Price | 0.93 | EPS | -0 | |
Shares | 8 | P/E | -5 | |
MCap | 7 | P/FCF | -8 | |
Net Debt | -0 | EBIT | -1 | |
TEV | 7 | TEV/EBIT | -4 | TTM 2019-09-30, in MM, except price, ratios |
10-Q | 2020-09-30 | Filed 2020-11-12 |
10-Q | 2020-06-30 | Filed 2020-08-12 |
10-Q | 2020-03-31 | Filed 2020-06-19 |
10-K | 2019-12-31 | Filed 2020-06-01 |
10-Q | 2019-09-30 | Filed 2019-11-12 |
10-Q | 2019-06-30 | Filed 2019-08-27 |
10-Q | 2019-03-31 | Filed 2019-05-15 |
10-K | 2018-12-31 | Filed 2019-04-15 |
10-Q | 2018-09-30 | Filed 2018-11-14 |
10-Q | 2018-06-30 | Filed 2018-08-14 |
10-Q | 2018-03-31 | Filed 2018-05-21 |
10-K | 2017-12-31 | Filed 2018-04-09 |
10-Q | 2017-09-30 | Filed 2017-11-14 |
10-Q | 2017-06-30 | Filed 2017-08-11 |
10-Q | 2017-03-31 | Filed 2017-05-15 |
10-K | 2016-12-31 | Filed 2017-03-31 |
10-Q | 2016-09-30 | Filed 2016-11-14 |
10-Q | 2016-06-30 | Filed 2016-08-15 |
10-Q | 2016-03-31 | Filed 2016-05-16 |
10-K | 2015-12-31 | Filed 2016-03-30 |
10-Q | 2015-09-30 | Filed 2015-11-13 |
10-Q | 2015-06-30 | Filed 2015-08-13 |
10-Q | 2015-03-31 | Filed 2015-05-11 |
10-K | 2014-12-31 | Filed 2015-03-30 |
10-Q | 2014-09-30 | Filed 2014-11-13 |
10-Q | 2014-06-30 | Filed 2014-08-08 |
10-Q | 2014-03-31 | Filed 2014-05-13 |
10-K | 2013-12-31 | Filed 2014-03-17 |
10-Q | 2013-09-30 | Filed 2013-11-13 |
10-Q | 2013-06-30 | Filed 2013-08-08 |
10-Q | 2013-03-31 | Filed 2013-05-14 |
10-K | 2012-12-31 | Filed 2013-03-26 |
10-Q | 2012-06-30 | Filed 2012-08-08 |
10-Q | 2012-03-31 | Filed 2012-05-14 |
10-K | 2011-12-31 | Filed 2012-03-16 |
10-Q | 2011-09-30 | Filed 2011-11-14 |
10-Q | 2011-06-30 | Filed 2011-08-15 |
10-Q | 2011-03-31 | Filed 2011-06-23 |
10-K | 2010-12-31 | Filed 2011-03-24 |
10-Q | 2010-09-30 | Filed 2010-11-08 |
10-Q | 2010-06-30 | Filed 2010-08-06 |
10-Q | 2010-03-31 | Filed 2010-05-14 |
10-K | 2009-12-31 | Filed 2010-03-23 |
8-K | 2020-06-23 | |
8-K | 2020-05-13 | |
8-K | 2020-04-28 | |
8-K | 2020-03-30 | |
8-K | 2019-12-17 | |
8-K | 2019-07-25 | |
8-K | 2019-06-03 | |
8-K | 2019-04-17 | |
8-K | 2019-01-21 | |
8-K | 2018-11-12 | |
8-K | 2018-09-27 | |
8-K | 2018-06-21 | |
8-K | 2018-05-31 | |
8-K | 2018-05-14 | |
8-K | 2018-03-06 | |
8-K | 2018-02-13 |
Part I - Financial Information |
Item 1. Condensed Consolidated Financial Statements (Unaudited) |
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations |
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
Item 4. Controls and Procedures |
Part II - Other Information |
Item 1. Legal Proceedings |
Item 1A. Risk Factors |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
Item 3. Defaults Upon Senior Securities |
Item 4. Mine Safety Disclosures |
Item 5. Other Information |
Item 6. Exhibits |
EX-31.1 | isco-ex311_7.htm |
EX-31.2 | isco-ex312_10.htm |
EX-32.1 | isco-ex321_9.htm |
EX-32.2 | isco-ex322_11.htm |
Balance Sheet | Income Statement | Cash Flow |
---|---|---|
Assets, Equity
|
Rev, G Profit, Net Income
|
Ops, Inv, Fin
|
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
or
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-51891
INTERNATIONAL STEM CELL CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware |
| 20-4494098 |
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
5950 Priestly Drive Carlsbad, CA |
| 92008 |
(Address of Principal Executive Offices) |
| (Zip Code) |
(760) 940-6383
(Registrant’s telephone number)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
None |
| None |
| None |
Indicated by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
| ☐ |
| Accelerated filer |
| ☐ |
|
|
|
| |||
Non-accelerated filer |
| ☒ |
| Smaller reporting company |
| ☒ |
|
|
|
|
|
|
|
Emerging growth company |
| ☐ |
|
|
|
|
If an emerging growth company, indicate by check mark if the registrant elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
As of November 10, 2020, the Registrant had 7,539,089 shares of Common Stock outstanding.
