UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended
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.:
(Exact name of Registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip code) |
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Trading Symbol(s) |
Name of each exchange on which registered |
None |
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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.
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).
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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
The registrant had
EMMAUS LIFE SCIENCES, INC.
For the Quarterly Period Ended March 31, 2023
TABLE OF CONTENTS
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Part I. Financial Information |
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Item 1. |
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(a) Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Part II Other Information |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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Item 1. Financial Statements
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
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As of |
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March 31, 2023 |
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December 31, 2022 |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Equity method investment |
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Right of use assets |
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Investment in convertible bond |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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CURRENT LIABILITIES |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Operating lease liabilities, current portion |
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Conversion feature derivative, notes payable |
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Other current liabilities |
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Warrant derivative liabilities |
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Notes payable, current portion, net of discount |
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Notes payable to related parties |
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Convertible notes payable, net of discount |
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Total current liabilities |
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Operating lease liabilities, less current portion |
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Other long-term liabilities |
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Notes payable, less current portion |
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Notes payable to related parties, net |
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Convertible notes payable to related parties |
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— |
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Total liabilities |
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STOCKHOLDERS’ DEFICIT |
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Preferred stock, par value $ |
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— |
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Common stock, par value $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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Total stockholders’ deficit |
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( | ) |
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Total liabilities & stockholders’ deficit |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
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Three months Ended March 31, |
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2023 |
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2022 |
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REVENUES, NET |
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$ |
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$ |
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COST OF GOODS SOLD |
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GROSS PROFIT |
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OPERATING EXPENSES |
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Research and development |
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Selling |
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General and administrative |
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Total operating expenses |
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LOSS FROM OPERATIONS |
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( | ) |
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( | ) |
OTHER INCOME (EXPENSE) |
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Change in fair value of warrant derivative liabilities |
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Change in fair value of conversion feature derivative, notes payable |
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Realized loss on investment in convertible bond |
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— |
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Net loss on equity method investment |
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Foreign exchange loss |
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Interest and other income |
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Interest expense |
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Total other income (expense) |
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LOSS BEFORE INCOME TAXES |
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Income tax provision (benefit) |
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( |
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NET LOSS |
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COMPONENTS OF OTHER COMPREHENSIVE LOSS |
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Unrealized gain (loss) on debt securities available for sale (net of tax) |
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Reclassification adjustment for gain included in net income |
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— |
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Foreign currency translation adjustments |
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Other comprehensive income (loss) |
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( |
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COMPREHENSIVE LOSS |
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$ |
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$ |
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NET LOSS PER COMMON SHARE - BASIC AND DILUTED |
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$ |
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$ |
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WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
(In thousands, except share and per share amounts)
(Unaudited)
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders' |
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Shares |
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Amount |
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capital |
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income (loss) |
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deficit |
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deficit |
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Balance, January 1, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Change in fair value of warrants including down-round protection adjustments |
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— |
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— |
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— |
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( | ) |
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— |
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Convertible notes converted to shares |
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— |
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— |
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Warrants issued for services |
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— |
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— |
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— |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gain on debt securities available for sale (net of tax) |
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— |
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— |
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— |
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— |
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Foreign currency translation effect |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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Balance, March 31, 2023 |
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( | ) |
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( | ) |
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders' |
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Shares |
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Amount |
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capital |
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income (loss) |
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deficit |
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deficit |
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Balance January 1, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gain on debt securities available for sale (net of tax) |
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— |
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— |
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— |
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— |
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Reclassification adjustment for gain included in net income |
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— |
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— |
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— |
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— |
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Foreign currency translation effect |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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Balance, March 31, 2022 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
EMMAUS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Three months Ended March 31, |
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2023 |
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2022 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
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$ |
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$ |
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Adjustments to reconcile net loss to net cash flows used in operating activities |
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Depreciation and amortization |
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Inventory reserve |
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— |
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Amortization of discount of notes payable and convertible notes payable |
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Foreign exchange adjustments |
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Tax benefit recognized on unrealized gain on debt securities |
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— |
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( |
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Realized loss on investment on convertible bond |
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— |
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Loss on equity method investment |
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Share-based compensation |
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Fair value of warrants issued for services |
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— |
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Change in fair value of warrant derivative liabilities |
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( |
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Change in fair value of conversion feature derivative, notes payable |
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Changes in fair value option instrument |
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— |
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Net changes in operating assets and liabilities |
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Accounts receivable |
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Inventories |
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Prepaid expenses and other current assets |
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Other non-current assets |
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Accounts payable and accrued expenses |
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Other current liabilities |
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( |
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Other long-term liabilities |
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( |
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Net cash flows used in operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Sale of convertible bond |
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— |
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Purchase of property and equipment |
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Loan to equity method investee |
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Net cash flows provided by (used in) investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Proceeds from notes payable issued, net of issuance cost |
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Proceeds from notes payable issued, related parties |
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Proceeds from convertible notes payable issued, related party |
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— |
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Payments of notes payable |
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— |
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Payments of notes payable, related party |
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— |
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Net cash flows provided by financing activities |
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Effect of exchange rate changes on cash |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period |
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$ |
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$ |
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SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES |
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Interest paid |
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$ |
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$ |
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Income taxes paid |
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$ |
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$ |
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NON-CASH INVESING AND FINANCING ACTIVITIES |
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Renewal of notes payable including interests capitalized |
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$ |
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$ |
— |
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Conversion of convertible note payable to common stock |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
EMMAUS LIFE SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 — BASIS OF PRESENTATION
The accompanying unaudited condensed 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”) on the basis that the Company will continue as a going concern. 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 condensed consolidated interim financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023. The accompanying condensed consolidated balance sheet at December 31, 2022 has been derived from the audited consolidated balance sheet at December 31, 2022 contained in the Annual Report. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year or any future interim period.
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. The Company’s lead product Endari® (prescription grade L-glutamine oral powder) is approved by the U.S. Food and Drug Administration, or FDA, and in certain foreign markets to reduce the acute complications of sickle cell disease (“SCD”) in adult and pediatric patients five years of age and older.
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 Annual Report. There have been no material changes in these policies or their application.
Going concern— The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. The Company incurred a net loss of $
Management has considered all recent accounting pronouncements and determined that they will not have a material effect on the Company’s condensed consolidated financial statements.
