Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Mar. 31, 2015 |
Accounting Policies [Abstract] | |
Nature of Operations and Basis of Presentation | Nature of operations and basis of presentation |
References in these notes to the consolidated financial statements to “Organovo Holdings, Inc.,” “Organovo Holdings,” “we,” “us,” “our,” “the Company” and “our Company” refer to Organovo Holdings, Inc. and its consolidated subsidiaries. Our consolidated financial statements include the accounts of the Company as well as its wholly-owned subsidiaries, with all material intercompany accounts and transactions eliminated in consolidation. In December 2014, we established a wholly-owned subsidiary, Samsara Sciences, Inc., to focus on the acquisition of qualified cells in support of our commercial and research endeavors. |
Since its inception, the Company has devoted its efforts primarily to developing and commercializing a platform technology and functional human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs, raising capital and building infrastructure. In November 2014, the Company announced the full commercial release of its first product, the exVive3D ™ Human Liver Tissue for use in toxicology and other preclinical drug testing. As of March 31, 2015, the Company has not yet realized significant revenues from its planned principal operations. The Company’s activities are subject to significant risks and uncertainties including failing to secure additional funding to fully operationalize the Company’s current technology and continue to implement its business plan. |
Reverse merger transaction | Reverse merger transaction |
On February 8, 2012, Organovo, Inc., a privately held Delaware corporation, merged with and into Organovo Acquisition Corp., a wholly-owned subsidiary of Organovo Holdings, Inc., a publicly traded Delaware corporation (“the Company”), with Organovo, Inc. surviving the merger as a wholly-owned subsidiary of the Company (the “Merger”). As a result of the Merger, the Company acquired the business of Organovo, Inc., and has continued the existing business operations of Organovo, Inc. |
Simultaneously with the Merger, on February 8, 2012 (the “Closing Date”), all of the issued and outstanding shares of Organovo, Inc.’s common stock converted, on a 1 for 1 basis, into shares of the Company’s common stock, par value $0.001 per share. Also, on the closing date, all of the issued and outstanding options to purchase shares of Organovo, Inc.’s common stock and other outstanding warrants to purchase Organovo, Inc.’s common stock, and all of the issued and outstanding bridge warrants to purchase shares of Organovo, Inc.’s common stock, converted on a 1 for 1 basis, into options, warrants and new bridge warrants to purchase shares of the Company’s common stock. |
Immediately following the consummation of the Merger: (i) the former security holders of Organovo, Inc. common stock had an approximate 75% voting interest in the Company and the Company stockholders retained an approximate 25% voting interest, (ii) the former executive management team of Organovo, Inc. remained as the only continuing executive management team for the Company, and (iii) the Company’s ongoing operations consisted solely of the ongoing operations of Organovo, Inc. Based primarily on these factors, the Merger was accounted for as a reverse merger and a recapitalization in accordance with U.S. generally accepted accounting principles (“GAAP”). As a result, these financial statements reflect the historical results of Organovo, Inc. prior to the Merger, and the combined results of the Company following the Merger. The par value of Organovo, Inc. common stock immediately prior to the Merger was $0.0001 per share. The par value subsequent to the Merger is $0.001 per share, and therefore the historical results of Organovo, Inc. prior to the Merger have been retroactively adjusted to affect the change in par value. |
In connection with three separate closings of a private placement transaction completed in connection with the Merger (the “Private Placement”), the Company received gross proceeds of approximately $5.0 million, $1.8 million and $6.9 million on closings on February 8, 2012, February 29, 2012 and March 16, 2012, respectively. In 2011, the Company received $1.5 million from the purchase of 6% convertible notes which were automatically converted into 1,500,000 shares of common stock, plus 25,387 shares for accrued interest of $25,387 on the principal, on February 8, 2012. |
The cash transaction costs related to the Merger were approximately $2.1 million. |
Before the Merger, the Company’s Board of Directors and stockholders adopted the 2012 Equity Incentive Plan (the “2012 Plan”). In addition, the Company assumed and adopted Organovo, Inc.’s 2008 Equity Incentive Plan. |
Liquidity | Liquidity |
As of March 31, 2015, the Company had an accumulated deficit of approximately $122.3 million. The Company also had negative cash flows from operations of approximately $19.6 million during the year ended March 31, 2015. |
Through March 31, 2015, the Company has financed its operations primarily through the sale of convertible notes, the private placement of equity securities, the public offering of common stock, and through revenue derived from grants, collaborative research agreements, and product and service agreements. Based on its current operating plan and available cash resources, the Company believes it has sufficient resources to fund its business for at least the next twelve months. |
