2019 Q2 Form 10-Q Financial Statement

#000086389419000007 Filed on May 15, 2019

View on sec.gov

Income Statement

Concept 2019 Q2 2019 Q1 2018 Q1
Revenue $9.727M $6.976M $2.573M
YoY Change 76.8% 171.14% 6.76%
Cost Of Revenue $3.156M $2.367M $1.375M
YoY Change 30.0% 72.17% 21.68%
Gross Profit $6.571M $4.609M $1.198M
YoY Change 113.75% 284.73% -6.41%
Gross Profit Margin 67.56% 66.07% 46.56%
Selling, General & Admin $3.547M $3.823M $3.818M
YoY Change -11.86% 0.14% 57.76%
% of Gross Profit 53.98% 82.95% 318.69%
Research & Development $4.866M $2.911M $2.077M
YoY Change 28.48% 40.15% 44.22%
% of Gross Profit 74.05% 63.15% 173.36%
Depreciation & Amortization $130.0K $110.0K $120.0K
YoY Change 18.18% -8.33% -7.69%
% of Gross Profit 1.98% 2.39% 10.02%
Operating Expenses $8.413M $6.733M $5.894M
YoY Change 4.66% 14.23% 53.1%
Operating Profit -$1.842M -$2.125M -$4.697M
YoY Change -62.9% -54.76% 82.75%
Interest Expense $1.091M $1.258M $350.6K
YoY Change -20.93% 258.9% -1852.98%
% of Operating Profit
Other Income/Expense, Net -$932.5K -$1.884M -$437.1K
YoY Change -47.0% 331.1% 4270.84%
Pretax Income -$2.775M -$4.009M -$5.134M
YoY Change -58.74% -21.91% 97.45%
Income Tax -$458.00 $25.17K -$1.302M
% Of Pretax Income
Net Earnings -$2.774M -$4.034M -$3.831M
YoY Change -65.02% 5.29% 115.24%
Net Earnings / Revenue -28.52% -57.83% -148.91%
Basic Earnings Per Share
Diluted Earnings Per Share -$44.02K -$64.20K -$71.78K
COMMON SHARES
Basic Shares Outstanding 62.79M 62.78M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q2 2019 Q1 2018 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $8.000M $5.900M $9.000M
YoY Change 42.86% -34.44% 718.18%
Cash & Equivalents $8.039M $5.897M $8.972M
Short-Term Investments
Other Short-Term Assets $1.200M $1.200M $600.0K
YoY Change 20.0% 100.0% -14.29%
Inventory $3.131M $2.998M $3.600M
Prepaid Expenses
Receivables $4.767M $4.027M $2.900M
Other Receivables $0.00 $0.00 $100.0K
Total Short-Term Assets $17.14M $14.14M $16.20M
YoY Change 32.89% -12.7% 38.46%
LONG-TERM ASSETS
Property, Plant & Equipment $314.7K $320.8K $500.0K
YoY Change -37.06% -35.84% -28.57%
Goodwill $6.879M $6.879M
YoY Change
Intangibles $20.25M $20.32M
YoY Change
Long-Term Investments
YoY Change
Other Assets $684.1K $776.2K $14.10M
YoY Change -94.61% -94.5% 53.26%
Total Long-Term Assets $36.70M $36.87M $42.00M
YoY Change -9.61% -12.22% -7.69%
TOTAL ASSETS
Total Short-Term Assets $17.14M $14.14M $16.20M
Total Long-Term Assets $36.70M $36.87M $42.00M
Total Assets $53.84M $51.01M $58.20M
YoY Change 0.64% -12.35% 1.75%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.135M $2.525M $3.500M
YoY Change -10.43% -27.85% 150.0%
Accrued Expenses $3.900M $2.900M $2.300M
YoY Change 85.71% 26.09% 15.0%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $4.700M $5.800M $3.900M
YoY Change -26.56% 48.72%
Total Short-Term Liabilities $11.66M $11.27M $10.60M
YoY Change -8.16% 6.34% 211.76%
LONG-TERM LIABILITIES
Long-Term Debt $6.300M $5.100M $6.200M
YoY Change 31.25% -17.74%
Other Long-Term Liabilities $30.00K $30.00K $100.0K
YoY Change -70.0% -70.0% -92.31%
Total Long-Term Liabilities $30.00K $30.00K $6.300M
YoY Change -99.39% -99.52% 384.62%
TOTAL LIABILITIES
Total Short-Term Liabilities $11.66M $11.27M $10.60M
Total Long-Term Liabilities $30.00K $30.00K $6.300M
Total Liabilities $19.10M $17.47M $16.90M
YoY Change 8.55% 3.36% 196.49%
SHAREHOLDERS EQUITY
Retained Earnings -$67.16M -$64.38M
YoY Change
Common Stock $670.0K $649.7K
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost) $7.807M $7.807M
YoY Change
Treasury Stock Shares $2.184M $2.184M
Shareholders Equity $34.74M $33.54M $41.33M
YoY Change
Total Liabilities & Shareholders Equity $53.84M $51.01M $58.20M
YoY Change 0.64% -12.35% 1.75%

Cashflow Statement

Concept 2019 Q2 2019 Q1 2018 Q1
OPERATING ACTIVITIES
Net Income -$2.774M -$4.034M -$3.831M
YoY Change -65.02% 5.29% 115.24%
Depreciation, Depletion And Amortization $130.0K $110.0K $120.0K
YoY Change 18.18% -8.33% -7.69%
Cash From Operating Activities -$530.0K -$2.490M -$4.480M
YoY Change -88.35% -44.42% 100.9%
INVESTING ACTIVITIES
Capital Expenditures -$70.00K $0.00 $0.00
YoY Change 40.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$70.00K $0.00 $0.00
YoY Change 40.0% -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 2.740M -590.0K 9.880M
YoY Change 128.33% -105.97%
NET CHANGE
Cash From Operating Activities -530.0K -2.490M -4.480M
Cash From Investing Activities -70.00K 0.000 0.000
Cash From Financing Activities 2.740M -590.0K 9.880M
Net Change In Cash 2.140M -3.080M 5.400M
YoY Change -162.94% -157.04% -341.07%
FREE CASH FLOW
Cash From Operating Activities -$530.0K -$2.490M -$4.480M
Capital Expenditures -$70.00K $0.00 $0.00
Free Cash Flow -$460.0K -$2.490M -$4.480M
YoY Change -89.78% -44.42% 101.8%

Facts In Submission