Factoring accounts receivable — Emmaus Medical, Inc., or Emmaus Medical, the Company's indirect wholly owned subsidiary, has entered into a purchase and sales agreement with Prestige Capital Finance, LLC or Prestige Capital, pursuant to which Emmaus Medical may offer and sell to Prestige Capital from time to time eligible accounts receivable in exchange for Prestige Capital’s down payment, or advance, to Emmaus Medical of
5
receivable and other current liabilities included approximately $
Net loss per share — In accordance with Accounting Standard Codification (“ASC”) 260, “Earnings per Share,” the basic net loss per common share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding. Dilutive net loss per share is computed in a similar manner, except that the denominator is increased to include the number of additional shares of common stock 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, 2023 and March 31, 2022, the Company had outstanding potentially dilutive securities exercisable for or convertible into
Recent Accounting Pronouncement - Effective
NOTE 3 — REVENUES
Revenues disaggregated by category were as follows (in thousands):
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Three months ended March 31, |
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2023 |
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2022 |
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Endari® |
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$ |
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$ |
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Other |
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Revenues, net |
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$ |
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$ |
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The following table summarizes the revenue allowance and accrual activities for the three months ended March 31, 2023 and March 31, 2022 (in thousands):
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Trade Discounts, Allowances and Chargebacks |
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Government Rebates and Other Incentives |
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Returns |
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Total |
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Balance as of December 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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Provision related to sales in the current year |
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Adjustments related to prior period sales |
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( |
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|
|
— |
|
|
|
( | ) |
|
Credits and payments made |
|
|
( |
) |
|
|
( |
) |
|
|
( | ) |
|
|
( |
) |
Balance as of March 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Balance as of December 31, 2021 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Provision related to sales in the current year |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Adjustments related to prior period sales |
|
|
( | ) |
|
|
|
|
|
( |
) |
|
$ |
( |
) |
|
Credits and payments made |
|
|
( |
) |
|
|
( |
) |
|
|
( | ) |
|
$ |
( |
) |
Balance as of March 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
6
The following table summarizes revenues attributable to each of our customers that accounted for 10% or more of our net revenues in any of the periods shown:
|
|
Three months ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Customer A |
|
|
% |
|
|
% |
||
Customer B |
|
|
% |
|
|
% |
||
Customer C |
|
|
% |
|
|
% |
||
Customer D |
|
|
% |
|
|
% |
||
Customer E |
|
|
% |
|
|
% |
||
Customer F |
|
|
% |
|
|
% |
On June 15, 2017, the Company entered into a distributor agreement with Telcon RF Pharmaceutical, Inc., or Telcon, pursuant to which it granted Telcon exclusive rights to the Company’s prescription grade L-glutamine (“PGLG”) oral powder for the treatment of diverticulosis in South Korea, Japan and China in exchange for Telcon’s payment of a $
NOTE 4 — SELECTED FINANCIAL STATEMENT — ASSETS
Inventories consisted of the following (in thousands):
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Raw materials and components |
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
||
Inventory reserve |
|
( | ) |
|
|
( | ) |
Total inventories, net |
$ |
|
|
$ |
|
Prepaid expenses and other current assets consisted of the following (in thousands):
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Prepaid insurance |
$ |
|
|
$ |
|
||
Prepaid expenses |
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
||
Total prepaid expenses and other current assets |
$ |
|
|
$ |
|
Property and equipment consisted of the following (in thousands):
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Equipment |
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
||
Total property and equipment |
|
|
|
|
|
||
Less: accumulated depreciation |
|
( |
) |
|
|
( |
) |
Total property and equipment, net |
$ |
|
|
$ |
|
During the three months ended March 31, 2023 and 2022, depreciation expense was approximately $
7
NOTE 5 — INVESTMENTS
Investment in convertible bond - On September 28, 2020, the Company entered into a convertible bond purchase agreement pursuant to which it purchased at face value a convertible bond of Telcon in the principal amount of approximately $
Concurrent with the purchase of the convertible bond, the Company entered into an agreement dated
The investment in convertible bond is classified as an available for sale security and remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other comprehensive loss. The fair value and any changes in fair value in the convertible bond is determined using a binominal lattice model. The model produces an estimated fair value based on changes in the price of the underlying common stock over successive periods of time.
In February 2022, the Company and Telcon agreed to settle a “target shortfall” under the revised API agreement with Telcon for the years ended 2020 and 2021 by exchanging KRW
The following table sets forth the fair value and changes in fair value of the investment in the Telcon convertible bond as of March 31, 2023 and December 31, 2022 (in thousands):
Investment in convertible bond |
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Balance, beginning of period |
|
$ |
|
|
$ |
|
||
Sales of convertible bond |
|
|
— |
|
|
|
( |
) |
Net loss on investment on convertible bond |
|
|
— |
|
|
|
( |
) |
Change in fair value included in the statement of other comprehensive income |
|
|
( |
) |
|
|
( |
) |
Balance, end of period |
|
$ |
|
|
$ |
|
The fair value as of March 31, 2022 and December 31, 2022 was based upon following assumptions:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Principal outstanding (South Korean won) |
|
KRW |
|
|
KRW |
|
||
Stock price |
|
KRW |
|
|
KRW |
|
||
Expected life (in years) |
|
|
|
|
|
|
||
Selected yield |
|
|
% |
|
|
% |
||
Expected volatility (Telcon common stock) |
|
|
% |
|
|
% |
||
Risk-free interest rate (South Korea government bond) |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
— |
|
|
|
— |
|
Conversion price |
|
KRW |
|
|
KRW |
|
Equity method investment – During 2018, the Company and Japan Industrial Partners, Inc., or JIP, formed EJ Holdings, Inc., or EJ Holdings, to acquire, own and operate an amino acids manufacturing facility in Ube, Japan. In connection with the formation, the Company invested approximately $
8
made an unsecured loan to EJ Holdings in the amount of $
EJ Holdings is engaged in seeking to refurbish and phase in the Ube facility with objective of eventually obtaining regulatory clearance for the manufacture of PGLG in accordance with cGMP. EJ Holdings has had no substantial revenues since its inception, has depended on loans from the Company to acquire the Ube facility and fund its operations and will continue to be dependent on loans from the Company or other financing unless and until its plant is activated and it can secure customers, including the Company, for its products. There is no assurance the Company can continue to provide needed funding EJ Holdings, or that needed funding will be available from other source. EJ Holdings has no commitments or understandings regarding any additional funding. If EJ Holdings fails to obtain needed funding, it may need to suspend activities at the Ube plant. Under the asset purchase agreement by which EJ Holdings purchased the Ube plant, the seller has the right to repurchase the plant at the purchase price, plus certain taxes, paid by EJ Holdings if the plant does not become operational within a reasonable period of time (not to exceed five years). In such event, it is likely that the Company would lose some or all of its investment.
