The accompanying notes are an integral part of these condensed consolidated financial statements.
The accompanying notes are an integral part of these condensed consolidated financial statements.
The accompanying notes are an integral part of these condensed consolidated financial statements.
During the six months ended September 30, 2015, the warrant liability was reduced by approximately $138 as a result of warrant exercises.
During the six months ended September 30, 2015, approximately $374 of leasehold improvements were funded by the Company’s landlord as a lease incentive. The Company capitalized these costs as property, plant and equipment, with a corresponding increase in deferred rent that will be amortized over the remaining lease term.
The accompanying notes are an integral part of these condensed consolidated financial statements.
Notes to Unaudited Condensed Consolidated Financial Statements
Note
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 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. In September 2015, we established another wholly-owned subsidiary in the United Kingdom, Organovo U.K., Ltd., for the primary purpose of establishing a sales presence in Europe.
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. The Company has also focused efforts on raising capital and building infrastructure. In November 2014, the Company announced the commercial release of its first product, the ExVive™ Human Liver Tissue for use in toxicology and other preclinical drug testing. In September 2016, the Company announced that it had begun commercial contracting for services relating to its second product, the ExVive Human Kidney tissue.
The Company’s activities are subject to significant risks and uncertainties including failing to successfully develop products and services based on its technology and to achieve the market acceptance necessary to generate sufficient revenues to support its operations and to achieve and sustain profitability.
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, 2016 is derived from the Company’s 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 Company’s 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 Company’s Annual Report on Form 10-K for the year ended March 31, 2016, filed with the Securities and Exchange Commission (the “SEC”) on June 9, 2016. Operating results for interim periods are not necessarily indicative of operating results for the Company’s fiscal year ending March 31, 2017.
Liquidity
As of September 30, 2016, the Company had an accumulated deficit of approximately $179.1 million. The Company also had negative cash flows from operations of approximately $14.9 million during the six months ended September 30, 2016.
Through September 30, 2016, the Company has financed its operations primarily through the sale of convertible notes, the private placement of equity securities, the sale of common stock through public offerings, and through revenue derived from product and research service-based agreements, collaborative research agreements, and grants. In addition, on October 25, 2016, the Company closed the issuance and sale of 10,065,000 shares of its common stock in an underwritten public offering. The Company received net proceeds of approximately $25.6 million in the offering, after deducting underwriting discounts and commissions and the Company’s estimated expenses. 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’s future capital needs will depend on the revenues it generates through its commercialization efforts and the resources it elects to spend to pursue its product development efforts and implement its business plan. As a result, the Company cannot predict with certainty when it may be required or otherwise elect to secure additional capital to fund its future operations and business plans.
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.
7
Depending on market conditions, we cannot be sure that additional financing will be available when needed or that, if available, fin
ancing 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
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.
Fair value measurement
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 (unobservable inputs that are supported by little or no market activity, and that are significant to the fair value of the assets or liabilities) 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 Company’s derivative liabilities are adjusted to reflect estimated fair value at each period end, with any change 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 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. Future changes in these factors may have an 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:
|
|
Fair Value Measurements at September 30 and March 31, 2016 (in thousands):
|
|
|
|
Balance at
September 30, 2016
|
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
|
Significant
Other
Unobservable
Inputs
(Level 3)
|
|
Warrant liability
|
|
$
|
9
|
|
|
|
—
|
|
|
|
—
|
|
|
$
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
March
31,
2016
|
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
|
Significant
Other
Unobservable
Inputs
(Level 3)
|
|
Warrant liability
|
|
$
|
4
|
|
|
|
—
|
|
|
|
—
|
|
|
$
|
4
|
|
8
The following table presents the activity for liabilities measured at estimated fair value using unobservable inputs for the six months ended September 30, 2016:
Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
|
Warrant
Derivative
Liability
(in thousands)
|
|
Balance at March 31, 2016
|
$
|
4
|
|
Issuances
|
|
—
|
|
Adjustments to estimated fair value
|
|
5
|
|
Warrant liability removal due to settlements
|
|
—
|
|
Warrant liability reclassified to equity
|
|
—
|
|
Balance at September 30, 2016
|
$
|
9
|
|
Revenue recognition
The Company’s revenues are derived from research service agreements, product sales, collaborative research agreements, and grants from the National Institutes 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 September 30, 2016 and March 31, 2016, the Company had approximately $479,000 and $1,110,000, respectively, in deferred revenue related to its grants, collaborative research programs and research service agreements.
