See accompanying notes to the unaudited condensed consolidated financial statements.
See accompanying notes to the unaudited condensed consolidated financial statements.
See accompanying notes to the unaudited condensed consolidated financial statements.
See accompanying notes to the unaudited condensed consolidated financial statements.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Description of Business, Basis of Presentation and Summary of Significant Accounting Policies
Description of Business
International Stem Cell Corporation (the “Company”) was organized in Delaware in June 2005 and is publicly traded on the OTCQX under the symbol “ISCO”. The Company is primarily a research and development company, for the therapeutic market, which has focused on advancing potential clinical applications of human parthenogenetic stem cells (“hpSCs”) for the treatment of various diseases of the central nervous system and liver diseases. The Company has the following wholly-owned subsidiaries:
|
•
|
Lifeline Cell Technology, LLC (“LCT”) – for the biomedical market, develops, manufactures and commercializes primary human cell research products including over 208 human cell culture products, including frozen human “primary” cells and the reagents (called “media”) needed to grow, maintain and differentiate the cells;
|
|
•
|
Lifeline Skin Care, Inc. (“LSC”) – for the anti-aging cosmetic market, develops, manufactures and markets a category of anti-aging cosmetic skin care products based on the Company’s proprietary parthenogenetic stem cell technology and small molecule technology;
|
|
•
|
Cyto Therapeutics Pty. Ltd. (“Cyto Therapeutics”) – performs research and development for the therapeutic market and is currently conducting clinical trials in Australia for the use of ISC-hpNSC® in the treatment of Parkinson’s disease.
|
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2019 included in the Company’s annual report on Form 10-K filed with the SEC on June 1, 2020.
Liquidity and Going Concern
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses and the uncertainties surrounding its ability to raise additional capital as needed, as discussed below, raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these financial statements are issued. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.
The Company had an accumulated deficit of approximately $106.8 million as of March 31, 2020 and has, on an annual basis, incurred net losses and negative operating cash flows since inception. The Company has had no revenue from its principal operations in therapeutic and clinical product development through research and development efforts. Unless we obtain additional financing, we do not have sufficient cash on hand to sustain our operations at least through one year after the issuance date. There can be no assurance that the Company will be successful in maintaining normal operating cash flow or obtaining additional funding. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. For the foreseeable future, the Company’s ability to continue its operations is dependent upon its ability to obtain additional capital.
The Company continues to evaluate various financing sources and options to raise working capital to help fund current research and development programs and operations. The Company will need to obtain significant additional capital from sources including the exercise of outstanding warrants, equity and/or debt financings, license arrangements, grants and/or collaborative research arrangements to sustain its operations and develop products.
8
The timing and degree of any future capital requirements will depend on many factors, including:
|
•
|
the accuracy of the assumptions underlying the estimates for capital needs in 2020 and beyond;
|
|
•
|
the extent that revenues from sales of LSC and LCT products cover the related costs and provide capital;
|
|
•
|
scientific progress in research and development programs;
|
|
•
|
the magnitude and scope of the Company’s research and development programs and its ability to establish, enforce and maintain strategic arrangements for research, development, clinical testing, manufacturing and marketing;
|
|
•
|
the progress with preclinical development and clinical trials;
|
|
•
|
the time and costs involved in obtaining regulatory approvals;
|
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims;
|
|
•
|
the number and type of product candidates that the Company decides to pursue; and
|
|
•
|
the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the current and future impact of it and COVID-19 on our business operations and funding requirements.
|
Additional financing through strategic collaborations, public or private equity financings or other financing sources may not be available on acceptable terms, or at all. Additional equity financing could result in significant dilution to stockholders. Additional debt financing may be expensive and require the Company to pledge all or a substantial portion of its assets. Further, if additional funds are obtained through arrangements with collaborative partners, these arrangements may require the Company to relinquish rights to some of its technologies, product candidates or products that the Company would otherwise seek to develop and commercialize on its own. If sufficient capital is not available, the Company may be required to delay, reduce the scope of or eliminate one or more of its product initiatives.