The Company has determined that EJ Holdings is a variable interest entity, or VIE, based upon its dependence on loan financing provided by the Company to acquire the Ube facility and to carry on EJ Holdings’ activities and that the EJ Holdings’ activities are principally for the Company’s benefit. JIP, however, owns
The Company’s share of the losses reported by EJ Holdings are classified as net losses on equity method investment. The investment is evaluated for impairment if facts and circumstances indicate that the carrying value may not be recoverable, an impairment charge would be recorded.
The following table sets forth certain unaudited financial information of EJ Holdings for the three months ended March 31, 2023 and 2022 (in thousands):
|
3 Month Ended March 31, |
|
|||||
|
2023 |
|
|
2022 |
|
||
Revenue, net |
$ |
|
|
$ |
|
||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
9
N
Accounts payable and accrued expenses consisted of the following at March 31, 2023 and December 31, 2022 (in thousands):
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Accounts payable: |
|
|
|
|
|
|
||
Clinical and regulatory expenses |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Selling expenses |
|
|
|
|
|
|
||
Manufacturing costs |
|
|
|
|
|
|
||
Non-employee board member compensation |
|
|
|
|
|
|
||
Other vendors |
|
|
|
|
|
|
||
Total accounts payable |
|
|
|
|
|
|
||
Accrued interest payable, related parties |
|
|
|
|
|
|
||
Accrued interest payable |
|
|
|
|
|
|
||
Accrued expenses: |
|
|
|
|
|
|
||
Payroll expenses |
|
|
|
|
|
|
||
Government rebates and other rebates |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Total accrued expenses |
|
|
|
|
|
|
||
Total accounts payable and accrued expenses |
|
$ |
|
|
|
|
Other current liabilities consisted of the following at March 31, 2023 and December 31, 2022 (in thousands):
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Trade discount |
$ |
|
|
$ |
|
||
Unearned revenue (a) |
|
|
|
|
|
||
Other current liabilities |
|
|
|
|
|
||
Total other current liabilities |
$ |
|
|
$ |
|
(a)
Other long-term liabilities consisted of the following at March 31, 2023 and December 31, 2022 (in thousands):
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Trade discount |
$ |
|
|
$ |
|
||
Other long-term liabilities |
|
|
|
|
|
||
Total other long-term liabilities |
$ |
|
|
$ |
|
On June 12, 2017, the Company entered into an API Supply Agreement with Telcon pursuant to which Telcon advanced to the Company approximately $
NOTE 7 — NOTES PAYABLE
Notes payable consisted of the following at March 31, 2023 and December 31, 2022 (in thousands except for number of underlying shares):
10
Year |
|
Interest Rate |
|
Term of Notes |
|
Conversion |
|
|
Principal |
|
|
Unamortized Discount March 31, 2023 |
|
|
Carrying |
|
|
Underlying Shares March 31, 2023 |
|
|||||
Notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
2013 |
|
|
|
|
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
— |
|
||||
2021 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2022 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||||
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
Notes payable - related parties |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
2020 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2021 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2022 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
(c) |
|
— |
|
|||||
2023 |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
— |
|
|||
|
|
|
|
Non-current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
Convertible notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
2020 |
|
|
|
$ |
|
(a) |
|
|
|
|
— |
|
|
|
|
|
|
|
||||||
2021 |
|
|
|
$ |
|
(b) |
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|||||
Convertible notes payable - related parties |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
2023 |
|
|
|
$ |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
|
||||
|
|
|
|
Non-current |
|
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
|
||||
|
|
|
|
Total |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
Year |
|
Interest Rate |
|
Term of Notes |
|
Conversion |
|
|
Principal |
|
|
Unamortized |
|
|
Carrying |
|
|
Underlying Shares |
|
|||||
Notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
2013 |
|
|
|
|
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
— |
|
||||
2021 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2022 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
$ |
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
|
|
|
|
Non-current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
Notes payable - related parties |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
2020 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2021 |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||||
2022 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
(c) |
|
— |
|
|||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
|
— |
|
|||
|
|
|
|
Non-current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
— |
|
||||
Convertible notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
2020 |
|
|
|
$ |
|
(a) |
|
|
|
|
— |
|
|
|
|
|
|
|
||||||
2021 |
|
|
|
$ |
|
(b) |
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|||||
|
|
|
|
Current |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|||||
|
|
|
|
Grand Total |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
11
The weighted-average stated annual interest rate of notes payable was
As of March 31, 2023, future contractual principal payments due on notes payable were as follows (in thousands):
Year Ending |
|
|
|
|
2023 (nine months) |
$ |
|
(a) |
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2027 |
|
|
|
|
Total |
$ |
|
|
On February 9, 2021, the Company entered into a securities purchase agreement pursuant to which the Company agreed to sell and issue to the purchasers thereunder in a private placement pursuant to Rule 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D thereunder a total of up to $
Commencing one year from the original issue date, the convertible promissory notes became convertible at the option of the holder into shares of the Company’s common stock at an initial conversion price of $
The conversion feature of the convertible promissory notes is separately accounted for at fair value as a derivative liability under guidance in ASC 815 that is remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value of the conversion feature liability recorded in the condensed consolidated statements of operations.
Convertible promissory notes |
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Balance, beginning of period |
|
$ |
|
|
$ |
|
||
|
|
( |
) |
|
|
( |
) |
|
Balance, end of period |
|
$ |
|
|
$ |
|
The fair value and any change in fair value of conversion feature liability are determined using a binominal lattice model. The model produces an estimated fair value based on changes in the price of the underlying common stock.
