The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
Notes to Consolidated Financial Statements
1. Description of Business and Summary of Significant Accounting Policies
Nature of operations and basis of presentation
Organovo Holdings, Inc. (“Organovo Holdings,” “we,” “us,” “our,” “the Company” and “our Company”) is a biotechnology company pioneering the development of bioprinted human tissues that emulate human biology and disease. Initially, we are developing our
in vivo
liver tissues to treat end-stage liver disease and a select group of life-threatening, orphan diseases, for which there are limited treatment options other than organ transplantation. Our objective is to serve as a ‘bridge-to-transplant’ for these patients, with an ultimate goal of delaying or reducing the overall need for transplant. The Company’s program focused on an orphan disease known as Alpha-1-antitrypsin deficiency (“A1AT”), received the U.S. Food and Drug Administration’s (“FDA”) orphan drug designation in December 2017. We are also utilizing our foundational ability to isolate highly specialized human cells to build robust, functional human tissues by creating a range of novel preclinical
in vitro
disease modeling platforms, including a broad set of non-alcoholic fatty liver disease (“NAFLD”) and non-alcoholic steatohepatitis (“NASH”) conditions. Our clients can access these diseased tissue platforms through collaborative, revenue-generating agreements.
Except where specifically noted or the context otherwise requires, references to “Organovo Holdings,” “the Company,” “we,” “our,” and “us” in these notes to the condensed consolidated financial statements refers to Organovo Holdings, Inc. and its wholly owned subsidiaries, Organovo, Inc., Samsara Sciences, Inc., and Organovo UK Ltd in March 2018, the U.K. operations were combined with Organovo, Inc.’s operations.
The Company’s activities are subject to significant risks and uncertainties including failing to successfully develop products and services based on its technology, failing to achieve regulatory approvals for its therapeutic candidates, and failing to achieve the market acceptance necessary to generate sufficient revenues to achieve and sustain profitability.
Reclassification of prior year presentation
As a result of the adoption of the new accounting standard associated with clarifying presentation and classification in the statement of cash flows, certain reclassifications have been made to the prior period financial statements to conform with the current period presentation. These reclassifications did not have any effect on previously reported cash flows, net loss, or financial position.
Nasdaq listing
On August 8, 2016, the Company moved its stock exchange listing to the Nasdaq Global Market, under the “ONVO” ticker symbol. From July 11, 2013 through August 5, 2016, the Company listed its shares on the NYSE MKT. Prior to July 11, 2013, the Company’s shares were quoted on the OTC QX.
Liquidity
As of March 31, 2019, the Company had cash and cash equivalents of approximately $36.5 million and restricted cash of less than $0.1 million. The restricted cash was pledged as collateral for two letters of credit the Company is required to maintain as security deposits under the terms of the leases of its facilities. The Company had an accumulated deficit of approximately $260.8 million. The Company also had negative cash flows from operations of approximately $20.4 million during the year ended March 31, 2019.
Through March 31, 2019, 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 and at-the-market (“ATM”) offerings, and through revenue derived from product and research service-based agreements, collaborative agreements, grants, and licenses. During the year ended March 31, 2019, the Company issued 11,631,803 shares of its common stock through its ATM facility and received net proceeds of approximately $13.2 million.
Based on its current operating plan and available cash resources, the Company believes it has sufficient resources to fund its business for at least the next twelve months.
The Company will need additional capital to further fund the development of its proprietary platform to produce and study living tissues focusing on critical unmet medical needs in the liver disease space. The Company intends to cover its future operating expenses through cash on hand, through revenue derived from research service agreements, product sales, collaborative agreements, grants and license payments, and through the issuance of additional equity or debt securities. Depending on market conditions, we cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders.
F-8
Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs or r
elinquish 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 e
quity 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 fina
ncial 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 consolidated financial statements include those assumed in revenue recognition, the valuation of stock-based compensation expense, and the valuation allowance on deferred tax assets. On an ongoing basis, management reviews these estimates and assumptions.
Financial instruments
For certain of the Company’s financial instruments, including cash and cash equivalents, inventory, prepaid expenses and other assets, accounts payable, accrued expenses, deferred revenue, and capital lease obligations, the carrying amounts are generally considered to be representative of their respective fair values because of the short-term nature of those instruments.
Cash and cash equivalents
The Company considers all highly liquid investments with original maturities of 90 days or less to be cash equivalents.
Foreign Currency
The functional currency of our U.K. operations was the pound sterling. Accordingly, all assets and liabilities of this subsidiary were translated to US dollars based on the applicable exchange rate on the balance sheet date. Revenue and expense components were translated to US dollars at the exchange rates in effect during the period. Gains and losses resulting from foreign currency translation are reported as a separate component of accumulated other comprehensive income or loss in the equity section of our consolidated balance sheets.
Foreign currency transaction gains and losses, which are primarily the result of remeasuring United States dollar-denominated receivables and payables, are recorded in our Consolidated Statements of Operations and Other Comprehensive Loss. For the years ended March 31, 2019 and 2018, we recognized foreign currency translation losses of approximately $0 and $1,000, respectively.
As of March 31, 2019 and 2018, we realized $0 and $11,000 of cumulative foreign currency translation losses as Other Expense on the Consolidated Statement of Operations and Other Comprehensive Loss for the years ending March 31, 2019 and 2018, respectively. No further foreign currency translation losses will be recorded as the U.K. operations have been combined with Organovo, Inc.’s operations as of March 31, 2018.
Restricted cash
As of March 31, 2019 and 2018, the Company had approximately $79,000 and $127,000 of restricted cash, respectively, deposited with a financial institution. The entire amount is held in certificates of deposit to support a letter of credit agreement related to the Company’s facility lease.
Inventory
Inventories are stated at the lower of the cost or net realizable value (first-in, first-out). Inventory at March 31, 2019 consists of approximately $361,000 in raw materials, approximately $0 in work-in-process inventory, and approximately $129,000 in finished goods net of reserve. Inventory at March 31, 2018 consisted of approximately $578,000 in raw materials, approximately $26,000 in work-in progress inventory, and approximately $238,000 in finished goods net of reserve.
F-9
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 one and seven 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 occurred as of March 31, 2019.
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 Company generates revenues from payments received from research service agreements, product sales, collaborative agreements with partners including pharmaceutical and biotechnology companies and academic institutions, licenses, and grants from the National Institutes of Health (“NIH”) and private not-for-profit organizations.