International Stem Cell Corporation and Subsidiaries
Form 10-Q
Table of Contents
|
| Page Numbers | |
|
| ||
|
|
| |
Item 1. |
| 3 | |
| Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019 (Unaudited) |
| 3 |
|
| 4 | |
|
| 5 | |
|
| 6 | |
| Notes to Condensed Consolidated Financial Statements (Unaudited) |
| 7 |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
| 22 |
Item 3. |
| 29 | |
Item 4. |
| 30 | |
|
|
| |
|
|
| |
Item 1. |
| 31 | |
Item 1A. |
| 31 | |
Item 2. |
| 31 | |
Item 3. |
| 31 | |
Item 4. |
| 31 | |
Item 5. |
| 31 | |
Item 6. |
| 32 | |
|
| 34 |
2
Item 1. Condensed Consolidated Financial Statements (Unaudited)
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except share and par value data)
(Unaudited)
| September 30, |
|
| December 31, |
| ||
| 2020 |
|
| 2019 |
| ||
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash | $ | 1,026 |
|
| $ | 484 |
|
Accounts receivable, net |
| 509 |
|
|
| 1,515 |
|
Inventory, net |
| 937 |
|
|
| 1,246 |
|
Prepaid expenses and other current assets |
| 159 |
|
|
| 207 |
|
Total current assets |
| 2,631 |
|
|
| 3,452 |
|
Non-current inventory |
| 383 |
|
|
| 358 |
|
Property and equipment, net |
| 568 |
|
|
| 668 |
|
Intangible assets, net |
| 1,266 |
|
|
| 1,335 |
|
Right-of-use assets |
| 939 |
|
|
| 717 |
|
Deposits and other assets |
| 64 |
|
|
| 90 |
|
Total assets | $ | 5,851 |
|
| $ | 6,620 |
|
Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable | $ | 391 |
|
| $ | 654 |
|
Accrued liabilities |
| 374 |
|
|
| 642 |
|
Operating lease liabilities, current |
| 332 |
|
|
| 367 |
|
Advances |
| 250 |
|
|
| 250 |
|
Related party note payable |
| 2,448 |
|
|
| — |
|
Paycheck Protection Program loan, current |
| 57 |
|
|
| — |
|
Total current liabilities |
| 3,852 |
|
|
| 1,913 |
|
Related party note payable |
| — |
|
|
| 2,370 |
|
Paycheck Protection Program loan, net of current portion |
| 599 |
|
|
| — |
|
Fair value of warrant liability |
| 40 |
|
|
| 207 |
|
Operating lease liabilities, net of current portion |
| 936 |
|
|
| 718 |
|
Total liabilities |
| 5,427 |
|
|
| 5,208 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
|
Series D redeemable convertible preferred stock, $0.001 par value; 50 shares authorized; 43 shares issued and outstanding; liquidation preference of $4,300 at September 30, 2020 and December 31, 2019 |
| 4,300 |
|
|
| 4,300 |
|
Stockholders' Deficit: |
|
|
|
|
|
|
|
Non-redeemable convertible preferred stock, $0.001 par value; 10,006,310 shares authorized; 5,255,124 shares issued and outstanding; liquidation preference of $10,562 and $10,550 at September 30, 2020 and December 31, 2019, respectively |
| 5 |
|
|
| 5 |
|
Common stock, $0.001 par value; 120,000,000 shares authorized; 7,539,089 shares issued and outstanding at September 30, 2020 and December 31, 2019 |
| 8 |
|
|
| 8 |
|
Additional paid-in capital |
| 104,505 |
|
|
| 103,490 |
|
Accumulated deficit |
| (108,394 | ) |
|
| (106,391 | ) |
Total stockholders' deficit |
| (3,876 | ) |
|
| (2,888 | ) |
Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ | 5,851 |
|
| $ | 6,620 |
|
See accompanying notes to the unaudited condensed consolidated financial statements.