The fair value as of March 31, 2023 and December 31, 2022 was based upon following assumptions:
Convertible promissory notes |
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Stock price |
|
$ |
|
|
$ |
|
||
Conversion price |
|
$ |
|
|
$ |
|
||
Selected yield |
|
|
% |
|
|
% |
||
Expected volatility |
|
|
% |
|
|
% |
||
Time until maturity (in years) |
|
|
|
|
|
|
||
Dividend yield |
|
— |
|
|
— |
|
||
Risk-free rate |
|
|
% |
|
|
% |
In June 2022, the Company entered into a Business Loan and Security Agreement and Addenda with a third-party lender pursuant to which the lender loaned the Company $
12
proceeds of approximately $
In July 2022, Dr. Niihara, a Director and the Chairman, and Chief Executive Officer of the Company, and his wife loaned the Company $
In August 2022, Dr. Niihara and his wife loaned the Company $
In September 2022, Seah Lim, M.D., Ph.D., a Director of the Company, loaned the Company $
In July 2022, the Company's Emmaus Medical subsidiary, entered into a Standard Merchant Cash Advance Agreement with a third party pursuant to which it sold $
In December 2022, the Company entered an Agreement for the Purchase and Sales of Future Receipts with a third party pursuant to which it sells $
In January 2023, Wei Pei Zen, a Director of the Company, loaned the Company $
In February 2023, the Company entered into a promissory note agreement with a third party pursuant to which the lender loaned the Company $
In March 2023, Dr. Niihara and his wife and Hope International Hospice, Inc. loaned the Company $
In March 2023, Emmaus Medical entered into Revenue Purchase Agreement with third party pursuant to which it sold and assigned $
13
Except as otherwise indicated above, the proceeds of the foregoing loans and other arrangements were used to augment the Company's working capital.
NOTE 8 — STOCKHOLDERS’ DEFICIT
Warrants —In September 2022, in connection with the loans from Dr. Niihara and Mrs. Niihara, the Company granted Dr. Niihara a
Warrant issued for services - On January 12, 2023, the Company granted Dr. Niihara a
On January 12, 2023, the Company granted to each of two consultants to the company
The following table presents the assumptions used to value the most recent warrants granted by the Company.
|
|
January 2023 |
Stock price |
|
$ |
Exercise price |
|
$ |
Expected term |
|
|
Risk-free rate |
|
|
Dividend yield |
|
— |
Volatility |
|
A summary of outstanding warrants as of March 31, 2023 and December 31, 2022 is presented below:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||||||||||
|
|
Number of |
|
|
Weighted‑ |
|
|
Number of |
|
|
Weighted‑ |
|
||||
Warrants outstanding, beginning of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Cancelled, forfeited or expired |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Warrants outstanding, end of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Warrants exercisable end of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
As of March 31, 2023, the weighted-average remaining contractual life of outstanding warrants was
Stock options— The Company's former 2011 Stock Incentive Plan permitted grants of incentive stock options to employees, including executive officers, and other share-based awards such as stock appreciation rights, restricted stock, stock units, stock bonus and unrestricted stock awards to employees, directors, and consultants for up to
14
other option grants vest over a minimum period of
The Company also formerly had an Amended and Restated 2012 Omnibus Incentive Compensation Plan under which the Company could grant incentive stock options and non-qualified stock option to selected employees including officers, non-employee consultants and non-employee directors. The Plan was terminated in September 2021.
On September 29, 2021, the Board of Directors of the Company adopted the Emmaus Life Sciences, Inc. 2021 Stock Incentive Plan upon the recommendation of the Compensation Committee of the Board of Directors. The 2021 Stock Incentive Plan was approved by stockholders on November 23, 2021. No more than
Management has valued stock options at their date of grant utilizing the Black-Scholes-Merton Option pricing model. The fair value of the underlying shares was determined by the market value of the Company's stock. The expected volatility was adjusted using the historical volatility of the Company and a comparative public traded companies.
|
|
January 12, 2023 |
|
|
Stock Price |
|
$ |
|
|
Exercise Price |
|
$ |
|
|
Expected term |
|
|
||
Risk-Free Rate |
|
|
||
Dividend Yield |
|
— |
|
|
Volatility |
|
|
A summary of outstanding stock options as of March 31, 2023 and December 31, 2022 is presented below.
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||||||||||
|
|
Number of |
|
|
Weighted‑ |
|
|
Number of |
|
|
Weighted‑ |
|
||||
Options outstanding, beginning of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted or deemed granted |
|
|
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
||
Exercised |
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
Cancelled, forfeited and expired |
|
|
( |
) |
|
$ |
|
|
|
( |
) |
|
$ |
|
||
Options outstanding, end of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options exercisable, end of period |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options available for future grant |
|
|
|
|
|
|
|
|
|
|
|
|
During three months ended March 31, 2023 and March 31, 2022, the Company recognized approximately $
Amended and Restated Warrants – The Company evaluated its outstanding amended and restated warrants to purchase up to
15
In January 2023, the exercise price of outstanding amended and restated warrants was reduced to $
NOTE 9 — INCOME TAX
The quarterly provision for or benefit from income taxes is computed based upon the estimated annual effective tax rate and the year-to-date pre-tax income (loss) and other comprehensive income.
NOTE 10 — LEASES
Operating leases — The Company leases its office space under operating leases with unrelated entities.