Billings to customers or payments received from customers are included in deferred revenue on the balance sheet until all revenue recognition criteria are met. As of March 31, 2019 and 2018, the Company had approximately $525,000 and $687,000, respectively, in deferred revenue related to its research service agreements, collaborative agreements, and licenses within the scope of Topic 606. In the twelve months ended March 31, 2019 the Company recognized revenue on approximately $178,000 that had been recorded as deferred revenue at March 31, 2018.
Effective April 1, 2018, the Company adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 606,
Revenue from Contracts with Customers
(“Topic 606”).
Under Topic 606, the Company recognizes revenue when (or as) the promised services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements the Company concludes are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Service revenues
The Company’s service-based business, Organovo, Inc., utilizes its NovoGen® bioprinting platform to provide customers access to its highly specialized tissues that model human biology and disease, and to
in vitro
testing services based on that technology. These contracts with customers contain multiple performance obligations including: (i) bioprinting tissues for the customer, (ii) reporting the results of tests performed on the printed tissues pursuant to the agreed upon work plan through exposure of the tissue to various factors (including the customer’s proprietary compound), and (iii) delivering specific byproduct study materials, which are satisfied, respectively, at each of the following points in time: (i) upon completion of manufacturing of the bioprinted tissue for the customer,
F-10
(ii) upon delivery of the report on tests performed on the tissue, and (iii) upon making cert
ain study materials generated from the aforementioned testing process available to the customer. The customer does not have access or control of any performance obligation prior to the point in time of full completion of the corresponding performance satis
fying event as defined above. Furthermore, although the service can be customized for each customer, it is not so highly customized as to not have an alternative use either to other customers or to the Company without significant economic consequences or r
ework. Accordingly, the Company’s service-based business utilizes point-in-time recognition under Topic 606.
For service contracts, the Company allocates the transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The transaction price for service business contracts is a fixed consideration.
Product sales, net
The Company’s product-based business, Samsara Sciences, Inc., produces cell-based products for use in Organovo’s 3D tissue manufacturing and for use by life science customers. The Company recognizes product revenue when the performance obligation is satisfied, which is at the point in time the customer obtains control of the Company’s product, typically upon delivery. Product revenues are recorded at the transaction price, net of any estimates for variable consideration under Topic 606. The Company’s process for estimating variable consideration does not differ materially from its historical practices. Variable consideration is estimated using the expected value method which considers the sum of probability-weighted amounts in a range of possible amounts under the contract. Product revenue reflects the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the individual contracts. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.
The Company provides no right of return to its customers except in cases where a customer obtains authorization from the Company for the return. To date, there have been no product returns. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust its estimates accordingly.
Collaborative research, development, and licenses
The Company enters into collaborative agreements with partners that typically include one or more of the following: (i) non-exclusive license fees; (ii) non-refundable up-front fees; (iii) payments for reimbursement of research costs; (iv) payments associated with achieving specific development milestones; and (v) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company analyzes whether it results in a contract with a customer under Topic 606 or in an arrangement with a collaborator subject to guidance under ASC 808,
Collaborative Arrangements
(“Topic 808”).
The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are determinable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, non-exclusive license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
The Company’s collaborative agreements that were not completed at the implementation of Topic 606 on April 1, 2018, consisted of research collaboration and limited technology access licenses. These agreements provide the licensee with a non-exclusive, non-transferable, limited, royalty-free technology license, including access to Organovo’s proprietary bioprinter platform, training, and continued support by means of consumables and consultation throughout the duration of the contract. The Company has determined the intellectual property license is not distinct from the continued support promised under the agreement and is therefore a single combined performance obligation. The Company recognizes revenue for these combined performance obligations over time for the duration of the license period, as the combined performance obligation will not be fully satisfied until the end of the contract.
For the year ended March 31, 2019, all collaborations and licenses revenue was within the scope of Topic 606 and recognized accordingly
.
See “Note 4. Collaborative Research, Development, and License Agreements” for more information on the Company’s collaborative agreements.
F-11
Grant revenues
In July 2017, the NIH awarded the Company a “Research and Development” grant totaling approximately $1,657,000 of funding over three years. The Company has concluded this government grant is not within the scope of Topic 606, as government entities do not meet the definition of a “customer” as defined by Topic 606, as there is not considered to be a transfer of control of goods or services to the government entity funding the grant. Additionally, the Company has concluded this government grant does not meet the definition of a contribution and is a non-reciprocal transaction, however, Subtopic 958-605,
Not-for-Profit-Entities-Revenue Recognition
does not apply, as the Company is a business entity and the grant is with a governmental agency.
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.
T
he Company believes this policy is consistent with the overarching premise in Topic 606, to ensure that it recognizes revenues to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services, even though there is no “exchange” as defined in the ASC. The Company believes the recognition of revenue as costs are incurred and amounts become earned/realizable is analogous to the concept of transfer of control of a service over time under ASC 606.
Revenue recognized under this grant was approximately $587,000 and $554,000 during the years ended March 31, 2019 and 2018, respectively.
Cost of revenue
The Company reported $0.5 million and $1.0 million in cost of revenue for the years ended March 31, 2019 and 2018, respectively. Cost of revenues consists of our costs related to manufacturing and delivering our product and service revenue.
Stock-based compensation
The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Board’s ASC Topic 718,
Compensation — Stock Compensation,
which establishes accounting for equity instruments exchanged for employee services. Under such provisions, stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense, under the straight-line method, over the employee’s requisite service period (generally the vesting period of the equity grant).
The Company accounts for equity instruments, including restricted stock or stock options, issued to non-employees in accordance with authoritative guidance for equity-based payments to non-employees. Stock options issued to non-employees are accounted for at their estimated fair value determined using the Black-Scholes option-pricing model. The fair value of options granted to non-employees is re-measured as they vest, and the resulting increase in value, if any, is recognized as expense during the period the related services are rendered. Restricted stock issued to non-employees is accounted for at its estimated fair value as it vests.
Comprehensive income (loss)
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all components of comprehensive income (loss) in the financial statements in the period in which they are recognized. Net income (loss) and other comprehensive income (loss), including unrealized gains and losses on investments, are reported, net of their related tax effect, to arrive at comprehensive income (loss). For the years ended March 31, 2019 and 2018, the comprehensive loss was materially equal to the net loss and consisted of net loss and foreign currency translation. As of March 31, 2019, unrealized foreign currency translation previously recorded in other comprehensive loss was realized and recorded to other 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 years ended March 31, 2019 and 2018 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 14.4 million and 12.6 million for the years ended March 31, 2019 and 2018, respectively.
