12 Months Ended |
Sep. 30, 2019 | |
Contingent Liabilities [Abstract] | |
Contingent Liabilities | Note 1 3 – 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 The two purported derivative and class action lawsuits that 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 , were resolved in the Company’s favor during the fourth quarter of fiscal 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. The plaintiffs did not file to appeal this decision during the time period permitted for appeal. No amount had been accrued for possible losses relating to this litigation as any such losses were 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 consolidated financial statements for any of these contingencies. |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | Note 1 4 – 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 T ax 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 in 2018, 2019 and 2020, to the extent the AMT credit carryovers exceed regular tax liability, 50 percent of the excess AMT credit carryovers will be refundable. Any remaining credits will be fully refundable in 2021. The Company has $0.5 million of its AMT credit carryovers in prepaid expenses and other current assets and 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 freque ntly 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, forecast s 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. 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 201 9 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 re cent 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 n additional valuation allowance of $2.2 million should be recorded against the U.S. deferred tax assets related to federal and state net operating loss carryforwards as of September 30, 201 9 . As of September 30, 2019 and 2018, respectively, the Company has recorded a valuation allowance of $7.6 million and $5.5 million against U.S. deferred tax assets. In addition, the Company’s U.K. holding company for the non-U.S. operating com panies, The Female Health Company Limited, continues to have a full valuation allowance of $2.2 million. 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, 201 9 , the Company had U.S. federal and state net operating loss carryforwards of approximately $42.7 million and $25.4 million, respectively, for income tax purposes with $14.4 million and $20.5 million, respectively, expiring in y ears 2022 to 2038 and $28.3 million and $4.9 million, respectively, which can be carried forward indefinitely. The Company’s U.K. subsidiary has U.K. net operating loss carryforwards of approximately $61.7 million as of September 30, 201 9 , which can be carried forward indefinitely to be used to offset future U.K. taxable income. Income before income taxes was taxed by the following jurisdictions for the years ended September 30, 2019 and 2018: 2019 2018 Domestic $ (12,838,076) $ (22,327,527) Foreign 516,777 (744,760) Total $ (12,321,299) $ (23,072,287) A reconciliation of income tax (benefit) expense and the amount computed by applying the statutory federal income tax rate to income before income taxes is as follows: 2019 2018 Income tax benefit at U.S. federal statutory rates $ (2,587,472) $ (5,820,180) State income tax benefit, net of federal benefits (200,385) (1,148,308) Effect of change in U.S. tax rate — 3,319 Non-deductible expenses – other 8,171 14,856 Effect of lower foreign income tax rates 67,637 349,818 Effect of deemed dividend and repatriation tax 99,514 402,760 Effect of change in state tax rate 57,981 — Other 51,490 265,330 Recharacterization of foreign tax credits to net operating loss — 1,311,429 Change in valuation allowance 2,199,131 5,487,078 Income tax (benefit) expense $ (303,933) $ 866,102 The federal and state income tax (benefit) expense for the years ended September 30, 201 9 and 201 8 is summarized below: 2019 2018 Deferred – U.S. $ (552,018) $ 629,381 Deferred – U.K. 76,246 34,612 Deferred – Malaysia 37,708 (33,843) Subtotal (438,064) 630,150 Current – U.S. (2,728) — Current – U.K. — 24,662 Current – Malaysia 136,859 211,290 Subtotal 134,131 235,952 Income tax (benefit) expense $ (303,933) $ 866,102 Significant components of the Company’s deferred tax assets and liabilities are as follows: 2019 2018 Deferred tax assets: Federal net operating loss carryforwards $ 8,971,569 $ 6,973,047 State net operating loss carryforwards 1,689,536 2,195,865 AMT credit carryforward 35,180 — Foreign net operating loss carryforwards – U.K. 10,486,476 10,595,518 Foreign capital allowance – U.K. 103,400 102,098 U.K. bad debts 1,700 1,700 Share-based compensation – U.K. 49,081 17,586 U.S. deferred rent 43,558 22,902 Share-based compensation 804,378 622,442 Other, net – U.S. 356,026 91,419 Other, net – Malaysia — 33,843 Gross deferred tax assets 22,540,904 20,656,420 Valuation allowance for deferred tax assets (9,830,209) (7,631,078) Net deferred tax assets 12,710,695 13,025,342 Deferred tax liabilities: In process research and development (4,072,740) (4,675,860) Developed technology (424,657) (549,318) Covenant not-to-compete (65,993) (94,321) Other, net – Malaysia (3,865) — Other (6,376) (6,843) Net deferred tax liabilities (4,573,631) (5,326,342) Net deferred tax asset $ 8,137,064 $ 7,699,000 The deferred tax amounts have been classified in the accompanying consolidated balance sheets as follows: 2019 2018 Long-term deferred tax asset – U.K. $ 8,433,669 $ 8,509,915 Long-term deferred tax asset – Malaysia — 33,843 Total long-term deferred tax asset $ 8,433,669 $ 8,543,758 Long-term deferred tax liability – U.S. $ (292,740) $ (844,758) Long-term deferred tax liability – Malaysia (3,865) — Total long-term deferred tax liability $ (296,605) $ (844,758) The valuation allowance for our deferred tax assets increased by $2.2 million for the year ended September 30, 2019 and increased by $5.5 million for the year ended September 30, 2018. ASC Topic 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740 developed a two-step process to evaluate a tax position and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company has not recorded a reserve for any tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility. The Company files tax returns in all appropriate jurisdictions, including foreign, U.S. federal and state tax returns. The following summarizes open tax years in the relevant jurisdictions: · For the U.S., a tax return may be audited any time within 3 years from filing date. The U.S. open tax years are for fiscal years 2016 through 2018, which expire in years 2020 through 2022, respectively. · For Malaysia, a tax return may be audited any time within 5 years from filing date (7 months after the fiscal year end). The Malaysia open tax years are for 2014 through 2018, which expire on December 31, 2019 through 2023, respectively. · For the U.K., a tax return may be audited within 1 year from the later of: the filing date or the filing deadline (1 year after the end of the accounting period). The U.K. open tax year is for 2018, which expires in 2020. The fiscal year 2018 state tax returns and the fiscal year 2019 tax returns for all jurisdiction have not been filed as of the date of this filing. As of September 30, 2019 and 2018 , the Company has no recorded liability for unrecognized tax benefits. The Company recognizes interest and penalties related to uncertain tax positions as income tax expense as incurred. No expense for interest and penalties was recognized for the years ended September 30, 2019 and 2018 . |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Sep. 30, 2019 | |
Net Loss Per Share [Abstract] | |
