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 200 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 market, develops, manufactures and markets a category of anti-aging 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 (“R&D”) 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.
|
COVID-19 Pandemic
The COVID-19 pandemic has caused business disruptions in the Company’s business globally. The Company’s condensed consolidated financial statements reflect judgments and estimates that could change in the future as a result of the COVID-19 pandemic. For the six months ended June 30, 2021, the Company experienced a year-over-year decline in product sales. In response, the Company has reduced its capital spending and, where possible, operating expenses while facilitating ongoing safe and reliable operations. As of the date of this report, the Company expects the COVID-19 pandemic will continue to adversely impact its business, financial condition, liquidity, and future results of operations. The full extent to which the COVID-19 pandemic will impact the Company remains uncertain and ultimately will be dictated by the length and severity of the pandemic, as well as the economic recovery and federal, state and local government actions taken in response. The Company is continuing to monitor the impact of COVID-19 on the Company’s operations, workforce, suppliers, customers and industry.
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”) applicable to interim financial statements. 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 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, 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 30, 2021.
Liquidity and Going Concern
The Company had an accumulated deficit of approximately $109.5 million as of June 30, 2021 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 the Company obtains additional financing, the Company does not have sufficient cash on hand to sustain operations at least through one year after the issuance date of these condensed consolidated financial statements.
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 financing. The accompanying condensed consolidated 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.
7
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 funding from sources, including through debt and/or equity financing, license arrangements, grants and/or collaborative research arrangements to sustain its operations and develop products.
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 2021 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;
|
|
•
|
demand from the Company’s largest original equipment manufacturer customers; and
|
|
•
|
the development of major public health concerns, including COVID-19 or other pandemics arising globally, and the current and future impact that such concerns may have on the Company’s operations and funding requirements.
|
As a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have experienced volatility and disruptions, including inconsistent liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. As the pandemic continues and restrictions remain in place or new restrictions are imposed, it may make any additional debt and/or equity financing more difficult, more costly and more dilutive.
In addition, debt financing may be expensive and require the Company to pledge all or a substantial portion of its assets. 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. Furthermore, 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. The Company’s failure to raise capital or enter into applicable arrangements when needed would have a negative impact on its financial condition.
Principles of Consolidation and Foreign Currency Transactions
The 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. The functional currency of the Company and its subsidiaries, including its wholly-owned Australian subsidiary, Cyto Therapeutics, is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the respective balance sheet dates. Revenue and expenses are translated at the average rate in effect on the date of the transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in general and administrative expense in the accompanying condensed consolidated statements of operations and were not material for the periods presented.
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 the fair value of stock option grants using the Black-Scholes option valuation model. Actual results could differ from those estimates.
8
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 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. LCT’s inventory has a long product life cycle, does not have a shelf life when frozen, and future demand is uncertain. As such, at each reporting period, the Company estimates its reserve for allowance and obsolescence using historical sales data and inventory turnover rates. The establishment of a reserve for excess and obsolete inventory establishes a new cost basis in the inventory. If the Company is able to sell such inventory, any related reserves would be reduced in the period of sale. 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 accompanying 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. The Company recorded an allowance for doubtful accounts of $3,000 and $12,000 as of June 30, 2021 and December 31, 2020, respectively.
Research and Development Tax Credit Receivable
As of June 30, 2021, the Company recognized a research and development tax credit receivable of $113,000 within prepaid expenses and other current assets on the accompanying condensed consolidated balance sheets earned by its wholly-owned subsidiary, Cyto Therapeutics, which conducts various research and development activities on the Company’s product candidates in Australia. Under Australian tax law, the Australian Taxation Office provides for a refundable tax credit in the form of a cash refund equal to 43.5% of qualified research and development expenditures, not to exceed established thresholds. The Company recognizes the R&D tax credit as a reduction to research and development expense when there is reasonable assurance that the tax credit will be received, the relevant expenses have been incurred, and the amount can be reliably measured.
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 June 30, 2021, 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. Costs related to 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 useful life of the underlying patent, which is generally 15 years, or when the intangible asset is rejected or abandoned. All amortization expense related to intangible assets is included in general and administrative expense in the accompanying condensed consolidated statements of operations.
9
Long-Lived Asset Impairment
The Company reviews long-lived assets for impairment when events or changes in circumstances (“triggering event”) indicate that the carrying value of an asset or group of assets may not be recovered. If a triggering event is determined to have occurred, the carrying value of an asset or group of assets is compared to the future undiscounted cash flows expected to be generated by the asset or group of assets. If the carrying value exceeds the undiscounted cash flows of the asset or group of assets, then impairment exists. Fair value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable.
