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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 March 31, 2021
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 No.: 001-35527
EMMAUS LIFE SCIENCES, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
|
87-0419387 |
|
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
21250 Hawthorne Boulevard, Suite 800, Torrance, California |
|
90503 |
(Address of principal executive offices) |
|
(Zip code) |
(310) 214-0065
(Registrant’s telephone number, including area code)
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 |
|
|
Indicate 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, smaller reporting company, or an emerging growth company. See the definition 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 has 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 ☒
The registrant had 49,311,864 shares of common stock, par value $0.001 per share, outstanding as of August 24, 2021.
EMMAUS LIFE SCIENCES, INC.
For the Quarterly Period Ended March 31, 2021
INDEX
Item 1. Financial Statements
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
|
|
As of |
|
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,759 |
|
|
$ |
2,487 |
|
Accounts receivable, net |
|
|
2,372 |
|
|
|
198 |
|
Inventories, net |
|
|
6,740 |
|
|
|
7,087 |
|
Prepaid expenses and other current assets |
|
|
1,270 |
|
|
|
1,485 |
|
Total current assets |
|
|
14,141 |
|
|
|
11,257 |
|
Property and equipment, net |
|
|
109 |
|
|
|
120 |
|
Equity method investment |
|
|
15,790 |
|
|
|
15,925 |
|
Right of use assets |
|
|
3,947 |
|
|
|
4,072 |
|
Investment in convertible bond |
|
|
27,943 |
|
|
|
27,866 |
|
Other assets |
|
|
293 |
|
|
|
296 |
|
Total assets |
|
$ |
62,223 |
|
|
$ |
59,536 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
5,991 |
|
|
$ |
7,460 |
|
Operating lease liabilities, current portion |
|
|
661 |
|
|
|
1,143 |
|
Conversion feature derivative, notes payable |
|
|
7,900 |
|
|
|
— |
|
Other current liabilities |
|
|
2,739 |
|
|
|
2,706 |
|
Revolving line of credit from related party |
|
|
800 |
|
|
|
800 |
|
Warrant derivative liabilities |
|
|
1,600 |
|
|
|
1,071 |
|
Notes payable, current portion |
|
|
4,616 |
|
|
|
4,588 |
|
Notes payable to related parties |
|
|
100 |
|
|
|
134 |
|
Convertible debentures, net of discount |
|
|
— |
|
|
|
5,480 |
|
Total current liabilities |
|
|
24,407 |
|
|
|
23,382 |
|
Operating lease liabilities, less current portion |
|
|
3,824 |
|
|
|
3,470 |
|
Other long-term liabilities |
|
|
34,473 |
|
|
|
34,470 |
|
Notes payable, less current portion |
|
|
89 |
|
|
|
222 |
|
Convertible notes payable |
|
|
12,106 |
|
|
|
3,150 |
|
Total liabilities |
|
|
74,899 |
|
|
|
64,694 |
|
STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
|
Preferred stock, par value $0.001 per share, 15,000,000 shares authorized, none issued or outstanding |
|
|
— |
|
|
|
— |
|
Common stock, par value $0.001 per share, 250,000,000 shares authorized, 49,311,864 and 48,987,189 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively |
|
|
49 |
|
|
|
49 |
|
Additional paid-in capital |
|
|
219,650 |
|
|
|
218,728 |
|
Accumulated other comprehensive income |
|
|
1,367 |
|
|
|
1,144 |
|
Accumulated deficit |
|
|
(233,742 |
) |
|
|
(225,079 |
) |
Total stockholders’ deficit |
|
|
(12,676 |
) |
|
|
(5,158 |
) |
Total liabilities & stockholders’ deficit |
|
$ |
62,223 |
|
|
$ |
59,536 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share amounts)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
REVENUES, NET |
|
$ |
5,335 |
|
|
$ |
6,954 |
|
COST OF GOODS SOLD |
|
|
436 |
|
|
|
478 |
|
GROSS PROFIT |
|
|
4,899 |
|
|
|
6,476 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,809 |
|
|
|
617 |
|
Selling |
|
|
1,283 |
|
|
|
1,068 |
|
General and administrative |
|
|
3,422 |
|
|
|
3,657 |
|
Total operating expenses |
|
|
6,514 |
|
|
|
5,342 |
|
INCOME (LOSS) FROM OPERATIONS |
|
|
(1,615 |