The Company leases
The lease expense during the three months ended March 31, 2023 and 2022 was approximately $
Future minimum lease payments under the lease agreements were as follows as of March 31, 2023 (in thousands):
|
|
Amount |
|
|
2023 (nine months) |
|
$ |
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Total lease payments |
|
|
|
|
Less: Interest |
|
|
|
|
Present value of lease liabilities |
|
$ |
|
As of March 31, 2023, the Company had an operating lease right-of-use asset of $
NOTE 11 — COMMITMENTS AND CONTINGENCIES
API Supply Agreement — On June 12, 2017, the Company entered into an API Supply Agreement (the “API Agreement”) with Telcon pursuant to which Telcon paid the Company approximately $
16
NOTE 12 — RELATED PARTY TRANSACTIONS
The following table sets forth information relating to loans from related parties outstanding at any time during the three months ended March 31, 2023 (in thousands):
Class |
Lender |
|
Interest |
|
Date of |
|
Term of Loan |
|
Principal Amount Outstanding at March 31, 2023 |
|
|
Highest |
|
|
Amount of |
|
|
Amount of |
|
||||
Promissory note payable to related parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Willis Lee(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Wei Peu Derek Zen(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Willis Lee(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Seah Lim(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
|
|
|
|
|
|
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Convertible notes payable - related parties |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Wei Peu Derek Zen(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
|
|
|
|
|
|
Subtotal |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
|
|
|
|
|
|
|
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
17
The following table sets forth information relating to loans from related parties outstanding at any time during the year ended December 31, 2022:
Class |
Lender |
|
Interest |
|
Date of |
|
Term of Loan |
|
Principal Amount Outstanding at December 31, 2022 |
|
|
Highest |
|
|
Amount of |
|
|
Amount of |
|
||||
Current, Promissory note payable to related parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Willis Lee(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Soomi Niihara(1) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
Yasushi Nagasaki(2) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
George Sekulich(2) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
Soomi Niihara(1) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Wei Peu Derek Zen(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Willis Lee(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||||
|
Hope International Hospice, Inc.(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Yutaka and Soomi Niihara(1) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Seah Lim(2) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
Hope International Hospice, Inc. |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|||||
|
|
|
|
|
|
|
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Revolving line of credit agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Yutaka Niihara(2) |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
Subtotal |
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
See Notes 6 and 11 for a discussion of the Company’s agreements with Telcon, which holds
18
NOTE 13 — SUBSEQUENT EVENTS
See Note 11 for information relating to our revised API agreement with Telcon, which provides for target annual revenue of more than US$
After March 31, 2023, $
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
In the following discussion, the terms, “we,” “us,” “our,” “Emmaus” or the “Company” refer to Emmaus Life Sciences, Inc. and its direct and indirect subsidiaries.
Forward-Looking Statements
This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023 (the “Annual Report”).
This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than historical facts contained in this report, including statements regarding our future financial position, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations are forward-looking statements. The words “anticipate,” “believe,” “expect,” “plan,” “intend,” “seek,” “estimate,” “project,” “could,” “may” and similar expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow. Such statements reflect our management’s current views with respect to future events and financial performance and involve risks and uncertainties, including those set forth in the “Risk Factors” section of the Annual Report, many of which are beyond our control.
Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all forward-looking statements made in this Form 10-Q are qualified by these cautionary statements. We undertake no duty to amend or update these statements beyond what is required by SEC reporting requirements.
Company Overview
We are a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, primarily for rare and orphan diseases. Our lead product, Endari® (prescription-grade L-glutamine oral powder) is approved by the U.S. Food and Drug Administration, or FDA, to reduce the acute complications of sickle cell disease (“SCD”), in adult and pediatric patients five years of age and older. In April 2022, Endari® was approved by the Ministry of Health and Prevention in the United Arab Emirates, or U.A.E, in adults and pediatric patients five years of age and older. In November and December of 2022, we received marketing authorizations for Endari® in Qatar and Kuwait, respectively. Applications for marketing authorization in other Gulf Cooperation Council, or GCC, countries are pending. While the applications are pending, the FDA approval of Endari® can be referenced to allow access to Endari® on a named-patient basis.
Endari® is marketed and sold in the U.S. by our internal commercial sales team. Endari® is reimbursable by the Centers for Medicare and Medicaid Services, and every state provides coverage for Endari® for outpatient prescriptions to all eligible Medicaid enrollees within their state Medicaid programs. Endari® is also reimbursable by many commercial payors. We have agreements in place with the nation’s leading distributors as well as physician group purchasing organizations and pharmacy benefits managers, making Endari® available at selected retail and specialty pharmacies nationwide. In April 2022, we launched a telehealth solution to afford SCD patients’ direct access to Endari® remotely through a web portal managed by our strategic partners, including Asembia LLC, US Bioservices Corporation and UpScript IP Holdings, LLC.
As of March 31, 2023, our accumulated deficit was $255.9 million and we had cash and cash equivalents of $1.8 million. We expect net revenues to increase as we expand our commercialization of Endari® in the U.S. and the Middle East North Africa, or MENA, region. Until we can generate sufficient net revenues from Endari® sales, our future cash requirements are expected to be financed through loans from related parties, third-party loans, public or private equity or debt financings or possible corporate collaboration and licensing arrangements. We are unable to predict if or when we will become profitable.
Financial Overview
Revenues, net
We realize net revenues primarily from sales of Endari® to our distributors and specialty pharmacy providers. Distributors resell our products to other pharmacy and specialty pharmacy providers, health care providers, hospitals, and clinics. In addition to agreements with these distributors, we have contractual arrangements with specialty pharmacy providers, in-office dispensing providers, physician group purchasing organizations, pharmacy benefits managers and government entities that provide for government-mandated or privately negotiated rebates, chargebacks and discounts with respect to the purchase of our products. These
20
various discounts, rebates, and chargebacks are referred to as “variable consideration.” Revenue from product sales is recorded net of variable consideration.
Under the Accounting Standards Codification (“ASC”) 606, we recognize revenue when our customers obtain control of our product, which typically occurs on delivery. Revenue is recognized in an amount that reflects the consideration that we expect to receive in exchange for the product, or transaction price. To determine revenue recognition for contracts with customers within the scope of ASC 606, we perform the following: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligations.
Management estimates variable consideration using the expected-value amount method, which is the sum of probability-weighted amounts in a range of possible transaction prices. Actual variable consideration may differ from our estimates. If actual results vary from the estimates, we adjust the variable consideration in the period such variances become known, which adjustments are reflected in net revenues in that period. The following are our significant categories of variable consideration:
Sales Discounts: We provide our customers prompt payment discounts and additional discounts to encourage bulk orders to generate needed working capital. Sales at bulk discounts offered by us increased in late 2021 and adversely affected sales in the three months ended March 31, 2022.
Product Returns: We offer our distributors a right to return product principally based upon (i) overstocks, (ii) inactive product or non-moving product due to market conditions, and (iii) expired product. Product return allowances are estimated and recorded at the time of sale.
Government Rebates: We are subject to discount obligations under state Medicaid programs and the Medicare Part D prescription drug coverage gap program. We estimate Medicaid and Medicare Part D prescription drug coverage gap rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenues are recognized, resulting in a reduction of product revenues and the establishment of a current liability that is included as accounts payable and accrued expenses on our balance sheet. Our liability for these rebates consists primarily of estimates of claims expected to be received in future periods related to recognized revenues.