The Company will need additional capital to further fund the development and commercialization of its human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. The Company intends to cover its future operating expenses through cash on hand, through revenue derived from research service agreements, product sales, collaborative research agreements, grants, and through the issuance of additional equity or debt securities. Depending on market conditions, we cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. |
Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs or relinquish rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could eventually adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. |
Use of estimates | Use of estimates |
The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Significant estimates used in preparing the consolidated financial statements include those assumed in computing the valuation of warrants and conversion features, revenue recognized under the proportional performance model, the valuation of stock-based compensation expense, and the valuation allowance on deferred tax assets. |
Financial instruments | Financial instruments |
For certain of the Company’s financial instruments, including cash and cash equivalents, inventory, prepaid expenses and other assets, accounts payable, accrued expenses, deferred revenue, and capital lease obligations, the carrying amounts are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. |
Cash and cash equivalents | Cash and cash equivalents |
The Company considers all highly liquid investments with original maturities of 90 days or less to be cash equivalents. |
Derivative financial instruments | Derivative financial instruments |
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency. |
The Company reviews the terms of convertible debt and equity instruments it issues to determine whether there are derivative instruments, including an embedded conversion option that is required to be bifurcated and accounted for separately as a derivative financial instrument. In circumstances where a host instrument contains more than one embedded derivative instrument, including a conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. Also, in connection with the sale of convertible debt and equity instruments, the Company may issue freestanding warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity. |
Derivative instruments are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the convertible debt or equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds allocated to the convertible host instruments are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. |
The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense, using the effective interest method. |
Restricted cash | Restricted cash |
As of March 31, 2015 and 2014, the Company had approximately $78,800 of restricted cash deposited with a financial institution. The entire amount is held in certificates of deposit to support a letter of credit agreement related to the Company’s facility lease. |
Inventory | Inventory |
Inventories are stated at the lower of the cost or market (first-in, first-out). Inventory consists of approximately $66,000, and $63,000 in raw materials as of March 31, 2015 and 2014, respectively, net of reserves. |
Fixed assets and depreciation | Fixed assets and depreciation |
Property and equipment are carried at cost. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets or, in the case of leasehold improvements, over the lesser of the useful life of the related asset or the remaining lease term. The estimated useful lives of the fixed assets range between three and seven years. |
Impairment of long-lived assets | Impairment of long-lived assets |
In accordance with authoritative guidance the Company reviews its long-lived assets, including property and equipment and other assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be fully recoverable. To determine recoverability of its long-lived assets, the Company evaluates whether future undiscounted net cash flows will be less than the carrying amount of the assets and adjusts the carrying amount of its assets to fair value. Management has determined that no impairment of long-lived assets occurred as of March 31, 2015. |
Fair value measurement | Fair value measurement |
Financial assets and liabilities are measured at fair value, which is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The following is a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: |
· | Level 1 — Quoted prices in active markets for identical assets or liabilities. | | | | | | | | | | | | | | | |
· | Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | | | | | | | | | | | | | | | |
· | Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | | | | | | | | | | | | | | | |
The Company has issued warrants, of which some are classified as derivative liabilities as a result of the terms in the warrants that provide for down-round protection in the event of a dilutive issuance. The Company uses Level 3 inputs for its valuation methodology for the warrant derivative liabilities. The estimated fair values were determined using a Monte Carlo option pricing model based on various assumptions (see Note 5). The Company’s derivative liabilities are adjusted to reflect estimated fair value at each period end, with any decrease or increase in the estimated fair value being recorded in other income or expense accordingly, as adjustments to the fair value of derivative liabilities. Various factors are considered in the pricing models we use to value the warrants, including the Company’s current stock price, the remaining life of the warrants, the volatility of the Company’s stock price, and the risk free interest rate. Changes in these factors have had and may continue in the future to have a significant impact on the computed fair value of the warrant liability. |