Principles of Consolidation
The unaudited condensed consolidated financial statements include the accounts of International Stem Cell Corporation and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Reclassifications
For the three months ended March 31, 2020, the Company reclassified certain prior period amounts to conform to the current period presentation, as follows:
|
•
|
The carrying value and shares of the Company’s Series B, Series G, Series I-1 and Series I-2 non-redeemable convertible preferred stock were aggregated on the accompanying condensed consolidated balance sheets and statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficit). Refer to Note 5 – Convertible Preferred Stock and Stockholders’ Equity (Deficit) for further information;
|
|
•
|
Non-cash operating lease expense was reclassified from changes in operating assets and liabilities to adjustments to reconcile net loss to net cash used in operating activities on the accompanying condensed consolidated statements of cash flows; and
|
|
•
|
Financed insurance premiums and payments on financed insurance premiums were reclassified from non-cash financing activities and cash flows from financing activities, respectively, to cash flows from operating activities on the accompanying condensed consolidated statements of cash flows;
|
These reclassifications had no effect on previously reported net loss, stockholders’ equity (deficit) or cash flows for the prior period.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the accompanying condensed consolidated financial statements. Significant estimates include patent life (remaining legal life versus remaining useful life), inventory carrying values, allowance for excess and obsolete inventories, allowance for sales returns and doubtful accounts, and transactions using the Black-Scholes option valuation model, for example, common stock options and common stock warrants, as well as the Monte-Carlo simulation method for certain common stock warrants. Actual results could differ from those estimates.
9
Segments
The Company’s chief operating decision-maker reviews financial information presented on a consolidated basis, accompanied by disaggregated information by each reportable company’s statement of operations. The Company operates the business on the basis of three reporting segments, the parent company and two business units: ISCO – therapeutic market; LCT – biomedical market, and; LSC – anti-aging cosmetic market.
Inventory
Inventory is accounted for using the average cost and first-in, first-out (FIFO) methods for LCT cell culture media and reagents, average cost and specific identification methods for LSC products, and specific identification method for other LCT products. Inventory balances are stated at the lower of cost or net realizable value. Laboratory supplies used in the research and development process are expensed as consumed. Inventory is reviewed periodically for product expiration and obsolescence and is adjusted accordingly. The value of the inventory that is not expected to be sold within twelve months of the current reporting period is classified as non-current inventory on the condensed consolidated balance sheets.
Accounts Receivable
Trade accounts receivable are recorded at the net invoice value and are not interest bearing. Accounts receivable primarily consist of trade accounts receivable from the sales of LCT’s products, timing of cash receipts by the Company related to LSC credit card sales to customers, as well as LSC trade receivable amounts related to spa and distributor sales. The Company considers receivables past due based on the contractual payment terms. The Company reviews its exposure to accounts receivable and reserves specific amounts if collectability is no longer reasonably assured. As of March 31, 2020 and December 31, 2019, the Company had an allowance for doubtful accounts totaling $12,000.
Advances
On June 18, 2008, the Company entered into an agreement with BioTime, Inc. (“BioTime”), whereby BioTime paid an advance of $250,000 to LCT to produce, make, and distribute certain products. The $250,000 advance will be paid down with the first $250,000 of net revenues that otherwise would be allocated to LCT under the agreement. As of March 31, 2020, no revenues were realized and attributable to BioTime under this agreement.
Property and Equipment
Property and equipment are stated at cost. The provision for depreciation and amortization is computed using the straight-line method over the estimated useful lives of the assets, which are generally three to five years. The costs of major remodeling and leasehold improvements are capitalized and amortized over the shorter of the remaining term of the lease or the estimated life of the asset.
Intangible Assets
Intangible assets consist of acquired patent licenses and capitalized legal fees related to the acquisition, filing, maintenance, and defense of patents and trademarks. Amortization begins once the patent is issued by the appropriate authoritative bodies. In the period in which a patent application is rejected or efforts to pursue the patent are abandoned, all the related accumulated costs are expensed. Patents and other intangible assets are amortized on a straight-line basis over the shorter of the lives of the underlying patents, generally 15 years. All amortization expense and impairment charges related to intangible assets are included in general and administrative expense in the accompanying condensed consolidated statements of operations.
Long-Lived Asset Impairment
The Company reviews long-lived assets for impairment when events or changes in business conditions indicate that their carrying value may not be recovered. The Company considers assets to be impaired and writes them down to fair value if expected associated undiscounted cash flows derived from the asset (or group of assets) are less than the carrying amounts. Fair value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable.