F-12
2. Fixed Assets
Fixed assets consisted of the following (in thousands):
|
|
March 31,
2019
|
|
|
March 31,
2018
|
|
Construction in Progress
|
|
$
|
47
|
|
|
$
|
—
|
|
Laboratory equipment
|
|
$
|
3,690
|
|
|
$
|
3,695
|
|
Leasehold improvements
|
|
|
1,809
|
|
|
|
2,177
|
|
Computer software and equipment
|
|
|
645
|
|
|
|
656
|
|
Furniture and fixtures
|
|
|
213
|
|
|
|
319
|
|
Vehicles
|
|
|
9
|
|
|
|
9
|
|
Fixed Assets, gross
|
|
|
6,413
|
|
|
|
6,856
|
|
Less accumulated depreciation
|
|
|
(4,581
|
)
|
|
|
(4,068
|
)
|
Fixed Assets, net
|
|
$
|
1,832
|
|
|
$
|
2,788
|
|
Depreciation expense for the years ended March 31, 2019 and 2018 was approximately $969,000 and $1,253,000, respectively.
3. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
|
|
March 31,
2019
|
|
|
March 31,
2018
|
|
Accrued compensation
|
|
$
|
2,160
|
|
|
$
|
2,735
|
|
Accrued legal and professional fees
|
|
|
152
|
|
|
|
99
|
|
Other accrued expenses
|
|
|
237
|
|
|
|
507
|
|
|
|
$
|
2,549
|
|
|
$
|
3,341
|
|
4. Collaborative Research, Development, and License Agreements
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 for the years ended March 31, 2019 and 2018, the Company has recorded approximately $0 and $150,000, respectively, in collaboration revenue. The Company has completed its obligations under this agreement as of March 31, 2018.
In June 2016, 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 skeletal disease research. The Company received an up-front payment in June 2016, which has initially been recorded as deferred revenue. Revenues of $0 and $65,000 were recognized under this agreement during the years ended March 31, 2019 and 2018, respectively. The Company does not anticipate recording any further revenue under this agreement.
In December 2016, the Company signed 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 an architecturally correct kidney for potential therapeutic applications. The Company received up-front payments in January and March of 2017, which has been recorded as deferred revenue. Revenue of $39,000 has been recorded under this agreement during each of the years ended March 31, 2019 and 2018.
In April 2017, the Company signed a collaborative non-exclusive research affiliation with a university, under which the Company received a one-time nonrefundable payment toward the placement of a NovoGen Bioprinter
®
at the university for the purpose of specific research projects mutually agreed upon by the university and the Company in the field of volumetric muscle loss. The Company received an up-front payment in May 2017, which was recorded as deferred revenue. Revenue of approximately $57,000 and $43,000 has been recorded during the year ended March 31, 2019 and 2018, respectively, beginning subsequent to the installation of the printer in July of 2017. In addition, during April 2017, the Company signed a non-exclusive patent license agreement with the university including an annual fee of $75,000 for each of two years for the license to Company patents for research use limited to the field of volumetric muscle loss. The Company received the first annual payment of $75,000 in April 2017, which was initially
F-13
recorded as deferred revenue. The Company received the second annual payment of $75,000 in May 2018. Revenue of $75,000 has been recorded under this agreement during each of the years ended
March 31, 2019 and 2018.
In September 2017, the Company entered into an agreement with a company, under which the Company received a one-time non-refundable payment of $50,000 for limited use of a Company patent in reference to four bioprinters developed and placed at research and academic facilities. The Company has recorded $0 and $50,000 in revenue during the year ended March 31, 2019 and 2018, respectively.
5. Stockholders’ Equity
Stock-based compensation expense and valuation information
Stock-based awards include stock options and restricted stock units under the 2012 Equity Incentive Plan, as amended (“2012 Plan”) and Inducement Awards, performance-based restricted stock units under an Incentive Award Performance-Based Restricted Stock Unit Agreement, and rights to purchase stock under the 2016 Employee Stock Purchase Plan (“ESPP”). The Company calculates the grant date fair value of all stock-based awards in determining the stock-based compensation expense.
Stock-based compensation expense for all stock awards consists of the following (in thousands):
|
|
Year Ended
March 31, 2019
|
|
|
Year Ended
March 31, 2018
|
|
Research and development
|
|
$
|
911
|
|
|
$
|
1,174
|
|
General and administrative
|
|
$
|
4,282
|
|
|
$
|
5,729
|
|
Total
|
|
$
|
5,193
|
|
|
$
|
6,903
|
|
The total unrecognized compensation cost related to unvested stock option grants as of March 31, 2019 was approximately $7,439,000 and the weighted average period over which these grants are expected to vest is 2.74 years.
The total unrecognized stock-based compensation cost related to unvested restricted stock units (not including performance-based restricted stock units) as of March 31, 2019 was approximately $3,234,000, which will be recognized over a weighted average period of 2.49 years.
The total unrecognized stock-based compensation cost related to unvested performance-based restricted stock units as of March 31, 2019 was approximately $136,000, which will be recognized over a weighted average period of 4.07 years.
The total unrecognized stock-based compensation cost related to unvested employee stock purchase plan (“ESPP”) shares as of March 31, 2019 was approximately $10,000, which will be recognized over a period of 5 months.
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:
|
|
Year Ended
March 31, 2019
|
|
|
Year Ended
March 31, 2018
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
|
72.99
|
%
|
|
|
76.86
|
%
|
Risk-free interest rate
|
|
|
2.75
|
%
|
|
|
1.81
|
%
|
Expected life of options
|
|
6.00 years
|
|
|
6.00 years
|
|
Weighted average grant date fair value
|
|
$
|
0.84
|
|
|
$
|
1.73
|
|
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Considering the expected life of these options, the Company determined that a blend of historical volatility and implied volatility of comparable companies whose share prices are publicly available is more reflective of market conditions and a better indicator of expected volatility than using purely Company-specific historical volatility. The risk-free interest rate assumption was based on 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.
F-14
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 pric
e on the date of the grant.