) |
|
|
1,134 |
|
OTHER INCOME (EXPENSE) |
|
|
|
|
|
|
|
|
Loss on debt extinguishment |
|
|
(1,172 |
) |
|
|
— |
|
Change in fair value of warrant derivative liabilities |
|
|
(529 |
) |
|
|
25 |
|
Change in fair value of conversion feature derivative, notes payable |
|
|
(2,338 |
) |
|
|
(29 |
) |
Net gain on investment in marketable securities |
|
|
— |
|
|
|
6,839 |
|
Net losses on equity method investment |
|
|
(754 |
) |
|
|
(407 |
) |
Foreign exchange gain (loss) |
|
|
(1,132 |
) |
|
|
1 |
|
Interest and other income |
|
|
190 |
|
|
|
32 |
|
Interest expense |
|
|
(1,054 |
) |
|
|
(1,800 |
) |
Total other income (expense) |
|
|
(6,789 |
) |
|
|
4,661 |
|
INCOME (LOSS) BEFORE INCOME TAXES |
|
|
(8,404 |
) |
|
|
5,795 |
|
INCOME TAXES |
|
|
18 |
|
|
|
286 |
|
NET INCOME (LOSS) |
|
|
(8,422 |
) |
|
|
5,509 |
|
|
|
|
|
|
|
|
|
|
COMPONENTS OF OTHER COMPREHENSIVE INCOME (LOSS) |
|
|
|
|
|
|
|
|
Unrealized gain on debt securities available for sale (net of tax) |
|
|
58 |
|
|
|
— |
|
Foreign currency translation adjustments |
|
|
165 |
|
|
|
61 |
|
Other comprehensive income (loss) |
|
|
223 |
|
|
|
61 |
|
COMPREHENSIVE INCOME (LOSS) |
|
$ |
(8,199 |
) |
|
$ |
5,570 |
|
EARNINGS (NET LOSS) PER COMMON SHARE - BASIC and DILUTED |
|
$ |
(0.17 |
) |
|
$ |
0.11 |
|
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING |
|
|
49,073,769 |
|
|
|
48,624,469 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
(In thousands, except share and per share amounts)
(Unaudited)
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders' |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Deficit |
|
|
Deficit |
|
Balance at January 1,2021 |
|
48,987,189 |
|
|
$ |
49 |
|
|
$ |
218,728 |
|
|
$ |
1,144 |
|
|
$ |
(225,079 |
) |
|
$ |
(5,158 |
) |
Fair value of warrants including down-round protection adjustments |
|
— |
|
|
|
— |
|
|
|
241 |
|
|
|
— |
|
|
|
(241 |
) |
|
|
— |
|
Common stock issued for services |
|
324,675 |
|
|
|
— |
|
|
|
500 |
|
|
|
— |
|
|
|
— |
|
|
|
500 |
|
Share-based compensation |
|
— |
|
|
|
— |
|
|
|
181 |
|
|
|
— |
|
|
|
— |
|
|
|
181 |
|
Unrealized gain on debt securities available for sale (net of tax) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
58 |
|
|
|
— |
|
|
|
58 |
|
Foreign currency translation effect |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
165 |
|
|
|
— |
|
|
|
165 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(8,422 |
) |
|
|
(8,422 |
) |
Balance, March 31, 2021 |
|
49,311,864 |
|
|
$ |
49 |
|
|
$ |
219,650 |
|
|
$ |
1,367 |
|
|
$ |
(233,742 |
) |
|
$ |
(12,676 |
) |
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders' |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Deficit |
|
Balance at January 1, 2020 |
|
48,471,446 |
|
|
$ |
48 |
|
|
$ |
215,207 |
|
|
$ |
(79 |
) |
|
$ |
(226,229 |
) |
|
$ |
(11,053 |
) |
Fair value of warrants including down-round protection adjustments |
|
— |
|
|
|
— |
|
|
|
600 |
|
|
|
— |
|
|
|
(200 |
) |
|
|
400 |
|
Common stock issued for cash (net of issuance cost) |
|
515,743 |
|
|
|
1 |
|
|
|
141 |
|
|
|
— |
|
|
|
— |
|
|
|
142 |
|
Share-based compensation |
|
— |
|
|
|
— |
|
|
|
209 |
|
|
|
— |
|
|
|
— |
|
|
|
209 |
|
Foreign currency translation effect |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
61 |
|
|
|
— |
|
|
|
61 |
|
Net income |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,509 |
|
|
|
5,509 |
|
Balance, March 31, 2020 |
|
48,987,189 |
|
|
$ |
49 |
|
|
$ |
216,157 |
|
|
$ |
(18 |
) |
|
$ |
(220,920 |
) |
|
$ |
(4,732 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
2020 |
|
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(8,422 |
) |
|
$ |
5,509 |
|
Adjustments to reconcile net loss to net cash flows (used in) provided by operating activities |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
15 |
|
|
|
15 |
|
Inventory reserve |
|
|
162 |
|
|
|
— |
|
Amortization of discount of notes payable and convertible notes payable |