10
Revenue Recognition
Revenue is recognized at an amount that reflects the consideration to which the Company expects to be entitled in exchange for transferring goods or services to a customer. This principle is applied using the following five-step process:
|
1.
|
Identify the contract with the customer
|
|
2.
|
Identify the performance obligations in the contract
|
|
3.
|
Determine the transaction price
|
|
4.
|
Allocate the transaction price to the performance obligations in the contract
|
|
5.
|
Recognize revenue when (or as) each performance obligation is satisfied
|
The Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services.
The following table presents the Company's revenue disaggregated by segment, product and geography (in thousands):
Biomedical market:
|
Three Months Ended March 31, 2020
|
|
|
Domestic
|
|
|
International
|
|
|
Total Revenues
|
|
|
% of Total Revenues
|
|
Biomedical products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cells
|
$
|
262
|
|
|
$
|
117
|
|
|
$
|
379
|
|
|
|
19
|
%
|
Media
|
|
1,466
|
|
|
|
125
|
|
|
|
1,591
|
|
|
|
81
|
%
|
Total
|
$
|
1,728
|
|
|
$
|
242
|
|
|
$
|
1,970
|
|
|
|
100
|
%
|
|
Three Months Ended March 31, 2019
|
|
|
Domestic
|
|
|
International
|
|
|
Total Revenues
|
|
|
% of Total Revenues
|
|
Biomedical products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cells
|
$
|
172
|
|
|
$
|
100
|
|
|
$
|
272
|
|
|
|
15
|
%
|
Media
|
|
1,401
|
|
|
|
117
|
|
|
|
1,518
|
|
|
|
85
|
%
|
Total
|
$
|
1,573
|
|
|
$
|
217
|
|
|
$
|
1,790
|
|
|
|
100
|
%
|
Anti-aging cosmetic market:
|
Three Months Ended March 31, 2020
|
|
|
Three Months Ended March 31, 2019
|
|
|
Total Revenues
|
|
|
% of Total Revenues
|
|
|
Total Revenues
|
|
|
% of Total Revenues
|
|
Cosmetic sales channels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ecommerce
|
$
|
224
|
|
|
|
57
|
%
|
|
$
|
215
|
|
|
|
50
|
%
|
Professional
|
|
166
|
|
|
|
43
|
%
|
|
|
213
|
|
|
|
50
|
%
|
Total
|
$
|
390
|
|
|
|
100
|
%
|
|
$
|
428
|
|
|
|
100
|
%
|
The Company's revenue consists primarily of sales of products from its two revenue-generating operating segments, the biomedical products market and anti-aging cosmetic products market business segments. The biomedical market segment markets and sells primary human cell research products with two product categories, cells and media, which are sold both domestically within the United States and internationally. The anti-aging cosmetic market segment markets and sells a line of luxury skincare products sold through two sales channels: ecommerce and professional. The ecommerce channel sells direct to customers through online orders, while professional sales are to spas, salons and other skincare providers.
Contract terms for unit price, quantity, shipping and payment are governed by sales agreements, invoices or online order forms which the Company considers to be a customer's contract in all cases. The unit price is considered the observable stand-alone selling price for the performance obligation(s) within the arrangements. Any promotional or volume sales discounts are applied evenly to the units sold for purposes of calculating standalone selling price.
11
The Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. Product sales generally consist of a single performance obligation that the Company satisfies at a point in time (i.e., upon delivery of the product).
For LSC products, ecommerce sales are primarily paid through credit card charges, while professional sales are invoiced. The professional sales and biomedical products' standard payment terms for its customers are generally 30 days after the Company satisfies the performance obligation(s). For anti-aging cosmetic products, the Company honors a 30-day return policy, but historical returns have been minimal and as such, no estimated allowance for sales returns was recorded as of March 31, 2020 and December 31, 2019.
The Company elects to account for shipping and handling costs as activities to fulfill the promise to transfer the goods to a customer. As a result, no consideration is allocated to shipping and handling costs. Rather, the Company accrues the cost of shipping and handling upon shipment of the product, and all contract revenue (i.e., the transaction price) is recognized at the same time.
Variable Consideration
The Company records revenue from customers in an amount that reflects the consideration it expects to be entitled to after transferring control of those goods or services to a customer. From time to time, the Company offers sales promotions on its cosmetic products such as discounts and free product offers. Variable consideration is estimated at contract inception only to the extent that it is probable that a significant reversal of revenue will not occur and is updated at the end of each reporting period as additional information becomes available.