Net Loss Per Share | Note 1 5 – 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 loss 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. See Notes 10 and 11 for a discussion of these potentially dilutive instruments . Due to our net loss for the periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. Therefore, the number of shares used to calculate basic net loss per common share is also used for the diluted net loss per share calculation. |
Industry Segments
Industry Segments | 12 Months Ended |
Sep. 30, 2019 | |
Industry Segments [Abstract] | |
Industry Segments | Note 1 6 – Industry Segments The Company currently operates in two reporting segments: Commercial and Research and Development . The Commercial segment consists of FC2 and PREBOOST ® . 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 : 2019 2018 (In thousands) Commercial $ 15,858 $ 1,944 Research and development (13,692) (10,808) Corporate (8,602) (12,008) Operating loss $ (6,436) $ (20,872) 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 informatio n regarding our net revenues. Costs related to the office located in London, England are fully dedicated to FC2 and are presented as a component of the Commercial segment. 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. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Sep. 30, 2019 | |
Employee Benefit Plans [Abstract] | |
Employee Benefit Plans | Note 1 7 – Employee Benefit Plans Effective January 1, 2018, the Company established a 401(k) plan in which substantially all U.S. employees are eligible to participate. Contributions made by employees are limited to the maximum allowable for U.S. federal income tax purposes. The Company matches employee contributions at a rate of 100% of applicable contributions up to 4% of incl uded compensation. Company contributions to the 401(k) plan were approximately $121,000 a nd $83,000 for the year s ended September 30, 2019 and 2018 , respectively. Prior to the 401(k) plan, the Company had a Simple Individual Retirement Account plan for its U.S. employees. Employees were eligible to participate in the plan if their compensation reached certain minimum levels and they were allowed to contribute up to a maximum of $15,500 of their annual compensation to the plan. The plan was terminated effective December 31, 2017. The Company had elected to match 100% of employee contributions to the plan up to a maximum of 3% of employee compensation. Company contributions to the plan were approximately $22,000 for the year ended September 30, 2018. In March 2014, the Company elected to contribute 3% of eligible employee compensation into the personal pension schemes of certain senior U.K. employees. Effective January 1, 2019, this contribution amount was increased to 4% . Company contributions were approximately $29,000 and $23,000 for the years ended September 30, 201 9 and 201 8 , respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 1 8 – Related Party Transactions K. Gary Barnette, the Company’s Chief Scientific Officer, holds a 25% equity interest in a company from which Aspen Park purchased intellectual property assets relating to our Tamsulosin DRS drug candidate in 2016. We have continuing installment and milestone payment obligations to this company under the purchase agreement. We did not make any payments to this company during the year s ended September 30, 2019 and 2018. |
Nature of Business And Signif_2
Nature of Business And Significant Accounting Policies (Policy) | 12 Months Ended |
Sep. 30, 2019 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Principles of consolidation and nature of operations | Principles of consolidation and nature of operations: Veru Inc. is referred to in these notes collectively with its subsidiaries as “we,” “our,” “us,” “Veru” or the “Company.” The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, 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 health care 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 fiscal 2019 and 2018 were derived from sales of FC2. FC2 has been distributed in either or both commercial (private sector) and public health sector markets in 150 countries. It is marketed to consumers in 25 countries through distributors, public health programs, and/or retailers and in the U.S. by prescription. |
Reclassifications | Reclassifications: Certain prior period amounts in the accompanying 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. |
Use of estimates | Use of estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. |
Cash and cash equivalents and concentration | Cash and cash equivalents and concentration : Cash and cash equivalents, which primarily consist of cash on deposit with financial institutions and highly liquid money market funds, are recorded in the consolidated balance sheets at cost, which approximates fair value. The Company treats short-term, highly liquid funds that are readily convertible to known amounts of cash and have original maturities of three months or less as cash equivalents. The Company’s cash is maintained primarily in three financial institutions, located in Chicago, Illinois; London, England; and Kuala Lumpur, Malaysia. |
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 September 30, 2019. Restricted cash was $135,000 at September 30, 2018 and is included in cash and cash equivalents on the accompanying consolidated balance sheets. |
Accounts receivable and concentration of credit risk | Accounts receivable and concentration of credit risk : Accounts receivable are carried at original invoice amount less an estimate made for doubtful receivables based on a review of all outstanding amounts on a periodic basis. |
Inventory | 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. |
Fixed assets | Fixed assets : We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method, over the estimated useful lives of the assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the assets. |
Leases | Leases : Leases are classified as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for capital lease obligations are established at an amount equal to the present value of minimum lease payments during the lease term. The capital lease obligation is amortized over the life of the lease. |
Patents and trademarks | Patents and trademarks : The costs for patents and trademarks are expensed when incurred. |
Goodwill and intangible assets | Goodwill and intangible assets : The Company’s goodwill and intangible assets, primarily developed technology and in-process research and development (“IPR&D”), arose from the APP A cquisition on October 31, 2016. Goodwill and indefinite-lived intangible assets are not amortized. IPR&D is accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a finite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off. Goodwill and indefinite-lived assets are subject to an impairment review annually, in the fourth quarter of each fiscal year, and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Intangible assets with finite lives are tested for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. These intangible assets are carried at cost less accumulated amortization. Goodwill consists of the cost of an acquired business in excess of the fair value of the net assets acquired. The Company’s goodwill is assigned to the Company’s sole reporting unit in the Company’s Research and Development reporting segment. The Company tests goodwill and indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the Company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the Company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and potentially result in different impacts to the Company's results of operations. Actual results may differ from the Company's estimates. Regarding goodwill, the estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Changes in these assumptions may impact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results are not consistent with our estimates and assumptions, we may be exposed to an impairment charge that could be material. Intangible assets are highly vulnerable to impairment charges, particularly IPR&D . These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval, additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. 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. |
