Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business and Summary of Significant Accounting Policies
Nature of operations and basis of presentation
References in these notes to the unaudited condensed 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 subsidiary Organovo, Inc. The Company is developing and
commercializing functional three-dimensional (3D) 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.
As of June 30, 2014, the Company has devoted its efforts primarily to developing a platform technology for the generation of 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. The Company has not
yet realized significant revenues from its planned principal operations. The Companys activities are subject to significant risks and uncertainties including failing to secure additional funding to operationalize the Companys
current technology before another company develops similar technology or products.
The accompanying interim condensed consolidated financial statements
have been prepared by the Company, without audit, in accordance with the instructions to Form 10-Q and, therefore, do not necessarily include all information and footnotes necessary for a fair statement of its financial position, results of
operations, stockholders equity and cash flows in accordance with generally accepted accounting principles (GAAP). The balance sheet at March 31, 2014 is derived from the audited balance sheet at that date.
In the opinion of management, the unaudited financial information for the interim periods presented reflects all adjustments, which are only normal and
recurring, necessary for a fair statement of the Companys financial position, results of operations, stockholders equity and cash flows. These financial statements should be read in conjunction with the financial statements included in
the Companys Annual Report filed on Form 10-K for the year ended March 31, 2014 filed with the Securities and Exchange Commission (the SEC) on June 10, 2014. Operating results for interim periods are not necessarily
indicative of operating results for the Companys fiscal year ending March 31, 2015.
NYSE:MKT Listing
On July 9, 2013, the Company announced that its common stock had been approved for listing on the NYSE:MKT. Shares began trading on the New York Stock
Exchange on July 11, 2013 under the symbol ONVO. Prior to that time, the Companys shares were quoted on the OTC QX.
Liquidity
As of June 30, 2014, the Company had an accumulated deficit of approximately $98.6 million. The Company also had negative cash flows from
operations of approximately $3.4 million during the three months ended June 30, 2014.
Through June 30, 2014, 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 or collaborative research agreements or the commercialization of
products and services. Based on its current operating plan and available cash resources, the Company has sufficient resources to fund its business for at least the next twelve months.
The Company will need additional capital to further fund product 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 additional financing from
existing and prospective investors, from revenue derived from grants and collaborative research agreements, and revenue from the commercialization of products and services. However, we may not be successful in obtaining sufficient funding to support
our operations from new or existing collaborative research agreements or the commercialization of products and services. In addition, 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. Further, we cannot assure you that we will receive 100% of the potential funding under existing grants, and we may not be successful in securing additional grants in the future.
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
7
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
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 condensed consolidated financial statements include those assumed in computing the valuation of warrants, revenue recognized under the proportional performance model, the valuation of
stock-based compensation expense, and the valuation allowance on deferred tax assets.
Financial instruments
For certain of the Companys financial instruments, including cash and cash equivalents, accounts receivable, inventory, prepaid expenses and other
current 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
The Company
considers all highly liquid investments with original maturities of 90 days or less to be cash equivalents.
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
As of June 30, 2014 and March 31, 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 Companys facility lease.
Inventory
Inventories are stated at the lower of the cost or market (first-in, first-out). Inventory consisted of approximately $71,000 and $63,000 in raw materials as
of June 30, 2014 and March 31, 2014, respectively, net of reserves.
The Company provides inventory allowances based on excess or obsolete
inventories determined based on anticipated use in the final product. The reserve for obsolete inventory at June 30, 2014 and March 31, 2014 was approximately $31,000.
8
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 two and five years.
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 has occurred through June 30, 2014.
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:
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Level 1 Quoted prices in active markets for identical assets or liabilities.
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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.
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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.
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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 2). The Companys 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 the Company uses to value the warrants, including the Companys current stock price, the remaining life of the warrants, the
volatility of the Companys stock price, and the risk-free interest rate. Future changes in these factors will have a significant impact on the computed fair value of the warrant liability. As such, future changes in the fair value of the
warrants could vary significantly from quarter to quarter.