The Company uses the Black-Scholes valuation model to calculate the fair value of shares issued pursuant to the Company’s ESPP. 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:
|
|
Year Ended
March 31, 2019
|
|
|
Year Ended
March 31, 2018
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
43.7 - 80.2%
|
|
|
43.0% - 74.7%
|
|
Risk-free interest rate
|
|
1.85 - 2.52%
|
|
|
0.79% - 1.85%
|
|
Expected term
|
|
6 months
|
|
|
6 months
|
|
Grant date fair value
|
|
$ 0.29 - $0.45
|
|
|
$ 0.30 - $1.04
|
|
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. For the first full year of ESPP offering periods, beginning September 1, 2016, the Company determined that a blend of historical volatility and implied volatility of comparable companies whose share prices are publicly available was more reflective of market conditions and a better indicator of expected volatility than using purely Company-specific historical volatility. As of September 1, 2017 and the beginning of the second year of ESPP offering periods, the Company is using the Company-specific historical volatility rate as the 6-month historical volatility is now a better indicator of expected volatility. The risk-free interest rate assumption was based on U.S. Treasury rates. The expected life is the 6-month purchase period.
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.
Common stock
In May of 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 terminated on July 1, 2018. As of March 31, 2019, 896,256 shares under the 2008 Plan have been issued.
In January 2012, the Board of Directors of the Company approved 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 August 2015, 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. In July 2018, the Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan to further increase the number of shares of common stock that may be issued under the 2012 Plan by 11,000,000 shares, bringing the aggregate shares issuable under the 2012 Plan to 28,553,986. The 2012 Plan as amended and restated became effective on July 26, 2018 and terminates ten years after such date. As of March 31, 2019, 13,464,720 shares remain available for issuance under the 2012 Plan.
On April 24, 2017 the Company filed a Registration Statement on Form S-8 with the SEC authorizing the issuance of 2,297,034 shares of the Company’s Common Stock, pursuant to the terms of an Inducement Award Stock Option Agreement and an Inducement Award Performance-Based Restricted Stock Unit Agreement (collectively, the “Inducement Award Agreements”).
On August 14, 2018 the Company filed a Registration Statement on Form S-8 with the SEC authorizing the issuance of 1,135,408 shares of the Company’s Common Stock, pursuant to the terms of an Inducement Award Stock Option Agreement and an Inducement Award Restricted Stock Unit Agreement (collectively, the “Inducement Award Agreements”).
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. This 2013 Shelf was declared effective by the SEC on July 26, 2013.
F-15
A shelf registration statement on Form S-3 (File No. 333-202382), or the 2015 shelf, was filed 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, d
ebt 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. The 2015 shelf was declared effective by the SEC o
n March 17, 2015.
In December 2014, the Company entered into an equity offering sales agreement (“2014 Sales Agreement”) with an investment banking firm. Under the terms of the sales agreement, the Company was eligible to offer and sell 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 Company’s 2013 Shelf. During the year ended March 31, 2018, the Company issued 5,307,105 shares of common stock in at-the-market offerings under the sales agreement with net proceeds of $9.2 million. The 2014 Sales Agreement expired on March 17, 2018. Prior to its expiration, the Company sold an aggregate of 7,304,286 shares of common stock in at-the-market offerings under the 2014 Sales Agreement, with net proceeds of approximately $19.9 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. On the same date, the Company filed a post-effective amendment to the 2013 Shelf de-registering all remaining securities that could have been offered by the Company pursuant to the 2013 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 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 issuable 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.
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 affected pursuant to an Underwriting Agreement (the “2016 Underwriting Agreement”) 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 $25.7 million after deducting underwriting discounts and commissions and expenses payable by the Company. The 2016 Offering was made pursuant to the Company’s 2015 Shelf.
The Company has an effective shelf registration statement on Form S-3 (File No. 333-222929) and the related prospectus previously declared effective by the Securities and Exchange Commission (the “SEC”) on February 22, 2018, as supplemented by a prospectus supplement, dated March 16, 2018 (the “2018 Shelf”), that expires on February 22, 2021. This replaces the 2015 Shelf which expired on March 17, 2018.
On March 16, 2018, the Company entered into a Sales Agreement (“2018 Sales Agreement”) with H.C. Wainwright & Co., LLC and Jones Trading Institutional Services LLC (each an “Agent” and together, the “Agents”), pursuant to which the Company may offer and sell, from time to time through the Agents, shares of its common stock in “at the market” sales transactions having an aggregate offering price of up to $50,000,000 (the “Shares”). Any shares offered and sold will be issued pursuant to the Company’s 2018 Shelf. During the year ended March 31, 2019, the Company issued 11,631,803 shares of common stock in at-the-market offerings under the sales agreement with net proceeds of $13.2 million.
As of March 31, 2019, the Company had sold an aggregate of 11,631,803 shares of common stock in at-the-market offerings under the 2018 Sales Agreement, with net proceeds of approximately $13.2 million.
Based on these sales, the Company cannot raise more than an aggregate of $86.4 million future offerings under the 2018 Shelf, including the $36.4 million remaining available for future issuance through its at-the-market program under the 2018 Sales Agreement. The Company intends to use the net proceeds raised through any at-the-market sales for general corporate purposes, general administrative expenses, and working capital and capital expenditures.
In addition, during the years ended March 31, 2019 and 2018, the Company issued no shares of common stock upon exercise of no warrants, respectively.
F-16
During the years ended March 31, 2019 and 2018, the Company issued 622,192 and 500,000 shares of common stock upon exercise of 622,192 and 500,000 stock options, respectively.
Restricted stock units
During the year ended March 31, 2019, the Company issued restricted stock units for an aggregate of 1,916,802 shares of common stock to its employees and directors. These shares of common stock will be issued upon vesting of the restricted stock units.
On August 14, 2018, in connection with the appointment of a new Chief Medical Officer (“CMO”), the Company allocated 160,714 Restricted Stock Units (“RSUs”) outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of these awards are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan.