Revenue arrangements with multiple deliverables
The Company follows ASC 605-25
Revenue Recognition – Multiple-Element Arrangements
for 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.
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 periodically receives 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
For research service agreements that contain only a single or primary deliverable, the Company defers any up-front fees collected from customers, and recognizes revenue for the delivered element only when it determines there are no uncertainties regarding customer acceptance. For agreements that contain multiple deliverables, the Company follows ASC 605-25 as described above.
9
Research and development revenue under collaborative agreements
The Company’s collaboration revenue consists of license and collaboration agreements that contain multiple elements, which may include 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 services are provided or substantive milestones are achieved. We recognize revenue that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is considered substantive when the consideration payable to us for the milestone (i) is consistent with our performance necessary to achieve the milestone or the increase in value to the collaboration resulting from our performance, (ii) relates solely to our past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this assessment, we consider all facts and circumstances relevant to the arrangement, including factors such as the risks that must be overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the milestone consideration is related to future performance or deliverables.
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, using the appropriate method of revenue recognition based on its analysis of the related contractual element(s).
In November 2014, the Company entered into a collaborative nonexclusive research affiliation with a university medical school and a non-profit medical charity, under which the Company received a one-time grant from the charity towards the placement of a NovoGen Bioprinter at the university for the purpose of developing bioprinted tissues for surgical transplantation research. The Company has recorded $12,500 for each of the three months ended September 30, 2016 and 2015 and $25,000 for each of the six months ended September 30, 2016 and 2015, respectively, in revenue related to this collaboration in recognition of the proportional performance achieved.
In April 2015, the Company entered into a research collaboration agreement with a third party to develop custom tissue models for fixed fees. Based on the proportional performance achieved under this agreement, no collaboration revenue was recorded for the three and six months ended September 30, 2016 or 2015. Approximately $352,000 in collaboration revenue has been recognized to date under this agreement as of September 30, 2016.
Also in April 2015, the Company entered into a multi-year research agreement with a third party to develop multiple custom tissue models for use in drug development. Approximately $332,000 and $533,000 were recorded as revenue in recognition of the proportional performance achieved under this agreement during the three and six months ended September 30, 2016, respectively. Approximately $5,000 was recorded as revenue in recognition of the proportional performance achieved under this agreement during the three and six months ended September 30, 2015.
In June 2016, the Company announced it had entered into another collaborative nonexclusive research affiliation with a university medical school and a non-profit medical charity, under which the Company received a one-time grant from the charity towards the placement of a NovoGen Bioprinter at the university for the purpose of developing bioprinted tissues for skeletal disease research. The Company received an up-front payment in June 2016, which has initially been recorded as deferred revenue. No revenue has been recorded under this agreement as of September 30, 2016.
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. This 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.
10
Grant revenues
During August 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 $8,000 and $12,000 for the three and six months ended September 30, 2016, respectively. Revenue recognized under this grant was approximately $21,000 and $30,000 for the three and six months ended September 30, 2015, respectively.
During September 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 is recognized upon completion of substantive milestones. Revenue recognized under this grant was approximately $74,000 and $148,000 for the three and six months ended September 30, 2015, respectively. The full amount of this grant has been recognized as revenue as of September 30, 2015.
Cost of revenues
We reported $0.4 million and $0.6 million in cost of revenues for the three and six months ended September 30, 2016, respectively. This is our second period reporting this expense line item, which captures all of our costs related to manufacturing and delivering our product and service revenue. Cost of revenues for the three and six months ended September 30, 2015 was minimal and was included in research and development expense.