The estimated fair values of the liabilities measured on a recurring basis are as follows:
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Fair Value Measurements at June 30 and March 31, 2014 (in thousands):
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Balance at
June 30,
2014
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Quoted
Prices in
Active
Markets
(Level 1)
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Significant
Other
Observable
Inputs
(Level 2)
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Significant
Other
Unobservable
Inputs
(Level 3)
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Warrant liability
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$
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352
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$
|
352
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Balance at
March 31,
2014
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Quoted
Prices in
Active
Markets
(Level 1)
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Significant
Other
Observable
Inputs
(Level 2)
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Significant
Other
Unobservable
Inputs
(Level 3)
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Warrant liability
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$
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377
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$
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377
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9
The following table presents the activity for liabilities measured at estimated fair value using unobservable
inputs for the three months ended June 30, 2014:
Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
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Warrant
Derivative
Liability
(in thousands)
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Balance at March 31, 2014
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$
|
377
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Issuances
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Adjustments to estimated fair value
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30
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|
Warrant liability removal due to settlements
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(55
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)
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Warrant liability reclassified to equity
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Balance at June 30, 2014
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$
|
352
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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
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
The Companys revenues are
derived from collaborative research agreements, grants from the 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 June 30, 2014 and March 31, 2014, the Company had approximately $147,000 and $17,000, respectively, in deferred revenue related to its grants and
collaborative research programs.
Research and Development Revenue Under Collaborative Agreements
The Companys 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 on each 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.
10
Revenue Arrangements with Multiple Deliverables
The Company occasionally 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 Companys 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.
Grant Revenues
During 2012, the NIH awarded the Company a
research grant totaling approximately $290,000. Revenue from the NIH grant is based upon internal and subcontractor costs incurred that are specifically covered by the grant, and an additional facilities and administrative rate that provides funding
for overhead expenses. This revenue is recognized when expenses have been incurred by subcontractors and as the Company incurs internal expenses that are related to the grants. Activities under this grant concluded in April 2013. Revenue recognized
under the grant was approximately $12,000 for the three months ended June 30, 2013.
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 $30,000 for the three months ended June 30, 2014.
Stock-based compensation
The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Boards (FASB) 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 employees 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.
11
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 three months ended June 30, 2014 and 2013, the comprehensive loss was equal to the net loss.
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 warrants,
the assumed release of restriction of restricted stock units, and shares subject to repurchase as the effect would be anti-dilutive. No dilutive effect was calculated for the three months ended June 30, 2014 or 2013, as the Company reported a
net loss for each respective period and the effect would have been anti-dilutive. Common stock equivalents excluded from computing diluted net loss per share were approximately 7.8 million and 8.7 million for the three months ended
June 30, 2014 and 2013, respectively.
Reclassifications
Certain reclassifications were made to the Condensed Consolidated Statement of Operations for the three months ended June 30, 2013 in order to conform to
the presentation of the Condensed Consolidated Statement of Operations for the three months ended June 30, 2014. The reclassifications did not have any effect on previously reported net loss.
2. Derivative Liability
During 2011 and 2012, the Company issued five-year warrants to purchase its common stock. For certain of these warrants, the exercise price
is protected against down-round financing throughout the term of the warrant. Pursuant to ASC 815-15 and ASC 815-40, the fair value of the warrants was recorded as a derivative liability on the issuance dates.
The Company revalues the warrants classified as derivative liabilities as of the end of each reporting period. The estimated fair value of the outstanding
warrant liabilities was approximately $0.4 million as of June 30, 2014 and March 31, 2014. The changes in fair value of the derivative liabilities for the three months ended June 30, 2014 and 2013 were increases of approximately
$30,000 and $23,000, respectively, and are included in other expense in the statement of operations.