A summary of the Company’s restricted stock unit (not including performance-based restricted stock units) activity for the year ended March 31, 2019 is as follows:
|
|
Number of
Shares
|
|
|
Weighted
Average Price
|
|
Unvested at March 31, 2018
|
|
|
2,035,345
|
|
|
$
|
2.89
|
|
Granted
|
|
|
1,916,802
|
|
|
$
|
1.18
|
|
Vested
|
|
|
(766,187
|
)
|
|
$
|
2.39
|
|
Canceled / forfeited
|
|
|
(1,105,237
|
)
|
|
$
|
2.33
|
|
Unvested at March 31, 2019
|
|
|
2,080,723
|
|
|
$
|
1.80
|
|
Performance-based restricted stock units
On April 24, 2017, the Company issued a Performance-Based Restricted Stock Unit Award for 208,822 shares of common stock (the “PBRSU”) to its newly hired Chief Executive Officer. The PBRSU was issued outside of the 2012 Plan, in the Inducement Award Agreement, as an “inducement award” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of this award are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. On August 23, 2017, the Board of Directors formally approved the vesting criteria for the PBRSU. The vesting of the PBRSU is divided into five separate tranches each with independent vesting criteria. The first four tranches have performance criteria related to annual revenue goals with measurement at the end of fiscal year 2018 (20 percent), fiscal year 2019 (20 percent), fiscal year 2020 (20 percent), and fiscal year 2021 (20 percent). The fifth tranche has a performance metric related to a path to profitability goal measured as Negative Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) achievable at any point between the grant date and the end of fiscal year 2020 (20 percent). The number of units that ultimately vest for each tranche will range from 0 percent to 120 percent of the target amount, not to exceed 208,822 in aggregate. Based on changes to the Company’s strategy, on December 12, 2018, the Board of Directors formally approved an amendment to the vesting criteria for the PBRSUs. As of March 31, 2019, 100% of the Negative Adjusted EBITDA tranche, or 41,764 shares had vested and 8,352 units had been forfeited. Based on the amendment to the vesting criteria, the remaining 158,706 units eligible to vest upon future performance were divided into three separate but equal tranches with independent vesting criteria based on the achievement of certain regulatory milestones. As of March 31, 2019, no tranches had vested.
Based on the amended PBRSU vesting terms, which the Company believes are probable of being achieved, a Type III modification, the modified grant date fair value of the PBRSUs is $165,000 of which one-third is being recognized over the expected service period of each tranche ending April 23, 2023. The Company began recording stock-based compensation expense for the initial performance tranches after the August 23, 2017 grant date when the initial financial performance goals were established and approved and has modified its recording of compensation expense in accordance with the amended performance tranches beginning on December 12, 2018.
F-17
A summary of the Company’s performance-based restricted stock unit activity from March 31, 2018 through March 31, 2019 is as follows:
|
|
Number of
Shares
|
|
|
Weighted
Average Price
|
|
Unvested at March 31, 2018
|
|
|
200,470
|
|
|
$
|
1.88
|
|
Granted
|
|
|
—
|
|
|
$
|
—
|
|
Vested
|
|
|
(41,764
|
)
|
|
$
|
1.88
|
|
Canceled / forfeited
|
|
|
—
|
|
|
$
|
—
|
|
Unvested at December 12, 2018
|
|
|
158,706
|
|
|
$
|
1.88
|
|
Impact of modification
|
|
|
—
|
|
|
$
|
(0.74
|
)
|
Granted
|
|
|
—
|
|
|
$
|
—
|
|
Vested
|
|
|
—
|
|
|
$
|
—
|
|
Canceled / forfeited
|
|
|
—
|
|
|
$
|
—
|
|
Unvested at March 31, 2019
|
|
|
158,706
|
|
|
$
|
1.04
|
|
Stock options
During the year ended March 31, 2019 under the 2012 Equity Incentive Plan, 7,049,500 stock options were issued at various exercise prices.
On April 24, 2017, in connection with the appointment of a new CEO, the Company granted 2,088,212 stock options outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While granted outside the Company’s 2012 Plan, the terms and conditions of this stock option award are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. On August 14, 2018, in connection with the appointment of a new CMO, the Company allocated 974,694 stock options outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of these awards are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. These stock options vest over a four-year period, with a quarter of the option shares vesting on the one-year anniversary of the vesting commencement date and the remaining options shares vesting in equal quarterly installments over the next 12 quarterly periods.
The following table summarizes stock option activity for the year ended March 31, 2019:
|
|
Options
Outstanding
|
|
|
Weighted-
Average
Exercise Price
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding at March 31, 2018
|
|
|
10,132,312
|
|
|
$
|
4.01
|
|
|
$
|
591,082
|
|
Options granted
|
|
|
8,024,194
|
|
|
$
|
1.29
|
|
|
$
|
—
|
|
Options canceled
|
|
|
(5,495,050
|
)
|
|
$
|
4.37
|
|
|
$
|
—
|
|
Options exercised
|
|
|
(622,192
|
)
|
|
$
|
0.08
|
|
|
$
|
561,591
|
|
Outstanding at March 31, 2019
|
|
|
12,039,264
|
|
|
$
|
2.24
|
|
|
$
|
—
|
|
Vested and Exercisable at March 31, 2019
|
|
|
3,810,831
|
|
|
$
|
3.68
|
|
|
$
|
—
|
|
The weighted-average remaining contractual term of stock options exercisable and outstanding at March 31, 2019 was approximately 6.9 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”). The Company 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 per employee per year or 10,000 shares per employee per six-month purchase period. 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. During the year ended March 31, 2019, 96,385 shares were issued under the ESPP. At March 31, 2019, there were 1,188,718 shares remaining available for the purchase under the ESPP.
F-18
Warrants
From 2012 to 2014, the Company issued a total of 650,000 warrants to purchase common stock, in connection with consulting agreements, 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. During the years ended March 31, 2019 and 2018, no warrants held by consultants were exercised. As of March 31, 2019, none of these warrants are outstanding.
Additionally, during September 2014, the Company issued 50,000 warrants to purchase common stock, at a price of $7.62 with a life of five years to a consultant in recognition of services previously provided. These warrants were classified as equity instruments because they do not contain any anti-dilution provisions. As of December 31, 2014, the full amount of the warrants related to these services, approximately $237,000 had been recognized.
In November 2014, in connection with a consulting 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 ended 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 do 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 approximately $6,000 during the year ended March 31, 2016 related to these services. As of March 31, 2016, these warrants were fully expensed.
The following table summarizes warrant activity for the year ended March 31, 2019:
|
|
Warrants
|
|
|
Weighted-Average
Exercise Price
|
|
Balance at March 31, 2018
|
|
|
220,000
|
|
|
$
|
7.19
|
|
Granted
|
|
|
—
|
|
|
$
|
—
|
|
Expired / Canceled
|
|
|
(75,000
|
)
|
|
$
|
7.36
|
|
Exercised
|
|
|
—
|
|
|
$
|
—
|
|
Balance at March 31, 2019
|
|
|
145,000
|
|
|
$
|
7.11
|
|
The warrants outstanding at March 31, 2019 are exercisable at prices of $6.84 and $7.62 per share and have a weighted average remaining term of approximately 0.53 years.