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, shares reserved for purchase under the Company’s 2016 Employee Stock Purchase Plan (“ESPP”), 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 and six months ended September 30, 2016 or 2015, 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 13.2 million for the three and six months ended September 30, 2016, and 10.5 million for the three and six months ended September 30, 2015.
Note 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 $9,000 and $4,000 as of September 30, 2016 and March 31, 2016, respectively. The changes in fair value of the derivative liabilities were decreases of approximately $0 and $9,000 for the three months ended September 30, 2016 and 2015, respectively, and increases of approximately $5,000 and $28,000 for the six months ended September 30, 2016 and 2015, respectively, and are included in other income (expense) in the statements of operations.
During the three months ended September 30, 2016 and 2015, no warrants that were classified as derivative liabilities were exercised. During the six months ended September 30, 2016 and 2015, 0 and 38,234 warrants, respectively, that were classified as derivative liabilities were exercised. The warrants were revalued as of the applicable settlement dates, and the change in fair value was recognized to earnings.
11
The derivative liabilities were valued at the end of each reporting period using a Monte Carlo valuation model with the following assumptions:
|
|
September 30, 2016
|
|
|
March 31, 2016
|
|
Closing price per share of common stock
|
|
$
|
3.79
|
|
|
$
|
2.17
|
|
Exercise price per share
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
Expected volatility
|
|
|
72.82
|
%
|
|
|
73.35
|
%
|
Risk-free interest rate
|
|
|
0.45
|
%
|
|
|
0.59
|
%
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Remaining expected term of underlying securities (years)
|
|
|
0.46
|
|
|
|
0.96
|
|
Note
3. Stockholders’ Equity
Common stock
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 August 2013 to increase the number of shares of common stock that may be issued under the 2012 Plan by 5,000,000 shares. In addition, the Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan in August 2015 to further increase the number of shares of common stock that may be issued under the 2012 Plan by 6,000,000 shares, bringing the aggregate shares issuable under the 2012 Plan to 17,553,986. The 2012 Plan as amended and restated became effective on August 20, 2015 and terminates ten years after such date. As of September 30, 2016, 3,578,760 shares remain available for issuance under the 2012 plan.
The Company filed a shelf registration statement on Form S-3 (File No. 333-189995), or the 2013 Shelf, 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, or 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. The 2013 Shelf was declared effective by the SEC on July 26, 2013. On July 20, 2016, the Company filed a post-effective amendment to the 2013 Shelf to deregister the $26,777,784 of common stock remaining unsold as of such date under the 2013 Shelf. As a result of the post-effective amendment, no further shares of common stock may be issued pursuant to the 2013 Shelf.
The Company filed a second shelf registration statement on Form S-3 (File No. 333-202382), or the 2015 Shelf, with the SEC on February 27, 2015 authorizing the offer and sale in one or more offerings of up to $190,000,000 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 compromised one or more of the other securities. The 2015 Shelf was declared effective by the SEC on March 17, 2015.
On October 25, 2016, the Company closed the issuance and sale of 10,065,000 shares (the “2016 Offering”) of its common stock. The 2016 Offering was effected pursuant to an Underwriting Agreement (the “2016 Underwriting Agreement”), dated October 20, 2016, with Jefferies LLC (the “Representative”), acting as representative of the underwriters named in the 2016 Underwriting Agreement. The price to the public in the 2016 Offering was $2.75 per share, and the underwriters purchased the shares from the Company pursuant to the 2016 Underwriting Agreement at a price of $2.585 per share. The net proceeds to the Company from the 2016 Offering were approximately $25.6 million after deducting underwriting discounts and commissions and estimated expenses payable by the Company. The 2016 Offering was made pursuant to the Company’s 2015 Shelf.
On June 18, 2015, the Company entered into an Underwriting Agreement with Jefferies LLC and Piper Jaffray & Co., acting as representatives of the underwriters named in the 2015 Underwriting Agreement and as joint book-running managers, relating to the issuance and sale of 9,425,000 shares of the Company’s common stock, par value $0.001 per share (the “2015 Offering”). The price to the public in the 2015 Offering was $4.25 per share, and the Underwriters agreed to purchase the shares from the Company pursuant to the 2015 Underwriting Agreement at a price of $3.995 per share. Under the terms of the 2015 Underwriting Agreement, the
12
Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,413,750 shares. The Company issued 10,838,750 shares of common stock pursuant to the 2015 Underwriting Agreement, including shares iss
uable upon the exercise of the over-allotment option, with net proceeds of approximately $43.1 million, after deducting underwriting discounts and commissions and expenses payable by the Company. The shares were issued pursuant to the 2015 Shelf.