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<div> <div style="margin-left:0pt;margin-right:0pt;"> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;font-weight:bold;">Note 1 &#x2013; Basis of Presentation</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">The accompanying unaudited interim condensed consolidated financial statements for Veru Inc. (&#x201C;we,&#x201D; &#x201C;our,&#x201D; &#x201C;us,&#x201D; &#x201C;Veru&#x201D; or the &#x201C;Company&#x201D;) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (&#x201C;SEC&#x201D;) for reporting of interim financial information. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (&#x201C;U.S. GAAP&#x201D;) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. Accordingly, these statements do not include all the disclosures normally required by U.S. GAAP for annual financial statements and should be read in conjunction with Management&#x2019;s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended </font><font style="display: inline;">September 30, 2018</font><font style="display: inline;">. The accompanying condensed consolidated balance sheet as of </font><font style="display: inline;">September 30, 2018</font><font style="display: inline;"> has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations for the three and six months ended March 31, 2019 and cash flows for the </font><font style="display: inline;">six months ended March 31, 2019</font><font style="display: inline;"> are not necessarily indicative of the results to be expected for any future period or for the fiscal year ending </font><font style="display: inline;">September 30, 201</font><font style="display: inline;">9</font><font style="display: inline;">. &nbsp;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">The preparation of our unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments (consisting of only normally recurring adjustments) necessary to present fairly the financial position and results of operations as of the dates and for the periods presented.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Principles of consolidation and nature of operations</font><font style="display: inline;">: Veru Inc. is </font><font style="display: inline;color:#000000;">referred to in these notes collectively with its subsidiaries as &#x201C;we,&#x201D; &#x201C;our,&#x201D; &#x201C;us,&#x201D; &#x201C;Veru&#x201D; or the &#x201C;Company.&#x201D; </font><font style="display: inline;">The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, Aspen Park Pharmaceuticals, Inc. (&#x201C;APP&#x201D;) and The Female Health Company Limited, and The Female Health Company Limited&#x2019;s wholly owned subsidiary, The Female Health Company (UK) plc (The Female Health Company Limited and The Female Health Company (UK) plc, collectively, the &#x201C;U.K. subsidiary&#x201D;), and The Female Health Company (UK) plc&#x2019;s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the &#x201C;Malaysia subsidiary&#x201D;). All significant intercompany transactions and accounts have been eliminated in consolidation. Prior to the completion of the October 31, 2016 acquisition (the &#x201C;APP Acquisition&#x201D;) 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 </font><font style="display: inline;">Female Condom/FC2 Internal Condom&#xAE; (&#x201C;FC2&#x201D;)</font><font style="display: inline;">.&nbsp;&nbsp;The completion of the APP Acquisition transitioned the Company into a biopharmaceutical company </font><font style="display: inline;">focused on oncology and urology</font><font style="display: inline;"> with multiple drug products under clinical development.&nbsp;&nbsp;Most of the Company&#x2019;s net revenues during the three and six months ended March 31, 2019 and 2018 were derived from sales of FC2.&nbsp; </font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Reclassifications</font><font style="display: inline;">: &nbsp;</font><font style="display: inline;">Certain prior period amounts in the accompanying unaudited interim condensed consolidated financial statements have been reclassified to conform with the current period presentation. </font><font style="display: inline;">These reclassifications had no effect on </font><font style="display: inline;color:#000000;">the results of operations or financial position for any period presented.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;text-decoration:underline;">Cash concentration</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">: The Company&#x2019;s cash is maintained primarily in three financial institutions, located in Chicago, Illinois, London, England and Kuala Lumpur, Malaysia.</font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Restricted cash</font><font style="display: inline;">: Restricted cash relates to security provided to one of the Company&#x2019;s U.K. banks for performance bonds issued in favor of customers. The Company has a facility of </font><font style="display: inline;">$250,000</font><font style="display: inline;"> for such performance bonds.&nbsp;&nbsp;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.