Common stock reserved for future issuance
Common stock reserved for future issuance consisted of the following at March 31, 2019:
Common stock warrants outstanding
|
|
|
145,000
|
|
Common stock options outstanding and reserved under the 2012 Plan
|
|
|
8,976,358
|
|
Common stock reserved under the 2012 Plan
|
|
|
13,464,720
|
|
Common stock reserved under the 2016 Employee Stock Purchase Plan
|
|
|
1,188,718
|
|
Restricted stock units outstanding under the 2012 Plan
|
|
|
1,920,009
|
|
Common stock options outstanding and reserved under the Incentive Award Agreement
|
|
|
3,062,906
|
|
Restricted stock units outstanding under the Incentive Award Agreement
|
|
|
160,714
|
|
Performance-based restricted stock units outstanding under the Incentive Award Agreement
|
|
|
158,706
|
|
Total
|
|
|
29,077,131
|
|
6. Commitments and Contingencies
Operating leases
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, 2015, 2016, 2018, and 2019, consisted of approximately 45,580 rentable square feet containing laboratory, clean room and office space. Monthly rental payments are currently approximately $120,000 per month with 3% annual escalators. The lease term for 14,685 of the total rentable square footage was amended to accelerate the expiration date from December 15, 2018 to October 31, 2018. On November 30, 2018, the Company agreed to extend the term for the remainder of the total rentable square footage under the lease from August 31, 2021 to August 31, 2024 in exchange for $500,000 of landlord funded tenant improvements and a rescission of its option to terminate the lease on or after September 1, 2019 with 9 months prior written notice.
F-19
The Company also previously leased a second facility from February 1, 2015 through January 31, 2018 consisting of 5,803 rentable square feet of
office and lab space located at 6310 Nancy Ridge Drive, San Diego, CA 92121, with a monthly rent of $12,000 commencing on April 1, 2015, which increased by 3% each 12-month anniversary of the 36 month lease.
The Company records rent expense on a straight-line basis over the life of the leases and records the excess of expense over the amounts paid as deferred rent. In addition, one of the leases provides for certain improvements made for the Company’s benefit to be funded by the landlord. Such costs, totaling approximately $518,000 to date, have been capitalized as fixed assets and included in deferred rent. As a result of the Company’s lease amendment, which extends the term of the lease from August 31, 2021 to August 31, 2024, the landlord agreed to fund up to $500,000 in additional tenant improvements, which have not been capitalized or included in deferred rent
Rent expense was approximately $1,173,000 and $1,458,000 for the years ended March 31, 2019 and 2018, 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 March 31, 2019, are as follows (in thousands):
Fiscal year ended March 31, 2020
|
|
$
|
1,084
|
|
Fiscal year ended March 31, 2021
|
|
|
1,116
|
|
Fiscal year ended March 31, 2022
|
|
|
1,158
|
|
Fiscal year ended March 31, 2023
|
|
|
1,183
|
|
Fiscal year ended March 31, 2024
|
|
|
1,218
|
|
Thereafter
|
|
|
514
|
|
Total
|
|
$
|
6,273
|
|
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.
As of March 31, 2019, the Company had no claims outstanding.
7. Licensing Agreements and Research Contracts
University of Missouri
In March 2009, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain technology and intellectual property relating to self-assembling cell aggregates and to intermediate cellular units. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University of Missouri royalties ranging from 1% to 3% of net sales of covered tissue products, and of the fair market value of covered tissues transferred internally for use in the Company’s commercial service business, depending on the level of net sales achieved by the Company each year. The Company paid minimum annual royalties of $25,000 in January 2018, and January 2019 for their respective calendar years, which is credited against royalties due during the subsequent twelve months. No payments have been made in excess of the minimum annual royalties in the years ended March 31, 2019 and 2018.The license agreement
F-20
terminates upon expiration of the patents licensed and is subject to certain conditions as defined in the license agreement, which are expected to expire after 2029.
In March 2010, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain technology and intellectual property relating to engineered biological nerve grafts. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University of Missouri royalties ranging from 1% to 3% of net sales of covered tissue products depending on the level of net sales achieved by the Company each year. The license agreement terminates upon expiration of the patents licensed and is subject to certain conditions as defined in the license agreement. No payments have been made in the years ended March 31, 2019 and 2018.
Clemson University
In May 2011, the Company entered into a license agreement with Clemson University Research Foundation to in-license certain technology and intellectual property relating to ink-jet printing of viable cells. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University royalties ranging from 1.5% to 3% of net sales of covered tissue products and the fair market value of covered tissues transferred internally for use in the Company’s commercial service business, depending on the level of net sales reached each year. The license agreement terminates upon expiration of the patents licensed, which is expected to expire in May 2024, and is subject to certain conditions as defined in the license agreement. Minimum annual royalty payments of $20,000 were due for each of the two years beginning with calendar 2014, and $40,000 per year beginning with calendar 2016. The annual minimum royalty is creditable against royalties owed during the same calendar year.
Capitalized license fees consisted of the following (in thousands):
|
|
March 31,
2019
|
|
|
March 31,
2018
|
|
License fees
|
|
$
|
218
|
|
|
$
|
218
|
|
Less accumulated amortization
|
|
|
(81
|
)
|
|
|
(67
|
)
|
License fees, net
|
|
$
|
137
|
|
|
$
|
151
|
|
The above license fees, net of accumulated amortization, are included in Other Assets in the accompanying balance sheets and are being amortized over the life of the related patents. Amortization expense of licenses was approximately $14,000 and $13,600 for the years ended March 31, 2019 and 2018, respectively. At March 31, 2019, the weighted average remaining amortization period for all licenses was approximately 11 years. The annual amortization expense of licenses for the next five years is estimated to be approximately $14,000 per year.