The estimated fair values of the liabilities measured on a recurring basis are as follows: |
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| | Fair Value Measurements at March 31, 2015 and 2014 (in thousands): | |
| | Balance at | | | Quoted | | | Significant | | | Significant | |
March 31, | Prices in | Other | Other |
2015 | Active | Observable | Unobservable |
| Markets | Inputs | Inputs |
| (Level 1) | (Level 2) | (Level 3) |
Warrant liability | | $ | 126 | | | $ | — | | | $ | — | | | $ | 126 | |
| | | | | | | | | | | | | | | | |
| | Balance at | | | Quoted | | | Significant | | | Significant | |
March 31, | Prices in | Other | Other |
2014 | Active | Observable | Unobservable |
| Markets | Inputs | Inputs |
| (Level 1) | (Level 2) | (Level 3) |
Warrant liability | | $ | 377 | | | $ | — | | | $ | — | | | $ | 377 | |
The following table presents the activity for liabilities measured at estimated fair value using unobservable inputs for the years ended March 31, 2015 and 2014: |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
|
| | Warrant | | | | | | | | | | | | | |
Derivative | | | | | | | | | | | | |
Liability | | | | | | | | | | | | |
(in thousands) | | | | | | | | | | | | |
Balance at March 31, 2013 | | $ | 6,898 | | | | | | | | | | | | | |
Issuances | | $ | — | | | | | | | | | | | | | |
Adjustments to estimated fair value | | $ | 5,120 | | | | | | | | | | | | | |
Warrant liability removal due to settlements | | $ | (10,874 | ) | | | | | | | | | | | | |
Warrant liability reclassified to equity | | $ | (767 | ) | | | | | | | | | | | | |
Balance at March 31, 2014 | | $ | 377 | | | | | | | | | | | | | |
Issuances | | $ | — | | | | | | | | | | | | | |
Adjustments to estimated fair value | | $ | (196 | ) | | | | | | | | | | | | |
Warrant liability removal due to settlements | | $ | (55 | ) | | | | | | | | | | | | |
Balance at March 31, 2015 | | $ | 126 | | | | | | | | | | | | | |
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Research and development | Research and development |
Research and development expenses, including direct and allocated expenses, consist of independent research and development costs, as well as costs associated with sponsored research and development. Research and development costs are expensed as incurred. |
Income taxes | Income taxes |
Deferred income taxes are recognized for the tax consequences in future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the combination of the tax payable for the year and the change during the year in deferred tax assets and liabilities. |
Revenue recognition | Revenue recognition |
The Company’s revenues are derived from research service agreements, product sales, collaborative research agreements, and grants from the National Institute of Health (“NIH”), U.S. Treasury Department and private not-for-profit organizations. |
The Company recognizes revenue when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) services have been rendered or product has been delivered; (iii) price to the customer is fixed and determinable; and (iv) collection of the underlying receivable is reasonably assured. |
Billings to customers or payments received from customers are included in deferred revenue on the balance sheet until all revenue recognition criteria are met. As of March 31, 2015 and 2014 the Company had approximately $259,000 and $17,000, respectively, in deferred revenue related to its grants, collaborative research programs and research service agreements. |
Revenue arrangements with multiple deliverables | Revenue arrangements with multiple deliverables |
The Company periodically enters into revenue arrangements that contain multiple deliverables. Judgment is required to properly identify the accounting units of the multiple deliverable transactions and to determine the manner in which revenue should be allocated among the accounting units. Moreover, judgment is used in interpreting the commercial terms and determining when all criteria of revenue recognition have been met for each deliverable in order for revenue recognition to occur in the appropriate accounting period. For multiple deliverable agreements, consideration is allocated at the inception of the agreement to all deliverables based on their relative selling price. The relative selling price for each deliverable is determined using vendor-specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, the Company uses its best estimate of the selling price for the deliverable. |
The Company recognizes revenue for delivered elements only when it determines there are no uncertainties regarding customer acceptance. While changes in the allocation of the arrangement consideration between the units of accounting will not affect the amount of total revenue recognized for a particular sales arrangement, any material changes in these allocations could impact the timing of revenue recognition, which could affect the Company’s results of operations. |