&nbsp;&nbsp;The Company had </font><font style="display: inline;">no</font><font style="display: inline;"> restricted cash at March 31, 2019. Restricted cash was approximately </font><font style="display: inline;">$135,000</font><font style="display: inline;"> at September 30, 2018 and is included in cash on the accompanying unaudited condensed consolidated balance sheets</font><font style="display: inline;color:#FF0000;">. &nbsp;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#FF0000;text-decoration:underline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Patents and trademarks</font><font style="display: inline;">: The costs for patents and trademarks are expensed when incurred.&nbsp; </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Deferred financing costs</font><font style="display: inline;">:</font><font style="display: inline;font-weight:bold;font-style:italic;">&nbsp;</font><font style="display: inline;">Costs incurred in connection with the </font><font style="display: inline;">common stock purchase agreement discussed in Note 8 </font><font style="display: inline;">have been included in other assets on the accompanying unaudited condensed consolidated balance sheets at March 31, 2019 and September 30, 2018. When shares of the Company&#x2019;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. </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">As discussed in Note 8, in connection with the </font><font style="display: inline;">common stock offering that closed on October 1, 2018, we incurred c</font><font style="display: inline;">osts </font><font style="display: inline;">of approximately </font><font style="display: inline;">$190,000</font><font style="display: inline;"> through September 30, 2018. This amount was included in </font><font style="display: inline;">other assets on the accompanying unaudited condensed consolidated balance sheet at September 30, 2018. These costs were charged to additional paid-in capital in the six months ended March 31, 2019 after the common stock offering was closed.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">Costs incurred in connection with the </font><font style="display: inline;">issuance of debt discussed in Note 7 are presented as a reduction of the debt on the accompanying unaudited condensed consolidated balance sheets at March 31, 2019 and September 30, 2018. These issuance costs are being amortized using the effective interest method over the expected repayment period of the debt, which is currently estimated to occur in the third quarter of fiscal 2021. The amortization is included in interest expense on the accompanying unaudited condensed consolidated statements of operations.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Fair value measurements</font><font style="display: inline;">: Financial Accounting Standards Board (&#x201C;FASB&#x201D;) Accounting Standards Codification (&#x201C;ASC&#x201D;) Topic 820 &#x2013;</font><font style="display: inline;font-style:italic;"> Fair Value Measurements and Disclosures,</font><font style="display: inline;"> defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying unaudited condensed consolidated financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note 3 </font><font style="display: inline;">for a discussion of fair value measurements</font><font style="display: inline;">.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">The carrying amounts reported in the accompanying unaudited condensed consolidated balance sheets for cash, accounts receivable, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of long-term debt, taking into consideration debt discounts and related derivative instruments, is estimated to approximate fair value.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Unearned revenue</font><font style="display: inline;">: The Company records an unearned revenue liability if a customer pays consideration before the Company transfers the product to the customer under the terms of a contract. Unearned revenue is recognized as revenue after control of the product is transferred to the customer and all revenue recognition criteria have been met.&nbsp;&nbsp;The Company had no unearned revenue at March 31, 2019. Unearned revenue at September&nbsp;30, 2018 was approximately </font><font style="display: inline;">$187,000</font><font style="display: inline;color:#000000;">&nbsp;</font><font style="display: inline;">and was comprised of sales made to a large distributor who has the right to return product under certain conditions. </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Derivative instruments</font><font style="display: inline;">: The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments. Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities incurred in connection with an embedded derivative are discussed in Note 7.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Revenue recognition</font><font style="display: inline;">: 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.