Deferred financing costs | Deferred financing costs : Costs incurred in connection with the common stock purchase agreement discussed in Note 10 have been included in other assets on the accompanying consolidated balance sheets at September 30, 2019 and 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 10, 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 is included in other assets on the accompanying consolidated balance sheet at September 30, 2018. These costs were charged to additional paid-in capital in the first quarter of fiscal 2019 when the common stock offering closed. Costs incurred in connection with the issuance of debt discussed in Note 9 are presented as a reduction of the debt on the accompanying consolidated balance sheet at September 30, 2019 and 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 third quarter of fiscal 2021. The amortization is included in interest expense on the accompanying 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 consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 for a discussion of fair value measurements . The carrying amounts reported in the accompanying consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of 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 in curred in connection with an embedded derivative are discussed in Note 9. |
Revenue recognition | Revenue recognition : Revenue is recognized when control of the promised goods is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products. See Note 4 for further discussion on revenue. |
Research and development costs | Research and development costs : Research and development costs are expensed as they are incurred and include salaries and benefits, costs to conduct clinical trials, and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did not have any capitalized nonrefundable advance payments as of September 30, 2019 and 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 rate. |
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 years ended September 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 , resulting in the adoption of the U.S. dollar as the functional currency for all foreign subsidiaries . The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $0.6 million as of September 30, 2019 and 2018 . Assets located outside of the U.S. totaled approximately $8.2 million and $5.2 million at September 30, 2019 and 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 consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. The U.S. parent company and its U.K. subsidiary routinely purchase inventory produced by its Malaysia subsidiary for sale to their respective customers. These intercompany trade accounts are eliminated in consolidation. The Company’s policy and intent is to settle the intercompany trade account on a current basis. Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October 1, 2009, no foreign currency gains or losses from intercompany trade are recognized. In fiscal 2019 and 201 8 , 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. In July 2018, the FASB issued ASU 2018‑10, Codification Improvements to Topic 842, Leases to clarify the implementation guidance and ASU 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. In 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. In 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, using the optional transition method provided by ASU 2018-11, under which we will apply the new requirements to only those leases that exist as of October 1, 2019. Prior periods will be presented under existing lease guidance. Upon adoption, we will elect the package of practical expedients permitted under the transition guidance, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification, and the initial direct costs. We do not expect to elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to us. We will make an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company currently estimates the adoption of this guidance will result in the recognition of right of use assets and lease liabilities for operating leases, which will increase our total assets and total liabilities by approximately $1.2 million, as of October 1, 2019. The Company does not expect the adoption will have a material impact on its consolidated statement of operations or cash flows. The adoption will have no impact on our debt covenant compliance under our current agreements. 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 implied fair value of goodwill by assigning the fair value of a reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. Under this amendment, an entity will perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge is recognized for the amount by which the carrying value exceeds the reporting unit's fair value. 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) | 12 Months Ended |
Sep. 30, 2019 | |
Fair Value Measurements [Abstract] | |
Reconciliation of the Beginning and Ending Liability Balance | 2019 2018 Beginning balance $ 2,426,000 $ — Additions — 3,319,000 Change in fair value of derivative liabilities 1,199,000 (893,000) Ending balance $ 3,625,000 $ 2,426,000 |
Schedule of Qualitative Information | Weighted Average (range, if applicable) Valuation Methodology Significant Unobservable Input 2019 2018 Monte Carlo Simulation Estimated change of control dates September 2020 to December 2021 September 2019 to December 2021 Discount rate 14.4% to 16.8% 11.1 % to 12.0 % Probability of change of control 10% to 90% 10 % to 90 % |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Revenue from Contracts with Customers [Abstract] | |
Revenue from Customers by Products | 2019 2018 FC2 Global public sector $ 16,835,998 $ 13,458,365 U.S. prescription channel 14,083,368 2,394,219 Total FC2 30,919,366 15,852,584 PREBOOST ® 884,021 11,899 Net revenues $ 31,803,387 $ 15,864,483 |
Revenue by Geographic Area | 2019 2018 United States $ 17,260,174 $ 5,221,052 Zimbabwe * 2,159,263 South Africa * 2,960,677 Other 14,543,213 5,523,491 Net revenues $ 31,803,387 $ 15,864,483 |
Accounts Receivable and Conce_2
Accounts Receivable and Concentration of Credit Risk (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |
Components of Accounts Receivable | 2019 2018 Trade receivables $ 5,103,823 $ 4,046,733 Less: allowance for doubtful accounts (33,143) (36,201) Less: allowance for sales returns and payment term discounts (49,623) (37,900) Trade receivables, net $ 5,021,057 $ 3,972,632 |
Summary of Components of Allowance for Doubtful Accounts | 2019 2018 Beginning balance $ 36,201 $ 38,103 Charges to expense — 16,058 Charge-offs (3,058) (17,960) Ending balance $ 33,143 $ 36,201 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Inventory [Abstract] | |
Components of Inventory | 2019 2018 FC2 Raw material $ 426,590 $ 366,220 Work in process 187,970 77,669 Finished goods 3,157,952 2,232,864 FC2, gross 3,772,512 2,676,753 Less: inventory reserves (125,106) (391,861) FC2, net 3,647,406 2,284,892 PREBOOST ® Finished goods — 17,138 Inventory, net $ 3,647,406 $ 2,302,030 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Property and Equipment [Abstract] | |