The Company expects to periodically receive license fees for non-exclusive research licensing associated with funded research projects. License fees under these arrangements are recognized over the term of the contract or development period as it has been determined that such licenses do not have stand-alone value. |
Revenue from research service agreements | Revenue from research service agreements |
For research service agreements, the Company defers any up-front fees collected from customers and recognizes revenue when earned, typically when services are rendered or deliverables are provided to the customer. When substantial customer acceptance terms exist, the Company recognizes revenue for delivered elements only when it determines there are no uncertainties regarding customer acceptance. |
Research and development revenue under collaborative agreements | Research and development revenue under collaborative agreements |
The Company’s collaboration revenue consists of license and collaboration agreements that contain multiple elements, including non-refundable up-front fees, payments for reimbursement of third-party research costs, payments for ongoing research, payments associated with achieving specific development milestones and royalties based on specified percentages of net product sales, if any. The Company considers a variety of factors in determining the appropriate method of revenue recognition under these arrangements, such as whether the elements are separable, whether there are determinable fair values and whether there is a unique earnings process associated with each element of a contract. |
The Company recognizes revenue from research funding under collaboration agreements when earned on a “proportional performance” basis as research hours are incurred. The Company performs services as specified in each respective agreement on a best-efforts basis, and is reimbursed based on labor hours incurred or achievement of milestones or certain deliverables as specified in the contract. The Company initially defers revenue for any amounts billed or payments received in advance of the services being performed, and recognizes revenue pursuant to the related pattern of performance, based on total labor hours incurred relative to total labor hours estimated under the contract. |
In December 2010, the Company entered into a 12 month research contract agreement with a third party, whereby the Company was engaged to perform research and development services on a fixed-fee basis for approximately $600,000. Based on the proportional performance criteria, the Company recognized approximately $150,000 in revenue related to the contract during the year ended December 31, 2012. Total revenue recognized on the contract as of March 31, 2015 was approximately $600,000. |
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In October 2011, the Company entered into a research contract agreement with a third party to perform research and development services for a fixed-fee of $1,365,000. The agreement included an initial payment to the Company of approximately $239,000 with remaining payments occurring over a twenty-one month period. On November 27, 2012, the agreement was amended to include additional research and development services, for an additional $135,000, bringing the total contract value to $1,500,000. The third party ultimately elected to have only $40,000 of these additional research and development services performed by the Company, resulting in a total contract value of $1,405,000. The amendment extended the original contract (which ran concurrently) from twenty-one months to twenty-eight months. The Company recorded approximately $0, $184,000, $97,000, $120,000, and $885,000 for the years ended March 31, 2015 and 2014, the three months ended March 31, 2013 and 2012, and the year ended December 31, 2012, respectively, in revenue related to the research contract in recognition of the proportional performance achieved. |
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In September 2013, the Company entered into a research contract agreement with a third party to perform research and development services for fixed fees ranging from approximately $7,000 to $83,000, depending on go/no-go decisions made along the way. The agreement included an initial payment to the Company of approximately $7,000 with remaining payments occurring at the completion of each phase of work. The third party ultimately elected to have $76,000 of work performed under the agreement, and as such the Company recorded approximately $69,000 and $7,000, for the years ended March 31, 2015 and 2014, respectively, in revenue related to the research contract in recognition of the proportional performance achieved. |
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In October 2013, the Company entered into a research contract agreement with a third party to perform research and development services for fixed fees ranging from approximately $59,000 to approximately $93,000, depending on go/no-go decisions made along the way. The agreement included an initial payment to the Company of approximately $29,000 with remaining payments occurring at the beginning of each phase of work. The third party elected to have all potential work performed under the agreement, and as such the Company recorded approximately $41,000 and $52,000, for the years ended March 31, 2015 and 2014, respectively, in revenue related to the research contract in recognition of the proportional performance achieved. |