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">The Company generates nearly all of 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 Company does not typically have significant unusual payment terms beyond </font><font style="display: inline;">120</font><font style="display: inline;"> days in its contracts with customers. See Note 4 for additional information regarding credit terms.</font> </p> <p style="margin:0pt;text-indent:18pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">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 </font><font style="display: inline;color:#000000;">assessment of current contract sales terms and historical payment experience.</font> </p> <p style="margin:0pt;text-indent:18pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">Product returns are typically not significant because returns are generally not allowed unless the product is damaged at time of receipt.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;border-bottom:1pt none #D9D9D9 ;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Research and development costs</font><font style="display: inline;">: Research and development costs are expensed as they are incurred and include salaries and benefits, clinical trial costs and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods are no longer expected to be delivered or the services are no longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company did not have any capitalized nonrefundable advance payments as of March 31, 2019 and September 30, 2018.</font> </p> <p style="margin:0pt;border-top:1pt none #D9D9D9 ;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">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&#x2019;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&#x2019;s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company&#x2019;s accruals could materially affect the Company&#x2019;s results of operations. </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Share-based compensation</font><font style="display: inline;">: The Company recognizes share-based compensation expense in connection with its share-based awards based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rates.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;font-weight:bold;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;text-decoration:underline;">Advertising</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">: The Company's policy is to expense advertising costs as incurred. Advertising costs were immaterial to the Company&#x2019;s results of operations for the three and six months ended March 31, 2019 and 2018.</font> </p> <p style="margin:0pt;border-bottom:1pt none #D9D9D9 ;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">&nbsp;</font> </p> <p style="margin:0pt;border-top:1pt none #D9D9D9 ;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;text-decoration:underline;">Income taxes</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">: The Company files separate income tax returns for its foreign subsidiaries. FASB ASC Topic&nbsp;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.&nbsp;&nbsp;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.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&nbsp;</font> </p> <p style="margin:0pt;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;text-decoration:underline;">Foreign currency translation and operations</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">: Effective October&nbsp;1, 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries&#x2019; functional currency.&nbsp;&nbsp;The evaluation indicated that the U.S. dollar is the currency with the most significant influence upon the subsidiaries.&nbsp;&nbsp;Because all of the U.K. subsidiary's future sales and cash flows would be denominated in U.S. dollars following the October 2009 cessation of production of the Company&#x2019;s first-generation product, FC1, the U.K. subsidiary adopted the U.S. dollar as its functional currency effective October&nbsp;1, 2009. As the Malaysia subsidiary is a direct and integral component of the U.K. parent&#x2019;s operations, it, too, adopted the U.S. dollar as its functional currency as of October&nbsp;1, 2009. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was </font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">$0.6</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;"> million as of March 31, 2019 and September 30, 2018. Assets located outside of the U.S. totaled approximately </font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">$5.0</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;"> million and </font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">$5.2</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;"> million at March 31, 2019 and September 30, 2018, respectively.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;"> &nbsp; &nbsp;</font> </p> <p style="margin:0pt;border-bottom:1pt none #D9D9D9 ;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;text-decoration:underline;">Other comprehensive loss</font><font style="display: inline;font-family:Times New Roman;font-size:10pt;">: Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss.