Basis of Presentation | 3 Months Ended |
Mar. 31, 2015 |
Accounting Policies [Abstract] | |
Basis of Presentation | BASIS OF PRESENTATION |
Financial Statement Presentation |
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto as of and for the year ended December 31, 2014 included in the Apricus Biosciences, Inc. and subsidiaries (the “Company”) Annual Report on Form 10-K (“Annual Report”) filed with the Securities and Exchange Commission (the “SEC”) on March 16, 2015. The accompanying financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. In the opinion of the Company’s management, all adjustments that are of a normal recurring nature and considered necessary for fair statement have been included in the accompanying condensed consolidated financial statements. Certain prior year items in the statement of cash flows have been reclassified to conform to the current year presentation. The condensed consolidated balance sheet was derived from audited financial statements, but does not include all GAAP disclosures. The unaudited condensed consolidated financial statements for the interim periods are not necessarily indicative of results for the full year. The preparation of these unaudited condensed consolidated financial statements requires the Company to make estimates and judgments that affect the amounts reported in the financial statements and the accompanying notes. The Company’s actual results may differ from these estimates under different assumptions or conditions. |
Liquidity |
The accompanying unaudited condensed consolidated financial statements have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company had an accumulated deficit of approximately $296.3 million as of March 31, 2015, recorded a net loss of approximately $6.4 million for the three months ended March 31, 2015 and has principally been financed through the sale of its common stock and other equity securities, debt financing and up-front payments received from commercial partners for the Company’s products under development. |
In February 2015, the Company entered into subscription agreements with certain purchasers pursuant to which it sold an aggregate of 6,043,955 shares of its common stock and issued warrants to purchase up to an additional 3,021,977 shares of its common stock. Each share of common stock was sold at a price of $1.82 and included one half of a warrant to purchase a share of common stock. The warrants have an exercise price of $1.82 per share, are exercisable beginning six months and one day after the date of issuance and expire on the seventh anniversary of the date of issuance. The total net proceeds from the offering were $10.9 million after deducting expenses of approximately $0.1 million. The subscription agreements grant certain of the purchasers preemptive rights to participate in future equity issuances by the Company, subject to certain exceptions, and require that the Company obtain permission from certain of the purchasers prior to selling shares under its committed equity financing facility with Aspire Capital Fund, LLC (“Aspire Capital”). |
Based upon its current operating plan, the access to additional capital under its committed equity financing facility, potential to borrow an additional amount of up to $5.0 million under its credit facility with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”), and the $10.9 million received from the Company’s February 2015 financing, the Company believes it has sufficient cash to fund its on-going operations through the second quarter of 2016. |
Based on its recurring losses, negative cash flows from operations and working capital levels, the Company will need to raise substantial additional funds to finance its operations. If the Company is unable to maintain sufficient financial resources, including by raising additional funds when needed, its business, financial condition and results of operations will be materially and adversely affected. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or debt financings may have a dilutive effect on the holdings of the Company’s existing stockholders. |
Warrant Liabilities |
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The Company’s outstanding common stock warrants issued in connection with its February 2015 financing are classified as liabilities in the accompanying condensed consolidated balance sheets as they contain provisions that could require the Company to settle the warrants in cash. The warrants were recorded at fair value using the Black-Scholes option pricing model. The fair value of these warrants is re-measured at each financial reporting period with any changes in fair value being recognized as a component of other income (expense) in the accompanying condensed consolidated statements of operations. |
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Fair Value Measurements |
The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Financial assets and liabilities that are measured or disclosed at fair value on a recurring basis, and are classified within the Level 3 designation include the common stock warrant liabilities. None of the Company’s non-financial assets and liabilities are recorded at fair value on a non-recurring basis. |
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. |
The following table presents the Company’s fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2015 (in thousands): |
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| | Fair Value | | Quoted Market Prices for Identical Assets | | Significant Other | | Significant |
(Level 1) | Observable Inputs | Unobservable |
| (Level 2) | Inputs (Level 3) |
Warrant liability related to February 2015 financing | | $ | 5,213 | | | — | | | $ | — | | | $ | 5,213 | |
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The common stock warrant liabilities are recorded at fair value using the Black-Scholes option pricing model. The following weighted-average assumptions were used in determining the fair value of the common stock warrant liabilities valued using the Black-Scholes option pricing model as of March 31, 2015: |
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Risk-free interest rate | | 1.46 | % | | | | | | | | | | | |
Volatility | | 132.47 | % | | | | | | | | | | | |
Dividend yield | | — | % | | | | | | | | | | | |
Expected term | | 6.86 years | | | | | | | | | | | | |
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Weighted average fair value | | $ | 1.72 | | | | | | | | | | | | |
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The following table is a reconciliation for all liabilities measured at fair value using Level 3 unobservable inputs (in thousands): |