Summary of Property and Equipment | Estimated Useful Life 2019 2018 Property and equipment: Manufacturing equipment 5 - 8 years $ 2,716,647 $ 3,256,884 Office equipment, furniture and fixtures 3 - 10 years 795,228 761,400 Leasehold improvements 3 - 8 years 298,886 287,686 Total property and equipment 3,810,761 4,305,970 Less: accumulated depreciation and amortization (3,458,866) (3,901,418) Property and equipment, net $ 351,895 $ 404,552 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Intangible Assets and Goodwill [Abstract] | |
Gross Carrying Amounts and Net Book Value of Intangible Assets | Gross Carrying Accumulated Net Book Amount Amortization Value Intangible assets with finite lives: Developed technology - PREBOOST ® $ 2,400,000 $ 523,172 $ 1,876,828 Covenants not-to-compete 500,000 208,333 291,667 Total intangible assets with finite lives 2,900,000 731,505 2,168,495 Acquired in-process research and development assets 18,000,000 — 18,000,000 Total intangible assets $ 20,900,000 $ 731,505 $ 20,168,495 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 |
Estimated Future Amortization Expense | Estimated Year Ending September 30, Amortization Expense 2020 $ 316,368 2021 323,706 2022 331,316 2023 339,062 2024 281,603 Thereafter 576,440 Total $ 2,168,495 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Debt [Abstract] | |
Credit Agreement | 2019 2018 Aggregate repayment obligation $ 17,650,000 $ 17,500,000 Less: payments (5,578,085) (642,485) Less: unamortized discounts (4,590,974) (8,475,874) Less: unamortized deferred issuance costs (107,910) (204,353) Credit agreement, excluding embedded derivative liability, net 7,373,031 8,177,288 Add: embedded derivative liability at fair value (see Note 3) 899,000 1,217,000 Credit agreement, net 8,272,031 9,394,288 Credit agreement, short-term portion (5,385,649) (6,692,718) Credit agreement, long-term portion $ 2,886,382 $ 2,701,570 |
Residual Royalty Agreement Liability | 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 773,518 201,225 Residual royalty agreement, excluding embedded derivative liability, net 1,119,518 544,805 Add: embedded derivative liability at fair value (see Note 3) 2,726,000 1,209,000 Residual royalty agreement $ 3,845,518 $ 1,753,805 |
Credit Agreement Interest Expense | 2019 2018 Amortization of discounts $ 4,037,320 $ 2,686,706 Accretion of residual royalty agreement 572,293 201,225 Amortization of deferred issuance costs 96,443 62,570 Interest expense $ 4,706,056 $ 2,950,501 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Share-based Compensation [Abstract] | |
Recorded Share-Based Compensation Expenses | 2019 2018 Cost of sales $ 38,026 $ 19,187 Selling, general and administrative 1,471,391 1,284,287 Research and development 396,681 335,031 $ 1,906,098 $ 1,638,505 |
Weighted Average Assumptions for Options Granted | 2019 2018 Weighted Average Assumptions: Expected Volatility 65.85% 60.95% Expected Dividend Yield 0.00% 0.00% Risk-free Interest Rate 2.36% 2.65% Expected Term (in years) 5.9 5.9 Fair Value of Options Granted $ 0.93 $ 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 2,295,407 1.54 Exercised (427,383) 1.11 Forfeited (485,347) 1.89 Outstanding at September 30, 2019 7,027,989 $ 1.58 7.95 $ 4,098,686 Exercisable at September 30, 2019 2,700,166 $ 1.47 7.11 $ 1,855,420 |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Schedule of Future Minimum Payments Under Leases | Operating Sublease Leases Income Net Total 2020 $ 469,002 $ 193,753 $ 275,249 2021 433,751 198,668 235,083 2022 337,456 203,584 133,872 2023 114,493 190,749 (76,256) 2024 11,238 — 11,238 Total minimum lease payments $ 1,365,940 $ 786,754 $ 579,186 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Income Taxes [Abstract] | |
Schedule of Income Before Income Taxes by Jurisdictions | 2019 2018 Domestic $ (12,838,076) $ (22,327,527) Foreign 516,777 (744,760) Total $ (12,321,299) $ (23,072,287) |
Reconciliation of Income Tax Expense (Benefit) | 2019 2018 Income tax benefit at U.S. federal statutory rates $ (2,587,472) $ (5,820,180) State income tax benefit, net of federal benefits (200,385) (1,148,308) Effect of change in U.S. tax rate — 3,319 Non-deductible expenses – other 8,171 14,856 Effect of lower foreign income tax rates 67,637 349,818 Effect of deemed dividend and repatriation tax 99,514 402,760 Effect of change in state tax rate 57,981 — Other 51,490 265,330 Recharacterization of foreign tax credits to net operating loss — 1,311,429 Change in valuation allowance 2,199,131 5,487,078 Income tax (benefit) expense $ (303,933) $ 866,102 |
Summary of Federal and State Income Tax Provision (Benefit) | 2019 2018 Deferred – U.S. $ (552,018) $ 629,381 Deferred – U.K. 76,246 34,612 Deferred – Malaysia 37,708 (33,843) Subtotal (438,064) 630,150 Current – U.S. (2,728) — Current – U.K. — 24,662 Current – Malaysia 136,859 211,290 Subtotal 134,131 235,952 Income tax (benefit) expense $ (303,933) $ 866,102 |
Significant Components of Deferred Tax Assets and Liabilities | 2019 2018 Deferred tax assets: Federal net operating loss carryforwards $ 8,971,569 $ 6,973,047 State net operating loss carryforwards 1,689,536 2,195,865 AMT credit carryforward 35,180 — Foreign net operating loss carryforwards – U.K. 10,486,476 10,595,518 Foreign capital allowance – U.K. 103,400 102,098 U.K. bad debts 1,700 1,700 Share-based compensation – U.K. 49,081 17,586 U.S. deferred rent 43,558 22,902 Share-based compensation 804,378 622,442 Other, net – U.S. 356,026 91,419 Other, net – Malaysia — 33,843 Gross deferred tax assets 22,540,904 20,656,420 Valuation allowance for deferred tax assets (9,830,209) (7,631,078) Net deferred tax assets 12,710,695 13,025,342 Deferred tax liabilities: In process research and development (4,072,740) (4,675,860) Developed technology (424,657) (549,318) Covenant not-to-compete (65,993) (94,321) Other, net – Malaysia (3,865) — Other (6,376) (6,843) Net deferred tax liabilities (4,573,631) (5,326,342) Net deferred tax asset $ 8,137,064 $ 7,699,000 |
Schedule of Deferred Tax Amounts Classified in Balance Sheets | 2019 2018 Long-term deferred tax asset – U.K. $ 8,433,669 $ 8,509,915 Long-term deferred tax asset – Malaysia — 33,843 Total long-term deferred tax asset $ 8,433,669 $ 8,543,758 Long-term deferred tax liability – U.S. $ (292,740) $ (844,758) Long-term deferred tax liability – Malaysia (3,865) — Total long-term deferred tax liability $ (296,605) $ (844,758) |
Industry Segments (Tables)
Industry Segments (Tables) | 12 Months Ended |
Sep. 30, 2019 | |
Industry Segments [Abstract] | |
Schedule of Segment Reporting Information | 2019 2018 (In thousands) Commercial $ 15,858 $ 1,944 Research and development (13,692) (10,808) Corporate (8,602) (12,008) Operating loss $ (6,436) $ (20,872) |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (Narrative) (Details) | Oct. 01, 2019USD ($) | Sep. 30, 2019USD ($)countryitem | Sep. 30, 2018USD ($) |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Number of countries in which entity operates | country | 150 | ||
Number of countries in which entity marketed directly to consumers | country | 25 | ||
Number of Primary Financial Institutions Where Cash is Maintained | item | 3 | ||
Restricted cash | $ 135,000 | ||
Stock issuance costs incurred | 190,000 | ||
Total assets | $ 53,628,770 | 48,452,639 | |
Accumulated Foreign Currency Translation Loss [Member] | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Accumulated other comprehensive income | (600,000) | (600,000) | |
