0000822370 false 0000822370 2023-11-14 2023-11-14 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 14, 2023

 

Emmaus Life Sciences, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-35527   87-0419387
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification No.)

 

21250 Hawthorne Boulevard, Suite 800, Torrance, CA   90503
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code (310) 214-0065

 

 

(Former name or former address, if changed, since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))

 

Securities registered pursuant to Section 12(b) of the Act: 

 

Title of each class   Trading Symbol   Name of each exchange on which registered
None        

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

 Item 2.02 Results of Operation and Financial Condition.

 

On November 14, 2023, Emmaus Life Sciences, Inc. issued a press release announcing the results of operations and financial condition for the quarter ended September 30, 2023, a copy of which is included as Exhibit 99.1 to this Current Report and incorporated herein by reference.

 

The information included in this Item 2.02 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (“Exchange Act”) 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 Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

See the accompanying Index to Exhibits, which information is incorporated herein by reference.

 

1

 

 

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 hereunto duly authorized.

 

Date: November 14, 2023 Emmaus Life Sciences, Inc.
     
  By: /s/ YASUSHI NAGASAKI
    Name:  Yasushi Nagasaki
    Title: Chief Financial Officer

 

2

 

 

INDEX TO EXHIBITS

 

Exhibit Number   Description
99.1   November 14, 2023 press release
104   Cover Page Interactive Date File (embedded within Inline XBRL document)

 

 

3

 

Exhibit 99.1 

 

 

 

Emmaus Life Sciences Reports Q3 2023 Financial Results

 

Torrance CA, November 14, 2023 - Emmaus Life Sciences, Inc. (OTCQX: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported on its financial condition and results of operations as of and for the three and nine months ended September 30, 2023.

 

Recent Highlights

 

“We experienced lower net revenues in the third quarter compared to the second quarter due to a shortage of finished inventory of Endari, which has been remedied, and we expect our sales to recover in this quarter. Even so, we were able to generate modest net income as we curtailed spending on activities unrelated to Endari sales,” remarked Willis Lee, Chairman of the Board and Co-president of Emmaus.

 

Financial and Operating Results

 

Net Revenues. Net revenues for the three months and nine months ended September 30, 2023 were $5.0 million and $22.5 million, respectively, compared to $4.9 million and $12.5 million, respectively, for same periods in 2022. The increased net revenues were primarily attributable to increased net revenues from sales in the Middle East North Africa (MENA) region, as well as increased U.S. sales compared to the same periods in 2022.

 

Operating Expenses. Total operating expenses for the three months ended September 30, 2023 were $4.8 million, compared with $5.1 million for the same period in 2022 due primarily to reduced general and administrative expenses. Total operating expenses for the nine months ended September 30, 2023 were $19.2 million, compared with $15.7 million for the same period in 2022. The increase was due to increases of $1.2 million in share-based compensation, $0.9 million in professional fees and $0.7 million in transaction costs.

 

Income From Operations. Income from operations for the three months ended September 30, 2023 was $0.02 million, compared to a loss from operations of $0.7 million in the same period in 2022. Income from operations for the nine months ended September 30, 2023 increased to $2.2 million, compared to a loss from operations of $5.2 million for the same period last year. The increase resulted from higher new revenues in 2023 compared to 2022.

 

Other Income (Expense). The company realized other income of $0.08 million for the three months ended September 30, 2023, compared to $0.2 million of other expense in the same period in 2022. Other expense for the nine months ended September 30, 2023 increased to $7.1 million from $5.6 million in the same period in 2022 due primarily to an increase of $1.7 million in interest expenses and a decrease of $1.1 million in change in fair value of conversion feature derivative, partially offset by a $1.9 million decrease in foreign exchange loss compared to Q3 2022.

 

 

 

 

Net Income (Loss). For the quarter, the company realized net income of $0.1 million, or $0.00 per share based on approximately 53.6 million weighted average basic common shares and a net loss of $0.01 per share based on approximately 138.4 million weighted average diluted common shares. This compares to a net loss of $0.4 million, or $0.01 per share based on approximately 49.6 million weighted average basic and diluted common shares for the third quarter of 2022. The decrease in net loss was primarily attributable to the increase in income from operations and decrease in other expenses discussed above.

 

For the nine months ended September 30, 2023, the company reported a net loss of $4.9 million, or $0.09 per share, based on approximately 52.4 million weighted average basic and diluted common shares. This compares to a net loss of $10.8 million, or $0.22 per share, based on approximately 49.4 million weighted average basic and diluted common shares for the nine months ended September 30, 2022. The decrease was primarily due to the increase in net revenues of $10.1 million, partially offset by the increase of $3.5 million in operating expenses and $1.5 million in other expenses.