Contract Balances
The Company records a receivable when it has an unconditional right to receive consideration after a performance obligation is satisfied. As of March 31, 2020 and December 31, 2019, accounts receivable totaled $1.1 million and $1.5 million, respectively. For the three months ended March 31, 2020 and 2019, the Company did not incur material write-offs with respect to its receivables.
Practical Expedients
The Company has elected the practical expedient to not determine whether contacts with customers contain significant financing components. The Company pays commissions on certain sales for its biomedical and cosmetic product markets once the customer payment has been received, which are accrued at the time of the sale. The Company generally expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses. In addition, the Company has elected to exclude sales taxes consideration from the determined transaction price.
Allowance for Sales Returns
The Company’s cosmetic products have a 30-day product return guarantee; however, the Company determined that there is a low probability that returns will occur based on its historical rate of returns. Historically, returns have not been significant and are recognized as a reduction to current period revenue. As of March 31, 2020 and December 31, 2019, the Company recorded no allowance for sales returns.
Cost of Sales
Cost of sales consists primarily of salaries and benefits associated with employee efforts expended directly on the production of the Company’s products, as well as related direct materials, general laboratory supplies and an allocation of overhead. Certain of the Company’s licensed technology agreements may require the Company to pay royalties based on the future sale of the Company’s products. Such royalties will be recorded as a component of cost of sales when incurred. Additionally, milestone payments or the amortization of license fees related to developed technologies used in the Company’s products will be included as a component of cost of sales to the extent that such payments become due in the future.
Research and Development Costs
Research and development costs, which are expensed as incurred, primarily consist of salaries and benefits associated with research and development personnel, overhead and occupancy costs, contract services costs, and amortization of license costs for technology used in research and development with alternative future uses.
12
Stock-Based Compensation
The Company recognizes stock-based compensation expense associated with stock options and other stock-based awards in accordance with the authoritative guidance for stock-based compensation. The cost of a stock-based award is measured at the grant date based on the estimated fair value of the award, and is recognized as expense on a straight-line basis, net of forfeitures, over the requisite service period of the award. The fair value of stock options is estimated using the Black-Scholes option valuation model, which requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The fair value of restricted stock awards is based on the market value of the Company’s common stock on the date of grant.
Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets.
Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly.
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The Company has no financial assets or liabilities, other than the warrant liability described below, measured at fair value on a recurring basis. No transfers between levels have occurred during the periods presented.
The following table presents a summary of the Company’s liabilities which are measured at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 (in thousands):
|
Fair Value Measurements at
|
|
|
Reporting Date Using
|
|
|
|
|
|
|
Quoted Prices
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
in Active
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
Markets for
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Identical Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Total
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
As of March 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
$
|
97
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
97
|
|
As of December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
$
|
207
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
207
|
|
The following table presents the rollforward activity of liabilities with inputs that are both significant to the fair value measurement and unobservable (supported by little or no market activity) (in thousands):
|
Warrant
|
|
|
Liability
|
|
Balance at December 31, 2019
|
$
|
207
|
|
Change in fair value of warrant liability
|
|
(110
|
)
|
Balance at March 31, 2020
|
$
|
97
|
|
13
Warrant Liability
The Company is required to recognize warrant agreements as a liability since they did not meet the specific conditions for equity classification and therefore need to be recognized at its fair value. The fair value of the warrant liability is calculated using the Monte-Carlo simulation model, which requires the use of certain estimates. The fair value of these warrants is re-measured at each financial reporting period with any changes in fair value being recognized as a component of other income, net, in the accompanying condensed consolidated statements of operations.
The following assumptions were used as inputs to the model:
|
Three Months Ended March 31,
|
|
|
2020
|
|
|
2019
|
|
Significant assumptions:
|
|
|
|
|
|
|
|
Risk-free interest rate
|
0.05% - 0.17%
|
|
|
2.27% - 2.40%
|
|
Volatility
|
90.0%
|
|
|
77.2%
|
|
Term to expiration (in years)
|
0.04 - 0.96
|
|
|
1.04 - 1.96
|
|
Subsequent financing
|
0.0%
|
|
|
90.0%
|
|
Income Taxes
The Company accounts for income taxes in accordance with applicable authoritative guidance, which requires the Company to provide a net deferred tax asset/liability equal to the expected future tax benefit/expense of temporary reporting differences between book and tax accounting methods and any available operating loss or tax credit carryforwards.