Accounting Standards Update 2016-02 [Member] | Subsequent Event [Member] | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Line Items] | |||
Effect of adoption | $ 1,200,000 | ||
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 | $ 8,200,000 | $ 5,200,000 |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) | 12 Months Ended |
Sep. 30, 2019USD ($) | |
Fair Value Measurements [Abstract] | |
Transfers to level 1 | $ 0 |
Transfers to level 2 | 0 |
Transfers to Level 3 | $ 0 |
Fair Value Measurements (Reconc
Fair Value Measurements (Reconciliation of the Beginning and Ending Liability Balance) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Fair Value Measurements [Abstract] | ||
Beginning balance | $ 2,426,000 | |
Additions | 3,319,000 | |
Change in fair value of derivative liabilities | 1,199,000 | (893,000) |
Ending balance | $ 3,625,000 | $ 2,426,000 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Qualitative Information) (Details) - item | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | Dec. 1, 2021 | Dec. 1, 2021 |
Maximum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Discount rate | 16.80 | 12 |
Maximum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Discount rate | 90 | 90 |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Estimated change of control dates | Sep. 1, 2020 | Sep. 1, 2019 |
Minimum [Member] | Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Discount rate | 14.40 | 11.1 |
Minimum [Member] | Probability Of Change Of Control [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Discount rate | 10 | 10 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Narrative) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Revenue from Contracts with Customers [Abstract] | ||
Contract liability | $ 249,000 | $ 4,000 |
Unearned revenue | $ 187,000 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Revenue from Customers by Products) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue, Major Customer [Line Items] | ||
Revenues | $ 31,803,387 | $ 15,864,483 |
FC2 Segment [Member] | ||
Revenue, Major Customer [Line Items] | ||
Revenues | 30,919,366 | 15,852,584 |
PREBOOST Segment [Member] | ||
Revenue, Major Customer [Line Items] | ||
Revenues | 884,021 | 11,899 |
Global Public Sector [Member] | FC2 Segment [Member] | ||
Revenue, Major Customer [Line Items] | ||
Revenues | 16,835,998 | 13,458,365 |
U.S. Prescription Channel Segment [Member] | FC2 Segment [Member] | ||
Revenue, Major Customer [Line Items] | ||
Revenues | $ 14,083,368 | $ 2,394,219 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers (Revenue by Geographic Area) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 31,803,387 | $ 15,864,483 |
United States [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 17,260,174 | 5,221,052 |
Zimbabwe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 2,159,263 | |
South Africa [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 2,960,677 | |
Other Countries [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 14,543,213 | $ 5,523,491 |
Accounts Receivable and Conce_3
Accounts Receivable and Concentration of Credit Risk (Narrative) (Details) | Dec. 27, 2017USD ($) | Jul. 31, 2018USD ($) | Sep. 30, 2019USD ($)customer | Sep. 30, 2018USD ($)customer | Feb. 28, 2018USD ($) |
Current accounts receivable, net | $ 5,021,057 | $ 3,972,632 | |||
Loss on settlement of accounts receivable | $ (3,986,518) | ||||
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 | 64.00% | 74.00% | |||
Number of Customers | customer | 2 | 3 | |||
Total Revenue [Member] | |||||
Concentration risk, percentage | 64.00% | 63.00% | |||
Number of Customers | customer | 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 | ||||
Loss on settlement of accounts receivable | $ 4,000,000 | ||||
Brazil [Member] | |||||
Credit terms | 180 days | ||||
Long term trade receivable | $ 300,000 |
Accounts Receivable and Conce_4
Accounts Receivable and Concentration of Credit Risk (Components of Accounts Receivable) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2017 |
Accounts Receivable and Concentration of Credit Risk [Abstract] | |||
Trade receivables | $ 5,103,823 | $ 4,046,733 | |
Less: allowance for doubtful accounts | (33,143) | (36,201) | $ (38,103) |
Less: allowance for sales and payment term discounts | (49,623) | (37,900) | |
Accounts receivable, net | $ 5,021,057 | $ 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 ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Accounts Receivable and Concentration of Credit Risk [Abstract] | ||
Beginning balance | $ 36,201 | $ 38,103 |
Charges to expense | 16,058 | |
Charge-offs | (3,058) | (17,960) |
Ending balance | $ 33,143 | $ 36,201 |
Inventory (Components Of Invent
Inventory (Components Of Inventory) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Inventory [Line Items] | ||
Inventory, net | $ 3,647,406 | $ 2,302,030 |
FC2 [Member] | ||
Inventory [Line Items] | ||
Raw material | 426,590 | 366,220 |
Work in process | 187,970 | 77,669 |
Finished goods | 3,157,952 | 2,232,864 |
Inventory, gross | 3,772,512 | 2,676,753 |
Less: inventory reserves | (125,106) | (391,861) |
Inventory, net | $ 3,647,406 | 2,284,892 |
PREBOOST [Member] | ||
Inventory [Line Items] | ||
Finished goods | $ 17,138 |
Property and Equipment (Narrati
Property and Equipment (Narrative) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Property and Equipment [Abstract] | ||
Depreciation and amortization | $ 162,187 | $ 176,786 |
Capital leased assets | $ 44,000 | $ 0 |
Property And Equipment (Summary
Property And Equipment (Summary of Property and Equipment) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 3,810,761 | $ 4,305,970 |
Less: accumulated depreciation and amortization | (3,458,866) | (3,901,418) |
Plant and equipment, net | 351,895 | 404,552 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 2,716,647 | 3,256,884 |
Manufacturing Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P5Y | |
Manufacturing Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P8Y | |
Office Equipment, Furniture And Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 795,228 | 761,400 |
Office Equipment, Furniture And Fixtures [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P3Y | |
Office Equipment, Furniture And Fixtures [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P10Y | |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 298,886 | $ 287,686 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P3Y | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimate Useful Life | P8Y |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Narrative) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Amortization expense | $ 309,234 | $ 275,262 |
Goodwill | $ 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 ($) | Sep. 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 | 731,505 | 422,271 |
Intangible assets with finite lives, Net Book Value | 2,168,495 | 2,477,729 |
Total intangible assets, Gross Carrying Amount | 20,900,000 | 20,900,000 |
Total intangible assets, Net Book Value | 20,168,495 | 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 | 523,172 | 285,366 |
Intangible assets with finite lives, Net Book Value | 1,876,828 | 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 | 208,333 | 136,905 |
Intangible assets with finite lives, Net Book Value | $ 291,667 | $ 363,095 |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill (Estimated Future Amortization Expense) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Intangible Assets and Goodwill [Abstract] | ||
2020 | $ 316,368 | |
2021 | 323,706 | |
2022 | 331,316 | |