3
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
|
| Three Months Ended September 30, |
|
| Nine Months Ended September 30, |
| ||||||||||
|
| 2020 |
|
| 2019 |
|
| 2020 |
|
| 2019 |
| ||||
Product sales |
| $ | 1,481 |
|
| $ | 2,096 |
|
| $ | 5,652 |
|
| $ | 6,635 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
| 563 |
|
|
| 799 |
|
|
| 2,138 |
|
|
| 2,497 |
|
Research and development |
|
| 255 |
|
|
| 79 |
|
|
| 758 |
|
|
| 1,001 |
|
Selling and marketing |
|
| 403 |
|
|
| 626 |
|
|
| 1,347 |
|
|
| 2,057 |
|
General and administrative |
|
| 1,058 |
|
|
| 1,405 |
|
|
| 3,494 |
|
|
| 4,324 |
|
Total operating expenses |
|
| 2,279 |
|
|
| 2,909 |
|
|
| 7,737 |
|
|
| 9,879 |
|
Loss from operations |
|
| (798 | ) |
|
| (813 | ) |
|
| (2,085 | ) |
|
| (3,244 | ) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
| 282 |
|
|
| 837 |
|
|
| 167 |
|
|
| 1,745 |
|
Interest expense |
|
| (28 | ) |
|
| (21 | ) |
|
| (85 | ) |
|
| (55 | ) |
Miscellaneous income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| 2 |
|
Total other income (expense), net |
|
| 254 |
|
|
| 816 |
|
|
| 82 |
|
|
| 1,692 |
|
Net income (loss) |
| $ | (544 | ) |
| $ | 3 |
|
| $ | (2,003 | ) |
| $ | (1,552 | ) |
Net income (loss) per common share, basic and diluted |
| $ | (0.07 | ) |
| $ | 0.00 |
|
| $ | (0.27 | ) |
| $ | (0.21 | ) |
Weighted-average common shares used to compute net income (loss) per share, basic and diluted |
|
| 7,539 |
|
|
| 7,546 |
|
|
| 7,539 |
|
|
| 7,502 |
|
See accompanying notes to the unaudited condensed consolidated financial statements.