|
|
669 |
|
|
|
1,302 |
|
Foreign exchange adjustments |
|
|
1,180 |
|
|
|
(50 |
) |
Tax benefit recognized on unrealized gain on debt securities |
|
|
(19 |
) |
|
|
— |
|
Net gain on investment in marketable securities |
|
|
— |
|
|
|
(6,839 |
) |
Loss on equity method investment |
|
|
754 |
|
|
|
407 |
|
Loss on debt extinguishment |
|
|
1,172 |
|
|
|
— |
|
Gain on disposal of property and equipment |
|
|
(1 |
) |
|
|
— |
|
Share-based compensation |
|
|
181 |
|
|
|
209 |
|
Shares issued for services |
|
|
500 |
|
|
|
— |
|
Change in fair value of warrant derivative liabilities |
|
|
529 |
|
|
|
(25 |
) |
Change in fair value of conversion feature derivative, notes payable |
|
|
2,338 |
|
|
|
29 |
|
Net changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(2,176 |
) |
|
|
249 |
|
Inventories |
|
|
180 |
|
|
|
(285 |
) |
Prepaid expenses and other current assets |
|
|
158 |
|
|
|
260 |
|
Other non-current assets |
|
|
122 |
|
|
|
133 |
|
Income tax receivable and payable |
|
|
33 |
|
|
|
286 |
|
Accounts payable and accrued expenses |
|
|
(1,295 |
) |
|
|
2,449 |
|
Other current liabilities |
|
|
42 |
|
|
|
(5,025 |
) |
Other long-term liabilities |
|
|
(123 |
) |
|
|
3,184 |
|
Net cash flows (used in) provided by operating activities |
|
|
(4,001 |
) |
|
|
1,808 |
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
|
(3 |
) |
Loan to equity method investee |
|
|
(1,769 |
) |
|
|
— |
|
Net cash flows used in investing activities |
|
|
(1,769 |
) |
|
|
(3 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Proceeds from notes payable issued, net of issuance cost and discount |
|
|
700 |
|
|
|
— |
|
Proceeds from convertible notes payable issued, net of issuance cost and discount |
|
|
14,390 |
|
|
|
— |
|
Payments of notes payable |
|
|
(844 |
) |
|
|
— |
|
Payments of convertible notes |
|
|
(7,200 |
) |
|
|
(1,500 |
) |
Proceeds from issuance of common stock, net of issuance cost |
|
|
— |
|
|
|
142 |
|
Net cash flows provided by (used in) financing activities |
|
|
7,046 |
|
|
|
(1,358 |
) |
Effect of exchange rate changes on cash |
|
|
(4 |
) |
|
|
(3 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
1,272 |
|
|
|
444 |
|
Cash and cash equivalents, beginning of period |
|
|
2,487 |
|
|
|
1,769 |
|
Cash and cash equivalents, end of period |
|
$ |
3,759 |
|
|
$ |
2,213 |
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
319 |
|
|
$ |
312 |
|
Income taxes paid |
|
$ |
5 |
|
|
$ |
— |
|
NON-CASH INVESTING AND FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Debt discount due to conversion features derivative |
|
$ |
5,555 |
|
|
$ |
— |
|
Debt discount due to warrant issued with debt |
|
$ |
— |
|
|
$ |
400 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
EMMAUS LIFE SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 — BASIS OF PRESENTATION
The accompanying unaudited consolidated interim financial statements of Emmaus Life Sciences, Inc., (“Emmaus”) and its direct and indirect consolidated subsidiaries (collectively, “we,” “our,” “us” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All significant intercompany transactions have been eliminated. The Company’s unaudited condensed consolidated interim financial statements contain adjustments, including normal recurring accruals necessary to fairly state the Company’s consolidated financial position, results of operations and cash flows. The consolidated interim financial statements should be read in conjunction with the Annual Report on Form 10-K/A for the year ended December 31, 2020 (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on August 10, 2021. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited consolidated balance sheet at December 31, 2020 contained in the Form 10-K/A. The results of operations for the three months ended March 31, 2021, are not necessarily indicative of the results to be expected for the full year or any future interim period.