2023 | 339,062 | |
2024 | 281,603 | |
Thereafter | 576,440 | |
Total | $ 2,168,495 | $ 2,477,729 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Mar. 05, 2018USD ($) | Sep. 30, 2019USD ($)item | Sep. 30, 2018USD ($) |
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 | ||
Unamortized discounts | 11,300,000 | $ 4,590,974 | $ 8,475,874 |
Pledge percentage | 65.00% | ||
Net proceeds after fees and expenses | 9,900,000 | ||
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, elapsed period payment threshold | $ 12,500,000 | ||
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, 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, 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 | ||
Residual Royalty Agreement [Member] | |||
Line of Credit Facility [Line Items] | |||
Repayment percentage | 5.00% | ||
Payment terms, period of revenue calculation | 12 months | ||
Payment terms, payment percentage | 175.00% | ||
Payment terms, change in control or sale of business fee, amount | $ 2,000,000 | ||
Payment terms, change in control or sale of business fee, percentage of product revenue | 5.00% | ||
Payment terms, change in control or sale of business fee, percentage multiple | item | 5 | ||
Unamortized discounts | $ 2,420 | ||
Maximum [Member] | SWK Credit Agreement [Member] | Product Revenue Over $10 Million, 2020 [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 ($) | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Mar. 05, 2018 | |
Credit agreement, short-term portion | $ (5,385,649) | $ (6,692,718) | |
Credit agreement, long-term portion | 2,886,382 | 2,701,570 | |
SWK Credit Agreement [Member] | |||
Aggregate repayment obligation | 17,650,000 | 17,500,000 | |
Less: payments | (5,578,085) | (642,485) | |
Less: unamortized discounts | (4,590,974) | (8,475,874) | $ (11,300,000) |
Less: unamortized deferred issuance costs | (107,910) | (204,353) | |
Credit agreement, excluding embedded derivative liability, net | 7,373,031 | 8,177,288 | |
Add: embedded derivative liability at fair value (see Note 3) | 899,000 | 1,217,000 | |
Credit agreement, net | 8,272,031 | 9,394,288 | |
Credit agreement, short-term portion | (5,385,649) | (6,692,718) | |
Credit agreement, long-term portion | $ 2,886,382 | $ 2,701,570 |
Debt (Residual Royalty Agreemen
Debt (Residual Royalty Agreement Liability) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Add: Accretion of liability using effective interest rate | $ 572,293 | $ 201,225 |
Residual royalty agreement | 3,845,518 | 1,753,805 |
Residual Royalty Agreement [Member] | ||
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 | 773,518 | 201,225 |
Residual Royalty Agreement liability, net | 1,119,518 | 544,805 |
Add: embedded derivative liability at fair value (see Note 3) | 2,726,000 | 1,209,000 |
Residual royalty agreement | $ 3,845,518 | $ 1,753,805 |
Debt (Credit Agreement Interest
Debt (Credit Agreement Interest Expense) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Debt [Abstract] | ||
Amortization of Credit Agreement and Residual Royalty Agreement discounts | $ 4,037,320 | $ 2,686,706 |
Accretion of Residual Royalty Agreement liability | 572,293 | 201,225 |
Amortization of deferred issuance costs | 96,443 | 62,570 |
Interest expense | $ 4,706,056 | $ 2,950,501 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) | Oct. 01, 2018USD ($)$ / sharesshares | May 31, 2018$ / sharesshares | Sep. 30, 2019USD ($)item / shares$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017$ / sharesshares | Mar. 26, 2019shares | Dec. 29, 2017USD ($) |
Preferred stock, issued | 0 | 0 | |||||
Preferred stock, outstanding | 0 | 0 | |||||
Common Stock, shares authorized | 154,000,000 | 77,000,000 | 77,000,000 | ||||
Common Stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||
Common stock, voting rights per share | item / shares | 1 | ||||||
Aggregate purchase price of shares | $ | $ 672,220 | $ 574,687 | |||||
Stock issuance price | $ / shares | $ 1.40 | ||||||
Maximum purchase of shares per business day | 154,000,000 | 77,000,000 | 77,000,000 | ||||
Sale of shares under common stock purchase agreement | $ | $ 3,600,000 | $ 3,000,000 | |||||
Shares issued in connection with public offering of common stock, net of fees and costs (in Shares) | 7,142,857 | ||||||
Net proceeds from sale of shares | $ | $ 9,100,000 | 9,131,967 | |||||
Additional paid-in capital | $ | $ 101,981 | 84,984 | |||||
Aspire Capital Purchase Agreement [Member] | |||||||
Common Stock, shares authorized | 200,000 | ||||||
Aggregate purchase price of shares | $ | $ 8,400,000 | $ 15,000,000 | |||||
Term of purchase agreement | 36 months | ||||||
Stock issuance price | $ / shares | $ 0.50 | ||||||
Maximum purchase of shares per business day | 200,000 | ||||||
Maximum VWAP percentage | 30.00% | ||||||
General percentage of VWAP pursuant to notice | 97.00% | ||||||
Sale of shares under common stock purchase agreement | $ | $ 347,000 | ||||||
Shares issued in connection with public offering of common stock, net of fees and costs (in Shares) | 2,000,000 | 1,717,010 | |||||
Net proceeds from sale of shares | $ | $ 3,600,000 | $ 3,000,000 | |||||
Additional paid-in capital | $ | 102,000 | 85,000 | |||||
Related expenses | $ | 78,000 | ||||||
Deferred assets | $ | 425,000 | ||||||
Unamortized deferred assets | $ | $ 238,000 | $ 340,000 | |||||
Shares issued in connection with common stock purchase agreement (in Shares) | 304,457 | ||||||
Financial Advisor Warrant [Member] | |||||||
Warrant to purchase common stock shares | 2,585,379 | ||||||
Award expiration period | 5 years | ||||||
Strike price per share | $ / shares | $ 1.93 | ||||||
Consulting Services Warrants [Member] | |||||||
Number or Warrants Issued | 2 | ||||||
Warrant to purchase common stock shares | 750,000 | ||||||
Strike price per share | $ / shares | $ 2.31 | ||||||
Fair value of warrant | $ | $ 0 | ||||||
Preferred Class A [Member] | |||||||
Preferred stock, shares authorized | 5,000,000 | ||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.01 | ||||||
Preferred stock, issued | 0 | 0 | |||||
Preferred stock, outstanding | 0 | 0 | |||||
Preferred Class A Series 1 [Member] | |||||||
Preferred stock, shares authorized | 1,040,000 | ||||||
Preferred Class A Series 2 [Member] | |||||||
Preferred stock, shares authorized | 1,500,000 | ||||||
Preferred Class A Series 3 [Member] | |||||||
Preferred stock, shares authorized | 700,000 | ||||||
Preferred Class A Series 4 [Member] | |||||||
Preferred stock, shares authorized | 548,000 | ||||||
Preferred Class B [Member] | |||||||
Preferred stock, shares authorized | 15,000 | ||||||
Preferred stock, par or stated value per share (in Dollars per share) | $ / shares | $ 0.50 | ||||||
Preferred stock, issued | 0 | 0 | |||||
Preferred stock, outstanding | 0 | 0 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Jul. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Tax benefit of stock-based compensation expense | $ 431,000 | $ 426,000 | |
Proceeds from stock option exercises | 333,000 | 66,000 | |
Options, exercises in period, intrinsic value | 274,000 | 44,000 | |
Expense recognized | $ 1,906,098 | 1,638,505 | |
Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share price | $ 2.16 | ||
Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 3 years | ||
Award expiration period | 10 years | ||
Unrecognized compensation expense, stock options | $ 3,000,000 | ||
Unrecognized compensation expense, period for recognition | 3 years | ||
Expense recognized | $ 53,000 | 362,000 | |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair value of restricted stock vested | $ 272,000 | ||