 

Liquidity and Capital Resources. At September 30, 2023, the company had cash and cash equivalents of $1.5 million, compared with $2.0 million on December 31, 2022.

 

About Emmaus Life Sciences

 

Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. Endari® (L-glutamine oral powder), indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older, is approved for marketing in the United States, Israel, Kuwait, Qatar, the United Arab Emirates, Bahrain and Oman and is available on a named patient or early access basis in France, the Netherlands, and the Kingdom of Saudi Arabia, where Emmaus’ application for marketing authorization is awaiting final action by the Saudi Food & Drug Authority. For more information, please visit www.emmausmedical.com.

 

About Endari® (prescription grade L-glutamine oral powder)

 

Endari®, Emmaus’ prescription grade L-glutamine oral powder, was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older.

 

Indication

 

Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.

 

Important Safety Information

 

The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.

 

Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.

 

The safety and efficacy of Endari® in pediatric patients with sickle cell disease younger than five years of age has not been established.

 

For more information, please see full Prescribing Information of Endari® at: www.ENDARIrx.co/PI.

 

2

 

 

About Sickle Cell Disease

 

There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual’s red blood cells to distort into a “C” or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.2

 

Forward-looking Statements

 

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the trend in sales in the MENA region and in the U.S. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company’s need for related-party loans or other financing to meet its current liabilities and fund its business and operations and other factors disclosed in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and most recent Quarterly Reports on Form 10-Q, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law.

 

Company Contact:

 

Emmaus Life Sciences, Inc.

Willis Lee

Chairman and Co-president

(310) 214-0065, Ext. 1130

[email protected]

 

(Financial Tables Follow)

 

 

 

 

1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020.
2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020.

 

3

 

 

Emmaus Life Sciences, Inc.

Condensed Consolidated Statement of Operations and Comprehensive Income Loss

(In thousands, except share and per share amounts) (Unaudited)

 

   Three Months Ended
September 30
   Nine Months Ended
September 30
 
   2023   2022   2023   2022 
Revenues, Net  $5,018   $4,939   $22,530   $12,460 
Cost of Goods Sold   214    540    1,151    1,943 
Gross Profit   4,804    4,399    21,379    10,517 
Operating Expenses   4,780    5,059    19,194    15,685 
Income (Loss) from Operations   24    (660)   2,185    (5,168)
Total Other Income (Expenses)   81    234    (7,074)   (5,613)
Net Income (Loss)    67    (391)   (4,942)   (10,825)
Comprehensive Loss   (1,322)   (2,957)   (3,826)   (16,475)
Net Income (Loss) Per Share - Basic  $0.00   $(0.01)  $(0.09)  $(0.22)
Net Loss Per Share - Diluted  $(0.01)  $(0.01)  $(0.09)  $(0.22)
Weighted Average Common Shares Outstanding - Basic   53,637,554    49,558,501    52,414,903    49,397,690 
Weighted Average Common Shares Outstanding - Diluted   138,375,065    49,558,501    52,414,903    49,397,690 

 

4

 

 

Emmaus Life Sciences, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

 

   As of 
   September 30,
2023
(Unaudited)
   December 31,
2022
 
Assets        
Current         
Assets:        
Cash and cash equivalents  $1,505   $2,021 
Accounts receivable, net   4,587    375 
Inventories, net   1,650    2,379 
Prepaid expenses and other current assets   1,515    1,514 
Total Current Assets   9,257    6,289 
Property and equipment, net   60    75 
Equity method investment   17,737    18,828 
Right of use assets   2,510    2,799 
Investment in convertible bond   17,596    19,971 
Other Assets   293    263 
Total Assets  $47,453   $48,225 
           
Liabilities and Stockholders’ Deficit          
Current Liabilities:          
Accounts payable and accrued expenses  $16,285   $13,549 
Conversion feature derivative, notes payable   1,251    3,248 
Notes payable, current portion   8,488    6,814 
Convertible notes payable, net of discount   15,819    14,655 
Other current liabilities   19,074    16,057 
Total Current Liabilities   60,917    54,323 
Notes payable, less current portion   156    380 
Other long-term liabilities   22,710    27,613 
Total Liabilities   83,783    82,316 
Stockholders’ Deficit   (36,330)   (34,091)
Total Liabilities & Stockholders’ Deficit  $47,453   $48,225 

 

 

5