In December 2014, the Company entered into an equity offering sales agreement, or the 2014 Sales Agreement, with Cantor Fitzgerald. Under the terms of the 2014 Sales Agreement, the Company may offer and sell shares of its common stock, from time to time, through the investment bank in at-the-market offerings. During the three and six months ended September 30, 2015, the Company issued no shares of common stock in at-the-market offerings under the 2014 Sales Agreement. During the three and six months ended September 30, 2016, the Company issued 997,181 shares of common stock in at-the-market offerings under the 2014 Sales Agreement with net proceeds of approximately $4.5 million, after deducting underwriting discounts and commissions and expenses payable by the Company. As of September 30, 2016, the Company has sold an aggregate of 1,997,181 shares of common stock in at-the-market offerings under the 2014 Sales Agreement, with net proceeds of approximately $10.8 million. On July 20, 2016, the Company filed a prospectus supplement to move the remaining shares of common stock that previously could have been sold pursuant to the 2014 Sales Agreement under the 2013 Shelf to the 2015 Shelf, which does not expire until March 17, 2018. Based on sales through September 30, 2016, the Company can sell an additional $21.9 million of shares pursuant to the 2014 Sales Agreement under the 2015 Shelf.
During the three months ended September 30, 2016 and 2015, the Company issued 123,104 and 0 shares of common stock upon the exercise of 160,000 and 0 warrants, respectively. During the six months ended September 30, 2016 and 2015, the Company issued 123,104 and 30,186 shares of common stock upon the exercise of 160,000 and 38,234 warrants, respectively.
Finally, during the three months ended September 30, 2016 and 2015, the Company issued 206,266 and 2,060 shares of common stock upon the exercise of 206,266 and 2,060 stock options, respectively. During the six months ended September 30, 2016 and 2015, the Company issued 206,266 and 27,563 shares of common stock upon exercise of 206,266 and 27,563 stock options, respectively.
Restricted stock awards
During the three months ended September 30, 2016 and 2015, there were 0 and 100,692 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 0 and 187,500 restricted stock awards, respectively. During the six months ended September 30, 2016 and 2015, there were 2,259 and 102,951 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 193,750 restricted stock awards, 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. A summary of the Company’s restricted stock award activity from March 31, 2016 through September 30, 2016 is as follows:
|
|
Number of
Shares
|
|
Unvested at March 31, 2016
|
|
|
6,250
|
|
Granted
|
|
|
—
|
|
Vested
|
|
|
(6,250
|
)
|
Canceled / forfeited
|
|
|
—
|
|
Unvested at September 30, 2016
|
|
|
—
|
|
The fair value of each restricted 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 general and administrative expenses for employees and non-employees of approximately $0 and $71,000 for the three months ended September 30, 2016 and 2015, respectively, and approximately $3,000 and $174,000 for the six months ended September 30, 2016 and 2015, respectively. The Company recorded restricted stock-based compensation expense in research and development expenses for employees of approximately $0 and $3,000 for the three months ended September 30, 2016 and 2015, respectively, and approximately $0 and $3,000 for the six months ended September 30, 2016 and 2015, respectively.
As of September 30, 2016, there was no unrecognized stock-based compensation expense for restricted stock awards.