Fair Value of Financial Instruments
The Company believes that the carrying value of its cash, accounts receivables, accounts payable, accrued liabilities and related party note payable as of March 31, 2020 and December 31, 2019 approximate their fair values because of the short-term nature of those instruments. The fair value of warrants was determined at each issuance date, reporting date and other applicable re-measurement dates for the periods ended using the Monte-Carlo simulation model.
Net Loss Per Share
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of stock options, common stock warrants and convertible preferred stock. For the periods ended March 31, 2020 and 2019, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive common stock equivalents would be anti-dilutive.
For the periods below, these common stock options, common stock warrants and convertible preferred stock were not included in the diluted loss per share calculation because the effect would be anti-dilutive.
|
Three Months Ended March 31,
|
|
|
2020
|
|
|
2019
|
|
Options outstanding
|
|
4,837,580
|
|
|
|
5,479,187
|
|
Common stock warrants outstanding
|
|
3,951,052
|
|
|
|
3,951,052
|
|
Redeemable convertible preferred stock
|
|
2,457,143
|
|
|
|
2,457,143
|
|
Non-redeemable convertible preferred stock
|
|
3,675,135
|
|
|
|
3,675,133
|
|
Total
|
|
14,920,910
|
|
|
|
15,562,515
|
|
Comprehensive Loss
Comprehensive loss includes all changes in stockholders’ equity except those resulting from investments by owners and distributions to owners. The Company did not have any items of comprehensive loss other than net loss from operations for the three months ended March 31, 2020 and 2019.
14
Risks and Uncertainties
COVID-19
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally.
The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations. Management is actively monitoring the situation on its financial condition, liquidity, operations, customers, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the response to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak to its results of operations, financial condition, or liquidity for fiscal year 2020.
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions and technical corrections to tax depreciation methods for qualified improvement property. The Company continues to examine the impact that the CARES Act may have on its business. Currently, the Company is unable to determine the impact that the CARES Act will have on its financial condition, results of operations, or liquidity. The CARES Act also appropriated funds for the U.S. Small Business Administration Paycheck Protection Program (“PPP”) loans that are forgivable in certain situations to promote continued employment, as well as Economic Injury Disaster Loans to provide liquidity to small businesses harmed by COVID-19.
Customer Concentration
During the three months ended March 31, 2020 and 2019, for the biomedical market segment, one customer accounted for approximately 49% and 42%, respectively, of consolidated revenues. No other single customer accounted for more than 10% of revenues for the periods ended.
Vendor Concentration
During the three months ended March 31, 2020, two vendors accounted for approximately 14% and 11% of consolidated purchases, while during the same period in 2019 no single vendor accounted for more than 10% of consolidated purchases.
Recently Issued Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments— Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The new standard will be effective for the Company on January 1, 2023 or at such time where it is no longer a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. ASU 2019-12 also improves the consistent application, and the simplification, of other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
15
Recently Adopted Accounting Pronouncements
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). ASU 2018-13 removes the valuation processes for Level 3 fair value measurements and adds the disclosure for the range and weighted-average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements or related disclosures.
2. Inventory
The components of inventory are as follows (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Raw materials
|
|
$
|
630
|
|
|
$
|
688
|
|
Work in process
|
|
|
537
|
|
|
|
492
|
|
Finished goods
|
|
|
1,155
|
|
|
|
1,219
|
|
|
|
|
2,322
|
|
|
|
2,399
|
|
Less: allowance for inventory excess and obsolescence
|
|
|
(847
|
)
|
|
|
(795
|
)
|
Total current and non-current inventory, net
|
|
$
|
1,475
|
|
|
$
|
1,604
|
|
|
|
|
|
|
|
|
|
|
Inventory, net
|
|
$
|
1,100
|
|
|
$
|
1,246
|
|
Non-current inventory
|
|
|
375
|
|
|
|
358
|
|
Total current and non-current inventory, net
|
|
$
|
1,475
|
|
|
$
|
1,604
|
|
3. Property and Equipment
Property and equipment consist of the following (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Machinery and equipment
|
|
$
|
1,645
|
|
|
$
|
1,642
|
|
Computer equipment and software
|
|
|
236
|
|
|
|
236
|
|
Office equipment
|
|
|
230
|
|
|
|
230
|
|
Leasehold improvements
|
|
|
1,290
|
|
|
|
1,290
|
|
Construction in progress
|
|
|
12
|
|
|
|
12
|
|
|
|
|
3,413
|
|
|
|
3,410
|
|
Less: accumulated depreciation and amortization
|
|
|
(2,783
|
)
|
|
|
(2,742
|
)
|
Property and equipment, net
|
|
$
|
630
|
|
|
$
|
668
|
|
Depreciation expense for the three months ended March 31, 2020 and 2019 was $41,000 and $37,000 respectively.