&nbsp;&nbsp;Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss.</font> </p> <p style="margin:0pt;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">&#xFEFF;</font> </p> <p style="margin:0pt;border-top:1pt none #D9D9D9 ;font-family:Arial Narrow;font-size: 10pt"> <font style="display: inline;font-family:Times New Roman;font-size:10pt;">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&#x2019;s policy and intent is to settle the intercompany trade account on a current basis.&nbsp;&nbsp;Since the U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currencies effective October&nbsp;1, 2009, no foreign currency gains or losses from intercompany trade are recognized.&nbsp;&nbsp;For the three and six months ended March 31, 2019 and 2018, comprehensive loss is equivalent to the reported net loss. </font><font style="display: inline;font-family:Times New Roman;color:#000000;font-size:10pt;"> &nbsp; &nbsp;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Recently Issued Accounting Pronouncements</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">In May 2014, the FASB issued Accounting Standards Update (&#x201C;ASU&#x201D;) 2014-09, </font><font style="display: inline;font-style:italic;color:#000000;">Revenue from Contracts with Customers (Topic 606)</font><font style="display: inline;color:#000000;">.&nbsp;&nbsp;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.&nbsp;&nbsp;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 discussion above for disclosures relating to the Company's revenue recognition.</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">In February 2016, the FASB issued ASU 2016-02, </font><font style="display: inline;font-style:italic;">Leases (Topic 842)</font><font style="display: inline;">, &nbsp;</font><font style="display: inline;color:#000000;">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</font><font style="display: inline;"> key information about leasing arrangements.&nbsp;&nbsp;ASU 2016-02 </font><font style="display: inline;color:#000000;">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.</font><font style="display: inline;"> &nbsp;Early adoption is permitted. I</font><font style="display: inline;color:#000000;">n July 2018, the FASB issued ASU No. 2018-10, </font><font style="display: inline;font-style:italic;color:#000000;">Codification Improvements to Topic 842, Leases</font><font style="display: inline;color:#000000;"> to clarify the implementation guidance and ASU No. 2018-11, </font><font style="display: inline;font-style:italic;color:#000000;">Leases (Topic 842) Targeted Improvements</font><font style="display: inline;color:#000000;">. 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. </font><font style="display: inline;">I</font><font style="display: inline;color:#000000;">n December 2018, the FASB issued ASU 2018-20, </font><font style="display: inline;font-style:italic;color:#000000;">Leases (Topic 842): Narrow-Scope Improvements for Lessors</font><font style="display: inline;color:#000000;"> to address certain implementation issues facing lessors when adopting ASU 2016-02. </font><font style="display: inline;">I</font><font style="display: inline;color:#000000;">n March 2019, the FASB issued ASU 2019-01, </font><font style="display: inline;font-style:italic;color:#000000;">Leases (Topic 842): Codification Improvements</font><font style="display: inline;color:#000000;"> 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 </font><font style="display: inline;">on October&nbsp;1, 2019 and intends to elect certain </font><font style="display: inline;color:#000000;">practical expedients,&nbsp;including the optional transition method that allows for the application of the new standard at its adoption date with no restatement of prior period amounts</font><font style="display: inline;">. &nbsp;</font><font style="display: inline;color:#000000;">We have begun to identify our significant lease contracts and are in the process of </font><font style="display: inline;">evaluating the effect of the new guidance on our consolidated financial statements and related disclosures. </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">In November 2016, the FASB issued ASU 2016-18,&nbsp;</font><font style="display: inline;font-style:italic;">Statement of Cash Flows</font><font style="display: inline;">&nbsp;</font><font style="display: inline;font-style:italic;">(Topic 230):</font><font style="display: inline;">&nbsp;</font><font style="display: inline;font-style:italic;">Restricted Cash</font><font style="display: inline;">.&nbsp;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.