13
Restricted stock units
During the three and six months ended September 30, 2016, the Company issued restricted stock units for an aggregate of 645,900 and 1,165,750 shares of common stock, respectively, to its employees and directors. These shares of common will be issued upon vesting of the restricted stock units. Vesting generally occurs (i) on the one-year anniversary of the grant date, (ii) quarterly over a three-year period, (iii) quarterly over a four-year period, (iv) over a four-year period, with 25% vesting on the one-year anniversary of the vesting commencement date and the remainder vesting ratably on a quarterly basis over the next twelve quarters, or (v) over a three-year period with 50% vesting on the two-year anniversary of the vesting commencement date and 50% vesting on the three-year anniversary of the vesting commencement date. A summary of the Company’s restricted stock unit activity from March 31, 2016 through September 30, 2016 is as follows:
|
|
Number of
Shares
|
|
|
Weighted
Average Price
|
|
Unvested at March 31, 2016
|
|
|
—
|
|
|
$
|
—
|
|
Granted
|
|
|
1,165,750
|
|
|
$
|
3.66
|
|
Vested
|
|
|
(34,581
|
)
|
|
$
|
3.85
|
|
Canceled / forfeited
|
|
|
(1,700
|
)
|
|
$
|
3.21
|
|
Unvested at September 30, 2016
|
|
|
1,129,469
|
|
|
$
|
3.66
|
|
The fair value of each restricted stock unit is recognized as stock-based compensation expense over the vesting term of the award. The fair value is based on the closing stock price on the date of the grant. The Company recorded restricted stock-based compensation expense in operating expenses for employees of approximately $349,000 and $370,000 for the three and six months ended September 30, 2016, respectively. Stock-based compensation expense included in research and development was $114,000 and $132,000 for the three and six months ended September 30, 2016, respectively. Stock-based compensation expense included in general and administrative expense was $235,000 and $238,000 for the three and six months ended September 30, 2016, respectively.
As of September 30, 2016, total unrecognized stock-based compensation expense related to restricted stock units was approximately $3,896,000, which will be recognized over a weighted average period of 3.25 years.
Stock options
Under the 2012 Plan, 1,386,500 and 692,092 stock options were issued during the three months ended September 30, 2016 and 2015, respectively, and 1,803,140 and 2,454,733 stock options were issued during the six months ended September 30, 2016 and 2015, respectively, at various exercise prices based on the closing market price of the Company’s common stock on the date of the grant. The stock options generally vest (i) on the one-year anniversary of the grant date, (ii) quarterly over a three-year period, (iii) quarterly over a four-year period, or (iv) over a four-year period, with 25% vesting on the one-year anniversary of the vesting commencement date, and the remainder vesting on a monthly basis ratably over the remaining term.
A summary of the Company’s stock option activity for the six months ended September 30, 2016 is as follows:
|
|
Options
Outstanding
|
|
|
Weighted-
Average
Exercise Price
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding at March 31, 2016
|
|
|
9,614,627
|
|
|
$
|
4.79
|
|
|
$
|
1,927,137
|
|
Options granted
|
|
|
1,803,140
|
|
|
$
|
3.85
|
|
|
|
|
|
Options canceled / forfeited
|
|
|
(56,955
|
)
|
|
$
|
5.05
|
|
|
|
|
|
Options exercised
|
|
|
(206,266
|
)
|
|
$
|
2.42
|
|
|
$
|
328,691
|
|
Outstanding at September 30, 2016
|
|
|
11,154,546
|
|
|
$
|
4.68
|
|
|
$
|
7,439,063
|
|
Vested and Exercisable at September 30, 2016
|
|
|
6,347,222
|
|
|
$
|
4.59
|
|
|
$
|
6,054,006
|
|
The weighted-average remaining contractual term of options exercisable and outstanding at September 30, 2016 was approximately 5.96 years.