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| | Warrant liability | | | | | | | | | | | |
Balance as of December 31, 2014 | | $ | — | | | | | | | | | | | | |
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Issuance of warrants in connection with February 2015 financing | | 5,077 | | | | | | | | | | | | |
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Change in fair value measurement of warrant liability | | 136 | | | | | | | | | | | | |
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Balance as of March 31, 2015 | | $ | 5,213 | | | | | | | | | | | | |
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Of the inputs used to value the outstanding common stock warrant liabilities as of March 31, 2015, the most subjective input is the Company’s estimate of expected volatility. If volatility were increased to 150%, the weighted average fair market value of the outstanding common stock warrants outstanding would increase approximately $0.2 million, or 3.4%. |
Revenue Recognition |
The Company generates revenues from the licensing of technology rights, the sale of products, and historically, from the performance of contract sales services. Payments received under commercial arrangements, such as the licensing of technology rights, may include non-refundable fees at the inception of the arrangements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. |
The Company recognizes revenue when all of the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the Company’s price to the buyer is fixed or determinable; and (4) collectability is reasonably assured. |
Consideration received for the Company’s license arrangements may consist of non-refundable upfront license fees, various performance or sales milestones, royalties upon sales of product, and the delivery of product and/or research services. The Company considers a variety of factors in determining the appropriate method of accounting under its license agreements, including whether the various elements can be separated and accounted for individually as separate units of accounting. Deliverables under the arrangement will be separate units of accounting, provided (i) a delivered item has value to the customer on a standalone basis; and (ii) the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. |
Multiple element arrangements |
The Company accounts for revenue arrangements with multiple elements by separating and allocating consideration according to the relative selling price of each deliverable. If an element can be separated, an amount is allocated based upon the relative selling price of each element. The Company determines the relative selling price of a separate deliverable using the price it charges other customers when it sells that product or service separately. If the product or service is not sold separately and third party pricing evidence is not available, the Company will use its best estimate of selling price. |
Milestones |
Revenue is recognized when earned, as evidenced by written acknowledgment from the collaborator or other persuasive evidence that the milestone has been achieved, provided that the milestone event is substantive. A milestone event is considered to be substantive if its achievability was not reasonably assured at the inception of the arrangement and the Company’s efforts led to the achievement of the milestone (or if the milestone was due upon the occurrence of a specific outcome resulting from the Company’s performance). Events for which the occurrence is either contingent solely upon the passage of time or the result of a counterparty’s performance are not considered to be milestone events. If both of these criteria are not met, the milestone payment is recognized over the remaining minimum period of the Company’s performance obligations under the arrangement, if any. The Company assesses whether a milestone is substantive at the inception of each arrangement. |
License Fee Revenue |
The Company defers recognition of non-refundable upfront fees if it has continuing performance obligations, without which the technology, right, product or service has no utility to the licensee separate and independent of its performance under the other elements of the applicable arrangement. Non-refundable, up-front fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the Company’s part are recognized as revenue when the license term commences and the licensed data, technology and/or compound is delivered. The specific methodology for the recognition of the revenue is determined on a case-by-case basis according to the facts and circumstances of the applicable agreement. |
Product Sales Revenue |
The Company has supply and manufacturing agreements with certain of its licensee partners for the manufacture and delivery of Vitaros® product. These agreements do not permit the Company’s licensee partners to return product, unless the product sold to the licensee partner is short-dated as defined in each respective license agreement. In those cases, the Company defers revenue recognition until the right of return no longer exists, which is the earlier of: (i) evidence that the product has been sold to an end customer or (ii) the right of return has expired. As such, the Company does not have a sales and returns allowance recorded as of March 31, 2015. |
Beginning in 2014, the Company commenced shipment of its Vitaros® product to its licensee partners and recognized product sales revenue on certain of these shipments since the criteria for revenue recognition was met. |
Royalty Revenue |
The Company relies on its commercial partners to sell Vitaros® in approved markets. The Company receives royalties from licensee partners based upon the amount of sales of licensed Vitaros® product by its commercial partners. Royalty revenues are computed based on sales reported to the Company by its licensee partners on a quarterly basis and at the contractual royalty rates for each respective license agreement. |
Cost of Product Sales |
The Company’s cost of product sales includes direct material and manufacturing overhead associated with production. Cost of product sales is also affected by manufacturing efficiencies, allowances for scrap or expired material and additional costs related to initial production quantities of new products. |
Deferred Cost of Product Sales |
Deferred cost of product sales is stated at the lower of cost or net realizable value and includes product sold where title has transferred, but the criteria for revenue recognition have not been met. The Company’s deferred cost of product sales is included in prepaid expenses and other current assets in the condensed consolidated balance sheets. |