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 June 30, 2021
|
|
|
|
Six Months Ended June 30, 2021
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
% of Total
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
% of Total
|
|
|
Domestic
|
|
|
International
|
|
|
Revenues
|
|
|
Revenues
|
|
|
|
Domestic
|
|
|
International
|
|
|
Revenues
|
|
|
Revenues
|
|
Biomedical products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cells
|
$
|
186
|
|
|
$
|
171
|
|
|
$
|
357
|
|
|
|
24
|
%
|
|
|
$
|
351
|
|
|
$
|
329
|
|
|
$
|
680
|
|
|
|
23
|
%
|
Media
|
|
939
|
|
|
|
197
|
|
|
|
1,136
|
|
|
|
76
|
%
|
|
|
|
1,912
|
|
|
|
328
|
|
|
|
2,240
|
|
|
|
77
|
%
|
Total
|
$
|
1,125
|
|
|
$
|
368
|
|
|
$
|
1,493
|
|
|
|
100
|
%
|
|
|
$
|
2,263
|
|
|
$
|
657
|
|
|
$
|
2,920
|
|
|
|
100
|
%
|
|
Three Months Ended June 30, 2020
|
|
|
|
Six Months Ended June 30, 2020
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
% of Total
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
% of Total
|
|
|
Domestic
|
|
|
International
|
|
|
Revenues
|
|
|
Revenues
|
|
|
|
Domestic
|
|
|
International
|
|
|
Revenues
|
|
|
Revenues
|
|
Biomedical products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cells
|
$
|
213
|
|
|
$
|
87
|
|
|
$
|
300
|
|
|
|
22
|
%
|
|
|
$
|
475
|
|
|
$
|
204
|
|
|
$
|
679
|
|
|
|
20
|
%
|
Media
|
|
994
|
|
|
|
85
|
|
|
|
1,079
|
|
|
|
77
|
%
|
|
|
|
2,461
|
|
|
|
210
|
|
|
|
2,671
|
|
|
|
79
|
%
|
Other
|
|
16
|
|
|
|
—
|
|
|
|
16
|
|
|
|
1
|
%
|
|
|
|
16
|
|
|
|
—
|
|
|
|
16
|
|
|
|
1
|
%
|
Total
|
$
|
1,223
|
|
|
$
|
172
|
|
|
$
|
1,395
|
|
|
|
100
|
%
|
|
|
$
|
2,952
|
|
|
$
|
414
|
|
|
$
|
3,366
|
|
|
|
100
|
%
|
Anti-aging market:
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
|
2021
|
|
|
2020
|
|
|
|
2021
|
|
|
2020
|
|
|
Total
|
|
|
% of Total
|
|
|
Total
|
|
|
% of Total
|
|
|
|
Total
|
|
|
% of Total
|
|
|
Total
|
|
|
% of Total
|
|
|
Revenues
|
|
|
Revenues
|
|
|
Revenues
|
|
|
Revenues
|
|
|
|
Revenues
|
|
|
Revenues
|
|
|
Revenues
|
|
|
Revenues
|
|
Skin care sales channels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ecommerce
|
$
|
245
|
|
|
|
72
|
%
|
|
$
|
299
|
|
|
|
72
|
%
|
|
|
$
|
411
|
|
|
|
72
|
%
|
|
$
|
522
|
|
|
|
65
|
%
|
Professional
|
|
95
|
|
|
|
28
|
%
|
|
|
118
|
|
|
|
28
|
%
|
|
|
|
160
|
|
|
|
28
|
%
|
|
|
283
|
|
|
|
35
|
%
|
Total
|
$
|
340
|
|
|
|
100
|
%
|
|
$
|
417
|
|
|
|
100
|
%
|
|
|
$
|
571
|
|
|
|
100
|
%
|
|
$
|
805
|
|
|
|
100
|
%
|
The Company's revenue consists primarily of sales of products from its two revenue-generating operating segments, the biomedical market and anti-aging 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 market segment markets and sells a line of skincare products sold through two sales channels: ecommerce and professional. The ecommerce channel sells direct to customers through online orders, while professional sales are primarily to spas, salons and other skincare providers.
10
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.
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).