During the three months ended June 30, 2014 and
2013, 8,647 and 35,000 warrants, respectively, that were classified as derivative liabilities were exercised. The warrants were revalued as of the settlement dates, and the change in fair value was recognized to earnings. In addition, during the
three months ended June 30, 2013, the Company entered into amendment agreements with certain of the warrant holders, which removed the down-round pricing protection provisions, resulting in 269,657 of these warrants being reclassified from
liability instruments to equity instruments. The Company also recognized a reduction in the warrant liability based on the fair value as of the settlement date for the warrants exercised and as of the modification date for the warrants that were
amended, with a corresponding increase in additional paid-in capital.
The derivative liabilities were valued at the closing dates of the Private
Placement and the end of each reporting period using a Monte Carlo valuation model with the following assumptions:
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June 30, 2014
|
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|
March 31, 2014
|
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|
June 30, 2013
|
|
Closing price per share of common stock
|
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$
|
8.35
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|
|
$
|
7.64
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|
|
$
|
3.78
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|
Exercise price per share
|
|
$
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1.00
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|
$
|
1.00
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|
$
|
1.00
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Expected volatility
|
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|
78.20
|
%
|
|
|
76.50
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%
|
|
|
86.90
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%
|
Risk-free interest rate
|
|
|
1.62
|
%
|
|
|
0.90
|
%
|
|
|
1.04
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%
|
Dividend yield
|
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Remaining expected term of underlying securities (years)
|
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2.71
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|
|
|
2.96
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|
|
|
3.63
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3. Stockholders Equity
Common stock
A shelf registration
statement on Form S-3 (File No. 333-189995), or shelf, was filed with the SEC on July 17, 2013 authorizing the offer and sale in one or more offerings of up to $100,000,000 in aggregate of common stock, preferred stock, debt securities,
warrants to purchase common stock, preferred stock or debt securities, or any combination of the foregoing, either individually or as units comprised of one or more of the other securities. This shelf was declared effective by the SEC on
July 26, 2013.
12
On August 2, 2013, the Company, entered into an Underwriting Agreement (the Underwriting
Agreement) with Lazard Capital Markets LLC, acting as representative of the underwriters named in the Underwriting Agreement (the Underwriters) and joint book-runner with Oppenheimer & Co. Inc., relating to the issuance
and sale of 10,350,000 shares of the Companys common stock, which includes the issuance and sale of 1,350,000 shares pursuant to an overallotment option exercised by the Underwriters on August 5, 2013 (the Offering). JMP
Securities LLC and Maxim Group LLC each acted as co-managers for the Offering. The price to the public in the Offering was $4.50 per share, and the Underwriters purchased the shares from the Company pursuant to the Underwriting Agreement at a price
of $4.23 per share. The net proceeds to the Company from the Offering were approximately $43.4 million, after deducting underwriting discounts and commissions and other offering expenses of $3.2 million payable by the Company, including the
Underwriters exercise of the overallotment option. The transactions contemplated by the Underwriting Agreement closed on August 7, 2013.
In
November 2013, the Company entered into an equity distribution agreement with an investment banking firm. Under the terms of the distribution agreement, the Company may offer and sell up to 4,000,000 shares of its common stock, from time to time,
through the investment bank in at the market offerings, as defined by the SEC, and pursuant to the Companys effective shelf registration statement previously filed with the SEC. During the year ended March 31, 2014, the
Company issued 334,412 shares of common stock in at the market offerings under the distribution agreement with net proceeds of $3.5 million. No shares of common stock were issued under the distribution agreement during the three months ended
June 30, 2014. See Note 7.
In addition, during the three months ended June 30, 2014 and 2013, the Company issued 110,600 and 200,135 shares of
common stock upon exercise of 111,647 and 252,129 warrants, respectively.
Finally, during the three months ended June 30, 2014, the Company issued
60,522 shares of common stock upon exercise of 60,522 stock options. No stock options were exercised during the three months ended June 30, 2013.