4
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Changes in Redeemable Convertible
Preferred Stock and Stockholders’ Deficit
(In thousands)
(Unaudited)
| Three and Nine Months Ended September 30, 2020 |
| ||||||||||||||||||||||||||||||||||
| Series D Redeemable |
|
|
| Non-redeemable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
| Convertible |
|
|
| Convertible |
|
| Common |
|
| Additional |
|
|
|
|
|
| Total |
| |||||||||||||||||
| Preferred Stock |
|
|
| Preferred Stock |
|
| Stock |
|
| Paid-in |
|
| Accumulated |
|
| Stockholders' |
| ||||||||||||||||||
| Shares |
|
| Amount |
|
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Capital |
|
| Deficit |
|
| Deficit |
| |||||||||
Balance at December 31, 2019 |
| — |
|
| $ | 4,300 |
|
|
|
| 5,255 |
|
| $ | 5 |
|
|
| 7,539 |
|
| $ | 8 |
|
| $ | 103,490 |
|
| $ | (106,391 | ) |
| $ | (2,888 | ) |
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 418 |
|
|
| — |
|
|
| 418 |
|
Net loss |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (373 | ) |
|
| (373 | ) |
Balance at March 31, 2020 |
| — |
|
|
| 4,300 |
|
|
|
| 5,255 |
|
|
| 5 |
|
|
| 7,539 |
|
|
| 8 |
|
|
| 103,908 |
|
|
| (106,764 | ) |
|
| (2,843 | ) |
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 324 |
|
|
| — |
|
|
| 324 |
|
Net loss |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (1,086 | ) |
|
| (1,086 | ) |
Balance at June 30, 2020 |
| — |
|
|
| 4,300 |
|
|
|
| 5,255 |
|
|
| 5 |
|
|
| 7,539 |
|
|
| 8 |
|
|
| 104,232 |
|
|
| (107,850 | ) |
|
| (3,605 | ) |
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 273 |
|
|
| — |
|
|
| 273 |
|
Net loss |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (544 | ) |
|
| (544 | ) |
Balance at September 30, 2020 |
| — |
|
| $ | 4,300 |
|
|
|
| 5,255 |
|
| $ | 5 |
|
|
| 7,539 |
|
| $ | 8 |
|
| $ | 104,505 |
|
| $ | (108,394 | ) |
| $ | (3,876 | ) |
| Three and Nine Months Ended September 30, 2019 |
| ||||||||||||||||||||||||||||||||||
| Series D Redeemable |
|
|
| Non-redeemable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
| Convertible |
|
|
| Convertible |
|
| Common |
|
| Additional |
|
|
|
|
|
| Total |
| |||||||||||||||||
| Preferred Stock |
|
|
| Preferred Stock |
|
| Stock |
|
| Paid-in |
|
| Accumulated |
|
| Stockholders' |
| ||||||||||||||||||
| Shares |
|
| Amount |
|
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Capital |
|
| Deficit |
|
| Deficit |
| |||||||||
Balance at December 31, 2018 |
| — |
|
| $ | — |
|
|
|
| 5,255 |
|
| $ | 5 |
|
|
| 6,934 |
|
| $ | 7 |
|
| $ | 109,188 |
|
| $ | (106,663 | ) |
| $ | 2,537 |
|
Out of period correction |
| — |
|
|
| 4,300 |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (8,837 | ) |
|
| 4,537 |
|
|
| (4,300 | ) |
Conversion of bridge loan from a related party to common stock |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| 599 |
|
|
| 1 |
|
|
| 1,048 |
|
|
| — |
|
|
| 1,049 |
|
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 506 |
|
|
| — |
|
|
| 506 |
|
Net loss |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (906 | ) |
|
| (906 | ) |
Balance at March 31, 2019, as revised |
| — |
|
|
| 4,300 |
|
|
|
| 5,255 |
|
|
| 5 |
|
|
| 7,533 |
|
|
| 8 |
|
|
| 101,905 |
|
|
| (103,032 | ) |
|
| (1,114 | ) |
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 571 |
|
|
| — |
|
|
| 571 |
|
Net loss |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (648 | ) |
|
| (648 | ) |
Balance at June 30, 2019 |
| — |
|
|
| 4,300 |
|
|
|
| 5,255 |
|
|
| 5 |
|
|
| 7,533 |
|
|
| 8 |
|
|
| 102,476 |
|
|
| (103,680 | ) |
|
| (1,191 | ) |
Stock-based compensation |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 512 |
|
|
| — |
|
|
| 512 |
|
Net income |
| — |
|
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 3 |
|
|
| 3 |
|
Balance at September 30, 2019 |
| — |
|
| $ | 4,300 |
|
|
|
| 5,255 |
|
| $ | 5 |
|
|
| 7,533 |
|
| $ | 8 |
|
| $ | 102,988 |
|
| $ | (103,677 | ) |
| $ | (676 | ) |
See accompanying notes to the unaudited condensed consolidated financial statements.