14
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 gra
nt date using the following weighted average assumptions:
|
|
Three Months Ended
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
Six Months Ended
|
|
|
|
September 30, 2016
|
|
|
September 30, 2015
|
|
|
September 30, 2016
|
|
|
September 30, 2015
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
|
72.28
|
%
|
|
|
74.26
|
%
|
|
|
72.04
|
%
|
|
|
74.25
|
%
|
Risk-free interest rate
|
|
|
1.07
|
%
|
|
|
1.48
|
%
|
|
|
1.10
|
%
|
|
|
1.60
|
%
|
Expected life of options
|
|
6.00 years
|
|
|
6.00 years
|
|
|
6.00 years
|
|
|
6.00 years
|
|
Weighted average grant
date fair value
|
|
$
|
2.57
|
|
|
$
|
1.39
|
|
|
$
|
2.44
|
|
|
$
|
2.70
|
|
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Due to the Company’s 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 $1,734,000 and $2,098,000 for the three months ended September 30, 2016 and 2015, respectively, and $3,139,000 and $3,775,000 for the six months ended September 30, 2016 and 2015, respectively. Expense included in research and development was $260,000 and $277,000 for the three months ended September 30, 2016 and 2015, respectively, and $650,000 and $626,000 for the six months ended September 30, 2016 and 2015, respectively. Expense included in general and administrative was $1,474,000 and $1,821,000 for the three months ended September 30, 2016 and 2015, respectively, and $2,489,000 and $3,149,000 for the six months ended September 30, 2016 and 2015, respectively.
The total unrecognized compensation cost related to unvested stock option grants as of September 30, 2016 was approximately $13,580,000 and the weighted average period over which these awards are expected to vest is 2.52 years.
Employee Stock Purchase Plan
In June 2016, our Board of Directors adopted, and in August 2016 stockholders subsequently approved, the 2016 Employee Stock Purchase Plan (“ESPP”). We reserved 1,500,000 shares of common stock for issuance thereunder. The ESPP permits employees after five months of service to purchase common stock through payroll deductions, limited to 15 percent of each employee’s compensation up to $25,000 or 10,000 shares per employee per year. Shares under the ESPP are purchased at 85 percent of the fair market value at the lower of (i) the closing price on the first trading day of the six-month purchase period or (ii) the closing price on the last trading day of the six-month purchase period. The initial offering period commenced in September 2016. At September 30, 2016, there were 1,500,000 shares available for purchase under the ESPP.
The Company uses the Black-Scholes valuation model to calculate the fair value of ESPP shares. Stock-based compensation expense is recognized over the purchase period using the straight-line method. The fair value of ESPP shares was estimated at the purchase period commencement date using the following weighted average assumptions:
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
September 30, 2016
|
|
|
September 30, 2016
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
|
72.89
|
%
|
|
|
72.89
|
%
|
Risk-free interest rate
|
|
|
0.47
|
%
|
|
|
0.47
|
%
|
Expected term
|
|
0.50 years
|
|
|
0.50 years
|
|
Weighted average grant date fair value
|
|
$
|
1.22
|
|
|
$
|
1.22
|
|
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Due to the Company’s 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 expected life is the 6-month purchase period.
15
Warrants
During the three and six months ended September 30, 2016, 160,000 warrants were exercised through a cashless exercise provision in exchange for the issuance of 123,104 shares of common stock. During the three and six months ended September 30, 2015, 0 and 38,234 warrants were exercised through a cashless exercise provision in exchange for the issuance of 0 and 30,186 shares of common stock.
In addition,
during
the six
months
ended
September 30, 2015, a warrant that was previously
expected to be issued to a service provider and had been expensed
in prior periods
at its approximate value of
$130,000, was cancelled,
and
the amount was reversed against operating expense during the period.
Of the warrants exercised during the six months ended September 30, 2016 and 2015, 0 and 38,234, respectively, were derivative liabilities and were valued at the settlement date. For the six months ended September 30, 2016 and 2015, respectively, approximately $0 and $138,000, respectively, of the warrant liability was extinguished due to the exercise of these warrants. (See Note 2).
During November 2014, the Company entered into an agreement with a consultant for services. In connection with the agreement, the Company issued 145,000 warrants to purchase common stock, at a price of $6.84, with a life of five years, to be earned over a seventeen-month service period ending on March 31, 2016.
The final number of vested warrant shares was 95,000, based on management’s judgment of the satisfaction of specific performance metrics.
The fair value of the warrants was estimated to be approximately $74,000, which was revalued and amortized over the term of the consulting agreement.