Restricted stock awards
In May 2008, the Board of
Directors of the Company approved the 2008 Equity Incentive Plan (the 2008 Plan). The 2008 Plan authorized the issuance of up to 1,521,584 common shares for awards of incentive stock options, non-statutory stock options, restricted stock
awards, restricted stock award units, and stock appreciation rights. The 2008 Plan terminates on July 1, 2018. No shares have been issued under the 2008 Plan since 2011, and the Company does not intend to issue any additional shares from the
2008 Plan in the future.
In January 2012, the Board of Directors of the Company approved the 2012 Equity Incentive Plan (the 2012 Plan). The 2012
Plan authorized the issuance of up to 6,553,986 shares of common stock for awards of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units, performance shares,
and other stock or cash awards. The Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan in July 2013 and August 2013, respectively, to increase the number of shares of common stock that may be issued under the
2012 Plan by 5,000,000 shares, for an aggregate of 11,553,986 shares issuable under the 2012 Plan. The 2012 Plan terminates ten years after its adoption.
During the three months ended June 30, 2013, the Company issued an aggregate of 60,000 restricted stock units with immediate vesting to a consultant. No
restricted stock units were awarded during the three months ended June 30, 2014.
During the three months ended June 30, 2014 and 2013, there
were 2,301 and 2,543 shares of restricted stock, respectively, cancelled related to shares of common stock returned to the Company, at the option of the holders, to cover the tax liability related to the vesting of 6,250 and 6,250 restricted stock
units, respectively. Upon the return of the common stock, an equal number of stock options with immediate vesting were granted to the individuals at the vesting date market value strike price.
There are 200,000 of restricted stock awards that were issued to a member of senior management in a prior year, the vesting of which is performance based. As
of June 30, 2014, the Company believed the financial targets would be met, and accordingly is recognizing the related stock-based compensation expense over the requisite service period.
13
A summary of the Companys restricted stock award activity from March 31, 2014 through June 30,
2014 is as follows:
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Number of
Shares
|
|
Unvested at March 31, 2014
|
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573,495
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|
Granted
|
|
|
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Vested
|
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|
(6,250
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)
|
Canceled / forfeited
|
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|
|
|
|
|
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Unvested at June 30, 2014
|
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567,245
|
|
The fair value of each restricted common stock award is recognized as stock-based compensation expense over the vesting term
of the award. The Company recorded restricted stock-based compensation expense in operating expenses for employees and non-employees of approximately $133,000 and $402,000 for the three months ended June 30, 2014 and 2013, respectively.
Stock-based compensation expense included in research and development was $4,000 and $4,000 for the three months ended June 30, 2014 and 2013, respectively. Stock-based compensation expense included in general and administrative expense was
$129,000 and $398,000 for the three months ended June 30, 2014 and 2013, respectively.
As of June 30, 2014, total unrecognized restricted
stock-based compensation expense was approximately $600,000, which will be recognized over a weighted average period of 1.24 years.
Stock options
Under the 2012 Plan, 266,801 and 51,500 incentive stock options were issued during the three months ended June 30, 2014 and 2013, respectively,
at various exercise prices. The stock options generally vest over a four-year period, with a quarter vesting on either the one year anniversary of employment or the one year anniversary of the vesting commencement date, and the remainder vesting
ratably over the remaining 36 month terms. The Company also issued 45,500 non-qualified stock option grants during the three month period ended June 30, 2013, which vest quarterly over three years.
A summary of the Companys stock option activity for the three months ended June 30, 2014 is as follows:
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Options
Outstanding
|
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Weighted-
Average
Exercise Price
|
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Aggregate
Intrinsic
Value
|
|
Outstanding at March 31, 2014
|
|
|
5,935,888
|
|
|
$
|
4.87
|
|
|
$
|
20,482,823
|
|
Options granted
|
|
|
266,801
|
|
|
$
|
7.31
|
|
|
|
|
|
Options canceled
|
|
|
(22,125
|
)
|
|
$
|
7.22
|
|
|
|
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|
Options exercised
|
|
|
(60,522
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)
|
|
$
|
1.83
|
|
|
$
|
279,284
|
|
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|
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|
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Outstanding at June 30, 2014
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|
|
6,120,042
|
|
|
$
|
5.00
|
|
|
$
|
23,228,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Exercisable at June 30, 2014
|
|
|
1,942,013
|
|
|
$
|
2.48
|
|
|
$
|
11,491,009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average remaining contractual term of options exercisable and outstanding at June 30, 2014 was approximately
8.16 years and 8.73 years, respectively.