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 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 June 30, 2021 and December 31, 2020, accounts receivable, net, totaled $547,000 and $403,000, respectively. During the six months ended June 30, 2021 and 2020, the Company did not incur material write-offs of its accounts receivable.
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 anti-aging 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 anti-aging 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 June 30, 2021 and December 31, 2020, 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.
11
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, offset by the research and development tax credit provided by the Australian Taxation Office for qualified expenditures.
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 which are recognized as incurred, 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 of Financial Instruments
The Company believes that the carrying value of its cash, accounts receivables, accounts payable, accrued liabilities, Paycheck Protection Program loan and related party note payable as of June 30, 2021 and December 31, 2020 approximate their fair values because of the short-term nature of those instruments.
Fair Value Measurements
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.
As of June 30, 2021, the Company had no financial assets or liabilities measured at fair value on a recurring basis. As of December 31, 2020, the Company had outstanding a warrant liability which was measured at fair value on a recurring basis. The fair value of the warrant liability was calculated using the Monte-Carlo simulation model, which required the use of certain estimates. As of December 31, 2020, the fair value of the warrant liability was estimated to be zero.
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.
Net Income (Loss) Per Share
Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the net income (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 three and six months ended June 30, 2021 and 2020, there was no difference in the number of shares used to calculate basic and diluted shares outstanding.
12
For the three and six months ended June 30, 2021 and 2020, the following common stock options, common stock warrants and convertible preferred stock were not included in the diluted net income (loss) per share calculation because the effect would be anti-dilutive.
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Options outstanding
|
|
4,545,211
|
|
|
|
4,620,033
|
|
|
|
4,386,367
|
|
|
|
4,739,281
|
|
Common stock warrants outstanding
|
|
—
|
|
|
|
3,948,951
|
|
|
|
—
|
|
|
|
3,950,002
|
|
Redeemable convertible preferred stock
|
|
2,457,143
|
|
|
|
2,457,143
|
|
|
|
2,457,143
|
|
|
|
2,457,143
|
|
Non-redeemable convertible preferred stock
|
|
3,452,533
|
|
|
|
3,675,135
|
|
|
|
3,563,219
|
|
|
|
3,675,135
|
|
Total
|
|
10,454,887
|
|
|
|
14,701,262
|
|
|
|
10,406,729
|
|
|
|
14,821,561
|
|
Comprehensive Income (Loss)
Comprehensive income (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 income (loss) other than net income (loss) from operations for the three and six months ended June 30, 2021 and 2020.
Customer Concentrations
During the six months ended June 30, 2021, two customers accounted for approximately 35% and 10%, respectively, of consolidated revenues. During the six months ended June 30, 2020, one customer accounted for approximately 47% of consolidated revenues. As of June 30, 2021 and December 31, 2020, the two customers accounted for approximately 42% and 62%, respectively, of accounts receivable, net. No other single customer accounted for more than 10% of revenues for the periods then ended for any segment.
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 earlier 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 August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt instruments by reducing the number of accounting models and the number of embedded features that could be recognized separately from the host contract. Consequently, more convertible debt instruments will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. ASU 2020-06 also requires use of the if-converted method in the diluted earnings per share calculation for convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years for smaller reporting companies, with early adoption permitted. The new standard will be effective for the Company on January 1, 2024 or at such earlier 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.
Recently Adopted Accounting Pronouncements
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 adopted ASU 2019-12 on January 1, 2021. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements or related disclosures.
13
2. Inventory
The components of inventory are as follows (in thousands):
|
June 30,
|
|
|
December 31,
|
|
|
2021
|
|
|
2020
|
|
Raw materials
|
$
|
595
|
|
|
$
|
427
|
|
Work in process
|
|
411
|
|
|
|
481
|
|
Finished goods
|
|
994
|
|
|
|
991
|
|
|
|
2,000
|
|
|
|
1,899
|
|
Less: allowance for inventory excess and obsolescence
|
|
(564
|
)
|
|
|
(611
|
)
|
Total current and non-current inventory, net
|
$
|
1,436
|
|
|
$
|
1,288
|
|
|
|
|
|
|
|
|
|
Inventory, net
|
$
|
1,073
|
|
|
$
|
917
|
|
Non-current inventory
|
|
363
|
|
|
|
371
|
|
Total current and non-current inventory, net
|
$
|
1,436
|
|
|
$
|
1,288
|
|
During the six months ended June 30, 2021, the Company disposed of obsolete inventory in the amount of $45,000. The inventory had been fully reserved for and the write-off had no impact on the Company’s consolidated statements of operations for the periods presented.