8. Income Taxes
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets are as follows as of March 31, 2019 and March 31, 2018 (in thousands):
|
March 31,
2019
|
|
|
March 31,
2018
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
$
|
—
|
|
|
$
|
—
|
|
Research and development credits
|
|
—
|
|
|
|
—
|
|
Depreciation and amortization
|
|
28
|
|
|
|
25
|
|
Accrued expenses and reserves
|
|
886
|
|
|
|
1,050
|
|
Stock compensation
|
|
3,941
|
|
|
|
3,753
|
|
Other, net
|
|
20
|
|
|
|
8
|
|
Total deferred tax assets
|
|
4,875
|
|
|
|
4,836
|
|
Valuation allowance
|
|
(4,875
|
)
|
|
|
(4,836
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
A full valuation allowance has been established to offset the deferred tax assets as management cannot conclude that realization of such assets is more likely than not. Under the Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of our net operating loss and research tax credit carryforwards to offset taxable income may be limited based on cumulative changes in ownership. We
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have not completed an analysis to determine whether any such limitations have been triggered as of March 31, 2019. Until
this analysis is completed, we have removed the deferred tax assets related to net operating losses and research credits from our deferred tax asset schedule. Further, until a study is completed and any limitation known, no amounts are being considered as
an uncertain tax position or disclosed as an unrecognized tax benefit. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact its effective tax rate. Any carryforwards that will expire pri
or to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. The valuation allowance increased by approximately $39,000 and decreased by approximately $3.2 million for
the years ended March 31, 2019 and 2018, respectively.
The Company had federal and state net operating loss carryforwards of approximately $170.3 million and $49.2 million, respectively, as of March 31, 2019. The federal net operating loss carryforward generated during the year ended March 31, 2019 of approximately $24.1 million will carryforwards indefinitely and be available to offset up to 80% of future taxable income each year. Federal net operating losses generated previously will begin to expire in 2028, unless previously utilized. The state net operating loss carryforwards (“NOLs”) will begin to expire in 2028, unless previously utilized.
The Company had federal and state research tax credit carryforwards of approximately $4.0 million and $3.6 million at March 31, 2019, respectively. The federal research tax credit carryforwards begin expiring in 2028. The state research tax credit carryforwards do not expire.
The Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The Act (i) reduces the US federal corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, (ii) generally reduces a company’s ability to utilize accumulated net operating losses, an (iii) requires the calculation of a one-time transition tax on certain previously unrepatriated foreign earnings and profits (“E&P”). The Act also impacts the valuation of a company’s deferred tax assets and liabilities. The Company applied the guidance in Staff Accounting Bulletin No. 118 when accounting for the enactment-date effects of the Act in the year ended March 31, 2019.
As of December 31, 2017, the Company remeasured certain deferred tax assets and liabilities based on the rates at which they are expected to reverse in the future (which is generally 21%), by recording a provisional amount of $2.7 million, which was fully offset by the valuation allowance.
Due to the deficit in post-1986 E&P from the foreign subsidiary, there was no increase in income tax expense related to the one-time transition tax. As of March 31, 2019, the Company has completed its accounting for the Act and determined that no adjustment was necessary to the provisional amounts.
The Company did not record any accruals for income tax accounting uncertainties for the year ended March 31, 2019.
The Company’s policy is to recognize interest and penalties that would be assessed in relation to the settlement value of unrecognized tax benefits as a component of income tax expense. The Company did not accrue either interest or penalties from inception through March 31, 2019.
The Company does not expect its unrecognized tax benefits to significantly increase or decrease within the next 12 months.
The Company is subject to tax in the United States and in various state jurisdictions. As of March 31, 2019, the Company’s tax years from inception are subject to examination by the tax authorities due to the generation of net operating losses. The Company is not currently under examination by any jurisdiction.
9. Concentrations
Credit risk and significant customers
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 March 31, 2019.
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10. Related Parties
From time to time, the Company will enter into an agreement with a related party in the ordinary course of its business and on terms and conditions it believes are as fair as those it offers and receives from independent third parties. These agreements are ratified by the Company’s Board of Directors or a committee thereof pursuant to its related party transaction policy.
In August 2017, the Company entered into a services agreement with Cirius Therapeutics, Inc. (“Cirius”), an entity for which Robert Baltera, Jr., a director of the Company, serves as Chief Executive Officer. Under this agreement and its amendments, the Company has provided ExVive™ Liver Tissue Services for Cirius in the amount of $281,000 to date, of which $120,000 and $161,000 was recognized as revenue in the years ended March 31, 2019 and March 31, 2018, respectively.
In November 2017, the Company entered into a collaboration agreement with Viscient Biosciences (“Viscient”), an entity for which Keith Murphy, a former director and former Chief Executive Officer of the Company, serves as Chief Executive Officer. Under this agreement and its amendments, the Company provided research services amounting to $358,000 recognized as revenue in the year ended March 31, 2018. In September 2018, Viscient purchased study materials from Organovo in the amount of $2,000 to date, pursuant to the terms of a Quote, of which $2,000 was recognized as revenue in the year ended March 31, 2019. In November 2018, Viscient executed a Quote to purchase research services from Organovo in the amount of $142,000, of which $42,000 was recognized as revenue in the year ended March 31, 2019. Additionally, Viscient purchased primary human cell-based products from our subsidiary, Samsara, in the amount of $165,000 to date, pursuant to the terms of multiple Quotes entered into throughout the 2018 and 2019 fiscal years, of which $96,000 and $14,000 were recognized as revenue in the years ended March 31, 2019 and March 31, 2018, respectively.
11. Defined Contribution Plan
The Company has a defined contribution 401(k) plan covering substantially all employees. During the year ended March 31, 2015, the 401(k) plan was amended (the “Amended Plan”) to include an employer matching provision. Under the terms of the Amended Plan, the Company will make matching contributions on up to the first 6% of compensation contributed by its employees. Amounts expensed under the Company’s 401(k) plan for the years ended March 31, 2019 and 2018 were approximately $240,000 and $337,000, respectively.
12. Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise stated, the Company believes that the impact of the recently issued accounting pronouncements that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.