The Company uses the Black-Scholes valuation model to calculate the fair value of stock options. Stock-based
compensation expense is recognized over the vesting period using the straight-line method. The fair value of stock options was estimated at the grant date using the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, 2014
|
|
|
Three Months Ended
June 30, 2013
|
|
Dividend yield
|
|
|
|
|
|
|
|
|
Volatility
|
|
|
78.02
|
%
|
|
|
86.90
|
%
|
Risk-free interest rate
|
|
|
1.56
|
%
|
|
|
1.04
|
%
|
Expected life of options
|
|
|
6.00 years
|
|
|
|
6.00 years
|
|
Weighted average grant date fair value
|
|
$
|
4.94
|
|
|
$
|
2.99
|
|
14
The assumed dividend yield was based on the Companys expectation of not paying dividends in the foreseeable
future. Due to the Companys limited historical data, the estimated volatility incorporates the historical and implied volatility of comparable companies whose share prices are publicly available. The risk-free interest rate assumption was
based on the U.S. Treasury rates. The weighted average expected life of options was estimated using the average of the contractual term and the weighted average vesting term of the options. Certain options granted to consultants are subject to
variable accounting treatment and are required to be revalued until vested.
The total stock option-based compensation recorded as operating expense was
approximately $1,405,000 and $400,000 for the three months ended June 30, 2014 and 2013, respectively. Expense included in research and development was $248,000 and $67,000 for the three months ended June 30, 2014 and 2013, respectively.
Expense included in general and administrative was $1,157,000 and $333,000 for the three months ended June 30, 2014 and 2013, respectively.
The
total unrecognized compensation cost related to unvested stock option grants as of June 30, 2014 was approximately $15,800,000 and the weighted average period over which these grants are expected to vest is 3.32 years.
Warrants
During the three months ended June 30,
2014 and 2013, 8,647 and 252,129 warrants, respectively, were exercised through a cashless exercise provision for issuance of 7,600 and 200,135 shares of common stock, respectively. Also during the three months ended June 30, 2014 and 2013,
103,000 and 100,000 warrants, respectively, were exercised at prices ranging from $1.00 to $2.21 for total proceeds of $224,000 and $100,000, respectively.
8,647 and 35,000 of the warrants exercised during the three months ended June 30, 2014 and 2013, respectively, were derivative liabilities and were
valued at the settlement date. For the three months ended June 30, 2014 and 2013, approximately $55,000 and $129,000, respectively, of the warrant liability was removed due to the exercise of these warrants. (See Note 2).
During April 2013, the Company entered into amendment agreements for 269,657 warrants to purchase common stock which reduced the exercise price of the
warrants from $1.00 to $0.85 and removed the down-round price protection provision of the warrant agreement related to the adjustment of exercise price upon issuance of additional shares of common stock. As a result of the removal of the down-round
price protection provision, the warrants were reclassified from liability to equity instruments at their fair value of $767,000. The Company determined the incremental expense associated with the modification based on the fair value of the awards
prior to and subsequent to the modification. The fair value of the awards subsequent to modification was calculated using the Black-Scholes model. The incremental expense associated with the modification of approximately $12,000 was recognized as
interest expense for the three months ended June 30, 2013.