These warrants were classified as equity instruments because they did not contain any anti-dilution provisions. The Black-Scholes model, using a volatility rate of 73.4% and a risk-free interest rate factor of 1.21%, was used to determine the value as of March 31, 2016. The Company recognized an expense reduction of approximately $9,000 and expense of approximately $25,000 during the three and six months ended September 30, 2015, respectively, related to these services. As of March 31, 2016, these warrants were fully expensed.
The following table summarizes warrant activity for the six months ended September 30, 2016:
|
|
Warrants
|
|
|
Weighted-
Average
Exercise Price
|
|
Balance at March 31, 2016
|
|
|
1,046,813
|
|
|
$
|
2.29
|
|
Granted
|
|
|
—
|
|
|
$
|
—
|
|
Exercised
|
|
|
(160,000
|
)
|
|
$
|
1.00
|
|
Cancelled
|
|
|
—
|
|
|
$
|
—
|
|
Balance at September 30, 2016
|
|
|
886,813
|
|
|
$
|
2.52
|
|
The warrants outstanding at September 30, 2016 are exercisable at prices between $0.85 and $7.62 per share, and have a weighted average remaining term of approximately 0.86 years.
Common stock reserved for future issuance
Common stock reserved for future issuance consisted of the following at September 30, 2016:
Common stock warrants outstanding
|
|
|
886,813
|
|
Common stock options outstanding under the 2008 Plan
|
|
|
622,192
|
|
Common stock options outstanding and reserved under the 2012
Plan
|
|
|
14,111,114
|
|
Common stock reserved under the 2016 Employee Stock
Purchase Plan
|
|
|
1,500,000
|
|
Restricted stock units outstanding under the 2012 Plan
|
|
|
1,129,469
|
|
Total
|
|
|
18,249,588
|
|
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 current plans to issue shares of preferred stock.
16
Note
4. Commitments and Contingencies
Operating leases
The Company leases laboratory and office space in San Diego, California under three non-cancelable leases as described below.
Since July 2012, the Company has leased its main facilities at 6275 Nancy Ridge Drive, San Diego, CA 92121. The lease, as amended in 2013 and 2015, consists of approximately 30,895 rentable square feet containing laboratory, clean room and office space. Monthly rental payments are currently approximately $83,000 per month with 3% annual escalators. The lease term expires September 1, 2021 with the option to terminate on or after September 1, 2019. The Company also has a right of first refusal on adjacent additional premises of approximately 14,700 square feet.
On January 9, 2015, the Company entered into an agreement to lease a second facility consisting of 5,803 rentable square feet of office and lab space located at 6310 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 36 months, beginning on February 1, 2015 and ending on January 31, 2018, with monthly rental payments of approximately $12,000 commencing on April 1, 2015. In addition, there are annual rent escalations of 3% on each 12-month anniversary of the lease commencement date.
On December 28, 2015, the Company entered into an agreement to lease a third facility consisting of 12,088 rentable square feet of office space located at 6166 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 12 months, beginning on February 1, 2016 and ending on January 31, 2017, with monthly rental payments of $15,000 commencing on February 1, 2016.
Rent expense was approximately $302,000 and $272,000 for the three months ended September 30, 2016 and 2015, respectively, and $605,000 and $549,000 for the six months ended September 30, 2016 and 2015, respectively.
Future minimum rental payments required under operating leases that have initial or remaining non-cancelable lease terms in excess of one year as of September 30, 2016, are as follows (in thousands):
Fiscal year ended March 31, 2017
|
|
$
|
642
|
|
Fiscal year ended March 31, 2018
|
|
|
1,148
|
|
Fiscal year ended March 31, 2019
|
|
|
1,044
|
|
Fiscal year ended March 31, 2020
|
|
|
1,072
|
|
Fiscal year ended March 31, 2021
|
|
|
1,104
|
|
Thereafter
|
|
|
468
|
|
Total
|
|
$
|
5,478
|
|
Legal Matters
In addition to commitments and obligations in the ordinary course of business, the Company may be subject, from time to time, 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. 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. During the period presented, the Company has not recorded any accrual for loss contingencies associated with such claims or legal proceedings; determined that an unfavorable outcome is probable or reasonably possible; or determined that the amount or range of any possible loss is reasonably estimable. However, the outcome of legal proceedings and claims brought against the Company is subject to significant uncertainty. Therefore, although management considers the likelihood of such an outcome to be remote, if one or more of these legal matters were resolved against the Company in a reporting period, the Company’s consolidated financial statements for that reporting period could be materially adversely affected.