Product revenue | Product revenue |
The Company recognizes product revenue at the time of shipment to the customer, provided all other revenue recognition criteria have been met. To date, the Company has not recognized significant revenue from commercial product sales. |
As our commercial sales increase, we expect to establish a reserve for estimated product returns that will be recorded as a reduction to revenue. That reserve will be maintained to account for future return of products sold in the current period. The reserve will be reviewed quarterly and will be estimated based on an analysis of our historical experience related to product returns. |
Grant revenues | Grant revenues |
During 2012, 2010 and 2009, the NIH awarded the Company three research grants totaling approximately $558,000. Revenues from these NIH grants were based upon internal and subcontractor costs incurred that were specifically covered by the grants, and where applicable, an additional facilities and administrative rate that provided funding for overhead expenses. These revenues were recognized when expenses had been incurred by subcontractors and as the Company incurred internal expenses that were related to the grants. Revenue recognized under these grants for the years ended March 31, 2015 and 2014, the three months ended March 31, 2013 and 2012, and the year ended December 31, 2012 was approximately $0, $12,000, $117,000, $0, and $162,000, respectively. |
During August of 2013, the Company was awarded a research grant by a private, not-for-profit organization for up to $251,700, contingent on go/no-go decisions made by the grantor at the completion of each stage of research as outlined in the grant award. Revenues from the grant are based upon internal costs incurred that are specifically covered by the grant, plus an additional rate that provides funding for overhead expenses. Revenue is recognized when the Company incurs expenses that are related to the grant. Revenue recognized under this grant was approximately $49,000 and $119,000 for the years ended March 31, 2015 and 2014, respectively. |
During September of 2014, the NIH awarded the Company a research grant totaling approximately $222,000. The grant provides for fixed payments based on the achievement of certain milestones. As such, revenue will be recognized upon completion of those milestones. Revenue recognized under this grant was approximately $74,000 for the year ended March 31, 2015. |
Stock-based compensation | Stock-based compensation |
The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Board’s ASC Topic 718, Compensation — Stock Compensation, which establishes accounting for equity instruments exchanged for employee services. Under such provisions, stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense, under the straight-line method, over the employee’s requisite service period (generally the vesting period of the equity grant). |
The Company accounts for equity instruments, including restricted stock or stock options, issued to non-employees in accordance with authoritative guidance for equity based payments to non-employees. Stock options issued to non-employees are accounted for at their estimated fair value determined using the Black-Scholes option-pricing model. The fair value of options granted to non-employees is re-measured as they vest, and the resulting increase in value, if any, is recognized as expense during the period the related services are rendered. Restricted stock issued to non-employees is accounted for at its estimated fair value as it vests. |
Comprehensive income (loss) | Comprehensive income (loss) |
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all components of comprehensive income (loss) in the financial statements in the period in which they are recognized. Net income (loss) and other comprehensive income (loss), including unrealized gains and losses on investments, are reported, net of their related tax effect, to arrive at comprehensive income (loss). For the years ended March 31, 2015 and 2014, the three months ended March 31, 2013 and 2012, and the year ended December 31, 2012 the comprehensive loss was equal to the net loss. |
Net loss per share | Net loss per share |
Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted-average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options, and the assumed issuance of common stock under restricted stock units, shares subject to repurchase and warrants as the effect would be anti-dilutive. No dilutive effect was calculated for the years ended March 31, 2015 and 2014, the three months ended March 31, 2013 or 2012, or the year ended December 31, 2012 as the Company reported a net loss for each respective period and the effect would have been anti-dilutive. Total common stock equivalents that were excluded from computing diluted net loss per share were approximately 8.6 million, 7.7 million, 8.9 million, 25.8 million, and 15.2 million for the years ended March 31, 2015 and 2014, the three months ended March 31, 2013 and 2012 and the year ended December 31, 2012, respectively. |
Reclassifications | Reclassifications |
Certain reclassifications were made to the Consolidated Balance Sheet as of March 31, 2014 in order to conform to the presentation of the Consolidated Balance Sheet as of March 31, 2015. The reclassifications did not have any effect on previously reported financial position. |