Organization and Nature of Operations
The Company is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sales of innovative treatments and therapies primarily for rare and orphan diseases. On July 17, 2019, we completed a merger transaction with EMI Holding, Inc., formerly known as Emmaus Life Sciences, Inc. (“EMI”), into a subsidiary of the Company (the “Merger”), with EMI surviving the Merger as a wholly owned subsidiary. Immediately after completion of the Merger, we changed our name to “Emmaus Life Sciences, Inc.”
Principles of consolidation—The consolidated financial statements include the accounts of Emmaus and its direct and indirect consolidated subsidiaries. All significant intercompany transactions have been eliminated.
The preparation of the consolidated financial statements requires the use of management estimates that affect the reported amounts of assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses for the reported period. Actual results could differ materially from those estimates.
NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Company’s Annual Report on Form 10K/A for the year ended December 31, 2020. There have been no material changes in these policies or their application.
Management has considered all recent accounting pronouncements will not have a material effect on the Company’s condensed consolidated financial statements.
Factoring accounts receivables — The Company entered into a factoring agreement with Prestige Capital Finance, LLC on February 22, 2021. Under the agreement, the Company may factor its accounts receivables of up to 70% of the face value with maximum outstanding balance of $7.5 million and the fee ranges between 2.25% and 7.25% depending on the period when customers pay the outstanding accounts receivables. The Company had no factoring accounts receivables outstanding as of March 31, 2021. For three month ended March 31, 2021, the Company incurred approximately $31,000 of factoring fees.
Net loss per share — In accordance with ASC 260, “Earnings per Share,” the basic loss per common share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding. Dilutive loss per share is computed in a manner similar to basic loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. As of March 31, 2021 and March 31, 2020, the Company had outstanding potentially dilutive securities exercisable for or convertible into 24,515,738 shares and 16,698,829 shares, respectively, of the Company’s common stock. No potentially dilutive securities were included in the calculation of diluted net income per share since the potential dilutive securities were out of the money for the period ended March 31, 2020 and were anti-dilutive for period ended March 31, 2021.
7
NOTE 3 — REVENUES
Revenues disaggregated by category were as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
Endari® |
|
$ |
5,176 |
|
|
$ |
6,714 |
|
Other |
|
|
159 |
|
|
|
240 |
|
Revenues, net |
|
$ |
5,335 |
|
|
$ |
6,954 |
|
The following table summarizes the revenue allowance and accrual activities for the three months ended March 31, 2021 and March 31, 2020 (in thousands):
|
|
Trade Discounts, Allowances and Chargebacks |
|
|
Government Rebates and Other Incentives |
|
|
Returns |
|
|
Total |
|
Balance as of December 31, 2020 |
|
$ |
134 |
|
|
$ |
2,119 |
|
|
$ |
473 |
|
|
$ |
2,726 |
|
Provision related to sales in the current year |
|
|
575 |
|
|
|
864 |
|
|
|
57 |
|
|
|
1,496 |
|
Adjustments related prior period sales |
|
|
14 |
|
|
|
2 |
|
|
|
(37 |
) |
|
|
(21 |
) |
Credit and payments made |
|
|
(281 |
) |
|
|
(792 |
) |
|
|
— |
|
|
|
(1,073 |
) |
Balance as of March 31, 2021 |
|
$ |
442 |
|
|
$ |
2,193 |
|
|
$ |
493 |
|