Non-option equity instruments outstanding | 0 | 0 | |
Shares of restricted stock vested | 0 | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-option equity instruments outstanding | 0 | ||
Shares vested, intrinsic value | $ 230,000 | ||
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 | ||
Number of shares issued | 77,559 | ||
Non-option equity instruments, exercised | 140,000 | ||
Exercise price per share | $ 0.95 | ||
Non-option equity instruments outstanding | 50,000 | ||
Stock Appreciation Rights (SARs) [Member] | The APP Merger [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vest date | Oct. 31, 2018 | ||
Stock Appreciation Rights (SARs) [Member] | Employee [Member] | The APP Merger [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares issued | 50,000 | ||
Stock Appreciation Rights (SARs) [Member] | Outside Directors [Member] | The APP Merger [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares issued | 140,000 | ||
Minimum [Member] | Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 1 year | ||
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 | 49,514 | ||
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 | 2,967,614 |
Share-based Compensation (Recor
Share-based Compensation (Recorded Share-Based Compensation Expenses) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 1,906,098 | $ 1,638,505 |
Cost of Sales [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | 38,026 | 19,187 |
Selling, General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | 1,471,391 | 1,284,287 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 396,681 | $ 335,031 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted Average Assumptions for Options Granted) (Details) - Stock Option [Member] - $ / shares | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected Volatility | 65.85% | 60.95% |
Expected Dividend Yield | 0.00% | 0.00% |
Risk-free Interest Rate | 2.36% | 2.65% |
Expected Term (in years) | 5 years 10 months 24 days | 5 years 10 months 24 days |
Fair Value of Options Granted | $ 0.93 | $ 1 |
Share-based Compensation (Summa
Share-based Compensation (Summary of Stock Options Outstanding and Exercisable) (Details) - Stock Option [Member] | 12 Months Ended |
Sep. 30, 2019USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Outstanding at Beginning of Period | shares | 5,645,312 |
Number of Shares Granted | shares | 2,295,407 |
Number of Shares Exercised | shares | (427,383) |
Number of Shares Forfeited | shares | (485,347) |
Number of Shares Outstanding at End of Period | shares | 7,027,989 |
Number of Shares Exercisable at End of Period | shares | 2,700,166 |
Weighted Average Exercise Price Per Share, Outstanding at Beginning of Period | $ / shares | $ 1.59 |
Weighted Average Exercise Price Per Share, Granted | $ / shares | 1.54 |
Weighted Average Exercise Price Per Share, Exercised | $ / shares | 1.11 |
Weighted Average Exercise Price Per Share, Forfeited | $ / shares | 1.89 |
Weighted Average Exercise Price Per Share, Outstanding at End of Period | $ / shares | 1.58 |
Weighted Average Exercise Price Per Share, Exercisable at End of Period | $ / shares | $ 1.47 |
Weighted Average Remaining Contractual Term, Outstanding at End of Period | 7 years 11 months 12 days |
Weighted Average Remaining Contractual Term, Exercisable at End of Period | 7 years 1 month 10 days |
Aggregate Intrinsic Value, Outstanding at End of Period | $ | $ 4,098,686 |
Aggregate Intrinsic Value, Exercisable at End of Period | $ | $ 1,855,420 |
Operating Leases (Narrative) (D
Operating Leases (Narrative) (Details) | 12 Months Ended | |
Sep. 30, 2019USD ($)ft²$ / ft²item | Sep. 30, 2018USD ($) | |
Operating Leased Assets [Line Items] | ||
Total lease cost including real estate taxes, common area maintenance and insurance charges, net | $ 683,000 | $ 717,000 |
Miami, Florida [Member] | Corporate Headquarters [Member] | ||
Operating Leased Assets [Line Items] | ||
Area of real estate property | ft² | 4,640 | |
Operating lease term | 30 months | |
Base rent amount per square foot | $ / ft² | 33 | |
Annual base rent escalation | 2.90% | |
Security deposit | $ 12,000 | |
Capital lease obligations | $ 42,000 | |
Miami, Florida [Member] | Former Corporate Headquarters [Member] | ||
Operating Leased Assets [Line Items] | ||
Area of real estate property | ft² | 3,900 | |
Operating lease term | 3 years | |
Base rent amount per square foot | $ / ft² | 36 | |
Annual base rent escalation | 4.00% | |
Lease expiration date | Oct. 31, 2019 | |
Extension of term of lease | 3 years | |
Operating lease number of extensions | item | 2 | |
Chicago, Illinois [Member] | ||
Operating Leased Assets [Line Items] | ||
Area of real estate property | ft² | 6,600 | |
Chicago, Illinois [Member] | Office Space [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating lease term | 7 years | |
Operating lease holiday term | 7 months | |
Operating lease abatement term | 5 months | |
Lease expiration date | Oct. 31, 2023 | |
Security deposit | $ 55,000 | |
Chicago, Illinois [Member] | Office Space [Member] | Sublease [Member] | ||
Operating Leased Assets [Line Items] | ||
Lease expiration date | Oct. 31, 2023 | |
Security deposit | $ 30,000 | |
Chicago, Illinois [Member] | Minimum [Member] | Office Space [Member] | ||
Operating Leased Assets [Line Items] | ||
Base rent amount per square foot | $ / ft² | 14 | |
Chicago, Illinois [Member] | Minimum [Member] | Office Space [Member] | Sublease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating lease monthly payments | $ 15,200 | |
Chicago, Illinois [Member] | Maximum [Member] | Office Space [Member] | ||
Operating Leased Assets [Line Items] | ||
Base rent amount per square foot | $ / ft² | 17 | |
Chicago, Illinois [Member] | Maximum [Member] | Office Space [Member] | Sublease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating lease monthly payments | $ 17,300 | |
London, England [Member] | Office Space [Member] | ||
Operating Leased Assets [Line Items] | ||
Area of real estate property | ft² | 6,400 | |
Operating lease quarterly rental payments | $ 23,000 | |
Security deposit | $ 57,000 | |
Selangor D.E., Malaysia [Member] | Manufacturing Space [Member] | ||
Operating Leased Assets [Line Items] | ||
Area of real estate property | ft² | 45,800 | |
Operating lease term | 3 years | |
Extension of term of lease | 3 years | |
Operating lease renewal term | 3 years | |
Operating lease monthly payments | $ 15,300 | |
Security deposit | $ 46,000 |
Operating Leases (Schedule of F
Operating Leases (Schedule of Future Minimum Payments Under Leases) (Details) | Sep. 30, 2019USD ($) |
Operating Leased Assets [Line Items] | |
2020 | $ 275,249 |
2021 | 235,083 |
2022 | 133,872 |
2023 | (76,256) |
2024 | 11,238 |
Total minimum lease payments | 579,186 |
Operating Leases [Member] | |
Operating Leased Assets [Line Items] | |
2020 | 469,002 |
2021 | 433,751 |
2022 | 337,456 |
2023 | 114,493 |
2024 | 11,238 |
Total minimum lease payments | 1,365,940 |
Sublease Income [Member] | |
Operating Leased Assets [Line Items] | |
2020 | 193,753 |
2021 | 198,668 |
2022 | 203,584 |
2023 | 190,749 |
Total minimum lease payments | $ 786,754 |
Contingent Liabilities (Narrati
Contingent Liabilities (Narrative) (Details) | 12 Months Ended |
Sep. 30, 2019USD ($) | |
Contingent Liabilities [Abstract] | |
Product liability insurance, coverage amount | $ 10,000,000 |
Possible losses accrued | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | |
Income Tax Expense (Benefit) [Line Items] | |||
Corporate income tax rate | 21.00% | 35.00% | |
Valuation allowance, deferred tax asset, change in amount | $ 2,200,000 | $ 5,500,000 | |
Unrecognized tax benefits | 0 | 0 | |