3. Property and Equipment
Property and equipment consist of the following (in thousands):
|
June 30,
|
|
|
December 31,
|
|
|
2021
|
|
|
2020
|
|
Machinery and equipment
|
$
|
1,661
|
|
|
$
|
1,661
|
|
Computer equipment and software
|
|
243
|
|
|
|
241
|
|
Office equipment
|
|
230
|
|
|
|
230
|
|
Leasehold improvements
|
|
1,303
|
|
|
|
1,303
|
|
Construction in progress
|
|
1
|
|
|
|
3
|
|
|
|
3,438
|
|
|
|
3,438
|
|
Less: accumulated depreciation and amortization
|
|
(2,987
|
)
|
|
|
(2,904
|
)
|
Property and equipment, net
|
$
|
451
|
|
|
$
|
534
|
|
Depreciation and amortization expense for the three months ended June 30, 2021 and 2020 was $41,000 and $43,000, respectively. Depreciation and amortization expense for the six months ended June 30, 2021 and 2020 was $83,000.
4. Intangible Assets
Intangible Assets consists of the following (in thousands):
|
June 30,
|
|
|
December 31,
|
|
|
2021
|
|
|
2020
|
|
Patents
|
$
|
2,299
|
|
|
$
|
2,286
|
|
Less: accumulated amortization
|
|
(1,146
|
)
|
|
|
(1,099
|
)
|
|
|
1,153
|
|
|
|
1,187
|
|
Indefinite life logos and trademarks
|
|
75
|
|
|
|
75
|
|
Intangible assets, net
|
$
|
1,228
|
|
|
$
|
1,262
|
|
Amortization expense for the three months ended June 30, 2021 and 2020 was $23,000. Amortization expense for the six months ended June 30, 2021 and 2020 was $47,000 and $45,000, respectively.
14
5. Paycheck Protection Program Loan
In May 2020, the Company received a loan of $654,000 from its lender under the Paycheck Protection Program (“First Draw Loan”). The Paycheck Protection Program (“PPP”), as amended, was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (“SBA”). The First Draw Loan has a two-year term and bears interest at a rate of 1% per annum. Principal and interest payments are deferred for ten months following the loan forgiveness period, which is defined as the 24-week period following the loan origination date, at which time the loan balance is payable in monthly installments unless the Company applies for, and receives, forgiveness in accordance with the CARES Act and the terms of the loan executed by the Company and its lender. As required by the CARES Act, the Company used the proceeds from the PPP Loan for payroll, healthcare benefits, rent and other qualifying expenses.
In March 2021, the Company received a loan of $474,000 from its lender under the PPP (“Second Draw Loan”). The Second Draw Loan has a five-year term and bears interest at a rate of 1% per annum. Principal and interest payments are deferred until August 2022, at which time the loan balance is payable in monthly installments unless the Company applies for, and receives, forgiveness in accordance with the CARES Act and the terms of the loan executed by the Company and its lender. The Second Draw Loan may be used to help fund payroll, healthcare benefits, rent, worker protection costs related to COVID-19, certain supplier costs and other qualifying expenses.
In June 2021, the Company applied for and received forgiveness of its First Draw Loan in whole from the SBA and its lender. The amount of forgiveness totaled $661,000, which consisted of unpaid principal and accrued interest. The Company recorded the forgiveness of debt as a gain in other income (expense), net on the accompanying condensed consolidated statements of operations. In August 2021, the Company applied for and received forgiveness of its Second Draw Loan in whole from the SBA and its lender. Refer to Note 10 – Subsequent Events for further discussion.
As of June 30, 2021, $476,000 of outstanding principal and accrued interest of the Second Loan Draw was classified as non-current on the accompanying condensed consolidated balance sheets based on the contractual payment schedule of the loan.
6. Convertible Preferred Stock and Stockholders’ 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.
During the three months ended June 30, 2021, holders of all remaining shares of the Company’s Series I-1 preferred stock converted 814 shares of issued and outstanding Series I-1 preferred stock into 465,300 shares of common stock of the Company. On June 25, 2021, the Company filed a Certificate of Elimination for the Series I-1 convertible preferred stock with the Secretary of State of the State of Delaware. The Certificate of Elimination amended the provisions of the Certificate of Incorporation of the Company to eliminate the powers, designations, preferences, privileges and other rights of the Series I-1 preferred stock.