4. Intangible Assets
Intangible Assets consists of the following (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Patents
|
|
$
|
2,306
|
|
|
$
|
2,268
|
|
Less: accumulated amortization
|
|
|
(1,030
|
)
|
|
|
(1,008
|
)
|
|
|
|
1,276
|
|
|
|
1,260
|
|
Indefinite life logos and trademarks
|
|
|
75
|
|
|
|
75
|
|
Intangible assets, net
|
|
$
|
1,351
|
|
|
$
|
1,335
|
|
Amortization expense for the three months ended March 31, 2020 and 2019 was $22,000 and $35,000, respectively.
16
5. Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Non-Redeemable Convertible Preferred Stock
The Company’s Series B, Series G, Series I-1 and Series I-2 non-redeemable convertible preferred stock has been classified as equity on the accompanying condensed consolidated balance sheets in accordance with authoritative guidance for the classification and measurement of non-redeemable securities whose redemption is based upon certain change in control events within the Company’s control, including liquidation, sale, or transfer of control of the Company.
The authorized, issued and outstanding shares of non-redeemable convertible preferred stock as of March 31, 2020 consist of the following:
|
|
Shares
|
|
|
Shares Issued
|
|
|
Liquidation
|
|
|
Carrying
|
|
|
|
Authorized
|
|
|
and Outstanding
|
|
|
Preference
|
|
|
Value
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
Series B
|
|
|
5,000,000
|
|
|
|
250,000
|
|
|
$
|
430
|
|
|
$
|
—
|
|
Series G
|
|
|
5,000,000
|
|
|
|
5,000,000
|
|
|
|
5,000
|
|
|
|
5
|
|
Series I-1
|
|
|
2,000
|
|
|
|
814
|
|
|
|
814
|
|
|
|
—
|
|
Series I-2
|
|
|
4,310
|
|
|
|
4,310
|
|
|
|
4,310
|
|
|
|
—
|
|
Total
|
|
|
10,006,310
|
|
|
|
5,255,124
|
|
|
$
|
10,554
|
|
|
$
|
5
|
|
The authorized, issued and outstanding shares of non-redeemable convertible preferred stock as of December 31, 2019 consist of the following:
|
|
Shares
|
|
|
Shares Issued
|
|
|
Liquidation
|
|
|
Carrying
|
|
|
|
Authorized
|
|
|
and Outstanding
|
|
|
Preference
|
|
|
Value
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
Series B
|
|
|
5,000,000
|
|
|
|
250,000
|
|
|
$
|
426
|
|
|
$
|
—
|
|
Series G
|
|
|
5,000,000
|
|
|
|
5,000,000
|
|
|
|
5,000
|
|
|
|
5
|
|
Series I-1
|
|
|
2,000
|
|
|
|
814
|
|
|
|
814
|
|
|
|
—
|
|
Series I-2
|
|
|
4,310
|
|
|
|
4,310
|
|
|
|
4,310
|
|
|
|
—
|
|
Total
|
|
|
10,006,310
|
|
|
|
5,255,124
|
|
|
$
|
10,550
|
|
|
$
|
5
|
|
Common Stock
As of March 31, 2020, the Company was authorized to issue 120,000,000 shares of common stock, $0.001 par value per share, and 20,000,000 shares of preferred stock, $0.001 par value per share. Of the 20,000,000 total authorized shares of preferred stock, the Company had authorized 50 shares of Series D redeemable convertible preferred stock and 10,006,310 shares of Series B, Series G, Series I-1 and Series I-2 non-redeemable convertible preferred stock were authorized.