Penalties and interest expense | 0 | 0 | |
Alternative Minimum Tax [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Prepaid Taxes | 500,000 | ||
Maximum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2038 | ||
Minimum [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards, expiration date | Dec. 31, 2022 | ||
Foreign [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 61,700,000 | ||
Domestic [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 42,700,000 | ||
Domestic [Member] | 2022 to 2038 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 14,400,000 | ||
Domestic [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 28,300,000 | ||
State [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 25,400,000 | ||
State [Member] | 2022 to 2038 [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 20,500,000 | ||
State [Member] | Indefinite [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Operating loss carryforwards | 4,900,000 | ||
United States [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | 7,600,000 | $ 5,500,000 | |
U.K. [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance, deferred tax asset, change in amount | 2,200,000 | ||
U.K. [Member] | The Female Health Company Limited [Member] | |||
Income Tax Expense (Benefit) [Line Items] | |||
Valuation allowance | $ 2,200,000 |
Income Taxes (Schedule of Incom
Income Taxes (Schedule of Income Before Income Taxes by Jurisdictions) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Income before income taxes | $ (12,321,299) | $ (23,072,287) |
Domestic [Member] | ||
Income before income taxes | (12,838,076) | (22,327,527) |
Foreign [Member] | ||
Income before income taxes | $ 516,777 | $ (744,760) |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Income Tax Expense (Benefit)) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Income tax benefit at U.S. federal statutory rates | $ (2,587,472) | $ (5,820,180) |
State income tax benefit, net of federal benefits | (200,385) | (1,148,308) |
Non-deductible expenses - other | 8,171 | 14,856 |
Effect of lower foreign income tax rates | 67,637 | 349,818 |
Effect of deemed dividend and repatriation tax | 99,514 | 402,760 |
Other | 51,490 | 265,330 |
Recharacterization of foreign income tax credits to net operating loss | 1,311,429 | |
Change in valuation allowance | 2,199,131 | 5,487,078 |
Income tax (benefit) expense | (303,933) | 866,102 |
State [Member] | ||
Effect of change in tax rate | $ 57,981 | |
United States [Member] | ||
Effect of change in tax rate | $ 3,319 |
Income Taxes (Summary of Federa
Income Taxes (Summary of Federal And State Income Tax Provision (Benefit)) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Components of Income Tax Expense (Benefit) [Line Items] | ||
Subtotal - Deferred | $ (438,064) | $ 630,150 |
Subtotal - Current | 134,131 | 235,952 |
Income tax (benefit) expense | (303,933) | 866,102 |
United States [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Federal | (552,018) | 629,381 |
Current - Federal | (2,728) | |
U.K. [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Foreign | 76,246 | 34,612 |
Current - Foreign | 24,662 | |
Malaysia [Member] | ||
Components of Income Tax Expense (Benefit) [Line Items] | ||
Deferred - Foreign | 37,708 | (33,843) |
Current - Foreign | $ 136,859 | $ 211,290 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Federal net operating loss carryforwards | $ 8,971,569 | $ 6,973,047 |
State net operating loss carryforwards | 1,689,536 | 2,195,865 |
AMT credit carryforward | 35,180 | |
Foreign net operating loss carryforwards - U.K. | 10,486,476 | 10,595,518 |
Foreign capital allowance - U.K. | 103,400 | 102,098 |
U.K. bad debts | 1,700 | 1,700 |
U.S. deferred rent | 43,558 | 22,902 |
Gross deferred tax assets | 22,540,904 | 20,656,420 |
Valuation allowance for deferred tax assets | (9,830,209) | (7,631,078) |
Net deferred tax assets | 12,710,695 | 13,025,342 |
Deferred Tax Liabilities: | ||
In process research and development | (4,072,740) | (4,675,860) |
Developed Technology | (424,657) | (549,318) |
Covenant not-to-compete | (65,993) | (94,321) |
Other, net - Malaysia | (3,865) | |
Other | (6,376) | (6,843) |
Net deferred tax liabilities | (4,573,631) | (5,326,342) |
Net deferred tax assets | 8,137,064 | 7,699,000 |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Other, net | 33,843 | |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Share-based compensation | 804,378 | 622,442 |
Other, net | 356,026 | 91,419 |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Share-based compensation | $ 49,081 | $ 17,586 |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Amounts Classified in Balance Sheets) (Details) - USD ($) | Sep. 30, 2019 | Sep. 30, 2018 |
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Long-term deferred tax asset | $ 8,433,669 | $ 8,543,758 |
Long-term deferred tax liability | (296,605) | (844,758) |
U.K. [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Long-term deferred tax asset | 8,433,669 | 8,509,915 |
United States [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Long-term deferred tax liability | (292,740) | (844,758) |
Malaysia [Member] | ||
Components Of Deferred Tax Assets And Liabilities [Line Items] | ||
Long-term deferred tax asset | $ 33,843 | |
Long-term deferred tax liability | $ (3,865) |
Industry Segments (Narrative) (
Industry Segments (Narrative) (Details) | 12 Months Ended |
Sep. 30, 2019segment | |
Industry Segments [Abstract] | |
Number of reportable segments | 2 |
Industry Segments (Schedule of
Industry Segments (Schedule of Segment Reporting Information) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating (loss) income | $ (6,435,894) | $ (20,872,407) |
Operating Segments [Member] | ||
Operating (loss) income | (6,436,000) | (20,872,000) |
Commercial [Member] | Operating Segments [Member] | ||
Operating (loss) income | 15,858,000 | 1,944,000 |
Research and development [Member] | Operating Segments [Member] | ||
Operating (loss) income | (13,692,000) | (10,808,000) |
Corporate [Member] | Operating Segments [Member] | ||
Operating (loss) income | $ (8,602,000) | $ (12,008,000) |
Employee Benefit Plans (Narrati
Employee Benefit Plans (Narrative) (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
401(k) [Member] | ||
Defined Contribution Plan [Line Items] | ||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Amount (in Dollars) | $ 83,000 | |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 100.00% | |
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4.00% | |
Defined Benefit Plan, Contributions by Employer (in Dollars) | $ 121,000 | |
Simple Individual Retirement Account Plan [Member] | ||
Defined Contribution Plan [Line Items] | ||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Amount (in Dollars) | $ 15,500 | |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 100.00% | |
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | |
Defined Benefit Plan, Contributions by Employer (in Dollars) | 22,000 | |
Foreign Postretirement Benefit Plan [Member] | ||
Defined Contribution Plan [Line Items] | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | |
Defined Benefit Plan, Contributions by Employer (in Dollars) | $ 29,000 | $ 23,000 |
Related Party Transactions (Nar
Related Party Transactions (Narrative) (Details) - Chief Scientific Officer [Member] - USD ($) | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Related Party Transaction [Line Items] | ||
Ownership interest | 25.00% | |
Aspen Park Pharmaceuticals, Inc. (APP) [Member] | ||
Related Party Transaction [Line Items] | ||
Related party transactions, amount | $ 0 | $ 0 |