During the year ended December 31, 2012, the Company entered into four agreements
with consultants for services. In connection with the agreements, the Company issued a total of 650,000 warrants to purchase common stock, at prices ranging from $1.70 to $3.24, with lives ranging from two to five years, to be earned over service
periods of up to six months. The fair value of the warrants was estimated to be approximately $890,000, which was recognized as a prepaid asset and was amortized over the term of the consulting agreements. These warrants were classified as equity
instruments because they do not contain any anti-dilution provisions. The Black-Scholes model, using volatility rates ranging from 79.8% to 103.8% and risk-free interest rate factors ranging from 0.24% to 0.63%, were used to determine the value. The
value has been amortized over the term of the agreements. The Company recognized approximately $72,000 during the three months ended June 30, 2013 related to these services.
Additionally, during November 2013 the Company entered into an agreement with a consultant for services. In connection with the agreement, the Company issued
75,000 warrants to purchase common stock, at a price of $7.36, with a life of five years, to be earned over a twelve month service period. The fair value of the warrants was estimated to be approximately $404,000, which was recognized as a prepaid
asset and is being amortized over the term of the consulting agreement. These warrants were classified as equity instruments because they do not contain any anti-dilution provisions. The Black-Scholes model, using a volatility rate of 96.90% and a
risk-free interest rate factor of 0.60%, was used to determine the value. The Company recognized approximately $101,000 during the three months ended June 30, 2014 related to these services.
The following table summarizes warrant activity for the three months ended June 30, 2014:
|
|
|
|
|
|
|
|
|
|
|
Warrants
|
|
|
Weighted-
Average
Exercise Price
|
|
Balance at March 31, 2014
|
|
|
1,194,756
|
|
|
$
|
1.79
|
|
Granted
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(111,647
|
)
|
|
$
|
2.08
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2014
|
|
|
1,083,109
|
|
|
$
|
1.76
|
|
|
|
|
|
|
|
|
|
|
15
The warrants outstanding at June 30, 2014 are immediately exercisable at prices between $0.85 and
$7.36 per share, and have a weighted average remaining term of approximately 2.73 years.
Common stock reserved for future issuance
Common stock reserved for future issuance consisted of the following at June 30, 2014:
|
|
|
|
|
Common stock warrants outstanding
|
|
|
1,083,109
|
|
Common stock options outstanding under the 2008 Plan
|
|
|
672,192
|
|
Common stock options outstanding and reserved under the 2012 Plan
|
|
|
9,476,768
|
|
|
|
|
|
|
Total
|
|
|
11,232,069
|
|
|
|
|
|
|
Preferred stock
The
Company is authorized to issue 25,000,000 shares of preferred stock. There are no shares of preferred stock currently outstanding, and the Company has no present plans to issue shares of preferred stock.
4. Commitments and Contingencies
Operating leases
The Company leases
office and laboratory space under a non-cancelable operating lease which was entered into in February 2012 and amended in December 2013, with the future minimum lease payments from the lease included below. The Company records rent expense on a
straight-line basis over the life of the lease and records the excess of expense over the amounts paid as deferred rent. Deferred rent is included in accrued expenses in the condensed consolidated balance sheets.
Rent expense was approximately $235,000 and $105,000 for the three months ended June 30, 2014 and 2013, respectively.
On February 27, 2012, the Company entered into a facilities lease at 6275 Nancy Ridge Drive (the Original Lease), San Diego, CA 92121, with
occupancy as of July 15, 2012. The base rent under the lease was approximately $38,800 per month with 3% annual escalators. The lease term was 48 months with an option for the Company to extend the lease at the end of the lease term.