On January 21, 2019, the Company issued 599,222 shares of common stock upon conversion of a portion of the Company’s outstanding indebtedness with a principal amount of $1.0 million and accrued and unpaid interest on the principal of $49,000. In accordance with the Series G Certificate of Designation, the issuance of Common Shares at the conversion price of $1.75 per share triggered further adjustment in the conversion price and conversion ratio of the Series G Preferred Stock from $9.92 per share and 0.1008 shares to $9.70 per share and 0.1031 shares, respectively. The deemed dividend as a result of the down-round adjustment was immaterial.
Common Stock Warrants
In October 2014 and March 2016, the Company issued warrants exercisable for 62,047 and 11,159,995 shares of common stock, respectively, at an exercise price of $1.75 per share, to certain placement agents and existing investors in conjunction with financing arrangements. The common stock warrants issued in October 2014 and March 2016 expire on April 14, 2020 and March 15, 2021, respectively. As of March 31, 2020 and December 31, 2019, 2,483 and 3,948,569 of common stock warrants issued in October 2014 and March 2016, respectively, were outstanding.
17
Equity Incentive Plans
The Company adopted the 2006 Equity Participation Plan (as amended the “2006 Plan”), which provides for the grant of stock options, restricted stock and other equity-based awards. Awards for up to 100,000 shares may be granted to employees, directors and consultants under this Plan. The options granted under the 2006 Plan may be either qualified or non-qualified options. Options may be granted with different vesting terms and expire no later than 10 years from the date of grant. The 2006 Plan expired on November 16, 2016. Options and other equity-based awards granted prior to the expiration of the 2006 Plan will continue in effect until the option or award is exercised or terminates pursuant to its terms. No new awards may be granted under the 2006 Plan following its expiration.
In April 2010, the Company adopted the 2010 Equity Participation Plan (as amended the “2010 Plan”), which provides for the grant of stock options, restricted stock and other equity-based awards. Awards for up to 9,700,000 shares may be granted to employees, directors and consultants under the 2010 Plan. The options granted under the 2010 Plan may be either qualified or non-qualified options. Options may be granted with different vesting terms and expire no later than 10 years from the date of grant.
Restricted stock awards are grants that entitle the holder to acquire shares of common stock at zero or a fixed price, which is typically nominal. The Company accounts for the restricted stock awards as issued and outstanding common stock, even though the shares covered by a restricted stock award cannot be sold, pledged, or otherwise disposed of until the award vests and any unvested shares may be reacquired by the Company for the original purchase price following the awardee’s termination of service.
No restricted stock was awarded for the three months ended March 31, 2020. For the year ended December 31, 2019, 6,006 shares of restricted stock were awarded and fully vested at a weighted-average grant date fair value of $0.62.
The fair value of the restricted stock awards is based on the market value of the common stock on the date of grant. For the three months ended March 31, 2020 and 2019, no restricted stock awards vested. As of March 31, 2020, there was no unrecognized compensation costs related to unvested awards.
In accordance with applicable authoritative guidance, the Company is required to establish assumptions and estimates of the fair value of stock options granted, as well as use a valuation model to calculate the fair value of stock-based awards. The Company uses the Black-Scholes option-pricing model to determine the fair-value of stock-based awards. All options are amortized over the requisite service periods.
Total stock-based compensation expense for the three months ended March 31, 2020 and 2019 was comprised of the following (in thousands):
Unrecognized compensation expense related to stock options as of March 31, 2020 was $1.4 million, which is expected to be recognized over a weighted-average period of approximately 1.39 years.
6. Related Party Transactions
During the first quarter of 2011, the Company executed an operating lease for its corporate offices with S Real Estate Holdings LLC. S Real Estate Holdings LLC is owned by Dr. Russell Kern, the Company’s Executive Vice President and Chief Scientific Officer and a director and was previously owned by Dr. Andrey Semechkin, the Company’s Chief Executive Officer and Co-Chairman of the Board of Directors. The lease agreement was negotiated at arm’s length and was reviewed by the Company’s outside legal counsel. The terms of the lease were reviewed by a committee of independent directors, and the Company believes that, in total, those terms are at least as favorable to the Company as could be obtained for comparable facilities from an unaffiliated party. In March 2017 the Company signed an amendment to the lease agreement to extend the term of the lease until 2020 and include annual adjustments to the monthly lease payments. In March 2020, the Company entered into an amendment to the lease agreement. The amendment extended the term of the lease for three years (until February 28, 2023) and provided for a 2% increase in monthly rent. For the three months ended March 31, 2020 and 2019, the Company recorded $41,000 and $40,000, respectively, in rent expense that was related to the facility lease arrangement with related parties.