&nbsp; </font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&#xFEFF;</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">In January 2017, the FASB issued ASU 2017-04,&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">Intangibles - Goodwill and Other Topics&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">(Topic 350)</font><font style="display: inline;font-style:italic;color:#000000;">: Simplifying the Test for Goodwill Impairment</font><font style="display: inline;color:#000000;">. The purpose of ASU 2017-04 is to reduce the cost and complexity of evaluating goodwill for impairment. It eliminates the need for entities to calculate the impaired fair value of goodwill by assigning the fair value of a reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. Under this amendment, an entity will perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge is recognized for the amount by which the carrying value exceeds the reporting unit's fair value. ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December&nbsp;15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January&nbsp;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.</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">&#xFEFF;</font> </p> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">In May 2017, the FASB issued ASU 2017-09,&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">Compensation - Stock Compensation&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">(Topic 718)</font><font style="display: inline;font-style:italic;color:#000000;">: Scope of Modification Accounting</font><font style="display: inline;color:#000000;">. 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. </font><font style="display: inline;color:#000000;">The amendments in ASU 2017-09 should be applied prospectively to an award modified on or after the adoption date. We adopted </font><font style="display: inline;color:#000000;">ASU 2017-09 effective October&nbsp;1, 2018. The adoption of ASU 2017-09 did not have a material effect on our financial position or results of operations.&nbsp; </font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">&#xFEFF;</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">In June 2018, the FASB issued ASU 2018-07,&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">Compensation - Stock Compensation&nbsp;</font><font style="display: inline;font-style:italic;color:#000000;">(Topic 718)</font><font style="display: inline;font-style:italic;color:#000000;">: Improvements to Nonemployee Share-Based Payment Accounting</font><font style="display: inline;color:#000000;">. The purpose of ASU 2018-07 is to expand the scope of </font><font style="display: inline;font-style:italic;color:#000000;">Topic 718, Compensation&#x2014;Stock Compensation</font><font style="display: inline;color:#000000;"> (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&#x2019;s adoption date of </font><font style="display: inline;font-style:italic;color:#000000;">Topic 606, Revenue from Contracts with Customers</font><font style="display: inline;color:#000000;">. 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.</font><font style="display: inline;font-weight:bold;">&nbsp;</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&nbsp;</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;color:#000000;">In August 2018, the FASB issued ASU 2018-13, </font><font style="display: inline;font-style:italic;color:#000000;">Fair Value Measurement (Topic 820): Disclosure Framework &#x2013; Change to the Disclosure Requirements for Fair Value Measurement</font><font style="display: inline;color:#000000;">. ASU 2018-13 </font><font style="display: inline;color:#000000;">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.&nbsp;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</font><font style="display: inline;color:#000000;">. The adoption of ASU 2018-13 is not expected to have a material effect on our financial position or results of operations </font><font style="display: inline;color:#000000;">as it modifies disclosure requirements only.</font> </p> <p style="margin:0pt;line-height:normal;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;">&nbsp;</font> </p> <p><font size="1"> </font></p> </div> </div>
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<div> <div style="margin-left:0pt;margin-right:0pt;"> <p style="margin:0pt;font-family:Times New Roman;font-size: 10pt"> <font style="display: inline;text-decoration:underline;">Reclassifications</font><font style="display: inline;">: &nbsp;</font><font style="display: inline;">Certain prior period amounts in the accompanying unaudited interim condensed consolidated financial statements have been reclassified to conform with the current period presentation. </font><font style="display: inline;">These reclassifications had no effect on </font><font style="display: inline;color:#000000;">the results of operations or financial position for any period presented.</font> </p> <p><font size="1"> </font></p> </div> </div>
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63627
veru Number Of Class Action Lawsuits Filed
NumberOfClassActionLawsuitsFiled
2
veru Provision Charges To Expenses
ProvisionChargesToExpenses
3058
CY2018Q3 veru Residual Royalty Agreement Noncurrent
ResidualRoyaltyAgreementNoncurrent
1753805
CY2019Q1 veru Residual Royalty Agreement Noncurrent
ResidualRoyaltyAgreementNoncurrent
2341522

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