17
Note
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 within the United States. 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.
The Company is also potentially subject to concentrations of credit risk in its revenues and accounts receivable. Because it is in the early commercial stage, the Company’s revenues to date have been derived from a relatively small number of customers and collaborators. However, the Company has not historically experienced any accounts receivable write-downs and management does not believe significant credit risk exists as of September 30, 2016.
Note 6. Recent Accounting Pronouncements
In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The standard will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard was originally effective for public companies for annual reporting periods beginning after December 15, 2016, with no early application permitted. In August 2015, the FASB issued ASU No. 2015-14 that defers by one year the effective date for all entities, with application permitted as of the original effective date. The updated standard becomes effective for us on April 1, 2018, with early adoption permitted as of April 1, 2017. The standard permits the use of either the retrospective or cumulative effect transition method. We are evaluating the effect that this update will have on our consolidated financial statements and related disclosures. We have not yet selected a transition method nor have we determined the effect of this updated standard on our ongoing financial reporting.
In February 2016, the FASB issued ASU 2016-02, Leases, which requires an entity to recognize lease assets and lease liabilities on the balance sheet for leases with terms of more than 12 months and to disclose key information about leasing arrangements. This new guidance is effective for us on April 1, 2019, with early adoption permitted in any interim or annual period. The Company is currently evaluating the impact that this guidance will have on its financial statements and related disclosures.
Note 7. Subsequent Events
On October 25, 2016, the Company closed the issuance and sale of 10,065,000 shares (the “2016 Offering”) of its common stock, par value $0.001 per share, which included 1,065,000 shares of common stock issued pursuant to the partial exercise of the Underwriters’ option to purchase additional shares. The 2016 Offering was effected pursuant to an Underwriting Agreement (the “2016 Underwriting Agreement”), dated October 20, 2016, with Jefferies LLC (the “Representative”), acting as representative of the underwriters named in the 2016 Underwriting Agreement (the “Underwriters”). The price to the public in the 2016 Offering was $2.75 per share, and the Underwriters purchased the shares from the Company pursuant to the 2016 Underwriting Agreement at a price of $2.585 per share.
The net proceeds to the Company from the 2016 Offering were approximately $25,600,000, after deducting underwriting discounts and commissions and estimated expenses payable by the Company.
The 2016 Offering was made pursuant to the Company’s shelf registration statement on Form S-3, initially filed with the Securities and Exchange Commission (“SEC”) on February 27, 2015 and was declared effective by the SEC on March 17, 2015 (File No. 333-202382) and the related prospectus supplement filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”), on October 21, 2016.
The 2016 Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. Concurrently with the execution of the 2016 Underwriting Agreement, each of the Company’s directors and executive officers entered into a lock-up agreement with the Underwriters that prohibits, subject to specified exceptions, the sale, transfer or other disposition of securities of the Company without the consent of the Representative for a period ending 90 days following October 20, 2016. A copy of the 2016 Underwriting Agreement is filed as Exhibit 10.3 to this Quarterly Report on Form 10-Q. The 2016 Underwriting Agreement is included as an exhibit to provide interested persons with information regarding its terms, but is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the 2016 Underwriting Agreement were made only for purposes of the 2016 Underwriting Agreement as of specific dates indicated therein, were solely for the benefit of the parties to the 2016 Underwriting Agreement, and
18
may be subject to limitations agreed upon by the parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the
2016 Underwriting Agreement.
On October 24, 2016, the Company signed a third amendment to the existing lease for its main facilities at 6275 Nancy Ridge Drive, San Diego, CA to lease adjacent additional premises of approximately 14,685 rentable square feet containing laboratory, clean room and office space. Monthly rental payments for this additional space will be approximately $37,000 per month with 3% annual escalators. The lease term for this additional space expires December 15, 2018.
19