On December 5, 2013, the Company entered into a First Amendment (the Amendment) to the Original Lease, together with the Amendment, (the
Amended Lease). Pursuant to the Amendment, the Company expanded the size of its facility by approximately 15,268 square feet (the Expansion Premises) from approximately 15,539 square feet (the Original Premises)
for a total of approximately 30,807 square feet. The Amended Lease provides for base rent (i) on the Original Premises to continue at approximately $38,800 per month, with annual escalators, until August 1, 2016, at which point the base
rent shall be payable at the same rate per rentable square foot as the Expansion Premises and (ii) on the Expansion Premises of approximately $38,934 per month, with 3% annual escalators, not to commence until two months after the earlier of
(A) the date that the landlord delivers possession of the Expansion Premises to the Company with the work in the Expansion Lab Premises (as defined in the Amendment) substantially complete and (B) the date the landlord could have delivered
the Expansion Premises with the work in the Expansion Lab Premises (as defined in the Amendment) substantially complete but for certain delays of the Company. Additionally, the Company has a right of first refusal on adjacent additional premises of
approximately 14,500 square feet. The term of the Amended Lease expires on the seven-year anniversary of the earlier of (A) the date that the landlord delivers possession of the Expansion Premises to the Company and (B) the date the
landlord could have delivered the Expansion Premises but for certain delays of the Company (the Expansion Premises Commencement Date). The target Expansion Premises Commencement Date is September 1, 2014. The Company also has the
option to terminate the Amended Lease on the 5-year anniversary of the Expansion Premises Commencement Date. The Company intends for the Expansion Premises to contain office, laboratory, and clean room areas.
16
Future minimum rental payments required under operating leases that have initial or remaining non-cancelable
lease terms in excess of one year as of June 30, 2014, are as follows (in thousands):
|
|
|
|
|
Fiscal year ended March 31, 2015
|
|
$
|
567
|
|
Fiscal year ended March 31, 2016
|
|
|
979
|
|
Fiscal year ended March 31, 2017
|
|
|
984
|
|
Fiscal year ended March 31, 2018
|
|
|
1,001
|
|
Fiscal year ended March 31, 2019
|
|
|
1,031
|
|
Thereafter
|
|
|
2,527
|
|
|
|
|
|
|
Total
|
|
$
|
7,089
|
|
|
|
|
|
|
Legal Matters
In
addition to commitments and obligations in the ordinary course of business, the Company is subject to various claims and pending and potential legal actions arising out of the normal conduct of its business. The Company assesses contingencies to
determine the degree of probability and range of possible loss for potential accrual in its financial statements. An estimated loss contingency is accrued in its financial statements if it is probable that a liability has been incurred and the
amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing litigation contingencies is highly subjective and requires judgments about future events. When
evaluating contingencies, the Company may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery
and development of information important to the matters. In addition, damage amounts claimed in litigation against it may be unsupported, exaggerated or unrelated to possible outcomes, and as such are not meaningful indicators of its potential
liability. The Company regularly reviews contingencies to determine the adequacy of its accruals and related disclosures. The amount of ultimate loss may differ from these estimates. It is possible that cash flows or results of operations could be
materially affected in any particular period by the unfavorable resolution of one or more of these contingencies. Whether any losses finally determined in any claim, action, investigation or proceeding could reasonably have a material effect on the
Companys business, financial condition, results of operations or cash flows will depend on a number of variables, including: the timing and amount of such losses; the structure and type of any remedies; the monetary significance of any such
losses, damages or remedies may have on our consolidated financial statements; and the unique facts and circumstances of the particular matter that may give rise to additional factors.
Spencer Trask Matter
. On June 28, 2013, the Company filed a lawsuit for declaratory relief in the Supreme Court for the State of New York (case #
652305/2013) against Spencer Trask Ventures, Inc. (STV or Spencer Trask) in connection with a Warrant Solicitation Agency Agreement (the WSAA) that the Company entered into with STV in February 2013 (the New
York Action). In the New York Action, the Company is seeking a declaration that the WSAA remains a valid and enforceable agreement. Over the course of several weeks in February 2013, Organovo and STV, through their respective attorneys,
negotiated the WSAA pursuant to which the Company engaged STV as the Companys warrant solicitation agent in connection with the Companys efforts to solicit the exercise of outstanding Organovo warrants during the first quarter of 2013.
STVs President signed the WSAA on behalf of STV, and the Companys CEO executed the agreement on behalf of Organovo. Spencer Trask provided services to the Company pursuant to the WSAA, and the Company has paid STV for those services.