Chargebacks and Discounts: Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to certain specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities at prices lower than the list prices charged to distributors. The distributors charge us for the difference between what they pay for the products and our contracted selling price to these specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities. In addition, we have contractual agreements with pharmacy benefit managers who charge us for rebates and administrative fee in connection with the utilization of product. These reserves are established in the same period that the related revenues are recognized, resulting in a reduction of revenues. Chargeback amounts are generally determined at the time of resale of product by our distributors.
Cost of Goods Sold
Cost of goods sold consists primarily of expenses for raw materials, packaging, shipping, and distribution of Endari®.
Research and Development Expenses
Research and development expenses consist of expenditures for new products and technologies consisting primarily of fees paid to contract research organizations (“CRO”) that conduct clinical trials of our product candidates, payroll-related expenses, study site payments, consultant fees and other related costs. The costs of later-stage clinical studies such as Phase 2 and 3 trials are generally higher than those of earlier studies. This is primarily due to the larger size, expanded scope, patient related healthcare and regulatory compliance costs, and generally longer duration of later-stage clinical studies.
Our contracts with CROs are generally based on time and materials expended, whereas study site agreements are generally based on costs per patient as well as other pass-through costs, including start-up costs and institutional review board fees. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones.
Future research and development expenses will depend on any new product candidates or technologies that we may introduce into our research and development pipeline. In addition, we cannot predict which product candidates may be subject to future
21
collaborations, when such arrangements will be secured, if at all, and to what degree, if any, such arrangements would affect our development plans and capital requirements.
Due to the inherently unpredictable nature of the drug approval process and applicable regulatory requirements, we are unable to estimate the amount of costs of obtaining regulatory approvals of Endari® outside of the U.S. or the development of our other preclinical and clinical programs. Clinical development timelines, the probability of success and development costs can differ materially from expectations and can vary widely. These and other risks and uncertainties relating to product development are described in the Annual Report under the headings “Risk Factors—Risks Related to Our Business” and “Risk Factors—Risks Related to Regulatory Oversight of our Business and Compliance with Law.”
General and Administrative Expense
General and administrative expense consists principally of salaries and related employee costs, including share-based compensation for our directors, executive officers, and employees. Other general and administrative expense includes facility costs, and professional fees and expenses for audit, legal, consulting, and tax services.
Selling Expenses
Selling expenses consist principally of salaries and related costs for personnel involved in the promotion, sales, and marketing of Endari®. Other selling cost include advertising, third party consulting costs, the cost of in-house sales personnel and travel-related costs. We expect selling expenses to increase as we acquire additional sales personnel to support the commercialization of Endari® in the U.S. and abroad.
COVID-19
In retrospect, we believe our business and net revenues were adversely affected in 2020 and 2021 by lockdowns, travel-related restrictions and other governmental responses to the pandemic related to the COVID 19 pandemic which inhibited the ability of our sales force to visit doctors’ offices and clinics and may have adversely affected the willingness of SCD patients to seek the care of a physician or to comply with physician-prescribed care. Ongoing COVID-19 infections or future official responses could cause a temporary or prolonged decline in our revenues and have a material adverse effect on our results of operations and financial condition. COVID-19 or governmental responses also may adversely affect the timing and conduct of clinical studies or the ability of regulatory bodies to consider or grant approvals with respect to Endari® or our prescription grade L-glutamine, or PGLG, drug candidates or oversee the development of our drug candidates, may further divert the attention and efforts of the medical community to coping with COVID-19 or variants and disrupt the marketplace in which we operate. For example, we experienced a temporary disruption in 2020 in patient enrollment in our Pilot/Phase I study of PGLG oral powder in diverticulosis. Any outbreak of COVID-19 among our executives or key employees or their families and loved ones could disrupt our management and operations and adversely affect the effectiveness of our management, Endari® sales, and results of operations and financial condition. The foregoing factors could also have an adverse effect on economic and business conditions and the broad stock market, in general, or the market price of our common stock, in particular. We intend to consider changes to our business to adapt to the new post-pandemic environment, including an increased focus on our telehealth solution.
Inflation
Inflation has not had a material impact on our expenses or results of operations over the past two years, but may result in increased manufacturing, research and development, general and administrative and selling expenses in the foreseeable future.
Environmental Expenses
The cost of compliance with environmental laws has not been material over the past two years and any such costs are included in general and administrative costs.
Inventories
Inventories consist of raw materials, finished goods and work-in-process and are valued on a first-in, first-out basis and at the lower of cost or net realizable value. Substantially all raw materials purchased during each of the three months ended March 31, 2023 and 2022 were supplied by one supplier.
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Results of Operations:
Three months ended March 31, 2023 and 2022
Net Revenues. Net revenues increased by $3.5 million, or 109%, to $6.7 million for the three months ended March 31, 2023, compared to $3.2 million for the three months ended March 31, 2022. The increase was primarily attributable to a recovery in U.S. sales and a $1.4 million increase in net revenues in the Middle East and Africa ("MENA") region in 2023 compared to the same period in 2022.
Cost of Goods Sold. Cost of goods sold decreased by $0.6 million, or 57%, to $0.4 million for the three months ended March 31, 2023, compared to $1.0 million for the three months ended March 31, 2022. This decrease was primarily due to the establishment of an additional reserve relating to Endari® inventory with a shelf-life of less than two years for the three months ended March 31, 2022 compared to no additional reserve made to the same period in 2023.
Research and Development Expenses. Research and development expenses decreased by 0.2 million, or 38%, to $0.3 million for the three months ended March 31, 2023, compared to $0.5 million for the three months ended March 31, 2022. The decrease was primarily due to completion of the sub-study under our Pilot/Phase 1 study of PGLG in diverticulosis in 2022.
Selling Expenses. Selling expenses increased by $0.9 million, or 59%, to $2.3 million for the three months ended March 31, 2023, compared to $1.5 million for the three months ended March 31, 2022. The increase was primarily due to increases in consulting fees.
General and Administrative Expenses. General and administrative expenses increased by $1.5 million, or 45%, to $4.9 million for the three months ended March 31, 2023, compared to $3.4 million for the three months ended March 31, 2022. The increase was primarily due to a $1.2 million increase in share-based compensation.