The authorized, issued and outstanding shares of non-redeemable convertible preferred stock as of June 30, 2021 consist of the following:
|
Shares
|
|
|
Shares Issued
|
|
|
Liquidation
|
|
|
Carrying
|
|
|
Authorized
|
|
|
and Outstanding
|
|
|
Preference
|
|
|
Value
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
Series B
|
|
5,000,000
|
|
|
|
250,000
|
|
|
$
|
449
|
|
|
$
|
—
|
|
Series G
|
|
5,000,000
|
|
|
|
5,000,000
|
|
|
|
5,000
|
|
|
|
5
|
|
Series I-2
|
|
4,310
|
|
|
|
4,310
|
|
|
|
4,310
|
|
|
|
—
|
|
Total
|
|
10,004,310
|
|
|
|
5,254,310
|
|
|
$
|
9,759
|
|
|
$
|
5
|
|
15
The authorized, issued and outstanding shares of non-redeemable convertible preferred stock as of December 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
|
|
|
$
|
441
|
|
|
$
|
—
|
|
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
|
|
|
$
|
10,565
|
|
|
$
|
5
|
|
Common Stock
As of June 30, 2021, 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. The Company has designated 50 shares of Series D redeemable convertible preferred stock and a total of 10,004,310 shares of Series B, Series G and Series I-2 non-redeemable convertible preferred stock.
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 connection with financing arrangements. In April 2020, the common stock warrants issued in October 2014 expired unexercised. The common stock warrants issued in March 2016 expired unexercised in March 2021. As of December 31, 2020, 3,948,569 common stock warrants issued in March 2016 were outstanding.
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. In June 2020, the Company amended the 2010 Plan to extend the term of the 2010 Plan until March 2030. No other material provisions were amended.
16
The fair value of stock options granted is estimated at the date of grant using the Black-Scholes option valuation model. All options are amortized over the requisite service periods. The weighted-average assumptions used in the Black-Scholes option valuation model to determine the fair value of stock options granted for the three months and six ended June 30, 2021 and 2020 were as follows:
7. Related Party Transactions
In 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 2023) and provided for a 2% increase in monthly rent. For the six months ended June 30, 2021 and 2020, the Company recorded $86,000 and $84,000, respectively, in rent expense that was related to the facility lease arrangement with related parties.
Between March 6, 2018 and December 17, 2019, to obtain funding for working capital purposes, the Company borrowed a total of $2.3 million from Dr. Semechkin and issued an unsecured, non-convertible promissory note in the principal amount of $2.3 million (the “Note”) to Dr. Semechkin. The outstanding principal amount under the Note accrued interest at a rate of 4.5% per annum. The outstanding principal and accrued interest on the Note was due and payable on January 15, 2021 and could be pre-paid without penalty at any time.
On January 15, 2021, the Company and Dr. Semechkin modified the Note to extend the maturity date of the Note to January 15, 2022. No other terms of the Note were modified as a result of the extension.
On March 5, 2021, to obtain additional funding for working capital purposes, the Company further modified the Note and issued an unsecured, non-convertible promissory note (the “New Note”) in the amount of $2.650 million to Dr. Semechkin. In exchange, Dr. Semechkin surrendered the Note and provided additional funding in the amount of $350,000 to the Company. The outstanding principal amount under the New Note accrues interest at a rate of 4.5% per annum. The outstanding principal and accrued interest on the New Note is due and payable on January 15, 2022 and may be pre-paid by the Company without penalty at any time.
8. 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 June 30, 2021, total right-of-use assets and operating lease liabilities were approximately $733,000 and $1.0 million, respectively. All operating lease expense is recognized on a straight-line basis over the lease term. For the three months ended June 30, 2021 and 2020 lease expense totaled $118,000 and $119,000, respectively. For the six months ended June 30, 2021 and 2020 lease expense totaled $236,000 and $237,000, respectively. As of June 30, 2021, the Company had no finance leases.
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. The license agreement with Astellas Pharma may be terminated by the Company at any time with a 30-day notice.
9. Segments
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; LSC – anti-aging 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 and six months ended June 30, 2021 and 2020 by market segment were as follows (in thousands):
10. Subsequent Events
In August 2021, the Company applied for and received forgiveness of its Second Draw Loan. The amount of forgiveness totaled $476,000, which consisted of unpaid principal and accrued interest. The Company will record the forgiveness of debt as a gain in other income (expense), net on its condensed consolidated statements of operations for the three and nine months ending September 30, 2021.