The Companys dispute with Spencer Trask arose in March 2013 after the Company approached Spencer Trask about exercising its outstanding warrants to
help the Company qualify for up-listing its common stock on the NYSE MKT. Previously, Spencer Trask had not asserted any claims for additional compensation as a result of the warrant tender offer the Company completed in December 2012.
In March 2013, the Company received two demand letters from STV, and a demand for arbitration notice in June 2013. In the first demand letter, STV alleges
that it is entitled to compensation (including a cash fee and warrants to purchase common stock) as a result of the warrant tender offer the Company completed in December 2012 and as a result of the notice of warrant redemption the Company completed
in March 2013. In the second letter, STV alleges it is entitled to damages because the Company allegedly violated confidentiality provisions in the Placement Agency Agreement (the PAA) the Company had previously entered into with STV in
December 2012 in connection with the private placement financings the Company completed in February and March 2012 (the Private Placements), by contacting the warrant holders who participated in the warrant tender offer. In response, on
June 28, 2013, the Company filed a lawsuit for declaratory relief in the Supreme Court for the State of New York against STV. The Companys tender offer was made to warrant holders of record relating to warrants already owned by them and
whose identity was public information via a Registration Statement on Form S-1 the Company was required to file to register the resale of the shares underlying their warrants. For these and other reasons, including applicability of the WSAA, the
Company believes STV is not entitled to compensation under the PAA and there was no violation of confidentiality. The Company received notice on August 5, 2013 that STV had filed its arbitration demand with the arbitrator (the
Arbitration). In July, 2013, the Company filed a motion to
17
stay the arbitration pending determination of the New York Action. In January 2014, the New York Court stayed the New York Action, finding that the arbitrator should determine in the first
instance which disputes between the Company and Spencer Trask should proceed in the Arbitration and which disputes between the Company and Spencer Trask should proceed in the New York Court. The parties are proceeding in the Arbitration and the
Company has reserved its right to file a summary disposition motion with regard to the proper venue for its claims under the WSAA. The Arbitration is currently scheduled to commence during the second calendar quarter of 2015.
The Company believes that the assertions made against it by STV are without merit and the Company intends to continue to vigorously defend against the claims
made by STV. The Company has not established a loss contingency accrual for these claims because any potential liability is not probable or estimable. Nonetheless, an unfavorable resolution of these claims could have a material adverse effect on the
Companys business, liquidity or financial condition in the reporting period in which such resolution occurs.
Other Legal Matters
. In
addition to the matter described above, the Company is subject to normal and routine litigation in the ordinary course of business. The Company has not accrued any loss contingencies for such matters. The Company intends to defend itself in any such
matters and does not currently believe that the outcome of such matters will have a material adverse effect on its business, liquidity or financial position.
5. Concentrations
Credit risk
Financial instruments that
potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. The Company maintains cash balances at various financial institutions primarily located in San Diego. Accounts at these institutions
are secured by the Federal Deposit Insurance Corporation. Balances may exceed federally insured limits. The Company has not experienced losses in such accounts, and management believes that the Company is not exposed to any significant credit
risk with respect to its cash and cash equivalents.
6. Recently Adopted Accounting Standards
In June 2014, the FASB issued Accounting Standards Update (ASU) 2014-10, Development Stage Entities, which
eliminated certain financial reporting requirements under Topic 915 for entities considered to be in the development stage. This standard becomes effective for annual reporting periods beginning after December 15, 2014 and interim reporting
periods beginning after December 15, 2015, with earlier application permitted. The Company adopted this standard prospectively as of April 1, 2014. This adoption had no effect on current or previously reported amounts, but eliminated the
need to present inception-to-date financial information that was previously required under Topic 915.
7. Subsequent Events
From July 1, 2014 to August 6, 2014, the Company sold 292,865 shares of its common stock in at the market offerings
under its distribution agreement with an investment banking firm (see Note 3), for proceeds of approximately $2,391,700.
18