Other Income (Expense). Total other expense increased by $3.7 million, or 263%, to $2.3 million for the three months ended March 31, 2023, compared to $1.4 million of other income for the three months ended March 31, 2022. The increase was primarily due to a decrease of $3.0 million in change in fair value of embedded conversion option of convertible promissory notes, and an $0.8 million increase in interest expense.
Net Loss. Net loss increased by $2.0 million, or 129%, to a net loss of $3.5 million for the three months ended March 31, 2023, compared to net loss of $1.5 million for the three months ended March 31, 2022. The increase was primarily a result of an increase of $3.7 million in other expense, partially offset by a decrease of $1.9 million in loss from operations.
Liquidity and Capital Resources
Based on our losses to date, current liabilities and anticipated future net revenues and operating expenses, debt repayment obligations, anticipated continued funding of EJ Holdings and cash and cash equivalents balance of $1.8 million as of March 31, 2023, we do not have sufficient operating capital for our business without raising additional capital. We realized a net loss of $3.5 million for the three months ended March 31, 2023 and anticipate that we will continue to incur net losses for the foreseeable future and until we can generate increased net revenues from Endari® sales. While we anticipate increased net revenues as we continue to expand our commercialization of Endari® in the U.S. and in the MENA region, there is no assurance that we will be able to increase our Endari® sales or attain sustainable profitability or that we will have sufficient capital resources to fund our operations until we are able to generate sufficient cash flow from operations.
Our subsidiary, Emmaus Medical, Inc., or Emmaus Medical, is party a purchase and sale agreement with Prestige Capital Finance, LLC, or Prestige Capital, pursuant to which Emmaus Medical may offer and sell to Prestige Capital from time to time eligible accounts receivable in exchange for Prestige Capital’s down payment, or advance, to Emmaus Medical of 75% of the face amount of the accounts receivable, subject to a $7,500,000 cap on advances at any time. The balance of the face amount of the accounts receivable will be reserved by Prestige Capital and paid to Emmaus Medical, less discount fees of Prestige Capital ranging from 2.25% to 7.25% of the face amount, as and when Prestige Capital collects the entire face amount of the accounts receivable.
Liquidity represents our ability to pay our liabilities when they become due, fund our business operations, fund the operations and retrofitting of EJ Holdings’ amino acid production plant in Ube, Japan, and meet our contractual obligations, including our obligations to purchase API under our supply arrangements with Telcon, and execute our business plan. Our primary sources of liquidity are our cash balances at the beginning of each period, net revenues, proceeds from our accounts receivable factoring arrangement with Prestige Capital and similar sales of future receipts to other parties, proceeds from related-party loans and other financing activities. Our short-term and long-term cash requirements consist primarily of working capital requirements, general corporate needs, our contractual obligations to purchase API from Telcon, debt service under our convertible notes payable and notes
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payable and planned ongoing loan funding to sustain EJ Holdings’ operations. We have no contractual commitment to provide funding to EJ Holdings, but plan to continue to do so in the foreseeable to the extent we have cash available for this purpose.
As of March 31, 2023, we had outstanding $17.8 million principal amount of convertible promissory notes and $14.4 million principal amount of other notes payable. Our minimum lease payment obligations were $3.1 million, of which $0.7 million was payable within 12 months.
Our API supply agreement with Telcon provides for an annual API purchase target of $5 million and a target “profit” (i.e., gross margin) to Telcon of $2.5 million. To the extent these targets are not met, Telcon may be entitled to payment of the shortfall or to offset the shortfall against the Telcon convertible bond and proceeds thereof that are pledged as collateral to secure our obligations. With our consent in February 2022 Telcon retained cash collateral and made offsets against the outstanding balance of our Telcon convertible bond for shortfalls under the API supply agreement for 2020 and 2021.
Due to uncertainties regarding our ability to meet our current and future operating and capital expenses, there is substantial doubt about our ability to continue as a going concern for 12 months from the date that this condensed consolidated financial statements are issued, as referred to in the “Risk Factors” section of this Quarterly Report and Note 2 of the Notes to condensed consolidated financial statements included herein.
Cash flows for the three months ended March 31, 2023 and March 31, 2022
Net cash used in operating activities
Net cash used in operating activities decreased by $3.4 million, or 73%, to $1.3 million for the three months ended March 31, 2023 from $4.7 million for the three months ended March 31, 2022. This decrease was primarily due to a decrease of $1.9 million in loss from operations resulting from a $3.5 million increase in net revenues partially offset by a $1.5 million increase in operating expenses.
Net cash provided by (used in) investing activities
Net cash used in investing activities decreased by $2.3 million, or 189%, to $1.1 million for the three months ended March 31, 2023 from $1.2 million net cash provided by investing activities for the three months ended March 31, 2022. The decrease was primarily due to proceeds of $2.9 million from the deemed sale in the first quarter of 2022 of a portion of the Telcon convertible bond, resulting from the offset of target shortfalls under our revised API Agreement with Telcon against our trade discount.
Net cash from financing activities
Net cash from financing activities increased by $0.1 million, or 4%, to $2.1 million for the three months ended March 31, 2023 from $2.0 million for the three months ended March 31, 2022. This increase was the result of $0.7 million proceeds received from issuance of promissory notes and convertible notes partially offset by $0.5 million used to repay promissory notes in 2023.
Off-Balance-Sheet Arrangements
We have no off-balance sheet arrangements.
Critical Accounting Estimates
Management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of certain assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the present circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates.
Refer to “Critical Accounting Policies” in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the Annual Report for our critical accounting policies. There have been no material changes in any of our critical accounting policies during the three months ended March 31, 2023.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not required for a smaller reporting company.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (“DCP”) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. DCP include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is accumulated and communicated to our management, including our principal executive and financial officers, as appropriate to allow timely decisions regarding required disclosures.
As of the end of the period covered by this Form 10-Q, we conducted an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our DCP. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that the Company’s DCP were not effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2023 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Previously Identified Material Weakness
As previously reported, in connection with the preparation of our consolidated financial statements as of December 31, 2021, our management identified ongoing material weaknesses (the “Material Weaknesses”) in our internal control over financial reporting. The Material Weaknesses related to inadequate financial closing process, segregation of duties, including access control over information technology, especially financial information, inadequate documentation of policies and procedures over risk assessments, internal control and significant account processes, and insufficient entity risk assessment processes.