Loss per Common Share |
Basic and diluted net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding for the respective period, without consideration of common stock equivalents as they would have an anti-dilutive effect on per share amounts. |
The following securities that could potentially decrease net loss per share in the future are not included in the determination of diluted loss per share as they are anti-dilutive and are as follows: |
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| | Three Months Ended | | | | | | | | | |
March 31, | | | | | | | | | |
| | 2015 | | 2014 | | | | | | | | | |
Outstanding stock options | | 4,592,562 | | | 3,684,745 | | | | | | | | | | |
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Outstanding warrants | | 9,881,659 | | | 6,185,492 | | | | | | | | | | |
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Stock-Based Compensation |
The estimated grant date fair value of stock options granted to employees and directors is calculated based upon the closing stock price of the Company’s common stock on the date of the grant and recognized as stock-based compensation expense over the expected service period. The Company estimates the fair value of each option award on the date of grant using the Black-Scholes option pricing model. |
The Company also issues performance-based shares which represent a right to receive a certain number of shares of common stock based on the achievement of corporate performance goals and continued employment during the vesting period. At each reporting period, the Company reassesses the probability of the achievement of such corporate performance goals and adjusts expense as necessary. |
The following table presents the weighted average assumptions used by the Company to estimate the fair value of stock option grants using the Black-Scholes option-pricing model, as well as the resulting weighted average fair values: |
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| | Three Months Ended | | | | | | | |
March 31, | | | | | | | |
| | 2015 | | 2014 | | | | | | | |
Risk-free interest rate | | 1.39% - 1.67% | | | 1.58% - 1.96% | | | | | | | | |
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Volatility | | 81.13%- 101.54% | | | 80.75 | % | | | | | | | |
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Dividend yield | | — | % | | — | % | | | | | | | |
Expected term | | 5.25- 6.08 years | | | 5.25- 6.08 years | | | | | | | | |
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Forfeiture rate | | 11.54 | % | | 3.6 | % | | | | | | | |
Weighted average fair value | | $ | 1.05 | | | $ | 1.48 | | | | | | | | |
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The Company granted approximately 1.2 million and 1.3 million shares during the three months ended March 31, 2015 and 2014, respectively. During the three months ended March 31, 2015, approximately 40,000 shares were exercised and approximately 0.5 million shares were forfeited. |
The following table summarizes the total stock-based compensation expense resulting from share-based awards recorded in the Company’s condensed consolidated statements of operations (in thousands): |
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| | Three Months Ended | | | | | | | |
March 31, | | | | | | | |
| | 2015 | | 2014 | | | | | | | |
Research and development | | $ | 30 | | | $ | 89 | | | | | | | | |
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General and administrative | | 259 | | | 402 | | | | | | | | |
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Total | | $ | 289 | | | $ | 491 | | | | | | | | |
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Segment Information |
The Company operates under one segment which develops pharmaceutical products. |
Recent Accounting Pronouncements |
In November 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-16, Derivatives and Hedging (Topic 815): Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share is More Akin to Debt or to Equity. This update clarifies how current guidance should be interpreted in evaluating the economic characteristics and risks of a host contract in a hybrid financial instrument that is issued in the form of a share. In addition, it clarifies that in evaluating the nature of a host contract, an entity should assess the substance of the relevant terms and features (that is, the relative strength of the debt-like or equity-like terms and features given the facts and circumstances) when considering how to weight those terms and features. The effects of initially adopting the new standard should be applied on a modified retrospective basis to existing hybrid financial instruments issued in a form of a share as of the beginning of the fiscal year for which the amendments are effective. Retrospective application is permitted to all relevant prior periods. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted. The Company is currently in the process of evaluating whether the adoption of this update will have a material effect on its condensed consolidated financial statements and related disclosures. |
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this update will require management to assess, at each annual and interim reporting period, the entity’s ability to continue as a going concern and, if management identifies conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued, to disclose in the notes to the entity’s financial statements the principal conditions or events that raised substantial doubt about the entity’s ability to continue as a going concern, management’s evaluation of their significance, and management’s plans that alleviated or are intended to alleviate substantial doubt about the entity’s ability to continue as a going concern. This new standard is effective for annual periods ending after December 15, 2016 and early application is permitted. The Company is currently in the process of evaluating whether the adoption of this update will have a material effect on its condensed consolidated financial statements and related disclosures. |
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which requires entities to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This pronouncement is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period and is to be applied retrospectively, with early application not permitted. The Company is currently evaluating the effect that this pronouncement will have on its financial statements and related disclosures. |