Between March 6, 2018 and August 8, 2018, to obtain funding for working capital purposes, the Company borrowed a total of $2.0 million from Dr. Semechkin and issued an unsecured non-convertible promissory note in the principal amount of $2.0 million (the “Note”) to Dr. Semechkin (the “Noteholder”). The outstanding principal amount under the Note accrued interest at a rate of four percent (4%) per annum. The Note was due and payable November 1, 2018 and on November 12, 2018, to satisfy the indebtedness incurred on the Note, an amendment to the Note was entered into extending the due date to January 15, 2019.
On April 17, 2019, to obtain additional funding for working capital purposes, the Company issued an unsecured, non-convertible promissory note (the “New Promissory Note”) in the amount of $1.8 million to Dr. Semechkin. Dr. Semechkin surrendered an existing promissory note from the Company for $1.0 million and provided an additional $800,000 of funds to the Company. The outstanding principal amount accrued interest at a rate of 4.5% per annum and was due and payable on January 15, 2020, but may be pre-paid by the Company without penalty at any time.
On December 17, 2019, to obtain additional funding for working capital purposes the Company issued an unsecured, non-convertible promissory note in the principal amount of $2.3 million (the “New Note”) to Dr. Andrey Semechkin. On December 17, 2019 the Noteholder provided an additional $500,000 of funds to the Company and surrendered the New Promissory Note, in return for the New Note. The outstanding principal amount under the New Note accrues interest at a rate of 4.5% per annum. The New Note, including outstanding amounts of principal and accrued interest, is due and payable January 15, 2021 but may be pre-paid by the Company without penalty at any time.
7. Commitments and Contingencies
The Company has three operating leases for real estate in California and Maryland:
The Company’s operating leases for real estate are subject to additional variable charges for common area maintenance and other variable costs, and do not include an option to extend the lease term. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of future minimum lease payments over the lease term. As of March 31, 2020, total right-of-use assets and operating lease liabilities were approximately $1.1 million and $1.4 million, respectively. All operating lease expense is recognized on a straight-line basis over the lease term.
The Company has a minimum annual license fee of $75,000 payable in two installments per year to Astellas Pharma pursuant to the amended UMass IP license agreement and is noncancelable.
The Company operates the business on the basis of three reporting segments, the parent company and two business units: ISCO – therapeutic market; LCT – biomedical market, and; LSC – anti-aging cosmetic market.
The Company does not measure the performance of its segments on any asset-based metrics. Therefore, segment information is presented only for operating income (loss). Revenues, expenses and operating income (loss) for the three months ended March 31, 2020 and 2019 by market segment were as follows (in thousands):
9. Subsequent Events
In May 2020, the Company applied for and received $654,000 from the PPP (the “PPP Loan”) as government aid for payroll, rent and utilities. The application for these funds required the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to take into account its current business activity and its ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. The certification made by the Company did not contain any objective criteria and is subject to interpretation. Based in part on the Company’s assessment of other sources of liquidity, the uncertainty associated with future revenues created by the COVID-19 pandemic and related governmental responses, and the going concern uncertainty reflect in the Company’s consolidated financial statements, the Company believed in good faith that it met the eligibility requirements for the PPP Loan. If, despite the good-faith belief that given the Company’s circumstances all eligibility requirements for the PPP Loan were satisfied, it is later determined that the Company had violated any applicable laws or regulations or it is otherwise determined the Company was ineligible to receive the PPP Loan, it may be required to repay the PPP Loan in its entirety and/or be subject to additional penalties and potential liabilities.
On June 5, 2020, the Paycheck Protection Program Flexibility Act (the “PPP Flexibility Act”) was signed into law, extending the PPP Loan forgiveness period from 8 weeks to 24 weeks after loan origination, reducing the required amount of payroll expenditures from 75% to 60%, removing the prior ban on borrowers taking advantage of payroll tax deferral after loan forgiveness and allowing for the amendment of the maturity date on existing loans from two years to five years. The Company is evaluating the impact of these changes on its PPP Loan.