5
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
| Nine Months Ended September 30, |
| |||||
| 2020 |
|
| 2019 |
| ||
Cash flows from operating activities |
|
|
|
|
|
|
|
Net loss | $ | (2,003 | ) |
| $ | (1,552 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
| 192 |
|
|
| 203 |
|
Operating lease expense |
| 199 |
|
|
| 222 |
|
Stock-based compensation |
| 1,015 |
|
|
| 1,589 |
|
Change in fair value of warrant liability |
| (167 | ) |
|
| (1,745 | ) |
Allowance for inventory obsolescence |
| 36 |
|
|
| 89 |
|
Interest expense on related party note payable |
| 78 |
|
|
| 51 |
|
Impairment of intangible assets |
| 65 |
|
|
| 145 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
| 1,006 |
|
|
| (429 | ) |
Inventory |
| 248 |
|
|
| 63 |
|
Prepaid expenses and other current assets |
| 48 |
|
|
| 236 |
|
Deposits and other assets |
| 26 |
|
|
| (12 | ) |
Accounts payable |
| (263 | ) |
|
| 264 |
|
Accrued liabilities |
| (272 | ) |
|
| 84 |
|
Operating lease liabilities |
| (238 | ) |
|
| (224 | ) |
Net cash used in operating activities |
| (30 | ) |
|
| (1,016 | ) |
Cash flows from investing activities |
|
|
|
|
|
|
|
Purchases of property and equipment |
| (24 | ) |
|
| (146 | ) |
Payments for patent licenses |
| (58 | ) |
|
| (250 | ) |
Net cash used in investing activities |
| (82 | ) |
|
| (396 | ) |
Cash flows from financing activities |
|
|
|
|
|
|
|
Proceeds from Paycheck Protection Program loan |
| 654 |
|
|
| — |
|
Proceeds from note payable from a related party |
| — |
|
|
| 800 |
|
Net cash provided by financing activities |
| 654 |
|
|
| 800 |
|
Net increase (decrease) in cash |
| 542 |
|
|
| (612 | ) |
Cash, beginning of period |
| 484 |
|
|
| 1,075 |
|
Cash, end of period | $ | 1,026 |
|
| $ | 463 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
Cash paid for interest | $ | 4 |
|
| $ | 4 |
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
Right-of-use asset obtained in exchange for operating lease liability | $ | 421 |
|
| $ | — |
|
Patent license costs included in accrued liabilities | $ | 6 |
|
| $ | — |
|
Conversion of bridge loan from a related party to common stock | $ | — |
|
| $ | 1,049 |
|
See accompanying notes to the unaudited condensed consolidated financial statements.
6
International Stem Cell Corporation and Subsidiaries
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
In January 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus (“COVID-19”) originating in Wuhan, China and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified COVID-19 as a pandemic, based on its rapid increase in exposure globally.
The Company is uncertain as to the full magnitude of effects that the COVID-19 pandemic will have on its financial condition, liquidity, and future results of operations. As of the date of this report, the Company is currently experiencing a year-over-year decline in the volume of product sales and in response has reduced its capital spending and, where possible, operating expenses while facilitating ongoing safe and reliable operations. In addition, management is actively monitoring the impact of COVID-19 on the Company’s operations, workforce, suppliers, customers and industry. The full impact that COVID-19 will have on the Company’s consolidated financial statements throughout and beyond 2020 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. Therefore, the Company cannot reasonably predict the extent to which its consolidated financial statements will be impacted.
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, 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 Company had an accumulated deficit of approximately $108.4 million as of September 30, 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 the Company obtains additional
7
financing, the Company does not have sufficient cash on hand to sustain operations at least through one year after the issuance date of these 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.
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 the exercise of outstanding warrants, 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 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 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 extreme 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 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. 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.
8
For the three and nine months ended September 30, 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’ deficit. Refer to Note 6 – Convertible Preferred Stock and Stockholders’ Deficit for further discussion; |
| • | 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 income (loss), stockholders’ 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.
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. LCT’s cell inventory does not have a shelf life when frozen. 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. 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. Such reserves are not reduced until the product is sold. If the Company is able to sell such inventory, any related reserves would be reserved 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 $12,000 as of September 30, 2020 and December 31, 2019.
9
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 September 30, 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 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 September 30, 2020 |
|
| Nine Months Ended September 30, 2020 |
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| Total |
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| % of Total |
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|
| Total |
|
| % of Total |
| ||||
| Domestic |
|
| International |
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| Revenues |
|
| Revenues |
|
| Domestic |
|
| International |
|
| Revenues |
|
| Revenues |
| ||||||||
Biomedical products |
|
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