Since identifying the Material Weaknesses, we took several steps to remediate the Material Weaknesses, including:
More recently, in 2022 we completed the implementation of an integrated cloud-based enterprise resource planning system to manage our financial information and replace our outdated financial accounting systems and software. Management does not believe, however, that these deficiencies materially affect the accuracy of our financial statements.
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Part II. Other Information
Item 1. Legal Proceedings
Not applicable.
Item 1A. Risk Factors
The following should be read in conjunction with the “Risk Factors” section of the Annual Report.
The Company’s consolidated financial statements included in this Quarterly Report have been prepared on the basis that the Company will continue as a going concern. The Company incurred a net loss of $3.5 million for the three months ended March 31, 2023 and had a working capital deficit of $50.4 million at March 31, 2023. Management expects that the Company’s current liabilities and operating expenses, including the expected costs relating to the commercialization of Endari® in the Middle East North Africa region and elsewhere, will exceed our existing cash balances and cash expected to be generated from operations for the foreseeable future. To meet the Company’s current liabilities and operating expenses, the Company will need to restructure or refinance its existing indebtedness and raise additional funds through related-party loans, third-party loans, equity and debt financings or licensing or other strategic agreements. The Company has no understanding or arrangement to restructure or refinance its indebtedness or for any additional financing, and there can be no assurance that the Company will be able to restructure or refinance its existing indebtedness or complete any additional equity or debt financings on favorable terms, or at all, or enter into licensing or other strategic arrangements. If the Company is unable to do so, it may need to curtail business activities unrelated to the marketing and sale of Endari® or seek to restructure the Company in bankruptcy. Due to the uncertainty of the Company’s ability to meet its current liabilities and operating expenses, there is substantial doubt about the Company’s ability to continue as a going concern for 12 months from the date that this condensed consolidated financial statements are issued. The consolidated financial statements included in this Quarterly Report do not include any adjustments that might result from the outcome of these uncertainties.
Successful sales of Endari® depend on the availability of adequate coverage and reimbursement from third-party payors and governmental healthcare programs, such as Medicare and Medicaid. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse all or a significant part of the costs associated with their prescription drugs. Coverage determination depends on financial, clinical and economic outcomes that often disfavors new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Although Endari® is reimbursable by the Centers for Medicare and Medicaid Services, and every state provides coverage for Endari® for outpatient prescriptions to all eligible Medicaid enrollees within their state Medicaid programs, the reimbursement amounts are subject to change and may not be adequate and may require higher co-payments that patients find unacceptable. Patients are unlikely to use Endari® unless reimbursement is adequate to cover a significant portion of the cost of Endari®. Future coverage and reimbursement will likely be subject to increased pressure in the U.S. Third-party coverage and reimbursement for Endari® may cease to be available or adequate in the U.S., which could have a material adverse effect on our business, results of operations, financial condition, and prospects.
In addition, the market for Endari® will depend significantly on access to third-party payors’ drug formularies, which are lists of medications for which third-party payors provide coverage and reimbursement. The competition in the industry to be included in such formularies may lead to downward pricing pressures on us. Also, third-party payors may refuse to include Endari® in their formularies or otherwise restrict patient access to Endari® if a less costly generic equivalent or other alternative treatment is available.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On January 12, 2023, the Board of Directors (the “Board”) of the Company granted to Yutaka Niihara, M.D., M.P.H., the Company’s Chairman of the Board and Chief Executive Officer, a five-year warrant to purchase up to 7,500,000 shares of common stock of the Company at an exercise price of $4.50 a share, subject to adjustment in the event of a stock split, reverse stock split and similar events. The Board also granted to each of two consultants to the company five-year warrants to purchase up to 250,000 shares of common stock at an exercise price of $0.50 a share, subject to adjustment in the event of a stock split, reverse stock split and similar events. The warrants vested in full upon the grant date. The warrants were granted without registration under the Securities Act of 1933, as amended, in reliance on the exemptions from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Rule 506(c) of Regulation D under the Act.
On January 18, 2023, one of our directors loaned us $1 million in exchange for a convertible promissory note of the Company in the principal amount of $1 million. The convertible promissory note is due on demand after one year from the date of issuance until two years from such date, bears interest at the annual rate of 10%, payable quarterly, and is convertible at the option of
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the holder into shares of our common stock at a conversion price of $0.50 a share, subject to adjustment in the event of a stock split, reverse stock split and similar events.
On January 27, 2023, the Company issued a five-year warrant to purchase 500,000 shares of its common stock at an exercise price of $0.47 a share, subject to adjustment in the event of a stock split, reverse stock split and similar events, to a consulting firm in exchange for consulting services rendered to the Company.
The foregoing convertible promissory note and warrants were issued without registration under the Securities Act of 1933, as amended, in reliance on the exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), for transactions not involving a public offering.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
(a) Exhibits
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Incorporated by Reference |
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Exhibit Number |
Exhibit Description |
Form |
File No. |
Exhibit |
Filing Date |
Filed/ |
4.1 |
Form of Common Stock Purchase Warrants dated as of January 11, 2023 |
8-K |
001-35527 |
4.1 |
March 7, 2023 |
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4.2 |
8-K |
001-35527 |
4.2 |
March 7, 2023 |
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4.3 |
8-K |
001-35527 |
4.3 |
March 7, 2023 |
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4.4 |
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* |
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10.1 |
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* |
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10.2 |
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* |
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10.3 |
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* |
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10.4 |
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* |
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10.5 |
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* |
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10.6 |
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* |
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31.1 |
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* |
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31.2 |
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* |
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32.1 |
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** |
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101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Filed herewith.
** This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
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EMMAUS LIFE SCIENCES, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Emmaus Life Sciences, Inc. |
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Dated: May 12, 2023 |
By: |
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/s/ Yutaka Niihara |
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Name: |
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Yutaka Niihara, M.D., M.P.H. |
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Its: |
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Chief Executive Officer |
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By: |
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/s/ Yasushi Nagasaki |
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Name: |
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Yasushi Nagasaki |
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Its: |
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Chief Financial Officer |
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