Adoption of New Accounting Pronouncements
In May 2014, the FASB issued ASU No. 2014-09,
Revenue from Contracts with Customers
, which supersedes most existing revenue recognition guidance in GAAP, including most industry-specific guidance. The standard 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 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,
Revenue from Contracts with Customers,
which deferred by one year the effective date for all entities, with application permitted as of the original effective date. The standard allows for either a full retrospective or modified retrospective method of adoption. The Company adopted this standard on its effective date, April 1, 2018, under the modified retrospective method of adoption. Under this method, entities recognize the cumulative impact of applying the new standard at the date of adoption without restatement of prior periods presented. The cumulative effect of applying the new standard to contracts that were not completed as of April 1, 2018 did not have a material impact on the Company’s consolidated financial position, results of operations, or cash flows. The new standard also requires enhanced disclosures about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. See “Note 2. Summary of Significant Accounting Policies” for further discussion. Topic 606 supersedes the revenue recognition requirements in ASC Topic 605,
Revenue Recognition
(“Topic 605”). While results for reporting periods beginning after April 1, 2018 are presented under Topic 606, all prior period amounts are not adjusted and continue to be reported under the accounting standards in effect during these prior periods. The accounting policies for revenue recognition for periods prior to April 1, 2018 are described in “Note 1. Description of Business and Summary of Significant Accounting Policies”. Adoption of this ASC did not have a material impact on the Company’s financial statements.
In November 2016, the FASB issued ASU No. 2016-18,
Statement of Cash Flows
(Topic 230):
Restricted Cash
. The standard clarifies the presentation of restricted cash and cash equivalents and requires companies to include restricted cash and cash equivalents in the beginning and ending balances of cash and cash equivalents on the statement of cash flows. The standard also requires additional disclosures to describe the amount and detail of the restriction by balance sheet line item. The new standard was effective for the Company on April 1, 2018. The Company adopted this standard using the retrospective transition method by restating its condensed consolidated statements of cash flows to include restricted cash of $0.1 million in the beginning and ending cash, cash equivalents,
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and restricted cash balance.
Net cash flows for the twelve months ended Marc
h 31, 2018, did not change as a result of including restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period amounts presented on the statements of cash flows.
In May 2017, the FASB issued ASU No. 2017-09,
Compensation - Stock Compensation
(Topic 718):
Scope of Modification Accounting
, which provides clarity and guidance around which changes to the terms or conditions of a stock-based payment award require an entity to apply modification accounting. The new standard was effective for annual reporting periods beginning after April 1, 2018, and interim periods within those annual reporting periods. The adoption of this guidance had no impact on the Company’s financial statements.
In December 2017, the United States (“U.S.”) enacted the Tax Cuts and Jobs Act (the “2017 Act”), which changes existing U.S. tax law and includes various provisions that are expected to affect public companies. The 2017 Act (i) changes U.S. corporate tax rates, (ii) generally reduces a company’s ability to utilize accumulated net operating losses, and (iii) requires the calculation of a one-time transition tax on certain previously unrepatriated foreign earnings and profits (“E&P”). The 2017 Act will also impact estimates of a company’s deferred tax assets and liabilities. The Company applied the guidance in Staff Accounting Bulletin No. 118,
Income Tax Accounting Implications of the Tax Cuts and Jobs Act
(“SAB 118”), which resulted in a minimal impact to its financial statements. See “Note 8. Income Taxes” for more information.
Recent Accounting Pronouncements Not Yet Adopted
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the lease guidance under ASC 840 – Leases. The new accounting standard requires an entity to recognize right-of-use assets and corresponding lease liabilities on the balance sheet for all leases with terms of more than 12 months and to disclose key information about leasing arrangements. This new guidance is effective for the Company on April 1, 2019, with early adoption permitted in any interim or annual period. The Company will adopt ASU 2016-02 on April 1, 2019 and will elect the optional transition method that allows for a cumulative-effect adjustment in the period of adoption and will not restate prior periods. The Company will elect the package of practical expedients permitted under the transition guidance, but not the hindsight practical expedient. As a result of the adoption, the Company will record right-of-use assets and liabilities of approximately $4.5 million and $5.0 million, respectively, on its Consolidated Balance Sheet as of April 1, 2019, primarily associated with its operating leases.
In July 2017, the FASB issued ASU No. 2017-11,
Earnings Per Share
(Topic 260);
Distinguishing Liabilities from Equity
(Topic 480);
Derivatives and Hedging
(Topic 815):
(Part I) Accounting for Certain Financial Instruments with Down Round Features
, (Part II)
Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception
. These amendments simplify the accounting for certain financial instruments with down round features. The amendments require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. Companies that provide earnings per share (EPS) data will adjust their basic EPS calculation for the effect of the feature when triggered (i.e., when the exercise price of the related equity-linked financial instrument is adjusted downward because of the down round feature) and will also recognize the effect of the trigger within equity. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The adoption of this guidance will have no impact on the Company’s financial statements as the Company’s only derivative liabilities were all exercised or expired as of March 31, 2017.
In February 2018, the FASB issued ASU No. 2018-02,
Income Statement – Reporting Comprehensive Income
(“Topic 220”), which allows stranded tax effects resulting from the Tax Cuts and Jobs Act to be reclassified from accumulated other comprehensive income to retained earnings. The amendment only relates to the reclassification of the income tax effects of the Tax Cuts and Jobs Act; thus, the underlying guidance relating to the effect of a change in tax laws be included in income from continuing operations is not affected. The amendments in Topic 220 are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. This new guidance is effective for the Company on April 1, 2019. The requirements of ASU 2018-02 are not expected to have a significant impact on the Company’s financial statements.
In June 2018, the FASB issued ASU No. 2018-07,
Compensation - Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting
, which aligns the measurement and classification guidance for share-based payment to non-employees with the guidance for share-based payments to employees. Under the new guidance, the measurement period for equity-classified non-employee awards will be fixed at the grant date. This update is effective for annual periods beginning after December 15, 2018, and interim periods within those periods and early adoption is permitted. This new guidance is effective for the Company on April 1, 2019. The requirements of ASU 2018-07 are not expected to have a significant impact on the Company’s financial statements.
In November 2018, the FASB issued ASU 2018-18,
Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606
, which provides guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606. The amendments in this update provide more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The key improvements to GAAP for collaborative arrangements resulting from this amendment are to (i) clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit-of-account, (ii) add unit-of-account guidance in Topic 808 to align with the guidance in Topic 606, and (iii) require that in a
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transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangem
ent participant is not a customer. The amendments in this ASU are effective for all entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. This new guidance is effective for
the Company on April 1, 2020. The Company is currently evaluating the impact that this guidance will have on its financial statements.
13. Subsequent Events
Between April 1, 2019 and the date of filing, the Company issued 6,087,382 shares of its common stock pursuant to its ATM facility for net proceeds of approximately $5.0 million.
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